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NCT02685020

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

Completed Phase 1 Last updated 3 February 2025
What this trial tests

Phase 1 trial testing Ad26.Mos.HIV in Healthy in 36 participants. Completed in 3 January 2019.

Timeline
28 March 2016
Primary endpoint
5 January 2018
3 January 2019

Quick facts

Lead sponsorJanssen Vaccines & Prevention B.V.
PhasePhase 1
StatusCompleted
Study typeINTERVENTIONAL
Allocationrandomized
Designparallel
Maskingdouble
Primary purposeprevention
Enrollment36
Start date28 March 2016
Primary completion5 January 2018
Estimated completion3 January 2019
Sites1 location across United States

Drugs / interventions tested

Conditions studied

Sponsor

Janssen Vaccines & Prevention B.V. — full company profile →

Who can join

Adults 18 to 50, any sex, with Healthy. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

The primary purpose of this study is to assess safety, tolerability of the different vaccine schedules (different regimen durations and different number of dose administrations) with Ad26.Mos.HIV and Clade C Glycoprotein (gp) 140 and to assess Envelope (Env)-binding Antibody (Ab) responses of the different vaccine schedules.

Publications & conference data

5 peer-reviewed publications reference this trial (live from Europe PMC):

  1. Progress in HIV vaccine development.
    Hsu DC, O'Connell RJ. · · 2017 · cited 62× · PMID 28281871 · DOI 10.1080/21645515.2016.1276138
  2. Vaccines based on replication incompetent Ad26 viral vectors: Standardized template with key considerations for a risk/benefit assessment.
    Custers J, Kim D, Leyssen M, Gurwith M, et al · · 2021 · cited 59× · PMID 33676782 · DOI 10.1016/j.vaccine.2020.09.018
  3. New concepts in HIV-1 vaccine development.
    Stephenson KE, D'Couto HT, Barouch DH. · · 2016 · cited 58× · PMID 27268856 · DOI 10.1016/j.coi.2016.05.011
  4. Comparison of shortened mosaic HIV-1 vaccine schedules: a randomised, double-blind, placebo-controlled phase 1 trial (IPCAVD010/HPX1002) and a preclinical study in rhesus monkeys (NHP 17-22).
    Stephenson KE, Wegmann F, Tomaka F, Walsh SR, et al · · 2020 · cited 21× · PMID 32078815 · DOI 10.1016/s2352-3018(20)30001-1
  5. The Question of HIV Vaccine: Why Is a Solution Not Yet Available?
    Libera M, Caputo V, Laterza G, Moudoud L, et al · · 2024 · cited 9× · PMID 38628675 · DOI 10.1155/2024/2147912

Verify or expand the search:

Other trials of Ad26.Mos.HIV

Trials testing the same drug.

Other recruiting trials for Healthy

Currently open trials in the same condition.

Other Janssen Vaccines & Prevention B.V. trials

Trials by the same sponsor.

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Data sources for this page

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT02685020.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing