Delving into the Latest Updates on Live varicella vaccine (Rongsheng Bio-Tech) with Synapse

Overview

Basic Info

Drug Type

Live attenuated vaccine, Prophylactic vaccine

Synonyms

Live varicella vaccine, VacVar, Varicella Vaccine, Live

+ [2]

Target-

Action

stimulants

Mechanism

Immunostimulants

Therapeutic Areas

Infectious Diseases

Active Indication

Varicella Zoster Virus InfectionHerpes ZosterChickenpox

Inactive Indication-

Originator Organization

Shanghai Rongsheng Biotech Co., Ltd.

Active Organization

Shanghai Rongsheng Biotech Co., Ltd.

Inactive Organization-

License Organization-

Drug Highest PhaseApproved

First Approval Date

China (25 Oct 2016),

Varicella Zoster Virus Infection

Regulation-

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The varicella vaccine is a live attenuated varicella zoster virus (VZV), first produced by Michiaki Takahashi (1974). Subsequent development of the fluorescent antibody to VZV membrane antigen test (FAMA), an immune correlate, permitted vaccine efficacy to be established, initially in immunodeficient and then in typical children and adults. Varicella vaccine is effective and safe; universal vaccination has almost eliminated varicella; moreover, endogenous boosting from subclinical VZV reactivation has evidently prevented an anticipated epidemic of zoster from occurring in response to the vaccine-induced loss of circulating varicella. The vaccine virus, moreover, reactivates less frequently than wild-type and an adjuvanted subunit vaccine against VZV gE safely prevents zoster. Doing so is important because VZV establishes latency and reactivates in sympathetic and enteric neurons; therefore, in addition to the painful cutaneous rash and postherpetic neuralgia of zoster, VZV reactivation can be an occult cause of vasculopathy, stroke, intestinal dysmotility, and achalasia.

31 Dec 2025·Expert Review of Vaccines

Immunogenicity and safety of a live attenuated varicella vaccine in healthy subjects aged between 13 to 55 years: a double-blind, randomized, active-controlled phase III clinical trial in China

Article

Author: Sun, Jinfang ; Zhang, Hao ; Zhang, Yang ; Pan, Hongxing ; Li, Jingxin ; Zhu, Fengcai ; Shi, Jinhui ; Chang, Xianyun ; Wang, Shiyuan ; Li, Guifan

BACKGROUNDAdolescents and adults who contract chickenpox are at a higher risk of severe complications. Vaccination with the varicella vaccine (VarV) effectively prevents chickenpox.RESEARCH DESIGN AND METHODSIn this phase III, single-center, randomized, double-blind, active-controlled trial, 1,200 healthy participants were randomly assigned in a 1:1 ratio to receive two doses of either the test vaccine or the active control vaccine. Varicella-zoster virus (VZV) antibody was detected before vaccination and 42 days after the two doses of vaccination.RESULTSThe lower limits of the 95% CI for the differences in seroconversion rates and geometric mean titer (GMT) ratios between the two groups were greater than their respective pre-set non-inferiority margins. The overall incidence of Adverse events (AEs) and adverse reactions (ARs) in the test group was significantly lower than those in the control group. Additionally, the incidence rates of swelling and fatigue were lower in the test group compared to the control group after vaccination.CONCLUSIONSThe test freeze-dried live attenuated VarV demonstrated good immunogenicity and higher safety compared to the active control vaccine in healthy participants aged 13-55 years.CLINICAL TRIALS REGISTRATIONwww.clinicaltrials.gov identifier: NCT06592456.

01 May 2025·Infectious Diseases Now

Assessing the effectiveness of the varicella vaccine in primary and secondary school students in Qingdao, China: A matched case–control study

Article

Author: Li, Xiaofan ; Yang, Feng ; Zhang, Zhongyang ; Ren, Zhisheng ; Liu, Sitong ; Wang, Peng ; Hu, Ping

OBJECTIVESThe effectiveness of varicella vaccination strategies needs to be further evaluated. The vaccine effectiveness (VE) of the varicella vaccine was evaluated, and changes in VE of varicella vaccination in primary and secondary school students in Qingdao, China, over time were analyzed.PATIENTS AND METHODSWe conducted a 1:3 matched case-control study, using data from the Chinese Information System for Disease Control and Prevention, Qingdao Student Health Examination Management System, and Qingdao Immunization Program Information System. VE of the varicella vaccination was estimated using conditional logistic regression modeling.RESULTSA total of 3,249 varicella cases and 9,747 matched controls were included. One- and two-dose varicella vaccination had VE of 31.95 % (95 % confidence interval [CI]: 25.05 %-38.20 %) and 82.02 % (95 % CI: 78.33 %-85.07 %), respectively, and the incremental VE (two-dose versus one-dose vaccination) was 73.57 % (95 % CI: 68.26 %-78.00 %). VE remained at 71.46 % 10 years after the two-dose varicella vaccination, compared with a considerable decrease in VE to 29.73 % approximately 3-5 years after the one-dose varicella vaccination. VE of two-dose varicella vaccination was not related to the time interval between the two doses. The risk of varicella infection decreases with the number of doses of varicella vaccine received and with the age at which the first dose is given and increases with time after the last dose.CONCLUSIONSTwo-dose varicella vaccination provides better protection for children and is therefore recommended for inclusion in China's national immunization program.

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