Immunogenicity, Safety, and Lot Consistency of a Novel Inactivated Enterovirus 71 Vaccine in Chinese Children Aged 6 to 59 Months
| Autor: | Fan Gao, Yufei Song, Feng Cai Zhu, Lin Chang, Jie Lai Xia, Yue Mei Hu, Ya Ling Hu, Zheng Lun Liang, Xu Wang, Yong Jie Zhang, Qun Ying Mao, Jiang Ting Chen, Ling Wang, Qi Gang Dai, Jun Zhi Wang |
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| Jazyk: | angličtina |
| Rok vydání: | 2013 |
| Předmět: |
Microbiology (medical)
Male medicine.medical_specialty China Clinical Biochemistry Immunology Placebo Antibodies Viral law.invention Placebos Randomized controlled trial Double-Blind Method law Internal medicine medicine Enterovirus 71 Enterovirus Infections Immunology and Allergy Humans Adverse effect Vaccines biology business.industry Immunogenicity Vaccination Infant Viral Vaccines biology.organism_classification Antibodies Neutralizing Confidence interval Enterovirus A Human Titer Vaccines Inactivated Child Preschool Female business |
| Popis: | The determination of lot-to-lot consistency in the manufacturing process is a mandatory step in the clinical development of the novel enterovirus 71 (EV71) vaccine. A phase III, randomized, placebo-controlled, double-blind trial assessed the lot consistency, immunogenicity, and safety of the EV71 vaccine in children aged 6 to 59 months. Healthy children ( n = 1,400) received one of three lots of the EV71 vaccine containing 400 U of EV71 antigen or a placebo at days 0 and 28. Blood samples were collected before dose 1 and at 28 days after dose 2 (day 56) for an anti-EV71 neutralizing antibody (NTAb) assay. The geometric mean titer (GMT) and the seropositivity rates (with titers of ≥1:8) were compared at day 56. After each dose, the solicited injection site and general adverse events (AEs) were recorded for 7 days, and unsolicited AEs were recorded for 28 days. At day 56, the seropositivity rates ranged from 99.7% to 100% for the vaccine groups. The NTAb GMTs for the vaccine were 140.3 (95% confidence interval [CI], 117.8 to 167.1), 141.5 (95% CI, 118.0 to 169.6), and 146.6 (95% CI, 122.5 to 175.3). The two-sided 95% CI of the log difference in GMTs between the pairs of lots were between −0.176 and 0.176, therefore meeting the predefined equivalence criteria. The percentages of subjects reporting any injection site AEs, general AEs, or serious AEs were similar across the four vaccination groups. In conclusion, the demonstration of consistency between the manufacturing lots confirms for the purposes of clinical development the reliability of the EV71 vaccine production process. (This study has been registered at ClinicalTrials.gov under registration no. NCT01636245.) |
| Databáze: | OpenAIRE |
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