SEATTLE – (EMBARGOED UNTIL MARCH 17, 2021, AT 5 PM ET) – The AMP confirmatory studies showed that a highly neutralizing antibody (bnAb) called VRC01 was effective in inhibiting HIV strains get to 30% of bnAb-sensitive sequences. This discovery has been observed in both sub-Saharan Africa and the USA and South America. VRCO1 did not prevent HIV from reaching HIV-resistant strains. Since the protective rays made up nearly 70% of the circulating rays in these regions, no difference was identified between the VRC01 arm and the placebo arm in terms of complete inhibition of HIV transmission. The sensitivity to bNAbs was assessed by a laboratory test that measures the ability of a virus to neutralize with antibody.
Both studies (HVTN 704 / HPTN 085 and HVTN 703 / HPTN 081) opened in 2016 and successfully enrolled 4,623 participants. The AMP studies are supported and funded by the National Institute of Infectious and Infectious Diseases (NIAID), part of the National Institutes of Health. The studies are being carried out jointly by the HIV Vaccine Testing Network (HVTN) and the HIV Prevention Testing Network (HPTN).
The NIAID Vaccine Research Center (VRC) isolated VRC01 in 2010 from the blood of a person living with HIV and subsequently tested the antibody for the AMP tests. Data from the AMP studies were first reported at a press conference held by the 4th International Conference for the Prevention of HIV Prevention (HIVR4P) on 26 January 2021. VRC01 was 75% effective in preventing on bnAb-susceptible HIV strains (in vitro sensitivity to the antibody by IC80 of the New England Journal of Medicine.
Vulnerability to VRC01 of the HIV exposure to which a person was exposed was the main test of how well the antibody worked to prevent HIV. Among participants who received VRC01-sensitive HIV strain during the trials, the HIV incidence rate was 0.2 per 100 years for VRC01 recipients and 0.86 per 100 years for placebo recipients. The HVTN 704 / HPTN 085 test performed among cisgender men and transgender people in the US, Switzerland and South America had similar results (mostly open to subtype B modifications). and in HVTN 703 / HPTN 081 testing in cisgender females in Sub-Saharan Africa (mostly exposed to subtype C versions).
“The AMP tests were designed to determine whether long-term administration of bnAb could reduce HIV transmission, if the vulnerability of viruses circulating in the community to bnAb affected the effectiveness of prevention, and measuring this vulnerability would be a biomarker of prevention effectiveness. All three of these questions were answered by these two tests, “said Larry Corey, MD, Chair of AMP Protocol and Principal Investigator, HVTN Leadership Operations Center, which based at the Fred Hutchinson Cancer Research Center.
Cisgender men and transgender people who have sex with cisgender men were recorded from communities in Brazil, Peru, Switzerland, and the USA in HVTN 704 / HPTN 085. Cisgender women were recorded from communities in Botswana, Kenya, Malawi, Mozambique, South Africa, Tanzania, and Zimbabwe in HVTN 703 / HPTN 081. The median age of participants registered in HVTN 704 / HPTN 085 is 28 years, and 31.6% are white, and 15.1% black, and 57.1% Latinx. In HVTN 703 / HPTN 081, the median age of the participants is 26 years, and 98.9% are black. Study participants were randomized to receive intravenous infusions of VRC01 at 10 mg / kg (lower active dose), VRC01 at 30 mg / kg (higher active dose), or placebo administered every eight weeks (10 intravenous infusions all in all). Tests for HIV infection were performed every four weeks, and participants were followed for two years. PrEP use was evenly distributed among the randomized study arms. VRC01 performed well with participants in both trials, and no safety concerns were identified.
The results show that more than one bnAb is needed to prevent HIV. Similar to antiretroviral drugs, blended monoclonal antibody cocktails need to be developed to offer effective protection against the diverse population of HIV strains circulating in these communities.
“The results from the AMP trials will inform future trial development of a combination of the fully functional bnAbs under clinical development,” said Myron Cohen, MD, Chair of AMP Protocol, HPTN Principal Investigator, and Director of the Institute . for Global Health and Infectious Diseases at the University of North Carolina at Chapel Hill. “We look forward to using this knowledge as we move forward towards our goal of ending HIV. “
There are still more than 1.7 million new cases of HIV each year worldwide; more than 75 million people have contracted HIV and more than 32 million people have died from AIDS-related illnesses since the outbreak began. The need for safe and effective HIV immunization and other HIV prevention technologies is as urgent as ever.
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DOI: 10.1056 / NEJMoa2031738
About Fred Hutchinson Cancer Research Center
At the Fred Hutchinson Cancer Research Center, home to three Nobel laureates, interdisciplinary teams of world-renowned scientists will be looking for new and innovative ways to treat cancer, HIV / AIDS and other infectious diseases. ‘prevent, diagnose and treat life-threatening. Fred Hutch ‘s pioneering work in bone marrow transplantation has led to the development of immunotherapy, which uses the power of the immune system to treat cancer. A Seattle-based independent nonprofit research institute, Fred Hutch is home to the first cancer prevention research program funded by the National Cancer Institute, as well as the clinical coordination center of the Women’s Health Initiative and the international headquarters of NIAID-funded HIV Vaccine Testing. Network (HVTN).
About HPTN
The HIV Prevention Trials Network (HPTN) is a worldwide collaborative clinical trial network that brings together researchers, ethics, community members, and other partners to ensure the safety and effectiveness of plan future approaches to HIV prevention and uptake. U.S. National Institute for Allergies and Infectious Diseases, U.S. National Institute of Mental Health, Office of the Director, U.S. National Institute on Drug Abuse, and Eunice Kennedy Shriver National Institute of Child Health and Human Development, all part of the U.S. Institutes National Health, co-funding of the HPTN. The HPTN has collaborated with more than 85 clinical study sites in 19 countries to evaluate new HIV prevention interventions and strategies in populations with an unbalanced HIV burden. The HPTN research agenda – more than 50 trials in progress or completed with over 161,000 registered and evaluated participants – focuses specifically on finding new HIV prevention tools and evaluation of integrated strategies, including biochemical interventions combined with behavioral risk reduction interventions and structural interventions. For more information, visit hptn.org.
PRESS INFORMATION:
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