Trial reportHuman vaccines & immunotherapeutics2025
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.
Trial report in Human vaccines & immunotherapeutics, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 2 papers.
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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
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Who cites it
2 citing papers in PubMed.
- Anti-SARS-CoV-2 response in alveolar blood sample and bronchoalveolar lavage fluid of individuals vaccinated with inactivated COVID-19 vaccines.Human vaccines & immunotherapeutics · 2026Article
- An adenovirus-vectored recombinant vaccine confers passive immunity protection from swine acute diarrhea syndrome coronavirus challenge in neonatal mice.Virologica Sinica · 2025Article
Corrections and comments
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Authors and funding
15 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
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.
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