Randomized, Single-Blind, Placebo-Controlled, Dose-Escalation Phase 1c Study to Evaluate the Safety and Immunogenicity of an Intranasal Live Attenuated Respiratory Syncytial Virus Vaccine (MV-012-968) in Seronegative Children 6-36 Months
试验速览
- 阶段
- 1 期
- 入组人数
- 63
- 试验地点
- 21
- 主要终点
- Solicited adverse events (AEs)
研究概览
简要总结
This study evaluates an investigational vaccine that is designed to protect humans against infection with respiratory syncytial virus (RSV) and is administered as a nasal spray. Specifically, the study analyzes the safety of, and the immune response to, the vaccine when administered to healthy children between the ages of 6 and 24 months who are seronegative to RSV.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Sequential
- 主要目的
- Prevention
- 盲法
- Single (Participant)
盲法说明
The study is single-mask. Study participants and their parent(s)/guardian(s) will not know their child's study assignment; investigators, site staff, and site pharmacists will remain unmasked.
入排标准
- 年龄范围
- 6 Months 至 36 Months（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Children aged 6-36 months
- •Good health based on history, physical examination, and medical record review, without evidence or suspicion of chronic disease
- •Seronegative to RSV, as defined by serum nAb titer below the threshold described in the study protocol and operations manual
- •Written informed consent provided by parent(s)/guardian(s)
排除标准
- •Known or suspected chronic illness, particularly cardiopulmonary (including asthma or reactive airways disease), genetic or metabolic, hepatic, renal, infectious (including recurrent or chronic sinusitis), or immunodeficiency
- •Prior lab-confirmed RSV infection
- •Household or close contact (including but not limited to daycare) during the 21 days post-inoculation with anyone < 6 months old or immunocompromised (applies to first study inoculation)
- •Nasal obstruction (including due to anatomic/structural causes, acute or chronic rhinosinusitis, or other causes)
- •Receipt of immunoglobulins, monoclonal antibodies and/or any blood products, or ribavirin within 6 months prior to study inoculation, or planned use during study period
- •Receipt of an investigational RSV vaccine at any time
- •Any other condition that, in the judgment of the investigator, would be a risk to subject's safety and/or may interfere with study procedures or interpretation of results
结局指标
主要结局
Solicited adverse events (AEs)
时间窗: Immediate post-vaccination period
Frequency of solicited AEs will be measured, categorized by severity. Solicited AEs are predefined AEs that may occur after investigational vaccine administration
Unsolicited AEs
时间窗: Immediate post-vaccination period
Frequency of unsolicited AEs will be measured, categorized by severity. Unsolicited AEs are any untoward medical occurrences in a participant administered the investigational vaccine, regardless of causal relationship to the investigational vaccine. Unsolicited AEs can include unfavorable and unintended signs (including abnormal laboratory findings), symptoms, or diseases temporally associated with the use of the investigational vaccine.
Serious adverse events (SAEs)
时间窗: Full study duration, an average of 1 year
Frequency of SAEs will be measured, categorized by vaccine-relatedness . SAEs are AEs, whether considered causally related to the investigational vaccine or not, that threaten life or result in any of the following: death, inpatient hospitalization or prolongation of existing hospitalization, persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions, or congenital anomaly/birth defect.
Medically attended adverse events (MAEs)
时间窗: Full study duration, an average of 1 year
Frequency of MAEs will be measured, categorized by vaccine-relatedness. MAEs are AEs, whether considered causally related to the investigational vaccine or not, with unscheduled medically attended visits, such as urgent care visits, acute primary care visits, emergency department visits, or other previously unplanned visits to a medical provider. Scheduled medical visits such as routine physicals, wellness checks, 'check-ups', and vaccinations, are not considered MAEs.
Change in RSV-specific serum neutralizing antibody (nAb) titers (GMT)
时间窗: Baseline through Day 28, an average of six (6) weeks
Change in serum RSV-specific neutralizing antibody (nAb) titers will be measured per participant.
次要结局
- Change in serum binding (RSV F-specific) Immunoglobulin G (IgG) concentrations(Baseline through Day 28, an average of six (6) weeks)
- Change in nasal mucosal binding (RSV F-specific) Immunoglobulin A (IgA) concentrations(Baseline through Day 28, an average of six (6) weeks)
- Potential vaccine virus shedding after a single intranasal dose of MV-012-968: magnitude(Intranasal inoculation through Day 22, an average of three (3) weeks)
- Potential vaccine virus shedding after a single intranasal dose of MV-012-968: duration(Intranasal inoculation through Day 22, an average of three (3) weeks)
- Potential vaccine virus shedding after a single intranasal dose of MV-012-968: frequency(Intranasal inoculation through Day 22, an average of three (3) weeks)