Johnson & Johnson HIV vaccine fails initial efficacy trial

NSThe HIV vaccine, which uses the same basic technology as Johnson & Johnson’s Covid Shot, could not prevent the infection, the company said Tuesday.

The study, called Imbokodo, enrolled 2,600 women in southern Africa who were at very high risk of HIV transmission. J & J and its partners (including National Institutes of Health and Bill & Melinda Gates Foundation) Survey started in 2017 And announced it Received by all participants Last year it was either a vaccine or a placebo. The purpose of the vaccine was not to completely prevent the infection, but to reduce the chance of infection in half.

“If the vaccine is 50% effective, we can reduce the future of the HIV pandemic,” said Paul Stoffels, chief scientific officer and former HIV researcher at J & J. He said the actual efficacy was 25.2%, meaning that vaccinated patients had a significantly lower chance of getting infected 24 months after the first dose compared to the placebo group. rice field. The difference is not statistically significant, indicating that the results may be due to chance.

A second study, called Mosaico, will continue to test slightly different vaccine therapies in men who have sex with men in the Americas and Europe and transgender people.

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“Developing a safe and effective vaccine to prevent HIV infection has proven to be a formidable scientific challenge,” said Anthony Fauci, director of the National Institute for Allergic Infectious Diseases, in a statement. increase. “This is certainly not the result of the study we were hoping for, but we must continue our efforts to find a vaccine that prevents HIV by applying the knowledge we have learned from the Imbokodo trial.”

Scientists have been working on the development of HIV vaccines for decades.After the Merck vaccine wasn’t proven to be effective in 2007, researchers looked back at the data and discovered it. Increased the risk that people will develop the disease.. A 2009 study in Thailand showed limited but significant efficacy, with a reduction in infection rates of about 30%, raising expectations.But last year, effort The combination of Sanofi and GlaxoSmithKline vaccines did not prove effective..

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J & J has repeatedly been optimistic about vaccines. In 2015, Johan Van Hoof, who heads J & J’s vaccine research and development, pointed out data showing that vaccines can reduce infections by 90% in animals, “potentially a true breakthrough for future HIV vaccines. It suggests that there is. ” In a phone call with financial analysts in 2020 and 2021, Stoffels mentioned the HIV project as part of the company’s vaccine efforts and said it was “extremely encouraging.”

When the trial began five years ago, Fouch said:The development and delivery of safe, at least moderately effective prophylactic HIV vaccines will help end the HIV / AIDS pandemic permanently. “

Imbokodo means “rock” in isiZulu, a saying about women’s strength and community needs.

In this study, 63 of the 1,109 volunteers in the Placebo group were infected with HIV, and 51 of the 1,079 volunteers who received the vaccine were infected with HIV. The difference leaves a lot of uncertainty as to whether it worked. The 95% confidence interval used by researchers to define the range of expected results ranged from -10.5% to 49.3%.

However, J & J said in its announcement that no vaccine-related safety issues were identified. Stoffels told STAT that it was clear that the vaccine did not increase the risk of HIV.

Larry Corey, a principal investigator at the HIV trial network that helped conduct the study and a professor at the Fred Hutchinson Cancer Research Center in Seattle, said the results were both disappointing and a sign of progress. He said that non-neutralizing antibodies that bound the virus but did not completely stop the infectivity were expected to be sufficient to slow the rate of HIV infection, but vaccine developers understand. Learn how to generate antibodies that neutralize viruses that are starting to appear to be needed.

“It shows that non-neutralizing antibodies do not reduce acquisition, and probably how difficult and different HIV is than Covid-19,” Corey said.

Similar to the Covid-19 vaccine developed by Johnson & Johnson, this HIV vaccine uses a type of virus called adenovirus to deliver the genetic code of a protein to recipient cells. This produces proteins that the immune system learns to recognize and attack. The adenovirus strain used, Ad26, has also been used as an vaccine against Johnson & Johnson’s respiratory syncytial virus, which can be very serious in infants.

HIV vaccine therapy was tested for repeated doses. It was given four times and contained a “mosaic” genetic code of proteins from different strains of the HIV virus. Patients also received soluble protein injections on their third and fourth visits.

An ongoing Mosaico study (studies in the Americas and Europe) uses different mixtures of soluble proteins in the third and fourth vaccinations. Stoffels said this is one reason vaccines may work better in the study. Second, volunteers in the Mosaico study have a lower risk of infection, which can make vaccine use difficult.

Corey also said there was hope that Mosaiko would succeed where Inbokodo failed. He said the new formulation resulted in higher levels of antibodies against HIV in previous studies.

Stoffels said he didn’t think the results should color people’s feelings about J & J’s adenovirus vaccine platform, and he noted that it proved to be effective against Covid-19 and Ebola. .. (In Covid-19, widespread use of the vaccine was also associated with rare but serious side effects with both thrombus formation and excessive bleeding. The side effects are very rare and large. It may not be detected even in various clinical trials.)

“The HIV virus is a very specific virus, finding ways to escape the immune system and infect people, again showing that it is very difficult to boost immunity to the acquisition of HIV,” Stoffels said. Stated.

However, researchers will continue to make efforts.Modana Recently started a human clinical trial Development of an HIV vaccine that relies on the mRNA technology behind the Covid vaccine.

Corey noted that even under Covid’s blockade, the women surveyed had a 4% chance of being infected with HIV. He said it emphasized the need for vaccines.

“When you have an effective vaccine, the vaccine really makes a difference. See what happened with Covid,” Corey said. “I don’t think we can give up.”