J&J Tests COVID-19 Vaccine on Adolescents
New Brunswick-based Johnson & Johnson (J&J) confirmed today it is vaccinating adolescent participants in the ongoing Phase 2a clinical trial for its experimental COVID-19 vaccine, developed by the Janssen Pharmaceutical Companies of J&J.
The randomized, double-blind, placebo-controlled Phase 2a study has been ongoing since September 2020. and was initially designed to evaluate the safety, reactogenicity (expected reactions to vaccination in healthy adults aged 18 to 55 years, as well as adults aged 65 years and older. This clinical study is now including adolescents 12 to 17 years of age.
The study’s goals are to evaluate reactogenicity and immunogenicity of two dose levels of the vaccine candidate and evaluate potential vaccination schedules at one, two, and three-month intervals in two-dose vaccine regimens in 1,210 adolescents aged 16-17 years.
Following the initial data review in this Phase 2a trial, the study will be expanded to a larger group of younger adolescents in a stepwise approach.
This trial is currently enrolling participants in Spain and the UK. Enrollment will commence shortly in the USA, the Netherlands, and Canada, with Brazil and Argentina to follow, says JnJ.
“Our COVID-19 vaccine candidate development program is designed to deliver on our commitment to protect people of all ages from this pandemic,” commented Mathai Mammen, M.D., Ph.D., Global Head, Janssen Research & Development, J&J, in a press statement.
“In addition to expanding this ongoing study to include adolescents, we are in discussions with health authorities and are hard at work to initiate studies in pregnant women and children in the near future.”
The Janssen COVID-19 single-shot vaccine leverages Janssen's AdVac and PER.C6® technologies. Janssen’s AdVac® vectors are based on a specific type of adenovirus, which has been genetically modified so that it can no longer replicate in humans and cause disease.
On February 27, 2021, the U.S. Food and Drug Administration issued an emergency use authorization allowing the Janssen COVID-19 Vaccine to be distributed in the U.S for use in individuals 18 years of age and older.