SPECIAL NOTICE
A -- Request for Information (RFI): Human Parvovirus B19 Vaccine Development
- Notice Date
- 5/18/2016
- Notice Type
- Special Notice
- NAICS
- 541712
— Research and Development in the Physical, Engineering, and Life Sciences (except Biotechnology)
- Contracting Office
- Department of Health and Human Services, National Institutes of Health, National Heart, Lung and Blood Institute, Rockledge Dr. Bethesda, MD, Office of Acquisitions, 6701 Rockledge Dr RKL2/6100 MSC 7902, Bethesda, Maryland, 20892-7902
- ZIP Code
- 20892-7902
- Solicitation Number
- HHSN26816HB00001R
- Archive Date
- 7/21/2016
- Point of Contact
- Jeffrey Allen Williams, Phone: (301) 435-0335, Joanne F Deshler, Phone: (301) 435-0340
- E-Mail Address
-
NHLBIExtramuralContractsBranch@mail.nih.gov, deshlerj@nhlbi.nih.gov
(NHLBIExtramuralContractsBranch@mail.nih.gov, deshlerj@nhlbi.nih.gov)
- Small Business Set-Aside
- N/A
- Description
- Purpose This is a Request for Information (RFI). This is NOT a solicitation for proposals, proposal abstracts, or quotations. The purpose of this RFI is to obtain knowledge and information for project planning purposes. The National Heart, Lung, and Blood Institute (NHLBI) is interested in stimulating the development of a human parvovirus B19 vaccine that will protect individuals with sickle cell disease from serious infection- associated complications. The primary focus of this RFI is to seek information from companies, organizations, educational institutions, and consortia (hereafter referred to as companies) with the capabilities to support Stage 1 of a three staged approach to human parvovirus B19 vaccine development. The secondary focus of this RFI is to obtain information about the types of resources (cash and/or in-kind) that interested parties are willing to contribute toward Stage 1 vaccine development activities. Furthermore, the NHLBI intends to provide partial support for solicited Stage 1 activities. All relevant input will be used to ascertain project feasibility and facilitate planning to support the development and manufacture of clinical grade vaccine in Stage 1. Background Human parvovirus B19 infection is common in childhood and usually causes self-limited, flu-like symptoms (fifth disease) in healthy people. The infection can, however, cause significant morbidity and mortality in patients with sickle cell disease (SCD). These individuals may experience virus-related red cell aplasia that is often associated with serious anemia. Such episodes can be fatal and frequently require red cell transfusions to reduce the risk of circulatory collapse. Other documented complications in SCD patients include splenic sequestration crises, acute chest syndrome, nephrotic syndrome, and stroke. Since the worldwide burden of SCD is rising, parvovirus B19 infection will become an increasingly important problem. Between 2010 and 2050, it is expected that about 14.2 million babies will be born worldwide with homozygous hemoglobin S (Hb SS). Importantly, these estimates do not reflect the incidence of other sickle hemoglobinopathies (hemoglobin SC, SE, Sß thalassemia etc.) nor numbers of all age-affected individuals. There are other groups of disorders that have also been negatively affected by parvovirus B19. The virus has been linked to aplastic crises in hemolytic anemias, exacerbation of anemia in individuals with malaria, and chronic infection in immunocompromised hosts. Seronegative pregnant women are at risk for infection associated hydrops fetalis and spontaneous abortion. Clinicians have long awaited a human parvovirus B19 vaccine that would protect people with SCD and other disorders. Human parvovirus B19 is a non-enveloped virus with a single stranded DNA genome. Two proteins, VP1 and VP2 in a ratio of about 1:20, form the capsid. Infection raises humoral responses to both VP1 and VP2 but it is the increase in VP1 antibodies that is associated with viral clearance. Conversely, VP2 can spontaneously form virus-like particles (VLPs) but VP1 alone cannot. Vaccine candidates have required both antigens and, given its immunogenicity, have been VP-1 enriched. Two previous vaccine candidates were tested in human Phase I clinical trials. These were produced by co-infecting insect cells with bacilovirus recombinants, expressing VP1 and VP2. The MF59-adjuvanted vaccines elicited neutralizing antibodies but caused episodes of injection site pain and redness as well as a few more generalized reactions. Other investigators tried to circumvent these responses by using a yeast cell expression system to avoid insect cell contaminants and including a point mutation in the plasmid to inactivate VP-1's phospholipase A2 activity. MF59 adjuvant was needed to raise strong neutralizing antibody in immunized mice. No human trials have been pursued using this vaccine candidate. The NHLBI is interested in teaming arrangements with industry partners in order to complete process development and manufacture of clinical grade material. The overall strategy for these Stage 1 activities is shown in Table 1 below and will be pursued over a three year period of performance. If Stage 1 is successful, the next stages of vaccine