[Translation] A randomized, blinded, controlled, non-inferiority design clinical study to evaluate the immunogenicity and safety of group A and group C meningococcal polysaccharide conjugate vaccine after removing the aluminum adjuvant

与已上市含佐剂疫苗比较评价无佐剂A群C群脑膜炎球菌多糖结合疫苗的免疫原性和安全性。

[Translation]

To evaluate the immunogenicity and safety of non-adjuvanted group A and C meningococcal polysaccharide conjugate vaccine by comparing it with marketed adjuvanted vaccines.

Start Date21 Sep 2016

Sponsor / Collaborator

Beijing Luzhu Biopharmaceutical Co., Ltd.

100 Clinical Results associated with Meningococcal AC vaccine(Beijing Luzhu Biopharmaceutical Co., Ltd.)

100 Translational Medicine associated with Meningococcal AC vaccine(Beijing Luzhu Biopharmaceutical Co., Ltd.)

100 Patents (Medical) associated with Meningococcal AC vaccine(Beijing Luzhu Biopharmaceutical Co., Ltd.)

Literatures (Medical) associated with Meningococcal AC vaccine(Beijing Luzhu Biopharmaceutical Co., Ltd.)

01 Oct 2024·Vaccine

A phase 3 non-inferiority trial of locally manufactured Meningococcal ACWY vaccine ‘Ingovax ACWY’ among Bangladeshi adults

Article

Author: Muktadir, Hasneen ; Islam, Shaumik ; Islam, Samnun ; Sarower Bhuyan, Golam ; Hoque, Shahinur ; Tauheed, Imam ; Mainul Ahasan, Mohammad ; Qadri, Firdausi ; Islam Chowdhury, Mohiul ; Panday, Alex S ; Kundu Tanu, Tanni ; Shariful Bari, Shaikh ; Chowdhury, Fahima ; Rahad Hossain, Md ; Amir Hossain, Mohammad ; Masudur Rahman Mia, Md ; Ahmmed, Faisal ; Biswas, Rajib ; Karim, Mahbubul ; Muktadir Rahman Ashik, Md ; Muktadir, Abdul ; Khan, Imran ; Ahmed, Faez ; Rahman Bhuiyan, Taufiqur ; Tarikul Islam, Md ; Ahmed, Tasnuva ; Ahmed, Raziuddin

Meningococcal disease is caused by Neisseria meningitidis or meningococcus. Every year globally around 1.2 million people are affected and approximately 120,000 deaths occur due to meningitis. The disease can be prevented by a single dose of meningococcal vaccine. We carried out a randomized observer-blinded non-inferiority trial to evaluate and compare the immunogenicity and safety of a local meningococcal polysaccharide vaccine 'Ingovax ACWY' (test) with Quadri Meningo^TM (comparator), an approved meningococcal polysaccharide vaccine in India. A total of 88 healthy adults (18-45 years old) were randomized at a 1:1 ratio in two vaccine groups receiving a single dose vaccine subcutaneously. All participants were followed until three months post-vaccination. Blood for clinical parameters (hematology and biochemistry) and serum bactericidal assay (SBA) was collected prior to vaccination and one-month post-vaccination. Solicited adverse events (AEs) were assessed up to 6 days following vaccination and unsolicited AEs were monitored throughout the follow-up period. There was no significant difference in rates of AE between the two groups. The commonest solicited AE was injection site pain. No serious AEs were reported. There was no significant difference (p<0.05) in seroconversion rate as well as pre and post-vaccination SBA geometric mean titers (GMT)between test and comparator vaccine. The post-vaccination GMT ratio (GMR) of the test and comparator vaccine was found to be 0.9, 1, 1.29, and 0.85 for serogroup A, C, W135, and Y respectively. For all the serogroups, lower limit of 95% CI of the GMR was found to be greater than the pre-defined 0.5 non-inferiority margin suggesting that Ingovax ACWY is similar to Quadri Meningo^TM vaccine. We observed the immunogenicity and safety of Ingovax ACWY is non-inferior to comparator vaccine. The development of facilities for manufacturing polysaccharide ACWY vaccines locally will further lead to capacity building in the field of vaccines for Bangladesh.

