COVID-19 trials registries data warehouse

https://clinicaltrials.gov/show/NCT05343871

Denise Garrett, MD

sabin@sabin.org

2022-04-25

Recruiting

RCT

Randomized

Parallel

Blind label

multi-center

Prevention

inclusion criteria: healthy male or female individuals aged 18 years to 60 years participant is willing and able to give written informed consent for participation in the trial individuals who can comply with trial procedures and are available for the duration of follow-up. brazil: ● previous vaccination with a complete primary series of sinovac (priming group 1), azd1222 (priming group 2), or bnt162b2 (priming group 3-b) at least 6 months prior to screening pakistan: ● previous vaccination with a complete primary series of sinovac (priming group 1) or azd1222 (priming group 2) at least 6 months prior to screening, or pcr-confirmed natural infection (priming group 3-p) between february 2021 - 6 months prior to screening

has a contraindication to bnt162b2, azd1222 or sinovac has received an incomplete primary covid-19 vaccination series has received 3 doses of covid-19 vaccine has received heterologous primary covid-19 vaccination series history of a solid organ or bone marrow transplant history of malignancy (other than non-melanoma skin cancer) within the past five years currently on hemodialysis any confirmed or suspected immunosuppressive or immunodeficiency condition or diagnosis on chronic (>30 days) use of immunosuppressive medications at the time of enrollment (except topical steroids or short-term oral steroids, i.e., ≤14 days) known diagnosis of hiv with cd4 count <200 cells/mm3 (in the past 6 months) active or history of previous auto-immune neurological disorders (e.g., multiple sclerosis, guillain-barre syndrome, transverse myelitis) (excluding bell's palsy) has received anti-cd20 monoclonal antibodies for any reason in the past 12 months has received monoclonal antibodies to treat a previous covid-19 event pregnant at screening positive sars-cov-2 antigen test in respiratory specimen at screening planning to migrate out of the study area within 6 months of the enrollment participants currently enrolled in any other covid-19 vaccine research trial in which they are getting a covid-19 vaccine during the study period illiterate individuals (brazil only) has a severe and/or uncontrolled comorbidity pakistan (natural infection priming group (priming group 3-p)): ● prior vaccination with any vaccine against covid-19

19

Albert B. Sabin Vaccine Institute

18

60

Brazil;Pakistan

Healthy volunteers

N/A

2340

Safety and reactogenicity profile of fractional and full dose of study vaccines at 28 days post-booster vaccination;Sero-response rate by Spike IgG binding ELISA at 28 days post booster

None

Phase 4

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