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Virus Therapy

Clade C and Mosaic gp140 HIV bivalent vaccine for Healthy Subjects (MOSAICO Trial)

Phase 3
Waitlist Available
Research Sponsored by Janssen Vaccines & Prevention B.V.
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 up to 43 months (participants will be followed until the last participant reaches month 30)
Awards & highlights

MOSAICO Trial Summary

This trial is testing a new HIV vaccine to see if it can prevent HIV-1 infection in cis-gender men and transgender individuals.

Eligible Conditions
  • Healthy Subjects

MOSAICO Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 43 months (participants will be followed until the last participant reaches month 30)
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 43 months (participants will be followed until the last participant reaches month 30) for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Vaccine Efficacy (VE) as Derived From Confirmed HIV-1 Infections Diagnosed Between the Month 7 and Month X (with 24 Less Than or Equal to [<=] X <= 30) Visits
Secondary outcome measures
Antibody Titers for Ad26 as Determined by Vector Neutralization Assay
Number of Participants who Discontinue from the Study or Vaccination due to Adverse Events
Number of Participants who are Ad26 Seropositive
+10 more

MOSAICO Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: Group1:Ad26.Mos4.HIV,Clade C and Mosaic gp140 bivalent vaccineExperimental Treatment2 Interventions
Participants will receive adenovirus serotype 26.Mosaic 4.human immunodeficiency virus (Ad26.Mos4.HIV) via intramuscular (IM) injection into the deltoid muscle at months 0 (Day 1) and 3 (preferably the deltoid of the non-dominant upper arm) and, Ad26.Mos4.HIV together with Clade C and Mosaic gp140 HIV bivalent vaccine IM into the deltoid muscle at Months 6 and 12 (different deltoid for each injection).
Group II: Group 2: PlaceboPlacebo Group1 Intervention
Participants will receive placebo into the deltoid muscle on Months 0 (Day 1), 3 (1 injection), 6 and 12 (2 injections).
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Clade C and Mosaic gp140 HIV bivalent vaccine
2019
Completed Phase 3
~3900
Ad26.Mos4.HIV
2016
Completed Phase 3
~4130

Find a Location

Who is running the clinical trial?

Janssen Vaccines & Prevention B.V.Lead Sponsor
55 Previous Clinical Trials
1,130,448 Total Patients Enrolled
Janssen Vaccines & Prevention B.V. Clinical TrialStudy DirectorJanssen Vaccines & Prevention B.V.
47 Previous Clinical Trials
131,656 Total Patients Enrolled

Frequently Asked Questions

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

Would this be an appropriate treatment regimen for elderly patients?

"This study requires that potential participants be aged 18-60."

Answered by AI

Are there any qualifications required to participate in this experiment?

"This international trial is looking for 3,900 individuals currently infected with HIV. In addition to being between 18-60 years old, participants must meet the following requirements: Be in good health based on medical history, physical examination, and vital sign measurement performed at screening, Be a cis-gender man having sex with cis-gender men and/or transgender individuals or transgender woman having sex with cis-gender men and/or transgender individuals or transgender man having sex with cis-gender men and/or transgender women or gender non-conforming individual having receptive or insertive anal and/or vaginal condom-less intercourse and who is considered by the"

Answered by AI

Is it dangerous to receive the Clade C and Mosaic gp140 HIV bivalent vaccine?

"There is some prior data supporting the efficacy of Clade C and Mosaic gp140 HIV bivalent vaccine, making it a safe choice with a score of 3."

Answered by AI

Are there any spots left for volunteers in this clinical trial?

"The study in question, while not recruiting at this moment, was last edited on 10/25/2022. According to the data on clinicaltrials.gov, there are 1671 other trials that are actively seeking patients."

Answered by AI
~731 spots leftby Mar 2025