Go Directly to the GSID HIV Data Browser
If you are a new user of the GSID HIV Data Browser website, please click here to go to the GSID HIV Data Browser login tutorial and begin the registration process. If you are a current registered user and have a username and password, please click here to go directly to the login page.
History and Background
Between 1998 and 2003, the world’s first Phase III clinical trials of a HIV/AIDS vaccine – AIDSVAX - were conducted by VaxGen, Inc., a South San Francisco-based biotechnology company. The first trial, known as VAX004 was conducted in North America and Europe; and the second trial, VAX003, was conducted in Bangkok, Thailand in collaboration with the Thai Ministry of Public Health and the School of Tropical Medicine of Mahidol University. For the first release of the GSID HIV Data Browser, the primary focus will be VAX004, the North American and European clinical trial. Data from VAX003 will be added to the browser in an upcoming release.
The founders of GSID - Don Francis, Phil Berman and Carter Lee - were all senior executives with VaxGen, Inc. Together, all three left VaxGen in early 2004 to form GSID, where one of their first milestones was to negotiate a license and material transfer agreement with VaxGen to obtain rights to all of the clinical data and specimens gathered during the AIDSVAX clinical trials. Under this agreement, GSID took possession of amore 300,000 tubes of serological material, over 1.2 million electronic pages of clinical information and volumes of other scientific data generated during and after the conduct of the trials.
AIDSVAX Trial Design
Both Phase III clinical trials were double-blind and placebo-controlled, where the test group of volunteers received AIDSVAX while the placebo group received a comparable-appearing placebo containing alum alone. During the trials, neither volunteers, clinical researchers, nor VaxGen knew which volunteers were given the vaccine or placebo until the trials were completed and un-blinded. Each volunteer was vaccinated seven times over a 30-month period. The purpose of the booster doses, at months 1, 6, 12, 18, 24 and 30 was to stimulate high antibody levels throughout the entire trial period. During each follow-up visit, the volunteers received counseling on how to avoid the risk of HIV infection, were asked a series of clinical questions and had their blood drawn at months 0, 1, 6, 12, 18, 24, 30 and 36 for serological testing.
VAX004 Trial Design Summary |
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|---|---|
| HIV transmission: | Sexual |
| Volunteers: | 5,100 MSM and 300 women |
| Expected annual infection rate: | 1.50% |
| Expected retention rate: | 80% |
| Duration of follow-up: | 36 months |
| Follow-up after infection: | 24 months |
| Clinical trial sites: | 61 |
| VAX004 Study Vaccine Summary | |
| Vaccine: | AIDSVAX B/B |
Vaccine design |
Bivalent rgp120 with alum |
| Vaccine antigens: | MN plus GNE8 (subtype B) |
| Placebo: | alum |
| Randomization: | Vaccine to Placebo = 2:1 |
| Vaccine administration: | Intramuscular (deltoid) |
| Vaccination schedule: | 0, 1, 6, 12, 18, 24, and 30 months |
Determination of efficacy
The degree to which AIDSVAX prevented infection was determined by comparing the number of infections between the vaccine and placebo groups. If AIDSVAX was determined effective, the number of infections in the placebo group would have had to been higher than the number of infections in the vaccine group.
Results and Subgroup Analyses
In the overall trial, no efficacy for prevention of acquisition or for modification of HIV infection was detected. Intriguing findings in subgroup analyses suggested vaccine efficacy for acquisition of HIV infection in Blacks or non-whites, women and high risk volunteers. However vaccine efficacy in the subgroups could not be explained because of the small number of infections in each subgroup.
GSID HIV Data Browser - Description and Analytical Tools
The first version release of the GSID HIV Data Browser has been developed in collaboration with the Genome Bioinformatics Group at the University of California, Santa Cruz (UCGBG), which is a cross-departmental team within the Center of Biomolecular Sciences and Engineering (CBSE). Under the guidance of Jim Kent and Fan Hsu, UCGBG developed a relational database containing the significant clinical data and sequence information pertaining to the infected subjects participating in the VAX004 Phase III clinical trial. GSID has made this valuable resource of information available to the HIV vaccine research community via a web-accessible database. Additionally, serological samples associated with the viral sequences contained on the website are also available to investigators for further in-depth analysis. The first version release of the GSID HIV Data Browser contains three main “view” pages:
Subject View Page
This view allows the user to capture all of the available information for individual subjects identified by a blinded subject identification number. As was required during the conduct of the trial, both GSID and UCGBG will continue to blind the information contained in the database to ensure volunteer (subject) confidentiality and privacy. A filter control page is available to allow the user to set search parameters to retrieve and display information. The current data elements included in the database are as follows:
Demographic and clinical information (click here for subject summary):
Table View Page
This view allows users to construct tables containing selected information from multiple subjects. In this view, users have the ability to sort, display information broadly or based upon data specific criteria and output the text in tab delineated format. Additionally, the user is able to retrieve associated DNA or protein sequences from this view.
Sequence View Page
Sequence view contains tools which allow for sequences to be aligned with ach other, with reference sequences or with consensus sequences. The primary alignment tool included in this view is called BLAT. More information about the tools, including BLAT is available at the GSID HIV Data Browser website. The database contains three sequences per infected subject.
Future Releases of the GSID HIV Data Browser
Over the coming months GSID intends to release updated versions of the GSID HIV Data Browser. For example, GSID plans to include the following in future releases:
Concept Sheets for Specimen Sample Requests
Registered subscribers of the GSID HIV Data Browser have a unique opportunity to obtain certain serological samples, including serum and plasma, related to the viral sequences contained in the database. In addition, the specimen repository also contains samples from uninfected subjects. Interested investigators should submit a written concept sheet outlining the information shown directly below and submitting it via email to GSID.
Concept sheet and sample request information:
The specimens are a limited resource; therefore the volumes and the availability of samples may vary by each subject. GSID cannot guarantee that it will be able to fulfill a request to the exact specifications of the scientific investigator, but every effort will be made to accommodate the request. However, GSID reserves the right to adjust the request based upon availability of material and/or make recommendations to satisfy the volume requirements of the planned experiments.
Please note that any scientific publication resulting from the use of the materials provided by GSID must contain an attribution to GSID and/or the GSID HIV Data Browser. Additionally, GSID requires that it be able to review and comment on the publication at least 30 days prior to finalization.
Gaining Access to the GSID HIV Data Browser
In order to access the GSID HIV Data Browser, you will be asked to read and accept the terms and conditions of an Access Agreement. Once you accept the terms of use, you will be asked to provide some information identifying yourself and the organization you are affiliated with. An access fee payable by credit card via PayPal® will be required to register your username and password. The access fee has been established to be affordable to academic and other not-for-profit organizations, but set higher for commercial/private sector organizations. The access fees, which are comparable to the cost of research publications and online research tools, are necessary to help GSID offset some of the unfunded costs related to maintaining the website.
Access the GSID HIV Data Browser website
If you are new user, please click here to access the login tutorial and being the registration process. If you are a registered user and already have a username and password, please click here.
Contact us
GSID invites you to visit the GSID HIV Data Browser website and to use this unique research tool. We are interested to hear your feedback. If you have any questions or comments about the browser, please click here to contact GSID.
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