[Translation] A single-center, randomized, double-blind, controlled clinical trial to evaluate the immunogenicity and safety of the scaled-up recombinant human papillomavirus 6/11/16/18/31/33/45/52/58 9-valent vaccine (Escherichia coli) in Chinese women aged 18-26 years

主要目的：评价重组人乳头瘤病毒6/11/16/18/31/33/45/52/58型九价疫苗（大肠埃希菌，600L工艺）的免疫原性是否非劣效于重组人乳头瘤病毒6/11/16/18/31/33/45/52/58型九价疫苗（大肠埃希菌，60L工艺）。次要目的：评价试验疫苗的安全性。

[Translation]

Primary objective: To evaluate whether the immunogenicity of the recombinant human papillomavirus 6/11/16/18/31/33/45/52/58 nine-valent vaccine (Escherichia coli, 600L process) is non-inferior to that of the recombinant human papillomavirus 6/11/16/18/31/33/45/52/58 nine-valent vaccine (Escherichia coli, 60L process). Secondary objective: To evaluate the safety of the experimental vaccine.

Start Date06 Apr 2024

Sponsor / Collaborator

Xiamen Innovax Biotech Co., Ltd.

[+2]

NCT06306196 / Not yet recruitingPhase 2IIT

A Phase 2b, Open-label Study to Evaluate the Immunogenicity and Safety of Hecolin® in HIV Positive/Negative Adult Participants Followed by a Randomized, Placebo-controlled, Observer-blind Study to Evaluate the Immunogenicity and Safety of Hecolin® in Children

The primary goal of this clinical trial is to demonstrate non-inferiority of 30 µg of Hecolin® in healthy children, compared to healthy adults as measured by seroresponse rates (SR) of anti-HEV IgG titers, 4 weeks after 3 doses (0, 1 and 6 months) and to assess and descriptively compare safety profile data intra and inter age Strata. As secondary objectives, Geometric Mean Concentration (GMC) of anti-HEV IgG ELISA will be evaluated 4 weeks after 3 doses (0, 1 and 6 months) and 4 weeks after 2 doses (0- and 6-months dose) in healthy children. SR and GMC will also be evaluated 24 weeks after 3 doses and 2 doses. The immune response will be compared among adult participants between HIV positive and HIV negative individuals and between virally suppressed and virally unsuppressed HIV positive individuals

Start Date01 Apr 2024

Sponsor / Collaborator

International Vaccine Institute

[+2]

NCT06243666 / Not yet recruitingNot ApplicableIIT

Long-term Effectiveness and Immuno-persistence Study of a Recombinant Human Papillomavirus 16/18 Bivalent Vaccine in Girls Aged 9-17 Years

The primary objective of this study is to evaluate the protective efficacy against future infections of HPV types 16/18 or related diseases and immuno-persistence (type specific IgG antibody) of the bivalent HPV vaccine in young female populations aged 9-17 years.

Start Date20 Feb 2024

Sponsor / Collaborator

Xiamen University

[+1]

100 Clinical Results associated with Xiamen Innovax Biotech Co., Ltd.

0 Patents (Medical) associated with Xiamen Innovax Biotech Co., Ltd.

Literatures (Medical) associated with Xiamen Innovax Biotech Co., Ltd.

01 May 2024·Vaccine

Wa-VP4* as a candidate rotavirus vaccine induced homologous and heterologous virus neutralizing antibody responses in mice, pigs, and cynomolgus monkeys

Article

Author: Zeng, Yuanjun ; Xia, Ningshao ; Ge, Shengxiang ; Zhang, Shiyin ; Yang, Han ; Li, Tingdong ; Zhang, Zhishan ; Chen, Yaling ; Zhang, Jun ; Sheng, Roufang ; Luo, Guoxing ; Song, Feibo ; Li, Cao

Group A rotavirus (RVA) is the primary etiological agent of acute gastroenteritis (AGE) in children under 5 years of age. Despite the global implementation of vaccines, rotavirus infections continue to cause over 120,000 deaths annually, with a majority occurring in developing nations. Among infants, the P[8] rotavirus strain is the most prevalent and can be categorized into four distinct lineages. In this investigation, we expressed five VP4(aa26-476) proteins from different P[8] lineages of human rotavirus in E. coli and assessed their immunogenicity in rabbits. Among the different P[8] strains, the Wa-VP4 protein, derived from the MT025868.1 strain of the P[8]-1 lineage, exhibited successful purification in a highly homogeneous form and significantly elicited higher levels of neutralizing antibodies (nAbs) against both homologous and heterologous rotaviruses compared to other VP4 proteins derived from different P[8] lineages in rabbits. Furthermore, we assessed the immunogenicity of the Wa-VP4 protein in mice, pigs, and cynomolgus monkeys, observing that it induced robust production of nAbs in all animals. Interestingly, there was no significant difference between in nAb titers against homologous and heterologous rotaviruses in pigs and mankeys. Collectively, these findings suggest that the Wa-VP4* protein may serve as a potential candidate for a rotavirus vaccine.

