Delving into the Latest Updates on Recombinant nine-valent human papillomavirus(6/11/16/18/31/33/45/52/58)vaccine(Beijing Health Guard Biotechnology) with Synapse

Overview

Basic Info

Drug Type

Prophylactic vaccine

Synonyms-

Target-

Action

stimulants

Mechanism

Immunostimulants

Therapeutic Areas

NeoplasmsInfectious DiseasesDigestive System Disorders+ [3]

Active Indication

Human Papillomavirus InfectionProstatic Intraepithelial NeoplasiaAnal intraepithelial neoplasia+ [8]

Inactive Indication-

Originator Organization

Beijing Health Guard Biotechnology, Inc.

Active Organization

Beijing Health Guard Biotechnology, Inc.

Inactive Organization-

Drug Highest PhasePhase 3

First Approval Date-

Regulation-

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

BackgroundA safe and highly efficacious Escherichia coli (E. coli)-produced HPV 16/18 bivalent vaccine has been prequalified by the World Health Organization. Here, we conducted a single-center, open-label, dose-escalation phase 1 clinical trial to evaluate the safety and immunogenicity of the second-generation nonavalent HPV 6/11/16/18/31/33/45/52/58 vaccine.MethodTwenty-four eligible volunteers aged 18-45 years were enrolled in January 2019 in Dongtai, China and received 0.5 mL (135 μg) or 1.0 mL (270 μg) of the candidate vaccine with a 0/1/6-month dose-escalation schedule. Local and systemic adverse events (AEs) occurring within 30 days after each vaccination and serious adverse events (SAEs) occurring within 7 months were recorded. Blood samples from each participant were collected before and 2 days after the first and third vaccinations to determine changes in laboratory parameters. Serum IgG and neutralizing antibody (nAb) levels against each HPV type at month 7 were analyzed (ClinicalTrials.gov: NCT03813940).FindingsThe incidences of total AEs in the 135 μg and 270 μg groups were 66.7% and 83.3%, respectively. All AEs were mild or moderate, and no SAEs were reported. No clinically significant changes were found in paired blood indices before or after any of the vaccinations. All the participants in the per-protocol set except for two who failed to seroconvert for HPV 11 or 58 in the 135 μg group seroconverted at month 7 for both IgG and nAbs.InterpretationThe candidate E. coli-produced 9vHPV vaccine has been preliminarily proven to be well tolerated and immunogenic, which encourages further studies in large cohorts with a wider age range.FundingThis study was supported by the National Natural Science Foundation of China, Fujian Provincial Natural Science Foundation, Fujian Province Health and Education Joint Research Program, Xiamen Science and Technology Plan Project, Fundamental Research Funds for the Central Universities, CAMS Innovation Fund for Medical Sciences of China, and Xiamen Innovax Biotechnology Co., Ltd.

30 Nov 2022·Human Vaccines & Immunotherapeutics

Immunogenicity and safety of quadrivalent and 9-valent human papillomavirus vaccines in Indian clinical trial participants

Article

Author: Walia, Anuj ; Anagani, Manjula ; Lin, Jianxin ; Garland, Suzanne M. ; Ross, Cecil ; Chatterjee, Sukanta ; Group, Thomas ; Lalwani, Sanjay ; Luxembourg, Alain ; Bhatla, Neerja ; Tu, Yingmei

The quadrivalent human papillomavirus (qHPV; HPV6/11/16/18) and 9-valent HPV (9vHPV; HPV6/11/16/18/31/33/45/52/58) vaccines have demonstrated efficacy, immunogenicity, and safety in international clinical trials. We report outcomes from three completed clinical trials in India: a single-arm study (V501-029 [NCT00380367]) in Indian girls (aged 9-15 years; N = 110) evaluating qHPV vaccine immunogenicity and safety; a subgroup analysis (n = 225) of Indian girls/boys (9-15 years) and women (16-26 years) from a global study (V503-002 [NCT00943722]) evaluating 9vHPV vaccine immunogenicity and safety; and a qHPV vaccine post-marketing safety surveillance study (V501-125) in Indian females (aged 9-45 years; N = 188) vaccinated during routine care. In V501-029 and V503-002, HPV vaccines were administered as 3 doses (Day 1, Month 2, Month 6). Serum HPV antibodies were evaluated by competitive Luminex immunoassays at Day 1 and Month 7 (both studies) and Months 12, 24, and 36 (V503-002 only). Adverse events (AEs) were collected by Vaccination Report Card. In V501-125, participants were actively surveilled for serious AEs (SAEs) within 30 days post-qHPV vaccination. In per-protocol analyses, qHPV and 9vHPV vaccines induced robust anti-HPV6/11/16/18 (V501-029) and HPV6/11/16/18/31/33/45/52/58 (V503-002) responses, respectively; ≥97% of participants seroconverted at Month 7 for each vaccine HPV type in both studies, and antibody responses persisted through 36 months in V503-002. The most common AEs were injection-site-associated. Most AEs were mild/moderate; no deaths, vaccine-related SAEs, or discontinuations due to AEs were reported. In V501-125, no SAE was reported. Overall, the qHPV and 9vHPV vaccines elicited robust antibody responses and were generally well tolerated in Indian participants.

