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Virus Therapy

HIV-1 Envelope Trimer 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
Be between 18 and 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 12 months following receipt of any study product
Awards & highlights

Study Summary

This trial will test a two-step vaccine regimen to induce HIV-fighting antibodies. It uses a protein to prime the immune system, then an mRNA to boost the response.

Who is the study for?
Adults aged 18-55 in good health, willing to consent and available for follow-up. They must not be at high risk of HIV, agree to avoid risky behaviors, and use effective birth control if applicable. Excluded are those with BMI ≥ 40, diabetes, immunodeficiencies, certain allergies or conditions that could compromise safety.Check my eligibility
What is being tested?
The trial tests a prime-boost vaccine strategy against HIV using ferritin nanoparticles (V3G CH848 Pr-NP1) followed by an mRNA lipid nanoparticle (V3G CH848 mRNA-Tr2). It aims to induce antibodies targeting the virus's envelope protein.See study design
What are the potential side effects?
Potential side effects may include typical vaccine reactions like soreness at injection site, fatigue, headache or fever. Since it's a first-in-human study assessing safety and immune response, close monitoring for any unexpected reactions is part of the protocol.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~12 months following receipt of any study product
This trial's timeline: 3 weeks for screening, Varies for treatment, and 12 months following receipt of any 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 the V3G-specific precursor IgM+ and IgG+ B cells.
Local reactogenicity signs and symptoms for a minimum of 14 days following receipt of any study vaccine
Number of AESIs (Adverse events of special interest) leading to early participant withdrawal or permanent discontinuation
+4 more
Secondary outcome measures
Magnitude of CD4+ T-cell responses
Magnitude of serum Ab autologous neutralization of vaccine-matched tier 2 HIV-1 strains
Magnitude of serum IgG binding Abs
+4 more

Trial Design

4Treatment groups
Experimental Treatment
Group I: Group 4: V3G CH848 Pr-NP1 with ACU-026-001-1Experimental Treatment3 Interventions
3 doses of V3G CH848 Pr-NP1 (100 mcg) combined with ACU-026-001-1 (2.0 mg) at the month 0, 2, and 6 visits, followed by 1 dose of V3G CH848 mRNA-Tr2 (50 mcg) at the month 10 visit
Group II: Group 3: V3G CH848 Pr-NP1 with 3M-052-AF + AlumExperimental Treatment4 Interventions
3 doses of V3G CH848 Pr-NP1 (100 mcg) combined with 3M-052-AF (5 mcg) and Alum (500 mcg) at the month 0, 2, and 6 visits, followed by 1 dose of V3G CH848 mRNA-Tr2 (50 mcg) at the month 10 visit
Group III: Group 2: Low dose V3G CH848 Pr-NP1 with ACU-026-001-1Experimental Treatment3 Interventions
3 doses of V3G CH848 Pr-NP1 (60 mcg) combined with ACU-026-001-1 (2.0 mg) at the month 0, 2, and 6 visits, followed by 1 dose of V3G CH848 mRNA-Tr2 (50 mcg) at the month 10 visit
Group IV: Group 1: Low dose V3G CH848 Pr-NP1 with 3M-052-AF + AlumExperimental Treatment4 Interventions
3 doses of V3G CH848 Pr-NP1 (60 mcg) combined with 3M-052-AF (5 mcg) and Alum (500 mcg) at the month 0, 2, and 6 visits, followed by 1 dose of V3G CH848 mRNA-Tr2 (50 mcg) at the month 10 visit

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
3,268 Previous Clinical Trials
5,481,096 Total Patients Enrolled

Media Library

V3G CH848 Pr-NP1 (Virus Therapy) Clinical Trial Eligibility Overview. Trial Name: NCT05903339 — Phase 1
HIV (Human Immunodeficiency Virus) Research Study Groups: Group 1: Low dose V3G CH848 Pr-NP1 with 3M-052-AF + Alum, Group 2: Low dose V3G CH848 Pr-NP1 with ACU-026-001-1, Group 4: V3G CH848 Pr-NP1 with ACU-026-001-1, Group 3: V3G CH848 Pr-NP1 with 3M-052-AF + Alum
HIV (Human Immunodeficiency Virus) Clinical Trial 2023: V3G CH848 Pr-NP1 Highlights & Side Effects. Trial Name: NCT05903339 — Phase 1
V3G CH848 Pr-NP1 (Virus Therapy) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05903339 — Phase 1

Frequently Asked Questions

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

Is geriatric participation a component of this experiment?

"To meet the requirements of this research project, participants must be between 18 and 55 years old."

Answered by AI

What demographic of individuals is most likely to benefit from this research initiative?

"Candidates that are 18 to 55 years old, and have HIV (human immunodeficiency virus) can apply for this clinical trial. Approximately 36 people will be accepted into the study overall."

Answered by AI

Has Group 1 received government sanction for its products or services?

"Based on the available evidence, our team at Power assess Group 1 to have a safety score of 1. This is because this trial just entered Phase 1 and thus has limited data in regards to both efficacy and security."

Answered by AI

What are the geographical coordinates of this trial's implementation?

"Potential recruits can participate in this medical trial at Emory University School of Medicine (Atlanta), Brigham & Women's Hospital (Boston) and Boston - BIDMC (Nashville), as well as 6 other sites."

Answered by AI

Are there vacancies available to those seeking treatment through this trial?

"This clinical trial, which was initially posted on the 19th of July 2023 has ended recruiting for participants. The last update to this study occurred in June 5th 23rd. Despite its conclusion, there are still 99 other trials actively seeking candidates at this time."

Answered by AI

What results is this research endeavor aiming to achieve?

"The primary objective of this clinical trial is to measure systemic reactogenicity symptoms over a 2 week period following any injection. Secondary outcomes include the magnitude of serum IgG binding antibodies evaluated by BAMA, response rate for neutralization of vaccine-matched tier 2 HIV-1 strains as measured by TZM-bl pseudovirus assay, and the magnitutde of Ab autologous neutralization responses pertaining to those same viral strains also assessed with TZM-bl pseudovirus assay."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
Clinical Trial to Evaluate the Safety and Immunogenicity of Ferritin Nanoparticles Expressing Native-like HIV-1 Envelope Trimers Followed by Boost With mRNA Lipid Nanoparticles Encoding a Native-like HIV-1 Envelope Trimer in Adults Without HIV
2023. "Clinical Trial to Evaluate the Safety and Immunogenicity of Ferritin Nanoparticles Expressing Native-like HIV-1 Envelope Trimers Followed by Boost With mRNA Lipid Nanoparticles Encoding a Native-like HIV-1 Envelope Trimer in Adults Without HIV". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05903339.
~24 spots leftby Aug 2025
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