COVID-19 trials registries data warehouse

https://pactr.samrc.ac.za/TrialDisplay.aspx?TrialID=12166

Theranne van Vuren

theranne.vanvuren@wits-vida.org

2020-06-22

Not recruiting

RCT

Randomized

Parallel

Blind label

multi-center

Prevention

Healthy adults aged 18-65 years. Documented result of not being infected with HIV (including screening by a rapid HIV antibody test) within two weeks of randomization into the study for Group-1 and Group-2 participants only. Able and willing (in the Investigator’s opinion) to comply with all study requirements. Willing to allow investigators review available medical records, and review all medical and laboratory records if participant is admitted to hospital with respiratory tract infection suspected or confirmed to be COVID-19. For females only, willingness to practice continuous effective contraception during the study and a negative pregnancy test on the day(s) of screening (within 14 days of randomization) or vaccination. For Group-3 only (i.e. HIV-infected), need to have been on anti-retroviral treatment for at least three months and HIV-1 viral load is <1,000 copies/ml within two weeks of randomization. Agreement to refrain from blood donation during the course of the study. Provide written informed consent.

Planned receipt of any vaccine other (licensed or investigational) than the study intervention within 30 days before and after each study vaccination. • Use of any unproven registered and unregistered treatments for COVID-19. • Prior receipt of an investigational or licensed vaccine likely to impact on interpretation of the trial data (e.g. Adenovirus vectored vaccines, any coronavirus vaccines). • Administration of immunoglobulins and/ or any blood products within the three months preceding the planned administration of the vaccine candidate. • HBSAg positivity on the screening sample. • Grade 2 or higher level of abnormality for FBC, U&E or LFT based on DAIDS Grading Criteria (Version 2.1, July 2017) • History of allergic disease or reactions likely to be exacerbated by any component of the ChAdOx1 nCoV-19 vaccine. • Any history of hereditary angioedema or idiopathic angioedema. • Any history of anaphylaxis in relation to vaccination. • 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. Bleeding disorder (e.g. factor deficiency, coagulopathy or platelet disorder), or prior history of significant bleeding or bruising following IM injections or venipuncture. • Any other serious chronic illness requiring hospital specialist supervision. • Chronic respiratory diseases, including asthma • Chronic cardiovascular disease, gastrointestinal disease, liver disease, renal disease, endocrine disorder and neurological illness • Seriously overweight (BMI = 40 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 enrollment. • Any clinically significant abnormal finding on screening urinalysis. • Any other significant disease

5

University of Oxford

18

65

South Africa

Healthy volunteers

N/A

2000

To assess the safety; tolerability and reactogenicity profile of the candidate vaccine ChAdOx1 nCoV;To assess efficacy of the candidate ChAdOx1 nCoV-19 against severe and non-severe COVID-19;To assess the safety; tolerability and reactogenicity profile of the candidate vaccine ChAdOx1 nCoV in people living with HIV;To assess cellular and humoral immunogenicity of ChAdOx1 nCoV-19 in people living with HIV after one and two doses of vaccine

| Declared number of arm (8.0) differs from found arms (9.0)

Phase 1

[{"arm_notes": "1 or 2;28 days apart", "treatment_id": 161, "treatment_name": "Chadox1 ncov-19", "treatment_type": "Non replicating viral vector", "pharmacological_treatment": "Vaccine"}, {"arm_notes": "1 or 2;28 days apart", "treatment_id": 161, "treatment_name": "Chadox1 ncov-19", "treatment_type": "Non replicating viral vector", "pharmacological_treatment": "Vaccine"}, {"arm_notes": "1 or 2;28 days apart", "treatment_id": 161, "treatment_name": "Chadox1 ncov-19", "treatment_type": "Non replicating viral vector", "pharmacological_treatment": "Vaccine"}, {"arm_notes": "1 or 2;28 days apart", "treatment_id": 161, "treatment_name": "Chadox1 ncov-19", "treatment_type": "Non replicating viral vector", "pharmacological_treatment": "Vaccine"}, {"arm_notes": "1 or 2", "treatment_id": 2187, "treatment_name": "Placebo", "treatment_type": "Placebo", "pharmacological_treatment": "Placebo"}]