NCT04436276

A Study of Ad26.COV2.S in Adults (COVID-19)

A Randomized, Double-blind, Placebo-controlled Phase 1/2a Study to Evaluate the Safety, Reactogenicity, and Immunogenicity of Ad26COVS1 in Adults Aged 18 to 55 Years Inclusive and Adults Aged 65 Years and Older

• Status: Completed
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 1,085 (actual)
• Sponsor: Janssen Vaccines & Prevention B.V. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

Summary

The purpose of the study is to assess the safety, reactogenicity, and immunogenicity of Ad26.COV2.S at 2 dose levels, administered intramuscularly (IM) as a single-dose or 2-dose schedule, with a single booster vaccination administered in one cohort in healthy adults aged greater than or equal to (\>=) 18 to less than or equal to (\<=) 55 years and in adults aged \>= 65 years in good health with or without stable underlying conditions. The purpose of the study is also to assess the safety and reactogenicity of Ad26.COV2.S administered as ad hoc booster vaccination in healthy adults aged \>= 18 to \<= 55 years and in adults \>= 65 years in good health with or without stable underlying conditions.

Conditions

• Covid-19 Prevention

Interventions

Type	Name	Description
BIOLOGICAL	Ad26.COV2.S	Participants will receive intramuscular (IM) injection of Ad26.COV2.S.
BIOLOGICAL	Placebo	Participants will receive Placebo.

Timeline

• Start date: 2020-07-15
• Primary completion: 2023-02-21
• Completion: 2023-02-21
• First posted: 2020-06-18
• Last updated: 2025-02-04
• Results posted: 2024-05-24

Locations

12 sites across 2 countries: United States, Belgium

Regulatory

• FDA-regulated drug study