A2_Influenza Sources Sought Notice.pdf

The Centers for Disease Control and Prevention (CDC) is issuing this sources sought synopsis as a means of conducting market research to identify parties having an interest in and the resources to support this requirement for Pre- and Post- Infulenza Human Sera Panels. The result of this market research will contribute to determining the method of procurement. The applicable North American Industry Classification System (NAICS) code assigned to this procurement is 621511 Testing Laboratories, Medical.

There is no solicitation at this time. This request for capability information does not constitute a request for proposals or quotes; submission of any information in response to this market survey is purely voluntary; the government assumes no financial responsibility for any costs incurred.

If your organization has the potential capacity to perform these contract services, please provide the following information: 1) organization name, address, email address, website address, telephone number, and size and type of ownership for the organization; and 2) tailored capability statements addressing the particulars of this effort, with appropriate documentation supporting claims of organizational and staff capability. If significant subcontracting or teaming is anticipated in order to deliver technical capability, organizations should address the administrative and management structure of such arrangements.

The government will evaluate market information to ascertain potential market capacity to 1) provide services consistent in scope and scale with those described in this notice and otherwise anticipated; 2) secure and apply the full range of corporate financial, human capital, and technical resources required to successfully perform similar requirements; 3) implement a successful project management plan that includes: compliance with program schedules; cost containment; meeting and tracking performance; hiring and retention of key personnel and risk mitigation; 4) provide services under a fixed unit price contract.

Based on the responses to this sources sought notice/market research, this requirement may be set-aside for small businesses or procured through full and open competition. Telephone inquiries will not be accepted or acknowledged, and no feedback or evaluations will be provided to companies regarding their submissions.

Submission Instructions: Interested parties who consider themselves qualified to perform the above-listed services are invited to submit a response to this Sources Sought Notice by 5:00 PM EDT on May 10, 2024. All responses under this Sources Sought Notice must be emailed to the Contract Specialist, Jennifer Gartzke, at xuy7@cdc.gov. If you have any questions concerning this opportunity, please contact the Contract Specialist.

Attachment 1 – Draft Statement of Work mailto:xuy7@cdc.gov

STATEMENT OF WORK

Title of Project: Pre and post Influenza Human Sera Panels

Period of Performance: August 1, 2024 - July, 31, 2029 Base Period: August 1, 2024 - July 31, 2025 Option Period One: August 1, 2025 - July 31, 2026 Option Period Two: August 1, 2026 - July 31, 2027 Option Period Three: August 1, 2027 - July 31, 2028 Option Period Four: August 1, 2028 - July 31, 2029

Section 1 Background and Need:

Influenza is a highly contagious respiratory disease and epidemics of influenza cause substantial morbidity and mortality worldwide. The Advisory Committee on Immunization Practices (ACIP) recommends influenza vaccination for all persons 6months of age and older who do not have contraindications. The seasonal influenza vaccine requires frequent updates due to the constant evolution of influenza viruses resulting in antigenic drift.

As a World Health Organization Collaborating Centers (WHO CC) for Reference and Research on Influenza and a member of the Global Influenza Surveillance Network, the Centers for Disease Control and Prevention (CDC) closely monitors the genetic and antigenic evolution of circulating influenza viruses. The five WHO CCs meet twice each year to recommend the virus strains composition for the upcoming season’s influenza vaccine. The meeting is held every February for the northern hemisphere influenza vaccine recommendations and every September for the southern hemisphere influenza vaccine recommendations. Epidemiological, genetic, antigenic, as well as serological data are critical in guiding vaccine recommendations.

CDC is seeking pre- and post- influenza immunization sera panels from six age cohorts, young pediatric (6 to 35months), older pediatric and adolescent (3 to 8years old and 9 to 17 years old), adult (18 to 49 years old), older adult (50 to 64 years old) and elderly (65 years or older) populations to determine if antibodies induced by the current influenza vaccine effectively inhibit currently circulating influenza viruses. The ability of antibodies in post-influenza vaccine serum samples to inhibit hemagglutination or to neutralize currently circulating influenza viruses is a measure of how effective the current vaccine will be at inducing protective antibodies against circulating influenza viruses.

All sera panels will be tested by hemagglutination inhibition (HI),microneutralizaiton (MN) assays and other immunological assays to evaluate the immune response induced by the current influenza vaccines to newly circulating viruses. HI and MN results will also be analyzed to compare the seroconversions or four-fold rise in titers between pre- and post-vaccination sera induced by the current influenza vaccine to titer response rises demonstrated against newly circulating viruses.

In addition, CDC is seeking large volume post-influenza immunization sera from adult donors for use in hemagglutination inhibition, virus neutralization, and other relevant immunological assays for antigenic characterization of virus isolates submitted to CDC for surveillance and characterization of immune responses following influenza vaccination.

Section 2 Purpose:

This contract is for the provision of anonymous serum samples from six age cohorts (young pediatric, older pediatric, adolescents, adult, older adults and elderly) with each individual providing blood prior to administration of the specified current, seasonal influenza vaccine (S1) and again 21-28 days after immunization (S2). For young pediatric populations (ages 6-35mo) and older pediatrics whom require two doses of influenza vaccines, the S2 blood will be collected 21-28 days after the second dose of influenza vaccine. Serum samples will be tested for vaccine-induced antibodies in order to determine if the current influenza vaccine strains induce protective levels of antibodies against newly circulating influenza virus strains.

This contract is also for the provision of large volume S2 samples from some of the adult participants for use in hemagglutination inhibition assays with virus isolates and characterization of immune responses following influenza vaccination.

Section 3 Scope of Work:

This is a five year contract (including options) for the provision of pre- and post- immunization serum samples from eligible young pediatric, older pediatric and adolescent, adult, older adult and elderly participants with the specified current, seasonal, influenza vaccines. All participants within each age panel cohort should receive the same vaccine. For each season, consult with CDC prior to finalizing the vaccines ordered and administered for each panel.

