Delving into the Latest Updates on Reassortant Rotavirus Vaccine, live, Oral, Trivalent (Vero Cell) (Lanzhou Institute of Biological Products) with Synapse

Overview

Basic Info

Drug Type

Live attenuated vaccine, Prophylactic vaccine, Multivalent vaccine

Synonyms

Rotavirus vaccine trivalent (Lanzhou Institute of Biological Products), Trivalent genetic reassortant rotavirus vaccine(Lanzhou Institute of Biological Products), Ⅲ价轮状病毒基因重配疫苗（兰州生物制品研究所）

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Target-

Mechanism

Immunostimulants

Therapeutic Areas

Digestive System Disorders

Active Indication

Viral gastroenteritis due to Rotavirus

Inactive Indication-

Originator Organization

Lanzhou Institute of Biological Products Co. Ltd.

Active Organization

Lanzhou Institute of Biological Products Co. Ltd.

Inactive Organization-

Drug Highest PhaseApproved

First Approval Date

CN (17 Apr 2023),

Viral gastroenteritis due to Rotavirus

Regulation-

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主要目的考核和评价Ⅲ价轮状病毒基因重配疫苗接种人体后对轮状病毒胃肠炎的预防效果和降低重症轮状病毒腹泻的效力。次要目的 1．进一步考察疫苗接种后安全性。 2．进一步评价疫苗免疫原性。 3. 评价疫苗对各基因型轮状病毒的预防效果。

[Translation]

Main purpose: To evaluate the preventive effect of rotavirus gastroenteritis and the effectiveness of reducing severe rotavirus diarrhea after vaccination with Ⅲ-valent rotavirus gene reassortment vaccine. Secondary purpose: 1. To further investigate the safety of vaccination. 2. To further evaluate the immunogenicity of the vaccine. 3. To evaluate the preventive effect of the vaccine on various genotypes of rotavirus.

Start Date07 Aug 2012

Sponsor / Collaborator

Lanzhou Institute of Biological Products Co. Ltd.

NCT01738074 / Unknown statusPhase 3IIT

Phase Three Clinical Trials of Trivalent Rotavirus Genetic Reassortment Vaccine

Assessment and evaluation the rotavirus gastroenteritis prevention effect and severe rotavirus diarrhea reducing effectiveness of human body, which inoculate trivalent rotavirus genetic reassortment vaccine.

Start Date01 Aug 2012

Sponsor / Collaborator-

100 Clinical Results associated with Reassortant Rotavirus Vaccine, live, Oral, Trivalent (Vero Cell) (Lanzhou Institute of Biological Products)

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100 Translational Medicine associated with Reassortant Rotavirus Vaccine, live, Oral, Trivalent (Vero Cell) (Lanzhou Institute of Biological Products)

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100 Patents (Medical) associated with Reassortant Rotavirus Vaccine, live, Oral, Trivalent (Vero Cell) (Lanzhou Institute of Biological Products)

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4

Literatures (Medical) associated with Reassortant Rotavirus Vaccine, live, Oral, Trivalent (Vero Cell) (Lanzhou Institute of Biological Products)

01 Oct 2020·VaccineQ3 · MEDICINE

Efficacy, immunogenicity and safety of a trivalent live human-lamb reassortant rotavirus vaccine (LLR3) in healthy Chinese infants: A randomized, double-blind, placebo-controlled trial

Q3 · MEDICINE

Article

Author: Du, Jialiang ; Yang, Huan ; Yu, Qingchuan ; Gao, Xuejun ; Su, Jia ; Xia, Shengli ; Liu, Yan ; Guo, Tai ; Zhou, Xu ; Xie, Zhiqiang ; Liu, Yueyue ; Huang, Lili ; Xu, Bianli ; Gao, Jiamei

