A Phase IV Open-label, Randomized, Parallel-group Study to Evaluate Pharyngeal Immunity to Poliovirus Type-2 in Healthy bOPV- Versus IPV-vaccinated Infants
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 501
- 试验地点
- 2
- 主要终点
- Poliovirus type-2 viral shedding
研究概览
简要总结
The study will compare the poliovirus type-2 pharyngeal mucosal excretion in the first week, and at 2 and 4 weeks following the administration of a challenge novel OPV2 (nOPV2) dose at 18 weeks of age in 2 parallel groups of infants
详细描述
In the light of the switch from OPV to IPV and the continued presence of cVDPV2 in many countries, it is important to understand and quantify the impact of IPV on pharyngeal mucosal immunity, to inform whether and to what extent the mucosal and humoral immune response following IPV could reduce transmission and spread.
This study will assess the effect of vaccination with IPV in parallel with poliovirus type-2 naïve infants (infants having received bOPV) on the pharyngeal and fecal shedding and the induction of immunity following type-2 poliovirus challenge. This understanding would provide critical information on the potential use of IPV in specific settings to interrupt transmission / reduce spread. The results from this study may potentially have important consequences on public health policy in countries which use IPV for infant priming, as they will help to show the extent to which a type-2 mucosal immunity gap remains following a primary series of IPV.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 5 Weeks 至 8 Weeks（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Infants aged 6 to 8 weeks with birth weight >2,500 g.
- •Healthy infants without obvious medical conditions like immunodeficiency diseases, severe congenital malformations, severe neurological diseases or any other disease that require high doses of corticosteroids or immunotherapies that preclude the subject from participating in the study as established by the medical history and physical examination.
- •Written informed consent obtained from both parents or legal guardian(s) as per country regulations.
排除标准
- •Infants who have received previous vaccination against poliomyelitis.
- •Any confirmed or suspected immunosuppressive or known immunodeficient condition including human immunodeficiency virus infection in the potential participant or any member of the subject's household.
- •Family history of congenital or hereditary immunodeficiency.
- •Major congenital defects or serious uncontrolled chronic illness (neurologic, pulmonary, gastrointestinal, hepatic, renal, or endocrine).
- •Known allergy to any component of the study vaccines or to any antibiotics that share molecular composition with a component of the study vaccines.
- •Uncontrolled coagulopathy or blood disorder contraindicating intramuscular injections (of IPV)
- •Administration of immunoglobulins and/or any blood products since birth or planned administration during the study period.
- •Acute severe febrile illness on the day of vaccination deemed by the Investigator to be a contraindication for vaccination (the child can be included at a later time if within age window and all inclusion criteria are met.).
- •Subject who, in the opinion of the Investigator, is unlikely to comply with the protocol or is inappropriate to be included in the study for the safety or the benefit-risk ratio of the subject.
- •Infants from multiple births or born prematurely (< 37 weeks of gestation).
研究组 & 干预措施
IPV-primed Group
Approximately 250 subjects to receive 3 doses of IPV administered at approx. 6, 10, 14 weeks of age and an nOPV2-002 challenge at approx. 18 weeks of age.
干预措施: nOPV2 (Biological)
bOPV-primed Group
Approximately 250 subjects to receive 3 doses of bOPV administered at approx. 6, 10, 14 weeks of age and an nOPV2-002 challenge at approx. 18 weeks of age.
干预措施: nOPV2 (Biological)
结局指标
主要结局
Poliovirus type-2 viral shedding
时间窗: 1 month
To compare the presence of poliovirus type-2 in pharyngeal samples detected by reverse-transcription polymerase chain reaction (RT PCR) in the first week, and at D14 and D28 in both groups.
Number of Participants Shedding Detectable Levels of Poliovirus Type-2 by RT PCR.
时间窗: 1 month
To compare the presence of poliovirus type-2 in pharyngeal samples detected by reverse-transcription polymerase chain reaction (RT PCR) in the first week, and at D14 and D28 in both groups.
次要结局
- Incidence of Serious Adverse Events (SAEs) and Important Medical Events (IMEs)(5 months)
- Pharyngeal neutralizing antibodies (NAbs) and IgA response to poliovirus type-2.(1 month)
- Seroconversion rate of poliovirus type-2 neutralizing antibodies (NAbs)(2 months)
- Pharyngeal Neutralizing Antibodies (NAbs) to Poliovirus Type-2.(1 month)
- Seroprotection Rate to Poliovirus Type-2 on D0, D28 and D56 in Both Groups.(2 months)
- Number of Participants That Experienced Serious Adverse Events (SAEs) and Important Medical Events (IMEs)(5 months)
- Pharyngeal Poliovirus Type-2-specific Immunoglobulin A (IgA) Concentrations(1 month)