development will consist of Phase I clinical trials in healthy adults, Phase I/II studies in children with SCD, and ultimately licensure based upon the vaccine's effect on established correlates of protection. A post-licensure effectiveness study may then be pursued. Table 1: Parvovirus B19 Vaccine Development Plan: Stage 1 A c t i v i ties Over Three Year Period of Performance Establishment of a strategy for vaccine preparation Process and assay development Regulatory review of toxicology protocol GLP toxicology material production Repeat dose GLP toxicology study Preparation of briefing book GMP clinical material production Quality review and release of material Secondary packaging IND publication and submission The NHLBI staff aims to work with the awardee to identify serologic correlates of protection and develop serologic assays. They will also perform the planning for the Phase I clinical trial in healthy adults. The NHLBI also intends to make available the information generated during their experience formulating a parvovirus B19 vaccine candidate. If Stage1 is successful, the NHLBI anticipates providing additional funding to help support the next stages of vaccine development pivotal to licensure. These include: 1. Stage 2- Phase I clinical trial in healthy adults to be performed at NHLBI's Clinical Center; 2. Stage 3- Phase I/II studies in children with sickle cell disease, based upon the vaccine's effect on established correlates of protection. A post-licensure effectiveness study may then be pursued after the completion of Stage 3. It is anticipated that the research effort(s) leading to the successful commercialization of this vaccine will realize significant tangible benefits worldwide. Information Requested The NHLBI requests input on the following issues related to the initial three year vaccine development strategy outlined above. •1 1. Describe your organization's experience and ability to design and manufacture clinical grade vaccine using VP1 (enriched) and VP2 capsid antigens. •2. 2. Describe the expression system that your organization would be most likely to use. •3. 3. Please provide any input or rough order of magnitude estimates for effort, time, and/or resources required for the completion Stage 1 activities related to, and necessary for, process development and clinical grade manufacture of a human parvovirus B19 vaccine. •4. 4. Describe the types of resources (cash or in-kind) that your organization may be willing to contribute to this requirement. •5. 5. Please provide your opinion(s) or other additional information that will be helpful in developing or finalizing our requirement. •6. 6. Provide DUNS number (if available), organization name, address, point of contact, and type of business. Requested response •· Please provide • The requested response/information electronically, in either Microsoft word or Adobe PDF. • Respondents' technical and administrative points of contact, including names, titles, addresses, telephone and fax numbers, and e-mail addresses as applicable •· Please send the information to: • Jeffrey Williams Contracting Officer NHLBI Extramural Contracts Branch Office of Acquisitions, Office of Management (OM) National Heart, Lung, and Blood Institute 6701 Rockledge Drive, Room 6105, MSC 7902 Bethesda, MD. 20892-7902 Telephone: 301-435-0335 Email: NHLBIExtramuralContractsBranch@mail.nih.gov FedConnect Interested parties are encouraged to register in Compusearch's FedConnect. Fed Connect is a web portal that connects agencies and vendors to streamline the process of doing business with the federal government. It also provides an open channel of communication with the government that is both secure and auditable. The use of FedConnect also furthers the NHLBI's commitment to moving towards a paperless acquisition environment by reducing its carbon footprint and conducting its business in an ecologically friendly manner. There is no cost to vendors to register. Vendors do not need to register to respond to this Notice. Vendors can register with FedConnect at https://www.fedconnect.net/FedConnect/default.htm. Please note that FedConnect is used by multiple federal agencies and therefore FedConnect assistance will be provided by Compusearch Software Systems, not the NHLBI OA. More information about registration requirements can be found by downloading the FedConnect Ready, Set, Go! Guide at: https://www.fedconnect.net/fedconnect/Marketing/Documents/FedConnect_Ready_Set_Go.pdf. For assistance in registering or for other FedConnect technical questions please call the FedConnect Help Desk at (800) 899-6665 or email at support@fedconnect.net. 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. Information provided will be used to assess tradeoffs and alternatives available for the potential requirement and may lead to the development of a solicitation. 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. Any solicitation resulting from the analysis of information obtained will be announced to the public in Federal Business Opportunities in accordance with the FAR Part 5. 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).
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