HIV Vaccine for HIV Prevention
Recruiting at 5 trial locations
Age: 18 - 65
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Phase 1
Waitlist Available
Sponsor: National Institute of Allergy and Infectious Diseases (NIAID)
Trial Summary
What is the purpose of this trial?
This trial is testing two vaccine methods to help people at risk of HIV infection produce special antibodies that can fight many types of HIV. The vaccine works by training the immune system to make strong antibodies that block HIV.
Research Team
HS
Hyman Scott, MD
Principal Investigator
University of California, San Francisco
KC
Kristen Cohen, MD
Principal Investigator
Fred Hutch Cancer Center, Seattle, WA
Eligibility Criteria
Healthy adults aged 18-55, at low risk for HIV, not pregnant or breastfeeding, with stable vital signs and normal blood work. Participants must understand the study details and consent to follow-up visits including lymph node sampling. They should not be on other investigational drugs or have conditions that could affect vaccine response.Inclusion Criteria
I am willing and able to understand and sign the consent form.
Agrees not to enroll in another study of an investigational agent during participation in the trial
Alanine aminotransferase (ALT) < 2.5 x upper limit of normal (ULN)
See 14 more
Exclusion Criteria
Investigator concern for difficulty with venous access based upon clinical history and physical examination
International normalized ratio (INR) >1.2
I do not have a spleen or my spleen does not work properly.
See 20 more
Treatment Details
Interventions
- 426c.Mod.Core-C4b (Virus Therapy)
Trial OverviewThe trial is testing different doses of a 'germline-targeting' HIV vaccine called 426c.Mod.Core-C4b against a placebo. It aims to see if the vaccine can induce special antibodies known as VRC01-class that are effective across all types of HIV strains.
Participant Groups
7Treatment groups
Experimental Treatment
Placebo Group
Group I: Optional Boost Regimen with BG505Experimental Treatment1 Intervention
SOSIP.GT1.1 gp140
Group II: Fractionated Delivery, Group 2: First injection - Medium dose, Final injection - Higher doseExperimental Treatment2 Interventions
The first dose for the Fractionated Delivery Arm Group 2 will be divided into 6 smaller amounts (2 visits per week for 3 weeks). The second dose will be given about 3 months later and will be given all at once. At each injection visit for the first dose, the patient will get one amount divided into 2 injections - one in the deltoid muscle of each arm.
Group III: Fractionated Delivery, Group 1: First injection - Medium dose, Final injection - Lower doseExperimental Treatment2 Interventions
The first dose for the Fractionated Delivery Arm Group 1 will be divided into 6 smaller amounts (2 visits per week for 3 weeks). The second dose will be given about 3 months later and will be given all at once. At each injection visit for the first dose, the patient will get one amount divided into 2 injections - one in the deltoid muscle of each arm.
Group IV: Bolus Delivery, Group 2: First injection - Medium dose, Final injection - Higher doseExperimental Treatment2 Interventions
The Bolus Delivery Arm Group 2 will receive injections at 2 visits scheduled 3 months apart. At each injection visit the patient will get one dose divided into 2 injections - one in the deltoid muscle of each arm.
Group V: Bolus Delivery, Group 1: First injection - Medium dose, Final injection - Lower doseExperimental Treatment2 Interventions
The Bolus Delivery Arm Group 1 will receive injections at 2 visits scheduled 3 months apart. At each injection visit the patient will get one dose divided into 2 injections - one in the deltoid muscle of each arm.
Group VI: Bolus Delivery, Group 3: First injection - Placebo, Final injection - PlaceboPlacebo Group1 Intervention
The Bolus Delivery Arm Group 2 will receive injections at 2 visits scheduled 3 months apart. At each injection visit the patient will get one dose divided into 2 injections - one in the deltoid muscle of each arm.
Group VII: Fractionated Delivery, Group 3: First injection - Placebo, Final injection - PlaceboPlacebo Group1 Intervention
The first dose for the Fractionated Delivery Arm Group 2 will be divided into 6 smaller amounts (2 visits per week for 3 weeks). The second dose will be given about 3 months later and will be given all at once. At each injection visit for the first dose, the patient will get one amount divided into 2 injections - one in the deltoid muscle of each arm.
Find a Clinic Near You
Who Is Running the Clinical Trial?
National Institute of Allergy and Infectious Diseases (NIAID)
Lead Sponsor
Trials
3,361
Recruited
5,516,000+
National Institutes of Health (NIH)
Collaborator
Trials
2,896
Recruited
8,053,000+
Department of Health and Human Services
Collaborator
Trials
240
Recruited
944,000+