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NCT02788045 · ClinicalTrials.gov registry record · Phase 1

Safety, Tolerability and Immunogenicity Study of Different Vaccine Regimens of Trivalent Ad26.Mos.HIV or Tetravalent Ad26.Mos4.HIV Along With Clade C Glycoprotein (gp)140 in Healthy Human Immunodeficiency Virus (HIV)-Uninfected Adults

A Phase 1 study, sponsored by Janssen Vaccines & Prevention B.V..

Completed
Registry status
Phase 1
Development phase
201
Enrollment target

NCT02788045: Completed Phase 1 study, sponsored by Janssen Vaccines & Prevention B.V..

NCT02788045 is a Phase 1 study that has completed, run by Janssen Vaccines & Prevention B.V.. The registered enrollment target is 201 participants, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (235% higher). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT02788045, a Phase 1 study, has completed, sponsored by Janssen Vaccines & Prevention B.V..

COMPLETED
Registry status
Phase 1
Development phase
201 participants
Enrollment target

Study Summary

The purpose of this study is to assess the safety/tolerability of the 2 different vaccine regimens of priming with trivalent Ad26.Mos.HIV and boosting with trivalent Ad26.Mos.HIV and Clade C gp140 plus adjuvant or priming with tetravalent Ad26.Mos4.HIV and boosting with Ad26.Mos4.HIV and Clade C glycoprotein (gp)140 plus adjuvant. Immune responses of the different vaccine schedules will be assessed.

Primary Outcome

Solicited local AEs were predefined local events (at the injection site: erythema, induration, swelling, itching and warmth) that were by definition considered as related to the study vaccine and collected within 7 days after vaccination.

Interventions

  • DRUG Placebo
  • BIOLOGICAL Ad26.Mos4.HIV
  • BIOLOGICAL Ad26.Mos.HIV
  • BIOLOGICAL Clade C gp140

Trial Details

FieldValue
Enrollment Target 201 participants
Start Date 2016-07-08
Est. Completion 2022-04-25
Phase Phase 1
Janssen Vaccines & Prevention B.V.

34 total trials

What the finished NCT02788045 record still lists

NCT02788045 is an interventional study that assigns participants to a tested intervention. The registered 201 participants enrollment target is mid-sized for trials with a published cap, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (235% higher).

The record links to 0 conditions, and to 4 interventions - of which Placebo is the first listed.

NCT02788045 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT02788045 about?

NCT02788045 is a clinical study titled "Safety, Tolerability and Immunogenicity Study of Different Vaccine Regimens of Trivalent Ad26.Mos.HIV or Tetravalent Ad26.Mos4.HIV Along With Clade C Glycoprotein (gp)140 in Healthy Human Immunodeficiency Virus (HIV)-Uninfected Adults". The purpose of this study is to assess the safety/tolerability of the 2 different vaccine regimens of priming with trivalent Ad26.Mos.HIV and boosting with trivalent Ad26.Mos.HIV and Clade C gp140 plus adjuvant or priming with tetravalent Ad26.Mos4.HIV and boosting with Ad26.Mos4.HIV and Clade C gly...

What is the current status of trial NCT02788045?

This trial is currently completed. It is a Phase 1 study. The enrollment target is 201 participants. The study started on 2016-07-08. Estimated completion is 2022-04-25.

What interventions are being tested in trial NCT02788045?

The interventions under investigation include: Placebo (DRUG), Ad26.Mos4.HIV (BIOLOGICAL), Ad26.Mos.HIV (BIOLOGICAL), Clade C gp140 (BIOLOGICAL).

Who is sponsoring clinical trial NCT02788045?

This trial is sponsored by Janssen Vaccines & Prevention B.V., which has 34 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT02788045's enrollment target sits among peer trials

201 258th of 2000 higher than 1,742 of 2,000 other Phase 1 trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT02788045, the US trial registry maintained by the National Library of Medicine. NCT02788045 (mid enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.