COVID-19 trials registries data warehouse

https://clinicaltrials.gov/show/NCT05231005

Gili Regev-Yocha

Not reported

2022-02-09

Not recruiting

nonRCT

Non-randomized

Parallel

Open label

single-center

Prevention

inclusion criteria: age: volunteer must be at least 18 years of age, at the time of signing the informed conset. sex: male or female. all female volunteers of reproductive age will be requested to use contraceptive measures for the two months following enrolment. received 3 doses of bnt162b2 with the 3rd dose at least 4 months previously. have a serology test within the previous 3 months of 700 bau or less. responded to the previous vaccine doses, i.e. at least one igg>100. medical conditions: volunteers with any medical condition are allowed, as long as they adhere to the criteria above. agreed to attend all visits and signed the informed consent -

- 1. had previous sars-cov-2 infection (detected by either pcr, anti-s igg before the 1st vaccine dose, anti-n igg at any stage). 2. had an allergic response to any of the previous bnt162b2 doses. 3. has history of myopericarditis. 4. report that they do not feel well or have a fever on the day of vaccination. 5. pregnant on day of recruitment.

2

Sheba Medical Center

18

100

Israel

Health workers

N/A

1000

Geometric mean of antibody titers of each arm, on each time point;Solicited and unsolicited adverse events

None

Phase 4

[{"arm_notes": "", "treatment_id": 222, "treatment_name": "Bnt162b2", "treatment_type": "Rna based vaccine", "pharmacological_treatment": "Vaccine"}, {"arm_notes": "", "treatment_id": 2188, "treatment_name": "Standard of care", "treatment_type": "Standard of care", "pharmacological_treatment": "Standard of care"}]