A Phase 1/2a Trial to Evaluate the Safety/Tolerability and Immunogenicity of Homologous Ad26 Mosaic Vector Regimens or Ad26 Mosaic and MVA Mosaic Heterologous Vector Regimens, With High-Dose, Low-Dose or no Clade C gp140 Protein Plus Adjuvant for HIV Prevention

Trial Profile

A Phase 1/2a Trial to Evaluate the Safety/Tolerability and Immunogenicity of Homologous Ad26 Mosaic Vector Regimens or Ad26 Mosaic and MVA Mosaic Heterologous Vector Regimens, With High-Dose, Low-Dose or no Clade C gp140 Protein Plus Adjuvant for HIV Prevention

Active, no longer recruiting
Phase of Trial: Phase I/II

Latest Information Update: 11 Nov 2017

At a glance

  • Drugs HIV vaccine Ad26 ENVA-01 (Primary) ; MVA-Mosaic-HIV-vaccine-Janssen-Vaccines-and-Prevention (Primary) ; HIV gp140 vaccine
  • Indications HIV infections
  • Focus Adverse reactions; Pharmacodynamics
  • Acronyms APPROACH
  • Sponsors Janssen Vaccines and Prevention
  • Most Recent Events

    • 06 Nov 2017 Planned End Date changed from 1 Jun 2023 to 18 Jul 2022.
    • 14 Aug 2017 Planned End Date changed from 1 Sep 2022 to 1 Jun 2023.
    • 24 Jul 2017 According to Johnson & Johnson media release, vaccination schedules have been completed for all study participants and 12-month follow-up after the 4th dose is underway.
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