Coronavirus-Like Particle COVID-19 Vaccine (CP-PRO-CoVLP-021) [COVID-19] [UPH]
Research type
Research Study
Full title
A Randomized, Observer-Blind, Placebo-Controlled, Phase 2/3 Study to Assess the Safety, Efficacy, and Immunogenicity of a Recombinant Coronavirus-Like Particle COVID-19 Vaccine in Adults 18 Years of Age or Older
IRAS ID
296247
Contact name
Christine Jones
Contact email
Sponsor organisation
Medicago Inc.
Eudract number
2020-005576-35
ISRCTN Number
ISRCTN00000000
Clinicaltrials.gov Identifier
Duration of Study in the UK
2 years, 2 months, 1 days
Research summary
Coronavirus disease 2019 (COVID-19) is a disease caused by a virus called “SARS-CoV-2”. The virus is spread by contact with nasal (nose) and oral (mouth) secretions. Individuals who have COVID-19 may show some symptoms or none at all (referred to as “asymptomatic”). A common way to prevent and control disease is vaccination.
This study sponsored by Medicago Inc. will evaluate an experimental vaccine to see if it can help prevent or control COVID-19 infections. The study will evaluate the efficacy and safety of the Coronavirus-Like Particle COVID-19 Vaccine.
Participants will receive 2 doses of the experimental vaccine (CoVLP vaccine combined with the adjuvant AS03 CoVLP formulation) and 2 doses of placebo (dummy drug). During each period, 2 injections of the same experimental study treatment will be given 21 days apart. In the 2-way cross-over design, participants who receive the experimental vaccine in Period 1 will receive the placebo in Period 2, while participants who receive the placebo in Period 1 will receive the experimental vaccine in Period 2.
Up to 30000 participants will be enrolled in the study. Participants will be randomly assigned in a 1:1 ratio to receive the experimental vaccine or placebo in the cross ever design in the Study Populations presented below.
Study Population #1: Healthy adults 18-64 years of age
Study Population #2: Healthy elderly adults ≥ 65 years of age
Study Population #3: Adults with significant comorbidities* ≥ 18 years of age
In the UK study population #1 will be the main target.Participation will involve up to 10 visits to the clinic over approximately 26 months. A final telephone contact will occur at the end of the study (Day 386 in Period 2).
The study will be conducted at multiple sites in the United States, Canada, United Kingdom, Europe and Latin America.
REC name
London - Fulham Research Ethics Committee
REC reference
21/HRA/0645
Date of REC Opinion
7 Apr 2021
REC opinion
Further Information Favourable Opinion