A randomized, blinded, positively controlled phase I clinical trial evaluating the safety of live attenuated varicella vaccine in a healthy population of different ages

Start Date15 Nov 2023

Sponsor / Collaborator-

ChiCTR2400091380 / CompletedPhase 4IIT

Single-center, randomized, double-blind design of an interbatch consistent clinical trial to evaluate the immunogenicity and safety of three consecutive batches of live attenuated varicella vaccine in healthy people aged 1-12 years

Start Date15 Jul 2023

Sponsor / Collaborator-

ChiCTR2300072153 / RecruitingPhase 3IIT

Phase III clinical trial of randomized, blinded, controlled immunogenicity and safety of live attenuated varicella vaccine in people aged 13 years and older

Start Date05 Jun 2023

Sponsor / Collaborator-

100 Clinical Results associated with Live attenuated varicella vaccine (Zhongyi Anke Biotechology/Liaoning Maokangyuan Biotech)

100 Translational Medicine associated with Live attenuated varicella vaccine (Zhongyi Anke Biotechology/Liaoning Maokangyuan Biotech)

100 Patents (Medical) associated with Live attenuated varicella vaccine (Zhongyi Anke Biotechology/Liaoning Maokangyuan Biotech)

172

Literatures (Medical) associated with Live attenuated varicella vaccine (Zhongyi Anke Biotechology/Liaoning Maokangyuan Biotech)

01 Jan 2024·Vaccine

Immunogenicity and safety of a live-attenuated varicella vaccine in a healthy population aged 13 years and older: A randomized, double-blind, controlled study

Article

Author: Wang, Yanxia ; Luan, Chunfang ; Jia, Ningning ; Chen, Zhen ; Huang, Lili ; Li, Changgui ; Feng, Guangwei ; Yuan, Hongxue ; Tan, Jiebing ; Quan, Yaru ; Song, Yufei ; You, Wangyang

OBJECTIVESVaccines for prevention against varicella are important for adolescents and adults, who have an increased risk of severe varicella. This study aimed to evaluate the immunogenicity and safety of a two-dose immunization schedule of a live-attenuated varicella vaccine (VarV) manufactured by Sinovac (Dalian) in healthy adolescents and adults.METHODSA randomized, double-blind, controlled clinical trial was conducted in healthy population aged ≥ 13 years old in China. Participants in block 1 were randomly assigned (1:1) to receive two doses of either the test vaccine or an active control vaccine, administered 4, 6 or 8 weeks apart. Participants in block 2 were randomly assigned (2:1) to receive two doses of test vaccine or placebo, administered 10 weeks apart. The primary immunogenicity endpoint was the seroconversion rates and GMTs of varicella zoster virus (VZV) antibodies measured by fluorescent-antibody-to-membrane-antigen (FAMA) 4 weeks post-immunization. The primary safety endpoint was the incidence of adverse reactions within 4 weeks after each dose.RESULTSA total of 2398 participants were enrolled. The seroconversion rates of VZV antibodies were 79.55 % in the test group and 76.41 % in the active control group respectively 4 weeks after two doses of pooled schedule, with the difference of 3.14 % (95 %CI: -0.69 %, 6.97 %). The GMTs were 1:162.07 and 1:160.04 respectively, with the ratio of 1.013 (95 %CI: 0.910, 1.127). Both the seroconversion rates and GMTs reached the prespecified non-inferiority criteria. Two-dose schedule with an interval of 10 weeks could also induce high immune responses, with a seroconversion rate of 83.22 % and a GMT of 1:160.38 in the test group. Safety profiles were similar among the test group, active control group and placebo group.CONCLUSIONVarV, manufactured by Sinovac (Dalian), demonstrated higher immune response and better flexibility in the immunization schedule among heathy population aged 13 years and older, without increased safety risk.

