[Translation] A phase IV clinical study to evaluate the antibody persistence after 4 or 5 doses of primary immunization with freeze-dried human rabies vaccine (Vero cells) and to observe the effect of 2 doses of booster immunization

主要目的：评价暴露后按照4剂免疫程序（2-1-1）或者5剂免疫程序（1-1-1-1-1）基础免疫全程接种华兰生物疫苗股份有限公司（以下简称“华兰生物”或“申办方”）正常市售冻干人用狂犬病疫苗（Vero细胞）（以下简称“试验疫苗”）的抗体持久性。为再暴露的加强免疫提供科学的临床依据。次要目的：评价暴露后按照4剂免疫程序（2-1-1）或者5剂免疫程序（1-1-1-1-1）基础免疫全程接种试验疫苗的安全性。评价完成暴露后基础免疫全程接种的人群在不同时间节点进行2剂（0，3天）加强免疫试验疫苗的免疫原性和安全性。

[Translation]

Main purpose: To evaluate the antibody persistence of the normal commercially available freeze-dried human rabies vaccine (Vero cells) (hereinafter referred to as the "experimental vaccine") of Hualan Bio-Vaccine Co., Ltd. (hereinafter referred to as "Hualan Bio-Vaccine" or "the sponsor") after the 4-dose immunization schedule (2-1-1) or 5-dose immunization schedule (1-1-1-1-1) after exposure. Provide scientific clinical basis for booster immunization after re-exposure. Secondary purpose: To evaluate the safety of the experimental vaccine after the 4-dose immunization schedule (2-1-1) or 5-dose immunization schedule (1-1-1-1-1) after exposure. To evaluate the immunogenicity and safety of the experimental vaccine after 2 doses (0, 3 days) of booster immunization at different time points for people who have completed the full course of basic immunization after exposure.

Start Date30 Jul 2024

Sponsor / Collaborator

Hualan Biological Vaccine, Inc.

CTR20213356 / Active, not recruitingPhase 1

评价吸附无细胞百（三组分）白破联合疫苗在儿童和婴幼儿中接种的安全性及初步观察免疫原性的Ⅰ期临床试验

[Translation] Phase I clinical trial to evaluate the safety of adsorbed acellular diphtheria and pertussis combined vaccine in children and infants and to observe the immunogenicity

通过对不同年龄儿童和婴幼儿接种DTacP后的观察，评价其安全性，并初步探索免疫原性。

[Translation]

By observing children and infants of different ages after vaccination with DTacP, its safety was evaluated and its immunogenicity was preliminarily explored.

Start Date15 Dec 2021

Sponsor / Collaborator

Hualan Biological Vaccine, Inc.

CTR20220316 / Active, not recruitingPhase 4

四价流感病毒裂解疫苗在更大规模人群的安全有效性Ⅳ期临床研究

[Translation] Phase IV clinical study on the safety and efficacy of quadrivalent influenza virus split vaccine in a larger population

评价四价流感病毒裂解疫苗在 18~59 岁健康人群中接种后的批间一致性。评价四价流感病毒裂解疫苗在 3 岁及以上扩大人群接种后安全性和免疫原性，以期观察到 1‰的罕见不良反应。

[Translation]

To evaluate the batch-to-batch consistency of quadrivalent influenza virus split vaccine after vaccination in healthy people aged 18 to 59 years. To evaluate the safety and immunogenicity of quadrivalent influenza virus split vaccine after vaccination in an expanded population of 3 years and above, in order to observe rare adverse reactions of 1‰.

Start Date17 Nov 2021

Sponsor / Collaborator

Hualan Biological Vaccine, Inc.

100 Clinical Results associated with Hualan Biological Vaccine, Inc.

0 Patents (Medical) associated with Hualan Biological Vaccine, Inc.

Literatures (Medical) associated with Hualan Biological Vaccine, Inc.

06 Feb 2023·Zhonghua yu fang yi xue za zhi [Chinese journal of preventive medicine]

[Safety and immunogenicity of freeze-dried rabies vaccine (Vero-cells) for human use in healthy people aged 9-65 years].

