Infectious Disease

HTI vaccines induce some level of viral control in patents with HIV who do not have ART

March 11, 2021

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Bailon L et al. Abstract 161. Presented at: Conference on Retroviruses and Opportunistic Infections; 6-10 March 2021 (virtual meeting).

Disclosure:
Kamarulzaman does not report any relevant financial information. Mothe reports that he is an inventor of the HTI vaccine and a part-time clinical advisor to Aelix Therapeutics.

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Vaccines containing a novel T-cell immunogen were safe and highly immunogenic in early treated people with HIV who discontinued ART. This is evident from study results presented at the conference on retroviruses and opportunistic infections.

HTI vaccines – HTI stands for HIVACAT T-Cell Immunogen (Aelix Therapeutics) – contain “a novel HIV vaccine immunogen designed to redirect cellular immune responses to HIV virus control-related targets,” the researchers explained in a summary.

The results presented at CROI are “an exciting step forward in HIV cure research,” said the President of the International AIDS Society Adeeba Kamarulzaman, MBBS, FRACP, FASc.

“The Aelix study showed that immunization with a mixture of DNA and viral vector vaccines containing a unique set of peptides called HTIs is feasible and induces some level of viral control in people with HIV who discontinue antiviral drugs Kamarulzaman said in a statement, “This vaccine used peptides that are widely recognized by elite controllers, people who can control viruses naturally without treatment.”

The HTI design “has shown for the first time that it is possible to induce an immune response that can contribute to better control of HIV”. Beatrice Mothe, MD, PhD, Associate investigator at the IrsiCaixa AIDS Research Institute in Badalona, ​​Spain, said Healio. “This is the first step towards a functional cure and positions HTI as the promising backbone of the vaccine in any combined cure strategy.”

Mothe and colleagues randomly assigned 45 early-treated HIV patients to receive the DNA.HTI and MVA.HTI vaccines, followed by the ChAdOx1.HTI and MVA.HTI vaccines, or a placebo. They monitored viral load for 24 weeks and resumed ART if a patient’s viral load exceeded 100,000 copies / ml, exceeded 10,000 copies / ml for 8 weeks, or if CD4 counts fell below 350.

A total of 30 participants received the ChAdOx.HTI and MVA.HTI vaccines, 15 received a placebo, and 41 of the 45 participants received the DNA.HTI and MVA.HTI or placebo regimens. The immunizations were found to be well tolerated, immunogenic – defined as a two-fold or greater increase in HTI-specific T-cell responses – and did not cause serious adverse events in 97% of the vaccinated patients, the researchers reported.

Among participants without potentially beneficial HLA Class I alleles, 40% of the vaccines were able to stay away from ART for 22 weeks, compared with 8% of participants in the placebo arm.

“The level of viral control outside of ART has not been as high as our long-term goal in HIV cure studies where we aim to achieve viral loads of less than 200 copies / ml without ART,” said Kamarulzaman. “The beneficial effect of immunization on viral load control was clear, however, and represents the first proof of concept in people with HIV that stimulating HIV-specific T cells can help healing strategies.”

Mothe said one of the limitations of the study was population specificity.

“This is a very specific population in which – in our environment – women are particularly underrepresented,” said Mothe. “For future studies, we plan to simplify the vaccination regimen in terms of the number of vaccines used to make it more practical and expand the study population to get closer to the ultimate target population of all people living with HIV.”

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Conference on Retroviruses and Opportunistic Infections (CROI)

Conference on Retroviruses and Opportunistic Infections (CROI)

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