COVID-19 trials registries data warehouse

https://clinicaltrials.gov/show/NCT05175950

Hee Jin Cheong

Not reported

2022-01-04

Not recruiting

RCT

Randomized

Parallel

Blind label

multi-center

Prevention

inclusion criteria: participant must be aged 19 years and older at the time of signing the informed consent. participants who are healthy or medically stabilized according to medical judgment of the investigator based on medical history, physical examination and clinical laboratory tests, etc. participants who are able to attend all scheduled visits and comply with all study procedures. (cohort 1~5) participants who received a primary series of covid-19 vaccination approved for use in korea by mfds and at least 12~24 weeks have passed with no additional covid-19 vaccination. (cohort 6~7) participants who received a primary series of covid-19 vaccination and the 1st booster vaccination at least 16 weeks ago through a homologous or heterologous vaccination with mrna vaccines (bnt162b2 (pfizer) and mrna-1273 (moderna)) only or at least more than a single dose of non-mrna vaccines (chadox1 ncov-19 (az), ad26.cov2.s (janssen), and nvx-cov2373 (novavax)). female participants of childbearing potential must agree to be heterosexually inactive, or agree to use at least one acceptable method of contraception from at least 4 weeks prior to the study vaccination (booster vaccination) to 12 weeks after the study vaccination. female participants with a negative urine or serum pregnancy test at screening (however, female participants who are surgically sterile or postmenopausal with amenorrhea for at least 12 months shall be excluded. participants who give signed informed consent which include compliance with the requirements and restrictions listed in the informed consent form and in the protocol.

any clinically significant respiratory symptoms (e.g. cough, sore throat), febrile illness (temperature >38°c), or acute illness within 72 hours prior to the study vaccination (a prospective participant should not be included until 72 hours after the condition has resolved). history of virologically-confirmed covid-19, sars or mers disease. history of confirmed sars-cov-2 infection within three months before screening. history of congenital or acquired immunodeficiency or autoimmune disease. history of bleeding disorder including thrombocytopenia which is judged by the investigator as a contraindication for intramuscular vaccination. history of hypersensitivity and severe allergic reaction (e.g. anaphylaxis, guillain-barre syndrome) to any components of the study intervention. history of malignancy within 1 year prior to the study vaccination (except for a participant judged by the investigator to have a low recurrence risk.) any other clinically significant conditions such as uncontrollable chronic or acute diseases which, in the opinion of the investigator, might cause a health threat to the participant or interfere with the clinical trial procedures or interpretation of the study results. any other conditions which might interfere with the evaluation of the study objectives (e.g. alcohol or drug abuse, neurologic or psychiatric conditions). female participants who are pregnant or breastfeeding. history of drug administration other than covid-19 vaccination intended to treat or prevent covid-19. history or planned other vaccination within 4 weeks prior to the study vaccination through 28 days after the study vaccination (except for influenza vaccination, which may be received at least 2 weeks prior to the study vaccination). receipt of immunoglobulins, whole blood or blood products within 12 weeks prior to the study vaccination. use of immunosuppressive therapy such as anti-cancer chemotherapy or radiation therapy for at least 2 consecutive weeks within 12 weeks prior to the study vaccination or long-term systemic corticosteroid therapy (e.g. ≥10mg prednisone/day or equivalent for more than 2 consecutive weeks) (however, the use of topical and nasal glucocorticoids will be permitted.) history of participation in another clinical study within 4 weeks prior to the study vaccination or planned participation in another clinical study during this study period. investigators, study staff who are directly involved in the conduct of this study or supervised by the investigator, or their family members.

