Clinical trial NCT04909021: Safety and Immunogenicity of an Intranasal Vaccine for Respiratory Syncytial Virus in Seronegative Children 6-36 Months
Official title: 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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
Conditions: Respiratory Syncytial Virus (RSV)
Keywords: live attenuated vaccine
safety
immunogenicity
Phase 1 clinical trial
Pediatric
seronegative
children
Lead sponsor: Meissa Vaccines, Inc.
Sponsor class: INDUSTRY
First posted: 2021-06-01
Enrollment: 63
Sex: ALL
Minimum age (years): 6
Maximum age (years): 36
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SEQUENTIAL
Intervention model description: 1st 5 subjects will be in Group 1 and randomized to investigational vaccine (IP) Dosage 1 or placebo. Safety Monitoring Committee (SMC) will review Group 1 data to Day 15 to allow dose escalation. Next 10 subjects will be in Group 2 and randomized to IP Dosage 2 or placebo. SMC will review Group 2 data to Day 15 to allow dose escalation. Next 12 enrolled subjects will be in Group 3 and randomized to IP Dosage 3 or placebo. SMC will review Group 3 data to Day 15 to allow dose escalation. Next 12 subjects will be in Group 4 and randomized to IP Dosage 4 or placebo. SMC will review Group 4 data to Day 15 to allow dose escalation. Next 12 subjects will be in Group 3a and randomized to IP Dosage 3 or placebo; if meet criteria will receive 2nd dose IP or placebo 28 days after 1st dose. Final 12 subjects will be in Group 4a and randomized to IP Dosage 4 or placebo; if meet criteria will receive 2nd dose IP or placebo 28 days after 1st dose.
Primary purpose: PREVENTION

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.


Eligibility criteria: Key Inclusion Criteria:

1. Children aged 6-36 months
2. Good health based on history, physical examination, and medical record review, without evidence or suspicion of chronic disease
3. Seronegative to RSV, as defined by serum nAb titer below the threshold described in the study protocol and operations manual
4. Written informed consent provided by parent(s)/guardian(s)

Key Exclusion Criteria:

1. 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
2. Prior lab-confirmed RSV infection
3. 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)
4. Nasal obstruction (including due to anatomic/structural causes, acute or chronic rhinosinusitis, or other causes)
5. 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
6. Receipt of an investigational RSV vaccine at any time
7. 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

Primary outcomes:
measure: Solicited adverse events (AEs)
timeFrame: Immediate post-vaccination period
measure: Unsolicited AEs
timeFrame: Immediate post-vaccination period
measure: Serious adverse events (SAEs)
timeFrame: Full study duration, an average of 1 year
measure: Medically attended adverse events (MAEs)
timeFrame: Full study duration, an average of 1 year
measure: Change in RSV-specific serum neutralizing antibody (nAb) titers (GMT)
timeFrame: Baseline through Day 28, an average of six (6) weeks
Secondary outcomes:
measure: Change in serum binding (RSV F-specific) Immunoglobulin G (IgG) concentrations
timeFrame: Baseline through Day 28, an average of six (6) weeks
measure: Change in nasal mucosal binding (RSV F-specific) Immunoglobulin A (IgA) concentrations
timeFrame: Baseline through Day 28, an average of six (6) weeks
measure: Potential vaccine virus shedding after a single intranasal dose of MV-012-968: frequency
timeFrame: Intranasal inoculation through Day 22, an average of three (3) weeks
measure: Potential vaccine virus shedding after a single intranasal dose of MV-012-968: magnitude
timeFrame: Intranasal inoculation through Day 22, an average of three (3) weeks
measure: Potential vaccine virus shedding after a single intranasal dose of MV-012-968: duration
timeFrame: Intranasal inoculation through Day 22, an average of three (3) weeks
Other outcomes:
measure: RSV-confirmed medically attended acute respiratory infection during peak RSV season following study inoculation
timeFrame: Approximately five (5) months duration during peak RSV season, adjusted for local epidemiology
measure: RSV-confirmed medically attended acute lower respiratory infection
timeFrame: Approximately five (5) months duration during peak RSV season, adjusted for local epidemiology
Locations:
city: Phoenix
country: United States
facility: MedPharmics
state: Arizona
city: La Mesa
country: United States
facility: Paradigm Clinical Research
state: California
city: Atlanta
country: United States
facility: The Emory Children's Center
state: Georgia
city: Idaho Falls
country: United States
facility: Clinical Research Prime
state: Idaho
city: Metairie
country: United States
facility: MedPharmics
state: Louisiana
city: Hastings
country: United States
facility: Meridian Clinical Research
state: Nebraska
city: Omaha
country: United States
facility: Meridian Clinical Research
state: Nebraska
city: Binghamton
country: United States
facility: Meridian Clinical Research
state: New York
city: Columbus
country: United States
facility: Aventiv Research
state: Ohio
city: Summerville
country: United States
facility: Coastal Pediatric Research
state: South Carolina
city: Brownsville
country: United States
facility: PanAmerican Clinical Research
state: Texas
city: San Antonio
country: United States
facility: Benchmark Research
state: Texas
Study officials:
affiliation: Meissa Vaccines, Inc.
name: Jay Lieberman, MD
role: STUDY_DIRECTOR
References:
citation: Stobart CC, Rostad CA, Ke Z, Dillard RS, Hampton CM, Strauss JD, Yi H, Hotard AL, Meng J, Pickles RJ, Sakamoto K, Lee S, Currier MG, Moin SM, Graham BS, Boukhvalova MS, Gilbert BE, Blanco JC, Piedra PA, Wright ER, Moore ML. A live RSV vaccine with engineered thermostability is immunogenic in cotton rats despite high attenuation. Nat Commun. 2016 Dec 21;7:13916. doi: 10.1038/ncomms13916.