← Back to Search

Cancer Vaccine

HIV Vaccines for HIV (CM HIV-Core008 Trial)

Q: What are the eligibility criteria for participating in this trial?

<p>This clinical trial seeks 18 individuals infected with <a href="https://www.withpower.com/clinical-trials/hiv">HIV</a>, aged between 18 and 70 years old. To meet the criteria for enrollment in this research project, patients must have documented evidence of their infection - either by a rapid test or E/CIA kit approved by the FDA - that is further confirmed through other tests such as Western Blot or viral assay; they also need to be compliant with ART medication regimen prior to screening, not having missed more than 14 days of treatment in 3 months before. Furthermore, participants are required to provide written consent and locator information for follow-up purposes.</p>

Phase 1

Recruiting

Led By Cindy L Gay, MD, MPH

Research Sponsored by University of North Carolina, Chapel Hill

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up first day of study treatment through day 196 (20 weeks following second vaccination), an average of 7 months

Awards & highlights

CM HIV-Core008 Trial Summary

This trial studies if HIV-1-specific vaccines can be safe and increase immune responses in people with HIV on antiretroviral therapy.

Who is the study for?

This trial is for adults aged 18-70 with HIV, on stable ART with undetectable viral load and CD4 count >=350. They must be willing to follow the study plan, have no recent serious illness or hospitalization, not pregnant or planning pregnancy, and agree to use birth control. Excluded are those with certain medical conditions, prior adenovirus vaccines including COVID-19 ones, live vaccines within 60 days, untreated syphilis or HCV treatment recently.Check my eligibility

What is being tested?

The trial tests if C62-M4 or C1C62-M3M4 vaccines are safe in HIV-positive individuals on ART and whether they boost immune responses against HIV. Participants will receive intramuscular injections of either vaccine formulation or a placebo and their T cell responses will be monitored.See study design

What are the potential side effects?

Potential side effects may include typical vaccine reactions like soreness at injection site, mild fever, fatigue; allergic reactions; possible impact on underlying condition due to immune response changes. Specific risks related to these experimental vaccines will be closely monitored.

CM HIV-Core008 Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ first day of study treatment through day 196 (20 weeks following second vaccination), an average of 7 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~first day of study treatment through day 196 (20 weeks following second vaccination), an average of 7 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and first day of study treatment through day 196 (20 weeks following second vaccination), an average of 7 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Percent of Participants With a Grade 3 or Higher Treatment-Related Adverse Event (AE)

Secondary outcome measures

Body Weight Changes

Percent of Participants With a Grade 1 or Higher Treatment-Related Adverse Event (AE)

Relative change in magnitude of T cell responses to HIV-1 conserved regions

CM HIV-Core008 Trial Design

3Treatment groups

Experimental Treatment

Placebo Group

Group I: C62Experimental Treatment2 Interventions

C62 administered at Day 0 and M4 on Day 28

Group II: C1C62Experimental Treatment2 Interventions

C1C62 administered at Day 0 and M3M4 on Day 28

Group III: PlaceboPlacebo Group1 Intervention

Placebo administered on Day 0 and Day 28

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

University of North Carolina, Chapel HillLead Sponsor

1,508 Previous Clinical Trials

4,190,964 Total Patients Enrolled

National Institute of Allergy and Infectious Diseases (NIAID)NIH

3,269 Previous Clinical Trials

5,481,451 Total Patients Enrolled

1 Trials studying HIV Vaccine

20 Patients Enrolled for HIV Vaccine

Cindy L Gay, MD, MPHPrincipal InvestigatorUniversity of North Carolina

2 Previous Clinical Trials

41 Total Patients Enrolled

Media Library

C1C62-M3M4 (Cancer Vaccine) Clinical Trial Eligibility Overview. Trial Name: NCT05604209 — Phase 1

HIV Vaccine Research Study Groups: C1C62, C62, Placebo

HIV Vaccine Clinical Trial 2023: C1C62-M3M4 Highlights & Side Effects. Trial Name: NCT05604209 — Phase 1

C1C62-M3M4 (Cancer Vaccine) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05604209 — Phase 1

Frequently Asked Questions

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

What are the eligibility criteria for participating in this trial?

"This clinical trial seeks 18 individuals infected with HIV, aged between 18 and 70 years old. To meet the criteria for enrollment in this research project, patients must have documented evidence of their infection - either by a rapid test or E/CIA kit approved by the FDA - that is further confirmed through other tests such as Western Blot or viral assay; they also need to be compliant with ART medication regimen prior to screening, not having missed more than 14 days of treatment in 3 months before. Furthermore, participants are required to provide written consent and locator information for follow-up purposes."

Answered by AI

Are individuals 45 years of age or older qualified to participate in this trial?

"As per the study requirements, only individuals between 18 and 70 years of age are eligible for this clinical trial. Furthermore, there is a separate cohort for those under 18 (18 studies) as well as another group recruited from adults over 65 (85 studies)."

Answered by AI

Is this research endeavor presently recruiting participants?

"Affirmative, clinicaltrials.gov records that this research project is currently enrolling patients. It was first posted on October 13th 2022 and last updated a fortnight later. The goal of the study is to recruit 18 individuals across two sites."

Answered by AI

What potential dangers should be considered when using C62?

"Due to the small amount of safety and efficacy data surrounding C62, its risk score is 1 on our scale."

Answered by AI

How many participants are being monitored in this research endeavor?

"Affirmative, the data located on clinicaltrials.gov confirms that this medical experiment is actively recruiting volunteers; it was published on October 13th 2022 and subsequently updated a fortnight later. Thus far 18 participants have been accepted from two sites."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Safety and Immunogenicity of HIV-1 Vaccines C62-M4 or C1C62-M3m4 in Persons With HIV-1 Suppressed on ART

2022. "Safety and Immunogenicity of HIV-1 Vaccines C62-M4 or C1C62-M3m4 in Persons With HIV-1 Suppressed on ART". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05604209.