 |
|
India continues to progress in AIDS vaccine development efforts
August 18, 2008A second Phase I AIDS vaccine clinical trial in India was successfully completed, the Indian Council of Medical Research, the National AIDS Control Organization and the International AIDS Vaccine Initiative announced. The results of the trial of an MVA-based AIDS vaccine candidate (TBC-M4), which was conducted in Chennai, indicated that the vaccine candidate had acceptable levels of safety and was well tolerated.
The proportion of volunteers whose immune systems responded to the vaccine candidate suggests the candidate holds promise. The trial was done using two doses of the candidate vaccine. After three injections, 82 percent of the volunteers who received a low dose and 100 percent of those who received a high dose registered immune responses to the vaccine. The 100 percent response rate is greater than that seen with the majority of AIDS vaccine candidates tested in humans to date. However the strength and diversity of these immune responses were modest. It may be possible to boost the immune response, if this vaccine is used in combination with other candidate AIDS vaccines.
"We are pleased to see that the MVA-based candidate tested in Chennai was safe and showed promising initial immune responses. We do not know whether these observed responses will ultimately translate into an effective vaccine that will help protect individuals from HIV infection, but hope to learn more through further testing," said Dr. S K Bhattacharya, Additional Director General of the Indian Council of Medical Research. "India is playing a significant role in global AIDS vaccine discovery efforts given our strong medical and scientific capabilities. There is a need for continued efforts for the creation of novel, reliable mechanisms for long-term research on AIDS vaccines and other new prevention technologies."
The Phase I clinical trial was initiated in January 2006 at the Tuberculosis Research Center (TRC), an Indian Council of Medical Research (ICMR) institute in Chennai, and was completed in February 2008. This trial was conducted under the aegis of a Memorandum of Understanding (MoU) between the Government of India-through the Indian Council of Medical Research (ICMR) and the National AIDS Control Organization (NACO)-and the not-for-profit International AIDS Vaccine Initiative (IAVI). YRG CARE, based in Chennai, collaborated with TRC to mobilize the community around the Phase I trial.
Dr. Narayanan, former Director of the Tuberculosis Research Center, added, "Consistent innovation in science despite setbacks has ensured the development of many effective prevention technologies. The successful conduct of the trial in Chennai re-affirms the need for continued vaccine development initiatives, where learnings from every effort will contribute to global advancement of the AIDS vaccine field."
About the Phase I MVA-based (TBC-M4) AIDS vaccine trial
The trial was a double blind, dose-escalation, randomized, placebo-controlled trial, which was initiated after receiving all necessary regulatory and ethical clearances. The objectives of such a Phase I trial are to evaluate the safety of the vaccine candidate and to gather preliminary results of immune responses induced by the candidate. The total duration of the trial was approximately 24 months. The volunteers recruited for this trial were 32 healthy, HIV-uninfected men and women between 18 and 50 years of age, from all socio-economic strata. Three intra-muscular injections of TBC-M4 or placebo were administered to the volunteers.
Moving forward
The results of the Phase I vaccine trial of TBC-M4 suggest that further research is warranted. Currently, two additional Phase I trials testing the MVA-based candidate in a prime-boost regime are planned and under review by the relevant authorities in India and approved in the UK. The trials are designed to use different modes of administration of the priming vaccine, different dosages and different vaccine regimens. It is hoped that the prime-boost regimen will help to strengthen the modest immune responses observed in the Phase I trial of the MVA-based candidate alone. Collectively, the results will help determine whether and how to move forward with additional testing of this MVA-based AIDS vaccine candidate.
Simultaneously, IAVI has undertaken work to modify the MVA-based vaccine candidate so that it is ready for large-scale manufacturing should the trial results suggest further testing is warranted.
