Last reviewed · How we verify
A Phase I Study to Determine Safety and Immunogenicity of the Candidate COVID-19 Vaccine AZD1222 Delivered by Aerosol in Healthy Adult Volunteers (COVAXAER01)
This study will test the COVID-19 vaccine candidate AZD1222 to investigate its safety, tolerability and capability of boosting immune responses both in the blood and the lung when administered to the respiratory tract, in volunteers previously vaccinated by intramuscular COVID-19 vaccination. Using standardised methods, we will measure immune responses in the blood, nose and lower airway and compare with data from ongoing clinical trials of intramuscular vaccination. Thus, we will show the effect of the delivery method and provide the critical information required to begin further clinical trials to show the efficacy of this needle-free vaccination strategy for booster vaccination.
Details
| Lead sponsor | Imperial College London |
|---|---|
| Phase | Phase 1 |
| Status | UNKNOWN |
| Enrolment | 28 |
| Start date | 2021-10-10 |
| Completion | 2024-06 |
Conditions
- Covid19
- SARS-CoV-2 Infection
Interventions
- 1x10^9 vp AZD1222
- 5x10^9 vp AZD1222
- 1x10^10 vp AZD1222
Primary outcomes
- To assess the safety, tolerability and reactogenicity profile of the candidate vaccine AZD1222 delivered by aerosol — Day 0-7
Occurrence of solicited local reactogenicity signs and symptoms for 7 days following vaccination, measured with self-reported symptoms recorded using vaccination diaries. - To assess the safety, tolerability and reactogenicity profile of the candidate vaccine AZD1222 delivered by aerosol — Day 0-7
Occurrence of solicited systemic reactogenicity signs and symptoms for 7 days following vaccination, measured with self-reported symptoms recorded using vaccination diaries. - To assess the safety, tolerability and reactogenicity profile of the candidate vaccine AZD1222 delivered by aerosol — Day 0-28
Occurrence of unsolicited adverse events (AEs) for 28 days following vaccination, measured with self-reported symptoms recorded using vaccination diaries and/or AEs reported post 7 days recorded in CRFs by study team. - To assess the safety, tolerability and reactogenicity profile of the candidate vaccine AZD1222 delivered by aerosol — Screening to Day 28
Change from baseline for safety laboratory measures, determined by blood samples drawn at enrolment (before vaccination), Day 3, 7 and 28. - To assess the safety, tolerability and reactogenicity profile of the candidate vaccine AZD1222 delivered by aerosol — Screening to Day 364
Occurence of SAEs reported throughout the study. - To assess the safety, tolerability and reactogenicity profile of the candidate vaccine AZD1222 delivered by aerosol — Screening to Day 364
Occurence of SAEs of special interest reported throughout the study.
Countries
United Kingdom