Trial Details

Not Recruiting
Basic Information
Clinical ID c2381
Identifier ISRCTN15354495
Trial Title A Phase III, multicentre, randomised trial comparing SARS-CoV-2 re-boost vaccine strategies in immunocompromised patients
Trial URL Visit Original Page
Study Information
Study Results

Yes

Conditions Patients with 1) solid cancer; 2) lymphoid malignancies; 3) immune-mediated rheumatic diseases; 4) end stage kidney disease; 5) liver disease; 6) inflammatory bowel disease on immune suppressive therapy; 7) haematopoietic stem cell transplant; and 8) primary immunodeficiency who have received two doses of SARS-CoV-2 vaccine but have proven inadequate response to the SARS-CoV-2 vaccine Infections and Infestations COVID-19 (SARS-CoV-2 infection)
Interventions For the main study randomised comparison, patients will randomised using a minimisation program (developed by the CRCTU) in a 1:1 ratio. Patients will be randomised to receive: Arm 1: Pfizer SARS-CoV2 Vaccine Arm 2: Moderna SARS-CoV2 Vaccine For the sub-study randomised comparison, patients will be randomised using a minimisation program in a 1:1:1 ratio. Patients will be randomised to receive: Arm 1: Pfizer SARS-CoV2 Vaccine Arm 2: Moderna SARS-CoV2 Vaccine Arm 3: Novavax SARS-CoV2 Vaccine The dose of Pfizer vaccine is 30 mg contained in 0.3 ml of the diluted vaccine given intramuscularly. The dose of Moderna vaccine is 0.5 ml, containing 100 micrograms of messenger RNA (mRNA), given intramuscularly. The dose of Novovax vaccine is 5 mg recombinant spike protein with 50 mg Matrix-M1 adjuvant (0.5 ml). A dose of 5 mg recombinant spike protein with 50 mg Matrix-M1 adjuvant (0.5 ml) will be given intramuscularly. Where possible participants will be followed up in accordance with standard clinical practice for the relevant disease cohort and data will be collected retrospectively from clinic records 3 months after re-boost vaccination. Where participants do not attend for a routine clinic visit, data may be collected following an additional telephone follow-up call.
Participant Information
Sponsor University of Birmingham
City -
Country/Region United Kingdom
Enrollment Criteria
Sex Requirement ALL
Age Requirement -
Study Design
Study Type Interventional
Phase PHASE3
Time Information
Start Date 2025-04-24
Primary Completion Date -
Completion Date 2024-08-20