- The Washington Times - Thursday, July 18, 2019

The National Institutes of Health will launch a large-scale trial of an experimental HIV vaccine in the coming weeks in North America, South America and Europe that looks to combat various global strains of the virus that causes AIDS.

This will be the only extensive HIV trial underway that specifically focuses on men who have sex with men and transgender women, according to Dr. Susan Buchbinder, one of the protocol chairs for this trial, called Mosaico.

“Throughout much of the Americas, men who have sex with men are one of the, if not the, predominant group most impacted by HIV as well as transgender women,” Dr. Buchbinder said. “This is a very important population that needs an HIV vaccine to try and prevent HIV acquisition.”

In the U.S., gay and bisexual men make up two-thirds of new HIV diagnoses although representing only an estimated 4% of the population, data from the Centers for Disease Control and Prevention suggests. About 14% of transgender women are living with HIV.

The U.N. World Health Organization estimates 37 million people globally were living with HIV at the end of 2017. Almost 60% of those living with HIV are women and girls in eastern and southern Africa, UNAIDS data says.

Mosaico trial researchers are aiming to recruit 3,800 HIV-negative volunteers aged 18 to 60 years in the U.S., Mexico, Peru, Brazil, Argentina, Poland, Spain and Italy. Volunteer enrollment will start in September, said Dr. Buchbinder.

“Our hope is that we will see a high level of protection against HIV acquisition in people who get the vaccine, and that protection is durable. That it is long-lasting,” she said. “If we got a vaccine, even a partially effective vaccine, it could substantially alter the trajectory of the HIV epidemic.”

Jesse Milan Jr., president and CEO of AIDS United, applauded the NIH and its study partners for trying to conduct research with diverse populations including what he described as “underserved populations that have not historically been engaged in HIV research.”

Mr. Milan has been living with HIV for 30 years and acquired it when he was a lawyer in Philadelphia. He said the inclusion of transgender people in the study is very exciting and will allow researchers to study how vaccines interact with various agents, such as hormones, in different bodies.

“It is certainly more cost-efficient to never have HIV than to have HIV,” Mr. Milan said. “The lifelong cost of HIV treatments and medications is very, very high, and it’s one we want to avoid at all costs.

“And then, of course, there isn’t just the health care costs. There’s the toll on the body of the person living with HIV,” he added. “Anything that can prevent someone from acquiring HIV is a strategy we should investigate as much as we possibly can.”

Mosaico trial researchers will randomly assign study volunteers to receive either four shots of the investigational vaccine or four shots of a placebo, said Anthony Fauci, director of the National Institute of Allergy and Infectious Diseases.

All participants will be offered a comprehensive HIV prevention package, including access to preexposure prophylaxis (PrEP), medication to prevent those without HIV from contracting the virus. After participants receive either the vaccine or placebo, the trial researchers will track them until 2022 or 2023 depending on the time it takes to enroll volunteers.

Dr. Fauci said the NIH doesn’t have an efficacy goal in mind with this trial, but that he expects the vaccine to be between 55% and 60% effective.

The upcoming Mosaico trial is one of three large HIV vaccine trials in progress. Imbokodo, another HIV vaccine trial, enrolled 2,600 sexually active women between 18 and 35 years across southern Africa this May. Initial results are expected in 2021.

The other ongoing trial, HVTN 702, began in late 2016 and finished enrolling 5,400 sexually active men and women aged 18 to 35 years in South Africa last month. It is assessing a newer version of the vaccine regimen tested in the RV144 Thai trial, which involved the only candidate regimen that has had modest success so far.

“If you have a vaccine that is reasonably effective and you combine it with the non-vaccine prevention modalities, you have a much greater chance of truly ending the epidemic as we know it,” Dr. Fauci said. “You’re not going to eradicate HIV but you can really dramatically turn around and diminish the dynamics of the outbreak.”

HIV usually spreads through unprotected sexual contact or sharing needles. It can lead to acquired immune deficiency syndrome (AIDS), a condition where the immune system stops working and patients can die from opportunistic infections that have no effect on most humans.

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