AMP Study

AMPing up for HIV Prevention

Jim Maynard, Director of Communications & Community Engagement

HIV continues to be a major health crisis worldwide with over 2 million1 new infections each year and 1000 per day in South Africa alone2 . Our current HIV prevention “toolbox” includes some highly effective tools like condoms and PrEP (Pre Exposure Prophylaxis), yet they have not proved to be enough to adequately curb the epidemic and protect our communities. The HVTN and HIV Prevention Trials Network (HPTN) will be partnering for the first ever proof of concept trials to test a new idea that offers great promise to prevent new infections.

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Participant receiving an IV "drip" Courtesy of Harlem Prevention Center (NY)

This new idea is called Antibody Mediated Prevention, or more simply, “AMP.” The goal of AMP is to prevent HIV infection using a broadly neutralizing antibody (BNAb) against HIV given through an IV infusion (sometimes called a drip). While a vaccine teaches the body to make antibodies on its own, AMP involves giving the antibody directly to people. The human immune system produces antibodies in response to potential invaders like viruses so that your body can block an infection, or prevent the invader from causing disease.

The VRC01 antibody, discovered by a team of researchers at the NIAID Vaccine Research Center (VRC), was initially identified in a person who had been infected with HIV for over 10 years but had never developed AIDS. Such individuals are known as “elite controllers.” VRC01 has been shown to neutralize (or block) over 90% of the 190 strains of HIV it has been tested against. Because of this, researchers are optimistic that this BNAb could be effective in preventing HIV for populations around the world and not just in a particular region. Dr. Larry Corey, principal investigator of the HVTN and co-chair of the AMP Studies, said, “We need to know if this antibody will protect against infection. The data from laboratory studies and animal models are very exciting, but we need to know if this ‘holy grail,’ a broadly neutralizing antibody, can actually be protective in people…

VRC01 antibodies neutralize HIV
(1) The VRC01 antibody is able to bind onto HIV at the (2) CD4 binding site on the gp120 protein. (3) This neutralizes HIV and prevents HIV from being able to attach to cells and infect them. Illustration by Lisa Donohue Click for high-res version

This will help us understand how to build vaccines that could cause the right immune responses. These are questions that phase 2b studies can help us to answer.”

Our two networks have a history of working closely with community members as full partners in research happening in their communities, and this is especially evident in preparing for the AMP Studies. The protocol teams include 3 CAB members and 2 CERs to ensure community input to the protocols. The AMP Community Working Group was formed with a CAB member and CER from each of the clinical trial sites conducting the trials to give real time feedback on everything from communication tools and recruitment materials to ongoing conduct of the trial at their sites.

US site staff took part in a 4 day AMP training in November 2015, which included a 6 hour cultural sensitivity training to help staff prepare for cohorts they may not have experience in working with such as transgender and MSM community members. Similar trainings are being planned for 2016, one for the South American sites and another for the African sites.

AMP may be an idea that helps us slow down the spread of HIV until we reach our ultimate goal of a safe and effective vaccine! Working together, we can reach that goal.

 

1. UNAIDS World AIDS Day 2015 Fact Sheet (pdf)

2. Rehle T, et al. “A Comparison of South African National HIV Incidence Estimates: A Critical Appraisal of Different Methods” Plos One. 2015 Jul 31; 10(7):e0133255

 


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