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
Indonesian vaccine producer (PT BIOFARMA), conducted a study to assess the safety and immunogenicity of a new COVID-19 vaccine candidate. This vaccine is based on a recombinant subunit protein platform, with the SARS-CoV-2 receptor-binding domain (RBD) as its target antigen. The study compared the c...
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| Format: | Article |
| Language: | English |
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Taylor & Francis Group
2025-12-01
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| Series: | Human Vaccines & Immunotherapeutics |
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| Online Access: | https://www.tandfonline.com/doi/10.1080/21645515.2025.2501467 |
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| author | Yetty Movieta Nency Rini Sekartini Angga Wirahmadi Suzy Maria Nur Farhanah Rebriarina Hapsari Endang Mahati Nani Maharani Mulyono Mulyono Dimas Tri Anantyo Setyo Gundi Pramudo Glenn Fernandez Yeremia Lilis Setyaningsih Mita Puspita Rini Mulia Sari |
| author_facet | Yetty Movieta Nency Rini Sekartini Angga Wirahmadi Suzy Maria Nur Farhanah Rebriarina Hapsari Endang Mahati Nani Maharani Mulyono Mulyono Dimas Tri Anantyo Setyo Gundi Pramudo Glenn Fernandez Yeremia Lilis Setyaningsih Mita Puspita Rini Mulia Sari |
| author_sort | Yetty Movieta Nency |
| collection | DOAJ |
| description | Indonesian vaccine producer (PT BIOFARMA), conducted a study to assess the safety and immunogenicity of a new COVID-19 vaccine candidate. This vaccine is based on a recombinant subunit protein platform, with the SARS-CoV-2 receptor-binding domain (RBD) as its target antigen. The study compared the candidate’s safety and immunogenicity to the control group vaccine, the Sinovac vaccine, 28 days after administration. This was an observer-blinded and randomized Phase 1 trial which recruited 175 subjects. The subject received 0.5 ml of vaccine in two doses. The subjects were split into five treatment groups, consisting of different combinations of doses between RBD and CpG. The safety of this vaccine was evaluated within 7 days after the first dose and for 6 months after the second dose, while the immunogenicity was evaluated on days 14 and 28 after the second dose. The overall incidence of AEs was 54.86% from the beginning of the vaccination to 28 days after each injection. Most AEs were local pain and had no serious AEs. 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. |
| format | Article |
| id | doaj-art-045c1e04960b4fa8a6c3e03148ea3ada |
| institution | OA Journals |
| issn | 2164-5515 2164-554X |
| language | English |
| publishDate | 2025-12-01 |
| publisher | Taylor & Francis Group |
| record_format | Article |
| series | Human Vaccines & Immunotherapeutics |
| spelling | doaj-art-045c1e04960b4fa8a6c3e03148ea3ada2025-08-20T02:31:59ZengTaylor & Francis GroupHuman Vaccines & Immunotherapeutics2164-55152164-554X2025-12-0121110.1080/21645515.2025.2501467Safety 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 studyYetty Movieta Nency0Rini Sekartini1Angga Wirahmadi2Suzy Maria3Nur Farhanah4Rebriarina Hapsari5Endang Mahati6Nani Maharani7Mulyono Mulyono8Dimas Tri Anantyo9Setyo Gundi Pramudo10Glenn Fernandez Yeremia11Lilis Setyaningsih12Mita Puspita13Rini Mulia Sari14Child Health Department, Faculty of Medicine, Universitas Diponegoro, Semarang, IndonesiaDepartment of Child Health, Faculty of Medicine, Universitas Indonesia, Jakarta, IndonesiaDepartment of Child Health, Faculty of Medicine, Universitas Indonesia, Jakarta, IndonesiaAllergy and Clinical Immunology Division, Department of Internal Medicine, Faculty of Medicine, Universitas Indonesia, Dr. Cipto Mangunkusumo Hospital, Jakarta, IndonesiaDepartment of Internal Medicine, Faculty of Medicine, Universitas Diponegoro, Semarang, IndonesiaDepartment of Microbiology, Faculty of Medicine, Universitas Diponegoro, Semarang, IndonesiaDepartment of Pharmacology and Therapy, Faculty of Medicine, Universitas Diponegoro, Semarang, IndonesiaDepartment of Pharmacology and Therapy, Faculty of Medicine, Universitas Diponegoro, Semarang, IndonesiaChild Health Department, Faculty of Medicine, Universitas Diponegoro, Semarang, IndonesiaChild Health Department, Faculty of Medicine, Universitas Diponegoro, Semarang, IndonesiaDepartment of Internal Medicine, Faculty of Medicine, Universitas Diponegoro, Semarang, IndonesiaCOVID 19 Vaccine Bio Farma-Universitas Diponegoro (COBIU) Study, Faculty of Medicine, Universitas Diponegoro, Semarang, IndonesiaClinical Trial Division, PT Bio Farma, Bandung, IndonesiaClinical Trial Division, PT Bio Farma, Bandung, IndonesiaClinical Trial Division, PT Bio Farma, Bandung, IndonesiaIndonesian vaccine producer (PT BIOFARMA), conducted a study to assess the safety and immunogenicity of a new COVID-19 vaccine candidate. This vaccine is based on a recombinant subunit protein platform, with the SARS-CoV-2 receptor-binding domain (RBD) as its target antigen. The study compared the candidate’s safety and immunogenicity to the control group vaccine, the Sinovac vaccine, 28 days after administration. This was an observer-blinded and randomized Phase 1 trial which recruited 175 subjects. The subject received 0.5 ml of vaccine in two doses. The subjects were split into five treatment groups, consisting of different combinations of doses between RBD and CpG. The safety of this vaccine was evaluated within 7 days after the first dose and for 6 months after the second dose, while the immunogenicity was evaluated on days 14 and 28 after the second dose. The overall incidence of AEs was 54.86% from the beginning of the vaccination to 28 days after each injection. Most AEs were local pain and had no serious AEs. 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.https://www.tandfonline.com/doi/10.1080/21645515.2025.2501467COVID-19 vaccineIndovacsafetyphase-1immunogenicity |
| spellingShingle | Yetty Movieta Nency Rini Sekartini Angga Wirahmadi Suzy Maria Nur Farhanah Rebriarina Hapsari Endang Mahati Nani Maharani Mulyono Mulyono Dimas Tri Anantyo Setyo Gundi Pramudo Glenn Fernandez Yeremia Lilis Setyaningsih Mita Puspita Rini Mulia Sari 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 Human Vaccines & Immunotherapeutics COVID-19 vaccine Indovac safety phase-1 immunogenicity |
| title | 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 |
| title_full | 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 |
| title_fullStr | 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 |
| title_full_unstemmed | 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 |
| title_short | 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 |
| title_sort | safety and immunogenicity of sars cov 2 protein subunit recombinant vaccine indovac r in healthy populations aged 18 years and above in indonesia a phase i observer blind randomized controlled study |
| topic | COVID-19 vaccine Indovac safety phase-1 immunogenicity |
| url | https://www.tandfonline.com/doi/10.1080/21645515.2025.2501467 |
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