01 Feb 2024·Science Bulletin

Rational design of a cross-type HPV vaccine through immunodominance shift guided by a cross-neutralizing antibody

Article

Author: Yang, Chengyu ; Li, Tingting ; Li, Shaowei ; Shen, Jingjia ; Chi, Xin ; Zhang, Shuyue ; Zheng, Qingbing ; Chen, Jie ; Gu, Ying ; Wang, Zhiping ; Yu, Hai ; Xu, Yujie ; Li, Jinjin ; Qian, Ciying ; Zhou, Lizhi ; Jiang, Yanan ; Xia, Ningshao ; Lu, Yihan ; Zhang, Chengzong ; Gao, Fei ; Wang, Daning

In vaccine development, broadly or cross-type neutralizing antibodies (bnAbs or cnAbs) are frequently targeted to enhance protection. Utilizing immunodominant antibodies could help fine-tune vaccine immunogenicity and augment the precision of immunization strategies. However, the methodologies to capitalize on the attributes of bnAbs in vaccine design have not been clearly elucidated. In this study, we discovered a cross-type neutralizing monoclonal antibody, 13H5, against human papillomavirus 6 (HPV6) and HPV11. This nAb exhibited a marked preference for HPV6, demonstrating superior binding activity to virus-like particles (VLPs) and significantly higher prevalence in anti-HPV6 human serum as compared to HPV11 antiserum (90% vs. 31%). Through co-crystal structural analysis of the HPV6 L1 pentamer:13H5 complex, we delineated the epitope as spanning four segments of amino acids (Phe42-Ala47, Gly172-Asp173, Glu255-Val275, and Val337-Tyr351) on the L1 surface loops. Further interaction analysis and site-directed mutagenesis revealed that the Ser341 residue in the HPV6 HI loop plays a critical role in the interaction between 13H5 and L1. Substituting Ser341 with alanine, which is the residue type present in HPV11 L1, almost completely abolished binding activity to 13H5. By swapping amino acids in the HPV11 HI loop with corresponding residues in HPV6 L1 (Ser341, Thr338, and Thr339), we engineered chimeric HPV11-6HI VLPs. Remarkably, the chimeric HPV11-6HI VLPs shifted the high immunodominance of 13H5 from HPV6 to the engineered VLPs and yielded comparable neutralization titers for both HPV6 and HPV11 in mice and non-human primates. This approach paves the way for the design of broadly protective vaccines from antibodies within the main immunization reservoir.

01 Dec 2023·Vaccine: X

Vaccine traceability: Key learnings from the supply chain initiative by manufacturers from emerging countries

Article

Author: Pagliusi, Sonia ; Yang, Lingjiang ; Yu, Huilin ; Wilmansyah, Taufik ; Krishnamurthy, Komarapuram R ; Bramanti, Yudha ; Raju Pinnamaraju, Venkatapathi ; Acebal, Analia ; Jadhav, Padmakar ; Madrid, Yvette ; Park, Rachel

The use of global standards, and the placement of barcodes and data matrix codes on vaccine labels and other levels of packaging are crucial elements for the traceability of finished vaccine products. Vaccine manufacturers are committed to improving health through their products, as vaccine production offers opportunities that can be leveraged to benefit immunization systems. In 2019 the Developing Countries Vaccine Manufacturers Network (DCVMN) created the Supply Chain Initiative aimed at prioritize and explore traceability opportunities; concomitantly procurement agencies announced traceability requirements for vaccine global supply. Vaccine traceability brings benefits including supply chain reliability and safety through enhanced product movement visibility, and a reduction of falsified and expired vaccines circulating in the supply chain. DCVMN has coordinated the development and implementation of global traceability standards, at both primary and secondary vaccine packaging levels, to encourage and enable sharing these experiences. Six pilot studies in four different countries showed successful implementation, and constituted part of larger vaccine traceability work within the respective organizations. The main findings from these pilot studies indicated that stepwise approaches to the adoption of traceability standards allowed vaccine manufacturers to learn by doing, initially with lower risk, and to spread their investments over time. Because the value of traceability is in its scale of adoption and the use of the data, it remains important for all stakeholders to engage in and prioritize the journey of vaccine traceability, but also to suitably manage the financial risks. The DCVMN Supply Chain Initiative has demonstrated that its members are committed to driving supply system changes that benefit immunization, while recognizing that supply chain traceability is part of a larger healthcare ecosystem and should be adopted by countries and immunization programmes as well.

News (Medical) associated with Xiamen Innovax Biotech Co., Ltd.

