HIV Vax therapeutic test takes its first human steps

The HIVACAT T-cell immunogenesis (HTI) vaccine schedule was safe, and about 40% of recipients were able to stay off antiretroviral therapy (ART) for several months, a researcher said.

In a first-stage randomized I / II trial initiated by 45 participants, eight out of 20 participants who were successfully vaccinated 22 weeks without ART, compared with one received a placebo, reports Beatriz Mothe, MD, of the IrsiCaixa Institute for AIDS Research in Badalona, ​​Spain.

In addition, five vaccine participants and one placebo partner maintained viral loads of less than 2,000 copies / mL during the analgesic treatment interruption period of up to 24 weeks, although all participants received degree of viral response.

These promising results, presented as a late study at the Virtual Conference on Retroviruses and Fair Diseases (CROI), caught the attention of the International AIDS Society. IAS President Adeeba Kamarulzaman, MD, identified the lawsuit as “an exciting step forward for HIV treatment research” in a statement.

“The level of viral control off ART was not as strong as our long-term goal in HIV treatment studies,” said Kamarulzaman, from the University of Malaya in Kuala Lumpur, Malaysia. “However, the beneficial effect of vaccination on the control of viral loading was clear and represents the first proof of the concept in People Living with HIV that HIV-specific T-cell stimulation can contribute to pre- medical devices. “

The goal of any treatment strategy is to have a viral load of less than 200 copies / mL without ART, she said.

Mothe confirmed that these findings are far from changing the current clinical use of HIV management, but “our encouraging data strongly support the use of HTI vaccines as a T-cell backbone for combination therapy strategies in the future. “

To date, therapeutic vaccines have shown limited ability to induce viral reproduction once ART has been suppressed, whereas HTI vaccines are designed to induce specific immune responses associated with promote better viral control, Mothe said.

AELIX-002 was a single-center randomized trial consisting of early-treated HIV-infected patients, necessitating early onset of side-effect drug therapy. within 6 months of HIV being registered and had to be virologically administered for at least a year.

Participants were randomized to 2: 1 to receive a primary-stimulation vaccine regimen: three doses of DNA vaccine followed by two doses of viral vector vaccine, followed by three additional doses of viral vector vaccine, or matched placebo before entering the analytical treatment break period of 24 weeks.

There were 45 participants in the first phase, and 42 agreed to continue to the second phase. All but one entered the breakdown period of analysis treatment. Almost all men who had sex with men (MSM) had participants, with an average age of 34-37.

In particular, a minority of participants may have beneficial class I human leukocyte antigen (HLA) alleles, which may have contributed to favorable virologic responses. Mothe and colleagues ruled out the exclusion when assessing participants’ ability to sustain an analytical treatment break, leaving 32 participants without any beneficial class I HLA alleles.

The Mothe group also noted that the magnitude of HTI-specific responses at the time of analgesia treatment was positively correlated with ART off time in the vaccine group.

The next steps include testing the vaccine in a wider population, which may include the introduction of the vaccine as part of a combination approach. combined with a latency return agent or agent to stimulate an immune response and help reduce the viral reservoir.

“That does not mean that therapeutic vaccines could not work among people who did not start ART,” Mothe said at a news conference.