Johnson & Johnson expands clinical trial to include adolescents

April 6, 2021

Johnson & Johnson has begun vaccinating adolescent participants in the ongoing Phase 2a clinical trial for its COVID-19 vaccine candidate, developed by the Janssen Pharmaceuticals, part of Johnson & Johnson, according to a news release.

Johnson & Johnson said 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 now includes 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.

“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,” said Mathai Mammen, MD, PhD, Global Head, Janssen Research & Development, Johnson & Johnson.

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.

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