HIV Vaccine Trial “Imbokodo” Will Not Progress to Next Steps

Date: August 31, 2021 By: Rachel Leeson

Today, Johnson & Johnson announced results from the primary analysis of the HIV vaccine trial “Imbokodo,” also called HVTN 705/HPX2008. Overall, the data showed the investigational HIV vaccine, which was tested in young women at high risk for HIV infection in sub-Saharan Africa, did not provide sufficient protection against HIV infection. While the results suggest some protection, they did not reach the study’s primary endpoint and did not reach statistical significance, meaning the trial will not progress to the next steps. Participants will be notified of the results and unblinded. Importantly, the study showed no evidence of any safety concerns. 

The vaccine used an adenovirus 26 (Ad26) platform developed by Ragon Member Dan Barouch, MD, PhD, and the Phase IIb trial was supported by Johnson and Johnson, the National Institutes of Health, the HIV Vaccine Trials Network (HVTN), the U.S. Army Medical Research and Development Command (USAMRDC), and the Ragon Institute of MGH, MIT and Harvard. 

The trial was conducted at 23 sites in Africa, enrolling approximately 2600 female participants.  At the recent analysis point, 24 months after vaccination, 51 vaccine recipients had acquired HIV compared to 63 participants who received the placebo, resulting in a non-statistically significant efficacy rate of 25%.  A Johnson and Johnson phase III trial, Mosaico, which uses a similar vaccine platform optimized for different strains of HIV found in men who have sex with men in the Americas and Europe, will continue. 

“HIV continues to be a formidable foe, due to its ability to cause immune system destruction, rapidly establish life-long infection, and evade immune responses,” said Ragon Director Bruce Walker, MD.   “Though these results are disappointing, we will continue our efforts toward the global priority of developing an effective HI vaccine and hope to use the Imbokodo data to better understand how to achieve this.”

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