International AIDS Vaccine Initiative
The Phase I clinical trial was initiated in January 2006 at the Tuberculosis Research Center (TRC), an Indian Council of Medical Research (ICMR) institute in Chennai, and was completed in February 2008. This trial was conducted under the aegis of a Memorandum of Understanding (MoU) between the Government of India-through the Indian Council of Medical Research (ICMR) and the National AIDS Control Organization (NACO)-and the not-for-profit International AIDS Vaccine Initiative (IAVI). YRG CARE, based in Chennai, collaborated with TRC to mobilize the community around the Phase I trial.
Dr. Narayanan, former Director of the Tuberculosis Research Center, added, "Consistent innovation in science despite setbacks has ensured the development of many effective prevention technologies. The successful conduct of the trial in Chennai re-affirms the need for continued vaccine development initiatives, where learnings from every effort will contribute to global advancement of the AIDS vaccine field."
About the Phase I MVA-based (TBC-M4) AIDS vaccine trial
The trial was a double blind, dose-escalation, randomized, placebo-controlled trial, which was initiated after receiving all necessary regulatory and ethical clearances. The objectives of such a Phase I trial are to evaluate the safety of the vaccine candidate and to gather preliminary results of immune responses induced by the candidate. The total duration of the trial was approximately 24 months. The volunteers recruited for this trial were 32 healthy, HIV-uninfected men and women between 18 and 50 years of age, from all socio-economic strata. Three intra-muscular injections of TBC-M4 or placebo were administered to the volunteers.
Moving forward
The results of the Phase I vaccine trial of TBC-M4 suggest that further research is warranted. Currently, two additional Phase I trials testing the MVA-based candidate in a prime-boost regime are planned and under review by the relevant authorities in India and approved in the UK. The trials are designed to use different modes of administration of the priming vaccine, different dosages and different vaccine regimens. It is hoped that the prime-boost regimen will help to strengthen the modest immune responses observed in the Phase I trial of the MVA-based candidate alone. Collectively, the results will help determine whether and how to move forward with additional testing of this MVA-based AIDS vaccine candidate.
Simultaneously, IAVI has undertaken work to modify the MVA-based vaccine candidate so that it is ready for large-scale manufacturing should the trial results suggest further testing is warranted.
International AIDS Vaccine Initiative
AIDS Vaccine Current Events and AIDS Vaccine News RSST cell-based HIV vaccine candidate demonstrates positive results
The question of whether or not to continue to pursue the development of T-cell-based HIV-1 vaccines has been a source of controversy following last year's widely publicized failure of the field's most promising candidate, a vaccine developed by Merck known as V520.
Personalized immunotherapy to fight HIV/AIDS
For a long time, the main obstacle to creating an AIDS vaccine has been the high genetic variability of the HIV virus. Dr. Jean-Pierre Routy and his team from the Research Institute of the McGill University Health Centre (MUHC), in collaboration with Dr. Rafick Sékaly from the Université de Montréal, have overcome this difficulty by designing a personalized immunotherapy for HIV-infected patients.
HIV conquers immune system faster than previously realized
New research into the earliest events occurring immediately upon infection with HIV-I shows that the virus deals a stunning blow to the immune system earlier than was previously understood.
UT Pathologists Believe They Have Pinpointed Achilles Heel of HIV
Human Immunodeficiency Virus (HIV) researchers at The University of Texas Medical School at Houston believe they have uncovered the Achilles heel in the armor of the virus that continues to kill millions.
Regulatory B cells exist -- and pack a punch
Researchers at Duke University Medical Center have uncovered definitive evidence that a small but potent subset of immune system B cells is able to regulate inflammation.
HIV Infection Stems From Few Viruses
A new study reveals the genetic identity of human immunodeficiency virus (HIV), the version responsible for sexual transmission, in unprecedented detail.
HIV isolate from Kenya provides clues for vaccine design
Two simple changes in its outer envelope protein could render the AIDS virus vulnerable to attack by the immune system, according to research from Kenya and the Fred Hutchinson Cancer Research Center published in PLoS Medicine.
IAVI statement on new analysis of STEP large-scale AIDS vaccine trial
The International AIDS Vaccine Initiative (IAVI) issued the following statement from its President and CEO, Dr. Seth Berkley, following the release of the first analysis of the entire study population from a late-stage AIDS vaccine trial, known as the STEP study.
