COVID-19 trials registries data warehouse

https://clinicaltrials.gov/show/NCT05736913

Ivan FN Hung, MD

ivanhung@hku.hk

2023-02-21

Recruiting

RCT

Randomized

Parallel

Open label

single-center

Prevention

inclusion criteria: recruited subjects include adult subjects ≥18 years immunocompromised subjects as defined by the following. patients who have undergone solid organ or stem cell transplantation and on immunosuppressive medication. patients who are on chemotherapy, biologics or other immunosuppressive therapy. patients who are on high-dose corticosteroid (prednisolone 0.5mg/kg daily or equivalent) negative igg antibody response against covid19 14 days after the second dose of covid19 vaccination. all subjects have to give written informed consent. subjects must be available to complete the study and comply with study procedures. willingness to allow for serum samples to be stored beyond the study period, for potential additional future testing to better characterize immune response

inability to comprehend and to follow all required study procedures. have a recent history (documented, confirmed or suspected) of a flu-like disease within a week of vaccination. have a known allergy to polyethylene glycol (peg) or other components of the study vaccines, or history of any anaphylaxis, serious vaccine reactions, to any excipients. have known active human immunodeficiency virus (hiv) infection. received an experimental agent (vaccine, drug, biologic, device, blood product, or medication) within 1 month prior to vaccination in this study or expect to receive an experimental agent during this study. unwilling to refuse participation in another clinical study through the end of this study. tympanic temperature ≥ 38°c within 3 days of intended study vaccination have a history of alcohol or drug abuse in the last 5 years. have any condition that the investigator believes may interfere with successful completion of the study

2

The University of Hong Kong

18

100

Hong Kong

Healthy volunteers

N/A

130

vMN geometric mean titre

None

Phase 2

[{"arm_notes": "intradermal ", "treatment_id": 222, "treatment_name": "Bnt162b2", "treatment_type": "Rna based vaccine", "pharmacological_treatment": "Vaccine"}, {"arm_notes": "intramuscular", "treatment_id": 222, "treatment_name": "Bnt162b2", "treatment_type": "Rna based vaccine", "pharmacological_treatment": "Vaccine"}]