Academic Staff Department of Pharmacology & Therapy, Faculty of Medicine, Public Health, and Nursing, Universitas Gadjah Mada, Yogyakarta, Indonesia Yogyakarta, Indonesia
Background: The BBIBP-CorV Sinopharm vaccine is an inactivated vaccine developed by Beijing Bi-Institute Biological Product-Co, Ltd, distributed in Indonesia by Kimia-Farma Persero Indonesia. Data on vaccine implementation in developing countries were limited; therefore, we performed a prospective cohort study to determine real-world vaccine immunogenicity and safety in Indonesia.
Objectives: To evaluate the vaccine immunogenicity and safety in Indonesia.
Methods: A multicenter prospective observational study evaluated the immunogenicity and safety of a two-dose regimen of BBIBP-CorV inactivated vaccine in the Indonesian adult population aged 18 years old and above. The level of serum SARS-CoV-2 surrogate virus neutralization test neutralizing antibody (sVNT Nab), anti-sRBD total antibody, and anti-nucleocapsid antibody were measured at the scheduled site visit before the vaccination (baseline on the same day) and on days 14, 90, and 180 after the second vaccine dose. Vaccination safety was assessed within 30-days after each dose and effectiveness was explored until 180 days after the second vaccine dose.
Results: Total of 417 healthy adults were enrolled and received at least one dose of vaccine, 62% male, and age were 30.8 years old (+/-12.2). There were significant increases sVNT NAbs from baseline 40 (13.25-72) to 90.5 (77.75-97) and 97 (85-98) and the anti-sRBD total antibody from baseline 35.2 (25.9-47.9) to 597.04 (472.06-756.83) and 1606.94 (1327.39-1945.36) at 14 and 90 after the second dose, respectively. However, these responses decline on days 180 after the second vaccine. Following vaccination, 98.4% of participants showed seropositivity of anti-nucleocapsid antibodies on days 90. The seropositivity decreased to 96.1% on days 180 after the second vaccine. Solicited and unsolicited adverse events were reported, and one serious adverse event occurred. There were no adverse event of special interest and symptomatic cases of COVID-19 during the study follow-up.
Conclusions: BBIBP-CorV inactivated vaccine was immunogenic in most of the Indonesian adult population with an acceptable safety profile and the antibody levels decreased after 180 days.
