IndoVac (SARS-CoV-2 protein subunit recombinant vaccine) / Bio Farma Indonesia, Fakultas Kedokteran Universitas Indonesia, Texas Children’s Hospital, Baylor College of Medicine, Dynavax - LARVOL DELTA

Safety and Immunogenicity of SARS-CoV-2 Protein Subunit Recombinant Vaccine in Healthy Children (clinicaltrials.gov) - P3 | N=1050 | Completed | Sponsor: PT Bio Farma | Recruiting ➔ Completed

Trial completion • Infectious Disease • Novel Coronavirus Disease • Respiratory Diseases

Booster Study of COVID-19 Protein Subunit Recombinant Vaccine (clinicaltrials.gov) - P2 | N=696 | Completed | Sponsor: PT Bio Farma | Recruiting ➔ Completed

Trial completion • Infectious Disease • Novel Coronavirus Disease • Respiratory Diseases

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. (PubMed, Hum Vaccin Immunother) - "The study revealed a significant rise in the Geometric Mean Titer (GMT) of IgG antibodies in every group, indicating a strong immune response. The phase I data demonstrated that the new vaccine candidate showed promising results in safety and immunogenicity."

Clinical • Journal • Infectious Disease • Novel Coronavirus Disease • Pain • Respiratory Diseases

Immunogenicity and Safety of SARS-CoV-2 Protein Subunit Recombinant Vaccine (IndoVac®) as a Heterologous Booster Dose against COVID-19 in Indonesian Adolescents. (PubMed, Vaccines (Basel)) - "At the 12-month follow-up after the booster dose, four serious adverse events (SAEs) not related to investigational products and research procedures were noted. This study showed that IndoVac® has a favorable immunogenicity and safety profile as a booster in adolescents and that the antibody titer decreases over time."

Journal • Infectious Disease • Musculoskeletal Pain • Novel Coronavirus Disease • Pain • Respiratory Diseases

Immunogenicity and Safety of SARS-CoV-2 Protein Subunit Recombinant Vaccine (IndoVac®) as a Booster Dose against COVID-19 in Indonesian Adults. (PubMed, Vaccines (Basel)) - "The groups were divided into the primary inactivated vaccine (CoronaVac®) group, the primary viral vector vaccine (ChAdOx1) group, and the primary mRNA vaccine (BNT162b2) group that received the recombinant protein (IndoVac®)...Until the 6-month follow-up after the booster dose, the IndoVac® vaccine was well tolerated and all reported AEs resolved. This vaccine is registered and can be included in the immunisation programme."

Journal • Infectious Disease • Novel Coronavirus Disease • Respiratory Diseases

Immunogenicity Assessment of the SARS-CoV-2 Protein Subunit Recombinant Vaccine (CoV2-IB 0322) in a Substudy of a Phase 3 Trial in Indonesia. (PubMed, Vaccines (Basel)) - "Both vaccines showed comparable B- and T-cell immunological response that diminish over time."

Journal • P3 data • Infectious Disease • Novel Coronavirus Disease • Respiratory Diseases • CD4 • CD8 • IFNG • IL2 • IL4

Immuno-bridging Study of COVID-19 Protein Subunit Recombinant Vaccine (clinicaltrials.gov) - P3 | N=4050 | Completed | Sponsor: PT Bio Farma | Active, not recruiting ➔ Completed

Trial completion • Infectious Disease • Novel Coronavirus Disease • Respiratory Diseases

Safety and Immunogenicity of SARS-CoV-2 Protein Subunit Recombinant Vaccine in Healthy Children (clinicaltrials.gov) - P3 | N=1050 | Recruiting | Sponsor: PT Bio Farma | Trial completion date: Dec 2022 ➔ Jan 2024 | Trial primary completion date: Dec 2022 ➔ Dec 2023

Trial completion date • Trial primary completion date • Infectious Disease • Novel Coronavirus Disease • Respiratory Diseases

Safety and Immunogenicity Study of COVID-19 Protein Subunit Recombinant Vaccine (clinicaltrials.gov) - P2/3 | N=360 | Completed | Sponsor: PT Bio Farma | Active, not recruiting ➔ Completed

Trial completion • Infectious Disease • Novel Coronavirus Disease • Respiratory Diseases

Safety and Immunogenicity Study of COVID-19 Protein Subunit Recombinant Vaccine Adjuvanted With Alum+CpG 1018 (clinicaltrials.gov) - P1 | N=175 | Completed | Sponsor: PT Bio Farma | Active, not recruiting ➔ Completed

Trial completion • Infectious Disease • Novel Coronavirus Disease • Respiratory Diseases • IL6

Safety and Immunogenicity of SARS-CoV-2 Protein Subunit Recombinant Vaccine in Healthy Children (clinicaltrials.gov) - P3 | N=1050 | Recruiting | Sponsor: PT Bio Farma | Not yet recruiting ➔ Recruiting

Enrollment open • Infectious Disease • Novel Coronavirus Disease • Respiratory Diseases

