COVID-19 trials registries data warehouse

https://pactr.samrc.ac.za/TrialDisplay.aspx?TrialID=10988

Marianne Munene

MMunene@kemri-wellcome.org

2020-04-26

Recruiting

RCT

Randomized

Parallel

Blind label

single-center

Prevention

• Frontline Staff as defined by the Government of Kenya (including healthcare workers, allied health professionals, truckers, security personnel, banking personnel, supermarket staff, police, security personnel, prison workers, laboratory technicians, scientists, logistics personnel, public transport workers including aviation industry amongst others) and other members of public. • Healthy adults aged 18-55 years for phase Ib, =18 years for phase II. • Able and willing (in the Investigators’ opinion) to comply with all study requirements, including making visits to KEMRI CGMRC or other designated study health facility for follow up under conditions with limited transport. • Agreement to refrain from blood donation during the course of the study • Use of effective method of contraception for duration of study for female participants. They should use effective contraception for 30 days prior to vaccination. For female participants, we will ask them to attend with their family planning records for verification. Effective contraception is defined as a contraceptive method with failure rate of less than 1% per year when used consistently and correctly, in accordance with the product label. Examples of these include: combined oral contraceptives, injectable progestogen, implants of etenogestrel or levonorgestrel, intrauterine device or intrauterine system, male partner sterilisation at least 6 months prior to the female subject’s entry into the study, and the relationship is monogamous, male condom combined with a vaginal spermicide (foam, gel, film, cream or suppository), and male condom combined with a female diaphragm, either with or without a vaginal spermicide (foam, gel, film, cream, or suppository). • Provide written informed consent. • Plan to remain resident in the study area for 1 year following vaccination

• Prior receipt of any vaccines (licensed or investigational) =30 days before enrolment • Volunteer who is not literate. • Planned receipt of any vaccine other than the study intervention within 30 days before or after study vaccination. • 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). • Planned or ongoing participation in any other interventional studies (of licensed or investigational products) =30 days before enrolment and for the duration of the study. • Administration of immunoglobulins and/or any blood products within the three months preceding the planned administration of the vaccine candidate. • Any confirmed or suspected immunosuppressive or immunodeficient state, including HIV infection, asplenia, recurrent severe infections and chronic use (more than 14 days) immunosuppressant medication within the past 6 months (inhaled and topical steroids are allowed). • History of allergic disease or reactions likely to be exacerbated by any component of the vaccine. • Any history of hereditary or idiopathic angioedema. • 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 venepuncture. • Any other serious chronic illness requiring hospital specialist supervision. • Suspected or known current alcohol abuse as defined by an alcohol intake of greater than 42 units every week (e.g. more than 2 bottles of 500mls Tusker (beer) a day, more than 2 large glasses of 12% wine per day)

2

University of Oxford

19

44

Kenya

Healthy volunteers

N/A

400

A. To assess the safety; tolerability and reactogenicity profile of the candidate vaccine ChAdOx1nCoV-19 1. Occurrence of serious adverse events (SAEs) throughout the study duration2. Occurrence of solicited local and systemic reactogenicity signs and symptoms for 7 days following vaccination3. Occurrence of unsolicited adverse events (AEs) at all scheduled visits;4. Change from baseline for safety laboratory measures and; 5. Occurrence of SAE of special interest: disease enhancement episodesB. To assess immunogenicity of ChAdOx1 nCoV-191. ELISA to quantify IgG antibodies against SARSCoV-2 spike protein (seroconversion rates)

| Declared number of arm (2.0) differs from found arms (3.0)

Phase 1

[{"arm_notes": "1", "treatment_id": 1054, "treatment_name": "Rabies vaccine", "treatment_type": "Non covid vaccine", "pharmacological_treatment": "Non covid vaccine"}, {"arm_notes": "1", "treatment_id": 161, "treatment_name": "Chadox1 ncov-19", "treatment_type": "Non replicating viral vector", "pharmacological_treatment": "Vaccine"}]