The contractor shall provide pre-and post-immunization serum samples from the below age panels:

1). 60 young pediatric participants (age 6 months to 35 months)

The 60 pediatric participants between the ages of 6 months and35 months must be healthy and eligible to receive the influenza vaccine for the first time. Infants and children with a prior history of vaccination or a prior history of laboratory confirmed influenza are excluded from participating. This cohort must receive the current licensed seasonal quadrivalent cell-based and /or egg-based influenza vaccine, as specified by CDC.

2). 60 older pediatric participants (age 3 years to 8 years) The 60 older pediatric participants between the ages of 3-8y must be healthy. 30 participants in this cohort must receive the current seasonal quadrivalent egg-based killed virus influenza vaccine and 30 participants in this cohort must receive the current licensed seasonal quadrivalent cell-based killed virus influenza vaccine, or other vaccine type as specified by

CDC.

3). 60 older pediatric/adolescent participants (age 9 years to 17 years) The 60 older pediatric/adolescent participants between the ages of 9 years to 17 years must be healthy. 30 participants in this cohort must receive the current seasonal quadrivalent egg-based killed virus influenza vaccine and 30 participants in this cohort must receive the current licensed seasonal quadrivalent cell-based killed virus influenza vaccine, or other vaccine type as specified by CDC.

4). 120 adult participants (age 18 years to 49 years) Adult participants must be between the ages of 18 years to 49 years and healthy.

• 40 participants in this cohort must receive the current seasonal egg-based killed virus influenza vaccine, or other vaccine type as specified by CDC.

• 40 participants in this cohort must receive the current licensed seasonal cell-based killed virus influenza vaccine, or other vaccine type as specified by CDC.

• 40 participants in this cohort must receive the current licensed seasonal recombinant vaccine, or other vaccine type as specified by CDC.

5). 30 older adult participants (age 50 years to 64 years) Older adult participants must be between the ages of 50 years to 64 years and healthy. This cohort must receive the current licensed seasonal egg-based killed virus influenza vaccine, or other vaccine type as specified by CDC.

6). 30 elderly participants (age 65 years and older) Elderly participants must be community dwelling, aged 65 years or older and healthy. This cohort must receive the current licensed seasonal high-dose egg-based killed virus influenza vaccine, or other vaccine type as specified by CDC.

In addition, anyone taking immune suppressing drugs or with a history of an immune compromising disease should be excluded from participation.

The contractor shall arrange for pre-immunization serum samples (S1) to be collected at the first visit followed by administration of the influenza vaccine.

For pediatric ages 9 years to 17 years, adult, older adult, and elderly participants, the contractor shall arrange for a post-immunization serum sample (S2) to be collected 21 to 28 days after the administration of the influenza vaccine.

For young pediatric participants ages 6 months to 35 months, and older pediatric participants age 3 years to 8 years whom require two doses according to recommendations of the ACIP, the contractor shall arrange for a second influenza vaccine to be given four weeks after the first vaccine and a post- immunization serum sample (S2) to be collected 21 to 28 days after administration of the second influenza vaccine dose.

For young pediatric participants ages 6 months to 35 months, the contractor shall arrange for the collection of approximately 5 ml of blood at each visit so that a minimum of 2.5 ml of serum is obtained. For older pediatric and adolescent participants ages 3 years to 17 years, the contractor shall arrange for the collection of approximately 10 ml of blood at each visit so that a minimum of 5 ml of serum is obtained. For older adult and elderly participants, the contractor shall arrange for the collection of approximately 20 ml of blood at each visit so that a minimum of 10 ml of serum is obtained.

For adult participants, the contractor shall arrange for the collection of approximately 100 ml of blood from the post-immunization sample (S2) from a total of 40 participants who received the egg-based vaccine, a total of 40 participants who received the cell-based vaccine, and a total of 40 participants who received the recombinant vaccine. This will allow for the collection of a minimum of 50 ml of serum.

The minimum acceptable sera volume criterion by age category is as follows:

• Pediatric (6 months to 35 months)= 2.5 ml

• Pediatric (3 years to 17 years)=5 ml

• Adult (18 years to 49 years)= 50 ml from 120 participants

• Older adult (50 years to 64 years) = 10 ml

• Elderly (65 years and older) = 10 ml

Participants in the same age panel should receive the same type of vaccines. With the increased number and types of influenza vaccines available on the market, CDC willspecify the types of influenza vaccines to be used for specific age panels and specific seasons. For each season, consult with CDC first prior to finalizing the vaccines ordered and administered for each panel.

For each participant, the contractor shall collect information on whether the participant received the prior seasonal influenza vaccine and whether the participant received the seasonal influenza vaccine within the last 2 years to 5 years. Contractor shall document whether the participant were enrolled in the same study in the prior season(s).

Section 4 Tasks to be Performed:

Independently, and not as an agent of the government, the contractor will provide all management, labor, facilities, materials (except as specified herein), supplies and equipment necessary to perform the following tasks:

a. Obtain Internal Review Board (IRB) approvals: The contractor shall prepare all required documentation, submit documentation as required, and track the IRB process and approvals for the project.

b. Order vaccine: The contractor shall order sufficient influenza vaccine specified in Section C.3 for the immunization of 60 young pediatric participants ages 6 months 35 months, 120 old pediatric and adolescent participants ages 3 years to 17 years, 120 adult participants, 30 older adults, and 30 elderly participants. The contractor shall place an early order for the vaccine so that delivery of the vaccine is expected in September. The contractor shall consult with CDC the specific vaccine that will be used for each age panel ahead of the order. CDC will specify the types of influenza vaccines to be used for specific age panels and specific seasons.

c. Enroll participants: The contractor shall randomly recruit participants eligible to receive the influenza vaccine.

• Young pediatric participants between the ages of 6 months to 35 months must be healthy, and eligible to receive influenza vaccine for the first time. Infants and children with a prior history or influenza vaccination or a prior history of laboratory confirmed influenza are excluded from participating.

• Older pediatric and adolescent participants between the ages of 3 years to 17 years must be healthy.

• Adult participants must be between the ages of 18 years to 49 years and healthy.

• Older adult participants must be between the ages of 50 years to 64 years and healthy. Elderly participants must be 65 years of age or older and community dwelling.

