← Back to Search

Cancer Vaccine

Treatment 1 for HIV/AIDS

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 aims to test two different vaccines in adults without HIV to see if they are safe and well-tolerated. The study will also explore whether the vaccines can help in the development of B-cell

Who is the study for?

This trial is for adults without HIV who are interested in testing new vaccine regimens aimed at preventing HIV/AIDS. Participants must attend scheduled visits and keep a daily eDiary of symptoms.Check my eligibility

What is being tested?

The study tests the safety and immune response to two experimental vaccines (16055 NFL delta Gly4 Env protein trimer and Trimer 4571) with an adjuvant, plus a viral particle booster (Ad4-Env145NFL).See study design

What are the potential side effects?

Potential side effects may include typical vaccine reactions such as soreness at injection site, fever, fatigue, headache, muscle pain, or allergic responses to components.

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

Local reactogenicity signs and symptoms

Magnitude of serum IgG binding antibodies to vaccine-matched HIV-1 Env trimers and specific epitopes (e.g., CD4 binding site, V2, base of trimer, etc.)

Number of Adverse Events (AEs) leading to early participant withdrawal or permanent discontinuation

+7 more

Secondary outcome measures

Epitope specific response rates as measured by electron microscopy polyclonal epitope mapping (EMPEM)

Flow cytometry analysis of the frequency of Env-specific IgG+ B cells

Flow cytometry analysis of the frequency of Env-specific IgG+ B cells at 26 weeks and 52 weeks after the fifth vaccination

+16 more

Trial Design

3Treatment groups

Experimental Treatment

Group I: Treatment 3Experimental Treatment3 Interventions

16055 NFL delta Gly4 trimer, 200 mcg admixed with 3M-052-AF, 5 mcg and Alum, 500 mcg to be administered as 2 separate IM injections (0.27 mL each) at months 0 and 2. Trimer 4571, 100 mcg admixed with 3M-052-AF, 5 mcg and Alum, 500 mcg to be administered as 2 separate IM injections (0.2 mL each) at month 4. Ad4-Env145NFL, 5 x 108 vp to be administered IN (0.07 mL into 1 nostril) at months 8 and 12.

Group II: Treatment 2Experimental Treatment3 Interventions

16055 NFL delta Gly4 trimer, 200 mcg admixed with 3M-052-AF, 5 mcg and Alum, 500 mcg to be administered as 2 separate IM injections (0.27 mL each) at months 0 and 2. Ad4-Env145NFL, 5 x 108 viral particles (vp) to be administered intranasally (IN) (0.07 mL into 1 nostril) at month 4. Trimer 4571, 100 mcg admixed with 3M-052-AF, 5 mcg and Alum, 500 mcg to be administered as 2 separate IM injections (0.2 mL each) at months 8 and 12.

Group III: Treatment 1Experimental Treatment1 Intervention

16055 NFL delta Gly4 trimer, 200 mcg admixed with 3M-052-AF, 5 mcg and Alum, 500 mcg to be administered as 2 separate intramuscular (IM) injections (0.27 mL each) at months 0, 2, 4, 8, and 12.

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 Institute of Allergy and Infectious Diseases (NIAID)Lead Sponsor

3,270 Previous Clinical Trials

5,485,187 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 potential participants currently able to apply for enrollment in this trial?

"As per clinicaltrials.gov, the current status of this medical trial does not involve patient recruitment. This study was first published on March 18th, 2024 and underwent its most recent update on March 25th, 2024. Although inactive in terms of participant enrollment presently, there are a total of 237 ongoing studies actively seeking participants at this time."

Answered by AI

Are individuals aged 40 and above eligible to participate in this medical study?

"Prospective participants aged between 18 and 55 are eligible to apply for this clinical investigation. It is worth noting that there are separate trials available, with a total of 54 catered specifically towards individuals under the age of 18, while an additional 176 studies target those over the age of 65."

Answered by AI

What is the level of safety associated with Treatment 2 in patients?

"Treatment 2 has been evaluated and received a safety rating of 1 by our team at Power, indicating that this Phase 1 trial lacks extensive data supporting its safety and effectiveness."

Answered by AI

Which individuals are eligible to partake in this experimental study?

"To qualify for participation in this medical research, individuals must be infected with HIV/AIDS and fall within the age bracket of 18 to 55 years. The trial is set to enroll approximately 50 participants."

Answered by AI

At how many distinct sites is the management of this study taking place?

"The trial is ongoing at various locations including Alabama CRS in Birmingham, Brigham and Women's Hospital Vaccine CRS (BWH VCRS) in Boston, and Columbia Partnership for Prevention and Control of HIV/AIDS CTU in New york. Additionally, there are six more sites participating in this study."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

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.

2024. "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.". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06332339.

All > Paid Studies Boston > Philadelphia