A phase Ⅲ clinical trial study on the safety and immunogenicity of ACYW135 group meningococcal conjugate vaccine inoculated in 3 month old infants
10.3760/cma.j.cn112150-20200520-00758
- VernacularTitle:ACYW135群脑膜炎球菌结合疫苗接种于3月龄婴儿的安全性和免疫原性Ⅲ期临床试验研究
- Author:
Zhiqiang XIE
1
;
Dongyang ZHAO
1
;
Haitao HUANG
2
;
Jinbo GOU
2
;
Wei ZHANG
1
;
Yongli YANG
3
;
Lili HUANG
1
;
Yanxia WANG
1
;
Xue WANG
2
;
Lifeng XU
2
;
Tao ZHU
2
;
Shengli XIA
1
Author Information
1. Center of Vaccine Clinical Trial, Henan Center for Disease Control and Prevention, Zhengzhou 450016, China.
2. CanSino Biologics Inc., Tianjin 300457, China.
3. Department of Epidemiology and Biostatistics, College of Public Health, Zhengzhou University, Zhengzhou 450001, China.
- Publication Type:Journal Article
- Keywords:
Control study;
Group A/C/Y/W135 meningococcal conjugate vaccine;
Immunogenicity;
Safety
- MeSH:
Antibodies, Bacterial;
Humans;
Infant;
Meningococcal Vaccines;
adverse effects;
immunology;
Vaccines, Conjugate
- From:
Chinese Journal of Preventive Medicine
2020;54(9):947-952
- CountryChina
- Language:Chinese
-
Abstract:
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. 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). 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 (<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) (<0.001). The local adverse reaction rate was 3.04% (32 cases), which was lower than the control group (7.84%) (83 cases) (<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) (<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%) (>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 (>0.05); the group C test vaccine (43.53) was higher than the control group (27.28) (<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) (<0.001). ACYW135 group meningococcal conjugate vaccine has more safety and immunogenicity after application to 3 month old infants.
