Covid19Phase 1COVAXAER01NCT05007275

A Study to Determine Safety and Immunogenicity of the Candidate COVID-19 Vaccine AZD1222 Delivered by Aerosol in Healthy Adult Volunteers

A Phase 1 study testing 1x10^9 vp AZD1222, 5x10^9 vp AZD1222 and 1x10^10 vp AZD1222 in people with Covid19 and SARS-CoV-2 Infection, run by Imperial College London at 1 site in United Kingdom.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record

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Trial summary

Who is it for?: Ages 30 to 55 yearsHealthy volunteers can take part
Conditions the study is for: Covid19, SARS-CoV-2 Infection
What is being tested?: 1x10^9 vp AZD1222, 5x10^9 vp AZD1222 and 1x10^10 vp AZD1222
Type of treatment: Vaccines
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 28 participants
Where: 1 siteUnited Kingdom
Study dates: 10 Oct 2021to Jun 2024
Phase: Phase 1
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 30 to 55 years
All sexes
Healthy volunteers accepted
Adult

Who may be able to join

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.

Who cannot join

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

Show all 28Show fewer

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.
History of frequent nose bleeds
Any other serious chronic illness requiring hospital specialist supervision.
Chronic respiratory diseases, including mild asthma (resolved childhood asthma is allowed)
Smoking (includes any inhaled product, such as cigarettes and vapes) in the past 6 months OR >5 pack-year lifetime history.
Chronic cardiovascular disease (including hypertension), gastrointestinal disease, liver disease (except Gilberts Syndrome), renal disease, endocrine disorder (including diabetes) and neurological illness (excluding migraine)
Seriously overweight (BMI≥40 Kg/m2) or underweight (BMI≤18 Kg/m2)
Suspected or known current alcohol abuse as defined by an alcohol intake of greater than 42 units every week.
Suspected or known injecting drug abuse in the 5 years preceding enrolment.
Use of any medication or other product (prescription or over-the-counter) for symptoms of rhinitis or nasal congestion within the last 3 months
Any clinically significant abnormal finding on screening biochemistry or haematology blood tests. Grade 1 abnormalities are permissible at investigator discretion.
Clinically relevant abnormality on chest X-ray
Any other significant disease, disorder or finding which may significantly increase the risk to the volunteer because of participation in the study, affect the ability of the volunteer to participate in the study or impair interpretation of the study data.
A history of cerebral venous sinus thrombosis, heparin-induced thrombocytopenia or antiphospholipid syndrome or vaccine-induced thrombosis with thrombocytopenia

Trial locations and contacts

1 site in 1 country.

United Kingdom1 site

Imperial College London
London

Other trials in United Kingdom

About this study

Official title: A Phase I Study to Determine Safety and Immunogenicity of the Candidate COVID-19 Vaccine AZD1222 Delivered by Aerosol in Healthy Adult Volunteers

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.

Read the detailed description

This is a Phase I, open label non-randomised dose escalation study in healthy adults aged 30-55 years recruited in the UK. AZD1222 will be administered by inhalation via vibrating mesh nebuliser. The study will assess safety and immunogenicity of AZD1222 with blood and respiratory tract samples. The dose evaluation will be conducted in a single centre supervised by the Chief Investigator and senior clinician experienced in first-in human studies in a cohort of 30 individuals. Approximately 14 days before vaccination, participants will undergo bronchoscopy to sample their lower airways, obtaining bronchoalveolar lavage (BAL), bronchial lining fluid and bronchial tissue. This will be repeated at day +21 and day +182 post-vaccination.

The dose escalation cohort will proceed through low (1x10^9), medium (5x10^9) and high (1x10^10 vp) dose as follows: The first participant will receive the low dose and be invited to enter information on local and systemic reactions into a diary that evening and daily thereafter for 6 days. At 48 hours post-vaccination, the team will call the first participant and go through their diary. If the reactions are Grade 1-2 or transient Grade 3 that resolved within 24 hours, two further participants will receive the same dose. At 48 hours post-vaccination, the team will call participants 2 and 3 to go through their diaries.

Provided there are no safety concerns, the fourth participant can proceed to receive the medium dose. The steps above will be repeated in order to escalate to the highest dose (1x 10^10 vp). Provided there are no safety concerns outlined, a further 6 participants will be vaccinated at the maximum tolerated dose - a total of 9 individuals vaccinated with the maximum tolerated dose. The DSMB chair will review safety data before each dose escalation and the full DSMB will periodically assess safety data every 4-8 weeks and/or as required.

Conditions: Covid19, SARS-CoV-2 Infection
Being tested: 1x10^9 vp AZD1222, 5x10^9 vp AZD1222, 1x10^10 vp AZD1222
Keywords: Vaccine, Vaccination, COVID-19, SARS-CoV-2, Pandemic, Immune system, Immune response
Medical subject headings: COVID-19

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

1x10^9 vp AZD1222Biological
A single dose of 1x 10^9 vp AZD1222
5x10^9 vp AZD1222Biological
A single dose of 5x 10^9 vp AZD1222
1x10^10 vp AZD1222Biological
A single dose of 1x10^10 vp AZD1222

Study groups in NCT05007275
Study group	Role	What they receive
Single arm, dose escalation	Experimental	Experimental: Healthy Volunteers Biological/Vaccine: AZD1222 (1x10^9 vp, 5x10^9 vp and 1x10^10 vp) Receives: Biological: 1x10^9 vp AZD1222; Biological: 5x10^9 vp AZD1222; Biological: 1x10^10 vp AZD1222

