COVID-19 trials registries data warehouse

https://clinicaltrials.gov/show/NCT05788185

Not reported

Not reported

2023-03-28

Terminated

RCT

Randomized

Parallel

Open label

single-center

Prevention

inclusion criteria: male and female healthy volunteers. aged 21 years and older on day 1 judged by the investigator to be healthy based on medical history, physical examination, and vital signs evaluation at screening visit. able to provide informed consent form. able and willing to comply with all study procedures over follow-up period of approximately 6 months. have documented completion of a 2-dose primary vaccination series and 1 booster vaccination with bnt162b2 or a 3-dose primary vaccination series, with or without 1 booster dose, with an approved inactivated virus vaccine (bbibp-corv or coronavac). the last dose in all cases should have been administered at least 6 months prior to enrolment in this study. for female subjects with childbearing potential: must agree to avoid pregnancy from 21 days prior to day 1 until at least 90 days after the last study vaccination. women physically capable of pregnancy (not sterilized and still menstruating or within 1 year of the last menses if menopausal) in sexual relationships with men must use an acceptable method of avoiding pregnancy during this period.

received any covid-19 vaccine other than bnt162b2, bbibp-corv, or coronavac. received more than 3 doses of bnt162b2 or more than 4 doses of bbibp-corv or coronavac. women who are pregnant or breastfeeding or intending to become pregnant; mend who will father children within the projected duration of the trial. positive serology test results for hepatitis c virus antibody, human immunodeficiency virus antibody, or hepatitis b viral surface antigen at screening. is currently participating in or has participated in a study with an investigational product within 30 days preceding day 1. history of severe allergic reactions (eg, acute anaphylaxis, urticaria, skin eczema, dyspnoea, angioneurotic oedema) or other significant adverse reactions to covid19 vaccines; allergy to known composition of rvm-001 and rvm-002. history of coagulation dysfunction (eg, coagulation factor deficiency, coagulation disease). vaccinated with live attenuated vaccine within 1 month, or any other vaccine within 14 days, of day 1 vaccination. received systemic immunosuppressants within 4 months prior to vaccination or an anticipated need for immunosuppressants at any time during the study. topical or inhaled treatment is allowed if not used within 14 days prior to day 1 vaccination. received blood products within 3 months prior to day 1 vaccination. history of alcohol or drug abuse within 3 years prior to day 1 vaccination. fever (temperature > 37.5°c), dry cough, fatigue, nasal obstruction, runny nose, sore throat, myalgia, diarrhoea, shortness of breath, or dyspnoea on the day of vaccination. any condition that, in the opinion of the investigator, would pose a health risk to the subject if enrolled, could interfere with the evaluation of the study vaccine, or interfere with interpretation of the study results (including neurologic or psychiatric conditions deemed likely to impair the quality of safety reporting).

6

RVAC Medicines (US), Inc.

21

100

Singapore

Healthy volunteers

N/A

24

Safety in terms of laboratory-based AEs;Safety in terms of SAEs, SUSARs, MAAEs and AESIs;Safety in terms of solicited adverse events;Safety in terms of solicited systemic adverse events;Safety in terms of unsolicited adverse events

None

Phase 1/Phase 2

[{"arm_notes": "BNT162b2 subjects; 30 \u00b5g", "treatment_id": 2533, "treatment_name": "Rvm-v001", "treatment_type": "Rna based vaccine", "pharmacological_treatment": "Vaccine"}, {"arm_notes": "BNT162b2 subjects; 30 \u00b5g", "treatment_id": 2705, "treatment_name": "Rvm-v002", "treatment_type": "Rna based vaccine", "pharmacological_treatment": "Vaccine"}, {"arm_notes": "BNT162b2 subjects", "treatment_id": 2706, "treatment_name": "Rvm-v001+rvm-v002", "treatment_type": "Rna based vaccine", "pharmacological_treatment": "Vaccine"}, {"arm_notes": "For BBIBP-CorV or CoronaVac subjects", "treatment_id": 2533, "treatment_name": "Rvm-v001", "treatment_type": "Rna based vaccine", "pharmacological_treatment": "Vaccine"}, {"arm_notes": "For BBIBP-CorV or CoronaVac subjects", "treatment_id": 2705, "treatment_name": "Rvm-v002", "treatment_type": "Rna based vaccine", "pharmacological_treatment": "Vaccine"}, {"arm_notes": "For BBIBP-CorV or CoronaVac subjects", "treatment_id": 2706, "treatment_name": "Rvm-v001+rvm-v002", "treatment_type": "Rna based vaccine", "pharmacological_treatment": "Vaccine"}]