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All Journal Medical Journal of Indonesia SPRINTER: Jurnal Ilmu Olahraga Journal of Physical Education and Sports ACTIVE: Journal of Physical Education, Sport, Health and Recreation
Soedjatmiko
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Journal : Medical Journal of Indonesia

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Safety and immunogenicity of the CoV2-Bio in a healthy population aged 18 years and older in Indonesia Maria, Suzy; Olfriani, Ciho; Koesnoe, Sukamto; Sekartini, Rini; Soedjatmiko; Medise, Bernie Endyarni; Yuniar, Irene; Indawati, Wahyuni; Wirahmadi, Angga; Sari, Rini Mulia; Adi, Nuri Purwito; Retnaningdyah, Windri
Medical Journal of Indonesia Vol. 34 No. 1 (2025): March
Publisher : Faculty of Medicine Universitas Indonesia

Show Abstract | Download Original | Original Source | Check in Google Scholar | DOI: 10.13181/mji.oa.247476

Abstract

BACKGROUND According to the WHO Target Product Profiles for COVID-19 Vaccines, vaccine development should be indicated for active immunization in all populations, in conjunction with other control measures to curtail the pandemic. Several RBD-based COVID-19 vaccines are being evaluated and have shown advantages. CoV2-Bio was developed based on the wild-type SARS-CoV-2 RBD amino acid sequence, representing residues of the spike protein of the Wuhan-Hu-1 isolate. This study aimed to evaluate the safety and immunogenicity of CoV2-Bio when compared to CoronaVac. METHODS This was an observer-blinded, randomized controlled prospective study of safety and immunogenicity of the CoV2-Bio in healthy adult population. A total of 54 healthy participants were randomized to receive either 3 doses of CoV2-Bio or 2 doses of CoronaVac, and 1 dose of placebo, administered 28 days apart. Participants were followed up for safety and immunogenicity. IgG antibody titers (ELISA) and neutralization assay against Wuhan and Delta strains were evaluated at baseline, Days 28, 56, and 84. We assessed seropositive rate, seroconversion, and GMT as parameters. RESULTS Both vaccines were well tolerated and induced good antibody response. The incidence rate and intensity of local and systemic adverse events did not differ between vaccine and control groups. The vaccine group showed a larger proportion of seroconversion (4-fold increase antibody) (87.5% versus 46.2%, p = 0.001) and higher GMT (305.9 AU/ml versus 102.4 AU/ml, p<0.001) when compared to control group. CONCLUSIONS 3 doses of the CoV2-Bio are safe and immunogenic in healthy adult population. 3 doses of the CoV2-Bio COVID-19 vaccine produce a better immunogenicity profile compared to CoronaVac.
Co-Authors Ayu Tri Agustin Bernie Endyarni Medise Dewangga Yudhistira Fitri, Adinda Syelvia Hadi Harry Pramono, Harry Irene Yuniar, Irene Maria, Suzy Maryono, Adi Nugroho Saputro, Imron Nuri Purwito Adi Olfriani, Ciho Retnaningdyah, Windri Rini Mulia Sari Rini Sekartini Semion Sukamto Koesnoe Sulaiman Sungkowo Tandiyo Rahayu Ulinnuha, Rizam Ahada Nur Wahyuni Indawati, Wahyuni Wirahmadi, Angga