RFP Announcement:  Staged Vaccine Development (SVD) BAA NIAID-DAIDS-NIHAI2012151


Notice Number: NOT-AI-13-025

Key Dates

Release Date:  February 5, 2013  

Issued by

National Institute of Allergy and Infectious Diseases (NIAID)

Purpose

The Division of Acquired Immune Deficiency Syndrome (DAIDS) of the National Institute of Allergy and Infectious Diseases (NIAID), National Institutes of Health (NIH), is committed to the development of efficacious preventive vaccines and against HIV-1 for worldwide use to end the AIDS epidemic.  While industry, government, and academia have contributed considerable resources to this effort over the past 30 years, no fully effective vaccine has emerged.  A wide assortment of candidate HIV-1 vaccines have reached Phase I clinical trials but only three vaccine regimens have advanced to efficacy testing.  One of these 3 trials, designated RV144, has shown modest efficacy in humans and this result coupled with promising results from nonhuman primate (NHP) studies has now stimulated the field to continue to test more advanced innovative vaccine candidates in humans.  To augment the development portion of the process for identifying and ultimately testing an improved HIV vaccine, NIAID will be using a staged development approach to allow the rapid advancement of promising HIV vaccine candidates to CGMP manufacturing for subsequent clinical testing.  The primary intent of this Broad Agency Announcement (BAA) solicitation is to provide support to multifunctional teams for the advanced development and manufacture of HIV vaccine candidates that have demonstrated success in NHP challenge studies, equivalent preclinical animal models or early human clinical trials, and have demonstrated manufacturing feasibility.  The activities supported through the contracts resulting from this BAA will allow the further development of the leading innovative HIV vaccine candidates listed below. 

  • Recombinant HIV proteins including HIV envelopes, envelope derivatives, Virus Like Particles
  • (VLPs), as well as formulations of HIV proteins with immune enhancers such as adjuvants and immune modulators.
  • POX virus (e.g. Fowlpox, NYVAC, ALVAC, Modified Vaccinia Ankara (MVA) vector-based vaccine candidates).
  • DNA vaccines, including DNA delivery device technologies and DNA expressed immune modulators.
  • Replication defective adenovirus vectors with low sero-prevelence in the relevant human population.
  • Replication competent viral vectors (e.g. Flaviviridae, Adenoviridae, Alphaherpesvirinae Rhabdoviridae).

Awards will be based on the evaluation of the potential to advance the vaccine candidates forward through a three-stage approach.  This staged approach will allow NIAID flexibility to quickly advance vaccine candidates into milestone driven CGMP manufacturing for testing in clinical trials.  Briefly, the 3 stages are as follows:

  • Stage I- refinement and implementation of the product development plan and the initiation of limited activities to prepare for the CGMP production of the vaccine candidate;
  • Stage II- manufacture, formulation, and release of the product for phase I/II/III clinical trials;
  • Stage III- continuation of the ongoing stability program, pre-licensure activities, continued product characterization studies, and updated regulatory submissions that would allow the product to remain in regulatory compliance and acceptable for future clinical trials.

NIAID anticipates making 4 to 6 awards for Stage I. Each contract will be initially awarded for up to a two year base period to support Stage I activities and will include two options for Stage II and Stage III activities.  Options for Stage II and III awards will be exercised based on Go/No Go decisions.  Once Stage I milestones are met, the decision to fund the option for Stage II will depend upon the scientific priority, program balance, and the availability of funds.  Likewise, the funding of the option for Stage III will depend on meeting Stage II milestones, as well as scientific priority, program balance, and the availability of funds.

The NIAID reserves the right to award all or any portion of the activities proposed based on technical merit, scientific priority, programmatic balance, and the availability of funds.  Furthermore, the NIAID recognizes that product development is an iterative process and that the progress of a candidate product through the development pathway requires ongoing evaluation to assess and reassess the likelihood of the candidate to meet the desired objectives.  Therefore, the NIAID reserves the right to determine, at any time during the contract period, that a particular candidate product has not demonstrated sufficient potential to merit further investment in the development and evaluation of that candidate vaccine.

The NIAID, therefore, reserves the right to modify or delete milestones, decision points, research plans, timelines, or re-budget as needs may arise.  At designated milestones or decision points, the NIAID will evaluate whether to continue, redirect or modify the proposed plans.  The NIAID reserves the right to change process, schedule, or event to add or delete part or all of these elements as necessary.

The NIAID is aware that no single organization or institution may have the expertise and facilities required to perform all parts of their proposed Statement of Work.  Therefore, it may be necessary for the Contractor to subcontract a portion of the work.  In addition, the Contractor is not limited to a domestic institution or organization, and subcontracting to foreign organizations/institutions is permitted.  The Contractor shall be responsible for ALL work performed under this contract including that performed by any subcontractor(s).

Research and Technical Objectives

This BAA targets development and production of novel, innovative, preventive HIV/AIDS vaccines for use in later phase clinical trials.  These vaccines will have been identified as promising preventive HIV vaccine candidates that have shown promise in nonhuman primate (NHP) efficacy studies, equivalent preclinical animal models or early clinical trials.  The goal of the BAA is to develop further a comprehensive strategic development plan for manufacturing several vaccine candidates and to initiate manufacture of a limited number of vaccine candidates suitable for subsequent safety and efficacy testing in humans.

