NCT05228613 is a Phase 1 clinical trial of SARS-CoV-2 protein subunit recombinant vaccine in COVID-19, sponsored by PT Bio Farma.

Who is sponsoring NCT05228613?

NCT05228613 is sponsored by PT Bio Farma.

Is NCT05228613 still recruiting?

NCT05228613 is currently completed. Last updated 27 February 2023.

Last reviewed 2023-02-27 · How we verify

NCT05228613

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

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

Completed Phase 1 Last updated 27 February 2023

What this trial tests

Phase 1 trial testing SARS-CoV-2 protein subunit recombinant vaccine in COVID-19 in 175 participants. Completed in 24 January 2023.

Timeline

16 February 2022

Primary endpoint
2 August 2022

24 January 2023

Quick facts

Lead sponsor	PT Bio Farma
Phase	Phase 1
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	double
Primary purpose	treatment
Enrollment	175
Start date	16 February 2022
Primary completion	2 August 2022
Estimated completion	24 January 2023
Sites	2 locations across Indonesia

Drugs / interventions tested

SARS-CoV-2 protein subunit recombinant vaccine — full drug profile →
SARS-CoV-2 inactivated vaccine — full drug profile →

Conditions studied

COVID-19 — all drugs for COVID-19 →

Sponsor

PT Bio Farma — full company profile →

Who can join

Adults 18 to 70, any sex, with COVID-19. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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

Publications & conference data

2 peer-reviewed publications reference this trial (live from Europe PMC):

Vaccine adjuvants: mechanisms and platforms.
Zhao T, Cai Y, Jiang Y, He X, et al · · 2023 · cited 519× · PMID 37468460 · DOI 10.1038/s41392-023-01557-7
Safety and immunogenicity of SARS-CoV-2 protein subunit recombinant vaccine (Indovac®) in healthy populations aged 18 years and above in Indonesia: A phase I, observer-blind, randomized, controlled study.
Nency YM, Sekartini R, Wirahmadi A, Maria S, et al · · 2025 · cited 1× · PMID 40381203 · DOI 10.1080/21645515.2025.2501467

Verify or expand the search:

Other trials of SARS-CoV-2 protein subunit recombinant vaccine

Trials testing the same drug.

NCT05313035 — Safety and Immunogenicity Study of COVID-19 Protein Subunit Recombinant Vaccine · Phase 2, PHASE3 · completed

Other recruiting trials for COVID-19

Currently open trials in the same condition.

NCT07183709 — Safety and Immunogenicity Trial of PepGNP-COVID19 Vaccine in Adults · Phase 1 · active not recruiting
NCT07300839 — A Study to Learn About a COVID-19 Vaccine in Healthy Adults 50 Through 64 Years of Age · Phase 3 · active not recruiting
NCT07221162 — A Safety and Immunogenicity Trial of Boost-2867 Vaccine, Via Intranasal and Intramuscular Routes · Phase 1 · recruiting
NCT07215520 — Safety and Tolerability of a Newcastle Disease Virus-Based Mucosal COVID-19 Vaccine in Previously Vaccinated Adults · Phase 2 · recruiting
NCT07222384 — A Study to Learn About BNT162b2 (LP.8.1)-Adapted Vaccine Against SARS-CoV-2 in Children 5 Through 11 Years of Age That A · Phase 3 · active not recruiting

Other PT Bio Farma trials

Trials by the same sponsor.

NCT06921460 — Long-Term Protection of Vi Antibodies Induced by Bio TCV in Indonesian Population Compared to PQed TCV · not yet recruiting
NCT06690515 — Phase I/II, Open Label, Randomized, Safety and Immunogenicity Following DTwP-Hepatitis B-Hib-IPV Vaccine (Bio Farma) in · Phase 1, PHASE2 · not yet recruiting
NCT06690502 — Post Authorization Safety Profile of Booster IndoVac COVID-19 Vaccination · completed
NCT05933278 — Homologous Booster Study of COVID-19 Protein Subunit Recombinant Vaccine · Phase 2 · completed
NCT06114641 — Effectiveness & Safety of Ovine Enoxaparin Sodium to Originator Enoxaparin in Non-ST-Segment Elevation ACS Patients · Phase 4 · completed

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT05228613 (US National Library of Medicine, public domain)
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by PT Bio Farma
Last refreshed: 27 February 2023

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT05228613.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing