Phase 2a COVID-19 Vaccine Study - VAC31518COV2001(COVID-19)(UPH)

• Research type

  Research Study

• Full title

  A Randomized, Double-blind, Placebo-controlled Phase 2a Study to Evaluate a Range of Dose Levels and Vaccination Intervals of Ad26.COV2.S in Healthy Adults Aged 18 to 55 Years Inclusive and Adults Aged 65 Years and Older and to Evaluate 2 Dose Levels of Ad26.COV2.S in Healthy Adolescents Aged 12 to 17 Years Inclusive.

• IRAS ID

  291996

• Contact name

  Saul Faust

• Contact email

  s.faust@soton.ac.uk

• Sponsor organisation

  Janssen Vaccines & Prevention B.V

• Eudract number

  2020-002584-63

• Clinicaltrials.gov Identifier

  NCT04535453

• Clinicaltrials.gov Identifier

  22657, IND

• Duration of Study in the UK

  1 years, 6 months, 1 days

• Research summary

  The sponsor is conducting this study to test the new experimental vaccine called Ad.COV2.S on adolescents and adults (Please note only the Adolescent Cohorts will be recruited in the UK). Doctors and scientists hope that this vaccine will prevent or lessen the severity of disease caused by Severe Acute Respiratory Syndrome Coronavirus-2 (SARS-COV-2). The main purpose of the study is to demonstrate the following:
  - How well Ad26.COV2.S works to prevent COVID-19 disease.
  - If the Ad26.COV2.S vaccine is safe.
  - If it causes any side effects and what are they.
  - How well the vaccine is tolerated by people in the study.
  - What the best dose of the vaccine is.
  The Sponsor will also test how long the effects of the study vaccine lasts, how it acts on the body and how the body reacts to the study vaccine (the immune response).

  The UK will only participate in the Adolescent Cohorts only (Groups A-F) no other cohorts will be recruited to in the UK, the participants in the UK will be ages 12-17 years inclusive. A total global number of 660 participants (adolescents) will be enrolled in these cohorts. There are 6 treatment groups for adolescents in this study. The participant will be randomly allocated either the Ad26.COV2.S or placebo vaccine group. There is 91% chance (600 out of 660 Participants) of getting the Ad26.COV2.S vaccine. There will be 3 doses of the vaccine or placebo given to all participants. In the UK approximately 100 participants are expected to take part in the study, both NHS and a commercial site will be used to recruit participants.

  Adolescents will participate in the study for approximately 19 months, this will include a 28 days screening phase, a 2-month vaccination phase, a booster vaccination 12 months after the first vaccination and a 6-month follow-up after the booster vaccination.

• REC name

  London - City & East Research Ethics Committee

• REC reference

  21/HRA/0433

• Date of REC Opinion

  7 Feb 2021

• REC opinion

  Favourable Opinion