Safety and Immunogenicity of an Intranasal Vaccine for Respiratory Syncytial Virus in Seronegative Children 6-36 Months
- Conditions
- Respiratory Syncytial Virus (RSV)
- Interventions
- Biological: Investigational RSV vaccine MV-012-968 (Dosage 2)Biological: Investigational RSV vaccine MV-012-968 (Dosage 1)Biological: Investigational RSV vaccine MV-012-968 (Dosage 3; single-dose)Biological: Investigational RSV vaccine MV-012-968 (Dosage 3; two-dose)Other: Placebo (single-dose)Other: Placebo (two-dose)
- Registration Number
- NCT04909021
- 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 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 63
- 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)
Key
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SEQUENTIAL
- Arm && Interventions
Group Intervention Description 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 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 3: RSV Vaccine Dosage 3 (Single-dose) Investigational RSV vaccine MV-012-968 (Dosage 3; single-dose) Participants in this arm will receive a single intranasal dose of the investigational RSV vaccine at Dosage 3 Dosage Group 3a: RSV Vaccine Dosage 3 (Two-dose) Investigational RSV vaccine MV-012-968 (Dosage 3; two-dose) Participants in this arm will receive a single intranasal dose of the investigational RSV vaccine at Dosage 3 followed by a second identical dose of the investigational RSV vaccine 28 days later Placebo (Single-dose) Placebo (single-dose) Participants in this arm will receive a single intranasal dose of placebo Placebo (Two-dose) Placebo (two-dose) Participants in this arm will receive a single intranasal dose of placebo followed by a second identical dose of placebo 28 days later
- Primary Outcome Measures
Name Time Method 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
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.
Serious adverse events (SAEs) 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) 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) Baseline through Day 28, an average of six (6) weeks Change in serum RSV-specific neutralizing antibody (nAb) titers will be measured per participant.
- Secondary Outcome Measures
Name Time Method Change in serum binding (RSV F-specific) Immunoglobulin G (IgG) concentrations Baseline through Day 28, an average of six (6) weeks Change in serum binding (RSV F-specific) IgG concentrations will be measured per participant
Change in nasal mucosal binding (RSV F-specific) Immunoglobulin A (IgA) concentrations Baseline through Day 28, an average of six (6) weeks Change in nasal mucosal binding (RSV F-specific) IgA concentrations will be measured per participant
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 If post-vaccination shedding of vaccine virus is detected by plaque assay after a single intranasal dose of MV-012-968, peak viral titer (measured in plaque forming units, PFU) will be measured per dosage group and overall
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 If post-vaccination shedding of vaccine virus is detected by plaque assay after a single intranasal dose of MV-012-968, duration of shedding (in days) will be measured per dosage group and overall.
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 Frequency of any post-vaccination shedding of vaccine virus (as detected by plaque assay) after a single intranasal dose of MV-012-968 will be measured per dosage group and overall.
Trial Locations
- Locations (9)
Clinical Research Prime
🇺🇸Idaho Falls, Idaho, United States
Coastal Pediatric Research
🇺🇸Summerville, South Carolina, United States
Benchmark Research
🇺🇸San Antonio, Texas, United States
MedPharmics
🇺🇸Metairie, Louisiana, United States
Meridian Clinical Research
🇺🇸Binghamton, New York, United States
The Emory Children's Center
🇺🇸Atlanta, Georgia, United States
Paradigm Clinical Research
🇺🇸La Mesa, California, United States
Aventiv Research
🇺🇸Columbus, Ohio, United States
PanAmerican Clinical Research
🇺🇸Brownsville, Texas, United States