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Virus Therapy

BG505 SOSIP.664 gp140, adjuvanted for Human Immunodeficiency Virus Infection

Phase 1

Waitlist Available

Led By Julie McElrath, MD, PhD

Research Sponsored by International AIDS Vaccine Initiative

Eligibility Criteria Checklist

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

Must have

Be between 18 and 65 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 20 months

Awards & highlights

Study Summary

This trial will test a new vaccine for HIV in 60 healthy adults who don't have the virus. They will be monitored for safety, tolerability, and immunogenicity (ability to create immunity).

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 20 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~20 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and 20 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Proportion of volunteers in each group with potential immune-mediated diseases (pIMD) from the day of injection throughout the study period

Proportion of volunteers with moderate or greater and/or vaccine related unsolicited adverse events (AEs), including safety laboratory (biochemical, haematological) parameters, from the day of each vaccination up to 28 days post each vaccination

Proportion of volunteers with moderate or greater reactogenicity (i.e., solicited adverse events) during a 7-day follow-up period after each vaccination

+1 more

Secondary outcome measures

To assess immune responses elicited by the different BG505 SOSIP.664 gp140 Vaccine, Adjuvanted, doses

Trial Design

5Treatment groups

Placebo Group

Group I: Group 5Placebo Group2 Interventions

HIV-Uninfected participants

Group II: Group 1Placebo Group2 Interventions

HIV-Uninfected participants

Group III: Group 2Placebo Group2 Interventions

HIV-Uninfected participants

Group IV: Group 3Placebo Group2 Interventions

HIV-Uninfected participants

Group V: Group 4Placebo Group2 Interventions

HIV-Uninfected participants

Do I qualify?Apply below to find out

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Logistics

Participation is compensated

You will be compensated for participating in this trial.

Who is running the clinical trial?

Fred Hutchinson Cancer Research Center - Seattle HIV Vaccine Trials UnitUNKNOWN

Kenya AIDS Vaccine Initiative - Institute of Clinical Research (KAVI-ICR)UNKNOWN

Massachusetts General HospitalOTHER

2,928 Previous Clinical Trials

13,198,294 Total Patients Enrolled

Frequently Asked Questions

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

Is there any availability for participants of this research endeavor?

"According to information available on clinicaltrials.gov, the application period for this research project has now closed. The trial was initially posted in December 2018 and modified lastly in May 2022 - nevertheless, there are currently 485 other trials actively searching for participants."

Answered by AI

Are minors able to partake in this experiment?

"This medical research is open to individuals that are between the age of 18 and 50."

Answered by AI

What types of individuals qualify as suitable participants in this clinical trial?

"Qualified participants for this research must meet two criteria: be between 18 to 50 years old and possess a HIV infection. The total amount of patients being recruited is 61 in number."

Answered by AI

Has this therapeutic intervention been sanctioned by the Food and Drug Administration?

"Due to the Phase 1 nature of this trial, our team assigned a score of 1 in terms of safety; limited data exists with regards to both efficacy and safety."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

A Randomized, Double-blinded, Placebo-controlled, Dose-escalation Phase 1 Clinical Trial to Evaluate the Safety and Immunogenicity of Recombinant HIV Envelope Protein BG505 SOSIP.664 gp140 Vaccine, Adjuvanted, in Healthy, HIV-1 Uninfected Adults

2018. "A Randomized, Double-blinded, Placebo-controlled, Dose-escalation Phase 1 Clinical Trial to Evaluate the Safety and Immunogenicity of Recombinant HIV Envelope Protein BG505 SOSIP.664 gp140 Vaccine, Adjuvanted, in Healthy, HIV-1 Uninfected Adults". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03699241.