SSN (Study of Infectious Diseases)_Final.pdf

SOURCES SOUGHT NOTICE

Clinical Studies of Infectious Agents, Vaccines and Antivirals in Adult and Pediatric Human Subjects

RFP# 75N93025R00014

Sources Sought Reference Number: 75N93025R00014

Type of Requirement

New Requirement

Follow-on (Contract No.:____75N93019D00031____) Other (specify):________________

Place of Performance

Place of performance is unknown at this time Place of performance is known. Address or general location:_______________

Recompetition (if applicable)

JOHNS HOPKINS UNIV.

3910 KESWICK ROAD

BALTIMORE MD 21211

Contracting Office Address

Department of Health and Human Services, National Institutes of Health, National Institute of Allergy and Infectious Diseases, Office of Acquisitions, 5601 Fishers Lane, MSC 9821, Bethesda, MD, 20892-9821

Sources Sought Notice Information

Introduction

This is a Small Business Sources Sought notice. This is NOT a solicitation for proposals, proposal abstracts, or quotations. The purpose of this notice is to obtain information regarding: (1) the availability and capability of qualified small business sources; (2) whether they are small businesses; HUBZone small businesses; service-disabled, veteran-owned small businesses; 8(a) small businesses; veteran-owned small businesses; woman-owned small businesses; or small disadvantaged businesses; and (3) their size classification relative to the North American Industry Classification System (NAICS) code for the proposed acquisition. Your responses to the information requested will assist the Government in determining the appropriate acquisition method, including whether a set-aside is possible.

An organization that is not considered a small business under the applicable NAICS code should not submit a response to this notice.

Background

The National Institutes of Health (NIH), the National Institute of Allergy and Infectious Diseases (NIAID), and the Laboratory of Infectious Diseases (LID) have been performing clinical studies in adult and/or pediatric volunteer populations since the 1950's, with the goal of developing safe and effective vaccines against influenza viruses, human parainfluenza viruses (HPIV), respiratory syncytial viruses

(RSV), human metapneumovirus (HMPV), viral agents of gastroenteritis, and flaviviruses. These studies have identified promising candidate vaccines against RSV and other viruses, leading to

Cooperative Research And Development Agreements (CRADAs) with commercial collaborators. Safe and immunogenic live-attenuated vaccines against all four dengue virus serotypes were identified and combined into a single-dose tetravalent vaccine, leading to licensing agreements in Brazil, India, Bangladesh, Vietnam, Taiwan, and the US. A Phase 3 study of the lead tetravalent dengue vaccine formulation was recently completed in Brazil, a Phase 3 study is currently underway in India, and other Phase 2 studies are being conducted in Bangladesh, India, and the US.

LID and the Laboratory of Viral Diseases (LVD) of NIAID require clinical trials to investigate the safety, immunogenicity, and protective efficacy of vaccines against pneumoviruses, paramyxoviruses

(primarily HPIVs), influenza viruses, flaviviruses, alphaviruses, and bunyaviruses, including newly emerging viruses such as Zika virus, noroviruses, rotavirus, and virally-vectored vaccines. Vaccine studies will include adult and pediatric subjects. Clinical trials in adults may also be required for pathogenesis research and to develop viral human challenge models for the testing of antivirals and vaccines.

Purpose and Objectives

To conduct clinical trials on a Task Order basis under the guidance of NIAID. This contract will be administered and used to support NIAID Intramural initiatives.

Project requirements

The Contractor shall furnish all the necessary services, qualified personnel, material, equipment, and facilities, not otherwise provided by the Government, as needed to perform requirements described below.

The Contractor shall perform clinical and research studies with infectious agents in humans. The Contractor shall recruit and select healthy adult volunteers and pediatric study participants.

Facility requirements: Storage of Test Materials

The Contractor shall provide facilities for documented and secure temperature-controlled storage of investigational vaccines and challenge virus preparations, and for storage of study specimens.

Facility requirements: Pharmacy

The Contractor shall have United States Pharmacopeia (USP) compliant pharmacy capabilities allowing for preparation of placebo doses, and for aseptic dilution of live virus vaccines and challenge virus material to dose. Institutional approval and Institutional Biosafety Committee (IBC) approval for handling clinical trial material containing biosafety level (BSL) 1 and 2 agents will be required.

