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Virus Therapy

HIV Vaccine + Adjuvant for HIV Prevention

Q: To what demographic is this clinical trial open?

<p>This clinical trial is seeking 84 participants who are <a href="https://www.withpower.com/clinical-trials/hiv">HIV</a>/<a href="https://www.withpower.com/clinical-trials/aids">AIDS</a> positive and range in age from 18 to 55. <a href="https://www.withpower.com/clinical-trials/all">All</a> candidates must meet these criteria before participating.</p>

Phase 1

Recruiting

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

Be between 18 and 65 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up through study completion, an average of 1 year

Awards & highlights

Study Summary

This trial will evaluate the safety & immunogenicity of an HIV vaccine in adults w/o HIV & in good health, to identify a safe & tolerable dose, route, & schedule of the novel adjuvant. It will also measure the induction of BG18-class immunoglobulin G responses in memory B cells.

Who is the study for?

Adults aged 18-55, in good health with a low risk of HIV, can join this trial. They must have normal blood counts and organ function tests, live near a participating research site, and commit to the study's duration. Those with certain cancers or lymph disorders cannot participate.Check my eligibility

What is being tested?

The trial is testing N332-GT5 gp140, an experimental HIV vaccine given with SMNP adjuvant via different methods and schedules. It aims to find safe doses and see if it triggers immune responses without causing HIV.See study design

What are the potential side effects?

Potential side effects may include typical vaccine reactions like soreness at the injection site, mild fever, fatigue or allergic reactions to components of the vaccine or adjuvant.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ through study completion, an average of 1 year

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~through study completion, an average of 1 year

This trial's timeline: 3 weeks for screening, Varies for treatment, and through study completion, an average of 1 year for reporting.

Treatment Details

Study Objectives

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

Primary outcome measures

Comparison of number of reported/assessed local and systemic reactogenicity, SAE's and AESI's and medically attended adverse events at increasing doses of adjuvant at constant dose of N332-GT5 gp140

Frequency of BG18 epitope-specific B cells as determined by flow cytometry

Frequency of BG18-class B cells among IgG memory B cells in PBMCs, measured by antigen-specific B-cell sorting, BCR sequencing, and bioinformatic analysis

+7 more

Secondary outcome measures

Concentration of serum nAbs that neutralize pseudoviruses engineered to be sensitive to BG18-precursors

Frequency of BG18 sequences isolated postvaccination

Frequency of BG18-class B cells among IgG B cells in germinal centers (GCs), measured by antigen-specific B-cell sorting, BCR sequencing, and bioinformatic analysis

+6 more

Trial Design

15Treatment groups

Experimental Treatment

Group I: Part B SC Immunogenicity - Group 14Experimental Treatment2 Interventions

Group II: Part B Immunogenicity - Group 15Experimental Treatment4 Interventions

Group 15 N332-GT5 gp140 with SMNP dose and route (SC or IM) is To Be Determined (TBD) based on groups 6 and 12 (Part A).

Group III: Part B IM Immunogenicity - Group 13Experimental Treatment2 Interventions

Group IV: Part A Subcutaneous (SC) safety with dose finding - Group 7Experimental Treatment2 Interventions

Group V: Part A SC safety with dose finding - Group 9Experimental Treatment2 Interventions

Group VI: Part A SC safety with dose finding - Group 8Experimental Treatment2 Interventions

Group VII: Part A SC safety with dose finding - Group 12Experimental Treatment2 Interventions

Group VIII: Part A SC safety with dose finding - Group 11Experimental Treatment2 Interventions

Group IX: Part A SC safety with dose finding - Group 10Experimental Treatment2 Interventions

Group X: Part A Intramuscular (IM) safety with dose finding - Group 1Experimental Treatment2 Interventions

Group XI: Part A IM safety with dose finding - Group 6Experimental Treatment2 Interventions

Group XII: Part A IM safety with dose finding - Group 5Experimental Treatment2 Interventions

Group XIII: Part A IM safety with dose finding - Group 4Experimental Treatment2 Interventions

Group XIV: Part A IM safety with dose finding - Group 3Experimental Treatment2 Interventions

Group XV: Part A IM safety with dose finding - Group 2Experimental Treatment2 Interventions

Do I qualify?Apply below to find out

Find a Location

Logistics

Participation is compensated

You will be compensated for participating in this trial.

Who is running the clinical trial?

National Institutes of Health (NIH)NIH

2,701 Previous Clinical Trials

7,506,766 Total Patients Enrolled

National Institute of Allergy and Infectious Diseases (NIAID)Lead Sponsor

3,270 Previous Clinical Trials

5,485,153 Total Patients Enrolled

Department of Health and Human ServicesFED

226 Previous Clinical Trials

928,865 Total Patients Enrolled

Frequently Asked Questions

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

Are individuals within the 45-and-under age bracket eligible for this trial?

"This trial is open to individuals between 18 and 55 years of age. For minors or seniors, 53 trials are available for those under 18 while 177 can be found for the elderly population."

Answered by AI

What adverse effects should be expected from administering Part A Intramuscular (IM) at varying doses for Group 1 participants?

"Our team at Power assigns a score of 1 to Part A Intramuscular (IM) safety with dose finding - Group 1 due to the fact that this is an early phase clinical trial and only limited data exists on its saftey or efficacy."

Answered by AI

What are the various sites conducting this research experiment within state borders?

"Currently, 8 different medical sites within the United States are offering this trial. These include Decatur, Boston and New york. For participants' convenience, it is advised to select the closest site in order to reduce travel requirements."

Answered by AI

Is there any remaining capacity for participants in this clinical trial?

"Based on the information available from clinicaltrials.gov, this trial is not actively recruiting candidates at present. This research project was initially posted in October of 2023 and last edited in September of that same year. Nevertheless, there are presently 230 other medical trials searching for participants right now."

Answered by AI

To what demographic is this clinical trial open?

"This clinical trial is seeking 84 participants who are HIV/AIDS positive and range in age from 18 to 55. All candidates must meet these criteria before participating."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

A Trial to Evaluate an HIV Envelope Trimer, N332-GT5 gp140, Adjuvanted With SMNP in Adult Participants Without HIV

2023. "A Trial to Evaluate an HIV Envelope Trimer, N332-GT5 gp140, Adjuvanted With SMNP in Adult Participants Without HIV". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06033209.