COVID-19 trials registries data warehouse

https://clinicaltrials.gov/show/NCT05633446

Alberto R Edison, MD

edisonalberto@rocketmail.com

2022-12-01

Not recruiting

RCT

Randomized

Parallel

Blind label

multi-center

Prevention

inclusion criteria: healthy volunteers aged 18 to 75 years on the day of inclusion participant signed informed consent residing in philippines. a participant can be included providing covid-19 polymerase chain reaction (pcr) test is negative at screening. a participant can be included providing, the participant haven't received any vaccination against covid-19 in the past, or if the participant had already received any of the following licensed vaccines against covid-19: oxford/astrazeneca; pfizer/biontech; moderna; or j&j/janssen, with the participants last dose received at least 6 months prior the inclusion in this trial.

participant is pregnant, lactating, or of childbearing potential participation in the 6 months preceding the first trial vaccination or planned participation during the present trial period in another clinical trial investigating a vaccine, drug, medical device, or medical procedure receipt of any vaccination against covid-19 less than 6 months prior to participation in study. receipt of any vaccine in the three months preceding the first trial vaccination or planned receipt of any vaccine in the 6 months following last trial vaccination. positive sars-cov-2 test in the 4 weeks preceding the first trial vaccination receipt of immunoglobulins, blood, or blood-derived products in the past 3 months known or suspected congenital or acquired immunodeficiency; or receipt of immunosuppressive therapy self-reported or documented seropositivity for human immunodeficiency virus (hiv), hepatitis b natural infection (hbcab positive serology), or hepatitis c known systemic hypersensitivity to any of the vaccine components (e.g. gold), or history of a life-threatening reaction to vaccines or to a vaccine containing any of the same substances current alcohol abuse or drug addiction (reported or suspected) chronic illness that, in the opinion of the investigator, is at a stage where it might interfere with trial conduct or completion thrombocytopenia or any coagulation disorder identified as an investigator or employee of the investigator or study centre with direct involvement in the proposed study, or identified as an immediate family member (i.e., parent, spouse, natural or adopted child) of the investigator or employee with direct involvement in the proposed study (i.e. in the employment of the clinical trial sites). refusal to be informed if relevant results concerning the participant's health are revealed

4

Emergex Vaccines Holding Ltd.

18

75

Philippines

Healthy volunteers

N/A

110

To assess the safety, tolerability and reactogenicity of the vaccine

None

Phase 1/Phase 2

[{"arm_notes": "One vaccination", "treatment_id": 2052, "treatment_name": "Pepgnp-sarscov2 vaccine", "treatment_type": "Protein subunit", "pharmacological_treatment": "Vaccine"}, {"arm_notes": "Two vaccinations", "treatment_id": 2052, "treatment_name": "Pepgnp-sarscov2 vaccine", "treatment_type": "Protein subunit", "pharmacological_treatment": "Vaccine"}, {"arm_notes": "One vaccination", "treatment_id": 2187, "treatment_name": "Placebo", "treatment_type": "Placebo", "pharmacological_treatment": "Placebo"}, {"arm_notes": "Two vaccinations", "treatment_id": 2187, "treatment_name": "Placebo", "treatment_type": "Placebo", "pharmacological_treatment": "Placebo"}]