Navigation Links
AIDS Vaccine Advocacy Coalition Voices Disappointment in Trial Result
Date:9/21/2007

Applauds Merck's Leadership and Calls for Reinvigorated Effort to Design

and Test AIDS Vaccines

NEW YORK, Sept. 21 /PRNewswire-USNewswire/ -- The AIDS Vaccine Advocacy Coalition (AVAC) released the following statement from Executive Director Mitchell Warren about the announcement that vaccinations have been discontinued in the STEP Study, a test-of-concept trial of the MRK-Ad5 AIDS vaccine candidate developed by the Merck Research Laboratories:

"Today's announcement about the STEP Study is a deep disappointment and a scientific setback for the AIDS vaccine field. However, it must be seen for what it is: the failure of a product to show efficacy in a specific trial. Clinical testing of AIDS vaccines is a scientific process and, while this is a disappointment, it is in no way the end of the search for an AIDS vaccine.

"These data are certainly not the ones that we had hoped for. The entire HIV vaccine field, including AVAC, had been looking to STEP and its companion Phambili trial in South Africa, to provide initial evidence of vaccine-related benefits. Even as the data disappoint, we also note the success of the STEP Study trial design in providing a swift answer to the critical question of whether or not the vaccine provided any benefits. A successful clinical trial is one that produces a scientifically accurate result. It may not be the result you had hoped for, but it answers questions that help the field move forward.

"We applaud Merck's tremendous leadership on HIV vaccine research. The company has set an example for the field, taking on one of the most important health technology challenges of our time. Merck and its collaborator, the US NIH-funded HIV Vaccine Trials Network, have been committed, strategic and willing to take risks at every stage of evaluating MRK-Ad5, and they must be commended for this. AVAC also recognizes the contributions of the thousands of volunteers in these trials. Their altruistic involvement makes HIV vaccine research possible. It is essential to build on what has been learned here and proceed with further research as rapidly as possible. Millions of lives are at stake.

"In the next weeks and months the AIDS vaccine field will need to make carefully-considered decisions about whether to move forward with planned trials of related vaccine strategies, and how to proceed with the Phambili trial, which has paused immunizations and enrollment. AVAC is committed to working with many other stakeholders in the AIDS vaccine field and in other areas of AIDS prevention research to ensure that these discussions are thoughtful, transparent, and clearly communicated to global audiences.

"These results do not change our fundamental view. Developing an AIDS vaccine will require a series of large-scale human trials in many different countries over a number of years. These trials need to be designed to produce clear results and to design better candidates in the future. This research must be complemented by ongoing studies of other new biomedical prevention strategies, and by full-scale, fully-funded implementation of proven prevention and treatment strategies."

About the STEP Study

An interim analysis of data from the study, involving over 3,000 people testing an adenovirus-based vaccine (MRK-Ad5) developed by the Merck Research Laboratories, showed no efficacy in protecting against new infections or in reducing viral load in people who received the vaccine and went on to become infected. The study was scheduled to end in 2009. Periodic reviews of data by an independent monitoring board are part of the clinical trials process, and the study was halted on the recommendation of the STEP Study monitoring board after a regularly-scheduled review.

There have been two previous efficacy trials of an AIDS vaccine candidate, called AIDSVAX. Both of these studies took more than five years from launch to announcement of the finding -- that the candidate did not protect against infection. The STEP Study enrolled its first participant in December 2004, and we have a definitive answer less than three years later. Getting swift, precise answers about candidates is crucial for the field. In this sense, the STEP Study fulfilled its purpose-as disappointing as the results may be.

One reason for this efficiency is that both STEP and its companion trial Phambili, which tested the candidate in South Africa, were designed as "test- of-concept" trials, to give an initial answer about vaccine benefits in a relatively abbreviated timeframe. The STEP Study met its enrollment targets and its endpoint goals within the timeframe specified by the trial planners.

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 http://www.avac.org.


