Navigation Links
AIDS Vaccine Advocacy Coalition Calls for AIDS Vaccine Field to Work Together to Analyze STEP Study Data and Determine Best Course to Move Forward

Safety of Trial Volunteers Must Remain Paramount Concern

SEATTLE, Nov. 7 /PRNewswire-USNewswire/ -- The AIDS Vaccine Advocacy Coalition (AVAC) released the following statement today from Executive Director Mitchell Warren in response to the release of new data from the STEP AIDS vaccine study by Merck & Co., the US National Institute for Allergy and Infectious Diseases (NIAID) and the HIV Vaccine Trials Network (HVTN) at a public forum at the HVTN meeting today.

The data from the STEP study released today confirm that the vaccine was not effective at either preventing infection in male volunteers or at reducing viral loads in male vaccine recipients who became infected with HIV during the trial. In addition, the data suggest that the vaccine may have made some volunteers more susceptible to acquiring HIV infection. The vaccine itself does not cause HIV. This trend was specifically observed among male volunteers who had high titers of antibody to adenovirus, the cold virus that was used, in a disabled form, in the MRK-Ad5 vaccine candidate.

"These data are deeply disappointing and troubling, and raise more questions than answers for the field of AIDS vaccine. Today's discussion of the data underscores the leadership and transparency that Merck, NIAID, and HVTN continue to show in this complex and challenging time. What is clear is that the field must continue to work on this challenge and on the larger goal of finding a safe and effective AIDS vaccine.

"As much as we would like to see a clear answer in these results to whether or not the vaccine made some volunteers more susceptible to HIV infection, the reality is that there is still significant confusion about the underlying explanation for the observed effect.

"As we move forward, the work of analyzing and interpreting the data from the STEP study, and from the companion Phambili study in South Africa, will become even more difficult and even more important.

"In the weeks and months to come, we look to the AIDS vaccine field as a whole to maintain a collaborative spirit and to commit all necessary resources to the critical work of understanding the potential explanations and implications for the trends observed in the STEP study.

"We commend the trial sponsors for their consistent commitment to the safety of the volunteers, which must be the top priority in this and every other HIV prevention trial. At every stage of this difficult process, trial sponsors and site-level staff must continue to clearly communicate key information about the data and the participants' potential risk to volunteers at every site.

"AVAC recognizes that these data leave the AIDS vaccine field with a range of difficult decisions. Going forward, we believe that the wisest course of action is also the most cautious. To safeguard future trials and volunteers, the trial sponsors and the field as a whole should take as long as is needed to analyze the data and attempt to come to more definitive conclusions about what these new data mean, before beginning efficacy trials of other vaccine candidates.

"In addition, if there is the possibility that unblinding the STEP study and informing every participant about whether he or she received the placebo or the vaccine will provide an additional safeguard for participants, then this is the course of action that should be taken. AVAC believes that ultimately the decision about unblinding the trial should be guided by the participants' own concerns and priorities.

"Above all, we must continue to see this for what it is: a major setback for the AIDS vaccine field, but one that can and must be overcome through rigorous scientific investigation, open communication with communities, and a firm commitment to the shared goal of reversing the course of the AIDS epidemic in our lifetimes."

AVAC will continue to provide updates, analysis and resource materials at as the decision about unbinding the trial is made and as more analyses and data are released.

About AVAC

Founded in 1995, the AIDS Vaccine Advocacy Coalition (AVAC) is a non-profit, community- and consumer-based organization that uses public education, policy analysis, advocacy and community mobilization to accelerate the ethical development and global delivery of AIDS vaccines and other HIV prevention options. To help assure its independence, AVAC does not accept funding from government or pharmaceutical industry sources. For more information, visit

SOURCE AIDS Vaccine Advocacy Coalition
Copyright©2007 PR Newswire.
All rights reserved

Related medicine technology :

1. Carrington Subsidiary DelSite Initiates Critical Toxicology Studies of Its Nasal Powder Bird Flu Vaccine
2. Iomai Trial Shows 100 Percent Immune Response in Elderly Subjects Vaccinated With Novel Travelers Diarrhea Patch Vaccine
3. GlaxoSmithKline Receives New HHS Order for H5N1 Bulk Antigen. First North American Clinical Trials with GSKs Candidate Pre-pandemic Flu Vaccine to Start.
4. Intellect Neurosciences, Inc. to Present Data on Alzheimers Vaccine at 13th International Congress of Immunology Conference
5. Pre-clinical Data on Recent Advances with HIV VLP Vaccine Presented at AIDS Vaccine 07 Conference
6. Multiple NIH Phase 2 HIV Vaccine Trials Using Vicals Technology Produce Encouraging Results
7. Iomai Announces Data from Phase 2 Field Study of Travelers Diarrhea Vaccine Accepted for Presentation at ICAAC
8. Vical Begins Phase 1 Trial of DNA Vaccine Against H5N1 Pandemic Influenza
9. Iomai Launches Phase 1/2 Safety Study of Dose-Sparing Patch for Use With Pandemic Influenza Vaccine
10. Sinovac Commences Vaccination on Volunteers for Phase II Clinical Trial on Pandemic Influenza H5N1 Vaccine
11. GeoVax Successful HIV/AIDS Vaccine Trial Data Presented at AIDS Vaccine 2007 Conference
Post Your Comments:
(Date:6/23/2016)... -- In a startling report released today, National Safety Council ... comprehensive, proven plan to eliminate prescription opioid overdoses. Prescription ... are tackling the worst drug crisis in recorded U.S. history, assigned ... Kentucky , New Mexico , ... 28 failing states, three – Michigan , ...
(Date:6/23/2016)... , June 23, 2016 Research ... Pharma News Issue 52" report to their offering. ... in influenza treatment creates a favourable commercial environment for MedImmune ... growing patient base that will serve to drive considerable growth ... vaccine would serve to cap sales considerably, but development is ...
(Date:6/23/2016)... and BOGOTA, Colombia , June 23, 2016  Astellas today announced the establishment of Astellas ... Brasil as the company,s second affiliate in Latin America . ... ... of Astellas Farma Colombia ... ...
Breaking Medicine Technology:
(Date:6/25/2016)... ... June 25, 2016 , ... ... issues and applications at AcademyHealth’s Annual Research Meeting June 26-28, 2016, at the ... several important health care topics including advance care planning, healthcare costs and patient ...
(Date:6/25/2016)... ... , ... First Choice Emergency Room , the largest network of independent ... Director of its new Mesquite-Samuell Farm facility. , “We are pleased to announce ... Dr. James M. Muzzarelli, Executive Medical Director of First Choice Emergency Room. , ...
(Date:6/25/2016)... ... June 25, 2016 , ... Conventional wisdom preaches the benefits ... terms of the latter, setting the bar too high can result in disappointment, perhaps ... slow progress toward their goal. , Research from reveals that ...
(Date:6/24/2016)... ... 24, 2016 , ... Marcy was in a crisis. Her son James, eight, was out of ... verbally and physically. , “When something upset him, he couldn’t control his emotions,” remembers Marcy. ... throw rocks at my other children and say he was going to kill them. ...
(Date:6/24/2016)... Diego, CA (PRWEB) , ... June 24, 2016 , ... ... with the American Cancer Society and the Road To Recovery® program to drive cancer ... to seniors and other adults to ensure the highest quality of life and ongoing ...
Breaking Medicine News(10 mins):