← Back to Search

Virus Therapy

HIV Vaccine for Healthy Subjects (IPCAVD-012 Trial)

Phase 1 & 2
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 older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline up to week 288
Awards & highlights

IPCAVD-012 Trial Summary

This trial is testing how safe and tolerable two different vaccine regimens are, as well as how well they stimulate the production of antibodies that bind to the envelope of the virus.

IPCAVD-012 Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline up to week 288
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline up to week 288 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Discontinuations From Vaccination/From Study due to AEs
Envelope (Env)-specific Binding Antibody (Abs) (Titers and Breadth)
Number of Participants With Adverse events (AEs)
+3 more
Secondary outcome measures
Cluster of Differentiation (Cd)4+ and Cd8+ T-Cell Functionality (Percentage [%] Cells Producing I-alpha, IFN-gamma, Interleukin [IL-2], IL-4, Tumor Necrosis Factor [TNF]-alpha)
Env-specific Binding Ab Isotypes (Immunoglobulin A [IgA], IgG1-4) (Titers and Breadth)
Env-specific Functional Abs (Phagocytosis Score and Breadth)
+3 more

IPCAVD-012 Trial Design

5Treatment groups
Experimental Treatment
Placebo Group
Group I: Group 2: Ad26.Mos4.HIV + Clade C gp140 + Mosaic gp140Experimental Treatment2 Interventions
Participants will receive Ad26.Mos4.HIV vaccine at Week 0 and 12; followed by Ad26.Mos4.HIV vaccine + combination of 125 mcg Mosaic gp140 and 125 mcg Clade C gp140 mixed with adjuvant (aluminum phosphate) at Week 24 and 48. Participants who receive all 4 vaccinations and are negative for HIV infection at Week 72 can consent to be included in a long-term extension (LTE) phase (approximately 3 years after Week 72).
Group II: Group 1b: Ad26.Mos4.HIV + gp140 HIV Bivalent VaccineExperimental Treatment2 Interventions
Participants enrolled in the LTE phase will receive late boost vaccination Ad26.Mos4.HIV and bivalent gp140 within 4 weeks prior to Week 192 until 4 months after Week 192 (that is, approximately 3 years after the 4th vaccination of the primary vaccination series).
Group III: Group 1: Ad26.Mos4.HIV + Clade C gp140Experimental Treatment2 Interventions
Participants will receive Ad26.Mos4.HIV vaccine at Week 0 and 12, followed by Ad26.Mos4.HIV vaccine + Clade C glycoprotein 140 vaccine containing 250 microgram (mcg) of total protein mixed with adjuvant (aluminium phosphate) at Week 24 and 48. Participants who receive all 4 vaccinations and are negative for HIV infection at Week 72 can consent to be included in a long-term extension (LTE) phase (approximately 3 years after Week 72).
Group IV: Group 3: PlaceboPlacebo Group1 Intervention
Participants will receive a single placebo injection at Weeks 0 and 12, followed by two placebo injections at Weeks 24 and 48.
Group V: Group 2b: PlaceboPlacebo Group1 Intervention
Participants will receive placebo injection at Week 192 -4 weeks/+4 months, that is, approximately 3 years after the 4th vaccination of the primary vaccination series.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Ad26.Mos4.HIV
2016
Completed Phase 3
~4130

Find a Location

Logistics

Participation is compensated

You will be compensated for participating in this trial.

Who is running the clinical trial?

Janssen Vaccines & Prevention B.V.Lead Sponsor
55 Previous Clinical Trials
1,134,193 Total Patients Enrolled
Janssen Vaccines & Prevention B.V. Clinical TrialStudy DirectorJanssen Vaccines & Prevention B.V.
47 Previous Clinical Trials
135,401 Total Patients Enrolled

Media Library

Ad26.Mos4.HIV (Virus Therapy) Clinical Trial Eligibility Overview. Trial Name: NCT02935686 — Phase 1 & 2
Healthy Subjects Research Study Groups: Group 1: Ad26.Mos4.HIV + Clade C gp140, Group 2: Ad26.Mos4.HIV + Clade C gp140 + Mosaic gp140, Group 3: Placebo, Group 1b: Ad26.Mos4.HIV + gp140 HIV Bivalent Vaccine, Group 2b: Placebo
Healthy Subjects Clinical Trial 2023: Ad26.Mos4.HIV Highlights & Side Effects. Trial Name: NCT02935686 — Phase 1 & 2
Ad26.Mos4.HIV (Virus Therapy) 2023 Treatment Timeline for Medical Study. Trial Name: NCT02935686 — Phase 1 & 2
Healthy Subjects Patient Testimony for trial: Trial Name: NCT02935686 — Phase 1 & 2

Frequently Asked Questions

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

Are people still able to join this clinical trial?

"Unfortunately, this study is not currently seeking patients. Although the trial was originally posted on March 31st, 2017, the most recent update occurred on October 25th, 2022. 895 other trials are presently enrolling participants if you are interested in taking part in medical research."

Answered by AI

At how many different hospitals can patients participate in this trial?

"The trial is being run by 12 different centres, including the Seattle Vaccine Trials Unit in Seattle, Washington, Strong Memorial Infectious disease in Rochester, New york, and Columbia University HIV Vaccine Unit in New York."

Answered by AI

What are we hoping to discover or confirm through this research?

"The primary focus of this trial, which will run for approximately 216 weeks, is to observe the number of participants that experience serious adverse events or AESIs related to confirmed HIV infection. Additionally, this study will also collect data on env-specific neutralizing antibodies, T-cell development & memory differentiation, and env-specific functional antibodies."

Answered by AI

Who else is applying?

What state do they live in?
New Jersey
Other
New York
Massachusetts
How old are they?
18 - 65
What site did they apply to?
Beth Israel Deaconess Medical Center
Columbia University HIV Vaccine Unit
New York Blood Center
Other
What portion of applicants met pre-screening criteria?
Did not meet criteria
Met criteria
How many prior treatments have patients received?
0

Why did patients apply to this trial?

I'm interested in helping find appropriate drugs for the right patient.
PatientReceived no prior treatments

What questions have other patients asked about this trial?

How long do screening visits take?
PatientReceived 2+ prior treatments
Recent research and studies
clinicaltrials.govStudy
A Safety, Tolerability and Immunogenicity Study of 2 Different Regimens of Tetravalent Ad26.Mos4.HIV Prime Followed by Boost With Tetravalent Ad26.Mos4.HIV Along With Either Clade C gp140 Plus Adjuvant OR With a Combination of Mosaic and Clade C gp140 Plus Adjuvant in Healthy HIV Uninfected Adults
2017. "A Safety, Tolerability and Immunogenicity Study of 2 Different Regimens of Tetravalent Ad26.Mos4.HIV Prime Followed by Boost With Tetravalent Ad26.Mos4.HIV Along With Either Clade C gp140 Plus Adjuvant OR With a Combination of Mosaic and Clade C gp140 Plus Adjuvant in Healthy HIV Uninfected Adults". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT02935686.
~19 spots leftby Apr 2025
Unbiased ResultsWe believe in providing patients with all the options.
Your Data Stays Your DataWe only share your information with the clinical trials you're trying to access.
Verified Trials OnlyAll of our trials are run by licensed doctors, researchers, and healthcare companies.
Back to top