Delving into the Latest Updates on Human papillomavirus 16/18 vaccine recombinant bivalent(Xiamen Innovax) with Synapse

Overview

Basic Info

Drug Type

Virus-like particle vaccine, Prophylactic vaccine, Multivalent vaccine

Synonyms

Human papillomavirus (types 16 and 18) L1 virus-like particle vaccine ( Xiamen Innovax), Recombinant Human Papillomavirus Bivalent (Types 16,18) Vaccine(Escherichia coli), Recombinant human papillomavirus bivalent (type 16/18) vaccine (Xiamen Innovax)

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Target-

Mechanism

Immunostimulants

Therapeutic Areas

NeoplasmsInfectious DiseasesUrogenital Diseases

Active Indication

Human Papillomavirus InfectionUterine Cervical Cancer

Inactive Indication-

Originator Organization

Xiamen Innovax Biotech Co., Ltd.

Active Organization

Xiamen UniversityXiamen Yangshengtang Biotechnology Co., Ltd.

Beijing Wantai Biological Pharmacy Enterprise Co., Ltd.

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Inactive Organization-

Drug Highest PhaseApproved

First Approval Date

CN (31 Dec 2019),

Uterine Cervical Cancer

Regulation-

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主要目的：描述馨可宁上市前和上市后观察期间9-45岁女性潜在免疫介导性疾病和妊娠结局发生情况。次要目的：1) 描述馨可宁上市前和上市后观察期间9-45岁女性其他严重疾病，包括原发性卵巢功能衰竭、面瘫、复杂性区域疼痛综合征、体位性直立性心动过速综合征的发生情况；2) 描述馨可宁上市前和上市后观察期间9-45岁女性特殊人群（包括HIV感染者、营养不良青少年、疟疾暴露高风险人群、肺结核）潜在免疫介导性疾病和其他严重疾病的发生情况。探索性目的：1) 比较未接种和接种馨可宁的9-45岁女性发生潜在免疫介导性疾病和妊娠结局的差异。

[Translation]

Primary objective: To describe the occurrence of potential immune-mediated diseases and pregnancy outcomes in women aged 9-45 years during the pre-marketing and post-marketing observation period of Xinkening. Secondary objectives: 1) To describe the occurrence of other serious diseases in women aged 9-45 years, including primary ovarian failure, facial palsy, complex regional pain syndrome, and postural orthostatic tachycardia syndrome, during the pre-marketing and post-marketing observation period of Xinkening; 2) To describe the occurrence of potential immune-mediated diseases and other serious diseases in special populations of women aged 9-45 years (including HIV-infected people, malnourished adolescents, people at high risk of malaria exposure, and tuberculosis) during the pre-marketing and post-marketing observation period of Xinkening. Exploratory objectives: 1) To compare the differences in the occurrence of potential immune-mediated diseases and pregnancy outcomes in women aged 9-45 years who were not vaccinated and vaccinated with Xinkening.

Start Date06 Jun 2023

Sponsor / Collaborator

Xiamen University

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NCT06345885 / CompletedPhase 4

Immunogenicity and Safety of One Dose of Cecolin and One Dose of Gardasil

This study will assess the immunogenicity and safety of one dose of Cecolin and one dose of Gardasil

Start Date23 Feb 2023

Sponsor / Collaborator

Xiamen Innovax Biotech Co., Ltd.

100 Clinical Results associated with Human papillomavirus 16/18 vaccine recombinant bivalent(Xiamen Innovax)

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100 Translational Medicine associated with Human papillomavirus 16/18 vaccine recombinant bivalent(Xiamen Innovax)

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100 Patents (Medical) associated with Human papillomavirus 16/18 vaccine recombinant bivalent(Xiamen Innovax)

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77

Literatures (Medical) associated with Human papillomavirus 16/18 vaccine recombinant bivalent(Xiamen Innovax)

01 Apr 2024·Vaccine

Safety and immunogenicity of Innovax bivalent human papillomavirus vaccine in girls 9–14 years of age: Interim analysis from a phase 3 clinical trial

Article

Author: Bhat, Niranjan ; Zaman, Khalequ ; Pinto, Ligia A ; Sukraw, Kristen ; Hossain, Lokman ; Buabeng, Patrick By ; Antony, Kalpana ; Qadri, Firdausi ; Adjei, Samuel ; Agbenyega, Tsiri ; Schuind, Anne E ; Kemp, Troy J ; Aponte, John J

