Establishing a Scientific Agenda for Laboratory Studies to Seek Better Understanding of the STEP Trial Results

Recent findings from the STEP trial indicate that the MrkAd5 HIV trivalent vaccine lacks efficacy in reducing HIV-1 acquisition or post-infection viral load. Additional Ad5 immune subgroup analyses reveal a trend of increased risk of HIV-1 acquisition in vaccine-treated participants with baseline Ad5 neutralizing antibody titer >200. Considerations for future HIV vaccine development and clinical evaluation hinge on better understanding both of why the vaccine regimen failed and of the potential safety concerns of Ad5 or similar vectors in persons with previous immunity. Many of the scientific questions can be addressed, at least in part, by laboratory studies utilizing stored volunteer specimens and reagents from the STEP trial and other HVTN trials (Phambili, HVTN 050, HVTN 071) that evaluated the MrkAd5 HIV vaccines. Thus, seeking the advice of and working in concert with the outside scientific community, the partners in the STEP trial (Merck, DAIDS, HVTN) will devise an expeditious process for pursuing these laboratory studies and curating the findings in a uniform manner for rapid dissemination to guide future vaccine development. To that end, the Step trial follow up Scientific Review Committee (SRC) has been formed.

This committee will serve as an advisory group to the Merck/DAIDS/HVTN Oversight Committee (OC), which was established with the initial planning of the STEP trial. The OC consists of the protocol chairs and the major scientific leaders of the STEP and Phambili trials: Susan Buchbinder (SF Dept of Public Health), Mike Robertson (Merck), Dan Fitzgerald (Haiti) for STEP; Glenda Gray (Soweto) and Jim Kublin (HVTN) for Phambili; and key statistical and laboratory investigators. The OC voting members are Keith Gottesdiener (Merck), Carl Dieffenbach (DAIDS) and Larry Corey (HVTN), and Peggy Johnston (DAIDS) as ex officio. The OC reports to Peter Kim (Merck) and Tony Fauci (NIAID).

If you are interested in submitting an unsolicited proposal to conduct scientific studies using previously collected specimens from the Step trial or one of the other trials mentioned above, click here for an ancillary study application.

Click here if you are interested in doing an ancillary study NOT related to the STEP trial.


Explore further:	Establishing a Scientific Agenda for Laboratory Studies to Seek Better Understanding of the STEP Trial Results Recent findings from the STEP trial indicate that the MrkAd5 HIV trivalent vaccine lacks efficacy in reducing HIV-1 acquisition or post-infection viral load. Additional Ad5 immune subgroup analyses reveal a trend of increased risk of HIV-1 acquisition in vaccine-treated participants with baseline Ad5 neutralizing antibody titer >200. Considerations for future HIV vaccine development and clinical evaluation hinge on better understanding both of why the vaccine regimen failed and of the potential safety concerns of Ad5 or similar vectors in persons with previous immunity. Many of the scientific questions can be addressed, at least in part, by laboratory studies utilizing stored volunteer specimens and reagents from the STEP trial and other HVTN trials (Phambili, HVTN 050, HVTN 071) that evaluated the MrkAd5 HIV vaccines. Thus, seeking the advice of and working in concert with the outside scientific community, the partners in the STEP trial (Merck, DAIDS, HVTN) will devise an expeditious process for pursuing these laboratory studies and curating the findings in a uniform manner for rapid dissemination to guide future vaccine development. To that end, the Step trial follow up Scientific Review Committee (SRC) has been formed. This committee will serve as an advisory group to the Merck/DAIDS/HVTN Oversight Committee (OC), which was established with the initial planning of the STEP trial. The OC consists of the protocol chairs and the major scientific leaders of the STEP and Phambili trials: Susan Buchbinder (SF Dept of Public Health), Mike Robertson (Merck), Dan Fitzgerald (Haiti) for STEP; Glenda Gray (Soweto) and Jim Kublin (HVTN) for Phambili; and key statistical and laboratory investigators. The OC voting members are Keith Gottesdiener (Merck), Carl Dieffenbach (DAIDS) and Larry Corey (HVTN), and Peggy Johnston (DAIDS) as ex officio. The OC reports to Peter Kim (Merck) and Tony Fauci (NIAID). If you are interested in submitting an unsolicited proposal to conduct scientific studies using previously collected specimens from the Step trial or one of the other trials mentioned above, click here for an ancillary study application. Click here if you are interested in doing an ancillary study NOT related to the STEP trial.