A phase III, observer-blind, randomized, placebo-controlled study of the efficacy, safety, and immunogenicity of SARS-CoV-2 inactivated vaccine in healthy adults aged 18–59 years: An interim analysis in Indonesia. Issue 44 (22nd October 2021)

• Record Type: Journal Article
• Authors: Fadlyana, Eddy; Rusmil, Kusnandi; Tarigan, Rodman; Rahmadi, Andri Reza; Prodjosoewojo, Susantina; Sofiatin, Yulia; Khrisna, Citra V.; Sari, Rini Mulia; Setyaningsih, Lilis; Surachman, Fikrianti; Bachtiar, Novilia Sjafri; Sukandar, Hadyana; Megantara, Imam; Murad, Chrysanti; Pangesti, Krisna Nur A.; Setiawaty, Vivi; Sudigdoadi, Sunarjati; Hu, Yaling; Gao, Qiang; Kartasasmita, Cissy B.
• Is Part Of: Vaccine. Volume 39:Issue 44(2021)
• Page Start: 6520
• Page End: 6528
• Publication Date: 2021-10-22
• Subjects: Adults -- Efficacy -- Safety -- Immunogenicity -- SARS-CoV-2 Inactivated Vaccine; COVID-19 Coronavirus Disease 2019 -- ELISA Enzyme Link Immunoassay -- GMT Geometric Mean Titer -- IgG Immunoglobulin G -- rRT-PCR Real-time Reverse Transcriptase-PCR -- SARS Severe Acute Respiratory Syndrome -- WHO World Health Organization; Vaccines -- Periodicals; 615.372
• DOI: 10.1016/j.vaccine.2021.09.052
• Languages: English
• ISSNs: 0264-410X

Abstract

Highlights: Most of the adverse reactions were mild in severity with pain at the injection site as the most frequently reported symptom. The inactivated SARS-CoV-2 vaccine capable of inducing immune response within 14 days after complete dose. The efficacy of the inactivated SARS-CoV-2 vaccine in preventing symptomatic confirmed cases of COVID-19 was 65.30%. Abstract: Background: The WHO declared COVID-19 a pandemic on March 11th, 2020. This serious outbreak and the precipitously increasing numbers of deaths worldwide necessitated the urgent need to develop an effective severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) vaccine. The development of COVID-19 vaccines has moved quickly. In this study, we assessed the efficacy, safety, and immunogenicity of an inactivated (SARS-CoV-2) vaccine. Methods: We conducted a randomized, double-blind, placebo-controlled trial to evaluate the efficacy, immunogenicity, and safety of an inactivated SARS-CoV-2 vaccine and its lot-to-lot consistency. A total of 1620 healthy adults aged 18–59 years were randomly assigned to receive 2 injections of the trial vaccine or placebo on a day 0 and 14 schedule. This article was based on an interim report completed within 3 months following the last dose of study vaccine. The interim analysis includes safety and immunogenicity data for 540 participants in the immunogenicity subset and an efficacy analysis of the 1620 subjects. For the safety evaluation, solicited and unsolicited adverse events were collected after the first and second vaccination within 14 and 28 days, respectively. Blood samples were collected for an antibody assay before and 14 days following the second dose. Results: Most of the adverse reactions were in the solicited category and were mild in severity. Pain at the injection site was the most frequently reported symptom. Antibody IgG titer determined by enzyme-linked immunosorbent assay was 97.48% for the seroconversion rate. Using a neutralization assay, the seroconversion rate was 87.15%. The efficacy in preventing symptomatic confirmed cases of COVID-19 occurring at least 14 days after the second dose of vaccine using an incidence rate was 65.30%. Conclusions: From the 3-month interim analysis, the vaccine exhibited a 65.30% efficacy at preventing COVID-19 illness with favorable safety and immunogenicity profiles.