Neonatal Immunization With Pneumococcal Conjugate Vaccine in Papua New Guinea
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 318
- 试验地点
- 2
- 主要终点
- Immunogenicity and Safety
研究概览
简要总结
The National Health Plan 2001-2010 calls for investigation of the feasibility of pneumococcal vaccines for Papau New Guinea. The Papua New Guinea (PNG) Institute of Medical Research, the Telethon Institute for Child Health Research and the Department of Paediatrics, University of Western Australia will collaborate to examine very closely the safety of neonatal vaccination, particularly with regard to impact on the development of immunity and response to other vaccines given to infants. This study will also provide a unique opportunity for training of PNG and Australian scientists in both countries.
详细描述
In order to obtain the earliest possible protection against invasive pneumococcal disease, achieve optimal coverage and reduce burden of early carriage, neonatal pneumococcal conjugate vaccine (PCV) immunization needs to be considered. This study in the PNG highlands will enrol 312 infants at birth, who will be randomised to receive PCV either at 1-2-3 months (infant schedule according to PNG national EPI schedule) or 0-1-2 months of age (neonatal schedule) or receive only routine immunizations (controls). Blood samples will be taken at birth-2-3-4 months of age, pre- and post-pneumococcal polysaccharide booster (23vPPV) at 9-10 months of age (to assess immune memory) and at 18 months at study completion. Carriage will be assessed weekly for the first month of life and at regular intervals thereafter. There will be ongoing surveillance for respiratory and other diseases throughout the study. In addition to serotype-specific IgG, we will examine IgG avidity, IgG subclasses, mucosal IgA and T-cell cytokine responses to PCV and pneumococcal protein antigens. To ensure immunological safety, particularly for neonatal PCV, immune responses to concomitant vaccines and viral and environmental antigens will also be examined as well as overall T-cell maturation.
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
- 1 Minute 至 3 Days（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •New born babies with birth weight >2000 g (2 kgs) and parents giving consent
排除标准
- •Acute neonatal infection;
- •Severe congenital abnormality;
- •Children of mothers known to be HIV positive will be excluded;
- •Serious asphyxia at birth;
- •Intended migration in the next 2 years;
- •Parents withdraw consent;
结局指标
主要结局
Immunogenicity and Safety
时间窗: 5 yrs
Serum PCV serotype-specific IgG antibody at 2, 4 and 9 mths. Mucosal PCV serotype-specific IgG antibody at 1, 3, 4 and 9 mths. PCV-induced T-cell memory (against vaccine protein carrier) at 3 and 9 mths. Local and systemic reactogenicity 48-96 hrs after vaccination. Monitoring of serious adverse events during 18 mth follow-up. T-cell development to bystander antigens at 3 and 9 mths.
次要结局
- Immunogenicity(5 years)
- Pneumococcal-specific acquired immunity(5 years)