NCT04614948

A Study of Ad26.COV2.S for the Prevention of SARS-CoV-2-mediated COVID-19 in Adults

A Randomized, Double-blind, 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

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 31,835 (actual)
• Sponsor: Janssen Vaccines & Prevention B.V. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

Summary

The study will evaluate the efficacy of Ad26.COV2.S in the prevention of molecularly confirmed moderate to severe/critical coronavirus disease-2019 (COVID-19), as compared to placebo, in SARS-CoV-2 seronegative adults in the double-blind phase and to describe COVID-19 outcomes, safety, and immunogenicity in the different study cohorts in open-label phase.

Detailed description

The aim of the COVID-19 vaccine clinical development program is to develop a safe and effective vaccine for the prevention of COVID-19. Ad26.COV2.S, a COVID-19 vaccine based on a human replication-incompetent Ad26 vector, constructed to encode the severe acute respiratory syndrome coronavirus-2 (SARS-CoV-2) virus spike (S) protein, is being developed. The study will consist of: a screening phase (up to 28 days), study period (60-week), and a long-term follow-up period (1 additional year). The total study duration will be maximum 2 years and 3 months for the participants. Assessments for efficacy (COVID-19 signs and symptoms, etc.), immunogenicity (such as humoral immune responses), and safety (such as adverse events \[AEs\] monitoring) will be performed throughout the study.

Conditions

• Participants With or Without Stable Co-morbidities Associated With Progression to Severe COVID-19

Interventions

Type	Name	Description
BIOLOGICAL	Ad26.COV2.S	Ad26.COV2.S vaccine will be administered on Day 1 and Day 57 in the double-blind phase. At unblinding visit Ad26.COV2.S vaccine will be administered to participants at Day 57 who have not yet received second vaccination and in newly enrolled participants as either single dose on Day 1 or two doses on Day 1 and Day 57. Single dose of Ad26.COV2.S vaccine will also be administered to participants initially receiving placebo. Single booster dose of Ad26.COV2.S vaccine will be given to participants in the open label phase who have received only a single vaccination with Ad26.COV2.S.
OTHER	Placebo	Placebo will be administered as IM injection on Day 1 and Day 57.

Timeline

• Start date: 2020-11-12
• Primary completion: 2023-06-18
• Completion: 2023-06-18
• First posted: 2020-11-04
• Last updated: 2025-02-04
• Results posted: 2024-10-09

Locations

126 sites across 10 countries: United States, Belgium, Brazil, Colombia, France, Germany, Philippines, South Africa, Spain, United Kingdom

Regulatory

• FDA-regulated drug study