Major setback as another large ongoing Phase 3 HIV vaccine trial fails

In a blow to researchers around the world, the only HIV vaccine currently in Phase 3 clinical trials was deemed a failure and was halted. Experimental vaccines have been tested in thousands of participants in Europe, North America, South America, and Africa, but their failures have made the focus of current research focused on other studies only in early-stage human trials. changes to several candidates for

The trial, called ‘Mosaico’, began in 2019 and is one of three promising late-stage real-world trials of several HIV vaccines that have been in development for more than a decade. Mosaico was the last hope of these three major trials of his.

The first trial began in 2016 and enrolled over 5,000 people in South Africa. The trial, called “Uhambo,” was testing a vaccine regimen combining two different experimental HIV vaccines. Uhambo was discontinued in his 2020 after early data analysis revealed similar numbers of HIV infections were detected in both the vaccine and placebo groups.

A second trial, known as “Imbokodo,” began in 2017, focusing on about 2,500 women in sub-Saharan Africa. That study tested a vaccine similar to the Mosaico trial, delivering a range of different HIV antigens in her single injection. Imbokodo was discontinued in mid-2021 for her, but an interim data analysis found the vaccine offered no protection against HIV infection.

Now, in a new joint announcement from the National Institutes of Health, Johnson & Johnson, and the HIV Vaccine Trials Network (HVTN), Mosaico has officially been discontinued. Mosaico’s story is sadly the same. After enrolling approximately 3,900 men at 50 study sites, interim data analysis revealed similar rates of HIV infection in him in the placebo and vaccine groups.

HVTN’s Susan Buchbinder and co-chair of the Mosaico trial expressed both disappointment and hope in a statement about the study’s failure.

“These results are disappointing for our research partners and others who have worked for decades to develop a vaccine to end the HIV/AIDS pandemic,” Buchbinder said. said. The HIV research community is committed to doing just that, and each study brings us one step closer to achieving this.”

Penny Heaton, a member of the Johnson & Johnson vaccine research team, also expressed disappointment at the results of years of work and investment. showed.

“We remain steadfast in our commitment to advancing HIV innovation, and we hope the data from Mosaico will provide insight into future efforts to develop safe and effective vaccines. ‘ said Heaton. “We would like to thank our partners, researchers, staff and participants at Mosaico.”

The Mosaico failure is another setback in a research field that has faced decades of difficult clinical trial failures. Indeed, there are several promising new HIV vaccine candidates in various stages of research. mRNA vaccines in particular have recently yielded exciting preclinical results.

Another researcher working on HVTN, Larry Corey, is still optimistic about progress. Corey says discoveries are made whenever clinical trials fail. Research is streamlined, and HIV treatments are constantly improving, even when vaccines are unsuccessful.

“HIV is an ever-changing and formidable foe. Even with our best efforts, it can be frustrating when you don’t get the results you’re looking for. Since then, we have come a long way and made many discoveries.”

Source: NIH, HVTN, Johnson & Johnson



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