A Study to Determine Safety and Immunogenicity of the Candidate COVID-19 Vaccine AZD1222 Delivered by Aerosol in Healthy Adult Volunteers
COVAXAER01
A Phase I Study to Determine Safety and Immunogenicity of the Candidate COVID-19 Vaccine AZD1222 Delivered by Aerosol in Healthy Adult Volunteers
1 other identifier
interventional
28
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_1 covid19
Started Oct 2021
Longer than P75 for phase_1 covid19
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 12, 2021
CompletedFirst Posted
Study publicly available on registry
August 16, 2021
CompletedStudy Start
First participant enrolled
October 10, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2024
CompletedSeptember 6, 2023
September 1, 2023
2.6 years
August 12, 2021
September 5, 2023
Conditions
Keywords
Outcome Measures
Primary Outcomes (6)
To assess the safety, tolerability and reactogenicity profile of the candidate vaccine AZD1222 delivered by aerosol
Occurrence of solicited local reactogenicity signs and symptoms for 7 days following vaccination, measured with self-reported symptoms recorded using vaccination diaries.
Day 0-7
To assess the safety, tolerability and reactogenicity profile of the candidate vaccine AZD1222 delivered by aerosol
Occurrence of solicited systemic reactogenicity signs and symptoms for 7 days following vaccination, measured with self-reported symptoms recorded using vaccination diaries.
Day 0-7
To assess the safety, tolerability and reactogenicity profile of the candidate vaccine AZD1222 delivered by aerosol
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.
Day 0-28
To assess the safety, tolerability and reactogenicity profile of the candidate vaccine AZD1222 delivered by aerosol
Change from baseline for safety laboratory measures, determined by blood samples drawn at enrolment (before vaccination), Day 3, 7 and 28.
Screening to Day 28
To assess the safety, tolerability and reactogenicity profile of the candidate vaccine AZD1222 delivered by aerosol
Occurence of SAEs reported throughout the study.
Screening to Day 364
To assess the safety, tolerability and reactogenicity profile of the candidate vaccine AZD1222 delivered by aerosol
Occurence of SAEs of special interest reported throughout the study.
Screening to Day 364
Secondary Outcomes (2)
To assess cellular and humoral immunogenicity of AZD1222
Screening to Day 364
To assess cellular and humoral immunogenicity of AZD1222
Screening to Day 364
Other Outcomes (6)
To explore the immunology of participants
Screening to Day 364
To explore the immunology of participants
Screening to Day 364
To explore the immunology of participants
Screening to Day 364
- +3 more other outcomes
Study Arms (1)
Single arm, dose escalation
EXPERIMENTALExperimental: Healthy Volunteers Biological/Vaccine: AZD1222 (1x10\^9 vp, 5x10\^9 vp and 1x10\^10 vp)
Interventions
Eligibility Criteria
You may qualify if:
- Healthy adults aged 30-55 years.
- Able and willing (in the Investigator's opinion) to comply with all study requirements.
- Willing to allow the investigators to discuss the volunteer's medical history with their General Practitioner and access all medical records when relevant to study procedures.
- For females only, willingness to practice continuous highly effective contraception (see below) during the study and a negative pregnancy test on the day(s) of screening, bronchoscopy and vaccination.
- Agreement to refrain from blood donation during the course of the study.
- Provide written informed consent.
- Have had a complete COVID-19 vaccination course (as one or two intramuscular injections depending on the authorisation schedule) with the last injection at least 30 days before enrolment
- Sero-suitable i.e. with evidence of SARS-CoV-2 vaccine-induced antibody responses but no evidence of previous SARS-CoV-2 infection by an authorised serology test. Those with indeterminate levels and no history of laboratory-confirmed SARS-CoV-2 infection may be included or excluded at the PI's discretion on a case-by-case basis.
You may not qualify if:
- History of laboratory-confirmed SARS-CoV-2 infection.
- Acute upper respiratory infection (URI or sinusitis) in the past 6 weeks
- Prior receipt of any vaccine within ≤30 days prior to enrolment or planned receipt of any vaccine within 30 days after the study vaccination
- Administration of immunoglobulins and/or any blood products within the three months preceding the planned administration of the vaccine candidate.
- Inhaled bronchodilator or steroid use within the last 12 months
- Intranasal steroid use within the last 6 months
- Any confirmed or suspected immunosuppressive or immunodeficient state, including HIV infection; asplenia; recurrent severe infections and use of immunosuppressant medication within the past 6 months, except topical steroids.
- Any autoimmune conditions, except mild psoriasis, well-controlled autoimmune thyroid disease, vitiligo or stable coeliac disease not requiring immunosuppressive or immunomodulatory therapy.
- History of allergic disease or reactions likely to be exacerbated by any component of the AZD1222 vaccine.
- Any history of angioedema.
- Any history of anaphylaxis.
- Pregnancy, lactation or willingness/intention to become pregnant during the study.
- History of cancer (except basal cell carcinoma of the skin and cervical carcinoma in situ).
- History of serious psychiatric condition likely to affect participation in the study (e.g. ongoing severe depression, history of admission to an in-patient psychiatric facility, recent suicidal ideation, history of suicide attempt, bipolar disorder, personality disorder, alcohol and drug dependency, severe eating disorder, psychosis, use of mood stabilisers or antipsychotic medication).
- Bleeding disorder (e.g. factor deficiency, coagulopathy or platelet disorder), or prior history of significant bleeding or bruising following IM injections or venepuncture.
- +13 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Imperial College Londonlead
- University of Oxfordcollaborator
- AstraZenecacollaborator
Study Sites (1)
Imperial College London
London, United Kingdom
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Chris Chiu, PhD
Imperial College London
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NA
- Masking
- NONE
- Purpose
- PREVENTION
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 12, 2021
First Posted
August 16, 2021
Study Start
October 10, 2021
Primary Completion
June 1, 2024
Study Completion
June 1, 2024
Last Updated
September 6, 2023
Record last verified: 2023-09
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, CSR
- Time Frame
- Data will become available approximately 6 months from the last patient's last visit and remain available indefinitely.
- Access Criteria
- According to study protocol.
The expectation is that after analysis the data from this study will be widely distributed in the medical and scientific community. Facilitated with presentations at local, national and international meetings, the hope is to publish widely in the medical literature. In addition, there is an excellent media department at Imperial College that will publicise research that has public interest when it is published. The Investigators will be involved in reviewing drafts of the manuscripts, abstracts, press releases and any other publications arising from the study. Data from the study may also be used as part of a thesis for a PhD or MD. All data will be anonymised and aggregated or pseudonymised; no identifying participant information will be published.