About this Study
WHAT:
We are testing a new biotherapeutic drug called MucoCept-CVN to see if it is safe, acceptable, and capable of growing in the vagina. MucoCept-CVN contains lactobacilli naturally found in a healthy human vagina.
Scientists added a gene (a piece of DNA) to the Lactobacillus jensenii 1153-1666 bacteria, which causes the bacteria to secrete an anti-HIV protein designed to block HIV infection.
When these bacteria live and grow in the vagina, they produce the built-in anti-HIV protein. MucoCept-CVN does not include the actual HIV virus, and you cannot rely on this experimental study drug to prevent HIV.
HOW:
We want to determine if a single dose and three consecutive daily doses of MucoCept-CVN, administered via a vaginal applicator, can be administered without causing harm, and if the Lactobacillus jensenii 1153-1666 bacteria can grow in the human vagina and be cleared with antibiotics.
This is the first time the drug is being tested in humans. It is an experimental drug, meaning it is not yet approved for HIV prevention by the Food and Drug Administration (FDA). To date, the drug has been tested in animals (including monkeys, rabbits, and mice), and no serious safety concerns have been reported. The bacteria were also easily eliminated with antibiotics.
WHERE:
All study visits will be conducted at the Zuckerberg San Francisco General Hospital. There will be approximately 15 study visits over the course of 8-10 weeks.
WHY:
If MucoCept-CVN proves to be safe and effective, this drug may one day help protect women against HIV by continuously producing anti-HIV proteins directly in the vagina!