For purposes of this BAA, a vaccine product is defined to be a material and its manner of administration that could reasonably be expected to provide protection against the establishment of HIV infection.  A vaccine concept includes both HIV immunogens that the immune system encounters for inducing protection against HIV or progression to AIDS and the methods of delivery, which can include adjuvants and new immunomodulators.  Examples of HIV immunogens include virus-like particles and adjuvanted proteins, either delivered directly in the manner of a traditional vaccine composition or delivered as part of a vector system.  DNA, viral vector approaches (e.g., pox adenoviral, etc.), or direct administration can accomplish the delivery of these HIV immunogens.  To date concepts based on these immunogen/vaccine platforms have shown promise in animal and human studies and may now need to be manufactured to scale for larger clinical trials.  The benefits anticipated from advancing these vaccine platforms containing HIV immunogens may include induction of more potent antibody responses with additional activities such as cross-clade neutralization, antibody-dependent cell-mediated cytotoxicity (ADCC), and antibody-dependent cell-mediated viral inhibition (ADCVI) activity.  Where appropriate, improvements (e.g., breadth, polyfunctionality, perforin and granzyme expression) to HIV specific CD4 and CD8 T-Lymphocyte responses may also be a component of the advanced vaccine platform.  Vaccine platforms, which have demonstrated feasibility of CGMP manufacturing and have undergone a Phase I clinical trial showing promising results, are highly desired. Additional technologies that increase vaccine stability and/or reduce logistical requirements will be supported as components of the candidate product.  Novel approaches such as mucosal delivery may be components of the vaccine platform as well. Offerors responding to this BAA shall have documented expertise in manufacturing and advancing innovative vaccine candidates to clinical trials, and experience with regulatory submissions.

The contracts awarded as a result of this BAA shall include a detailed Product Development Plan describing the activities for all the stages of the award.  Specifically, the BAA for Staged Vaccine Development requires the following 3 stages:

•   Stage I

    • Refinement of the PDP based on post-award peer-review/Program comments and implementation of early activities of the product development and manufacturing plans  
    • Further engagement and qualification of vendors and subcontractors that may be used for all phases of product development
    • Initiation of limited activities to prepare for CGMP manufacturing
    • Assurance of complete compliance with all CGMP regulations
    • Identify members for SAB

•    Stage II

    • cGMP Preparation of the Master Cell Banks/Seeds and Working Cell Banks/Seeds
    • cGMP Manufacturing, characterization, and release of bulk drug substance (BDS)
    • cGMP Manufacturing, characterization, and release of final drug product (FDP)
    • cGMP Formulation Fill/Finish vaccine material for use in Phase I/II/III human clinical trials
    • Preparation of all necessary documentation for Chemistry, Manufacturing and Control (CMC) sections; and letters of cross-references to Drug Master Files (DMF) that will allow the NIAID to perform subsequent clinical trials or allow their use for any other Government purpose to support Phase I/II/III clinical studies
    • cGMP release testing of the product 
    • Preparation of certificates of analyses and certificates of CGMP compliance
    • Initiation of a Stability Program for BDS and FDP
    • Initiation of a Storage Program for cell banks/seeds, product, and production materials (retains) as well as paper and electronic documents
    • Hold SAB at specific milestones as deemed necessary by the COR

•   Stage III

    • Continuation of Stability Program
    • Continuation of Storage Program
    • Preparation of documents for regulatory meetings with agencies /authorities and filing of appropriate updated regulatory submissions
    • Further process optimization to increase manufacturing scale (when requested by COR)

All activities must be performed in strict adherence to FDA regulations and guidance, including requirements for manufacturing of the vaccine candidate under CGMP (21 CFR 11, 210, 211, 600-680, and 820) and the conduct of animal studies and assays under GLP (21 CFR 58).

This contract will not support the following:

  • Proof-of-Concept Non-Human Primate (NHP) efficacy experiments.  However, CGLP preclinical NHP and small animal toxicology and immunogenicity studies will be allowed for vaccine safety, characterization, and quality control.
  • Human clinical trials.
  • The manufacture of the vaccine candidate in facilities NOT fully CGMP compliant (21 CFR 11, 210, 211, 600-680, and 820). 
  • Offerors who do not have the physical manufacturing capacity or a plan for accessing subcontract manufacturing capacity, to deliver final formulated, fill/finished vaccine doses to conduct Phase I/II/III clinical trials. 
  • Establishing a manufacturing facility.
  • Manufacture of therapeutic vaccines.

The NAICS Code is 541712 with a size standard of 500 employees.

Any responsible offeror may submit a proposal, which will be considered by the Agency.   This BAA will be available electronically on/about February 5, 2013, and may be accessed through Federal Business Opportunities website:  http://www.fedbizopps.gov/.  This notice does not commit the Government to award a contract.  No collect calls will be accepted.  No facsimile transmissions will be accepted.

Inquiries

Please direct all inquiries to:

Department of Health and Human Services
National Institutes of Health
National Institute of Allergy and Infectious Diseases
Division of Extramural Activities
Office of Acquisitions
6700B Rockledge Drive
Room 3214, MSC 7612
Bethesda, MD 20892-7612

POINT OF CONTACT

George Keane, Contract Specialist
Office of Acquisitions, Division of Extramural Activities, NIAID, NIH, DHHS
6700B Rockledge Drive Room 3214, MSC 7612 (Express mail:  Use Zip Code 20817)
Phone: 301-451-3690
Fax: 301-480-4675
Email: george.keane@nih.gov

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