COVID-19 trials registries data warehouse

https://clinicaltrials.gov/show/NCT04444674

Shabir A Madhi, MD, PhD

Clare L Cutland, cutlandc@rmpru.co.za (PI email not reported)

2020-06-23

Unknown

RCT

Randomized

Parallel

Blind label

multi-center

Prevention

inclusion criteria: - 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 (see below) 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, disorder or finding which may significantly increase the risk to the participant because of participation in the study, affect the ability of the participant to participate in the study or impair interpretation of the study data. history of laboratory confirmed covid-19 illness or known contact with a person that was infected with sars-cov-2. new onset of fever or a cough or shortness of breath in the 30 days preceding screening and/or enrollment travel history to any other country with widespread epidemic since january 2020 in addition to above, group 1 & 2 participants need to fulfill the following

5

University of Oxford

18

65

South Africa

Healthy volunteers

N/A

2130

Assess humoral immunogenicity of ChAdOx1 nCoV-19 in people living with HIV;Assess the incidence of adverse events (intervention-related and intervention-unrelated) in HIV-negative adults aged 18-65 year receiving candidate ChAdOx1 nCoV-19 vaccine or placebo (safety);Assess cellular Immunogenicity of ChAdOx1 nCoV-19 in people living with HIV (immunogenicity);Determine if there is a reduction of severe and non-severe COVID-19 disease in HIV-negative adults who receive candidate vaccine ChAdOx1 nCoV-19 compared to placebo recipients (efficacy);Assess the incidence of adverse events (intervention-related and intervention-unrelated) in HIV-positive adults aged 18-65 year receiving candidate ChAdOx1 nCoV-19 vaccine or placebo (safety)

None

Phase 1/Phase 2

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