B01-RFI Sources Sought_10AUG2022.pdf

Subject: Meningococcal Immunization Against Gonococcal Infection (MAGI) Trial/ RV564

THIS IS NOT A REQUEST FOR PROPOSALS (RFP) OR A REQUEST FOR QUOTATIONS (RFQ);

IT IS STRICTLY A REQUEST FOR INFORMATION (RFI). NEITHER UNSOLICITED PROPOSALS

NOR ANY OTHER KINDS OF OFFERS WILL BE CONSIDERED IN RESPONSE TO THIS RFI. NO

CONTRACT WILL BE AWARDED PURSUANT TO THIS ANNOUNCEMENT.

1.0 DISCLAIMER: This RFI is issued solely for information and planning purposes and does not constitute a solicitation. Neither unsolicited proposals nor any other kind of offers will be considered in response to this RFI. Responses to this notice are not offers and will not be accepted by the Government to form a binding contract. Responders are solely responsible for all expenses associated with responding to this RFI. All information received in response to this RFI that is marked Proprietary will be handled accordingly. Responses to the RFI will not be returned. At this time, questions concerning the composition and requirements for a future RFP will not be entertained.

2.0 SUBJECT: The Infectious Diseases Clinical Research Program (IDCRP) is a U.S. Military tri-service research center headquartered within the F. Edward Hebert School of Medicine at the Uniformed Services University (USU). It coordinates clinical research conducted within military medical treatment facilities under the command and control of the individual medical Services, the Defense Health Agency (DHA), and approved non- military collaborators, e.g., Veterans Health Administration (VHA) medical treatment facilities, etc., with the consent of these commands, agencies, and partners. Its mission is to perform multicenter, observational, and interventional clinical infectious disease research within the Military Health System (MHS) that informs and improves the care of the Warfighter. In line with the above goal, the IDCRP wishes to obtain information from all sources who possess the ability to perform the tasks required.

3.0 BACKGROUND: The National Institute of Allergy and Infectious Diseases Inter Agency Agreement (NIAID IAA) funding provides support to execute a specific research protocol at WNMMC and WRAIR/AFRIMS, led by IDCRP. The purpose of this funding is to support the execution of a phase II randomized, placebo-controlled study, to assess efficacy of meningococcal Group B vaccine rMenB+OMV NZ (Bexsero©, GSK) in preventing gonococcal infection. This NIAID sponsored study supports the mission of the IDCRP by aiming to reduce the impact of infectious diseases in the military population through collaborative clinical research. The study design is based on the accrual of incident cases of gonococcal infection to determine the final enrollment which will support a time to evidence analysis. Both domestic and international sites are needed allowing for accrual from a robust global subject pool to complete subject enrollment. The USU laboratory capacity, the Walter Reed Infectious Disease clinic, and the international capability of the AFRIMS and the Bangkok sites (the Royal Thai Army clinic and the Thai Red Cross clinic) provide a unique opportunity to evaluate this study adding value to the U.S. military.

4.0 RESPONSE INSTRUCTIONS: Respondents should address all of the following in their response:

4.1 Organization Information:

a. Organization’s full legal name and Address

b. DUNS Number, Cage Code, Tax Identification Number, and company structure

(Corporation, LLC, partnership, joint venture, etc). Companies must be registered in the System for Award Management (SAM, at www.sam.gov) to be considered as potential sources.

c. Small Business Designation certified by the Small Business Administration, if any.

d. Point of contact name, phone number, and email for individual with the authority and knowledge to clarify responses with Government representatives.

http://www.sam.gov/

e. Information pertaining to the following:

1. Does your company participate in any Government-wide Acquisition Contracts

(GWACS)?

2. Does your company have a Federal Support Schedule Contract?

3. Are you currently on GSA Oasis (Prime or Sub); and if so, which pool(s) does your company participate?

4. Does your company have a CAS approved accounting system and are you immediately postured to perform cost reimbursement type contracts?

4.2 Company Capabilities Statement: The capability statements provided must include the following:

a. Your company’s program management plan and control policies that adhere to standard industry practices. Must demonstrate the ability to accurately track projects and ensure timely completion of projects. Must include a recruitment and retention strategy to confirm their capability to provide varying levels of support for the tasks listed below.

b. General information and technical background describing your firm’s experience within the last three to five years; specifically with contracts similar in scope, complexity and size to meet the program objectives in accordance with the draft Statement Of Objectives (SOO) tasks outlined below, to include the simultaneous response to multiple stakeholders to account for program management, business analytics support, application planning, program analysis and support services.

c. Demonstrated working knowledge and experience with the following tasks in order to meet the

USUHS mission:

- The prime contractor will be required to partner with the following current collaborators associated with the ongoing trial and present an overarching management plan for coordination and execution of both the extramural and intramural activities:

o Government management: USUHS o Government stakeholders: NIAID o DoD clinical sites: Walter Reed National Military Medical Center

(WRNMMC), Thai Red Cross (TRC)/IHRI, and Royal Thai Army (RTA) o Academic institutions (the University of Alabama and Emory University) o Industry partner: GSK.