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Screening to Day 364

Secondary outcomes (2)

To assess cellular and humoral immunogenicity of AZD1222
Interferon-gamma (IFN-y) enzyme-linked immunospot (ELISpot) responses to SARS-CoV-2 spike protein in blood
Measured: Screening to Day 364
To assess cellular and humoral immunogenicity of AZD1222
Quantify antibodies against SARS-CoV-2 spike protein (seroconversion rates) in blood
Measured: Screening to Day 364

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

10 Oct 2021Jun 2024

First posted16 Aug 2021
Study start10 Oct 2021
Primary completionJun 2024 (estimated)
Study completionJun 2024 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Covid19Studies of the same condition, open and under way.
More trials run by Imperial College LondonThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 1
Primary purpose: Prevention
Allocation: Not applicable
Intervention model: Single group
Model description: This is a Phase I, open label non-randomised dose escalation study in healthy adults aged 30-55 years recruited in the UK. AZD1222 will be administered by inhalation via vibrating mesh nebuliser. The study will assess safety and immunogenicity of AZD1222 with blood and respiratory tract samples. The dose evaluation will be conducted in a single centre supervised by the Chief Investigator and senior clinician experienced in first-in human studies in a cohort of 30 individuals. Approximately 14 days before vaccination, participants will undergo bronchoscopy to sample their lower airways, obtaining bronchoalveolar lavage (BAL), bronchial lining fluid and bronchial tissue. This will be repeated at day +21 and day +182 post-vaccination.
Masking: None (open label)
Enrolment: 28 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05007275
Sponsor's protocol ID: 20HH6296
Acronym: COVAXAER01
Status last verified: Sep 2023
First submitted: 12 Aug 2021
Last updated: 6 Sep 2023
Results posted: No
Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: Yes: 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.

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 6 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Phase I Study to Determine Safety and Immunogenicity of the Candidate COVID-19 Vaccine AZD1222 Delivered by Aerosol in Healthy Adult Volunteers
ClinicalTrials.gov ID: NCT05007275
Acronym / sponsor ID: COVAXAER01 / 20HH6296
Conditions: Covid19, SARS-CoV-2 Infection
Keywords: Vaccine, Vaccination, COVID-19, SARS-CoV-2, Pandemic, Immune system, Immune response
Phase: Phase 1
Study type: Interventional
Recruitment status: Unknown status
Enrolment: 28 participants (actual)
Lead sponsor: Imperial College LondonUniversity, hospital or other
Collaborators: University of Oxford, AstraZeneca
Study start: 10 Oct 2021 (actual)
Primary completion: Jun 2024 (estimated)
Study completion: Jun 2024 (estimated)
First posted: 16 Aug 2021 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Prevention
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1
Model description: This is a Phase I, open label non-randomised dose escalation study in healthy adults aged 30-55 years recruited in the UK. AZD1222 will be administered by inhalation via vibrating mesh nebuliser. The study will assess safety and immunogenicity of AZD1222 with blood and respiratory tract samples. The dose evaluation will be conducted in a single centre supervised by the Chief Investigator and senior clinician experienced in first-in human studies in a cohort of 30 individuals. Approximately 14 days before vaccination, participants will undergo bronchoscopy to sample their lower airways, obtaining bronchoalveolar lavage (BAL), bronchial lining fluid and bronchial tissue. This will be repeated at day +21 and day +182 post-vaccination.

Arm	Type	Receives
Single arm, dose escalation	Experimental	Biological: 1x10^9 vp AZD1222, Biological: 5x10^9 vp AZD1222, Biological: 1x10^10 vp AZD1222Experimental: Healthy Volunteers Biological/Vaccine: AZD1222 (1x10^9 vp, 5x10^9 vp and 1x10^10 vp)

Who may qualify

Ages: 30 to 55 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult

Key inclusion criteria (8 listed)

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.

Key exclusion criteria (28 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
1x10^9 vp AZD1222A single dose of 1x 10^9 vp AZD1222	Biological	Single arm, dose escalation
5x10^9 vp AZD1222A single dose of 5x 10^9 vp AZD1222	Biological	Single arm, dose escalation
1x10^10 vp AZD1222A single dose of 1x10^10 vp AZD1222	Biological	Single arm, dose escalation

Primary outcome

To assess the safety, tolerability and reactogenicity profile of the candidate vaccine AZD1222 delivered by aerosol
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: Screening to Day 364
Occurence of SAEs of special interest reported throughout the study.

2 secondary outcomes

To assess cellular and humoral immunogenicity of AZD1222
Time frame: Screening to Day 364
To assess cellular and humoral immunogenicity of AZD1222
Time frame: Screening to Day 364

Results and safety

Results are not available in the source record.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 6 Sep 2023.
Individual participant dataSharing planned: Yes. 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.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Chris Chiu, PhD principal investigator

Imperial College London

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing 1x10^9 vp AZD1222, 5x10^9 vp AZD1222 and 1x10^10 vp AZD1222 in people with Covid19 and SARS-CoV-2 Infection, run by Imperial College London at 1 site in United Kingdom.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 8 inclusion and 28 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 6 Sep 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

To assess the safety, tolerability and reactogenicity profile of the candidate vaccine AZD1222 delivered by aerosol (time frame: Day 0-7). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05007275.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Sep 2023.