drugset / Trial / NCT05918939

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

NCT05918939

RandomizedParallel-groupDouble-blindPrevention

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.

Timeline

Start
2022-09-05
Primary completion
2023-08-05
Completion
2023-09-05

Publications

Drugs

EvaluationDrugModalityDoseRoute
Comparator CoronaVac Vaccine 3 ug Intramuscular
Subject Vaksin Merah Putih - UA SARS-CoV-2 (Vero Cell Inactivated) Vaccine 5 ug Intramuscular

Indications