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Wits RHI

Jansen ENSEMBLE: VAC31518COV3001

Infectious Diseases

A Randomized , Double -Blinded, Placebo-Controlled Phase 3 Study to assess the Efficacy and safety of Ad26.COV2.S for the Prevention of SARS-CoV-2-mediated COVID-19 in Adults Aged 18 Years and Older.

Rationale

The development of a vaccine against COVID-19 is essential to control the current pandemic and prevent future outbreaks. With no approved vaccines at the time of study initiation, Janssen undertook this global trial to evaluate the safety, efficacy, and immunogenicity of Ad26.COV2.S a vaccine candidate for SARS-CoV-2 infection prevention.

Primary Objective:

To demonstrate the efficacy of Ad26.COV2.S in preventing molecularly confirmed moderate to severe/critical COVID-19 in SARS-CoV-2 seronegative adults, compared to placebo.

Secondary Objectives:

  • Prevent molecularly confirmed moderate to severe/critical COVID-19 after day one of vaccination

  • Assess vaccine efficacy in reducing cases requiring medical intervention

  • Evaluate the effect on viral RNA load in moderate to severe/critical cases

  • Examine the vaccine’s impact on:

    • Mild COVID-19 cases

    • Cases defined under US FDA harmonized criteria

    • All symptomatic infections

    • Asymptomatic or undetected infections

Primary Endpoint:

First occurrence of molecularly confirmed moderate to severe/critical COVID-19 with onset ≥28 days post-vaccination.

Study Design:

  • Type: Randomized, double-blind, placebo-controlled, Phase 3

  • Enrolment: Staggered in two stages

    • Stage 1:

      • 1A: Healthy adults aged 18–59 without comorbidities

      • 1B: Adults aged 18–59 with or without comorbidities

    • Stage 2:

      • 2A: Healthy adults aged 60+ without comorbidities

      • 2B: Adults aged 60+ with or without comorbidities

Study Population & Sample Size:

  • Adults aged 18 years and older

  • Between 30,000–60,000 participants randomized 1:1 to vaccine or placebo

Investigators

  • Dr Faeezah Patel, Principal Investigator
  • Dr Elizea Horne, Co-Principal Investigator
  • Prof Lee Fairlie, Sub Investigator
  • Dr Masebole Masenya, Sub Investigator
  • Dr Gabrielle Benade, Sub Investigator
  • Dr Alden Nicholas Geldenhuys, Sub Investigator

Donor

Janssen Pharmaceutical Companies of Johnson Johnson

Latest Update:

September 2023

For more about Jansen ENSEMBLE VAC31518COV3001 please email rhicomms@wrhi.ac.za

Research Briefs

Project Brief: Jansen ENSEMBLE VAC31518COV3001 HG