Jansen ENSEMBLE: VAC31518COV3001

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 for Coronavirus disease -19 (COVID-19) will be critical for containing the current outbreak and preventing future outbreaks, as no vaccine is currently available.

Janssen is developing a vaccine for the prevention of SARS-CoV-2-mediated COVID-19 in adults.

In this study efficacy, safety and Immunogenicity will be evaluated in adults living in or going to locations with high risk of SARS-CoV-2 infection after vaccine administration.

Primary Objectives

To demonstrate the efficacy of AD26.COV2.S in the prevention of molecularly confirmed moderate to severe/critical COVID-19, as compared to Placebo, in SARS-CoV-2 Seronegative adults.

Study Population

Adults 18 Years and Older

Investigators

• Dr Faeezah Patel, Principal Investigator
• Dr Elizea Horne, Co-Principal Investigator
• Dr 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