Vax Update: HVTN 505
This page includes information on the Step and
Phambili trials of Merck's MRK-Ad5 vaccine
candidate (immunizations were stopped in
September 2007). It also includes information
on the NIH Vaccine Research Center's DNA
prime/Ad5 boost vaccine strategy—initially
planned to be tested in the proposed but never
conducted PAVE 100 vaccine trial—tested in
the trial HVTN 505.
Visit our vaccines page for more on the latest research.
The storylines of these trials are intertwined, making it important for advocates to understand the "big picture" as it has been revealed in recent years. These trials and their attendant issues have been explored in AVAC Report 2009: Piecing Together the HIV Prevention Puzzle. In the Report, we address the communications efforts, community engagement, and scientific discussions around these vaccine studies. To get a sense of the past and ongoing discussions, we invite you to download the following two pieces from the AVAC Report:
For additional background materials on Step, Phambili, PAVE 100, and HVTN 505, including press releases, fact sheets, call recordings, and comment letters filed in the last few years, please see below.
HVTN 505 Trial Stops Immunizations
PAVE 100 Trial
NIAID announces it will not move forward with the PAVE 100 HIV vaccine trial
Treatment Action Group (TAG) Position Statement on the Proposed PAVE 100A Vaccine Trial (May 30, 2008)
Community HIV/AIDS Mobilization Project (CHAMP) comments on PAVE 100A trial (May 29, 2008)
Making sense of the PAVE 100 debate: A tool for HIV prevention advocates (May 2008)
This document is designed to help advocates, community groups, and other stakeholders understand some of the key questions that have been raised in discussions about PAVE 100.
Making sense of the PAVE 100 debate: In Brief (May 2008)
This one-pager is designed to give advocates a quick look at the issues and key questions raised in discussions about PAVE 100.
En español
No português
Step and Phambili Trials
Key publications and materials on the Step results:
An Advocates' Guide to Recent Publications on the STEP AIDS Vaccine Trial Data - AVAC, December 2008
This publication discusses key articles looking at and analyzing data from the STEP AIDS vaccine trial. Two of the pieces reviewed were published in The Lancet and go over findings to date that have also been reported in conferences over the past years. These Lancet articles were accompanied by a commentary by Merlin Robb of the US Military HIV Research Program. Links to the abstract for all three articles can be found below.
HIV-1 vaccine-induced immunity in the test-of-concept Step Study: a case-cohort analysis. Lancet. 2008 Nov 29; 372(9653):1894-1905.
Failure of the Merck HIV vaccine: an uncertain step forward. Lancet, 2008 Nov 29; 372(9653):1857-1858.
Efficacy assessment of a cell-mediated immunity HIV-1 vaccine (the Step Study): a double-blind, randomised, placebo-controlled, test-of-concept trial. Lancet. 2008 Nov 29; 372(9653)1881-1893.
HIV Vaccine Trials Network fact sheet on the HVTN 505 trial. November 2008.
STEP Study Volunteers to be Informed Whether They Received Vaccine or Placebo. November 13, 2007.
Merck and the HVTN announce that they will disclose to Step study volunteers information on whether they received vaccine or placebo.
A timeline of the release of Step results:
November 7, 2007
Additional data from the Step study was presented at a public forum at the HIV Vaccine Trials Network full group meeting:
November 2007 HVTN Conference Presentations. (downloadable slide sets)
AVAC statement.
Draft Q&A on new data.
Merck/HVTN press release.
Statement from Dr. Anthony Fauci, Director of NIAID.
IAVI statement.
October 23, 2007
After further review of Step data, Phambili oversight committee decides to permanantly suspend enrollment and vaccination:
AVAC statement.
NIAID press release.
SAAVI press release.
Trials Q&A from NIAID.
September 21, 2007
Vaccinations discontinued in Step study of Merck Ad5 candidate and companion trial, Phambili, is paused:
AVAC statement.
IAVI statement.
Merck and HVTN press release.
NIAID press release.
Treatment Action Group (TAG) statement (September 24, 2007).
WHO statement (September 24, 2007).
AVAC summary coverage of the December 12, 2007 meeting of the AIDS Vaccine Research Subcommittee of the NIH AIDS Research Advisory Committee - PDF (December 20, 2007)
Visit our vaccines page for more on the latest research.
