How should HIV vaccine trials be conducted in the PrEP era?

According to the expert panel, methods to prevent HIV infection continue to expand from oral pre-exposure prophylaxis (PrEP) to injectable formulations, so HIV vaccine trials take these into account and adhere to ethical principles. You need to make sure that

From PrEP to widely neutralizing antibodies, “we have multiple ways to prevent biobehavioral HIV,” said Kenneth Mayer, MD, Fenway Institute, Boston. “The field is evolving in terms of its mindset…when comparing two active modalities to each other.”

As counseling on existing HIV prevention modalities has become an integral part of HIV healthcare, researchers may “need to enroll tens of thousands of people in vaccine trials,” Meyer said, “trials, tribulations and prevention. “In a session titled “. Virtual International AIDS Conference..

In fact, Dr. Stephaun Wallace of the University of Washington in Seattle, said approval of oral PrEP dramatically increased PrEP uptake. He takes PrEP from 5% HVTN 505, 2009-2013 trial of HIV vaccine targeting men (MSM) having sex with men and women of transgender. HVTN 704 / HPTN 085, Broad-area neutralizing antibody research, which has been ongoing since 2016 in the same population.

Given the complex nature and recent “field speed”, he talked about “design challenges for future HIV preventive efficacy studies”.

Holly Janes, PhD, of the University of Washington, also said that “the foundation of HIV prevention research” was a placebo-controlled trial, but researchers have been forced to consider this factor in advancing trial designs. She proposed a “targeted recruitment”. Those who refuse or are unable to use other prophylaxis, such as PrEP, will bring intervention to those who need it most.

Wallace talks about the ethics of conducting vaccination trials using PrEP in the background, and identifying participants who opt-out of PrEP is ethical and acceptable, and these trials Pointed out another expert who said “full transparency on effectiveness and continued education is needed” and the availability of PrEP. “

Meyer stressed that participants in HIV prevention trials could not be implicitly forced to take risks that they might not normally take, “they need to provide basic precautionary criteria.” ..

Making participants aware of PrEP services can be incorporated into HIV vaccine trials in a number of possible ways, Janes said.

“Participants of interest are linked to the verbal PrEP service before screening takes place and can make an informed and confident choice.” And if they subsequently refuse PrEP, “They are registered in court,” she said.

As a second option, Janes offered PrEP first to all participants and evaluated interest and adherence to PrEP three to six months later, placing those who had rejected or poor adherence in placebo. A controlled trial design that can be registered with.

“Individuals may take a while to determine if PrEP will work for them,” Janes said.

She also suggested following an observational cohort of PrEP users along with a randomized trial. This has the dual advantage of comparing the efficacy of new modalities such as vaccines to PrEP and produces additional data on the efficacy of PrEP.

Wallace MOSAICO StudyHowever, we recommended that participants interested in PrEP be linked to HIV prevention at screening, while individuals taking PrEP at screening were excluded.

Meyer said these questions will become more urgent as trials of HIV prevention modalities continue, with the first-generation efficacy of broad-spectrum neutralizing antibodies in the fall, and ongoing HIV vaccine trials, MOSAICO, and Noisy In the next few years.

He described all currently available HIV prevention products as “one of the risks or challenges of success” even if new products are being developed.