Photo: Tom Vieira Freitas / Globallookpress.com
An international group of scientists conducted a large-scale clinical trials of a new vaccine Ad26 against human immunodeficiency virus with the participation of almost 400 adults. The test results confirmed the presence of a persistent immune response against the virus and the safety of the drug. At the moment this vaccine is most effective among tested. Article researchers published in the Lancet, briefly about the tests described in the press release MedicalXpress.
In trials involving 393 healthy volunteers aged 18-50 years from 12 hospitals located in several regions: Eastern and southern Africa, Thailand and the United States. Experts have combined two phases of clinical trials (phase I and phase IIa), which checks the safety of the vaccine, and also the preferred dose level. All participants were randomly distributed into eight groups, two (experimental and control) on the region. The study was double blind, neither the participants nor the organizers did not know until the end of the test, which group receives the vaccine and which the dummy.
To zero and the 12th week test, participants in experimental groups received intramuscular vaccine Ad26.Mos.HIV, which is a mosaic, that is, include proteins from several strains of HIV-1. On the 28th and 48th week the volunteers underwent revaccination with the use of Ad26.Mos.HIV or modified virus Ankara, which were used as vectors for the delivery of gp140 protein shell of the HIV virus. The control group received saline solution as placebo.
The test results showed that all the tested schemes of vaccination with Ad26 was safe for the health of the volunteers and caused only minor side effects such as pain at the injection site (69-88 percent versus 49 percent in the control groups), pain in the abdomen and back, dizziness and diarrhoea (five participants). In addition, vaccination led to a significant increase in the number of antibodies against viral envelope proteins, intense phagocytosis and activation of immune T-cells.
In parallel, the researchers tested the vaccine on 72 rhesus monkeys, which had a similar immune response. How to write specialists in animal showed 67% protection against infection with the immunodeficiency virus of monkeys SHIV-SF162P3.
Video, photo All from Russia.