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.
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.
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DOI：
10.1016/j.vaccine.2021.09.052
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发表时间：
2021-10-22
期刊：
影响因子：
5.5
通讯作者：
Kartasasmita CB
中科院分区：
文献类型：
--
作者：
Fadlyana E;Rusmil K;Tarigan R;Rahmadi AR;Prodjosoewojo S;Sofiatin Y;Khrisna CV;Sari RM;Setyaningsih L;Surachman F;Bachtiar NS;Sukandar H;Megantara I;Murad C;Pangesti KNA;Setiawaty V;Sudigdoadi S;Hu Y;Gao Q;Kartasasmita CB
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. 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. 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%. From the 3-month interim analysis, the vaccine exhibited a 65.30% efficacy at preventing COVID-19 illness with favorable safety and immunogenicity profiles.
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BNT162B2 mRNA COVID-19疫苗的安全性和功效。
DOI：
10.1056/nejmoa2034577
发表时间：
2020-12-31
期刊：
The New England journal of medicine
影响因子：
--
作者：
Polack FP;Thomas SJ;Kitchin N;Absalon J;Gurtman A;Lockhart S;Perez JL;Pérez Marc G;Moreira ED;Zerbini C;Bailey R;Swanson KA;Roychoudhury S;Koury K;Li P;Kalina WV;Cooper D;Frenck RW Jr;Hammitt LL;Türeci Ö;Nell H;Schaefer A;Ünal S;Tresnan DB;Mather S;Dormitzer PR;Şahin U;Jansen KU;Gruber WC;C4591001 Clinical Trial Group
通讯作者：
C4591001 Clinical Trial Group
DOI：
10.1016/s1473-3099(20)30843-4
发表时间：
2021-03
期刊：
The Lancet. Infectious diseases
影响因子：
--
作者：
Zhang Y;Zeng G;Pan H;Li C;Hu Y;Chu K;Han W;Chen Z;Tang R;Yin W;Chen X;Hu Y;Liu X;Jiang C;Li J;Yang M;Song Y;Wang X;Gao Q;Zhu F
通讯作者：
Zhu F
DOI：
10.1056/nejmoa2107715
发表时间：
2021-09-02
期刊：
The New England journal of medicine
影响因子：
--
作者：
Jara A;Undurraga EA;González C;Paredes F;Fontecilla T;Jara G;Pizarro A;Acevedo J;Leo K;Leon F;Sans C;Leighton P;Suárez P;García-Escorza H;Araos R
通讯作者：
Araos R
影响因子：
17.1
作者：
Grzelak L;Temmam S;Planchais C;Demeret C;Tondeur L;Huon C;Guivel-Benhassine F;Staropoli I;Chazal M;Dufloo J;Planas D;Buchrieser J;Rajah MM;Robinot R;Porrot F;Albert M;Chen KY;Crescenzo-Chaigne B;Donati F;Anna F;Souque P;Gransagne M;Bellalou J;Nowakowski M;Backovic M;Bouadma L;Le Fevre L;Le Hingrat Q;Descamps D;Pourbaix A;Laouénan C;Ghosn J;Yazdanpanah Y;Besombes C;Jolly N;Pellerin-Fernandes S;Cheny O;Ungeheuer MN;Mellon G;Morel P;Rolland S;Rey FA;Behillil S;Enouf V;Lemaitre A;Créach MA;Petres S;Escriou N;Charneau P;Fontanet A;Hoen B;Bruel T;Eloit M;Mouquet H;Schwartz O;van der Werf S
通讯作者：
van der Werf S
影响因子：
5.5
作者：
Vellozzi, Claudia;Burwen, Dale R.;Haber, Penina
通讯作者：
Haber, Penina