14

Korea University Guro Hospital

19

100

Korea;Republic of

Healthy volunteers

N/A

770

Comparative GMT (Geometric Mean Titer) of neutralizing antibody to SARS-CoV-2 between the Test Group and Placebo Group, measured by wild-type virus neutralization assay at 2 weeks post heterologous booster vaccination;GMFR (Geometric Mean Fold Rise) of neutralizing antibody to SARS-CoV-2 from baseline measured by wild-type virus neutralization assay at each time point post heterologous booster vaccination;GMFR (Geometric Mean Fold Rise) of SARS-CoV-2 RBD-binding antibody from baseline measured by ECLIA at each time point post heterologous booster vaccination;GMT (Geometric Mean Titer) of neutralizing antibody to SARS-CoV-2 measured by wild-type virus neutralization assay at each time point post heterologous booster vaccination;GMT (Geometric Mean Titer) of SARS-CoV-2 RBD-binding antibody measured by ECLIA at each time point post heterologous booster vaccination;(Only applicable to CMI analysis set) Cell-mediated immunity assessment using IFN-γ ELISpot at each time point post heterologous booster vaccination;Percentage of participants with ≥4-fold rise from baseline in neutralizing antibody to SARS-CoV-2 measured by wild-type virus neutralization assay at each time point post heterologous booster vaccination;Percentage of participants with ≥4-fold rise from baseline in SARS-CoV-2 RBD-binding antibody measured by ECLIA at each time point post heterologous booster vaccination

None

Phase 2

[{"arm_notes": "primary vaccination completed with ChAdOx1 nCOV-19", "treatment_id": 1524, "treatment_name": "As03 adjuvant+gbp510", "treatment_type": "Adjuvant+protein subunit", "pharmacological_treatment": "Vaccine"}, {"arm_notes": "primary vaccination completed with ChAdOx1 nCOV-19", "treatment_id": 2187, "treatment_name": "Placebo", "treatment_type": "Placebo", "pharmacological_treatment": "Placebo"}, {"arm_notes": "primary vaccination completed with BNT162b2", "treatment_id": 1524, "treatment_name": "As03 adjuvant+gbp510", "treatment_type": "Adjuvant+protein subunit", "pharmacological_treatment": "Vaccine"}, {"arm_notes": "primary vaccination completed with BNT162b2", "treatment_id": 2187, "treatment_name": "Placebo", "treatment_type": "Placebo", "pharmacological_treatment": "Placebo"}, {"arm_notes": "primary vaccination completed with mRNA-1273", "treatment_id": 1524, "treatment_name": "As03 adjuvant+gbp510", "treatment_type": "Adjuvant+protein subunit", "pharmacological_treatment": "Vaccine"}, {"arm_notes": "primary vaccination completed with mRNA-1273", "treatment_id": 2187, "treatment_name": "Placebo", "treatment_type": "Placebo", "pharmacological_treatment": "Placebo"}, {"arm_notes": "primary vaccination completed with Ad26.COV2.S", "treatment_id": 1524, "treatment_name": "As03 adjuvant+gbp510", "treatment_type": "Adjuvant+protein subunit", "pharmacological_treatment": "Vaccine"}, {"arm_notes": "primary vaccination completed with Ad26.COV2.S", "treatment_id": 2187, "treatment_name": "Placebo", "treatment_type": "Placebo", "pharmacological_treatment": "Placebo"}, {"arm_notes": "primary vaccination completed with ChAdOx1 nCOV-19(AZ)-BNT162b2", "treatment_id": 1524, "treatment_name": "As03 adjuvant+gbp510", "treatment_type": "Adjuvant+protein subunit", "pharmacological_treatment": "Vaccine"}, {"arm_notes": "primary vaccination completed with ChAdOx1 nCOV-19(AZ)-BNT162b2", "treatment_id": 2187, "treatment_name": "Placebo", "treatment_type": "Placebo", "pharmacological_treatment": "Placebo"}, {"arm_notes": "primary and 1st booster vaccination completed with mRNA vaccine", "treatment_id": 1524, "treatment_name": "As03 adjuvant+gbp510", "treatment_type": "Adjuvant+protein subunit", "pharmacological_treatment": "Vaccine"}, {"arm_notes": "primary and 1st booster vaccination completed with mRNA vaccine", "treatment_id": 2187, "treatment_name": "Placebo", "treatment_type": "Placebo", "pharmacological_treatment": "Placebo"}, {"arm_notes": "primary and 1st booster vaccination completed with \u22651 dose of non-mRNA vaccine", "treatment_id": 1524, "treatment_name": "As03 adjuvant+gbp510", "treatment_type": "Adjuvant+protein subunit", "pharmacological_treatment": "Vaccine"}, {"arm_notes": "primary and 1st booster vaccination completed with \u22651 dose of non-mRNA vaccine", "treatment_id": 2187, "treatment_name": "Placebo", "treatment_type": "Placebo", "pharmacological_treatment": "Placebo"}]