BACKGROUNDWorld Health Organization human papillomavirus (HPV) vaccination recommendations include a single- or two-dose schedule in individuals 9-20 years old and advice for generating data on single-dose efficacy or immunobridging. The ongoing Phase 3 trial of Innovax's bivalent (types 16 and 18) HPV vaccine (Cecolin®) assesses in low- and middle-income countries alternative dosing schedules and generates data following one dose in girls 9-14 years old. Interim data for the 6-month dosing groups are presented.METHODSIn Bangladesh and Ghana, 1,025 girls were randomized to receive either two doses of Cecolin at 6-, 12-, or 24-month intervals; one dose of Gardasil® followed by one dose of Cecolin at month 24; or two doses of Gardasil 6 months apart (referent). Serology was measured by enzyme-linked immunosorbent assay (ELISA) and, in a subset, by neutralization assays. Primary objectives include immunological non-inferiority of the Cecolin schedules to referent one month after the second dose. Safety endpoints include reactogenicity and unsolicited adverse events for 7 and 30 days post-vaccination, respectively, as well as serious adverse events throughout the study.RESULTSInterim analyses included data from the two groups on a 0, 6-month schedule with 205 participants per group. One month after Dose 2, 100% of participants were seropositive by ELISA and had seroconverted for both antigens. Non-inferiority of Cecolin to Gardasil was demonstrated. Six months following one dose, over 96% of participants were seropositive by ELISA for both HPV antigens, with a trend for higher geometric mean concentration following Cecolin administration. Reactogenicity and safety were comparable between both vaccines.CONCLUSIONSCecolin in a 0, 6-month schedule elicits robust immunogenicity. Non-inferiority to Gardasil was demonstrated one month after a 0, 6-month schedule. Immunogenicity following one dose was comparable to Gardasil up to six months. Both vaccines were safe and well tolerated (ClinicalTrials.gov No. 04508309).

31 Dec 2023·Emerging Microbes & Infections

Safety of hepatitis E vaccination for pregnancy: a post-hoc analysis of a randomized, double-blind, controlled phase 3 clinical trial

Article

Author: Zhong, Guohua ; Jia, Xinhua ; Pan, Huirong ; Li, Yufei ; Hong, Ying ; Hu, Xiaowen ; Chen, Qi ; Xia, Ningshao ; Wei, Lihui ; Wu, Ting ; Zhang, Jun ; Huang, Yue ; Zhang, Qiufen ; Zhuang, Chunlan ; Huang, Shoujie ; Su, Yingying ; Peng, Siying ; Bi, Zhaofeng ; Qiao, Youlin

Special attention has been paid to Hepatitis E (HE) prophylaxis for pregnant women due to poor prognosis of HE in this population. We conducted a post-hoc analysis based on the randomized, double-blind, HE vaccine (Hecolin)-controlled phase 3 clinical trial of human papillomavirus (HPV) vaccine (Cecolin) conducted in China. Eligible healthy women aged 18-45 years were randomly assigned to receive three doses of Cecolin or Hecolin and were followed up for 66 months. All the pregnancy-related events throughout the study period were closely followed up. The incidences of adverse events, pregnancy complications, and adverse pregnancy outcomes were analysed based on the vaccine group, maternal age, and interval between vaccination and pregnancy onset. During the study period, 1263 Hecolin receivers and 1260 Cecolin receivers reported 1684 and 1660 pregnancies, respectively. The participants in the two vaccine groups showed similar maternal and neonatal safety profiles, regardless of maternal age. Among the 140 women who were inadvertently vaccinated during pregnancy, the incidences of adverse reactions had no statistical difference between the two groups (31.8% vs 35.1%, p = 0.6782). The proximal exposure to HE vaccination was not associated with a significantly higher risk of abnormal foetal loss (OR 0.80, 95% CI 0.38-1.70) or neonatal abnormality (OR 2.46, 95% CI 0.74-8.18) than that to HPV vaccination, as did distal exposure. Significant difference was not noted between pregnancies with proximal and distal exposure to HE vaccination. Conclusively, HE vaccination during or shortly before pregnancy is not associated with increased risks for both the pregnant women and pregnancy outcomes.

