gsidgsidgsid
Welcome to the Global Solutions For Infectious Diseases Website
GSID Home Page
About Us
Our Programs
Support GSID
News & Publications
Contact Us
header

AIDSVAX® Program

AIDSVAX® vials

GSID has long supported the development of a safe, effective, and affordable vaccine to control the HIV/AIDS pandemic. For more than two decades, GSID founders have managed the discovery, research, and development of AIDSVAX®, our primary HIV vaccine candidate. AIDSVAX® is a bivalent subunit vaccine composed of recombinantly expressed envelope proteins (gp120) designed to prevent infection from HIV-1.

GSID continues to evaluate AIDSVAX® through ongoing clinical trials around the world. A list of all current and planned clinical trials can be found here.

In addition, we continue to collaborate with leading HIV vaccine researchers, in order to gain a better understanding of HIV vaccines through the analysis of previous clinical studies and to guide future HIV vaccine development. A list of collaborating organizations can be found here, and a list of publications with GSID authors can be found here. If you're interested in collaborating with GSID, please follow the instructions here.

A brief history of our work with AIDSVAX® is provided below.

The Initial VaxGen Trials
RV144: First Signs of HIV Vaccine Efficacy
Correlates of Protection Studies
Ongoing Research and Clinical Trials
Additional Resources

 

The Initial VaxGen Trials

Since publicly advocating for the development of an HIV vaccine in the 1980s, GSID management has been at the forefront of the HIV vaccine field. Using a vaccine initially developed at Genentech, GSID management founded VaxGen, a South San Francisco-based biotechnology company, and proceeded to conduct the world’s first Phase III HIV vaccine trials between 1998 and 2003. The first Phase III trial of our AIDSVAX® vaccine (known as VAX004) was conducted in North America and Europe; and the second trial (VAX003) was conducted in Thailand in collaboration with the Thai Ministry of Public Health and the School of Tropical Medicine of Mahidol University. No efficacy for the prevention or modification of HIV was detected in either VAX003 or VAX004 (see VaxGen Trials for more information).

In early 2004, Don Francis, Carter Lee, and Phil Berman left VaxGen and founded GSID to continue the pursuit of an HIV vaccine obtained the rights to all of the clinical data and specimens gathered during the AIDSVAX® clinical trials. The specimen repository currently houses over 300,000 tubes of serological material. We also developed a web-accessible GSID HIV Data Browser containing clinical and viral sequence information related to the HIV infected subjects who participated in the VaxGen Phase III trials.Working with a consortium of academic and private sector investigators, GSID began analyzing the specimens and data from the VaxGen trials under a founding grant from the Bill & Melinda Gates Foundation.

Beginning in 2009, GSID consortium member Dr. Phil Berman and his lab at the University of California, Santa Cruz, identified a novel element in the HIV coat protein that could be useful for future vaccine development. The research was published in the Journal of Virology, with Dr. Faruk Sinangil, the program’s principal investigator, as one of the co-authors. Dr. Berman’s lab continues to pursue their findings under research grants from the NIH. A list of all collaborating organizations can be found here.

 

RV144: First Signs of HIV Vaccine Efficacy

In September 2009, GSID was proud to be a partner in the announcement of the results of the world's first Phase III vaccine trial that demonstrated a reduction in HIV infection in a community-based population. Known as RV144, the Thai HIV vaccine trial combined Sanofi Pasteur's ALVAC vCP1521 vaccine with GSID's AIDSVAX® B/E. The combined regimen demonstrated an efficacy of 31.2%. Detailed results from the trial were the highlight of the AIDS Vaccine 2009 Conference in Paris, France and published online in The New England Journal of Medicine. (Links to the paper and a complete list of GSID research publications can be found here).

The results of the RV144 trial were reported on the front pages of newspapers around the world, and they were widely recognized by the global health community as a major event that would re-invigorate the global HIV vaccine community. TIME Magazine declared the results the Number 2 Medical Breakthrough of the Year. As then President of the Global Health Program at the Gates Foundation, Dr. Tachi Yamada captured the global sentiment: “Today marks a critically important milestone in the fight against AIDS....These results offer new hope that it's possible to develop a highly effective vaccine with the power to break the back of the AIDS pandemic.”

 

Correlates of Protection Studies

While the RV144 results were an inspiring moment, they were just a step along the way to developing a safe and effective HIV vaccine. Following the announcements, GSID supported an international team of collaborators to analyze samples from the RV144 trial participants to look at immune response in the vaccine recipients. The results of the coordinated analysis were the highlight of the AIDS Vaccine 2011 Conference in Bangkok, Thailand.

Two key hypotheses were presented. First, antibodies specific to a particular region (V2) of the HIV protein (envelope) correlated with the lowest infection rate among those who were vaccinated. Second, among the vaccine recipients, those with high levels of vaccine-induced plasma IgA had the highest infection rate. These results are unique to the RV144 regimen but give an important lead for vaccine development to build on. (For additional information, see RV144 and Related Trials)

 

Ongoing Research and Clinical Trials

Despite the excitement generated by the RV 144 results and the correlates of protection data, GSID has not been able to identify funders willing to support the production of new lots of AIDSVAX vaccine for further clinical studies. With the remaining inventory of AIDSVAX® B/E, GSID continues to support the HIV research community by serving as manufacturing sponsor and product provider in several clinical studies around the world, AIDSVAX B/E currently is the only protein boost available and qualified for human clinical use. By applying AIDSVAX® with other priming vaccine candidates, GSID hopes help generate valuable data which will lead to optimizing vaccination schedules, developing more effective vaccine formulations and prepare for the future efficacy studies of the next generation of HIV vaccines. Additional information can be found on our page about Current Trials.

GSID has also been collaborating with virtually all of the leading HIV vaccine researchers around the world to analyze the data and specimens from previous trials, in hopes that a better understanding may allow us to refine all HIV vaccine candidates. A list of collaborating organizations can be found here, and a list of publications with GSID authors can be found here. If you're interested in collaborating with GSID, please follow the instructions here.

After more than twenty years of work on AIDSVAX®, GSID continues to seek the safe and effective vaccine solution that is still needed to halt the pandemic spread of this dangerous virus, especially in the developing world. Please consider supporting our work here.

 

Additional Resources

 

 


GSID to support four new AIDSVAX® B/E clinical trials in 2017
[more]