Immunogenicity and safety profiles of a new MAV/06 strain varicella vaccine in healthy children: A multinational, multicenter, randomized, double-blinded, active-controlled phase III study

Ui Yoon Choi; Ki Hwan Kim; Jin Lee; Byung Wook Eun; Dong Ho Kim; Sang Hyuk Ma; Chun Soo Kim; Keswadee Lapphra; Auchara Tangsathapornpong; Pope Kosalaraksa; Peninnah Oberdorfer; Hwang Min Kim; Son Moon Shin; Jin Han Kang

doi:10.1016/j.vaccine.2021.02.013

Immunogenicity and safety profiles of a new MAV/06 strain varicella vaccine in healthy children: A multinational, multicenter, randomized, double-blinded, active-controlled phase III study

Vaccine. 2021 Mar 19;39(12):1758-1764. doi: 10.1016/j.vaccine.2021.02.013. Epub 2021 Feb 21.

Authors

Ui Yoon Choi¹, Ki Hwan Kim², Jin Lee³, Byung Wook Eun⁴, Dong Ho Kim⁵, Sang Hyuk Ma⁶, Chun Soo Kim⁷, Keswadee Lapphra⁸, Auchara Tangsathapornpong⁹, Pope Kosalaraksa¹⁰, Peninnah Oberdorfer¹¹, Hwang Min Kim¹², Son Moon Shin¹³, Jin Han Kang¹⁴

Affiliations

¹ Department of Pediatrics, Eunpyeong St. Mary's Hospital, College of Medicine, The Catholic University of Korea, Seoul, Republic of Korea. Electronic address: uiyoon@catholic.ac.kr.
² Department of Pediatrics, Incheon St. Mary's Hospital, College of Medicine, The Catholic University of Korea, Seoul, Republic of Korea. Electronic address: poohwa99@gmail.com.
³ Department of Pediatrics, Hanil General Hospital, Seoul, Republic of Korea. Electronic address: pedleejin@naver.com.
⁴ Department of Pediatrics, Nowon Eulji Medical Center, Eulji University School of Medicine, Seoul, Republic of Korea. Electronic address: acet0125@hanmail.net.
⁵ Department of Pediatrics, Korea Cancer Center Hospital, Seoul, Republic of Korea. Electronic address: kdh281920@gmail.com.
⁶ Department of Pediatrics, Changwon Fatima Hospital, Changwon, Republic of Korea. Electronic address: msh6517@hanmail.net.
⁷ Department of Pediatrics, Dongsan Medical Center, Keimyung University School of Medicine, Daegu, Republic of Korea. Electronic address: cskim@dsmc.or.kr.
⁸ Pediatric Infectious Disease Unit, Department of Pediatrics, Faculty of Medicine Siriraj Hospital, Mahidol University, Bangkok Noi, Bangkok, Thailand. Electronic address: keswadee@gmail.com.
⁹ Department of Pediatrics, Faculty of Medicine, Thammasat University, Klong Luang, Thailand. Electronic address: dr.auchara@yahoo.com.
¹⁰ Department of Pediatrics, Faculty of Medicine, Khon Kaen University, Khon Kaen, Thailand. Electronic address: pkosalaraksa@gmail.com.
¹¹ Division of Pediatric Infectious Disease, Department of Pediatrics, Faculty of Medicine, Chiang Mai University, Chiang Mai, Thailand. Electronic address: oberdorferp@gmail.com.
¹² Department of Pediatrics, Wonju Severance Christian Hospital, Yonsei University Wonju College of Medicine, Wonju, Republic of Korea. Electronic address: khm9120@yonsei.ac.kr.
¹³ Department of Pediatrics, Cheil General Hospital, Seoul, Republic of Korea. Electronic address: smshinmd@hanmail.net.
¹⁴ Department of Pediatrics, Seoul St. Mary's Hospital, College of Medicine, The Catholic University of Korea, Seoul, Republic of Korea; Vaccine Bio Research Institute, College of Medicine, The Catholic University of Korea, Seoul, Republic of Korea. Electronic address: kjhan@catholic.ac.kr.

PMID: 33627245
DOI: 10.1016/j.vaccine.2021.02.013

Abstract

Immunization is the most effective preventive strategy against varicella. While the Oka strain is commonly used for varicella vaccination worldwide, Korea widely uses the MAV/06 strain. A new live attenuated MAV/06 strain varicella vaccine (MG1111), which uses the new cell line Medical Research Council-5 for better viral propagation, was developed. MG1111 was approved by Korean health authorities. Here, we report the results of phase III, randomized, double-blind, multicenter study conducted in Korea and Thailand, which compared the immunogenicity and safety profiles of MG1111 versus the control vaccine, Varivax^TM. In total, 515 healthy children (12 month-12 years) were randomized 1:1 to receive either the MG1111 or control vaccine (MG1111: 258, Control: 257). The seroconversion rate (SCR) and geometric mean titer (GMT) were measured using the fluorescent antibody to membrane antigen (FAMA) test. The MG1111 group achieved a SCR of 97.9% (95% CI: 95.2-99.3) after vaccination. The lower limit of 95% CI for SCR difference (MG1111-Varivax^TM) was -4.0%, which was higher than the specified non-inferiority margin of -10%. Further, the GMT of the MG1111 increased from 2.0 to 74.2 (95% CI: 65.0-84.8) and the lower limits of the 95% CI for post-vaccination GMT ratios (MG1111/Varivax^TM) were 0.55 higher than the specified parameter of 0.5. Therefore, the MG1111 group was not statistically inferior to the control vaccine group in terms of SCR and GMT. Furthermore, the MG1111 and control vaccine groups were not significantly different in the percentage of participants showing adverse events-solicited, local, or systemic during 43-day period of observation and serious adverse events during 6 month of observation. The present results indicate that MG1111was not immunologically inferior to Varivax^TM, and safety profiles of MG1111 are similar to those of Varivax^TM.

Keywords: Children; Double blind; Immunogenicity; MAV/06 strain; Multicenter; Multinational; Phase 3 Clinical trial; Safety; Varicella Vaccine.

Publication types

Clinical Trial, Phase III
Multicenter Study
Randomized Controlled Trial
Research Support, Non-U.S. Gov't

MeSH terms

Antibodies, Viral
Chickenpox Vaccine* / adverse effects
Chickenpox*
Child
Double-Blind Method
Humans
Immunogenicity, Vaccine
Republic of Korea
Thailand

Substances

Antibodies, Viral
Chickenpox Vaccine