The candidate HTI vaccine from AELIX Therapeutics was realized in a clinical trial. When antiretroviral therapy was temporarily withdrawn, 40% of the participants receiving drug treatment could better control the virus. In contrast, only 8% of those who received a placebo got it.
The person currently living with him VIA Must be taken every day Antiretroviral therapy,from immune system It cannot control the virus spontaneously.Now, the results of this clinical trial HTI therapeutic vaccine From AELIX Therapeutics Prove that this vaccine can “train” the immune system to improve the response to the virus.
To study its efficacy, once the drug is administered, participants will temporarily discontinue antiretroviral therapy and measure the level of virus in their blood weekly. 6 months. Studies have shown that the vaccine is safe, and the immune response produced by participants is directly related to how long they can stay without antiretroviral therapy.
Specifically, among trial participants who did not have any genetic factors that made it easy to control HIV spontaneously, one 40% Unlike the placebo group, 6 participants in the placebo group managed to undergo treatment for 6 months without treatment. In the placebo group, all but one participant Both must restart treatment 12 weeks ago.
This vaccine was designed by the AIDS Institute IrsiCaixa And in HIVACAT ConsortiumThe project jointly initiated by the “la Caixa” Foundation and the Ministry of Health of the Republic of Catalonia, combined with other vaccines, immunotherapy or drugs, opens the door to new treatment strategies.
The results of phase I/IIa clinical trials, in German Trias i Pujol Hospital By the Foundation for Fighting AIDS and Infectious Diseases (FLS) And IrsiCaixa, BCN checkpoint The study participants and their medical follow-up studies were included, and they were introduced at the 2021 Retroviral and Opportunistic Infections Conference (cut).
Clinical trials, called Alex 002, Including only those who were found to have been infected with HIV earlier and started receiving treatment soon. This inclusion criterion is key, because the immune system of these people is not weakened by the virus, and the virus pool is smaller than the later diagnosis.
Vaccines imitate “super controllers”
HIV is dormant in the immune system cells as a virus reservoir. This is why after stopping antiretroviral treatment, the virus will leave these virus reservoirs within a few weeks, and because the immune system of most infected people cannot spontaneously control HIV, the amount of virus in the blood increases rapidly. However, only a very small number of people will spontaneously develop a very strong immune response against the virus and can better control the infection.
“We studied which parts of the virus attacked these people’s immune systems, so that they could artificially simulate their response to the virus. He explained that from here we identified the vulnerable parts of the virus and designed it to express the virus. HTI vaccines in these areas. Beatriz Mothe, IrsiCaixa is an associate researcher and co-inventor of HTI vaccine Christian Brander with Anuska Llano.
Principal Investigator of IrsiCaixa and Scientific Director of AELIX Therapeutics Brand said: “The results obtained in the laboratory and in animal models are very good. This is why we decided to promote vaccine development and test it in clinical trials.”
Although all participants had a detectable virus in their blood at some point, for the first time the immune response could be modified to make it stronger and better control the virus
This 97% Among those who received the vaccine, at least twice the specific immune response to susceptible viruses, including the HTI vaccine, doubled. Among them, those who respond more strongly to these parts of the virus are those who can better control the virus and can take longer without treatment, which confirms the direct relationship between the vaccination response and virus control.
“The follow-up of patients has been carried out for nearly 3 years and was completed in the emergency medical incident caused by covid-19. This is a huge challenge,” Moltó said. “Although all participants had a detectable virus in their blood at some point, these results showed for the first time that the immune response can be altered to make it stronger and better control the virus.”
The next step will be to understand how to increase the response and allow more participants to stay longer at a lower viral load without the need for treatment.