Status:
UNKNOWN
Safety and Immunogenicity of an Intranasal Vaccine for Respiratory Syncytial Virus in Seronegative Children 6-36 Months
Lead Sponsor:
Meissa Vaccines, Inc.
Conditions:
Respiratory Syncytial Virus (RSV)
Eligibility:
All Genders
6-36 years
Phase:
PHASE1
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 stud...
Eligibility Criteria
Inclusion
- Key
- 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
Exclusion
- 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
Key Trial Info
Start Date :
June 3 2021
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
October 1 2023
Estimated Enrollment :
63 Patients enrolled
Trial Details
Trial ID
NCT04909021
Start Date
June 3 2021
End Date
October 1 2023
Last Update
August 2 2022
Active Locations (12)
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1
MedPharmics
Phoenix, Arizona, United States, 85015
2
Paradigm Clinical Research
La Mesa, California, United States, 91942
3
The Emory Children's Center
Atlanta, Georgia, United States, 30322
4
Clinical Research Prime
Idaho Falls, Idaho, United States, 83404