Randomised double-blinded placebo-controlled trial (Orange)
Control of the global COVID-19 pandemic will require the development and deployment of safe and effective vaccines. The objective of this study was to evaluate the immunogenicity of the Ad26.COV2.S vaccine (Janssen/Johnson & Johnson) in humans, including the kinetics, magnitude, and phenotype of SARS-CoV-2 spike-specific humoral and cellular immune responses. Twenty-five participants were enrolled from July 29, 2020, to August 7, 2020, and the follow-up for this day 71 interim analysis was completed on October 3, 2020; follow-up to assess durability will continue for 2 years. Participants were randomized to receive 1 or 2 intramuscular injections with 5 × 1010 viral particles or 1 × 1011 viral particles of Ad26.COV2.S vaccine or placebo administered on day 1 and day 57 (5 participants in each group). Main outcomes and measures comprise the humoral immune responses included binding and neutralizing antibody responses at multiple time points following immunization and cellular immune responses included immunospot-based and intracellular cytokine staining assays to measure T-cell responses. Twenty-five participants were randomized and all completed the trial through the day 71 interim end point. Binding and neutralizing antibodies emerged rapidly by day 8 after initial immunization in 90% and 25% of vaccine recipients, respectively. By day 57, binding and neutralizing antibodies were detected in 100% of vaccine recipients after a single immunization. On day 71, the geometric mean titers of spike-specific binding antibodies were 2432 to 5729 and the geometric mean titers of neutralizing antibodies were 242 to 449 in the vaccinated groups. A variety of antibody subclasses, Fc receptor binding properties, and antiviral functions were induced. CD4+ and CD8+ T-cell responses were induced. The authors concluded that in this phase 1 study, a single immunization with Ad26.COV2.S induced rapid binding and neutralization antibody responses as well as cellular immune responses.
Stephenson KE, et al. Immunogenicity of the Ad26.COV2.S Vaccine for COVID-19. JAMA. 2021 Mar 11. doi: 10.1001/jama.2021.3645