Study of SARS-CoV-2 boost vaccines in patients with B-cell deficiency
Research type
Research Study
Full title
A Phase 1, Open-Label, Parallel-Group Study to Evaluate the Safety, Immunogenicity, and Reactogenicity of Heterologous and Homologous Chimpanzee Adenovirus and Self-Amplifying mRNA Prime-Boost Prophylactic Vaccines Against SARS-CoV-2 in B-Cell Deficient Patients
IRAS ID
304379
Contact name
Amy Walia
Contact email
Sponsor organisation
Gritstone bio, Inc
Eudract number
2021-004179-14
Duration of Study in the UK
1 years, 2 months, 0 days
Research summary
Research Summary
The ongoing outbreak of COVID-19 is caused by a novel coronavirus, severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), that can cause serious respiratory infections.SARS-CoV-2 (COVID-19) has a high age-related mortality rate and has rapidly spread worldwide with over 212 million cases of infection and over 4.4 million deaths reported as of August 2021.
While the currently authorised vaccines have demonstrated a high degree of efficacy against common strains of SARS-CoV-2 in the UK healthy population, there are populations who remain at risk given pre-existing conditions that limit their ability to mount a sufficient immune response after vaccination. This includes patients who have B-cell deficiencies as a result of underlying health conditions and treatments.
GRT-C909 (adenovirus-based vaccine) and GRT-R910 (self-amplifying mRNA vaccine) are investigational products being developed by Gritstone bio as SARS-CoV-2 vaccine boosts.
The purpose of the study is to assess the safety and tolerability of two doses of an experimental COVID-19 vaccine (GRT-C909 and GRT-R910) when administered as a boost 2 months apart in volunteers over the age of 18 whose immune system has been weakened with a diagnosis of B-cell deficiency as a result of treatment for an underlying disease such as Multiple Sclerosis, Chronic Lymphocytic Leukaemia, Waldenstrom’s Disease, or Follicular Lymphoma.
Up to 30 males and females who have previously received 2 or 3 doses of an mRNA COVID-19 vaccine at least 2 months prior to study entry, will be enrolled in the United Kingdom and will be followed-up for 12 months after receiving their last study vaccine as an injection into the upper arm muscle.
Summary of Results
No patients were screened or treated in this clinical study. Hence there is no summary of results.REC name
South Central - Oxford A Research Ethics Committee
REC reference
21/SC/0401
Date of REC Opinion
18 Jan 2022
REC opinion
Further Information Favourable Opinion