Phase 1 Trial of ChAd68 and Ad5 Adenovirus COVID-19 Vaccines Delivered by Aerosol (NCT05094609) | Clinical Trial Compass
CompletedPhase 1
Phase 1 Trial of ChAd68 and Ad5 Adenovirus COVID-19 Vaccines Delivered by Aerosol
Canada36 participantsStarted 2022-01-03
Plain-language summary
This is a phase 1 study in healthy volunteers who have received at least three doses of an mRNA COVID-19 vaccine, to evaluate the safety and immune responses that develop in the blood and lungs following the administration by aerosol of either Ad5-triCoV/Mac or ChAd-triCoV/Mac, new experimental adenovirus-based vaccines expressing SARS-CoV-2 spike, nucleocapsid and RNA polymerase proteins.
Who can participate
Age range18 Years – 65 Years
SexALL
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Inclusion criteria
✓. Healthy human subjects who are between 18 and 65 years of age.
✓. Have completed a COVID vaccine series with at least three doses of a licensed mRNA vaccine at least 3 months prior.
✓. HIV antibody negative.
✓. Able to understand and comply with protocol requirements and instructions; able to attend scheduled study visits and complete required investigations.
✓. For women, negative pregnancy test and for those women of child-bearing potential practising two acceptable forms of contraception for the duration of the study.
✓. For men, using barrier contraception for the duration of the study.
✓. No history of COVID infection OR history of documented COVID infection at least 6 months prior, dated from either a self-reported positive rapid antigen test or positive PCR test (self-reported or documented). For participants with a history of COVID infection, anti-nucleocapsid antibodies will be measured prior to enrolment to confirm infection.
Exclusion criteria
✕. Subjects who have received any recombinant adenoviral-vectored COVID-19 vaccine, e.g. AstraZeneca COVISHIELD COVID-19 vaccine.
✕. Pregnant or lactating women.
✕. Subjects who have any acute or chronic illnesses, any relevant findings on physical examination or are receiving any immunosuppressive therapy in the opinion of the investigator likely to affect the immune system including current use of inhaled or nasal steroids.
What they're measuring
1
Number of participants reporting adverse events and severity of adverse events following Ad5-triCoV/Mac vaccination
Timeframe: Over 48 weeks post vaccination
2
Number of participants reporting adverse events and severity of adverse events following ChAd-triCoV/Mac vaccination
✕. Subjects with a history of any bleeding disorder or receiving any drug treatment that in the opinion of the investigator may increase the risk of bleeding.
✕. Subjects with a history of respiratory diseases requiring regular treatment, e.g. asthma, COPD, interstitial lung diseases, bronchiectasis.
✕. Current cigarette smokers, current e-cigarette smokers and ex-smokers who have quit less than a year ago, as reported by the subject.