COVID-19 trials registries data warehouse

https://clinicaltrials.gov/show/NCT05084989

Meng, F

None

2021-10-20

Completed

RCT

Randomized

Parallel

Blind label

single-center

Prevention

inclusion criteria: aged 18 years and older. all participants are able and willing to comply with all study requirements. willing to allow investigators to discuss the medical history with his/her general practitioner/personal doctors and access all medical records which are relevant to study procedures. healthy participants, or participants with stable medical condition who have a pre-existing medical condition that does not meet any exclusion criteria. a stable medical condition is defined as disease not requiring significant change in therapy or hospitalization for worsening disease during the 3 months before enrollment. for part 1, participants should have not received any covid-19 vaccine before the screening. for part 2, participants should have received complete 2-dose primary vaccination with an inactivated covid-19 vaccine (coronavac®), 90~365 days (included) prior to the study vaccination. provide written informed consent form (icf) prior to study enrollment. exclusion criteria laboratory confirmed sars-cov-2 infection, defined by rt-pcr assay. medical history of severe acute respiratory syndrome (sars), middle east respiratory syndrome (mers) and covid-19 within 12 months prior to the randomization. fever (oral temperature ≥ 37.5°c / axillary temperature ≥ 37.3°c) on the day of vaccination or within recent 72 hours. history of severe allergic disease or reactions likely to be exacerbated by any component of recov or the control vaccine, such as allergic shock, allergic laryngeal edema, allergic purpura, thrombocytopaenic purpura, local hypersensitive necrosis reaction (arthus reaction), or prior history of serious adverse reaction to any vaccine or drug, such as allergy, urticaria eczema, dyspnea, and angioneurotic edema. have malignant tumor (except for skin basal cell carcinoma or carcinoma uterine cervix in situ) and immune disease (e.g., human immunodeficiency virus [hiv] infection, systemic lupus erythematosus, rheumatoid arthritis, asplenia or splenectomy, and other immune disease that may influence immune response at investigator's discretion). have other severe and/or uncontrolled conditions, including but not limited to, acute infectious disease, cardiovascular disease, respiratory disease, gastrointestinal disease, liver disease, renal disease, hematology disease, endocrine disorder, psychiatric condition and neurological illness. mild/moderate well-controlled comorbidities are allowed to participate as deemed appropriate by the investigator.

None

4

Jiangsu Rec-Biotechnology Co., Ltd.

18

80

Philippines

Healthy volunteers

N/A

948

Part1, Primary immunogenicity;Part1, Primary Safety;Part2, Primary immunogenicity

None

Phase 2

[{"arm_notes": "Part1: 2 doses", "treatment_id": 1091, "treatment_name": "Recov - recombinant two-component covid-19 vaccine (cho cell)", "treatment_type": "Protein subunit", "pharmacological_treatment": "Vaccine"}, {"arm_notes": "Part1 ", "treatment_id": 2187, "treatment_name": "Placebo", "treatment_type": "Placebo", "pharmacological_treatment": "Placebo"}, {"arm_notes": "Part2: 1 dose", "treatment_id": 1091, "treatment_name": "Recov - recombinant two-component covid-19 vaccine (cho cell)", "treatment_type": "Protein subunit", "pharmacological_treatment": "Vaccine"}, {"arm_notes": "Part2: 1 dose ", "treatment_id": 222, "treatment_name": "Bnt162b2", "treatment_type": "Rna based vaccine", "pharmacological_treatment": "Vaccine"}]