BACKGROUNDA randomized, double-blind, placebo-controlled multicenter trial was conducted in healthy Chinese infants to assess the efficacy, immunogenicity and safety of a novel trivalent live human-lamb reassortant rotavirus vaccine (LLR3) against rotavirus gastroenteritis (RVGE).METHODSHealthy children aged 6-13 weeks were enrolled and randomized (1:1) to either 3 oral doses of LLR3 or placebo according to a 0, 1, 2 month schedule. The objectives were to evaluate vaccine efficacy (VE) against RVGE of any-severity, severe RVGE (sRVGE) and inpatient caused by rotavirus serotypes contained in the vaccine and not contained in the vaccine after the third dose. Immunogenicity was also assayed in a subgroup. All adverse events (AEs) were collected from 30 min after each dose for immediate reaction, even to the entire study period, including the serious AEs (SAEs) and intussusception.RESULTSVE against RVGE of any-severity, sRVGE and inpatient caused by any serotype was 56.6% (95% CI: 50.7, 61.8), 70.3% (95% CI: 60.6, 77.6) and 74.0% (95% CI: 57.5, 84.1) respectively. VE against RVGE of any-severity, sRVGE caused by serotypes not contained in vaccine were 54.2% (95% CI: 47.5, 60.1) and 70.4% (95% CI: 60.4, 77.9). The rate of seroconversion and four-fold increase of rotavirus serotype G2-, G3-, and G4-specific IgA is 60.8%, 58.0%, and 60.6% in vaccine group, which was higher than 21.35%, 22.7%, and 23.1% in placebo group (p < 0.0001 for G2, G3, G4), as well as the Geometric Mean Titer (GMT). Through the entire trial, 65.91% and 67.79% of participants reported at least one AE, and 0.02% and 0.02% reported SAEs in the vaccine and placebo groups, respectively. Two intussusception cases were reported both in vaccine and placebo group.CONCLUSIONSIn Chinese infants, LLR3 provided a substantial protection against RVGE of any-severity, sRVGE and inpatient caused by any serotype, and showed well immunogenicity and safety.

01 Oct 2018·MedicineQ4 · MEDICINE

Association of human leukocyte antigen alleles and supertypes with immunogenicity of oral rotavirus vaccine given to infants in China

Q4 · MEDICINE

ArticleOA

Author: Li, Qihan ; Liu, Yueyue ; Yu, Qingchuan ; Du, Jialiang ; Zhang, Haowen ; Yang, Huan ; Zhang, Yunqi ; Xia, Shengli ; Guo, Tai

AbstractRotavirus (RV) vaccines show distinct immunogenicity in dozens of clinical trials, which is associated with multiple host and environmental factors. Previous research has demonstrated that the highly polymorphic human leukocyte antigen (HLA) system plays an essential role in regulating immune response to a variety of vaccines. This study aims to investigate the relationship between HLA polymorphisms and immunogenicity of RV vaccine.A nested case-control study was carried out among infants enrolled in phase III clinical trial of trivalent human-lamb reassortant vaccine (RV3) in Henan province, China. Serum RV specific immunoglobulin A (RV-IgA) was detected before and after a 3-dose vaccination series, followed by calculation of seroconversion rates. Seroconversion was defined as a 4-fold or greater increase in RV-IgA titers between pre-vaccination and 1-month post-dose 3 vaccination. The infants who seroconverted were defined as responders, and the others without seroconversion were considered as non-responders. Their HLA genotypes were obtained by using the sequence-based typing method. The HLA allele and supertype frequencies of 2 groups were analyzed statistically.Eighty-three of 133 infants seroconverted after vaccination. Twenty-one HLA-A, 45 HLA-B, 24 HLA-Cw, 29 HLA-DRB1 and 16 HLA-DQB1 distinct alleles were detected. The frequency of HLA-B∗4001 (corrected P = .01, adjusted OR = 0.152, 95% CI = 0.048–0.475) in non-responder group was significantly higher than that in responder group. Furthermore, significant association was found between HLA-B44 supertype (corrected P = .02, adjusted OR = 0.414, 95% CI = 0.225–0.763) and RV non-response.Certain HLA allele (HLA-B∗4001) and supertype (HLA-B44) are potentially associated with non-response after immunization with the novel RV3 vaccine in Chinese infants.

Voprosy virusologii

[Humoral and local immune response to the influenza vaccine in people of old and young ages].

Article

Author: Grigor'eva, E P ; Desheva, Iu A ; Donina, S A ; Rekstin, A R ; Barantseva, I B ; Stepanova, L A ; Rudenko, L G ; Naĭkhin, A N

The specific features of the humoral and local immune responses to influenza vaccines were comparatively studied in people of different age groups. A total of 79 elderly people (aged 67-89) and 80 young people (aged 18-27) were immunized according to one of the four schemes: live cold-adapted reassortant trivalent influenza vaccine (LIV), administered intranasally; inactivated split trivalent influenza vaccine (IIV), administered parenterally; a combination of both above vaccines; and placebo. IIV was found, as compared to LIV, to stimulate more effectively the production of circulating antihaemagglutinins as well as of IgG,-, Ig1-, and Ig3-AT in young persons, while LIV has advantages before IIV in stimulating the synthesis of these immunoglobulins in the elderly. LIV has advantages before IIV in stimulating the synthesis of secretory IgA-AT irrespective of an age of the immunized persons. The combined immunization of the elderly by both vaccines increases the quantitative parameters of the humoral and local responses up to the level of intensity observed in young people. The obtained data are indicative of the possibility of correcting the immune response in the high-risk elderly in respect to influenza infection.

100 Deals associated with Reassortant Rotavirus Vaccine, live, Oral, Trivalent (Vero Cell) (Lanzhou Institute of Biological Products)

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