NCT05918939

UNAIR Inactivated COVID-19 Vaccine as Heterologue Booster (Immunobridging Study)

Immunobridging Study: Immunogenicity and Safety of Vaksin Merah Putih - UA SARS-CoV-2 (Vero Cell Inactivated) Vaccine as Heterologue Booster in Adult Subjects in Indonesia

• Status: Unknown
• Phase: EARLY_Phase 1
• Study type: Interventional
• Enrollment: 350 (estimated)
• Sponsor: Dr. Soetomo General Hospital · Other Government
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

Summary

This is an observer blind randomized controlled trial study to evaluate the humoral immunogenicity profile - neutralizing antibody - after 28 days following vaccination with Vaksin Merah Putih - UA SARS-CoV-2 (Vero Cell Inactivated) vaccine as heterologue booster compared with CoronaVac administered intramuscularly in healthy adults age 18 year and above. Vaksin Merah Putih - UA SARS-CoV-2 (Vero Cell Inactivated) vaccine is an inactivated vaccine made of SARS-CoV-2 virus isolated from a patient in Surabaya, composed with aluminium hydroxy gel, tween 80, and L-histidine, and this will be the first booster study in human.

Detailed description

This is an observer blind randomized controlled trial. There will be 2 groups in the study. First group will receive CoronaVac vaccine, manwhile the other group will receive Vaksin Merah Putih - UA SARS-CoV-2 (Vero Cell Inactivated) vaccine. The inclusion and exclusion criteria for the subjects were listed below. All subjects will receive either one dose of CoronaVac or Vaksin Merah Putih - UA SARS-CoV-2 (Vero Cell Inactivated) vaccine and be followed for 6 months. The vaccine will be administered intramuscularly. This study will have one interim and one full analysis reports. The main focus is immunogenicity and safety issues. Data Safety Monitoring Board will be commissioned for this study to evaluate safety data over the study period and to review any events that meet a specific study pausing rule or any other safety issue that may arise. They will review the blinded 7 and 28 days safety data following the vaccine, and then the 3 and 6 months safety data. The immunogenicity data will be evaluated until 6 months.

Conditions

• COVID-19 Pandemic
• COVID-19 Vaccines

Interventions

Type	Name	Description
BIOLOGICAL	Vaksin Merah Putih - UA SARS-CoV-2 (Vero Cell Inactivated) 5 µg	Vaksin Merah Putih - UA SARS-CoV-2 (Vero Cell Inactivated) contains purified S protein of SARSCoV-2 - Dose: 5 µg, aluminium hydroxide gel, 10 mM L-Histidine buffer, 0.005%, Tween Polysorbate 80, and 0.9% Sodium chloride. Vaccine will be prepared in vial (1 ml per vial). The vial should be shaken well before injection.
BIOLOGICAL	CoronaVac Biofarma COVID-1 9 Vaccine 3 µg	Control vaccine in this study is existing CoronaVacBioFarma inactivated COVID-19 vaccine which has been used widely in Indonesia.

Timeline

• Start date: 2022-09-05
• Primary completion: 2023-08-05
• Completion: 2023-09-05
• First posted: 2023-06-26
• Last updated: 2023-06-26

Locations

1 site across 1 country: Indonesia