Johnson & Johnson (J&J) has expanded Phase IIa clinical trial of Covid-19 vaccine candidate to include adolescent subjects aged 12 to 17 years.
Developed by the Janssen Pharmaceutical Companies of Johnson & Johnson, the single-shot vaccine is authorised for emergency use for active immunisation to prevent Covid-19 in adults.
The randomised, double-blind, placebo-controlled study had begun in September last year. It was primarily designed to assess the safety, reactogenicity and immunogenicity of single-dose and two-dose regimens of the vaccine candidate in healthy adults aged 18 to 55 years and elderly individuals aged 65 years and above.
It will also analyse possible vaccination schedules at one, two and three-month intervals in two-dose vaccine regimens.
Johnson & Johnson executive committee vice-chairman and chief scientific officer Paul Stoffels said: “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.
“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.”
In the initial stage, the vaccine candidate will be evaluated in a smaller number of adolescents. On reviewing the initial data from the Phase IIa trial, the study will be extended to a bigger group of younger adolescents in a stepwise manner.
Currently, the trial is enrolling subjects in Spain and the UK, with enrolment set to begin in the US, the Netherlands and Canada, Brazil and Argentina soon.
Johnson & Johnson Janssen Research & Development global head Mathai Mammen said: “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.”