VRC-HIVMAB95-00-AB

Background:
Human immunodeficiency virus (HIV) infection is a serious disease. There is no cure or vaccine to prevent infection. Using antibodies might be a good way to treat or prevent HIV. Antibodies are naturally made by the body to fight germs. Researchers want to test if two antibodies made artificially in a lab can help to prevent HIV infection. The antibodies are 10E8VLS and VRC07-523LS.
Objective:
To see if 10E8VLS and VRC07-523LS are safe and well-tolerated and how long they stay in the blood.
Eligibility:
Healthy adults ages 18-60
Design:
Volunteers were screened in another protocol.
Participants were enrolled in 1 of 4 groups:
Group 1 participants were enrolled to receive 1 dose of 10E8VLS.
Group 2 participants were enrolled to receive 3 doses of 10E8VLS.
Group 3 participants were enrolled to receive 1 dose of both 10E8VLS and VRC07-523LS.
Group 4 participants were enrolled to receive 3 doses of both 10E8VLS and VRC07-523LS.
Participants in Groups 1 and 3 were expected to be enrolled about 13 visits over 24 weeks.
Participants in Groups 2 and 4 were expected to be enrolled about 26 visits over 48 weeks.
Participants were weighed before each dose. Women may have had a pregnancy test. Participants had blood collected.
A small needle injected each dose into fatty tissue of the belly, upper arm, or thigh. Participants received between 1 and 8 injections per dose depending on their weight. Heavier participants received more injections.
Participants received a ruler and thermometer. They checked their temperature for 3 days after injection(s) and measured any redness, swelling, or bruising at the injection site.
At non-injection visits, participants had blood drawn and were checked for health changes or problems.