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Virus Therapy

Synthetic DNA + Adjuvanted HIV Env Trimer Vaccine for HIV

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 any receipt of study product
Awards & highlights

Study Summary

This trial will examine a potential vaccine against HIV to measure its safety & effectiveness. Results could lead to a vaccine that will protect against HIV.

Who is the study for?
Adults aged 18-55, at low risk for HIV, in good health with normal blood counts and organ function. Must not be pregnant or planning pregnancy, agree to use birth control, and avoid high-risk HIV behaviors. Excludes those with certain allergies, bleeding disorders, severe asthma, recent non-HIV vaccines or immunotherapies.Check my eligibility
What is being tested?
The trial tests INO-6160 (synthetic DNAs for an HIV protein & immune booster) alone or followed by VRC HIV Env Trimer 4571 with adjuvants. It aims to see if these can elicit antibody and T-cell responses against HIV in a randomized open-label setup.See study design
What are the potential side effects?
Potential side effects may include typical vaccine reactions like soreness at the injection site, mild fever or fatigue. Since it's testing new compounds there might also be unexpected immune reactions.

Timeline

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
Magnitude of CD4 + T-cell responses measured by flow cytometry, to HIV-1-specific Env peptide pools
Magnitude of CD8 + T-cell responses measured by flow cytometry, to HIV-1-specific Env peptide pools
Magnitude of vaccine-matched IgG binding Ab responses as assessed by multiplex assay
+9 more
Secondary outcome measures
Epitope specificity of HIV-1 specific IgG binding Ab responses
Magnitude of CD4 +T-cell responses
Magnitude of CD4 +T-cell responses measured by flow cytometry, to HIV-1-specific Env peptide pools
+12 more

Trial Design

2Treatment groups
Experimental Treatment
Group I: Group #2: INO-6160/ 2.0 mg with Trimer-4571 / 100 mcg 3M-052-AF (5 mcg) + Alum (500 mcg)Experimental Treatment2 Interventions
The dose of INO-6160, 2 mg, will be administered as 2 separate intradermal (ID) injections, one in each arm. The dose of Trimer 4571, 100 mcg, will be administered as 2 injections delivered intramuscularly (IM), one in each arm.
Group II: Group #1: INO-6160/ 2.0 mgExperimental Treatment1 Intervention
The dose of INO-6160, 2 mg, will be administered as 2 separate intradermal (ID) injections, one in 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
3,268 Previous Clinical Trials
5,481,112 Total Patients Enrolled

Media Library

INO-6160 (Virus Therapy) Clinical Trial Eligibility Overview. Trial Name: NCT05828095 — Phase 1
HIV Research Study Groups: Group #2: INO-6160/ 2.0 mg with Trimer-4571 / 100 mcg 3M-052-AF (5 mcg) + Alum (500 mcg), Group #1: INO-6160/ 2.0 mg
HIV Clinical Trial 2023: INO-6160 Highlights & Side Effects. Trial Name: NCT05828095 — Phase 1
INO-6160 (Virus Therapy) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05828095 — Phase 1

Frequently Asked Questions

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

Are individuals aged 35 and over permitted to partake in this investigation?

"The ideal participants for this trial are aged between 18 and 55 years old."

Answered by AI

May I be admitted to this clinical trial?

"According to the eligibility criteria, potential participants must have a diagnosis of HIV and be between 18-55 years old. Twenty individuals will receive admittance into this clinical trial."

Answered by AI

Is this research protocol currently recruiting participants?

"This investigation is actively recruiting patients as indicated by its clinicaltrials.gov page, which was initially posted on March 23rd of this year and last updated April 13th."

Answered by AI

Has the FDA officially sanctioned INO-6160/2.0 mg for Group #1?

"Given the limited evidence regarding its safety and efficacy, Group #1: INO-6160/ 2.0 mg scored a 1 on our scale of risk assessment at Power Research."

Answered by AI

What is the cumulative enrollment tally of this clinical research?

"That is correct. Clinicaltrials.gov reflects this trial's recruitment status, which began on March 23rd 2023 and was recently updated April 13th of the same year. This clinical research requires 20 participants from 3 different medical facilities."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
A Clinical Trial to Evaluate the Safety and Immunogenicity of Synthetic DNAs Encoding a Native-like HIV Env Trimer and Interleukin-12 (INO-6160), Alone or in a Prime-boost Regimen With 3M-052-AF + Alum Adjuvanted VRC HIV Env Trimer 4571 in Adult Participants Without HIV
2023. "A Clinical Trial to Evaluate the Safety and Immunogenicity of Synthetic DNAs Encoding a Native-like HIV Env Trimer and Interleukin-12 (INO-6160), Alone or in a Prime-boost Regimen With 3M-052-AF + Alum Adjuvanted VRC HIV Env Trimer 4571 in Adult Participants Without HIV". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05828095.
~9 spots leftby Mar 2025
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