Safety and Immunogenicity of an Intranasal Vaccine for Respiratory Syncytial Virus in Seronegative Children 6-36 Months

Respiratory Syncytial Virus (RSV) Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04909021
• Other study ID #: MV-006
• Status: Recruiting
• Phase: Phase 1
• Start date: June 3, 2021
• Est. completion date: October 2023

Study information

• Verified date: August 2022
• Source: Meissa Vaccines, Inc.
• Contact: Jay Lieberman, MD
• Phone: 3107538943
• Email: jay.lieberman[@]meissavaccines.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 63
• Est. completion date: October 2023
• Est. primary completion date: October 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 6 Months to 36 Months

Eligibility

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

Related Conditions & MeSH terms

• Respiratory Syncytial Virus (RSV)
• Virus Diseases

Intervention

Biological:
• 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

Other:
• 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

Locations

Country	Name	City	State
United States	The Emory Children's Center	Atlanta	Georgia
United States	Meridian Clinical Research	Binghamton	New York
United States	PanAmerican Clinical Research	Brownsville	Texas
United States	Aventiv Research	Columbus	Ohio
United States	Meridian Clinical Research	Hastings	Nebraska
United States	Clinical Research Prime	Idaho Falls	Idaho
United States	Paradigm Clinical Research	La Mesa	California
United States	MedPharmics	Metairie	Louisiana
United States	Meridian Clinical Research	Omaha	Nebraska
United States	MedPharmics	Phoenix	Arizona
United States	Benchmark Research	San Antonio	Texas
United States	Coastal Pediatric Research	Summerville	South Carolina

Sponsors (1)

Lead Sponsor	Collaborator
Meissa Vaccines, Inc.

Country where clinical trial is conducted

United States, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	RSV-confirmed medically attended acute respiratory infection during peak RSV season following study inoculation	Frequency of RSV-confirmed medically attended acute respiratory infection during peak RSV season following study inoculation will be measured, categorized by severity.	Approximately five (5) months duration during peak RSV season, adjusted for local epidemiology
Other	RSV-confirmed medically attended acute lower respiratory infection	Frequency of RSV-confirmed medically attended acute lower respiratory infection during peak RSV season following study inoculation will be measured, categorized by severity.	Approximately five (5) months duration during peak RSV season, adjusted for local epidemiology
Primary	Solicited adverse events (AEs)	Frequency of solicited AEs will be measured, categorized by severity. Solicited AEs are predefined AEs that may occur after investigational vaccine administration	Immediate post-vaccination period
Primary	Unsolicited AEs	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.	Immediate post-vaccination period
Primary	Serious adverse events (SAEs)	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.	Full study duration, an average of 1 year
Primary	Medically attended adverse events (MAEs)	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.	Full study duration, an average of 1 year
Primary	Change in RSV-specific serum neutralizing antibody (nAb) titers (GMT)	Change in serum RSV-specific neutralizing antibody (nAb) titers will be measured per participant.	Baseline through Day 28, an average of six (6) weeks
Secondary	Change in serum binding (RSV F-specific) Immunoglobulin G (IgG) concentrations	Change in serum binding (RSV F-specific) IgG concentrations will be measured per participant	Baseline through Day 28, an average of six (6) weeks
Secondary	Change in nasal mucosal binding (RSV F-specific) Immunoglobulin A (IgA) concentrations	Change in nasal mucosal binding (RSV F-specific) IgA concentrations will be measured per participant	Baseline through Day 28, an average of six (6) weeks
Secondary	Potential vaccine virus shedding after a single intranasal dose of MV-012-968: frequency	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.	Intranasal inoculation through Day 22, an average of three (3) weeks
Secondary	Potential vaccine virus shedding after a single intranasal dose of MV-012-968: magnitude	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	Intranasal inoculation through Day 22, an average of three (3) weeks
Secondary	Potential vaccine virus shedding after a single intranasal dose of MV-012-968: duration	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.	Intranasal inoculation through Day 22, an average of three (3) weeks