Safety and Immunogenicity of an Intranasal Vaccine for Respiratory Syncytial Virus in Seronegative Children 6-36 Months
NCT ID: NCT04909021
Last Updated: 2022-08-02
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE1
63 participants
INTERVENTIONAL
2021-06-03
2023-10-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
SEQUENTIAL
PREVENTION
SINGLE
Study Groups
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Dosage Group 1: RSV Vaccine Dosage 1
Participants in this arm will receive a single intranasal dose of the investigational RSV vaccine at Dosage 1
Investigational RSV vaccine MV-012-968 (Dosage 1)
Single dose administered intranasally on Day 1
Dosage Group 2: RSV Vaccine Dosage 2
Participants in this arm will receive a single intranasal dose of the investigational RSV vaccine at Dosage 2
Investigational RSV vaccine MV-012-968 (Dosage 2)
Single dose administered intranasally on Day 1
Dosage Group 3: RSV Vaccine Dosage 3 (Single-dose)
Participants in this arm will receive a single intranasal dose of the investigational RSV vaccine at Dosage 3
Investigational RSV vaccine MV-012-968 (Dosage 3; single-dose)
Single dose administered intranasally on Day 1
Dosage Group 3a: RSV Vaccine 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
Investigational RSV vaccine MV-012-968 (Dosage 3; two-dose)
Single dose administered intranasally on Day 1, followed by an identical dose administered intranasally at the Day 29 study visit
Placebo (Single-dose)
Participants in this arm will receive a single intranasal dose of placebo
Placebo (single-dose)
Single dose administered intranasally on Day 1
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
Placebo (two-dose)
Single dose administered intranasally on Day 1, followed by an identical dose administered intranasally at the Day 29 study visit
Interventions
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Investigational RSV vaccine MV-012-968 (Dosage 1)
Single dose administered intranasally on Day 1
Investigational RSV vaccine MV-012-968 (Dosage 2)
Single dose administered intranasally on Day 1
Investigational RSV vaccine MV-012-968 (Dosage 3; single-dose)
Single dose administered intranasally on Day 1
Investigational RSV vaccine MV-012-968 (Dosage 3; two-dose)
Single dose administered intranasally on Day 1, followed by an identical dose administered intranasally at the Day 29 study visit
Placebo (single-dose)
Single dose administered intranasally on Day 1
Placebo (two-dose)
Single dose administered intranasally on Day 1, followed by an identical dose administered intranasally at the Day 29 study visit
Eligibility Criteria
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Inclusion Criteria
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)
Exclusion Criteria
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
6 Months
36 Months
ALL
Yes
Sponsors
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Meissa Vaccines, Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Jay Lieberman, MD
Role: STUDY_DIRECTOR
Meissa Vaccines, Inc.
Locations
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MedPharmics
Phoenix, Arizona, United States
Paradigm Clinical Research
La Mesa, California, United States
The Emory Children's Center
Atlanta, Georgia, United States
Clinical Research Prime
Idaho Falls, Idaho, United States
MedPharmics
Metairie, Louisiana, United States
Meridian Clinical Research
Hastings, Nebraska, United States
Meridian Clinical Research
Omaha, Nebraska, United States
Meridian Clinical Research
Binghamton, New York, United States
Aventiv Research
Columbus, Ohio, United States
Coastal Pediatric Research
Summerville, South Carolina, United States
PanAmerican Clinical Research
Brownsville, Texas, United States
Benchmark Research
San Antonio, Texas, United States
Countries
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Central Contacts
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Facility Contacts
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References
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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.
Other Identifiers
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MV-006
Identifier Type: -
Identifier Source: org_study_id
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