A Phase I Study of the Safety and Immunogenicity of a Single Dose of the Live Recombinant RSV D46cpΔM2-2 Vero Grown Virus Vaccine (Lot RSV #008A), Delivered as Nose Drops to RSV-Seropositive Children 12 to 59 Months of Age and RSV-Seronegative Infants and Children 6 to 24 Months of Age
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 45
- 试验地点
- 1
- 主要终点
- Frequency of vaccine-related solicited adverse events (AEs) that occur during the acute monitoring phase of the study
研究概览
简要总结
The purpose of this study is to evaluate the safety and immunogenicity of the RSV D46cpΔM2-2 vaccine in RSV-seropositive children and RSV-seronegative infants and children.
详细描述
Human RSV is the most common viral cause of serious acute lower respiratory illness (LRI) in infants and children under 5 years of age worldwide. This study will evaluate the safety and immunogenicity of the RSV D46cpΔM2-2 vaccine in RSV-seropositive children and RSV-seronegative infants and children. The vaccine will be evaluated in a stepwise fashion beginning in RSV-seropositive children (Group 1), and then in RSV-seronegative infants and children (Group 2). In each group, participants will be randomly assigned to receive a single dose of D46cpΔM2-2 vaccine or placebo at study entry (day 0).
Participants will be enrolled in the study between April 1 and October 31, outside of the RSV season. Group 1 (RSV-seropositive children) will attend several study visits and will be followed for 28 days. Group 2 (RSV-seronegative infants and children) will remain on study until they complete the post-RSV season visit between April 1 and April 30 in the calendar year following enrollment. Participants in Group 2 will also attend several study visits during the time they are enrolled in the study. Study visits for all participants may include clinical assessments, blood collection, and nasal washes.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 6 Months 至 60 Months（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Greater than or equal to 12 months of age and less than 60 months of age
- •Received routine immunizations appropriate for age
- •Serum RSV neutralizing antibody titer greater than or equal to 1:40
- •Serum RSV neutralizing antibody result obtained this calendar year
- •Pre-inoculation serum RSV neutralizing antibody specimen obtained less than or equal to 56 days prior to inoculation
- •Parent/guardian has completed the study comprehension assessment
- •Parent/guardian has signed the study informed consent document (ICD)
- •Subject is expected to be available for the duration of the study
排除标准
- •Evidence of chronic disease
- •Within the past 6 months had a decline in height or weight growth that crosses two major growth percentiles (e.g., from above the 75th to below the 25th)
- •Known or suspected impairment of immune function
- •Maternal history of positive HIV test
- •Bone marrow/solid organ transplant recipient
- •Major congenital malformations, including congenital cleft palate or cytogenetic abnormalities
- •Current or unresolved suspected or documented developmental disorder, delay, or other developmental problem
- •Cardiac abnormality requiring treatment
- •Lung disease or reactive airway disease
- •More than one episode of wheezing in the first year of life
- •Wheezing episode or received bronchodilator therapy within the past 12 months
- •Previous immunization with an experimental RSV vaccine
- •Previous receipt or planned administration of anti-RSV antibody product
- •Previous serious vaccine-associated AE or anaphylactic reaction
- •Known hypersensitivity to any vaccine component
- •Previous receipt of immunoglobulin or any antibody products
- •Previous receipt of any other blood products within the past 6 months
- •Member of a household that contains an infant who is less than 12 months of age during study days 0 to 10
- •Member of a household that includes an immunocompromised individual
- •Member of a household that includes a person who has received chemotherapy within the past 12 months
- •Will attend a daycare facility that does not separate children by age and contains an infant who is greater than 12 months of age during study days 0 to 10
- •RSV-Seronegative Infants and Children:
- •Inclusion Criteria:
- •Greater than or equal to 6 months of age and less than 25 months of age
- •Received routine immunizations appropriate for age
- •Serum RSV neutralizing antibody titer is less than 1:40
- •Screening and pre-inoculation serum RSV neutralizing antibody specimen obtained less than or equal to 42 days prior to inoculation
- •Parent/guardian has completed the study comprehension assessment
- •Parent/guardian has signed the study ICD
- •Subject is expected to be available for the duration of the study
- •Born at greater than or equal to 37 weeks gestation or is currently greater than 1 year of age
- •Exclusion Criteria:
- •Evidence of chronic disease
- •Within the past 6 months had a decline in height or weight growth that crosses two major growth percentiles (e.g., from above the 75th to below the 25th)
- •Known or suspected impairment of immune function
- •Maternal history of positive HIV test
- •Bone marrow/solid organ transplant recipient
- •Major congenital malformations, including congenital cleft palate or cytogenetic abnormalities
- •Current or unresolved suspected or documented developmental disorder, delay, or other developmental problem
- •Cardiac abnormality requiring treatment
- •Lung disease or reactive airway disease
- •More than one episode of wheezing in the first year of life
- •Wheezing episode or received bronchodilator therapy within the past 12 months
- •Previous immunization with an experimental RSV vaccine
- •Previous receipt or planned administration of anti-RSV antibody product
- •Previous receipt of immunoglobulin or any antibody products
- •Previous receipt of any other blood products within the past 6 months
- •Previous serious vaccine-associated AE or anaphylactic reaction
- •Known hypersensitivity to any vaccine component
- •Member of a household which contains an infant who is less than 6 months of age during study days 0 to 28
- 另有 23 项未显示
研究组 & 干预措施
Group 1: D46cpΔM2-2 Vaccine
RSV-seropositive children will receive a single dose of 10^6 PFU D46cpΔM2-2 vaccine at study entry (day 0).
干预措施: D46cpΔM2-2 vaccine (Biological)
Group 1: Placebo
RSV-seropositive children will receive a single dose of placebo at study entry (day 0).
干预措施: Placebo (Biological)
Group 2: D46cpΔM2-2 Vaccine
RSV-seronegative infants and children will receive a single dose of 10^5 PFU D46cpΔM2-2 vaccine at study entry (day 0).
干预措施: D46cpΔM2-2 vaccine (Biological)
Group 2: Placebo
RSV-seronegative infants and children will receive a single dose of placebo at study entry (day 0).
干预措施: Placebo (Biological)
结局指标
主要结局
Frequency of vaccine-related solicited adverse events (AEs) that occur during the acute monitoring phase of the study
时间窗: Measured at days 0-10 for seropositive and days 0-28 for seronegative
Severity of vaccine-related solicited AEs that occur during the acute monitoring phase of the study
时间窗: Measured at days 0-10 for seropositive and days 0-28 for seronegative
Proportion of subjects shedding vaccine virus
时间窗: Measured during study days 0-28 for seropositive subjects and study days 0-56 for seronegative subjects
Frequency of vaccine-related lower respiratory illness
时间窗: Measured during study days 0-28 for seropositive subjects and study days 0-56 for seronegative subjects
Proportion of subjects that develop 4-fold or greater increases in RSV neutralizing antibody titer following vaccination
时间窗: Measured during study days 0-28 for seropositive subjects and study days 0-56 for seronegative subjects
次要结局
未报告次要终点