The Only H.I.V. Vaccine in Advanced Trials Has Failed. What Now?

H.I.V.V. is the only vaccine available. It is still being used in clinical trials in the late stages of development, but its manufacturer has declared it ineffective. announcedWednesday saw another setback in a field plagued with failure for years.

There are many H.I.V. Over the past decades, many vaccine candidates have been tested. Experts said that the latest defeat has set back progress towards a vaccine by three to five more years. However, there are still other options available in early-stage trials that could provide a strong bulwark against H.I.V.

The news is “disappointing, but it isn’t the end of the effort toward developing a vaccine,” Dr. Anthony S. Fauci, who led the National Institute of Allergy and Infectious Diseases until December, said in an interview. “There are other strategic approaches.”

A continuing study is called PrEPVaccA combination of experimental H.I.V. is being tested in Eastern and Southern Africa. Preventive drugs and vaccines are also available. Scientists have made significant progress in the development of powerful antibodies that can kill the virus. They are also testing new vaccine technologies against H.I.V.

The loss of the most recent candidate highlights the difficulties of creating a vaccine against an adversary as clever as H.I.V. It is still being infected four decades after its discovery. about 1.5 million peopleEach year, 650,000 people are killed.

H.I.V. can be a lifesaver for those living in richer countries. H.I.V. isn’t the death sentence that it used to be. Infected people can be suppressed with powerful drugs. There are many options for preventing infection. Shots and oral medications are approved in the United States. A shot that needs to be given only every six months is currently in late-stage clinical trials.

But these medications must be taken for the rest of the patient’s life, and are often inaccessible to those who need them the most. The best way to stop the virus is with a vaccine.

“The ultimate prevention modality for any infection, particularly viral infection, is a vaccine that’s safe and effective,” Dr. Fauci said. “That’s the reason why the field is going to continue to pursue very active research in that area.”

The trial is now over, and it’s called Mosaico, began in 2019 and was led by Janssen Pharmaceuticals, part of Johnson & Johnson. It tested the vaccine on 3,900 male cisgender cisgenders (those who identify as males from birth) and transgender persons who have had sex in over 50 locations across nine countries in North America, South America, Europe.

The vaccine was composed of a variety of components, which were designed to target H.I.V. subtypes. present worldwide. However, the virus was not able to produce significant immune responses against it.

While the trial’s failure does not spell the end of the mosaic approach, it does signal that a successful vaccine should rouse the body to produce broadly neutralizing antibodies, Dr. Fauci said.

An independent safety and data monitoring board reviewed early data from the trial. It concluded that the vaccine was safe but did not prevent any more H.I.V. The vaccine did not prevent more H.I.V. infections than a placebo. The board recommended that they stop the trial immediately and inform all participants.

Experts were not surprised by the results. A study on the same vaccine was called ImbokodoWas? haltedIn 2021. The vaccine was tested in five sub-Saharan African countries, where it was administered to cisgender females.

The failure of the studies is particularly disappointing partly because they were funded by Johnson & Johnson, said Mitchell Warren, executive director of the H.I.V. Prevention organization AVAC.

“Not that many companies get involved in infectious disease vaccines, so to see this not getting to market is a disappointment and a setback,” Mr. Warren said.

This news should encourage activists and policymakers to consider ways to make existing tools to prevent H.I.V. more accessible. more widely accessible, he added: “It’s not that all hope is lost, it’s that we need to redirect our resources to greatest impact.”