COVID-19 trials registries data warehouse

https://clinicaltrials.gov/show/NCT04830800

Not reported

Not reported

2021-04-05

Completed

RCT

Randomized

Parallel

Blind label

multi-center

Prevention

inclusion criteria: phase 1 only: adult 18 through 59 years of age inclusive at the time of randomization. healthy, as defined by absence of clinically significant medical condition, either acute or chronic, as determined by medical history, physical examination, screening laboratory test results, and clinical assessment of the investigator. phase 2 only: adult 18 through 75 years of age inclusive at the time of randomization. having no clinically significant acute medical condition, and no chronic medical condition that has not been controlled within 90 days of randomization, as determined by medical history, physical examination, screening laboratory test results, and clinical assessment of the investigator. both phase 1 and phase 2: has provided written informed consent prior to performance of any study-specific procedure. has a body mass index (bmi) of 17 to 40 kg/m2, inclusive, at screening. resides in study site area and is able and willing to adhere to all protocol visits and procedures. if a woman is of childbearing potential, must not be breastfeeding or be pregnant (based on a negative urine pregnancy test at screening and during the 24 hours prior to receipt of the first dose of ip), must plan to avoid pregnancy for at least 28 days after the last dose of ip, and be willing to use an adequate method of contraception consistently and have a repeated pregnancy test prior to the second (last) dose of ip.

use of any investigational medicinal product within 90 days prior to randomization or planned use of such a product during the period of study participation. history of administration of any non-study vaccine within 28 days prior to administration of study vaccine or planned vaccination within 3 months after enrolment. note: receipt of any covid-19 vaccine that is licensed or granted emergency use authorization in vietnam during the course of study participation is not exclusionary if administered after visit 5. previous receipt of investigational vaccine for sars or mers, or any investigational or licensed vaccine that may have an impact on interpretation of the trial results history of hypersensitivity reaction to any prior vaccination or known hypersensitivity to any component of the study vaccine history of egg or chicken allergy history of angioedema history of anaphylaxis acute illness (moderate or severe) and/or fever (body temperature measured orally ≥38°c) any abnormal vital sign deemed clinically relevant by the pi abnormality in screening laboratory test deemed exclusionary by the pi in consultation with the sponsor a positive serologic test for hepatitis b (hbsag) or hepatitis c (hcv ab) history of confirmed hiv history of laboratory-confirmed covid-19 history of malignancy, excluding non-melanoma skin and cervical carcinoma in situ any confirmed or suspected immunosuppressive or immunodeficient state administration of immunoglobulin or any blood product within 90 days prior to first study injection or planned administration during the study period. administration of any long-acting immune-modifying drugs (e.g., infliximab or rituximab) or the chronic administration (defined as more than 14 days) of immunosuppressants within six months prior to first study injection, or planned administration during the study period (includes systemic corticosteroids at doses equivalent to ≥ 0.5 mg/kg/day of prednisone; the use of topical steroids including inhaled and intranasal steroids is permitted). history of known disturbance of coagulation or blood disorder that could cause anemia or excess bleeding. (e.g, thalassemia, coagulation factor deficiencies). recent history (within the past year) or signs of alcohol or substance abuse. any medical, psychiatric or behavior condition that in the opinion of the pi may interfere with the study objectives, pose a risk to the subject, or prevent the subject from completing the study follow-up. employee of any person employed by the sponsor, the contract research organization (cro), the pi, study site personnel, or site.

5

Institute of Vaccines and Medical Biologicals, Vietnam

18

75

Vietnam

Healthy volunteers

N/A

420

Number and severity of solicited local and systemic adverse events (AEs);Number, severity and relatedness of adverse events of special interest (AESI) , including AESI relevant to COVID-19, and potential immune-mediated medical conditions (PIMMC);Number, severity and relatedness of all unsolicited AEs;Number, severity, and relatedness of clinically significant hematological and biochemical measurements;Number, severity and relatedness of medically-attended AEs (MAAEs);Number, severity and relatedness of serious adverse events (SAEs)

None

Phase 1/Phase 2

[{"arm_notes": "1mcg;2;days0-28", "treatment_id": 348, "treatment_name": "Covivac", "treatment_type": "Non replicating viral vector", "pharmacological_treatment": "Vaccine"}, {"arm_notes": "3mcg;2;days0-28", "treatment_id": 348, "treatment_name": "Covivac", "treatment_type": "Non replicating viral vector", "pharmacological_treatment": "Vaccine"}, {"arm_notes": "10mcg;2;days0-28", "treatment_id": 348, "treatment_name": "Covivac", "treatment_type": "Non replicating viral vector", "pharmacological_treatment": "Vaccine"}, {"arm_notes": "1mcg (COVIVAC) + 1.5mg (CpG1018);2;days0-28", "treatment_id": 1474, "treatment_name": "Covivac+cpg1018 adjuvant", "treatment_type": "Non replicating viral vector+adjuvant", "pharmacological_treatment": "Vaccine"}, {"arm_notes": "", "treatment_id": 2187, "treatment_name": "Placebo", "treatment_type": "Placebo", "pharmacological_treatment": "Placebo"}]