An international team of scientists conducted large-scale clinical trials of a new Ad26 vaccine against human immunodeficiency virus in almost 400 adults. The test results confirmed the presence of a stable immune response against the virus and the safety of the drug, according to Pannochka, an online publication for girls and women from 14 to 35 years old.. net This vaccine is currently the most effective among those tested. As Lenta writes. ru, researchers' article published in the Lancet, a brief summary of the trials is described in a press release on MedicalXpress.

The trial involved 393 healthy volunteers aged 18-50 from 12 clinics located in several regions: East and South Africa, Thailand and the USA. Experts combined two phases of clinical trials at once (phase I and phase IIa), which test the safety of the vaccine and the preferred dosage level. All participants were randomly divided into eight groups, two (experimental and control) per region. The study was double-blind, that is, neither the participants nor the organizers knew until the end of the trial which group received the vaccine and which received the dummy..

At week 0 and 12 of the trial, participants in the treatment groups received the Ad26 intramuscular vaccine.. mos. HIV, which is mosaic, that is, it includes proteins from several strains of HIV-1 at once. Volunteers were revaccinated with Ad26 at weeks 28 and 48.. mos. HIV or modified Ankara viruses that were used as delivery vectors for gp140, the envelope protein of the HIV virus. Control groups received saline as a placebo.

The results of the study showed that all tested Ad26 vaccination regimens were safe for the health of volunteers and caused only minor side effects in the form of pain at the injection site (69-88 percent vs. 49 percent in control groups), abdominal and back pain, dizziness and diarrhea.. In addition, vaccination contributed to a significant increase in the number of antibodies against viral envelope proteins, intensive phagocytosis and activation of immune T-cells..

In parallel, the researchers tested the vaccine on 72 rhesus monkeys, which had a similar immune response.. Animals showed a 67 percent protection against infection with simian immunodeficiency virus SHIV-SF162P3.

aspect. net.