01 Mar 2024

·www.prnewswire.com

Cervical Cancer Global Clinical Trials Review 2024: Clinical Trials by Region, Country (G7 & E7), Trial Status, Trial Phase, Sponsor Type and End Point Status

DUBLIN, March 1, 2024 /PRNewswire/ -- The "Cervical Cancer - Global Clinical Trials Review, 2024" clinical trials has been added to ResearchAndMarkets.com's offering. The clinical trial report provides an overview of Cervical Cancer Clinical trials scenario. This report provides top line data relating to the clinical trials on Cervical Cancer and includes an overview of trial numbers and their average enrollment in top countries conducted across the globe. The report offers coverage of disease clinical trials by region, country (G7 & E7), phase, trial status, end points status and sponsor type. The report also provides prominent drugs for in-progress trials (based on number of ongoing trials). Report Scope The report provides a snapshot of the global clinical trials landscape Report provides top level data related to the clinical trials by Region, Country (G7 & E7), Trial Status, Trial Phase, Sponsor Type and End point status The report reviews top companies involved and enlists all trials (Trial title, Phase, and Status) pertaining to the company The report provides all the unaccomplished trials (Terminated, Suspended and Withdrawn) with reason for unaccomplishment The Report provides enrollment trends for the past five years Report provides latest news for the past three months Key Benefits Assists in formulating key business strategies with regards to investment Helps in identifying prominent locations for conducting clinical trials which saves time and cost Provides top level analysis of Global Clinical Trials Market which helps in identifying key business opportunities Supports understanding of trials count and enrollment trends by country in global therapeutics market Aids in interpreting the success rates of clinical trials by providing a comparative scenario of completed and uncompleted (terminated, suspended or withdrawn) trials Facilitates clinical trial assessment of the indication on a global, regional and country level Key Topics Covered: Report Guidance Clinical Trials Report Coverage Clinical Trials by Region Clinical Trials and Average Enrollment by Country Top Five Countries Contributing to Clinical Trials in Asia-Pacific Top Five Countries Contributing to Clinical Trials in Europe Top Countries Contributing to Clinical Trials in North America Top Five Countries Contributing to Clinical Trials in Middle East and Africa Top Five Countries Contributing to Clinical Trials in Central and South America Clinical Trials by G7 Countries: Proportion of Cervical Cancer to Oncology Clinical Trials Clinical Trials by Phase in G7 Countries Clinical Trials in G7 Countries by Trial Status Clinical Trials by E7 Countries: Proportion of Cervical Cancer to Oncology Clinical Trials Clinical Trials by Phase in E7 Countries Clinical Trials in E7 Countries by Trial Status Clinical Trials by Phase In Progress Trials by Phase Clinical Trials by Trial Status Clinical Trials by End Point Status Subjects Recruited Over a Period of Time Clinical Trials by Sponsor Type Prominent Sponsors Top Companies Participating in Cervical Cancer Therapeutics Clinical Trials Prominent Drugs Clinical Trial Profile Snapshots Company Coverage: Merck & Co Inc GSK plc F. Hoffmann-La Roche Ltd AstraZeneca Plc Pfizer Inc Bristol-Myers Squibb Co Jiangsu Hengrui Medicine Co Ltd Xiamen Innovax Biotech Co Ltd Sanofi Yangshengtang Co Ltd For more information about this clinical trials report visit About ResearchAndMarkets.com ResearchAndMarkets.com is the world's leading source for international market research reports and market data. We provide you with the latest data on international and regional markets, key industries, the top companies, new products and the latest trends. Media Contact: Research and Markets Laura Wood, Senior Manager [email protected] For E.S.T Office Hours Call +1-917-300-0470 For U.S./CAN Toll Free Call +1-800-526-8630 For GMT Office Hours Call +353-1-416-8900 U.S. Fax: 646-607-1907 Fax (outside U.S.): +353-1-481-1716 Logo: SOURCE Research and Markets

Clinical StudyASCO

100 Deals associated with Xiamen Innovax Biotech Co., Ltd.

100 Translational Medicine associated with Xiamen Innovax Biotech Co., Ltd.

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Pipeline

Pipeline Snapshot as of 22 Nov 2024

The statistics for drugs in the Pipeline is the current organization and its subsidiaries are counted as organizations,Early Phase 1 is incorporated into Phase 1, Phase 1/2 is incorporated into phase 2, and phase 2/3 is incorporated into phase 3

Preclinical

Phase 1 Clinical

NDA/BLA

Approved

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Current Projects

Drug(Targets)	Indications	Global Highest Phase

Human papillomavirus 16/18 vaccine recombinant bivalent(Xiamen Innovax)	Uterine Cervical Cancer More	Approved
Hepatitis E vaccine recombinant(Xiamen Innovax Biotech Co. Ltd.)	Hepatitis E More	Approved
9-Valent HPV Vaccine(Xiamen Innovax)	Human Papillomavirus Infection More	NDA/BLA
20-valent neumococcal polysaccharide conjugate vaccine (Xiamen Innovax)	Pneumococcal Infections More	Phase 1
Rotavirus vaccine (Xiamen Innovax Biotech)	Rotavirus Infections More	Preclinical

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