• Anyone taking immune suppressing drugs or with a history of immune compromising disease is excluded from participation. Recruits are to be anonymous. Adult participants donating 100 ml of S2 blood will be recruited as early in the study as possible.

d. Collect blood and administer vaccine:

Pediatric participants ages 6 months to 35 months: The contractor shall confirm eligibility for the study at the first visit to the clinic. Prior to administration of the vaccine, approximately 5 ml of blood shall be collected. Blood shall be collected from each participant in a collection tube designed for the collection of serum (refer to Attachment 1). The first dose of vaccine shall be administered after the blood is collected. An appointment shall be made for the infant/child to return in four weeks. At the second visit, the second dose of vaccine shall be administered and an appointment will be made for the infant/child to return in 21 to 28 days. At the third visit, approximately 5 ml of blood shall be collected from each participant in a collection tube designed for the collection of serum (refer to Attachment 1).

Older pediatric and adolescent participants ages 3 years to 17 years: The contractor shall confirm eligibility for the study at the first visit to the clinic. Prior to the administration of the vaccine, approximately 10 ml of blood shall be collected. Blood shall be collected from each participant in a collection tube designed for the collection of serum (refer to Attachment 1). The first dose of vaccine shall be administered after the blood is collected.

For those older pediatrics age 3 years to 8 years, that may require a second dose of vaccine based on ACIP recommendations, an appointment shall be made for the child to return in four weeks to receive the second dose. At the second visit, the second dose of vaccine shall be administered and an appointment shall be made for the infant/child to return in 21 to 28 days. At the third visit, approximately 10 ml of blood shall be collected from each participant in a collection tube designed for the collection of serum.

For those older pediatric and adolescent aged 9 years to17 years, an appointment shall be made for the participant to return in 21 to 28 days. At the second visit, approximately 10 ml of blood shall be collected from each participant in a collection tube designed for the collection of serum (refer to Attachment 1).

Adult, older adult, and elderly participants: The contractor shall confirm eligibility for the study at the first visit to the clinic. Prior to the administration of the vaccine, approximately 20 ml of blood shall be collected. Blood will be collected from each participant in a collection tube designed for the collection of serum (refer to Attachment 1). The first dose of vaccine shall be administered after the blood is collected.

An appointment shall be made for the participant to return in 21 to 28 days. At the second visit, for 40 adult participants receiving the egg-based vaccine, 40 adult participants receiving the cell-based vaccine, and 40 adult participants receiving the recombinant vaccine, the contractor shall collect a total of 100 ml of blood.

e. Process blood samples: The contractor shall collect serum specimens according to

CDC influenza serology specimen collection guidelines (Attachment 1). Use serum collection tubes specified in CDC protocol. After full clotting (normally 30 minuntes to 1 hour) is achieved, clotted blood should be centrifuged as soon as possible (ideally within 2 hours), to separate the clotted blood from the serum. After centrifugation, the serum shall be moved to a clean tube and aliquoted as described in Section C.4.f below. The clotted blood may be discarded.

f. Aliquot serum: All tubes containing serum shall be kept on ice during the process of aliquoting. Serum shall be aliquoted into Sarstedt tubes, catalog # 72.694.007 (or an equivalent tube agreed to by the Contracting Officer’s Representative). Each tube shall contain approximately 1.0 ml of serum. The S1 and S2 aliquots shall be labeled with separate unique identification numbers with labels provided by CDC. Multiple labels of each unique identification number will be provided so that aliquots originating from the same collection time are labeled with the same identification number.

i. Serum from pediatric participants (6 months to 35 months): For each collection time, there should be a minimum of 2.5 ml of serum obtained from the 5 ml of blood collected. Three aliquots shall be prepared. Two tubes containing 1 ml of sera and one tube containing a minimum of 0.5 ml of sera.

ii. Serum from pediatric participants (3 years to 17 years): For each collection time, there should be a minimum of 5 ml of serum obtained from the 10 ml of blood collected. Five aliquots shall be prepared. Each tube shall contain 1 ml of sera.

iii. Serum from 120 adult participants from whom 100 ml of blood was collected during the second visit: A minimum of 50 ml of serum should be obtained from the 100 ml of S2 blood collected. The serum shall be aliquoted into ten 1.0 ml aliquots, and the remaining serum for each donor shall be divided equally between two 50 ml conical tubes, Falcon catalog #352098 (or an equivalent tube agreed by Contracting Officer’s Representative).

iv. Serum from older adult and elderly participants: For each collection time, there should be a minimum of 10 ml of serum obtained from the 20 ml of blood collected. Ten 1.0 ml aliquots shall be prepared.

v. Serum samples shall be immediately stored at -20° C or colder after aliquoting.

g. Record keeping: Information for each serum sample shall be recorded on an Excel spreadsheet provided by CDC (refer to Attachment 2)

h. Shipment of serum samples to CDC: The contractor shall arrange for four shipments of serum samples to CDC. The dates and contents of each shipment are defined in Section C.10. All shipments shall be sent via overnight carrier to ensure delivery and receipt by the CDC Contracting Officer’s Representative (COR) within 24 hours of shipment. All serum shipments shall be packed with sufficient dry ice to ensure that samples remain frozen for a minimum of 72 hours after shipment. For each shipment, the COR and the designated laboratory contact shall be notified of the planned shipment dates and shall be sent the tracking information as soon as it is available. The contractor shall create an inventory list (excel spreadsheet) of the contents of each box of sera samples. The inventory Excel spreadsheet must contain:

a. CSID (from labels provided by CDC)

b. CUID (from labels provided by CDC)

c. Study subject number

d. Draw (S1 or S2)

e. Volume of aliquot

f. Box name

g. Absolute location in box

h. Site

i. Cohort

The inventory list (excel spreadsheet) must be emailed to the COR and the designated laboratory contact at the time of each shipment. A hardcopy of the excel spreadsheet shall be included with each shipment. Prior to shipment all identifying linkage must be stripped from the study spreadsheet. The contractor shall ensure the anonymity of each participant’s serum samples. Serum samples are to be sent to:

TBD

Section 5 Government Furnished Property:

CDC will provide the contractor with the labels to be used on the serum sample vials. CDC will also provide a copy of the Excel spreadsheet to be used for record keeping.

