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PAVE 100

The National Institute of Allergy and Infectious Diseases (NIAID), in conjunction with several partner organizations, is planning a phase IIb HIV/AIDS vaccine study at multiple sites in the US and internationally.

The study-- currently referred to as PAVE 100 or The Pave Study-- will be a phase IIb test-of-concept, randomized, double-blind, placebo-controlled, international clinical trial to evaluate the efficacy, safety and immunogenicity of a multiclade HIV-1 DNA Plasmid Vaccine (VRC-HIVDNA016-00-VP), followed by a multiclade recombinant adenoviral vector vaccine (VRC-HIVADV014-00-VP), in HIV-uninfected persons.

The vaccine candidate is being developed by the NIAID Dale and Betty Bumpers Vaccine Research Center.

No significant safety issues have been identified in phase I/II trials to date. The upcoming phase IIb trial will assess the vaccine’s efficacy in a larger number of human volunteers, but the results most likely will be sufficient for licensure.

Ideally, the study will show that the vaccine offers a high level of protection from infection, and/or that it results in a large and sustained decrease in viral load among those who become infected despite vaccination. Whatever outcome, the hope is that this trial will offer insight into how future vaccine candidates might be improved.

LOCATIONS

Proposed sites are in East Africa, Southern Africa, Latin America, the Caribbean and the US--up to 13 countries total. Final site selection is pending FDA, host country and site regulatory approvals. As of June 2007, some host countries had not yet submitted documentation to their regulatory authorities and subsequently have not yet been approved to move forward. Once all documentation has been received, reviewed and approved, final study sites will be determined.

SIZE

The study will include approximately 3,000 participants in East Africa, 2,500 participants in Southern Africa and 3,000 participants in the Americas and the Caribbean.

PARTNERS

Sponsor: Division of AIDS, NIAID, National Institutes of Health, US Department of Health and Human Services
Product Developer: The Dale and Betty Bumpers Vaccine Research Center, NIAID
Trial Implementers:
The HIV Vaccine Trials Network (HVTN) (supported by a cooperative agreement with NIAID)
The International AIDS Vaccine Initiative (IAVI) (partially supported by a cooperative agreement with the US Agency for International Development) o The US Military HIV Research Program (USHMRP) o The US Centers for Disease Control and Prevention (CDCP) (decision pending site development progress) TRIAL OBJECTIVES The study will test: 1. Whether the vaccine prevents HIV-1 infection 2. Whether vaccination results in decreased levels of HIV-1 in the blood of volunteers who later become infected despite vaccination The vaccine does not cause HIV infection, and participants will receive repeated counseling on how to avoid exposure to HIV. All clinical trials will be governed by data safety and monitoring boards. RATIONALE 1. New tools for preventing HIV infection are needed. Vaccines have been proven effective in the prevention of many infectious diseases, and most scientists agree that a vaccine to bring HIV under control is both possible and essential. Despite important advances in antiretroviral therapy, new HIV infections annually still outnumber the people who are able to initiate ART. 2. Treatment and epidemiological studies in humans and experiments in animal models led to the hypothesis that vaccination could improve the immune control of viral load in vaccinees that subsequently become HIV-1-infected through natural exposure. This may result in longer disease-free survival, minimized need for anti-retroviral treatment, and diminished ability to transmit the virus to others. IMPLICATIONS Unless the vaccine is shown to be highly effective in preventing HIV-1 infection, the results from this study alone are unlikely to be sufficient for licensure of the vaccine. Study results will enable the sponsor to decide whether the product merits one or more large Phase III trials designed to support licensure. The trial may also provide information about the specific types of immune responses needed to protect from infection or control viral load and thus provide valuable guidance for improved vaccine design and accelerated development. CONTACT INFORMATION • Outside the US: • Contact information will be provided to each US Embassy and PEPFAR team in host countries once site selection is finalized. • In the US: • Media inquiries: NIAID media office, (301) 402-1663, niaidnews@niaid.nih.gov • Operational questions: Bob Gramzinski, rgramzinski@niaid.nih.gov