01 Dec 2021·VaccineQ3 · MEDICINE

Serogroup A, C, W, and Y meningococcal disease in persons previously vaccinated with a serogroup ACWY meningococcal vaccine – United States, 2014–2018

Q3 · MEDICINE

Article

Author: Mbaeyi, Sarah ; Marjuki, Henju ; McNamara, Lucy A ; Topaz, Nadav ; Blain, Amy E ; Reese, Heather E

BACKGROUNDThe Advisory Committee on Immunization Practices (ACIP) recommends routine vaccination with a quadrivalent meningococcal conjugate serogroup A,C,W,Y (MenACWY) vaccine at 11-12 years of age, with a booster dose at 16 years. ACIP also recommends meningococcal vaccination for persons at increased risk of meningococcal disease, including a 2-dose primary series and regular booster doses for persons at increased risk because of underlying medical conditions. U.S. cases of serogroup A, C, W, and Y meningococcal disease in persons previously vaccinated with MenACWY vaccine have not been systematically described since 2008. Characterization of these cases is important to understand potential factors leading to breakthrough disease.METHODSWe analyzed cases of serogroup A,C,W, and Y meningococcal disease reported through the National Notifiable Diseases Surveillance System (NNDSS) from 2014 through 2018. State health departments submitted additional information on risk factors and clinical course.RESULTSDuring 2014-2018, 822 cases of serogroup A, C, W, and Y meningococcal disease were reported through NNDSS; 34 (4%) were in patients who previously received ≥ 1 dose of MenACWY vaccine. Twenty-three vaccinated patients were up-to-date on MenACWY vaccine per recommendations, and seven were not up-to-date; four were missing information on the number of doses received. Seventeen cases (50%) occurred > 3 years after the most recent dose. A significantly higher proportion of vaccinated patients were people living with HIV (PLWH) compared to unvaccinated patients. Eight of the 34 vaccinated patients were immunosuppressed, including five PLWH, one taking eculizumab, and two taking other immunosuppressive medications. The case fatality ratio did not differ between vaccinated and unvaccinated patients.CONCLUSIONSImmunosuppression, incomplete vaccination, and waning immunity likely contributed to breakthrough cases of meningococcal disease among people who received MenACWY vaccine. Continued monitoring of serogroup A, C, W, and Y meningococcal disease in previously vaccinated persons will help inform meningococcal disease prevention efforts.

06 Sep 2020·Zhonghua yu fang yi xue za zhi [Chinese journal of preventive medicine]

[A phase Ⅲ clinical trial study on the safety and immunogenicity of ACYW135 group meningococcal conjugate vaccine inoculated in 3 month old infants].

Article

Author: Zhu, T ; Huang, H T ; Huang, L L ; Xie, Z Q ; Wang, Y X ; Xia, S L ; Zhao, D Y ; Xu, L F ; Gou, J B ; Wang, X ; Zhang, W ; Yang, Y L

Objective: The aim of this study was to evaluate the safety and immunogenicity of the first domestic ACYW135 meningococcal conjugate vaccine and a control vaccine named AC group meningococcal conjugate vaccine for 3 months (90-119 days) infants. Methods: From February 2017 to June 2018, a randomized, blinded, and similar vaccine-controlled clinical trial design was adopted at the Henan Vaccine Clinical Research Base. The subjects were 3 months old healthy infants, a total of 720, based on a 1∶1 ratio. The random allocation table for entry was randomly assigned to the experimental group and the control group. According to the 3, 4, and 5 month-old vaccination procedures, the subjects were vaccinated with test vaccine (ACYW135 group meningococcal conjugate vaccine) and control vaccine (group A group C meningococcal polysaccharide conjugate vaccine), of which 720 were given the first dose, 696 were given the second dose (test group: 346; control group: 350), and 692 were given the third dose (test group: 344; Control group: 348). Results: The overall adverse reaction rate of the test vaccine was 21.90% (230 cases), which was lower than the 32.04% (339 cases) of the control vaccine (P<0.001). The incidence of systemic adverse reactions was 19.52% (205 cases), which was lower than that of the control vaccine (27.69%) (293 cases) (P<0.001). The local adverse reaction rate was 3.04% (32 cases), which was lower than the control group (7.84%) (83 cases) (P<0.001). The graded adverse reaction test vaccine was 0.57% (6 cases), which was lower than the control group of 2.36% (25 cases) (P<0.001). The positive conversion rate of anti-bacterial serum antibodies showed that there was no significant difference between the test vaccine group A (91.42%), C (88.76%) and the control vaccine (92.92%) (87.02%) (P>0.05). Group Y and W135 was 88.17% (298 cases), 99.41% (336 cases), respectively. The GMT results showed that the test vaccine group A was 56.24, the control vaccine was 57.43 (P>0.05); the group C test vaccine (43.53) was higher than the control group (27.28) (P<0.001). The group Y and W135 are 89.22 and 140.66, respectively. Among them, the proportion of the group C GMT antibody ≥ 1∶128 for test vaccine (31.07%, 105 cases) was higher than the control vaccine (16.22%, 55 cases) (P<0.001). Conclusion: ACYW135 group meningococcal conjugate vaccine has more safety and immunogenicity after application to 3 month old infants.

100 Deals associated with Meningococcal AC vaccine(Beijing Luzhu Biopharmaceutical Co., Ltd.)

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Indication	Country/Location	Organization	Date
Meningitis, Meningococcal	CN	Beijing Luzhu Biopharmaceutical Co., Ltd.	29 Aug 2007

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