Article

Author: Zhang, K ; Xie, Z Q ; Wu, X J ; Zhang, W ; Wang, Y X ; Liu, D M ; Huang, L L ; Wang, Z Q

Objective: To assess the safety and immunogenicity of freeze-dried rabies vaccine (Vero-cells) for human use on different immunization procedures in healthy people aged 9-65 years. Methods: A randomized, blind, positive-controlled clinical study was conducted in March 2015. The eligible residents aged 9-65 were recruited in Dengfeng city and Biyang County, Henan Province. A total of 1 956 subjects were enrolled. The subjects were randomly (1∶1∶1) assigned to 5-dose control group, 4-dose trial group and 5-dose trial group, with 652 subjects in each group. The subjects of 5-dose control group were immunized with control vaccine on days 0, 3, 7, 14 and 28. The subjects of 4-dose trial group were immunized with trial vaccine on days 0, 7 and 21 (2-1-1 phases) and the subjects of 5-dose trial group were immunized with trial vaccine on days 0, 3, 7, 14 and 28. A combination of regular follow-up and active reporting was used to observe local and systemic adverse reactions till 30 days after the first and full immunization, and the incidence rate of adverse reactions in three groups was analyzed and compared. The venous blood was collected before the first immunization, 7 days after the first immunization, 14 days after the first immunization and 14 days after the full immunization. The neutralizing antibody of rabies virus was detected by rapid fluorescent focus inhibition test (RFFIT), and the seropositive conversion rate and geometric mean concentration (GMC) of antibody were calculated. Results: The adverse reaction rates in 5-dose control group, 4-dose trial group and 5-dose trial group were 41.87% (273/652), 35.43% (231/652) and 34.97% (228/652), respectively. The adverse reaction rates of 4-dose trial group and 5-dose trial group were lower than those of the 5-dose control group (P<0.05). The local reactions were mainly pain, itching, swelling and redness in injection site, while the systemic reactions were mainly fever, fatigue, headache and muscle pain. The severity of adverse reactions was mainly mild (level 1), accounting for 85.33% (518/607), 89.02% (373/419) and 88.96% (427/480) of the total number of adverse reactions in each group. At 14 days after the first immunization and 14 days after the full immunization, the antibody positive conversion rates of three groups were all 100%. At 7 days, 14 days after the first immunization and 14 days after the full immunization, the GMCs of three groups were 0.60, 0.72, 0.59 IU/ml, 20.42, 23.99, 24.38 IU/ml and 22.95, 23.52, 24.72 IU/ml, respectively, with no significant difference (P>0.05). Conclusion: The freeze-dried rabies vaccine (Vero-cells) for human use has good safety and immunogenicity when inoculated according to 5-dose and 4-dose immunization procedures.

Tropical Diseases, Travel Medicine and Vaccines

A post-marketing study to evaluate the safety and immunogenicity of a quadrivalent influenza split-virion vaccine in elderly people aged 60 years and older

Article

Author: Fan, Bei ; Pan, Ruowen ; Zhu, Nan ; Li, Xiaoyu ; Tang, Jingning ; Zhang, Ke ; Dang, Mingan ; Liu, Ti ; An, Wenjue ; Kou, Zengqiang ; An, Wenqi

