This phase 2 clinical trial will evaluate the safety and immunogenicity of additional doses
of prototype and variant (alone or in combination) vaccine candidates in previously
vaccinated participants with or without prior severe acute respiratory syndrome coronavirus 2
(SARS-CoV-2) infection and will evaluate innate, cellular, and humoral immune responses to
inform on how to shift the immune response to cover new variants as they emerge. A randomized
open-label, non-placebo controlled, multi-site, multi-stage clinical trial in individuals, 18
years of age and older, who are in a stable state of health, has received a complete
authorized/approved vaccine series (primary series + booster either with homologous or
heterologous vaccine products) >/ = 16 weeks prior to enrollment. Subjects will be stratified
by i) age (18-64 years and >/= 65 years of age) and ii) history of confirmed prior SARS-CoV-2
infection, and randomly assigned to receive one of several variant vaccines. Enrollment will
target a goal of approximately 45% of each of the variant vaccine arms to be in older adults
(>/= 65 years of age) and approximately 20% to have had confirmed COVID-19.The primary
objective is to evaluate humoral immune responses of candidate SARS-CoV-2 variant vaccines,
alone or in combination.
Phase:
Phase 1/Phase 2
Details
Lead Sponsor:
National Institute of Allergy and Infectious Diseases (NIAID)