Pharmacy personnel shall have access to a secure –80°C freezer approved for storage of BSL 1 and 2 agents.

Preparation of Protocols and Regulatory Requirements

The Contractor shall prepare clinical protocols and informed consent documents based on draft documents provided by NIAID investigators.

The Contractor's Institutional Review Board (IRB) and IBC shall approve each study, protocol or agent, as necessary. The Contractor shall provide IRB-approved protocols, consent forms, and study advertisements to the NIAID lead study investigator and assist in preparation of Investigator’s Brochures.

Laboratory processing and laboratory analysis

The Contractor shall test clinical study specimens to quantify and isolate viral test agents shed by vaccinees, and, in the event of illness, test for the presence of other (wild type) viral or bacterial agents. The Contractor shall perform antibody assays to evaluate immune responses to the virus under study. The Contractor shall separate, cryopreserve, and store peripheral blood mononuclear cells (PBMC) from whole blood if PBMC collection is required under a clinical protocol.

It is possible that the required assays would not be available at the Contractor's facility. In such a situation, the Contractor shall provide a mechanism for transferring the materials to another laboratory.

Data Management

The Contractor shall develop and maintain a system of records and data management. Record keeping shall be compliant with all applicable regulations. The Contractor shall establish procedures for tracking recruitment, retention, and follow-up of study patients.

Follow-up

The Contractor shall continue the clinical evaluation, collection, analysis, storage and shipment of samples, data collection and reporting on all volunteers enrolled during the Task Order period until the completion of the protocol, or until such tasks can be transferred to a new Task Order award.

Transition Period

The Contractor shall, subject to Contracting Officer direction, provide for an orderly transition of data and materials to a successor Contractor or to the Government.

DESCRIPTION FOR INDIVIDUAL TASK AREAS

Task Area A:

Scope: Evaluate safety and immunogenicity of vaccine candidates in infants and children

Description: It is estimated that the Contractor shall develop Phase 1A studies that typically involve up to 45 children (with an occasional larger study of up to 80), and that up to 400 infants and young children will be enrolled each year in such studies. Typically, a single dose of study product will be administered, and participants will have about 9 study visits scheduled during the 28 days following study product administration to assess safety.

Specimens (e.g., nasal wash samples) will be collected to assess shedding of live viral vaccines.

Follow-up visits to assess immunogenicity will be required until up to 25 months after study product administration. Phase 1B or Phase 2 multisite studies will require about 3 study visits during the first

28 days, and up to 13 months of follow-up for immunogenicity.

Task Area B:

Scope: Evaluate safety and immunogenicity of vaccine candidates in adults

Description: It is estimated that 400 adults will be studied per year in an outpatient setting (20 – 60 volunteers per cohort). The Contractor shall assess safety and vaccine virus replication, and perform immunological assessments (humoral and cellular) after vaccination and up to one year after vaccination, as required by the specific study protocol. Clinical follow-up may be required to determine if disease potentiation occurs during subsequent natural infection with wild type virus.

Task Area C:

Scope: Perform challenge or pathogenicity studies in adults in an inpatient setting

Description: It is estimated that approximately 60 adults will be studied per year in inpatient studies

(not more than 30 per cohort). Participants shall receive an infectious agent (e.g., a live virus vaccine or a wild type virus) and specimens shall be collected during the inpatient period (typical duration: up to two weeks) and after discharge. The Contractor shall provide careful clinical monitoring and follow-up visits of the study subjects per study specific protocol. Specimens (e.g., nasal wash, blood, PBMC, serum, saliva, urine, semen, vaginal swab) shall be collected, and observations be made per clinical study protocol. The Contractor's facility shall minimize the unintended introduction of infectious agents from the outside to the inpatient volunteers and, conversely, the spread of the infectious agents under study to the staff and to the community. An effective vector control program will shall be in operation if indicated by the protocol. Specific studies might require conditions of quarantine. It is anticipated that studies requiring quarantine will represent a minority of the research effort. In some studies, it might be necessary to evaluate the transmissibility of candidate virus vaccines administered live viruses from vaccinees subjects to mosquitoes.