AbstractBackgroundInfluenza remains a global public health concern. Understanding the vaccination-induced response in an aging population, which is susceptible and at high risk, is essential for disease prevention and control. Here, we report findings on the safety and immunogenicity of a quadrivalent influenza split-virion vaccine (15 µg/subtype/0.5 ml/dose) (hereinafter referred to as the “quadrivalent influenza vaccine”) in a population aged ≥ 60 years.MethodsThis open-label, pragmatic post-marketing trial enrolled 1399 older adults to receive one dose of an approved commercially available quadrivalent influenza vaccine manufactured by Hualan Biological Bacterin Inc. (hereinafter referred to as “Hualan Bio”). Participants with contraindications for the vaccine were excluded, while poor health condition was acceptable. All vaccinated subjects experienced adverse events collection within 30 days and serious adverse events within 180 days post-vaccination. 25% subjects, selected randomly, underwent venous blood sampling pre-vaccination and 30 days after post-vaccination, for detecting antibody titers against each subtype of influenza virus by hemagglutination inhibition assay. The incidences of adverse events and antibody titers against each subtype of influenza virus were statistically analyzed using SAS 9.4.ResultsNo grade 3 adverse reactions occurred within 30 days post-vaccination. The incidences of overall adverse reactions, local adverse reactions and systemic adverse reactions were 3.79%, 2.86% and 1.00%, respectively. No serious adverse reactions occurred within 180 days post-vaccination. There were 350 subjects who completed venous blood sampling pre-vaccination, among whom 348 subjects completed venous blood sampling at 30 days post-vaccination for immunogenicity assessment. With respect to hemagglutination inhibition antibodies against influenza viruses H1N1, H3N2, BV and BY subtypes, at 30 days post-vaccination, the seroconversion rates were 87.64%, 75.57%, 73.28% and 78.74%, respectively; the seropositive rates were 93.97%, 98.56%, 79.31% and 95.40%, respectively; and the geometric mean increase (GMI) in post-immunization/pre-immunization antibodies was 24.80, 7.26, 10.39 and 7.39, respectively.ConclusionOne 15 µg/subtype dose of the vaccine had a good safety profile and elicited favorable immunogenicity among subjects aged ≥ 60 years. The results of this study indicate that Hualan Bio quadrivalent influenza vaccine strike balance between safety and immunogenicity, supporting unnecessity to increase dosage or inoculation frequency for further enhancing immunogenicity.Trial registrationRegistered on ClinicalTrials.gov. Registration number: NCT06334510. Registered on 28/03/2024 (retrospectively registered).

Vaccines

Exploratory Study of the Phase IV Immunization Schedule of Quadrivalent Influenza Split-Virion Vaccine in Children Aged 3–8 Years

Article

Author: Dong, Jie ; Yu, Jiangxuan ; Li, Xiaoyu ; An, Wenjue ; Kou, Zengqiang ; Liu, Ti ; Zhang, Wei ; Li, Yaqi ; Zhao, Chenyan ; Zhang, Ke ; An, Wenqi

This study explored the optimum immunization schedule for the quadrivalent influenza split-virion vaccine containing influenza A strains (H1N1 and H3N2) and B lineage strains (Yamagata and Victoria) in children aged 3–8 years. The 652 participants enrolled were divided into two groups based on a history of influenza immunization (IH group) or no history of influenza immunization (NH group). The groups were administered a two-dose immunization schedule on days 0 and 30. In the NH group, on day 30 after the first dose, the positive rates of influenza hemagglutination-inhibition antibodies of strains H1N1, H3N2, BV, and BY were 85.85%, 71.70%, 65.27% and 60.45%, respectively. The positive rates of BV and BY failed to meet the absolute criteria for evaluating the immunogenicity of influenza vaccine in the population aged 3–60 years (for each strain antibody). On day 30 after the second dose, HI antibodies to strains H1N1, H3N2, BV, and BY met the immunogenicity acceptable criteria. In the IH group, on day 30 after the first dose, HI antibodies to strains H1N1, H3N2, BV, and BY met the acceptable criteria for immunogenicity. The incidence rates of adverse reactions (vaccine-related adverse events) from the first dose up until 30 days after the second dose were 20.80% in the IH group and 19.50% in the NH group. Only two Grade 3 adverse reactions (fever: temperature ≥ 39.5 °C, swelling: area ≥ 50% of the injection site area) occurred in the IH group, and no Grade 3 adverse reactions occurred in the NH group. No serious adverse reactions occurred in either group. We conclude that for the NH group, two doses of quadrivalent influenza vaccine should be administered, and for the IH group, a one-dose regimen is acceptable.

100 Deals associated with Hualan Biological Vaccine, Inc.

100 Translational Medicine associated with Hualan Biological Vaccine, Inc.

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Pipeline Snapshot as of 07 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

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Current Projects

Drug(Targets)	Indications	Global Highest Phase

Meningococcal A/C vaccine(Hualan Biological Bacterin Co., Ltd.)	Encephalomyelitis More	Approved
Influenza virus vaccine(Hualan Biological Bacterin Co., Ltd.)	Influenza, Human More	Approved
Rabies Vaccine(Hualan Biological Bacterin)	Rabies More	Approved
Tetravalent influenza split virion vaccine, inactivated (Hualan Biological)	Influenza, Human More	Approved
Tetanus Vaccine,Adsorbed (Hualan Biological Bacterin )	Tetanus More	Approved

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