- The ability to meet the objectives for the study Aims:

o Objective 1: To demonstrate efficacy of Bexsero in prevention of urogenital and/or anorectal gonococcal infection o Objective 2: To estimate efficacy of Bexsero in prevention of overall gonococcal infection and by anatomical site (urogenital, anorectal, or pharyngeal) o Objective 3: To assess safety of Bexsero o Objective 4: To explore measures of immune response to N. gonorrhoeae o Objective 5: To characterize genotypic, phenotypic, and antimicrobial resistance profiles of incident gonococcal infections

d. Sufficient information/details to determine how you fully meet the requirements as specified in the draft tasks listed in the Statement Of Objectives provided below.

5.0 SMALL BUSINESS SET ASIDE: The Government has not determined the set-aside capability, if possible, at this time. The Government will use the RFI results in analyzing small businesses’ capacity to perform this requirement and make its decision.

6.0 INSTRUCTIONS FOR RESPONDING:

Submission: Please submit RFI response via email in a “.pdf” file type, to Mr. Steven Davanzo at email address: Steven.a.davanzo.civ@mail.mil AND Steven.a.davanzo.civ@health.mil. Please CC Ms. Courtney Chase at email address courtney.f.chase.civ@mail.mil AND courtney.f.chase.civ@health.mil Please use the title in your email “Meningococcal Immunization Against Gonococcal Infection (MAGI) Trial/ RV564 for USUHS”.

Due Date: RFI response submission is due by 10:00 a.m. Eastern Standard Time on 16 August 2022.

Page Limit: Limit your total written response to 20 single-sided pages. The cover page and table of contents does not count towards the page limit. Beyond the 20 page limit, the Government may only review examples of media and graphic design, as requested above.

Draft Tasks Listed in the Statement Of Objectives:

a. Study Design:

This RPP is seeking a prime contractor with an established network and capability to continue progress on this clinical trial without significant delay and start-up costs. A significant amount of work has already been completed to date and cannot, where over 450 total study subjects (approximately 25% of the total projected) have already been enrolled, with over 300 of those enrollees from the three DoD supported enrollment sites.

The study is expected to continue to enroll at all current sites into FY23 with follow up to continue into FY25.

The prime contractor will be required to partner with the following current collaborators associated with the ongoing trial and present an overarching management plan for coordination and execution of both the extramural and intramural activities:

• Government management: USUHS

• Government stakeholders: NIAID

• DoD clinical sites: Walter Reed National Military Medical Center (WRNMMC), Thai Red Cross (TRC)/IHRI, and Royal Thai Army (RTA)

• Academic institutions (the University of Alabama and Emory University)

• Industry partner: GSK.

b. Objectives for the study Aims:

Overall study objectives:

• Objective 1: To demonstrate efficacy of Bexsero in prevention of urogenital and/or anorectal gonococcal infection

• Objective 2: To estimate efficacy of Bexsero in prevention of overall gonococcal infection and by anatomical site (urogenital, anorectal, or pharyngeal) mailto:Steven.a.davanzo.civ@mail.mil mailto:Steven.a.davanzo.civ@health.mil

• Objective 3: To assess safety of Bexsero

• Objective 4: To explore measures of immune response to N. gonorrhoeae

• Objective 5: To characterize genotypic, phenotypic, and antimicrobial resistance profiles of incident gonococcal infections

Specific milestones by quarter include:

FY23 QUARTER 1

• Enroll 30-38 subjects at WRNMMC

• Enroll 50-100 subjects at IHRI/RTA

• Complete follow-up of all Quarter 4 FY21 enrollments (WRNNMC, RTA, TRC)

• 100% of Whole blood samples collected in Quarter 4 FY22 shipped to CMS (Fisher

BioServices)

• 100% of GC isolates from local culture batched shipped to USUHS, Jerse lab for all

Quarter 4 isolates (WRNMMC, RTA, TRC)

FY23 QUARTER 2

• Complete follow-up of all Quarter 1 FY22 enrollments (WRNNMC, RTA, TRC)

• 100% of Whole blood samples collected in Quarter 1 shipped to CMS (Fisher

BioServices)

• 100% of GC isolates from local culture batched shipped to USUHS, Jerse lab for all

Quarter 1 isolates (WRNMMC, RTA, TRC)

FY23 QUARTER 3

• Complete follow-up of all Quarter 2 FY22 enrollments (WRNNMC, RTA, TRC)

• 100% of Whole blood samples collected in Quarter 2 shipped to CMS (Fisher

BioServices)

• 100% of GC isolates from local culture batched shipped to USUHS, Jerse lab for all

Quarter 1 isolates (WRNMMC, RTA, TRC)

Objectives for the study Approach:

• The proposal should determine the most effective way to achieve the study objectives and outcomes as outlined in the study protocol. Determination of the study approach should include assessment of feasibility, duration, and cost. The proposal should clearly articulate the rationale for the chosen study design.

