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Virus Therapy

HIV Vaccine 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
18-55 years old on day of enrollment
Be between 18 and 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up through week 64
Awards & highlights

Study Summary

This trial is designed to improve our understanding of how to create a vaccine that can elicit VRC01-class antibodies, which are broad-spectrum and have been shown to be effective in preventing HIV acquisition.

Who is the study for?
Healthy adults aged 18-55, at low risk for HIV, not pregnant or breastfeeding, with stable vital signs and normal blood work. Participants must understand the study details and consent to follow-up visits including lymph node sampling. They should not be on other investigational drugs or have conditions that could affect vaccine response.Check my eligibility
What is being tested?
The trial is testing different doses of a 'germline-targeting' HIV vaccine called 426c.Mod.Core-C4b against a placebo. It aims to see if the vaccine can induce special antibodies known as VRC01-class that are effective across all types of HIV strains.See study design
What are the potential side effects?
Specific side effects aren't listed but may include typical reactions to vaccines such as soreness at injection site, fever, fatigue, headache, muscle pain. Serious adverse events will be monitored throughout the trial.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I am between 18 and 55 years old.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~through week 64
This trial's timeline: 3 weeks for screening, Varies for treatment, and through week 64 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
CD4 Antigens
Frequency of VRC01-like BCR sequences
Number of AEs leading to early participant withdrawal or permanent discontinuation
+5 more
Secondary outcome measures
Avidity of Env-specific serum IgG binding antibodies.
Comparison of BCR sequences frequencies in fractionated dosing versus traditional bolus dosing.
Comparison of CD4-bs-specific B cell frequencies in fractionated dosing versus traditional bolus dosing.
+11 more

Trial Design

6Treatment groups
Experimental Treatment
Placebo Group
Group I: Fractionated Delivery, Group 2: First injection - Medium dose, Final injection - Higher doseExperimental Treatment2 Interventions
The first dose for the Fractionated Delivery Arm Group 2 will be divided into 6 smaller amounts (2 visits per week for 3 weeks). The second dose will be given about 3 months later and will be given all at once. At each injection visit for the first dose, the patient will get one amount divided into 2 injections - one in the deltoid muscle of each arm.
Group II: Fractionated Delivery, Group 1: First injection - Medium dose, Final injection - Lower doseExperimental Treatment2 Interventions
The first dose for the Fractionated Delivery Arm Group 1 will be divided into 6 smaller amounts (2 visits per week for 3 weeks). The second dose will be given about 3 months later and will be given all at once. At each injection visit for the first dose, the patient will get one amount divided into 2 injections - one in the deltoid muscle of each arm.
Group III: Bolus Delivery, Group 2: First injection - Medium dose, Final injection - Higher doseExperimental Treatment2 Interventions
The Bolus Delivery Arm Group 2 will receive injections at 2 visits scheduled 3 months apart. At each injection visit the patient will get one dose divided into 2 injections - one in the deltoid muscle of each arm.
Group IV: Bolus Delivery, Group 1: First injection - Medium dose, Final injection - Lower doseExperimental Treatment2 Interventions
The Bolus Delivery Arm Group 1 will receive injections at 2 visits scheduled 3 months apart. At each injection visit the patient will get one dose divided into 2 injections - one in the deltoid muscle of each arm.
Group V: Bolus Delivery, Group 3: First injection - Placebo, Final injection - PlaceboPlacebo Group1 Intervention
The Bolus Delivery Arm Group 2 will receive injections at 2 visits scheduled 3 months apart. At each injection visit the patient will get one dose divided into 2 injections - one in the deltoid muscle of each arm.
Group VI: Fractionated Delivery, Group 3: First injection - Placebo, Final injection - PlaceboPlacebo Group1 Intervention
The first dose for the Fractionated Delivery Arm Group 2 will be divided into 6 smaller amounts (2 visits per week for 3 weeks). The second dose will be given about 3 months later and will be given all at once. At each injection visit for the first dose, the patient will get one amount divided into 2 injections - one in the deltoid muscle of each arm.

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
5,483,050 Total Patients Enrolled
National Institutes of Health (NIH)NIH
2,678 Previous Clinical Trials
6,909,744 Total Patients Enrolled
Department of Health and Human ServicesFED
223 Previous Clinical Trials
928,170 Total Patients Enrolled

Media Library

426c.Mod.Core-C4b (Virus Therapy) Clinical Trial Eligibility Overview. Trial Name: NCT05471076 — Phase 1
HIV Research Study Groups: Bolus Delivery, Group 1: First injection - Medium dose, Final injection - Lower dose, Bolus Delivery, Group 2: First injection - Medium dose, Final injection - Higher dose, Bolus Delivery, Group 3: First injection - Placebo, Final injection - Placebo, Fractionated Delivery, Group 1: First injection - Medium dose, Final injection - Lower dose, Fractionated Delivery, Group 2: First injection - Medium dose, Final injection - Higher dose, Fractionated Delivery, Group 3: First injection - Placebo, Final injection - Placebo
HIV Clinical Trial 2023: 426c.Mod.Core-C4b Highlights & Side Effects. Trial Name: NCT05471076 — Phase 1
426c.Mod.Core-C4b (Virus Therapy) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05471076 — Phase 1

Frequently Asked Questions

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

What deleterious impacts might result from administering 426c.Mod.Core-C4b 100 mcg to individuals?

"Rated on a scale from 1 to 3, the 426c.Mod.Core-C4b 100 mcg drug was awarded a score of 1 due to its limited data regarding safety and efficacy as it is only in Phase I trials."

Answered by AI

Does the eligibility criteria for this trial encompass those aged eighty and above?

"Conforming to this clinical trial's requirements, the youngest possible participant must be 18 years of age while the oldest cannot surpass 55."

Answered by AI

Is this research endeavor still open to additional participants?

"According to the clinicaltrials.gov listing, this study is in need of participants. It was initially published on August 22nd 2022 and most recently updated November 21st 2022."

Answered by AI

At how many separate sites has this research been implemented?

"The research team requires participants to join from 8 different clinical trial sites, including Brigham and Women's Hospital Vaccine CRS (BWH VCRS) in Boston, Massachusetts; Alabama CRS in Birmingham, Alabama; and Seattle Vaccine and Prevention CRS in Seattle, Washington."

Answered by AI

How many volunteers are being enrolled in this clinical experiment?

"Affirmative. Clinicaltrials.gov showcases that, as of November 21st 2022, this clinical trial is enrolling participants. The study was first publicized on August 22nd 2022 and requires the recruitment of 52 individuals across 6 sites."

Answered by AI

Who meets the eligibility criteria to participate in this research endeavor?

"This clinical trial is admitting 52 adults aged 18-55 who have been diagnosed with HIV-1. These participants must also meet the following qualifications: consent to the informed process, be in good general health, possess laboratory results without clinically significant findings, evaluate as low risk for HIV acquisition according to guidelines given by the site investigator, agree not to enroll in another investigational drug study during participation and make themselves available through their last clinic visit, be willing to undergo lymph node fine needle aspiration if required and allow follow up contact 12 months after final vaccine administration. Additionally they must present a haemoglobin count of 11 g/dL or above (for"

Answered by AI

Who else is applying?

What state do they live in?
New York
What portion of applicants met pre-screening criteria?
Met criteria
What site did they apply to?
The Ponce de Leon Center CRS
~20 spots leftby Mar 2025