Section 6 Reporting Schedule and Special Considerations

Subsection A - Reporting Schedule

Monthly Progress Reports: The contractor shall submit monthly progress reports to the COR and the Contracting Officer (CO) by the 7th day of each month. Form, format, and content of reports shall be coordinated with the COR. It is anticipated that the progress reports for the months of July and August will be brief, but the progress reports for September, October, November, and December shall give a full accounting of the recruitment and sample collection to date. The reports shall be cumulative for the current influenza season. Each report shall list the number of participants, based on age category, for the current influenza vaccine season. The age categories shall be subdivided to indicate the number of individuals who have provided S1 and S2 serum samples.

Annual Report: By March 1 of each year, the contractor shall submit a draft annual report to the COR to document work performed during each contract year. Within 15 days of receipt, the COR will provide review comments to the contractor to be addressed and/or incorporated into the contractor’s final annual report. Form, format, and content of reports shall be coordinated with the COR. In addition, the contractor will be invited to include a narrative discussion of any changes that they recommend to enhance performance of any follow-up project for similar services.

SSubsection B - Special Considerations

Only clinics/laboratories with significant experience in performing human studies will be considered for award of this contract. Only clinics/laboratories with demonstrated access to patient populations in the pediatric, adult, and elderly age categories will be considered for award of this contract. Only clinics/laboratories that demonstrate the ability to adhere to the timelines defined in Section C.10 will be considered for award of this contract.

Section 7 Travel:

Travel will not be required for this contract.

a. Section 8 Deliverables:

Contract deliverables include four shipments of serum samples that together contain pre- and post-immunization samples from 360 individuals (60 pediatric ages 6 months to 35 months, 60 pediatric ages 3 years to 8 years, 60 pediatric ages 9 years to 17 years, 120 adult ages 18 years to 49 years, 30 older adult ages 50 years to 64 years, and 30 elderly ages 65 years or older, as described in sections 3 and 4), a completed Excel spreadsheet for sample submission, the designated Monthly Reports, and the Annual Report.

Schedule of Deliverables Base Period (8/1/2024-7/31/2025)

ITEM # DESCRIPTION QUANTITY DUE DATE

1 Manual of Procedures 1 electronic copy

02 September 2024

2 IRB Approval of collection site(s) 1 electronic copy 01 October 2024

3 Set-up of site(s), recruitment of participants 22 October 2024

4 Pediatric Study (6-35mo): One aliquot each of pre-immunization serum samples

60 @ 1 x 1.0 ml each 26 November 2024

5 Pediatric Study (6-35mo): One aliquot each of post-immunization serum samples

60 @ 1 x 1.0 ml each 26 November 2024

6 Pediatric Study (6-35mo): Remaining aliquots of pre-immunization serum samples

60 @ 1 x 1.0 ml each

60 @ 1 x 0.5 ml each

03 December 2023

7 Pediatric Study (6-35mo): Remaining aliquots of post-immunization serum samples

60 @ 1 x 1.0 ml each

60 @ 1 x 0.5 ml each

03 December 2023

8 Pediatric Study (3-8y): One aliquot each of pre-immunization serum samples

60 @ 1 x 1.0 ml each 26 November 2024

9 Pediatric Study (3-8y): One aliquot each of post-immunization serum samples

60 @ 1 x 1.0 ml each 26 November 2024

10 Pediatric Study (3-8y): Remaining aliquots of pre-immunization serum samples

60 @ 4 x 1.0 ml each 03 December 2024

11 Pediatric Study (3-8y): Remaining aliquots of post-immunization serum samples

60 @ 4 x 1.0 ml each 03 December 2024

12 Pediatric Study (9-17y): One aliquot each of pre-immunization serum samples

60 @ 1 x 1.0 ml each 26 November 2024

13 Pediatric Study (9-17y): One aliquot each of post-

60 @ 1 x 1.0 ml each 26 November 2024

14 Pediatric Study (9-17y): Remaining aliquots each of pre-immunization serum samples

60 @ 4 x 1.0 ml each 03 December 2024

15 Pediatric Study (9-17y): Remaining aliquots each of post-immunization serum samples

60 @ 4 x 1.0 ml each 03 December 2024

16 Adult Large Volume Donors: Two aliquots each of pre-immunization serum samples

120 @ 2 x 1.0 ml each 12 November 2024

17 Adult Large Volume Donors: Two aliquots each of post-immunization serum samples

120 @ 2 x 1.0 ml each 12 November 2024

18 Adult Large Volume Donors: One large aliquot each of post-immunization serum samples

120 @ 1 x 20.0 ml each 12 November 2024

19 Adult Large Volume Donors: Remaining aliquots of pre-immunization serum samples

120 @ 8 x 1.0 ml each 19 November 2024

20 Adult Large Volume Donors: Remaining small aliquots of post-immunization serum samples

120 @ 8 x 1.0 ml each 19 November 2024

21 Adult Large Volume Donors: Remaining large aliquot of post-immunization serum samples

120 @ 1 x 20.0 ml each 19 November 2024

22 Older adult: Two aliquots each of pre-immunization serum samples

30 @ 2 x 1.0 ml each 26 November 2024

23 Older adult: Two aliquots each of post-immunization serum samples

30 @ 2 x 1.0 ml each 26 November 2024

24 Older adult: Remaining aliquots of pre-immunization serum samples

30 @ 8 x 1.0 ml each 03 December 2024

25 Older adult: Remaining aliquots of post-immunization serum samples

30 @ 8 x 1.0 ml each 03 December 2024

26 Elderly: Two aliquots each of pre-immunization serum samples

30 @ 2 x 1.0 ml each 26 November 2024

27 Elderly: Two aliquots each of post-immunization serum samples

30 @ 2 x 1.0 ml each 26 November 2024

28 Elderly: Remaining aliquots of pre-immunization serum samples

30 @ 8 x 1.0 ml each 03 December 2024

29 Elderly: Remaining aliquots of post-immunization serum samples

30 @ 8 x 1.0 ml each 03 December 2024

1 First shipment: Due on or before November 12, 2024. This shipment shall be sent as soon as the 120 adult high volume donors S2 blood samples (i.e. 100 ml) have been collected. This first shipment shall contain: (1) Two 1.0 ml aliquots of the S1 adult samples and two 1.0 ml aliquots of the corresponding S2 adult high volume donor samples.