1. Program Management Objectives: (Key data to be collected)

a. Patient-level data – Patient-level data will be collected IAW the study design and provided to the Government in the following deliverables (where applicable):

1) Patient-Level Data for all enrolled subjects

2) Patient Characteristics including, but not limited to: age, gender, race/ethnicity, socioeconomic status, and other data outlined in the study protocol

3) Pre-hospital data for enrolled subjects obtained from the Military Health System Data

Repository (MDR)

4) Emergency room data including, but not limited to: arrival time, vital signs (initial, and every 15 minutes), physical exam, time and description of interventions and diagnostic tests, initial diagnosis, time and dose of any medications administered (especially for pain, infection, resuscitation), and disposition (e.g., discharge, admitting service, death)

5) Operating room data including, but not limited to: types of operative and other interventions, type of anesthesia, complications, blood, blood products, and other resuscitative fluids used, time and dose of any medications administered (especially for pain, infection, resuscitation and/or blood pressure maintenance), vital signs

6) Adjunctive treatment and imaging including, but not limited to: time of arrival, interventions, and findings/diagnosis

7) Inpatient data including but not limited to: vital signs, interventions, time and dose of any medications administered (especially for pain, infection, resuscitation and/or blood pressure maintenance), and disposition

8) Outcome data including but not limited to: medication usage, adverse effects/events

(e.g., respiratory depression following administration, emergence reactions), ventilator days, length of stay, length of stay in ICU, death, and re-admission within 30 days

b. Facility-Level Data: Facility-level data (including pre-hospital/en route) will be collected

IAW the study design and provided to the Government in the following deliverables (where applicable):

1) Geographic region data

2) Adherence to Clinical Practice Guidelines for management of infections, antibiotic prescriptions and other standard of care treatments and/or procedures.

c. Provider-Level Data:

1) Provider training/qualifications

d. Data reporting:

Patient-level data will be reported for each network facility using the IDCRP Network processes developed specifically for this study. Each clinical site participating within the IDCRP Network will have the capacity to collect all necessary data and transfer it within a reasonable time frame. Collection of complete data elements, as well as the facilities and capabilities to enable this collection, will be mandatory for involvement in the IDCRP Network. Data will include a sufficient number of facilities within the IDCRP Network to ensure an appropriate patient mix. Included patients will be followed for the duration of the hospital stay. A final de-identified data set of patient-level data will be provided to the Government.

e. Data collection, management, and harmonization:

Data collected at all sites will coordinate with the IDCRP Network to ensure harmonization of data where possible and standardized data reporting during all phases of the trial and across all data collection sites.

f. Ownership of Data and Analysis:

Data will be maintained by the IDCRP Network, and the primary statistical analysis for this project will be conducted by the IDCRP Network. Individual sites may conduct sub-analyses with data collected from their facility, and further analysis and dissemination of the data may be completed at the discretion of the IDCRP Network members, with all resulting abstracts and publications requiring clearance from the Government prior to submission. At the conclusion of the study, an electronic copy of the de-identified data set of patient-level data will be provided to the Government.

g. Sample collection and management:

Standard operating procedure manuals will be centrally developed, and site coordinators will be trained in data and sample collection methods. No changes to existing protocols will be directed; however, any changes to said protocols will be provided to the IDCRP’s Contracting Officer’s Representative upon implementation to adjust data analysis as appropriate.

h. Any program management or data objectives listed above that does not support the primary objectives of the study or support the study design may be recommended for removal by the study investigators with justification in the proposal. In like manner, any program management or data objective not listed above, but which will support the primary objectives of the study or study design may be recommended for addition by the study investigators with justification in the proposal.

i.

5. Timeframe: As best recommended by the PI based on study design

6. Outputs/Deliverables: Request the following outputs/deliverables:

a. Quarterly Report

b. Quarterly Quad Chart Summary

c. Operational Steering Committee (OSC) Annual Report

d. IRB protocol Continuing Reviews (annual)

e. Annual Report

f. Final Report

g. Annual Presentation (to be combined with other Task Orders)

h. Key Findings Presented at a DoD Conferences

i. Publishable Manuscripts (reviewed and approved by COR prior to publication)

j. Interim Analysis (for all relevant studies)

k. Complete De-Identified Patient-Level Data Set

l. Patient-Level Data Report

m. Facility-Level Data Report