A Study of Ad26.COV2.S Administered as Booster Vaccination in Adults Who Have Previously Received Primary Vaccination With Ad26.COV2.S or BNT162b2

Summary

The purposes of this study are to demonstrate the non-inferiority (NI) of the neutralizing antibody response to the original strain 14 days after booster vaccination with Ad26.COV2.S at the different dose levels, administered greater than or equal to (\>=) 6 months after single-dose primary vaccination with Ad26.COV2.S, compared to the neutralizing antibody response to the original strain induced by single-dose primary vaccination with Ad26.COV2.S; To demonstrate the NI of the neutralizing antibody response to the leading variant of high consequence or concern 14 days after booster vaccination with Ad26.COV2.S at the 5\*10\^10 virus particle (vp) dose level, administered \>= 6 months after single-dose primary vaccination with Ad26.COV2.S (5\*10\^10 vp dose level), compared to the neutralizing antibody response to the leading variant of high consequence or concern induced by single-dose primary vaccination with Ad26.COV2.S at the 5\*10\^10 vp dose level, if feasible; To demonstrate the NI of the neutralizing antibody response to the original strain 14 days after booster vaccination with Ad26.COV2.S at the different dose levels administered \>=6 months after completing a 2-dose primary vaccination with Pfizer BNT162b2, compared to the neutralizing antibody response to the original strain induced by 2-dose primary vaccination with Pfizer BNT162b2; To demonstrate the NI of neutralizing antibody response to the leading variant of high consequence or concern 14 days after booster vaccination with Ad26.COV2.S at the 5\*10\^10 vp dose level, administered \>= 6 months after completing a 2-dose primary vaccination with Pfizer BNT162b2, compared to the neutralizing antibody response to the leading variant of high consequence or concern induced by 2-dose primary vaccination with Pfizer BNT162b2, if feasible.

Timeline

Start

2021-08-06

Primary completion

2021-10-27

Completion

2022-11-22

Publications

• Roels S, Bruckner M, Sadoff J, Cardenas V, Tang C, Hagedoorn S, Heerwegh D, Stieh DJ, Le Gars M. Pre- and post-Ad26.COV2.S booster dose antibody levels predict COVID-19 disease risk. Vaccine. 2024 Sep 17;42(22):126159. doi: 10.1016/j.vaccine.2024.126159. Epub 2024 Aug 8.
• Le Gars M, Sadoff J, Cardenas V, Heerwegh D, Tesfaye F, Roey GV, Spicer C, Matias SS, Crayne O, Kamphuis T, Struyf F, Schuitemaker H, Douoguih M. Safety, reactogenicity, and immunogenicity of Ad26.COV2.S as homologous or heterologous COVID-19 booster vaccination: Results of a randomized, double-blind, phase 2 trial. Vaccine. 2024 Jul 25;42(19):3938-3952. doi: 10.1016/j.vaccine.2024.03.079. Epub 2024 Jun 25.

Drugs

Indications