Johnson & Johnson has begun vaccinating adolescent participants in the ongoing Phase 2a clinical trial for its COVID-19 vaccine candidate, developed by the Janssen Pharmaceutical Companies of Johnson & Johnson.
“The COVID-19 pandemic has had a profound impact on adolescents, not just with the complications of the disease, but with their education, mental health, and wellbeing,” said Paul Stoffels, M.D., Vice Chairman of the Executive Committee and Chief Scientific Officer at Johnson & Johnson. “It is vital that we develop vaccines for everyone, everywhere, to help combat the spread of the virus with the goal to return to everyday life.”
The randomized, double-blind, placebo-controlled Phase 2a study (VAC31518COV2001) has been ongoing since September 2020, and was initially designed to evaluate the safety, reactogenicity (expected reactions to vaccination, such as swelling or soreness) and immunogenicity (ability to induce an immune response) of single-dose and two-dose regimens of the Johnson & Johnson COVID-19 vaccine candidate in healthy adults aged 18 to 55 years, as well as adults aged 65 years and older. The study is now including adolescents 12 to 17 years of age.
Among the study’s goals are to evaluate reactogenicity and immunogenicity of two dose levels of the vaccine candidate, and to evaluate potential vaccination schedules at one, two and three-month intervals in two-dose vaccine regimens.
“Our COVID-19 vaccine candidate development program is designed to deliver on our commitment to protect people of all ages from this pandemic,” said Mathai Mammen, M.D., Ph.D., Global Head, Janssen Research & Development, Johnson & Johnson. “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 Johnson & Johnson COVID-19 vaccine candidate will initially be tested in a small number of adolescents aged 16-17 years. Following the review of initial data 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 United Kingdom; enrollment will commence shortly in the United States, the Netherlands and Canada, with Brazil and Argentina to follow.