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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
General and Demographic Criteria
Age of 18 through 50 years, inclusive
Timeline
Screening 3 weeks
Treatment Varies
Follow Up measured 6 and 12 months post third vaccination (through month 18)
Awards & highlights

Study 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.Check my eligibility
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.See study design
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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My general health and demographic details meet the study's requirements.
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I am between 18 and 50 years old.
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I meet the specific reproductive health criteria.
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My overall health is good, as confirmed by recent medical exams and tests.
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I am between 18 and 50 years old.

Timeline

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Frequency of AESIs (Part B)
Frequency of AESIs (Part C)
Frequency of AEs (Part B)
+12 more
Secondary outcome measures
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)
+37 more

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 3 (P3): PlaceboPlacebo Group1 Intervention
Participants will receive placebo as one IM injection at Months 0, 2, and 6.
Group X: Part B, Group 5 (P5): PlaceboPlacebo Group1 Intervention
Participants will receive placebo as one IM injection at Months 0, 2, and 6.
Group XI: Part C, Group 7 (P7): PlaceboPlacebo Group1 Intervention
Participants will receive placebo as one IM injection at Months 0, 2, and 6.
Group XII: Part C, Group 8 (P8): PlaceboPlacebo Group1 Intervention
Participants will receive placebo as one IM injection at Months 0, 2, and 6.
Group XIII: Part A, Group 2 (P2): PlaceboPlacebo Group1 Intervention
Participants will receive placebo as one IM injection at Months 0 and 2.
Group XIV: Part A, Group 1 (P1): PlaceboPlacebo Group1 Intervention
Participants will receive placebo as one IM injection at Months 0 and 2.
Group XV: Part B, Group 6 (P6): PlaceboPlacebo Group1 Intervention
Participants will receive placebo as one IM injection at Months 0, 2, and 6.
Group XVI: Group 4 (P4): PlaceboPlacebo Group1 Intervention
Participants will receive placebo as one IM injection at Months 0, 2, and 6.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
GLA-LSQ
2016
Completed Phase 1
~70

Find a Location

Logistics

Participation is compensated

You will be compensated for participating in this trial.

Who is running the clinical trial?

National Institute of Allergy and Infectious Diseases (NIAID)Lead Sponsor
3,261 Previous Clinical Trials
5,482,879 Total Patients Enrolled
HIV Vaccine Trials NetworkNETWORK
39 Previous Clinical Trials
10,630 Total Patients Enrolled
Access to Advanced Health Institute (AAHI)OTHER
28 Previous Clinical Trials
1,539 Total Patients Enrolled

Media Library

BG505 SOSIP.664 gp140 (Virus Therapy) Clinical Trial Eligibility Overview. Trial Name: NCT04177355 — Phase 1
Human Immunodeficiency Virus Infection Research Study Groups: Part B, Group 3 (P3): Placebo, Part B, Group 5 (P5): Placebo, Part C, Group 7 (T7): BG505 SOSIP.664 gp140 + Alum, Part C, Group 7 (P7): Placebo, Part C, Group 8 (T8): Trimer 4571 + Alum, Part C, Group 8 (P8): Placebo, Part A, Group 1 (T1): BG505 SOSIP.664 gp140 + 3M-052-AF + Alum, Part A, Group 2 (P2): Placebo, Part A, Group 1 (P1): Placebo, Part A, Group 2 (T2): BG505 SOSIP.664 gp140 + 3M-052-AF + Alum, Part B, Group 3 (T3): BG505 SOSIP.664 gp140 + CpG 1018 + Alum, Part B, Group 6 (P6): Placebo, Part B, Group 5 (T5): BG505 SOSIP.664 gp140 + GLA-LSQ, Group 4 (P4): Placebo, Part B, Group 4 (T4): BG505 SOSIP.664 gp140 + 3M-052-AF + Alum, Part B, Group 6 (T6): BG505 SOSIP.664 gp140 + Alum
Human Immunodeficiency Virus Infection Clinical Trial 2023: BG505 SOSIP.664 gp140 Highlights & Side Effects. Trial Name: NCT04177355 — Phase 1
BG505 SOSIP.664 gp140 (Virus Therapy) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04177355 — Phase 1

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

To what conditions is BG505 SOSIP.664 gp140 typically utilized?

"BG505 SOSIP.664 gp140 is a common treatment for colic and has been demonstrated to be effective at managing the symptoms of acid regurgitation, gastroesophageal reflux disease, and other forms of colicky pain."

Answered by AI

How many locations are carrying out this research experiment?

"Patients for this clinical trial may be recruited from multiple sites, including the University of Rochester Vaccines to Prevent HIV Infection CRS in Rochester, New york; The Hope Clinic of the Emory Vaccine Center CRS in Decatur, Georgia; and The Ponce de Leon Center CRS in Atlanta, Massachusetts. There are also 8 additional medical centres where recruitment is possible."

Answered by AI

Has the BG505 SOSIP.664 gp140 formulation been endorsed by the FDA?

"Due to the limited available clinical data, our team at Power considers BG505 SOSIP.664 gp140's safety and efficacy to be of a moderate risk, scoring it a 1 on our scale from 1 to 3."

Answered by AI

What are the foremost goals of this research project?

"This clinical trial, monitored for 18 months, aims to determine the Frequency of EAEs (Part B). Secondary objectives include measuring Alterations in RNAseq expression of leukocyte and/or immune cells (Part B), quantifying Alterations in blood leukocyte populations during the innate response (Part B), and assessing Percent HIV Env-specific CD4+ T cells in blood (Part A) via multiparameter flow cytometry."

Answered by AI

Who is eligible to participate in this research endeavor?

"This investigation is accepting 105 HIV-positive participants aged 18 to 50 who are willing to discussion the risks of their infections, assessed by clinic staff as "low risk", and committed to maintaining a low-risk lifestyle until after their final study contact. Furthermore, applicants must agree not to enroll in any other research studies involving investigational agents prior to this study's conclusion."

Answered by AI

How many participants are participating in this scientific experiment?

"This research requires 105 individuals that meet the designated criteria for participation. Patients may join from various clinical trial sites, such as University of Rochester Vaccines to Prevent HIV Infection CRS in Rochester, New york and The Hope Clinic of the Emory Vaccine Center CRS in Decatur, Georgia."

Answered by AI

Is the age limit for enrolling in this research higher than thirty years?

"This trial is open to patients aged 18-50, and there are 109 trials for minors and 354 studies targeting those who have surpassed retirement age."

Answered by AI

Is the research team currently enlisting participants for this experiment?

"According to the online clinicaltrials.gov database, this study is currently open for recruitment. The initial post date was January 13th 2020 with a subsequent update on July 11th 2022."

Answered by AI

Have any prior investigations been conducted concerning BG505 SOSIP.664 gp140?

"Currently, three ongoing clinical trials for BG505 SOSIP.664 gp140 are in Phase 3 of their research. Birmingham, Alabama is the primary site hosting these studies; however, 69 other locations have joined in this medical investigation."

Answered by AI

Is this a novel clinical trial?

"As of current, Dynavax Technologies Corporation's BG505 SOSIP.664 gp140 drug has 3 live trials across 24 cities and 11 nations. This medication was first trialled in 2020, involving 105 patients and reaching Phase 1 approval status. Since then, over 18358 studies have been completed."

Answered by AI
~16 spots leftby Nov 2024