Antibody Mediated Prevention (AMP) Studies fully enrolled

& HVTN and HPTN researchers converge at R4P Conference –
Madrid, Spain (October 21–25, 2018)




SEATTLE – OCTOBER 19, 2018

The precedent-setting AMP Studies--the most advanced clinical trials to test whether an antibody can prevent HIV infection in people--are fully enrolled. 

The pair of Phase 2b clinical trials run by the HIV Vaccine Trials Network (HVTN), which is headquartered at Fred Hutchinson Cancer Research Center, and the HIV Prevention Trials Network (HPTN) have enrolled 4,625 participants who are at risk for HIV infection from communities in the United States, Brazil, Peru, Switzerland, and sub-Saharan Africa. Complete enrollment will facilitate the timely analysis of the combined data of the AMP Studies as well as trial-specific data, enabling researchers to answer the study questions efficiently. The National Institute of Allergy and Infectious Diseases, part of the National Institutes of Health, is sponsoring and funding the trials.      

“We are grateful to each study participant and their communities for making a commitment to participate in the AMP Studies”, said Larry Corey, M.D., Principal Investigator of the HVTN, virologist and faculty member at Fred Hutchinson Cancer Research Center in Seattle. “Study participants are the heartbeat of our global clinical trials”.   

While an experimental HIV vaccine aims to prevent infection by stimulating the immune system of an uninfected person to produce protective antibodies, a technique called passive antibody transfer involves giving antibodies directly to an uninfected person by injections or intravenous infusions. The AMP Studies are the most advanced human trials to test whether this strategy can prevent HIV infection in humans. Study participants are receiving a so-called “broadly neutralizing antibody” named VRC01 as an intravenous infusion every 8 weeks.

Broadly neutralizing antibodies, or bnAbs, can stop many strains of HIV from infecting human cells in the laboratory. Roughly 50 percent of people living with HIV make bnAbs naturally, but only after years of infection, when it is too late for the antibodies to have a protective effect.

The AMP Studies are designed to determine if VRC01 can prevent HIV acquisition, to establish the concentrations of bnAbs required for protection, and to define the relationship between any “breakthrough infections” and in vitro sensitivity to VRC01. If VRC01 works as anticipated, the level of neutralization would inform the use of more monoclonal antibodies and help define the target level of neutralization required for an effective HIV vaccine.

“The development of bnAbs for HIV prevention and to identify targets for HIV vaccine design is a great example of how a concerted basic science program and important clinical observations lead to new prevention technologies,” said Myron Cohen, MD, HPTN co-principal investigator and director of the University of North Carolina at Chapel Hill Institute for Global Health and Infectious Diseases in Chapel Hill, NC. 




Phase 2b AMP study profiles:




Phase 1 bnAb study profile:

A third clinical trial, the Phase 1 study HVTN 127/HPTN 087, is being conducted to evaluate the safety and serum concentrations of a human monoclonal antibody, VRC07-523LS, in healthy, HIV-uninfected adults at low risk for HIV infection. The antibody is an antibody related to VRC01 that is more potent, binds to more strains of HIV, and lasts longer in the human body. VRC07-523LS is being administered at multiple doses via intravenous infusion, subcutaneous injection, or intramuscular injection.







Connect and engage HVTN at the HIV Research for Prevention (HIVR4P) Conference

  • Presenting a series of 11 general abstracts, 12 late breakers and two satellite sessions, the HVTN will demonstrate its scientific breadth and leadership at the upcoming HIV Research for Prevention (HIVR4P) conference scheduled to take place in Madrid, Spain from October 21–25, 2018.
  • Access HVTN’s presence: http://www.hvtn.org/en/media-room/hvtn-hivr4p-scheduleofevents.html



Connect and engage HVTN at the HIV Research for Prevention (HIVR4P) Conference

  • HPTN researchers will present 17 abstracts – six oral presentations and 11 poster presentations– and four satellite sessions. In addition, Raphael Landovitz, MD, MSc, HPTN 077 and HPTN 083 protocol chair, will deliver a talk during the October 24 plenary session entitled, “Beyond TDF/FTC: The Future of Systemic Pre-exposure Prophylaxis.”
  • View HPTN’s schedule of presentations and sessions: https://www.hptn.org/news-and-events/announcements/hptn-at-hivr4p-2018



We are on a scientific journey to find a safe and effective HIV vaccine to prevent new HIV infections in the future

An estimated 35 million lives have been lost since the HIV/AIDS pandemic began more than three decades ago.  The World Health Organization (WHO) estimated that 37.6 million people were living with HIV in 2016, and 1.8 million new infections were documented in the same year. There are an estimated 5,000 new HIV infections daily around the world. Key populations at risk of acquiring HIV, irrespective of epidemic type or local context, include men who have sex with men, people in prisons and other closed settings, sex workers and their clients, transgender people and people who inject drugs.




About the HVTN

The HVTN, which is headquartered at Fred Hutchinson Cancer Research Center, is the world’s largest collaboration facilitating the development of vaccines to prevent HIV/AIDS and has together with global partners demonstrated significant scientific progress in pursuit of an effective HIV vaccine.  Through an inclusive strategy, and by forging in-country relationships on four continents at 44 clinical trial sites, the network works collaboratively with global communities and partners in the search for a safe and effective HIV vaccine. Primarily funded by the National Institute of Allergy and Infectious Diseases (NIAID) of the National Institutes of Health (NIH), the network currently manages 18 active clinical trials of which four are large-scale in-human efficacy trials.  For more information, visit www.hvtn.org




About the HPTN

The HIV Prevention Trials Network (HPTN) is a worldwide collaborative clinical trials network that brings together investigators, ethicists, community and other partners to develop and test the safety and efficacy of interventions designed to prevent the acquisition and transmission of HIV. The HPTN has collaborated with more than 85 clinical research sites in 19 countries to evaluate new HIV prevention interventions and strategies in populations that bear a disproportionate burden of infection. The HPTN research agenda – more than 50 trials ongoing or completed with over 161,000 participants enrolled and evaluated – is focused primarily on the use of integrated strategies: use of antiretroviral drugs (antiretroviral therapy and pre-exposure prophylaxis); interventions for substance abuse, particularly injection drug use; behavioral risk reduction interventions and structural interventions.  NIAID, NIDA and the NIH’s National Institute of Mental Health co-fund the HPTN. For more information, visit hptn.org.




Aziel Gangerdine

HVTN: Director of Communications

C +1 206.384.0945 / O +1 206.667.7875

agangerd@fredhutch.org
www.hvtn.org
Facebook.com/helpendhiv
Twitter.com/helpendhiv

Eric Miller

HPTN Sr. Communications Officer

C +1 919.384.6465 / O +1 919.544.7040

emiller@fhi360.org
www.hptn.org
www.facebook.com/HIVptn
twitter.com/HIVptn