Thread by @sailorrooscout

So, not COVID related, however, this is REALLY exciting news I wanted to share. Only a Phase I study, BUT clinical trial results for HIV vaccine candidate eOD-GT8 60mer have shown 97% of participants (ALL but one) generated an antibody response against HIV! That is ASTOUNDING.

Vaccine candidate, eOD-GT8 60mer, had a favorable safety profile and induced broadly neutralizing antibody precursors in 97%, or all but one, of the 36 recipients. This study is a joint efforts between researchers from Scripps Research, the Fred Hutchinson Cancer Center,

the National Institutes of Health (NIH) and other institutions in the United States and Sweden.

The clinical trial results were published Thursday on World AIDS Day in the journal Science, and establish "clinical proof of concept" in support of developing boosting regimens to

induce immune responses against HIV infection, for which there is no cure and which can cause acquired immunodeficiency syndrome (AIDS).

The eOD-GT8 60mer vaccine candidate is germline-targeting, meaning it is designed to induce the production of broadly neutralizing antibodies

by targeting and stimulating the right antibody-producing cells. Broadly neutralizing antibodies are known to neutralize many genetic variants of HIV, but in the past, they have been difficult to elicit by vaccination. That is why this clinical trial data is SO ENCOURAGING.

The study findings suggest that a two-dose regimen of the vaccine, given eight weeks apart, can elicit immune responses against HIV. The International AIDS Vaccine Initiative announced the start of this Phase 1 clinical trial in 2018, to evaluate the safety of eOD-GT8 60mer

and the immune responses it is able to induce. The trial included a total of 48 healthy adults, ages 18 to 50, who were enrolled at two sites: George Washington University in Washington and Fred Hutchinson Cancer Center in Seattle. Among the participants, 18 received a

20-microgram dose of the vaccine and, eight weeks later, a same-size dose of the vaccine with an adjuvant; 18 received a 100-microgram dose of the vaccine and, eight weeks later, a same-size dose of the vaccine with an adjuvant; and 12 received two doses of a saline placebo,

eight weeks apart. The adjuvant is called AS01B, developed by the pharmaceutical company GSK. The vaccines and placebo were given into the arm muscle.

Researchers collected and analyzed immune cells from the blood and lymph nodes of participants during the study. They specifically examined how B cells, a type of white blood cell that makes antibodies in the immune system, responded to the vaccine. Researchers found no serious

adverse events reported among the study participants, and no participants acquired HIV infection during the study. About 97% -or all but one - of the 48 study participants reported local or systemic adverse events that were generally mild or moderate, such as pain at the

injection site, malaise and headache. In most cases, these events were resolved within a day or two. After the first immunization, all vaccine recipients but no placebo recipients were found to produce antibodies elicited by the eOD-GT8 60mer vaccine. Those vaccine-induced

responses INCREASED after the second vaccination. By showing that broadly neutralizing antibodies CAN be induced by a vaccine, this new study could help inform the development of other types of immunizations, not just HIV vaccines! This is an EXTREMELY important step forward.

I’ll be sure to post more updates on these studies. In the meantime, you can read all of this and more here:
•science.org/doi/10.1126/sc…
•iavi.org/news-resources…
•iavi.org/iavi-report/vo…
•amp.cnn.com/cnn/2022/12/01…