'/>"/>
SOURCE AIDS Vaccine Advocacy Coalition
Copyright©2007 PR Newswire.
All rights reserved

Related medicine technology :

1. BioSante Pharmaceuticals Announces New Findings for Potential Bird Flu Vaccine
2. DOR BioPharma Announces Issuance of European Patent for Its Oral Multivalent Botulinum Toxin Vaccine BT-VACC
3. From Clinical Cancer Research: Rethinking Therapeutic Cancer Vaccine Trials
4. DOR BioPharma Announces Publication Describing Results of Its Multivalent Botulinum Toxin Vaccine BT-VACC
5. Vaccine Can Prevent Cervical Cancer and Precancerous Lesions
6. Largest Cervical Cancer Vaccine Efficacy Trial Shows Cervarix Provides Excellent Protection Against Lesions Caused by Most Common Cancer-Causing Virus Types
7. Based on Up to 6 Years of Follow-Up, Biovest Announces Favorable Interim Blinded Data for Fast-Tracked Pivotal Phase 3 Clinical Trial of BiovaxID Anti-Cancer Vaccine for Non-Hodgkins Lymphoma
8. HepaLifes PBS-1 Cells for Influenza Vaccine Production Prove Superior at International Conference
9. New Flu Vaccine from PepTcell Could Provide Immunity Against All Strains of Influenza Virus
10. Hypertension Vaccine CYT006-AngQb Achieves Strong Blood Pressure Reduction During Important Early Morning Period When Most Adverse Cardiovascular Events Occur
11. New Flu Vaccine From PepTcell Could Provide Immunity Against All Strains of Influenza Virus
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:5/27/2016)... May 27, 2016 Amarantus BioScience Holdings, ... developing products for Regenerative Medicine, Neurology and Orphan Diseases, today announced ... presenting at two upcoming investor conferences: SeeThru Equity ... Avenue, New York City , NY ... Marcum MicroCap Conference   Where: Grand Hyatt Hotel, ...
(Date:5/26/2016)... , May 26, 2016   ... software and analytics, network solutions and technology-enabled ... announced it entered into a strategic channel ... of outpatient software solutions and revenue cycle ... specialty hospitals and rehabilitation clinics to optimize ...
(Date:5/25/2016)... and GERMANTOWN, Maryland , May 25, ... QGEN ; Frankfurt Prime Standard: QIA) today announced that the ... Therawis Diagnostics GmbH to develop and commercialize predictive assays in ... PITX2 as a marker to predict effectiveness of anthracycline treatment ... "We are pleased to partner with Therawis, which developed ...
Breaking Medicine Technology:
(Date:5/30/2016)... ... May 30, 2016 , ... ... Shaolin warrior 8-day-8 and 8-night special intensive summer training camp starts on June ... summer camp offers families and children a fun and unique experience with an ...
(Date:5/29/2016)... ... May 29, 2016 , ... Whole Health Supply is ... new KlipPro KP-240L clipper is available to the public. This is an unusual clipper ... wider than the average clipper. , Everything about this product is concentrated on ease ...
(Date:5/28/2016)... ... May 28, 2016 , ... "Color Grading media can be ... a preset onto their media," said Christina Austin - CEO of Pixel Film Studios. ... quickly and easily add stylish color grades to their footage. A LUT is a ...
(Date:5/28/2016)... ... , ... In a part of the city where’s it’s easy to spot the neon lights ... is hoping to attract diners with a taste for real food. , On May ... to Cornerstone Grill, an urban casual restaurant focusing on dishes made by hand with wholesome, ...
(Date:5/27/2016)... ... May 27, 2016 , ... Two director-level employees of Horizon Blue Cross Blue ... Industry (TWIN) 2016 honorees. The award recognizes businesswomen who excel in their fields ... Director of the MLTSS (Managed Long-Term Services and Supports) Program at Horizon NJ Health ...
Breaking Medicine News(10 mins):