(2) One of the two S2 aliquots in the 50 ml tube from the adult high volume donor samples. If available, samples scheduled for the third and fourth shipments may be included in the first shipment.

1 Second shipment: Due on or before November 19, 2024. The second shipment shall contain: (1) The remaining eight 1.0 ml aliquots of the S1 sample and the remaining eight 1.0 ml aliquots of the corresponding S2 sample from the adult high volume donors samples. (2) The remaining S2 aliquot in the 50 ml tube from the adult high volume donor samples. If available, samples scheduled for the third and fourth shipments may be included in the second shipment.

1 Third shipment: Due on or before November 26, 2024 for subjects requiring one dose of vaccine and on or before December 3, 2024 for subjects requiring two doses of vaccine. The third shipment shall contain: (1) One 1.0 ml aliquot of the S1 and one 1.0 ml aliquot of the corresponding S2 pediatric (6-35mo)samples, (2) One 1.0 ml aliquot of the S1 and one 1.0 ml aliquot of the corresponding S2 older pediatric (3-8y) samples, (3) One 1.0 ml aliquot of the S1 and one 1.0ml aliquot of the corresponding S2 older pediatric (9-17y) samples (4) Two 1.0 ml aliquots of the S1 and two 1.0 ml aliquots of the corresponding S2 older adult (50-64y) samples, and (5) Two 1.0 ml aliquots of the S1 and two 1.0 ml aliquots of the corresponding S2 serum from elderly(65y+) participants.

1 Fourth shipment: Due on or before December 3, 2024. After the third shipment has been received, the remaining samples shall be sent as specified in table above.

Schedule of Deliverables Option Period 1 (8/1/2025-7/31/2026):

1 Manual of Procedures 1 electronic copy 01 September 2025

2 IRB Approval of collection site(s) 1 electronic copy 01 October 2025

3 Set-up of site(s), recruitment of participants 21 October 2025

4 Pediatric Study (6-35mo): One aliquot each of pre-immunization serum samples

60 @ 1 x 1.0 ml each 25 November 2025

5 Pediatric Study (6-35mo): One aliquot each of post-immunization serum samples

60 @ 1 x 1.0 ml each 25 November 2025

6 Pediatric Study (6-35mo): Remaining aliquots of pre-immunization serum samples

60 @ 1 x 1.0 ml each

60 @ 1 x 0.5 ml each

02 December 2025

7 Pediatric Study (6-35mo): Remaining aliquots of post-immunization serum samples

60 @ 1 x 1.0 ml each

60 @ 1 x 0.5 ml each

02 December 2025

8 Pediatric Study (3-8y): One aliquot each of pre-immunization serum samples

60 @ 1 x 1.0 ml each 25 November 2025

9 Pediatric Study (3-8y): One aliquot each of post-immunization serum samples

60 @ 1 x 1.0 ml each 25 November 2025

10 Pediatric Study (3-8y): Remaining aliquots of pre-immunization serum samples

60 @ 4 x 1.0 ml each 02 December 2025

11 Pediatric Study (3-8y): Remaining aliquots of post-immunization serum samples

60 @ 4 x 1.0 ml each 02 December 2025

12 Pediatric Study (9-17y): One aliquot each of pre-immunization serum samples

60 @ 1 x 1.0 ml each 25 November 2025

13 Pediatric Study (9-17y): One aliquot each of post-immunization serum samples

60 @ 1 x 1.0 ml each 25 November 2025

14 Pediatric Study (9-17y): Remaining aliquots each of pre-immunization serum samples

60 @ 4 x 1.0 ml each 02 December 2025

15 Pediatric Study (9-17y): Remaining aliquots each of post-immunization serum samples

60 @ 4 x 1.0 ml each 02 December 2025

16 Adult Large Volume Donors: Two aliquots each of pre-immunization serum samples

120 @ 2 x 1.0 ml each 11 November 2025

17 Adult Large Volume Donors: Two aliquots each of post-immunization serum samples

120 @ 2 x 1.0 ml each 11 November 2025

18 Adult Large Volume Donors: One large aliquot each of post-immunization serum samples

120 @ 1 x 20.0 ml each 11 November 2025

19 Adult Large Volume Donors: Remaining aliquots of pre-immunization serum samples

120 @ 8 x 1.0 ml each 18 November 2025

20 Adult Large Volume Donors: Remaining small aliquots of post-immunization serum samples

120 @ 8 x 1.0 ml each 18 November 2025

21 Adult Large Volume Donors: Remaining large aliquot of post-immunization serum samples

120 @ 1 x 20.0 ml each 18 November 2025

22 Older adult: Two aliquots each of pre-immunization serum samples

30 @ 2 x 1.0 ml each 25 November 2025

23 Older adult: Two aliquots each of post-immunization serum samples

30 @ 2 x 1.0 ml each 25 November 2025

24 Older adult: Remaining aliquots of pre-immunization serum samples

30 @ 8 x 1.0 ml each 02 December 2025

25 Older adult: Remaining aliquots of post-immunization serum samples

30 @ 8 x 1.0 ml each 02 December 2025

26 Elderly: Two aliquots each of pre-immunization serum samples

30 @ 2 x 1.0 ml each 25 November 2025

27 Elderly: Two aliquots each of post-immunization serum samples

30 @ 2 x 1.0 ml each 25 November 2025

28 Elderly: Remaining aliquots of pre-immunization serum samples

30 @ 8 x 1.0 ml each 02 December 2025

29 Elderly: Remaining aliquots of post-immunization

30 @ 8 x 1.0 ml each 02 December 2025

1 First shipment: Due on or before November 11, 2025. This shipment shall be sent as soon as the 120 adult high volume donors S2 blood samples (i.e. 100 ml) have been collected. This first shipment shall contain: (1) Two 1.0 ml aliquots of the S1 adult samples and two 1.0 ml aliquots of the corresponding S2 adult high volume donor samples.

(2) One of the two S2 aliquots in the 50 ml tube from the adult high volume donor samples. If available, samples scheduled for the third and fourth shipments may be included in the first shipment.

