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Virus Therapy

MVA.tHIVconsv3 for HIV (M&M Trial)

Phase 1
Waitlist Available
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 168 (week 24) following vaccination
Awards & highlights

M&M Trial Summary

Study to Assess Safety and Ability to Induce Immune Responses of HIV-1 Vaccines M3 and M4 Given Alone or in Combination in HIV-infected Adults

Eligible Conditions
  • HIV

M&M Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~first day of study treatment through day 168 (week 24) following vaccination
This trial's timeline: 3 weeks for screening, Varies for treatment, and first day of study treatment through day 168 (week 24) following vaccination for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Therapeutic procedure
Secondary outcome measures
Therapeutic procedure

Side effects data

From 2022 Phase 1 trial • 26 Patients • NCT03844386
86%
Headache
86%
Injection site pain
86%
Procedural hypertension
71%
Malaise
57%
Decreased appetite
57%
Fatigue
57%
Chills
57%
Myalgia
57%
Influenza like illness
57%
Nausea
57%
Hyperhidrosis
43%
Dizziness
29%
Body temperature increased
29%
Arthralgia
14%
Citrate toxicity
14%
Blood creatinine increased
14%
Vomiting
14%
Presyncope
14%
Abdominal Pain
100%
80%
60%
40%
20%
0%
Study treatment Arm
MVA.tHIVconsv3 (M3)
MVA.tHIVconsv4 (M4)
MVA.tHIVconsv3 (M3)+MVA.tHIVconsv4 (M4)
Placebo

M&M Trial Design

4Treatment groups
Experimental Treatment
Placebo Group
Group I: MVA.tHIVconsv4 (M4)Experimental Treatment1 Intervention
Participants in this arm receive one vaccine dose of MVA.tHIVconsv4 (M4) given IM at Day 0
Group II: MVA.tHIVconsv3 (M3)+MVA.tHIVconsv4 (M4)Experimental Treatment2 Interventions
Participants in this arm receive a single combined dose containing each vaccine type MVA.tHIVconsv4 (M3) + MVA.tHIVconsv4 (M4) given IM at Day 0
Group III: MVA.tHIVconsv3 (M3)Experimental Treatment1 Intervention
Participants in this arm receive one vaccine dose of MVA.tHIVconsv3 (M3) given IM at Day 0
Group IV: PlaceboPlacebo Group1 Intervention
Participants in this arm receive one saline (placebo) dose given IM at Day 0
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
MVA.tHIVconsv3
2019
Completed Phase 1
~30
MVA.tHIVconsv4
2019
Completed Phase 1
~30

Find a Location

Who is running the clinical trial?

University of North Carolina, Chapel HillLead Sponsor
1,508 Previous Clinical Trials
4,191,016 Total Patients Enrolled
National Institute of Allergy and Infectious Diseases (NIAID)NIH
3,270 Previous Clinical Trials
5,485,211 Total Patients Enrolled
Cindy L Gay, MD, MPHPrincipal InvestigatorUNC-Chapel Hill
2 Previous Clinical Trials
33 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Recent research and studies
clinicaltrials.govStudy
Study to Assess Safety and Ability to Induce Immune Responses of HIV-1 Vaccines M3 and M4 Given Alone or in Combination in HIV-infected Adults
2019. "Study to Assess Safety and Ability to Induce Immune Responses of HIV-1 Vaccines M3 and M4 Given Alone or in Combination in HIV-infected Adults". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03844386.
~4 spots leftby Apr 2025
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