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Safety and Immunogenicity Study of COVID-19 Protein Subunit Recombinant Vaccine Adjuvanted With Alum+CpG 1018

NCT05228613 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 175

Last updated 2023-02-27

No results posted yet for this study

Summary

The study is an observer-blind, randomized, controlled prospective intervention study of Phase I. The primary objective is to evaluate the safety and immunogenicity of the SARS-CoV-2 protein subunit recombinant vaccine adjuvanted with Alum+CpG1018

Conditions

Interventions

BIOLOGICAL

SARS-CoV-2 protein subunit recombinant vaccine

candidate vaccine manufactured by PT. Bio Farma

BIOLOGICAL

SARS-CoV-2 inactivated vaccine

active control manufactured by Sinovac Life Sciences Co.Ltd

Sponsors & Collaborators

  • Fakultas Kedokteran Universitas Indonesia

    collaborator OTHER

  • Faculty of Medicine, Diponegoro University, Semarang

    collaborator UNKNOWN

  • PT Bio Farma

    lead INDUSTRY

Principal Investigators

  • Prof Rini Sekartini, MD · Fakultas Kedokteran Universitas Indonesia

  • Yetty Movieta Nency, MD · Faculty of Medicine, Diponegoro University, Semarang

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2022-02-16
Primary Completion
2022-08-02
Completion
2023-01-24

Countries

  • Indonesia

Study Locations

More Related Trials

Entities

Diseases

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 NCT05228613 on ClinicalTrials.gov