Study of the Safety and Immunogenicity of an Intranasal Vaccine for Respiratory Syncytial Virus in Seropositive Children
- Conditions
- Respiratory Syncytial Virus Infections
- Interventions
- Other: PlaceboBiological: Investigational RSV vaccine MV-012-968 (Dosage 1)Biological: Investigational RSV vaccine MV-012-968 (Dosage 2)Biological: Investigational RSV vaccine MV-012-968 (Dosage 3)
- Registration Number
- NCT04444284
- Lead Sponsor
- Meissa Vaccines, Inc.
- Brief Summary
This study evaluates an investigational vaccine that is designed to protect humans against infection with respiratory syncytial virus (RSV) and is administered as drops in the nose. Specifically, the study analyzes the safety of, and the immune response to, the vaccine when administered to healthy children between the ages of 15 and 59 months who are seropositive to RSV.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 34
- Children aged 15-59 months
- Good health based on history, physical examination and medical record review, without evidence or suspicion of chronic disease
- Seropositive to RSV, as defined by serum neutralizing antibody titer above the threshold described in the study Analytical Plan
- Written informed consent provided by parent(s)/guardian(s)
Key
- Known or suspected chronic illness, particularly cardiopulmonary (including asthma or reactive airways disease), metabolic, hepatic, renal, or infectious (including recurrent or chronic sinusitis)
- Known or suspected immunodeficiency
- Household or close contact with anyone ≤ 6 months of age or with immunocompromised individual(s)
- 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 3 months prior to study inoculation, or planned 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 participant's safety and/or may interfere with study procedures or interpretation of results
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SEQUENTIAL
- Arm && Interventions
Group Intervention Description Dosage Group 2: Placebo Placebo Participants in this arm will receive a single intranasal dose of placebo. Dosage Group 1: RSV Vaccine Dosage 1 Investigational RSV vaccine MV-012-968 (Dosage 1) Participants in this arm will receive a single intranasal dose of the investigational RSV vaccine at Dosage 1. Dosage Group 1: Placebo Placebo Participants in this arm will receive a single intranasal dose of placebo. Dosage Group 2: RSV Vaccine Dosage 2 Investigational RSV vaccine MV-012-968 (Dosage 2) Participants in this arm will receive a single intranasal dose of the investigational RSV vaccine at Dosage 2. Dosage Group 3: RSV Vaccine Dosage 3 Investigational RSV vaccine MV-012-968 (Dosage 3) Participants in this arm will receive a single intranasal dose of the investigational RSV vaccine at Dosage 3.
- Primary Outcome Measures
Name Time Method Unsolicited AEs 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.
Solicited adverse events (AEs) 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
Serious adverse events (SAEs) Full study duration, an average of 6 months 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) Full study duration, an average of 6 months 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.
- Secondary Outcome Measures
Name Time Method Potential vaccine virus shedding: frequency Baseline through Day 28, an average of four (4) weeks Frequency of any post-vaccination shedding of vaccine virus (as detected by viral culture) will be measured per dosage group and overall.
Potential vaccine virus shedding: magnitude Baseline through Day 28, an average of four (4) weeks If post-vaccination shedding of vaccine virus is detected by culture, peak viral titer (measured in plaque forming units, PFU) will be measured per dosage group and overall.
Change in serum RSV-specific neutralizing antibody titers Baseline through Day 28, an average of six (6) weeks Change in serum RSV-specific neutralizing antibody (nAb) titers will be measured per participant.
Change in serum binding (RSV F-specific) antibody titers Baseline through Day 28, an average of six (6) weeks Change in serum binding (RSV F-specific) antibody titers will be measured per participant.
Change in nasal mucosal binding (RSV F-specific) antibody titers Baseline through Day 28, an average of six (6) weeks Change in mucosal binding (RSV F-specific) antibody titers will be measured per participant.
Potential vaccine virus shedding: duration Baseline through Day 28, an average of four (4) weeks If post-vaccination shedding of vaccine virus is detected by culture, duration of shedding (in days) will be measured per dosage group and overall.
Trial Locations
- Locations (2)
Meridian Clinical Research
🇺🇸Omaha, Nebraska, United States
Cincinnati Children's Hospital Medical Center
🇺🇸Cincinnati, Ohio, United States