Clinical Trial to Evaluate the Safety, Tolerability, and Immunogenicity of 16055 NFL Delta Gly4 Env Protein Trimer and Trimer 4571 Combined With 3M-052-AF + Alum Adjuvant and Ad4-Env145NFL Viral Particles as Heterologous Prime-boost Regimens in Adult Participants Without HIV. (NCT06332339)
A First-in-human Phase 1 Clinical Trial to Evaluate the Safety, Tolerability, and Immunogenicity of 16055 NFL Delta Gly4 Env Protein Trimer and Trimer 4571 Combined With 3M-052-AF + Alum Adjuvant and Ad4-Env145NFL Viral Particles as Heterologous Prime-boost Regimens in Adult Participants Without HIV
🩺 Plain-English Summary (8th-Grade Level)
The goal of this clinical trial is to test 16055 NFL delta Gly4 Env protein trimer and Trimer 4571 combined with 3M-052-AF + Alum adjuvant and Ad4-Env145NFL viral particles as heterologous prime-boost regimens in adult participants without HIV. The main question\[s\] it aims to answer are: * Are these vaccine regimens safe and well tolerated? * Are the prime-boost vaccine regimens that include Ad4-Env145NFL and Trimer 4571 as heterologous boosts going contribute to the development of B-cell and antibody responses? Participants will attend scheduled study visits to receive their vaccine and will record symptoms on a daily eDiary.
Who can join: Review the eligibility criteria below.
Location: Alabama CRS — Birmingham, Alabama
Age range: 18 Years to 55 Years
🧪 Interventions in This Study
📋 "Do I Qualify?" — 1-Minute Self Screener
Instant ChecklistFull eligibility criteria are available on the official NIH protocol. View the criteria ↗
📍 All Participating Trial Locations (6 Sites)
- Alabama CRS — Birmingham, Alabama
- The Hope Clinic of the Emory Vaccine Center CRS Site# 31440 — Decatur, Georgia
- Brigham and Women's Hospital Vaccine CRS (BWH VCRS) — Boston, Massachusetts
- Columbia P&S CRS — New York, New York
- University of Rochester HIV/AIDS CTU — Rochester, New York
- University of Pennsylvania HIV Therapeutics and Prevention Clinical Trials Unit — Philadelphia, Pennsylvania
💰 Cost, Insurance & Patient Rights
- 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
- Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
- Voluntary Participation: You may withdraw at any time without affecting your standard medical care.
More studies in HIV
- CD4 CAR+ ZFN-modified T Cells in HIV Therapy — Philadelphia, Pennsylvania
- Cisgender Female Patients Who Start on Long Acting Cabotegravir for PrEP — Orlando, Florida
- Safety Study of Zinc Finger Nuclease CCR5-modified Hematopoietic Stem/Progenitor Cells in HIV-1 Infected Patients — Duarte, California
- Urban Gardening and Peer Nutritional Counseling for People With HIV and Food Insecurity — Azua,
- Wellness, Intervention Strategies and HIV Care — Oakland, California
Explore by condition: All HIV clinical trials
💡 How to Participate
- Check the checklist above to see if you may qualify.
- Review the official NIH record below to find the coordinating site.
- Ask about the visit schedule, what is covered at no cost, and any travel support.
- Confirm with your own doctor before making a decision.