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Virus Therapy

HIV Vaccine + Adjuvants for HIV Prevention

Phase 1

Waitlist Available

Research Sponsored by National Institute of Allergy and Infectious Diseases (NIAID)

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Reproductive Status: Volunteers who were assigned female sex at birth must meet specific criteria

Age of 18 through 50 years, inclusive

Must not have

Seizure disorder

Asplenia

Timeline

Screening 3 weeks

Treatment Varies

Follow Up measured for 7 days after each injection

Summary

This trial is looking at whether or not a new HIV vaccine is safe and creates an immune response in healthy people who don't have HIV.

Who is the study for?

Healthy adults aged 18-50, at low risk for HIV, with normal blood tests and organ function. Participants must not be pregnant or breastfeeding, have received recent blood products or investigational agents, have a BMI ≥40 (or ≥35 with certain conditions), severe allergies, immune system disorders, active military duty status, or any condition that could affect study compliance.

What is being tested?

The trial is testing the safety and body's immune response to an experimental HIV vaccine called BG505 SOSIP.664 gp140 combined with different adjuvants like TLR agonists and alum. It involves healthy volunteers who do not have HIV to see how their bodies react to the vaccine.

What are the potential side effects?

Possible side effects may include pain at injection site, fatigue, headache, muscle pain, feverishness/chills. More serious reactions are less common but can involve allergic responses or autoimmune conditions where the body’s defense system reacts inappropriately.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I meet the specific reproductive health criteria.

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I am between 18 and 50 years old.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have a seizure disorder.

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I do not have a spleen.

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My asthma is more severe than mild and not well-controlled.

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I have had thyroid surgery or needed thyroid medication in the past year.

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I have been diagnosed with cancer.

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I have diabetes (type 1 or type 2).

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My blood pressure is under control.

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I have not received any blood products in the last 4 months.

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I am currently on medication for tuberculosis.

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I have a bleeding disorder.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ measured 6 and 12 months post third vaccination (through month 18)

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~measured 6 and 12 months post third vaccination (through month 18)

This trial's timeline: 3 weeks for screening, Varies for treatment, and measured 6 and 12 months post third vaccination (through month 18) for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Frequency of AESIs (Part B)

Frequency of AESIs (Part C)

Frequency of AEs (Part B)

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Secondary study objectives

Alterations in RNAseq expression of leukocyte and/or immune cells (Part B)

Alterations in RNAseq expression of leukocyte and/or immune cells (Part C)

Alterations in blood leukocyte populations during the innate response (Part B)

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Trial Design

16Treatment groups

Experimental Treatment

Placebo Group

Group I: Part C, Group 8 (T8): Trimer 4571 + AlumExperimental Treatment3 Interventions

Participants will receive Trimer 4571, 100 mcg admixed with 3M-052-AF, 5 mcg and Alum, 500 mcg to be administered as one 0.5-mL dose IM at months 0, 2, and 6.

Group II: Part C, Group 7 (T7): BG505 SOSIP.664 gp140 + AlumExperimental Treatment3 Interventions

Participants will receive BG505 SOSIP.664 gp140, 100 mcg admixed with 3M-052-AF, 3 mcg and Alum, 500 mcg to be administered as one 0.5-mL dose intramuscularly (IM) at months 0, 2, and 6.

Group III: Part B, Group 6 (T6): BG505 SOSIP.664 gp140 + AlumExperimental Treatment2 Interventions

Participants will receive 100 mcg of BG505 SOSIP.664 gp140, admixed with 500 mcg of Alum, administered as one IM injection at Months 0, 2, and 6.

Group IV: Part B, Group 5 (T5): BG505 SOSIP.664 gp140 + GLA-LSQExperimental Treatment2 Interventions

Participants will receive 100 mcg of BG505 SOSIP.664 gp140, admixed with GLA-LSQ (GLA 5 mcg, and QS-21 2 mcg), as one IM injection at Months 0, 2, and 6.

Group V: Part B, Group 4 (T4): BG505 SOSIP.664 gp140 + 3M-052-AF + AlumExperimental Treatment3 Interventions

Participants will receive 100 mcg of BG505 SOSIP.664 gp140, admixed with either 1 mcg or 5 mcg of 3M-052-AF (the highest tolerated dose from Part A), and 500 mcg of Alum, as one IM injection at Months 0, 2, and 6.

Group VI: Part B, Group 3 (T3): BG505 SOSIP.664 gp140 + CpG 1018 + AlumExperimental Treatment3 Interventions

Participants will receive 100 mcg of BG505 SOSIP.664 gp140, admixed with 300 mcg of CpG 1018 and 500 mcg of Alum, as one IM injection at Months 0, 2, and 6.

Group VII: Part A, Group 2 (T2): BG505 SOSIP.664 gp140 + 3M-052-AF + AlumExperimental Treatment3 Interventions

Participants will receive 100 mcg of BG505 SOSIP.664 gp140, admixed with 5 mcg of 3M-052-AF and 500 mcg of Alum, as one IM injection at Months 0 and 2.

Group VIII: Part A, Group 1 (T1): BG505 SOSIP.664 gp140 + 3M-052-AF + AlumExperimental Treatment3 Interventions

Participants will receive 100 mcg of BG505 SOSIP.664 gp140, admixed with 1 mcg of 3M-052-AF and 500 mcg of Aluminum Hydroxide Suspension (Alum), as one intramuscular (IM) injection at Months 0 and 2.

Group IX: Part B, Group 6 (P6): PlaceboPlacebo Group1 Intervention