Development of Vaccines for the Treatment of Opioid Use Disorder

The following information (below) was originally posted on FBO.gov when the pre-solicitation and solicitation were issued. The FBO system in no longer in use and all award announcements are now being publicized here in BETA.SAM.gov. Introduction: The National Institute of Allergy and Infectious Diseases (NIAID), National Institutes of Health (NIH), of the Department of Health and Human Services (DHHS) supports research related to the basic understanding of microbiology and immunology leading to the development of vaccines, therapeutics, and medical diagnostics for the prevention, treatment, and diagnosis of infectious and immune-mediated diseases. Requirement: To develop innovative and safe multivalent opioid vaccines that protect against heroin and fentanyl. Vaccine targets may include downstream metabolites (e.g., 6-acteylmorphine and morphine). Anti-opioid vaccines would induce high-affinity antibodies that bind specifically to the target opioid and prevent it from crossing the blood-brain barrier, thereby decreasing distribution of the opioid to the brain, blunting early peak exposure, and reducing neurotropic effects and opioid-induced respiratory depression. Opioid candidate vaccines are currently viewed primarily as adjunctive to other treatment modalities. Furthermore, because these candidate vaccines specifically target the opioid, rather than the opioid receptor, they should not interfere with OUD treatments or rescue drugs (e.g., methadone, buprenorphine, and naltrexone; and naloxone). Based on their specificity, vaccine induced antibodies should not interfere with physiological pain control (e.g., enkephalins and endorphins) or alternate pharmacological approaches to pain management which could be used in emergency medical situations. The work will support foundational vaccine development activities, including adjuvant screening, immunogen design, and elucidation of fundamental immune mechanisms required to induce protective anti-opioid antibodies. These mechanisms may include: determining the effect of immunogen design on immunity; the impact of opioid use on immune function and production of protective anti-opioid antibodies; and the importance of antibody subtypes on opioid vaccine efficacy. Vaccine candidates will be evaluated in appropriate animal models, and lead candidates will be selected for further testing using well defined evaluation criteria. Investigational New Drug application (IND)- enabling activities and current Good Manufacturing Practice (cGMP) production through early-stage safety and immunogenicity (Phase I) clinical trials of a lead vaccine candidate(s) will be supported. It is anticipated that multiple cost-reimbursement, completion type contracts will be awarded for a 12-month period of performance beginning on or about August 31, 2020. NIAID estimates the average annual total cost per award (direct and indirect costs) will be $2-3M per award, per year. Total cost for the award(s) may vary depending upon the scope of the project and the technical objectives of the award(s). The length of time for which funding is requested should be consistent with the nature and complexity of the proposed research. In no event shall the period of performance proposed by an offeror exceed 5 years. The research will be solicited through a Broad Agency Announcement (BAA). The BAA will only be available electronically on or about March 20, 2019 through the Government wide point of entry (GPE): FedBizOpps.gov (www.fbo.gov). Printed copies of the announcement will not be distributed. Updates or corrections to the announcement will be posted to the GPE. This notice does not commit the Government to award a contract. Collect calls will not be accepted. Facsimile transmissions will not be accepted. The BAA is governed by Federal Acquisition Regulation (FAR) 6.102(d)(2) and FAR 35.016, as well as the NIH Policy Manual, Manual Chapter 6035, Broad Agency Announcements. A BAA may be used as a solicitation mechanism for basic and applied research directed toward advancing the state-of-the-art or increasing knowledge or understanding and that part of development not related to the development of a specific system or hardware procurement. BAAs are general in nature, identifying areas of research interest, and shall only be used when meaningful proposals with varying technical/scientific approaches can be reasonably anticipated. Offers submitted in response to this BAA will be required to present separate detailed technical and business proposals designed to meet the Technical Objectives described for each Research Area proposed. The Statement of Work (SOW), including the specific technical requirements and performance specifications, shall be developed and proposed by the Offeror, not the Government.