To address these methodological issues, the scientists evaluated the leading mosaic adenovirus serotype 26 (Ad26)-based HIV-1 vaccine candidates in parallel clinical and pre-clinical studies to identify the optimal HIV vaccine regimen to advance into clinical efficacy trials. The achievement was considered to be too small for the drug to go ahead and come into the market as a HIV vaccine.
Researchers, including those from Harvard Medical School in the United States, found that the "mosaic" vaccine, created by combining pieces of different HIV viruses, is well-tolerated and generated comparable and robust immune responses against HIV in healthy adults and rhesus monkeys.
"These results represent an important milestone".
Clinical trials of an HIV vaccine that is supposed to protect the person from different strains have shown promising results.
Until now, all the positive results show that researchers can continue testing it. Further, Barouch, the Director of the Center for Virology and Vaccine Research, added, "We have to acknowledge that developing an HIV vaccine is an unprecedented challenge, and we will not know for sure whether this vaccine will protect humans".
Doctors diagnosed over 1.8 million new cases of HIV infection in 2016, the authors informed. The findings showed the vaccines induced robust and comparable immune responses in humans and monkeys and protected monkeys against acquisition of infection. We do not have a licensed prophylactic, i.e., meant to prevent disease, HIV vaccine.
To participate in a double blind test 393 healthy men 18-50 years of 12 hospitals in various countries, including the US, Uganda, Thailand, South Africa and Round randomly distributed into experimental and control groups.
People received the injections at weeks 0 and 12 of the study, with boosters at weeks 24 and 48.
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The new so-called mosaic vaccine is composed of proteins of various strains of this virus, so ideally should be universal protection.
All of the vaccines prompted anti-HIV immune responses in the participants, the results revealed. Five participants reported at least one vaccine-related grade 3 adverse event, including abdominal pain, diarrhea, postural dizziness, back pain and malaise.
A team of Harvard-led scientists is seeing positive results after testing a multi-strain HIV vaccine - dubbed the "mosaic" - in humans. They also note that there is no definitive immunological measurement that is known to predict protection against HIV-1 in humans.
"How do we make a vaccine that raises immune expenses relevant for all the HIV sequences?" said Barouch. It remains to be determined whether improved efficacy over RV144 will be achieved by either of the present efficacy trials (NCT02968849; NCT03060629).
These types of trials are created to test out whether an intervention is safe and works at the most basic level.
The developers eagerly preparing a drug to test for HIV people, and hope for success.
An accompanying editorial by George N. Pavlakis, MD, and Barbara K. Felber, PhD, both of the National Cancer Institute in Frederick, Maryland, discussed this approach, stating that it "defines an additional path for exploring the development of an effective HIV vaccine".