1 Second shipment: Due on or before November 18, 2025. The second shipment shall contain: (1) The remaining eight 1.0 ml aliquots of the S1 sample and the remaining eight 1.0 ml aliquots of the corresponding S2 sample from the adult high volume donors samples. (2) The remaining S2 aliquot in the 50 ml tube from the adult high volume donor samples. If available, samples scheduled for the third and fourth shipments may be included in the first shipment.

1 Third shipment: Due on or before November 25, 2025. The third shipment shall contain: (1) One 1.0 ml aliquot of the S1 and one 1.0 ml aliquot of the corresponding S2 pediatric (6-35mo)samples, (2) One 1.0 ml aliquot of the S1 and one 1.0 ml aliquot of the corresponding S2 older pediatric (3-8y) samples, (3) One 1.0 ml aliquot of the S1 and one 1.0ml aliquot of the corresponding S2 older pediatric (9-17y) samples (4) Two 1.0 ml aliquots of the S1 and two 1.0 ml aliquots of the corresponding S2 older adult (50-64y) samples, and (5) Two 1.0 ml aliquots of the S1 and two 1.0 ml aliquots of the corresponding S2 serum from elderly(65y+) participants.

1 Fourth shipment: Due on or before December 02, 2025. After the third shipment has been received, the

Option Period 2 : 8/1/2026-7/31/2027

ITEM # DESCRIPTION QUANTITY DUE DATE

1 Manual of Procedures 1 electronic copy 01 September 2026

2 IRB Approval of collection site(s) 1 electronic copy 01 October 2026

3 Set-up of site(s), recruitment of participants 23 October 2026

4 Pediatric Study (6-35mo): One aliquot each of pre-immunization serum samples

60 @ 1 x 1.0 ml each 24 November 2026

5 Pediatric Study (6-35mo): One aliquot each of post-immunization serum samples

60 @ 1 x 1.0 ml each 24 November 2026

6 Pediatric Study (6-35mo): Remaining aliquots of pre-immunization serum samples

60 @ 1 x 1.0 ml each

60 @ 1 x 0.5 ml each

01 December 2026

7 Pediatric Study (6-35mo): Remaining aliquots of post-immunization serum samples

60 @ 1 x 1.0 ml each

60 @ 1 x 0.5 ml each

01 December 2026

8 Pediatric Study (3-8y): One aliquot each of pre-immunization serum samples

60 @ 1 x 1.0 ml each 24 November 2026

9 Pediatric Study (3-8y): One aliquot each of post-immunization serum samples

60 @ 1 x 1.0 ml each 24 November 2026

10 Pediatric Study (3-8y): Remaining aliquots of pre-immunization serum samples

60 @ 4 x 1.0 ml each 01 December 2026

11 Pediatric Study (3-8y): Remaining aliquots of post-immunization serum samples

60 @ 4 x 1.0 ml each 01 December 2026

12 Pediatric Study (9-17y): One aliquot each of pre-immunization serum samples

60 @ 1 x 1.0 ml each 24 November 2026

13 Pediatric Study (9-17y): One aliquot each of post-immunization serum samples

60 @ 1 x 1.0 ml each 24 November 2026

14 Pediatric Study (9-17y): Remaining aliquots each of pre-immunization serum samples

60 @ 4 x 1.0 ml each 01 December 2026

15 Pediatric Study (9-17y): Remaining aliquots each of post-immunization serum samples

60 @ 4 x 1.0 ml each 01 December 2026

16 Adult Large Volume Donors: Two aliquots each of pre-immunization serum samples

120 @ 2 x 1.0 ml each 10 November 2026

17 Adult Large Volume Donors: Two aliquots each of post-immunization serum samples

120 @ 2 x 1.0 ml each 10 November 2026

18 Adult Large Volume Donors: One large aliquot each of post-immunization serum samples

120 @ 1 x 20.0 ml each

10 November 2026

19 Adult Large Volume Donors: Remaining aliquots of pre-immunization serum samples

120 @ 8 x 1.0 ml each 17 November 2026

20 Adult Large Volume Donors: Remaining small aliquots of post-immunization serum samples

120 @ 8 x 1.0 ml each 17 November 2026

21 Adult Large Volume Donors: Remaining large aliquot of post-immunization serum samples

120 @ 1 x 20.0 ml each

17 November 2026

22 Older adult: Two aliquots each of pre-immunization serum samples

30 @ 2 x 1.0 ml each 24 November 2026

23 Older adult: Two aliquots each of post-immunization serum samples

30 @ 2 x 1.0 ml each 24 November 2026

24 Older adult: Remaining aliquots of pre-immunization serum samples

30 @ 8 x 1.0 ml each 01 December 2026

25 Older adult: Remaining aliquots of post-immunization serum samples

30 @ 8 x 1.0 ml each 01 December 2026

26 Elderly: Two aliquots each of pre-immunization serum samples

30 @ 2 x 1.0 ml each 24 November 2026

27 Elderly: Two aliquots each of post-immunization serum samples

30 @ 2 x 1.0 ml each 24 November 2026

28 Elderly: Remaining aliquots of pre-immunization serum samples

30 @ 8 x 1.0 ml each 01 December 2026

29 Elderly: Remaining aliquots of post-immunization

30 @ 8 x 1.0 ml each 01 December 2026

1 First shipment: Due on or before November 10, 2026. This shipment shall be sent as soon as the 120 adult high volume donors S2 blood samples (i.e. 100 ml) have been collected. This first shipment shall contain: (1) Two 1.0 ml aliquots of the S1 adult samples and two 1.0 ml aliquots of the corresponding S2 adult high volume donor samples.

(2) One of the two S2 aliquots in the 50 ml tube from the adult high volume donor samples. If available, samples scheduled for the third and fourth shipments may be included in the first shipment.

1 Second shipment: Due on or before November 17, 2026. The second shipment shall contain: (1) The remaining eight 1.0 ml aliquots of the S1 sample and the remaining eight 1.0 ml aliquots of the corresponding S2 sample from the adult high volume donors samples. (2) The remaining S2 aliquot in the 50 ml tube from the adult high volume donor samples. If available, samples scheduled for the third and fourth shipments may be included in the first shipment.

