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About PAVE 100

The National Institute of Allergy and Infectious Diseases (NIAID), a component of the National Institutes of Health, US Department of Health and Human Services, is planning a phase IIb HIV/AIDS vaccine study currently referred to as PAVE 100 or The Pave Study, at multiple sites in the US and internationally, in conjunction with several partner organizations.

This 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 to be evaluated 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 most likely will not by itself be sufficient for licensure. The best outcome would be a finding that the vaccine offers a high level of protection from infection, or among those who become infected despite vaccination, results in a large and sustained decrease in viral load, with clinical benefits. Whatever type and level of protection the vaccine may be found to provide, this trial is critically important to help scientists learn how future effective vaccine candidates might be developed and improved.

Trial Information

Locations

Proposed sites in East Africa, Southern Africa, Latin America, the Caribbean, and the US (up to 13 countries total), pending FDA, host country and site regulatory approvals. As of June 2007, documents have not been submitted to all host country regulatory authorities, or approved to move forward, so specific countries or sites have not yet been determined.

Timing

A phased launch is planned, starting in the US in fall 2007, followed by international sites starting later in 2007 or early 2008. Results are anticipated in late 2011.

Size

Approximately 3,000 participants in East Africa, 2,500 participants in Southern Africa, and 3,000 participants in the Americas and the Caribbean.

Trial Objectives

The study will test:

Whether the vaccine prevents HIV-1 infection
Whether vaccination results in decreased levels of HIV-1 in the blood if volunteers later become infected despite vaccination

Please note, the vaccine does not cause HIV infection, and participants will receive repeated counseling on how to avoid exposure to HIV. All clinical trials also monitor safety.

Partners

Sponsor

Division of AIDS, National Institute of Allergy and Infectious Diseases (NIAID), National Institutes of Health, US Department of Health and Human Services

Vaccine Developer

The Dale and Betty Bumpers Vaccine Research Center, NIAID

The Trial will be Conducted by:

The HIV Vaccine Trials Network
(supported by a cooperative agreement with NIAID)
The International AIDS Vaccine Initiative
(partially supported by a cooperative agreement with the US Agency for International Development)
The US Military HIV Research Program
(partially supported by a cooperative agreement with the Henry M. Jackson Foundation for the Advancement of Military Medicine)
The US Centers for Disease Control and Prevention
(decision pending site development progress)

Why this Study is Important

New tools for preventing HIV infection are needed. Vaccines have been central in controlling 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 still annually outnumber the people who are able to initiate ART.

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.

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 each country where the trial will be conducted.

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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About PAVE 100 The National Institute of Allergy and Infectious Diseases (NIAID), a component of the National Institutes of Health, US Department of Health and Human Services, is planning a phase IIb HIV/AIDS vaccine study currently referred to as PAVE 100 or The Pave Study, at multiple sites in the US and internationally, in conjunction with several partner organizations. This 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 to be evaluated 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 most likely will not by itself be sufficient for licensure. The best outcome would be a finding that the vaccine offers a high level of protection from infection, or among those who become infected despite vaccination, results in a large and sustained decrease in viral load, with clinical benefits. Whatever type and level of protection the vaccine may be found to provide, this trial is critically important to help scientists learn how future effective vaccine candidates might be developed and improved. Trial Information Locations Proposed sites in East Africa, Southern Africa, Latin America, the Caribbean, and the US (up to 13 countries total), pending FDA, host country and site regulatory approvals. As of June 2007, documents have not been submitted to all host country regulatory authorities, or approved to move forward, so specific countries or sites have not yet been determined. Timing A phased launch is planned, starting in the US in fall 2007, followed by international sites starting later in 2007 or early 2008. Results are anticipated in late 2011. Size Approximately 3,000 participants in East Africa, 2,500 participants in Southern Africa, and 3,000 participants in the Americas and the Caribbean. Trial Objectives The study will test: Whether the vaccine prevents HIV-1 infection Whether vaccination results in decreased levels of HIV-1 in the blood if volunteers later become infected despite vaccination Please note, the vaccine does not cause HIV infection, and participants will receive repeated counseling on how to avoid exposure to HIV. All clinical trials also monitor safety. Partners Sponsor Division of AIDS, National Institute of Allergy and Infectious Diseases (NIAID), National Institutes of Health, US Department of Health and Human Services Vaccine Developer The Dale and Betty Bumpers Vaccine Research Center, NIAID The Trial will be Conducted by: The HIV Vaccine Trials Network (supported by a cooperative agreement with NIAID) The International AIDS Vaccine Initiative (partially supported by a cooperative agreement with the US Agency for International Development) The US Military HIV Research Program (partially supported by a cooperative agreement with the Henry M. Jackson Foundation for the Advancement of Military Medicine) The US Centers for Disease Control and Prevention (decision pending site development progress) Why this Study is Important New tools for preventing HIV infection are needed. Vaccines have been central in controlling 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 still annually outnumber the people who are able to initiate ART. 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. 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 each country where the trial will be conducted. 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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