01 Dec 2023·Analytical Biochemistry

Development of potentiometric immunosensor for determination of live attenuated Varicella Vaccine: Potency and stability studies

Article

Author: Nadim, Ahmed H. ; Mostafa, Moushira M. ; Elzanfaly, Eman S ; Nadim, Ahmed H ; Sedik, Ghada A. ; Elzanfaly, Eman S. ; Mostafa, Moushira M ; Sedik, Ghada A

Determination of Varicella vaccine's potency; containing live attenuated strain (Oka) of Varicella Zoster virus, has been limited to in vitro cell culture methods. In this study, a label free potentiometric biosensor has been developed for the first time and optimized to determine the content of varicella zoster virus. A passive ion-flux sensing platform has been developed using an anti-varicella monoclonal antibody and tetrabutyl ammonium bromide as a marker ion. The immunosensor has been optimized with respect to membrane diameter and concentration of the immobilized antibody. Linearity was achieved over a concentration range of 2.5-3.2 log PFU/dose with a LOD of 1.9 log PFU/dose. Potentiometric results were compared to the plaque-forming assay using the cell culture technique. The developed immunosensor was superior with respect to analysis time and cost without affecting critical analytical performance characteristics. Furthermore, in order to evaluate the stability indicating ability of the immunosensor, the effect of pH and temperature was investigated. Vaccine samples were subjected to forced degradation conditions; pH and elevated temperatures. Stability results showed the ability of immunosensor to differentiate between intact and degraded viral content. This would demonstrate the reliability of the immunosensor for evaluating the efficacy and stability of the vaccine.

27 Apr 2023·Communicable diseases intelligence (2018)

ATAGI Targeted Review 2022: Vaccination for prevention of herpes zoster in Australia.

Review

Author: Giles, Michelle ; Chiu, Clayton ; Burns, Penelope ; Liu, Bette ; Crawford, Nigel ; Jayasinghe, Sanjay ; Li-Kim-Moy, Jean ; Macartney, Kristine ; Huang, Yuanfei Anny

AbstractIn November 2016, herpes zoster (HZ) vaccination for older adults, using the live-attenuated zoster vaccine (Zostavax; ZVL) was added to the Australian National Immunisation Program (NIP) with the aim of reducing morbidity from HZ and its complications, particularly for people at increased risk. Prior to the program, there were on average 5.6 cases of HZ per 1,000 persons annually in Australia, with highest risk of disease in older and in immunocompromised people. The burden of complications of HZ, such as post-herpetic neuralgia (PHN), was also highest in older and immunocompromised groups. No formal comprehensive program evaluation has been undertaken since program commencement. This review examined published literature and available vaccine administration data to summarise the evidence and considerations underpinning current use of HZ vaccines and potential future program directions in Australia. There have been modest reductions in the incidence of HZ and its complications since program introduction. However, five years into the program, challenges remain, including suboptimal vaccine coverage and significant safety concerns arising from inadvertent use of ZVL in immunocompromised people, who are contraindicated to receive this vaccine. This reduces opportunities to offset the burden of HZ-related disease. The recombinant subunit zoster vaccine (Shingrix; RZV), first registered in Australia in 2018, became available on the Australian market in June 2021. This vaccine has higher efficacy than ZVL and, as a non-live vaccine, can be used in both immunocompetent and immunocompromised people. RZV has potential to address the unmet needs of at-risk population groups. However, it has not yet demonstrated cost-effectiveness for inclusion as a funded vaccine under the NIP. The Australian HZ vaccination program has had limited effectiveness in meeting its aim in highest risk groups. Future options and challenges anticipated in using vaccination to reduce the burden of HZ and its complications are discussed in this review.

100 Deals associated with Live attenuated varicella vaccine (Zhongyi Anke Biotechology/Liaoning Maokangyuan Biotech)

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Indication	Highest Phase	Country/Location	Organization	Date
Chickenpox	IND Application	CN	Zhongyianke Biotech Co., Ltd.	07 Jun 2022

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