Safety and Immunogenicity of SARS-CoV-2 Protein Subunit Recombinant Vaccine in Healthy Children (clinicaltrials.gov) - P3 | N=1050 | Not yet recruiting | Sponsor: PT Bio Farma | Phase classification: P2/3 ➔ P3

Phase classification • Infectious Disease • Novel Coronavirus Disease • Respiratory Diseases

Safety and Immunogenicity of SARS-CoV-2 Protein Subunit Recombinant Vaccine in Healthy Children (clinicaltrials.gov) - P2/3 | N=1050 | Not yet recruiting | Sponsor: PT Bio Farma

New P2/3 trial • Infectious Disease • Novel Coronavirus Disease • Respiratory Diseases

Immuno-bridging Study of COVID-19 Protein Subunit Recombinant Vaccine (clinicaltrials.gov) - P3 | N=4050 | Active, not recruiting | Sponsor: PT Bio Farma | Recruiting ➔ Active, not recruiting

Enrollment closed • Infectious Disease • Novel Coronavirus Disease • Respiratory Diseases

Booster Study of COVID-19 Protein Subunit Recombinant Vaccine (clinicaltrials.gov) - P2 | N=900 | Recruiting | Sponsor: PT Bio Farma

New P2 trial • Infectious Disease • Novel Coronavirus Disease • Respiratory Diseases

Safety and Immunogenicity of SARS-CoV-2 Protein Subunit Recombinant Vaccine (clinicaltrials.gov) - P1 | N=54 | Completed | Sponsor: PT Bio Farma | Active, not recruiting ➔ Completed | Trial completion date: May 2022 ➔ Aug 2022

Trial completion • Trial completion date • Infectious Disease • Novel Coronavirus Disease • Respiratory Diseases

Safety and Immunogenicity Study of COVID-19 Protein Subunit Recombinant Vaccine Adjuvanted With Alum+CpG 1018 (clinicaltrials.gov) - P1 | N=175 | Active, not recruiting | Sponsor: PT Bio Farma | Recruiting ➔ Active, not recruiting

Enrollment closed • Infectious Disease • Novel Coronavirus Disease • Respiratory Diseases • IL6

Safety and Immunogenicity Study of COVID-19 Protein Subunit Recombinant Vaccine (clinicaltrials.gov) - P2/3 | N=360 | Active, not recruiting | Sponsor: PT Bio Farma | Recruiting ➔ Active, not recruiting | N=3960 ➔ 360

Enrollment change • Enrollment closed • Infectious Disease • Novel Coronavirus Disease • Respiratory Diseases

Immuno-bridging Study of COVID-19 Protein Subunit Recombinant Vaccine (clinicaltrials.gov) - P3 | N=4050 | Recruiting | Sponsor: PT Bio Farma

New P3 trial • Infectious Disease • Novel Coronavirus Disease • Respiratory Diseases

Safety and Immunogenicity Study of COVID-19 Protein Subunit Recombinant Vaccine Adjuvanted With Alum+CpG 1018 (clinicaltrials.gov) - P1 | N=175 | Recruiting | Sponsor: PT Bio Farma | Trial completion date: May 2022 ➔ Nov 2022

Trial completion date • Infectious Disease • Novel Coronavirus Disease • Respiratory Diseases • IL6

Safety and Immunogenicity of SARS-CoV-2 Protein Subunit Recombinant Vaccine (clinicaltrials.gov) - P1 | N=54 | Active, not recruiting | Sponsor: PT Bio Farma | Recruiting ➔ Active, not recruiting

Enrollment closed • Infectious Disease • Novel Coronavirus Disease • Respiratory Diseases

Efficacy, Safety and Immunogenicity Study of COVID-19 Protein Subunit Recombinant Vaccine (clinicaltrials.gov) - P2/3 | N=3960 | Recruiting | Sponsor: PT Bio Farma | Not yet recruiting ➔ Recruiting

Enrollment open • Infectious Disease • Novel Coronavirus Disease • Respiratory Diseases

Efficacy, Safety and Immunogenicity Study of COVID-19 Protein Subunit Recombinant Vaccine (clinicaltrials.gov) - P2/3 | N=3960 | Not yet recruiting | Sponsor: PT Bio Farma

New P2/3 trial • Infectious Disease • Novel Coronavirus Disease • Respiratory Diseases

Safety and Immunogenicity Study of COVID-19 Protein Subunit Recombinant Vaccine Adjuvanted With Alum+CpG 1018 (clinicaltrials.gov) - P1 | N=175 | Recruiting | Sponsor: PT Bio Farma | Not yet recruiting ➔ Recruiting

Enrollment open • Infectious Disease • Novel Coronavirus Disease • Respiratory Diseases • IL6

Safety and Immunogencity Study of SARS-CoV-2 Protein Subunit Recombinant Vaccine Adjuvanted With Alum+CpG 1018 (clinicaltrials.gov) - P1 | N=175 | Not yet recruiting | Sponsor: PT Bio Farma

New P1 trial • Infectious Disease • Novel Coronavirus Disease • Respiratory Diseases • IL6