1 Third shipment: Due on or before November 24 2026. The third shipment shall contain: (1) One 1.0 ml aliquot of the S1 and one 1.0 ml aliquot of the corresponding S2 pediatric (6-35mo)samples, (2) One 1.0 ml aliquot of the S1 and one 1.0 ml aliquot of the corresponding S2 older pediatric (3-8y) samples, (3) One 1.0 ml aliquot of the S1 and one 1.0ml aliquot of the corresponding S2 older pediatric (9-17y) samples (4) Two 1.0 ml aliquots of the S1 and two 1.0 ml aliquots of the corresponding S2 older adult (50-64y) samples, and (5) Two 1.0 ml aliquots of the S1 and two 1.0 ml aliquots of the corresponding S2 serum from elderly (65y+) participants.

1 Fourth shipment: Due on or before December 01, 2026. After the third shipment has been received, the

Option Period 3: 8/1/2027-7/31/2028:

1 Manual of Procedures 1 electronic copy 01 September 2027

2 IRB Approval of collection site(s) 1 electronic copy 01 October 2027

3 Set-up of site(s), recruitment of participants 25 October 2027

4 Pediatric Study (6-35mo): One aliquot each of pre-immunization serum samples

60 @ 1 x 1.0 ml each 30 November 2027

5 Pediatric Study (6-35mo): One aliquot each of post-immunization serum samples

60 @ 1 x 1.0 ml each 30 November 2027

6 Pediatric Study (6-35mo): Remaining aliquots of pre-immunization serum samples

60 @ 1 x 1.0 ml each

60 @ 1 x 0.5 ml each

07 December 2027

7 Pediatric Study (6-35mo): Remaining aliquots of post-immunization serum samples

60 @ 1 x 1.0 ml each

60 @ 1 x 0.5 ml each

07 December 2027

8 Pediatric Study (3-8y): One aliquot each of pre-immunization serum samples

60 @ 1 x 1.0 ml each 30 November 2027

9 Pediatric Study (3-8y): One aliquot each of post-immunization serum samples

60 @ 1 x 1.0 ml each 30 November 2027

10 Pediatric Study (3-8y): Remaining aliquots of pre-immunization serum samples

60 @ 4 x 1.0 ml each 07 December 2027

11 Pediatric Study (3-8y): Remaining aliquots of post-immunization serum samples

60 @ 4 x 1.0 ml each 07 December 2027

12 Pediatric Study (9-17y): One aliquot each of pre-immunization serum samples

60 @ 1 x 1.0 ml each 30 November 2027

13 Pediatric Study (9-17y): One aliquot each of post-immunization serum samples

60 @ 1 x 1.0 ml each 30 November 2027

14 Pediatric Study (9-17y): Remaining aliquots each of pre-immunization serum samples

60 @ 4 x 1.0 ml each 07 December 2027

15 Pediatric Study (9-17y): Remaining aliquots each of post-immunization serum samples

60 @ 4 x 1.0 ml each 07 December 2027

16 Adult Large Volume Donors: Two aliquots each of pre-immunization serum samples

120 @ 2 x 1.0 ml each 09 November 2027

17 Adult Large Volume Donors: Two aliquots each of post-immunization serum samples

120 @ 2 x 1.0 ml each 09 November 2027

18 Adult Large Volume Donors: One large aliquot each of post-immunization serum samples

120 @ 1 x 20.0 ml each

09 November 2027

19 Adult Large Volume Donors: Remaining aliquots of pre-immunization serum samples

120 @ 8 x 1.0 ml each 16 November 2027

20 Adult Large Volume Donors: Remaining small aliquots of post-immunization serum samples

120 @ 8 x 1.0 ml each 16 November 2027

21 Adult Large Volume Donors: Remaining large aliquot of post-immunization serum samples

120 @ 1 x 20.0 ml each

16 November 2027

22 Older adult: Two aliquots each of pre-immunization

30 @ 2 x 1.0 ml each 30 November 2027

23 Older adult: Two aliquots each of post-immunization serum samples

30 @ 2 x 1.0 ml each 30 November 2027

24 Older adult: Remaining aliquots of pre-immunization serum samples

30 @ 8 x 1.0 ml each 07 December 2027

25 Older adult: Remaining aliquots of post-immunization serum samples

30 @ 8 x 1.0 ml each 07 December 2027

26 Elderly: Two aliquots each of pre-immunization serum samples

30 @ 2 x 1.0 ml each 30 November 2027

27 Elderly: Two aliquots each of post-immunization serum samples

30 @ 2 x 1.0 ml each 30 November 2027

28 Elderly: Remaining aliquots of pre-immunization serum samples

30 @ 8 x 1.0 ml each 07 December 2027

29 Elderly: Remaining aliquots of post-immunization

30 @ 8 x 1.0 ml each 07 December 2027

1 First shipment: Due on or before November 09, 2027. This shipment shall be sent as soon as the 120 adult high volume donors S2 blood samples (i.e. 100 ml) have been collected. This first shipment shall contain: (1) Two 1.0 ml aliquots of the S1 adult samples and two 1.0 ml aliquots of the corresponding S2 adult high volume donor samples.

(2) One of the two S2 aliquots in the 50 ml tube from the adult high volume donor samples. If available, samples scheduled for the third and fourth shipments may be included in the first shipment.

1 Second shipment: Due on or before November 16, 2027. The second shipment shall contain: (1) The remaining eight 1.0 ml aliquots of the S1 sample and the remaining eight 1.0 ml aliquots of the corresponding S2 sample from the adult high volume donors samples. (2) The remaining S2 aliquot in the 50 ml tube from the adult high volume donor samples. If available, samples scheduled for the third and fourth shipments may be included in the first shipment.

1 Third shipment: Due on or before November 30, 2027. The third shipment shall contain: (1) One 1.0 ml aliquot of the S1 and one 1.0 ml aliquot of the corresponding S2 pediatric (6-35mo)samples, (2) One 1.0 ml aliquot of the S1 and one 1.0 ml aliquot of the corresponding S2 older pediatric (3-8y) samples, (3) One 1.0 ml aliquot of the S1 and one 1.0ml aliquot of the corresponding S2 older pediatric (9-17y) samples (4) Two 1.0 ml aliquots of the S1 and two 1.0 ml aliquots of the corresponding S2 older adult (50-64y) samples, and (5) Two 1.0 ml aliquots of the S1 and two 1.0 ml aliquots of the corresponding S2 serum from elderly(65y+) participants.

