A Double-Blind Placebo-Controlled Trial of the Safety and Immunogenicity of a Seven Valent Pneumococcal Conjugate Vaccine in Presumed HIV-Infected Infants
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 60
- 试验地点
- 33
- 主要终点
- Comparison of seroconversion rates and changes in (IgG) ELISA antibody levels between PCV and placebo patients after the primary series
研究概览
简要总结
To assess whether HIV-infected infants who receive a heptavalent pneumococcal conjugate vaccine have more local reactions at the site of injection and systemic reactions than placebo subjects. To assess whether this vaccine is more immunogenic than placebo following the third vaccination.
Children with HIV infection are at increased risk for invasive pneumococcal infection, particularly bacteremia. A large proportion of pneumococcal disease is caused by a limited number of serotypes. The maximum number of pneumococcal serotypes that can be included in a new conjugate vaccine is felt to be limited by the amount of carrier protein. A heptavalent pneumococcal conjugate vaccine has been developed that consists of pneumococcal capsular saccharides from serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F bound to a diphtheria toxin mutant carrier protein.
详细描述
Children with HIV infection are at increased risk for invasive pneumococcal infection, particularly bacteremia. A large proportion of pneumococcal disease is caused by a limited number of serotypes. The maximum number of pneumococcal serotypes that can be included in a new conjugate vaccine is felt to be limited by the amount of carrier protein. A heptavalent pneumococcal conjugate vaccine has been developed that consists of pneumococcal capsular saccharides from serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F bound to a diphtheria toxin mutant carrier protein.
Infants are randomized to receive either heptavalent pneumococcal conjugate vaccine or placebo by intramuscular injection at study months 0, 2, and 4, and then at 15 months of age. Additionally, patients receive PNU-IMUNE 23 ( pneumococcal polyvalent vaccine ) at 24 months of age.
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
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 2 Months 至 6 Months（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Concurrent Medication:
- •Antipyretics for rectal temperature >= 100.4 F.
- •Antiretroviral therapy.
- •Patients must have:
- •HIV positivity.
- •Birth weight at least 1800 g (3.75 lb).
- •Consent and compliance of parent or guardian.
- •Coenrollment in other therapeutic protocols (except ACTG 218, 230, and 279) is permitted.
排除标准
- •Co-existing Condition:
- •Patients with the following symptoms or conditions are excluded:
- •Enrollment in HIV vaccine trials.
- •Major congenital anomalies that are incapacitating, result in immunologic abnormalities, or require major surgical procedures.
- •Congenital immunoglobulin deficiency, SS or SC hemoglobinopathy, or asplenia.
- •Hypogammaglobulinemia.
- •Concurrent Medication:
- •Prophylactic antipyretics.
- •Patients with the following prior conditions are excluded:
- •Acute moderate to severe intercurrent illness or fever within 72 hours prior to study entry.
- •Prior Medication:
- •Any prior pneumococcal vaccine.
- •Measles vaccine within 1 month prior to study vaccination.
- •Any other routine vaccine within 1 week prior to study vaccination.
- •Any immunosuppressant agent, including prednisone, for more than 6 weeks.
- •Prior Treatment:
- •Blood products within 56 days prior to study vaccination.
研究组 & 干预措施
2
Patients receiving placebo vaccine
干预措施: Pneumococcal Vaccine, Polyvalent (23-valent) (Biological)
2
Patients receiving placebo vaccine
干预措施: Placebo (Biological)
1
Patients receiving intramuscular heptavalent pneumococcal conjugate vaccine
干预措施: Pneumococcal Vaccine, Polyvalent (23-valent) (Biological)
1
Patients receiving intramuscular heptavalent pneumococcal conjugate vaccine
干预措施: Pneumococcal Conjugate Vaccine, Heptavalent (Biological)
结局指标
主要结局
Comparison of seroconversion rates and changes in (IgG) ELISA antibody levels between PCV and placebo patients after the primary series
时间窗: Throughout study
Comparison of adverse reactions between PCV and placebo patients that occur within 48 hours after each injection
时间窗: Throughout study
次要结局
- Comparison of booster rates in serum ELISA (IgG) antibody levels just before the 4th vaccination and one month after the 4th vaccination in children receiving PCV and placebo(Prior to 4th vaccination and at 1 month after 4th vaccination)
- To compare the decline of serum total IgG, IgG1, IgG2, and IgA pneumococcal type specific antibody after the 3rd and after the 4th vaccination in PCV versus placebo patients(At a time after the 3rd vaccination and at a time after the 4th vaccination)
- Modeling of the rates of seroconversion and changes in serum antibody levels in PCV patients, after the primary series and booster series, to clinical HIV staging and T-lymphocyte parameters, as well as B-lymphocyte parameters(Throughout study)
- Comparison of serum IgG1 and IgG2 subclass and IgA type specific seroconversion rates and changes in antibody levels in response to the primary immunization series and booster vaccination between PCV and placebo patients(Throughout study)