← Back to Search

Other

HIV Vaccine for Human Immunodeficiency Virus

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 12 months following any receipt of study product

Awards & highlights

Study Summary

This trial tests a potential HIV vaccine to see if it's safe and effective. It's the first of its kind.

Who is the study for?

This trial is for people aged 18-55 living with HIV on stable ART (antiretroviral therapy) for at least 48 weeks, with undetectable viral load and good immune health. They must be in overall good health, not pregnant or planning pregnancy, willing to use contraception, and able to complete the study. Those already in another trial need special approval.Check my eligibility

What is being tested?

The trial tests a new vaccine candidate (426c.Mod.Core-C4b) combined with an adjuvant (3M-052-AF+Alum) designed to stimulate immune responses in HIV-positive individuals. It's a phase 1 multicenter controlled interventional study assessing safety and immune response.See study design

What are the potential side effects?

Potential side effects are not specified but may include typical vaccine reactions like soreness at injection site, fever, fatigue or allergic reactions. Since it's a phase 1 trial, part of its purpose is to identify any side effects.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 12 months following any receipt of study product

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~12 months following any receipt of study product

This trial's timeline: 3 weeks for screening, Varies for treatment, and 12 months following any receipt of study product 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 Env-specific and CD4-bs-specific B cells

Frequency of VRC01-class BCR sequences of isolated CD4-bs B cells

Frequency of VRC01-class BCR sequences of isolated CD4-bs B cells, prior to ATI

+7 more

Secondary outcome measures

Compare Env sequences during ATI in Group 1 participants that initiated the development of VRC01 antibodies and those that did not

Magnitude of Binding of selected recEnvs from Group 1 participants that initiated the development of VRC01-class antibodies to B cells expressing VRC01-class BCRs.

Magnitude of Binding of selected recEnvs from Group 1 participants that initiated the development of VRC01-class antibodies to VRC01-class precursor and intermediate antibodies

Other outcome measures

Conduct analysis related to furthering the understanding of HIV, immunology, vaccines, and clinical trial conduct

Frequency of occurrence of similarities s in viral sequences of Group 2 participants (if any viruses emerge on study) with Group 1 participants

Magnitude of participant and potential participant decision-making quality, including perception of being informed, clarity and support in decision making, and satisfaction with their choice regarding participation.

+4 more

Trial Design

2Treatment groups

Experimental Treatment

Group I: Group 2 (No ATI) ControlExperimental Treatment2 Interventions

Group 2 transitions from Schedule 1 into Schedule 4, "Follow-up on ART," at the Week 14 visit, and remains on Schedule 4 through study week 64.

Group II: Group 1 (ATI)Experimental Treatment2 Interventions

Group 1 will receive 2 doses of the vaccine at Week 0 and 12. Group 1 will transition to Schedule 2 at the Week 14 visit. The Schedule 2 "ATI with Monitoring" phase can last for 24 weeks OR until any antiretroviral therapy (ART) re-initiation criteria are met, OR the ATI can continue longer with the approval of the Protocol Safety Review Team (PSRT) and the participant's primary HIV healthcare provider. Group 1 will transition to Schedule 3, the "Follow-up on ART restart" phase that lasts until study week 64, regardless of the point where it begins.

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

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

3,270 Previous Clinical Trials

5,485,197 Total Patients Enrolled

Frequently Asked Questions

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

Could I be considered an eligible participant in this clinical research?

"To be considered for this study, the requisites are that patients must have human immunodeficiency virus and should lie within 18 to 55 years of age. As of now, 40 individuals can participate in the trial."

Answered by AI

How many medical sites are currently implementing this clinical experiment?

"The current trial is taking place at 8 locations across the United States, such as Atlanta- Ponce in Atlanta, Hope Clinic in Decatur and BIDMC in Boston."

Answered by AI

Are there any vacancies within this trial for those seeking treatment?

"Data on clinicialtrials.gov shows that this research is no longer an active recruitment effort; the posting was first made available to patients on September 23rd 2023, but it has since been updated as of September 14th 2023. However, there are other 454 clinical trials seeking volunteers at present."

Answered by AI

Has Group 1 (ATI) been granted permission by the FDA?

"Given that Group 1 (ATI) is undergoing a Phase 1 trial, there is only limited evidence of its safety and efficacy. Thus, our team at Power has assigned it a score of 1 on the risk scale."

Answered by AI