OCTAVE-DUO [COVID-19]
Research type
Research Study
Full title
A Phase III, Multicentre, Randomised Trial Comparing SARS-CoV-2 Re-Boost Vaccine Strategies in Immunocompromised Patients
IRAS ID
302634
Contact name
Iain McInnes
Contact email
Sponsor organisation
University of Birmingham
Eudract number
2021-003632-87
ISRCTN Number
ISRCTN15354495
Clinicaltrials.gov Identifier
MX3010, CRCTU Ref No.
Duration of Study in the UK
1 years, 8 months, 0 days
Research summary
More than 32 million people in the UK have received 2 doses of COVID-19 vaccine. Research shows that this prevents infection in up to 90% of people. However, these vaccines were tested in healthy people. Recent research in individuals with chronic health problems or cancer, suggest that 30% are generating low levels of antibody or T-cells (a type of white blood cell that fight infection) after 2 doses of the Pfizer or AstraZeneca COVID-19 vaccines. This raises the question of the potential benefit of a third dose (re-boost) of vaccine in these vulnerable patients. A re-boost strategy has been successfully used for other vaccines but the limited research performed to date for COVID-19 has given variable results, so additional research is needed.
OCTAVE-DUO is a prospective, multicentre, multi-disease, randomised trial to determine whether a re-boost vaccine strategy can induce an immune response in clinically vulnerable patients who have not produced an adequate antibody response after 2 doses of COVID-19 vaccine. The trial will investigate this in a number of diseases: 1) breast or lung cancer; 2) certain types of blood cancer; 3) immune-mediated rheumatic diseases (e.g. rheumatoid arthritis); 4) chronic kidney disease; 5) chronic liver disease; 6) inflammatory bowel disease on immune suppressive therapy; 7) stem cell transplant; and 8) primary immunodeficiency (a group of disorders characterized by poor or absent immune function).
Consenting patients (1200) will be randomly allocated to receive: an additional dose of Pfizer or Moderna COVID-19 vaccine - the main study; or, for a sub-set of patients with blood cancer, Pfizer or Moderna or Novavax vaccine – sub-study randomisation.
Blood samples will be collected before and 21 days after the re-boost vaccine and the level of antibodies and T-cells determined. Patients will be followed-up for 3 months to see if they go on to catch COVID-19.
REC name
London - Fulham Research Ethics Committee
REC reference
21/HRA/3072
Date of REC Opinion
22 Jul 2021
REC opinion
Further Information Favourable Opinion