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Clinical Trial
. 2021 Oct 22;39(44):6520-6528.
doi: 10.1016/j.vaccine.2021.09.052. Epub 2021 Sep 24.

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

Eddy Fadlyana  1 , Kusnandi Rusmil  2 , Rodman Tarigan  2 , Andri Reza Rahmadi  2 , Susantina Prodjosoewojo  2 , Yulia Sofiatin  3 , Citra V Khrisna  2 , Rini Mulia Sari  4 , Lilis Setyaningsih  5 , Fikrianti Surachman  6 , Novilia Sjafri Bachtiar  7 , Hadyana Sukandar  2 , Imam Megantara  8 , Chrysanti Murad  2 , Krisna Nur A Pangesti  9 , Vivi Setiawaty  9 , Sunarjati Sudigdoadi  2 , Yaling Hu  10 , Qiang Gao  11 , Cissy B Kartasasmita  2
Affiliations
Clinical Trial

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

Eddy Fadlyana et al. Vaccine. .

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.

Keywords: Adults; Efficacy; Immunogenicity; SARS-CoV-2 Inactivated Vaccine; Safety.

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Conflict of interest statement

Declaration of Competing Interest The authors declare that they have no known competing financial interests or personal relationships that could have appeared to influence the work reported in this paper.

Figures

Fig. 1
Fig. 1
Participant Disposition.
Fig. 2
Fig. 2
Adverse Events occurring after the First and Second Vaccine Injection.
See this image and copyright information in PMC

References

    1. Ophinni Y., Hasibuan A.S., Widhani A., Maria S., Koesnoe S., Yunihastuti E., et al. COVID-19 Vaccines: Current Status and Implication for Use in Indonesia. Acta Med Indones. 2020;52:388–412. - PubMed
    1. WHO Coronavirus disease (COVID-19) Situation Report-132. 2020
    1. Gupta S.D. Coronavirus Pandemic: A Serious Threat to Humanity. J Health Manag. 2020;22(1):1–2. doi: 10.1177/0972063420921260. - DOI
    1. Zhu N.a., Zhang D., Wang W., Li X., Yang B.o., Song J., et al. A Novel Coronavirus from Patients with Pneumonia in China, 2019. N Engl J Med. 2020;382(8):727–733. doi: 10.1056/NEJMoa2001017. - DOI - PMC - PubMed
    1. García-Basteiro A.L., Chaccour C., Guinovart C., Llupià A., Brew J., Trilla A., et al. Monitoring the COVID-19 epidemic in the context of widespread local transmission. Lancet Respir Med. 2020;8(5):440–442. doi: 10.1016/S2213-2600(20)30162-4. - DOI - PMC - PubMed

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