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

NCT05918939 · Status: UNKNOWN · Phase: EARLY_PHASE1 · Type: INTERVENTIONAL · Enrollment: 350

Last updated 2023-06-26

No results posted yet for this study

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.

Conditions

  • COVID-19 Pandemic
  • COVID-19 Vaccines

Interventions

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.

Sponsors & Collaborators

  • Indonesia-MoH

    collaborator OTHER_GOV

  • Universitas Airlangga

    collaborator OTHER

  • Bioxis Pharmaceuticalls

    collaborator INDUSTRY

  • Dr. Soetomo General Hospital

    lead OTHER_GOV

Principal Investigators

  • Dominicus Husada, MD · Dr. Soetomo General Hospital

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

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

Countries

  • Indonesia

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05918939 on ClinicalTrials.gov