COV008: A Phase I study of intranasal ChAdOx1 nCOV-19 (version 1.0) (Covid 19)
Research type
Research Study
Full title
A Phase I study to determine safety, tolerability and immunogenicity of intranasal administration of the COVID vaccine ChAdOx1 nCOV-19 in healthy UK adults
IRAS ID
296376
Contact name
Alexander Douglas
Contact email
Sponsor organisation
University of Oxford / Clinical Trials and Research Governance (CTRG)
Eudract number
2021-001047-27
Clinicaltrials.gov Identifier
Duration of Study in the UK
0 years, 6 months, 0 days
Research summary
COV008 is a phase I study to determine the safety and tolerability of intranasal (IN) administration of the ChAdOx1 nCoV-19 vaccine developed by the University of Oxford. This vaccine is already in use, administed intramuscularly (IM). COV008 will also gather initial data on the immune response induced by IN administration of this vaccine.
IN administration is a simple, needle free method of delivering a vaccine. It stimulates the mucosal immune system in the area where exposure to the virus that causes Covid-19 occurs. It is possible that IN administration of the vaccine will lead to stronger protection against asymptomatic infection and transmission of the virus. These factors make it appealing for use in low-risk groups, and IN administration may have a major impact on slowing the current pandemic.
The trial will recruit 30 healthy adults aged 18 to 40. It will be conducted at a single site in Oxford. The study will last 6 months (4 months for each individual participant), with all participants receiving a single IN dose of the vaccine. 15 participants will receive a second IN dose 4 weeks later.
Safety and tolerability data from self-reporting (collected via a diary) and blood analysis will be collected. Nasal swabs and blood samples will also be taken for analysis of immune responses and viral shedding.
Summary of Results:
This was the first in-human study of intranasal COVID-19 vaccination with an adenovirus-vectored vaccine. Reactogenicity was acceptable at all doses, by immunogenicity was insufficient to warrant further development of the current formulation and device combination.REC name
London - Surrey Borders Research Ethics Committee
REC reference
21/HRA/0699
Date of REC Opinion
18 Mar 2021
REC opinion
Further Information Favourable Opinion