01 Aug 2018·VaccineQ3 · MEDICINE

Safety and perception: What are the greatest enemies of HPV vaccination programmes?

Q3 · MEDICINE

Article

Author: Zanella, Beatrice ; Boccalini, Sara ; Bechini, Angela ; Santomauro, Francesca ; Lorini, Chiara ; Bonanni, Paolo

Vaccines stimulate a person's immune system to produce an adequate reaction against a specific infectious agent; i.e. the person is protected from that disease without having to get it first. As vaccines are administrated to healthy subjects, they are held to the highest standards of safety. Regarding human papillomavirus (HPV) vaccines, at present three prophylactic vaccines are licensed (bivalent HPV 16/18, quadrivalent HPV 6/11/16/18 and the nonovalent HPV 6/11/16/18/31/33/45/52/58 vaccine). Pre- and post-licensure studies (i.e. not yet for nonovalent HPV vaccine) confirm that HPV vaccines are generally safe and well-tolerated, site injections symptoms are the most common adverse events (AEs) reported, and pain is the most frequently referred local symptom. Serious AEs are rare and not associated with severe sequelae, at least no vaccine-related deaths have occurred. Despite these scientific evidences, it is still difficult to explain to the population the importance of a good vaccination programme. There are many determinants for HPV vaccines hesitancy which represent a barrier that must be overcome in order to increase vaccine coverage, including psychological reactions, religious or cultural aspects, and fear of possible AEs (demyelinating diseases, Complex Regional Pain Syndrome - CRPS, or Postural Orthostatic Tachycardia Syndrome - POTS). A weak communication strategy which frequently suffers due to spread of unverified news by media and websites may lead to the failure of a vaccination programme. Such a situation happened in Japan (2013), due to which a great number of women remain vulnerable to HPV-related cancers. In order to resolve the issues around HPV vaccines acceptance, it is necessary to use good communication strategies. Multicomponent and dialogue-based interventions seem to be the most effective, especially if an adequate language is used, customized according to the vaccination programme target.

100 Deals associated with Recombinant nine-valent human papillomavirus(6/11/16/18/31/33/45/52/58)vaccine(Beijing Health Guard Biotechnology)

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R&D Status

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Prostatic Intraepithelial Neoplasia	Phase 3	China	Beijing Health Guard Biotechnology, Inc.	18 Dec 2022
Anal intraepithelial neoplasia	Phase 3	China	Beijing Health Guard Biotechnology, Inc.	05 Dec 2020
Condylomata Acuminata	Phase 3	China	Beijing Health Guard Biotechnology, Inc.	05 Dec 2020
Persistent Infection	Phase 3	China	Beijing Health Guard Biotechnology, Inc.	05 Dec 2020
Uterine Cervical Cancer	Phase 3	China	Beijing Health Guard Biotechnology, Inc.	05 Dec 2020
Uterine Cervical Dysplasia	Phase 3	China	Beijing Health Guard Biotechnology, Inc.	05 Dec 2020
Vagina Carcinoma	Phase 3	China	Beijing Health Guard Biotechnology, Inc.	05 Dec 2020
Vaginal intraepithelial neoplasia	Phase 3	China	Beijing Health Guard Biotechnology, Inc.	05 Dec 2020
Vulvar intraepithelial neoplasia	Phase 3	China	Beijing Health Guard Biotechnology, Inc.	05 Dec 2020
Vulvar Neoplasms	Phase 3	China	Beijing Health Guard Biotechnology, Inc.	05 Dec 2020

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Clinical Result

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NEWS Manual	Phase 3	Human Papillomavirus Infection	1,260	康乐卫士重组九价HPV疫苗	(pyzssavjjn) = 试验免疫原性终点已达到。 idclpybptx (sgklbwwads ) View more	Positive	07 Jan 2025
				默沙东九价HPV疫苗 Gardasil®9