1 Fourth shipment: Due on or before December 07, 2027. After the third shipment has been received, the remaining samples shall be sent as specified in the table above.

Option Period 4: 8/1/2028-7/31/2029

1 Manual of Procedures 1 electronic copy 01 September 2028

2 IRB Approval of collection site(s) 1 electronic copy 01 October 2028

3 Set-up of site(s), recruitment of participants 24 October 2028

4 Pediatric Study (6-35mo): One aliquot each of pre-

60 @ 1 x 1.0 ml each 29 November 2028

5 Pediatric Study (6-35mo): One aliquot each of post-

60 @ 1 x 1.0 ml each 29 November 2028

6 Pediatric Study (6-35mo): Remaining aliquots of pre-immunization serum samples

60 @ 1 x 1.0 ml each

60 @ 1 x 0.5 ml each

06 December 2028

7 Pediatric Study (6-35mo): Remaining aliquots of post-immunization serum samples

60 @ 1 x 1.0 ml each

60 @ 1 x 0.5 ml each

06 December 2028

8 Pediatric Study (3-8y): One aliquot each of pre-immunization serum samples

60 @ 1 x 1.0 ml each 29 November 2028

9 Pediatric Study (3-8y): One aliquot each of post-immunization serum samples

60 @ 1 x 1.0 ml each 29 November 2028

10 Pediatric Study (3-8y): Remaining aliquots of pre-immunization serum samples

60 @ 4 x 1.0 ml each 06 December 2028

11 Pediatric Study (3-8y): Remaining aliquots of post-immunization serum samples

60 @ 4 x 1.0 ml each 06 December 2028

12 Pediatric Study (9-17y): One aliquot each of pre-immunization serum samples

60 @ 1 x 1.0 ml each 29 November 2028

13 Pediatric Study (9-17y): One aliquot each of post-immunization serum samples

60 @ 1 x 1.0 ml each 29 November 2028

14 Pediatric Study (9-17y): Remaining aliquots each of pre-immunization serum samples

60 @ 4 x 1.0 ml each 06 December 2028

15 Pediatric Study (9-17y): Remaining aliquots each of post-immunization serum samples

60 @ 4 x 1.0 ml each 06 December 2028

16 Adult Large Volume Donors: Two aliquots each of pre-immunization serum samples

120 @ 2 x 1.0 ml each 08 November 2028

17 Adult Large Volume Donors: Two aliquots each of post-immunization serum samples

120 @ 2 x 1.0 ml each 08 November 2028

18 Adult Large Volume Donors: One large aliquot each of post-immunization serum samples

120 @ 1 x 20.0 ml each

08 November 2028

19 Adult Large Volume Donors: Remaining aliquots of pre-immunization serum samples

120 @ 8 x 1.0 ml each 15 November 2028

20 Adult Large Volume Donors: Remaining small aliquots of post-immunization serum samples

120 @ 8 x 1.0 ml each 15 November 2028

21 Adult Large Volume Donors: Remaining large aliquot of post-immunization serum samples

120 @ 1 x 20.0 ml each

15 November 2028

22 Older adult: Two aliquots each of pre-immunization serum samples

30 @ 2 x 1.0 ml each 29 November 2028

23 Older adult: Two aliquots each of post-immunization serum samples

30 @ 2 x 1.0 ml each 29 November 2028

24 Older adult: Remaining aliquots of pre-immunization serum samples

30 @ 8 x 1.0 ml each 06 December 2028

25 Older adult: Remaining aliquots of post-

30 @ 8 x 1.0 ml each 06 December 2028

26 Elderly: Two aliquots each of pre-immunization

30 @ 2 x 1.0 ml each 29 November 2028

27 Elderly: Two aliquots each of post-immunization serum samples

30 @ 2 x 1.0 ml each 29 November 2028

28 Elderly: Remaining aliquots of pre-immunization serum samples

30 @ 8 x 1.0 ml each 06 December 2028

29 Elderly: Remaining aliquots of post-immunization

30 @ 8 x 1.0 ml each 06 December 2028

1 First shipment: Due on or before November 8, 2028. This shipment shall be sent as soon as the 120 adult high volume donors S2 blood samples (i.e. 100 ml) have been collected. This first shipment shall contain: (1) Two 1.0 ml aliquots of the S1 adult samples and two 1.0 ml aliquots of the corresponding S2 adult high volume donor samples.

(2) One of the two S2 aliquots in the 50 ml tube from the adult high volume donor samples. If available, samples scheduled for the third and fourth shipments may be included in the first shipment.

1 Second shipment: Due on or before November 15, 2028. The second shipment shall contain: (1) The remaining eight 1.0 ml aliquots of the S1 sample and the remaining eight 1.0 ml aliquots of the corresponding S2 sample from the adult high volume donors samples. (2) The remaining S2 aliquot in the 50 ml tube from the adult high volume donor samples. If available, samples scheduled for the third and fourth shipments may be included in the first shipment.

1 Third shipment: Due on or beforeNovember 29, 2028. The third shipment shall contain: (1) One 1.0 ml aliquot of the S1 and one 1.0 ml aliquot of the corresponding S2 pediatric (6-35mo)samples, (2) One 1.0 ml aliquot of the S1 and one 1.0 ml aliquot of the corresponding S2 older pediatric (3-8y) samples, (3) One 1.0 ml aliquot of the S1 and one 1.0ml aliquot of the corresponding S2 older pediatric (9-17y) samples (4) Two 1.0 ml aliquots of the S1 and two 1.0 ml aliquots of the corresponding S2 older adult (50-64y) samples, and (5) Two 1.0 ml aliquots of the S1 and two 1.0 ml aliquots of the corresponding S2 serum from elderly(65y+) participants.

1 Fourth shipment: Due on or before December 06, 2028. After the third shipment has been received, the

Section 9 References:

b. Attachment 1: Human Sera Collection Guidelines for Flu Serology

c.…