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PAVE 100 The National Institute of Allergy and Infectious Diseases (NIAID), in conjunction with several partner organizations, is planning a phase IIb HIV/AIDS vaccine study at multiple sites in the US and internationally. The study-- currently referred to as PAVE 100 or The Pave Study-- will be a phase IIb test-of-concept, randomized, double-blind, placebo-controlled, international clinical trial to evaluate the efficacy, safety and immunogenicity of a multiclade HIV-1 DNA Plasmid Vaccine (VRC-HIVDNA016-00-VP), followed by a multiclade recombinant adenoviral vector vaccine (VRC-HIVADV014-00-VP), in HIV-uninfected persons. The vaccine candidate is being developed by the NIAID Dale and Betty Bumpers Vaccine Research Center. No significant safety issues have been identified in phase I/II trials to date. The upcoming phase IIb trial will assess the vaccine’s efficacy in a larger number of human volunteers, but the results most likely will be sufficient for licensure. Ideally, the study will show that the vaccine offers a high level of protection from infection, and/or that it results in a large and sustained decrease in viral load among those who become infected despite vaccination. Whatever outcome, the hope is that this trial will offer insight into how future vaccine candidates might be improved. LOCATIONS Proposed sites are in East Africa, Southern Africa, Latin America, the Caribbean and the US--up to 13 countries total. Final site selection is pending FDA, host country and site regulatory approvals. As of June 2007, some host countries had not yet submitted documentation to their regulatory authorities and subsequently have not yet been approved to move forward. Once all documentation has been received, reviewed and approved, final study sites will be determined. SIZE The study will include approximately 3,000 participants in East Africa, 2,500 participants in Southern Africa and 3,000 participants in the Americas and the Caribbean. PARTNERS Sponsor: Division of AIDS, NIAID, National Institutes of Health, US Department of Health and Human Services Product Developer: The Dale and Betty Bumpers Vaccine Research Center, NIAID Trial Implementers: The HIV Vaccine Trials Network (HVTN) (supported by a cooperative agreement with NIAID) The International AIDS Vaccine Initiative (IAVI) (partially supported by a cooperative agreement with the US Agency for International Development) o The US Military HIV Research Program (USHMRP) o The US Centers for Disease Control and Prevention (CDCP) (decision pending site development progress) TRIAL OBJECTIVES The study will test: 1. Whether the vaccine prevents HIV-1 infection 2. Whether vaccination results in decreased levels of HIV-1 in the blood of volunteers who later become infected despite vaccination The vaccine does not cause HIV infection, and participants will receive repeated counseling on how to avoid exposure to HIV. All clinical trials will be governed by data safety and monitoring boards. RATIONALE 1. New tools for preventing HIV infection are needed. Vaccines have been proven effective in the prevention of many infectious diseases, and most scientists agree that a vaccine to bring HIV under control is both possible and essential. Despite important advances in antiretroviral therapy, new HIV infections annually still outnumber the people who are able to initiate ART. 2. Treatment and epidemiological studies in humans and experiments in animal models led to the hypothesis that vaccination could improve the immune control of viral load in vaccinees that subsequently become HIV-1-infected through natural exposure. This may result in longer disease-free survival, minimized need for anti-retroviral treatment, and diminished ability to transmit the virus to others. IMPLICATIONS Unless the vaccine is shown to be highly effective in preventing HIV-1 infection, the results from this study alone are unlikely to be sufficient for licensure of the vaccine. Study results will enable the sponsor to decide whether the product merits one or more large Phase III trials designed to support licensure. The trial may also provide information about the specific types of immune responses needed to protect from infection or control viral load and thus provide valuable guidance for improved vaccine design and accelerated development. CONTACT INFORMATION • Outside the US: • Contact information will be provided to each US Embassy and PEPFAR team in host countries once site selection is finalized. • In the US: • Media inquiries: NIAID media office, (301) 402-1663, niaidnews@niaid.nih.gov • Operational questions: Bob Gramzinski, rgramzinski@niaid.nih.gov Printable View
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