Anticipated period of performance

The anticipated period of performance of the Base Contract is for seven (7) years: August 5, 2026, through August 4, 2033.

Other important considerations

It is anticipated that a cost reimbursement, single award Indefinite Delivery Indefinite

Quantity (IDIQ) type of contract will be awarded that will include three Task Areas as noted above.

Capability statement/information sought

Capability statements submitted as a result of this announcement should demonstrate the offeror's qualification, expertise and experience, specifically providing evidence as to the capability to immediately perform this requirement. Capability statements should clearly convey information regarding the respondent's capabilities.

Interested Contractors must submit a capability statement (5 page limitation, excluding resumes) describing their company's experience and ability to immediately perform this effort, which includes the following:

(1) a summary list of similar work previously performed; examples of prior completed similar

Government contracts, references, and other related information to the work to be performed

(2) the professional qualifications and specific experience of staff who may be assigned to the requirement; corporate experience and management capability to deliver comprehensive services of this scope and magnitude

(3) the professional qualifications and specific experience of staff who may be assigned to the requirement; resumes for proposed key personnel, including the Principal Investigator/co-Pl, which reflect education, and previous work relevant to the proposed requirement; staff expertise, including their availability, experience and formal and other training

(4) current in- house capability and/or capacity to perform the work, a general description of the facilities, and other resources needed to perform the work demonstrated ability to carry out the work

Capability Statements must not include links to internet web site addresses (URLs) or otherwise direct readers to alternate sources of information. Font size must be 10 to 12 points.

Spacing must be no more than 15 characters per inch. Within a vertical inch, there must be no more than six lines of text. Print margins must be at least one-inch on each edge of the paper.

Each response should include the following Business Information:

1. UEI number

2. Company Name

3. Company Address

4. Company Points of Contact (both technical and administrative), including names, titles, addresses, telephone and fax numbers and Email addresses

5. Current GSA Schedule appropriate to this Sources Sought if applicable

6. Do you have a Government-approved accounting system? If so, please identify the agency that approved the system.

7. Type of Company (i.e., large business, non-profit, educational institute, small business, 8(a), woman owned, veteran owned, etc.), as validated via the System for

Award Management (SAM). All offerors must be registered in the SAM, located at http://www.sam.gov/

Responses must be submitted no later than 3:00 PM (E.S.T.), January 30, 2025. Capability statements will not be returned and will not be accepted after the due date. These statements should be submitted electronically (via email) to Uju Obii-Obioha, Contracting Officer, at uju.obii-obioha@nih.gov and Christian Brown, Contracting Specialist at christian.brown@niaid.nih.gov. These statements should be submitted in Adobe Portable

Document Format (PDF); however, capability statements in Microsoft Word will also be accepted. The e-mail subject line must specify HHS-NIH-NIAID-75N93025R00014. Facsimile responses will not be accepted.

Common Cut-off Date:

Electronically submitted, tailored capability statements are due not later than 3:00 PM (E.S.T.), on January 30, 2025. CAPABILITY STATEMENTS WILL NOT BE RETURNED AND WILL

NOT BE ACCEPTED AFTER THE DUE DATE

http://www.sam.gov/

Disclaimer and Important Notes

This notice does not obligate the Government to award a contract or otherwise pay for the information provided in response. The Government reserves the right to use information provided by respondents for any purpose deemed necessary and legally appropriate. Any organization responding to this notice should ensure that its response is complete and sufficiently detailed to allow the Government to determine the organization’s qualifications to perform the work. Respondents are advised that the Government is under no obligation to acknowledge receipt of the information received or provide feedback to respondents with respect to any information submitted. After a review of the responses received, a pre-solicitation synopsis and solicitation may be published at SAM.gov. However, responses to this notice will not be considered adequate responses to a solicitation.

Confidentiality

No proprietary, classified, confidential, or sensitive information should be included in your response. The Government reserves the right to use any non-proprietary technical information in any resultant solicitation(s).