The storylines of these trials are intertwined, making it important for advocates to understand the "big picture" as it has been revealed in recent years. These trials and their attendant issues have been explored in AVAC Report 2009: Piecing Together the HIV Prevention Puzzle. In the Report, we address the communications efforts, community engagement, and scientific discussions around these vaccine studies. To get a sense of the past and ongoing discussions, we invite you to download the following two pieces from the AVAC Report:
- A Trial by Any Other Name: HVTN
505 and the VRC candidate
(2009)
- PAVE 100 to HVTN 505: Key
events and communications about testing the VRC
strategy (2009)
For additional background materials on Step, Phambili, PAVE 100, and HVTN 505, including press releases, fact sheets, call recordings, and comment letters filed in the last few years, please see below.
HVTN 505 Trial Stops Immunizations
- Read
NIAID's
statement and updated
Q&A
- Read the AVAC statement
- Join us for a global
advocates' webinar on April 30 11am
Eastern
PAVE 100 Trial
NIAID announces it will not move forward with the PAVE 100 HIV vaccine trial
- AVAC Statement (July 17, 2008)
- Statement from NIAID (July 17, 2008)
Treatment Action Group (TAG) Position Statement on the Proposed PAVE 100A Vaccine Trial (May 30, 2008)
Community HIV/AIDS Mobilization Project (CHAMP) comments on PAVE 100A trial (May 29, 2008)
Making sense of the PAVE 100 debate: A tool for HIV prevention advocates (May 2008)
This document is designed to help advocates, community groups, and other stakeholders understand some of the key questions that have been raised in discussions about PAVE 100.
Making sense of the PAVE 100 debate: In Brief (May 2008)
This one-pager is designed to give advocates a quick look at the issues and key questions raised in discussions about PAVE 100.
En español
- Comprendamos el debate en torno al PAVE 100: Una herramienta para los grupos de tareas que trabajan en la prevención del VIH
- Comprendamos el debate en torno al PAVE 100: En Breve
No português
- Entendendo o debate sobre a PAVE 100: Uma ferramenta para os defensores da prevenção ao HIV
- Entendendo o debate sobre a PAVE 100: No sumário
Step and Phambili Trials
Key publications and materials on the Step results:
An Advocates' Guide to Recent Publications on the STEP AIDS Vaccine Trial Data - AVAC, December 2008
This publication discusses key articles looking at and analyzing data from the STEP AIDS vaccine trial. Two of the pieces reviewed were published in The Lancet and go over findings to date that have also been reported in conferences over the past years. These Lancet articles were accompanied by a commentary by Merlin Robb of the US Military HIV Research Program. Links to the abstract for all three articles can be found below.
HIV-1 vaccine-induced immunity in the test-of-concept Step Study: a case-cohort analysis. Lancet. 2008 Nov 29; 372(9653):1894-1905.
Failure of the Merck HIV vaccine: an uncertain step forward. Lancet, 2008 Nov 29; 372(9653):1857-1858.
Efficacy assessment of a cell-mediated immunity HIV-1 vaccine (the Step Study): a double-blind, randomised, placebo-controlled, test-of-concept trial. Lancet. 2008 Nov 29; 372(9653)1881-1893.
HIV Vaccine Trials Network fact sheet on the HVTN 505 trial. November 2008.
STEP Study Volunteers to be Informed Whether They Received Vaccine or Placebo. November 13, 2007.
Merck and the HVTN announce that they will disclose to Step study volunteers information on whether they received vaccine or placebo.
A timeline of the release of Step results:
November 7, 2007
Additional data from the Step study was presented at a public forum at the HIV Vaccine Trials Network full group meeting:
November 2007 HVTN Conference Presentations. (downloadable slide sets)
AVAC statement.
Draft Q&A on new data.
Merck/HVTN press release.
Statement from Dr. Anthony Fauci, Director of NIAID.
IAVI statement.
October 23, 2007
After further review of Step data, Phambili oversight committee decides to permanantly suspend enrollment and vaccination:
AVAC statement.
NIAID press release.
SAAVI press release.
Trials Q&A from NIAID.
September 21, 2007
Vaccinations discontinued in Step study of Merck Ad5 candidate and companion trial, Phambili, is paused:
AVAC statement.
IAVI statement.
Merck and HVTN press release.
NIAID press release.
Treatment Action Group (TAG) statement (September 24, 2007).
WHO statement (September 24, 2007).
AVAC summary coverage of the December 12, 2007 meeting of the AIDS Vaccine Research Subcommittee of the NIH AIDS Research Advisory Committee - PDF (December 20, 2007)