Delving into the Latest Updates on Varicella zoster vaccine(Green Cross Holdings) with Synapse

The goal of this bridging study is to assess the safety and immunogenicity of BARYCELA inj. in healthy Vietnamese children aged between 12 months to 12 years. The main questions it aims to answer are:
Safety of BARYCELA inj. (Live attenuated varicella vaccine for injection)
Immunogenicity of BARYCELA inj. (Live attenuated varicella vaccine for injection)
Participants will be administered subcutaneously with a single dose(0.5 mL dose) of the BARYCELA inj.(MG1111) on the upper arm (brachia lateral).

Start Date01 Feb 2023

Sponsor / Collaborator

GC Biopharma Corp.

NCT05422508 / RecruitingPhase 2

A Double-blind, Randomized, Multi-Center, Active Controlled Phase 2 Clinical Trial to Evaluate the Safety and Immunogenicity After MG1111(BARICELA Inj.) as 2nd Vaccination in 4 ~ 6 Year Old Healthy Children With a History of 1st Varicella Vaccination

Primary objective is to assess the safety of MG1111 until Day 42 using as 2nd vaccination
Secondary objective to assess the immunogenicity and safety of MG1111 using as 2nd vaccination

Start Date05 Jul 2022

Sponsor / Collaborator

Green Cross Co., Ltd.

NCT02367638 / CompletedPhase 1

A Single-center, Dose Block-randomized, Single-blind, Active-controlled, Dose Escalation Phase 1 Clinical Trial to Evaluate the Safety and Efficacy (Immunogenicity) of MG1111 in Healthy Adults

The purpose of this study is to determine whether varicella live vaccine is safe and effective in the healthy adults.

Start Date01 Mar 2015

Sponsor / Collaborator

Green Cross Co., Ltd.

100 Clinical Results associated with Varicella zoster vaccine(Green Cross Holdings)

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100 Translational Medicine associated with Varicella zoster vaccine(Green Cross Holdings)

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100 Patents (Medical) associated with Varicella zoster vaccine(Green Cross Holdings)

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Literatures (Medical) associated with Varicella zoster vaccine(Green Cross Holdings)

01 Mar 2023·Journal of Medical Virology

Assessment of attenuation of varicella‐zoster virus vaccines based on genomic comparison

Article

Author: Park, Daechan ; Seo, Jina ; Moon, Jae Yun ; Lee, Jaewoo

AbstractLive attenuated varicella‐zoster virus (VZV) vaccines are used to prevent chickenpox and shingles. Single nucleotide polymorphisms (SNPs) that occur during the attenuation of parental strains are critical indicators of vaccine safety. To assess the attenuation of commercial VZV vaccines, genetic variants were comprehensively examined through high‐throughput sequencing of viral DNA isolated from four VZV vaccines (Barycela, VarilRix, VariVax, and SKY Varicella). Whole‐genome comparison of the four vaccines with the wild‐type strain (Dumas) revealed that the sequences are highly conserved on a genome‐wide scale. Among the 196 common variants across the four vaccines, 195 were already present in the genome of the parental strain (pOka), indicating that the variants occurred during the generation of the parental strain from the Dumas strain. Compared to the pOka genome, the vaccines exhibited distinct variant frequencies on a genome‐wide and within an attenuation‐related open reading frame. In particular, attenuation‐associated 42 SNPs showed that Barycela, VarilRix, VariVax, and SKY Varicella are in ascending order regarding similarity with pOka‐like genotypes, which in turn, might provide genomic evidence for the levels of attenuation. Finally, the phylogenetic network analysis demonstrated that genetic distances from the parental strain correlated with the attenuation levels of the vaccines.

02 Jan 2023·Human Vaccines & Immunotherapeutics

Cross-reactive humoral immunity of clade 2 Oka and MAV/06 strain-based varicella vaccines against different clades of varicella–zoster virus

Article

Author: Shin, Ok Sarah ; Shin, Younchul ; Kim, Yunhwa ; Gim, Jeong-An ; Hwang, Ji-Young ; Park, Hosun ; Lee, Kyung-Min

The currently used Japanese Oka and Korean MAV/06-attenuated varicella vaccine strains belong to clade 2 genotype varicella-zoster viruses (VZV). More than seven clades of VZV exist worldwide. In this study, we investigated the cross-reactivity of antibodies induced by clade 2 genotype vaccines against VZV strains belonging to clades 1, 2, 3, and 5 using a fluorescent antibody to membrane antigen (FAMA) test. Among 59 donors, 29 were vaccinated with the MAV/06 strain MG1111 (GC Biopharma, South Korea) and the other 30 were vaccinated with the Oka strain VARIVAX (Merck, USA). The sera were titrated using FAMA tests prepared with six different VZV strains (two vaccine strains, one wild-type clade 2 strain, and one each of clade 1, 3, and 5 strains). The ranges of geometric mean titers (GMTs) of FAMA against six different strains were 158.7-206.5 and 157.6-238.9 in MG1111 and VARIVAX groups, respectively. GMTs of the MG1111 group against all six strains were similar; however, GMTs of the VARIVAX group showed differences of approximately 1.5-fold depending on the strains. Nevertheless, the GMTs of the two vaccinated groups for the same strain were not significantly different. These results suggest that both MG1111 and VARIVAX vaccinations induce cross-reactive humoral immunity against other clades of VZV.

01 Mar 2021·VaccineQ3 · MEDICINE

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

Q3 · MEDICINE

Article

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

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.

100 Deals associated with Varicella zoster vaccine(Green Cross Holdings)

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