Scripps Research scientists shed new light on how antibodies fight HIV
By furthering scientists' understanding of the molecular mechanisms that separate the minority of successful HIV antibodies from the majority of ineffective antibodies, the work may have implications for future attempts to design an HIV vaccine.
First genome-wide study of infectious disease opens new avenues for HIV treatment, vaccines
The first genome-wide association study of an infectious disease, conducted by an international group of researchers through the Center for HIV/AIDS Vaccine Immunology (CHAVI), has yielded a new understanding of why some people can suppress virus levels following HIV infection.
More AIDS Vaccine Current Events and AIDS Vaccine News Articles
 | Big Shot: Passion, Politics, and the Struggle for an AIDS Vaccine by Patricia Thomas A veteran journalist dramatizes the controversial search for an AIDS vaccine-the players, the politics, the money-in a vivid, suspenseful story that reveals how science is done, and not done, in America today. . When the human immunodeficiency virus was identified in 1984, the competition to create an AIDS vaccine was fierce. Now Patricia Thomas brings the contenders to life in a fast-paced,... |
 | Shots in the Dark: The Wayward Search for an AIDS Vaccine by Jon Cohen In 1984 Health and Human Services Secretary Margaret Heckler announced that an AIDS vaccine would be ready for testing in two years. Since then, nearly 60 million persons worldwide have been infected by the human immunodeficiency virus (HIV), and only one vaccine, containing the gp120 surface protein of the virus, has made it to a large-scale, phase three efficacy field trial. This text explains... |
 | The Search for an AIDS Vaccine: Ethical Issues in the Development And Testing of a Preventive HIV Vaccine (Medical Ethics Series) by Christine Grady Efforts to halt the spread of AIDS have failed so far, and the creation of a vaccine now seems the best hope for controlling the disease. Yet developing and testing an HIV vaccine raises a host of difficult ethical issues. These concerns are the focus of this timely and important book. Christine Grady traces the history of vaccine research and surveys the guidelines, regulations, and attitudes... |
 | AIDS Vaccine Development: Challenges and Opportunities |
 | AIDS Vaccine Research by WonG-Staal/Gall This reference describes the latest advances in the development and design of an HIV preventive vaccine-detailing the pathogenesis and genetic variability of HIV infection for the construction of molecular and therapeutic strategies to reduce the progression and transmission of AIDS. With contributions by universally recognized authorities in the field, AIDS Vaccine Research discusses ... |
 | HIV And Molecular Immunity: Prospects for the AIDS Vaccine by Omar Bagasra How old is the AIDS virus (HIV-1) and where did it come from? Is it the result of a recombinant event in simian immunodeficiency viruses (SIVs)? Why do SIVs naturally occur in a variety of nonhuman African primates without inducing AIDS in their natural hosts? HIV-1 has devastated human society, although chimpanzees carry an SIV that is genetically almost identical to HIV-1 but causes no known... |
| International AIDS Vaccine Initiative, Targeted Genetics, and Children's Research Institute to collaborate to develop AIDS vaccine.: An article from: BIOTECH Patent News This digital document is an article from BIOTECH Patent News, published by Biotech Patent News on February 1, 2000. The length of the article is 1941 words. The page length shown above is based on a typical 300-word page. The article is delivered in HTML format and is available in your Amazon.com Digital Locker immediately after purchase. You can view it with any web browser.Citation... | |
| Vaccines 94: Modern Approaches to New Vaccines Including Prevention of AIDS by Erling Norrby | |
| Vaccines 93: Modern Approaches to New Vaccines Including Prevention of AIDS | |
| Vaccines '87: Modern Approaches to New Vaccines : Prevention of AIDS And Other Viral, Bacterial, And Parasitic Diseases (Vaccines) by Robert Chanock, Richard Lerner, Fred Brown |
| © 2008 BrightSurf.com |