COVID-19 trials registries data warehouse

http://www.chictr.org.cn/showproj.aspx?proj=56834

Zhu Fengcai

jszfc@jscdc.cn

2020-07-21

Not recruiting

RCT

Randomized

Parallel

Blind label

multi-center

Prevention

1. Male or female subjects aged 18 to 55 years old with body mass index (BMI) 18 to 30 at the Screening Visit. For the elderly subjects, aged >55 years old at Screening Visit, 2. Individuals who are in good health condition at the time of entry into the trial as determined by medical history, physical examination (including vital signs, ECG) and eligibility screening test (hematology, blood chemistry and urine analysis) and clinical judgment of the investigator at Screening Visit. For the elderly subjects, individuals who are in a health condition that can receive the investigation vaccine, 3. The subject can provide with informed consent and signs and dates a written informed consent form (ICF) prior to the initiation of any trial procedures, 4. They must be able to understand and follow trial-related instructions, 5. They must be willing and able to comply with planned visits, treatment schedule, laboratory tests and other requirements of the trial, 6. Negative in antibodies screening of SARS-CoV-2 (fingerstick), 7. Normal in chest CT scans (no imaging features of COVID-19). For the elderly subjects, No imaging features of COVID-19 in chest CT, 8. Axillary temperature <=37.0 degree C, 9. Negative SARS-CoV-2 test in throat swabs by RT-PCR, 10. Women of childbearing potential (WOCBP) must have a negative beta-human chorionic gonadotropin (beta-hCG) in serum sample at Screening Visit. Women that are postmenopausal (Menopause>=12 consecutive months) or permanently sterilized will be considered as not having reproductive potential, 11. WOCBP must have used effective contraception 14 days prior to screening and agree to use effective contraception continuously during the trial period, from 14 days prior to Screening Visit to 60 days after the last immunization, 12. WOCBP must agree not to donate eggs (ova, oocytes) for the purposes of assisted reproduction during trial, starting from Screening Visit and continuously until 60 days after be given the last immunization, 13. Men who are sexually active with a WOCBP and have not had a vasectomy must agree to practice a effective form of contraception with their female partner of childbearing potential during the trial, starting from Screening Visit and continuously until 60 days after be given the last immunization, 14. Men must be willing to refrain from sperm donation, starting from Screening Visit and continuously until 60 days after receiving the last immunization.

1. For the elderly subjects, Baseline laboratory abnormalities with Grade >=3 (according to the grading criteria in appendix B) during screening visits, by physical examination and eligibility screening, 2. Have had any acute illness, as determined by the investigator, with or without fever, within 72 h prior to the prime vaccination. An acute illness which is nearly resolved with only minor residual symptoms remaining is allowable if, in the opinion of the investigator, the residual symptoms will not compromise their well-being if they participate as trial subjects in the trial, or that could prevent, limit, or confound the protocol-specified assessments, 3. Are breastfeeding on the day of Screening Visit or who plan to breastfeed during the trial, starting from Screening Visit and continuously until at least 90 days after the last immunization. Women or partners who plan to become pregnant within 1 year post the screening visit, 4. Have a known allergy, hypersensitivity, or intolerance to the planned vaccine for trial including any excipients, 5. Had a history of hypersensitivity or serious reactions to vaccination, 6. Received any vaccination within 4 weeks prior to Visit 1. 7. Disagree for do not receive other vaccine during the trial, starting from Screening Visit and continuously until 28 days after receiving the last immunization, except emergency vaccination (e.g. rabies vaccine, tetanus vaccine), 8. Had any medical condition (e.g., autoimmune disease) or any major surgery (e.g., requiring general anesthesia) within the past 5 years, which in the opinion of the investigator, could compromise their well-being if they participate as trial subjects in the trial, or that could prevent, limit, or confound the protocol-specified assessments. For the elderly subjects, Had any serious or life-threatening medical condition (e.g., autoimmune disease, cardiovascular disease) within the past 5 years, which in the opinion of the investigator, could compromise their well-being if they participate as trial subjects in the trial, or that could prevent, limit, or confound the protocol-specified assessments, 9. Have any surgery planned during the trial, starting from Screening Visit and continuously until at least 90 days after the last immunization, 10. Had any chronic use (more than 14 continuous days) of any systemic medications that affects immune function, including immunosuppressant or other immune-modifying drugs, within 6 months prior to Screening Visit unless in the opinion of the investigator, the medication would not prevent, limit, or confound the protocol-specified assessments or could compromise safety of subjects, 11. Had administration of any immunoglobulins and/or any blood products within the 3 months prior to Screening Visit. 12. Had administration of another investigational product including vaccines within 60 days or 5 half-lives (whichever is longer), prior to Screening Visit, 13. With known history of AIDS or HIV test positive, 14. History of HBV or HCV infection, through medical inquiry, 15. History of SARS, SARS-CoV-2 or MERS infection. Suspected SARS patients should be screened for SARS antibodies. 16. Previously participated in a clinical trial involving lipid nanoparticles, 17. Are subject to exclusion periods of other clinical trials or simultaneous participation in another clinical trial, 18. Have any affiliation with the study site (e.g., are close relative of the investigator or dependent person,

3

Jiangsu Provincial Center for Disease Prevention and Control

18

100

China

Healthy volunteers

N/A

144

Occurrence of solicited local reactions;Occurrence of solicited systematic reactions;Occurrence of AE associated with vaccination;

| Declared number of arm (6.0) differs from found arms (7.0)

Phase 1

[{"arm_notes": "1 or 2", "treatment_id": 2187, "treatment_name": "Placebo", "treatment_type": "Placebo", "pharmacological_treatment": "Placebo"}, {"arm_notes": "low dose;2;21 days apart (adults)", "treatment_id": 221, "treatment_name": "Bnt162b1", "treatment_type": "Rna based vaccine", "pharmacological_treatment": "Vaccine"}, {"arm_notes": "high dose;2;21 days apart (elderly)", "treatment_id": 221, "treatment_name": "Bnt162b1", "treatment_type": "Rna based vaccine", "pharmacological_treatment": "Vaccine"}]