01 Oct 2023·Science Bulletin

Immunogenicity and safety of an Escherichia coli-produced human papillomavirus (types 6/11/16/18/31/33/45/52/58) L1 virus-like-particle vaccine: a phase 2 double-blind, randomized, controlled trial

Article

Author: Zheng, Feng-Zhu ; Yang, Chang-Lin ; Chu, Kai ; Sun, Guang ; Hu, Yue-Mei ; Huang, Wei-Jin ; Zhu, Kong-Xin ; Liu, Dong-Lin ; Wu, Ting ; Li, Ya-Fei ; Pan, Hong-Xing ; Wang-Jiang, Ya-Hui ; Bi, Zhao-Feng ; Xia, Ning-Shao ; Hu, Xiao-Wen ; Huang, Xing-Cheng ; Chen, Qi ; Zang, Xia ; Quan, Jia-Li ; Su, Ying-Ying ; Zhang, Jun ; Zhang, Qiu-Fen ; Zheng, Ya ; Huang, Yue ; Huang, Shou-Jie ; Zhang, Li ; Jiang, Han-Min

The Escherichia coli-produced human papillomavirus (HPV) 16/18 bivalent vaccine (Cecolin) has received prequalification by the World Health Organization based on its high efficacy and good safety profile. We aimed to evaluate the immunogenicity and safety of the second-generation nonavalent HPV 6/11/16/18/31/33/45/52/58 vaccine (Cecolin 9) through the randomized, blinded phase 2 clinical trial. Eligible healthy women aged 18-45 years were randomly (1:1) allocated to receive three doses of 1.0 mL (270 µg) of Cecolin 9 or placebo with a 0-1-6-month schedule. The primary endpoint was the seroconversion rate and geometric mean titer of neutralizing antibodies (nAbs) one month after the full vaccination course (month 7). The secondary endpoint was the safety profile including solicited adverse reactions occurring within 7 d, adverse events (AEs) occurring within 30 d after each dose, and serious adverse events (SAEs) occurring during the 7-month follow-up period. In total, 627 volunteers were enrolled and randomly assigned to Cecolin 9 (n = 313) or placebo (n = 314) group in Jiangsu Province, China. Almost all participants in the per-protocol set for immunogenicity (PPS-I) seroconverted for nAbs against all the nine HPV types at month 7, while two failed to seroconvert for HPV 11 and one did not seroconvert for HPV 52. The incidence rates of total AEs in the Cecolin 9 and placebo groups were 80.8% and 72.9%, respectively, with the majority of them being mild and recovering shortly. None of the SAEs were considered related to vaccination. In conclusion, the E. coli-produced 9-valent HPV (9vHPV) vaccine candidate was well tolerated and immunogenic, which warrants further efficacy studies in larger populations.

100 Deals associated with Human papillomavirus 16/18 vaccine recombinant bivalent(Xiamen Innovax)

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External Link

KEGG	Wiki	ATC	Drug Bank
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R&D Status

Approved

10 top approved records.

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Indication	Country/Location	Organization	Date
Human Papillomavirus Infection	MA	Xiamen Innovax Biotech Co., Ltd.	13 May 2022
Uterine Cervical Cancer	CN	Xiamen Innovax Biotech Co., Ltd.	31 Dec 2019

Developing

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Human Papillomavirus Infection	Phase 3	CN	Xiamen University	22 Nov 2012
Human Papillomavirus Infection	Phase 3	CN	Xiamen Yangshengtang Biotechnology Co., Ltd.	22 Nov 2012
Infectious Diseases	Discovery	CN	Xiamen Yangshengtang Biotechnology Co., Ltd.	01 Jul 2017
Infectious Diseases	Discovery	CN	Xiamen University	01 Jul 2017
Uterine Cervical Cancer	Discovery	CN	Xiamen Yangshengtang Biotechnology Co., Ltd.	01 Jul 2017
Uterine Cervical Cancer	Discovery	CN	Xiamen University	01 Jul 2017

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Clinical Result

Indication

Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


Pubmed	Not Applicable	Uterine Cervical Cancer	-	Human papillomavirus-16/18 AS04-adjuvanted vaccine	wddpqgferb(mzddvcukmv) = The frequencies of local injection site reactions were higher in the vaccine than placebo group; pain being the most common symptom in both groups kkobniejvm (anyykakkyd ) View more	Positive	01 Jun 2010