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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04909021
Recruitment Status : Recruiting
First Posted : June 1, 2021
Last Update Posted : August 2, 2022
Sponsor:
Information provided by (Responsible Party):
Meissa Vaccines, Inc.

Study Description
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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.

Condition or disease Intervention/treatment Phase
Respiratory Syncytial Virus (RSV) Biological: Investigational RSV vaccine MV-012-968 (Dosage 1) Biological: Investigational RSV vaccine MV-012-968 (Dosage 2) 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) Phase 1

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 63 participants
Allocation: Randomized
Intervention Model: Sequential Assignment
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.
Masking: Single (Participant)
Masking Description: The study is single-mask. Study participants and their parent(s)/guardian(s) will not know their child's study assignment; investigators, site staff, and site pharmacists will remain unmasked.
Primary Purpose: Prevention
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
Actual Study Start Date : June 3, 2021
Estimated Primary Completion Date : October 2023
Estimated Study Completion Date : October 2023

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: 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
 Biological: Investigational RSV vaccine MV-012-968 (Dosage 1)
Single dose administered intranasally on Day 1
Experimental: 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
 Biological: Investigational RSV vaccine MV-012-968 (Dosage 2)
Single dose administered intranasally on Day 1
Experimental: 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
 Biological: Investigational RSV vaccine MV-012-968 (Dosage 3; single-dose)
Single dose administered intranasally on Day 1
Experimental: 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
 Biological: 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 Comparator: Placebo (Single-dose)
Participants in this arm will receive a single intranasal dose of placebo
 Other: Placebo (single-dose)
Single dose administered intranasally on Day 1
Placebo Comparator: 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
 Other: Placebo (two-dose)
Single dose administered intranasally on Day 1, followed by an identical dose administered intranasally at the Day 29 study visit


Outcome Measures
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Primary Outcome Measures :
  1. Solicited adverse events (AEs) [ Time Frame: 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

  2. Unsolicited AEs [ Time Frame: 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.

  3. Serious adverse events (SAEs) [ Time Frame: 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.

  4. Medically attended adverse events (MAEs) [ Time Frame: 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.

  5. Change in RSV-specific serum neutralizing antibody (nAb) titers (GMT) [ Time Frame: 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 :
  1. Change in serum binding (RSV F-specific) Immunoglobulin G (IgG) concentrations [ Time Frame: Baseline through Day 28, an average of six (6) weeks ]
    Change in serum binding (RSV F-specific) IgG concentrations will be measured per participant

  2. Change in nasal mucosal binding (RSV F-specific) Immunoglobulin A (IgA) concentrations [ Time Frame: 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

  3. Potential vaccine virus shedding after a single intranasal dose of MV-012-968: frequency [ Time Frame: 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.

  4. Potential vaccine virus shedding after a single intranasal dose of MV-012-968: magnitude [ Time Frame: 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

  5. Potential vaccine virus shedding after a single intranasal dose of MV-012-968: duration [ Time Frame: 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.


Other Outcome Measures:
  1. RSV-confirmed medically attended acute respiratory infection during peak RSV season following study inoculation [ Time Frame: Approximately five (5) months duration during peak RSV season, adjusted for local epidemiology ]
    Frequency of RSV-confirmed medically attended acute respiratory infection during peak RSV season following study inoculation will be measured, categorized by severity.

  2. RSV-confirmed medically attended acute lower respiratory infection [ Time Frame: Approximately five (5) months duration during peak RSV season, adjusted for local epidemiology ]
    Frequency of RSV-confirmed medically attended acute lower respiratory infection during peak RSV season following study inoculation will be measured, categorized by severity.


Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   6 Months to 36 Months   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04909021


Contacts
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Contact: Jay Lieberman, MD 3107538943 jay.lieberman@meissavaccines.com

Locations
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United States, Arizona
MedPharmics Recruiting
Phoenix, Arizona, United States, 85015
Contact: Jason Wallace    602-368-1928    JasonWallace@medpharmics.co   
Principal Investigator: Charles S Plimpton, MD         
United States, California
Paradigm Clinical Research Not yet recruiting
La Mesa, California, United States, 91942
Contact: Jamie Howlett    858-274-4226    jhowlett@paradigm-research.com   
Contact: Andrea VanDucen    858-274-4226    avanducen@paradigm-research.com   
Principal Investigator: Shaun Berger, MD         
United States, Georgia
The Emory Children's Center Recruiting
Atlanta, Georgia, United States, 30322
Contact: Lisa Macoy    404-727-8440    lisa.simmons.macoy@emory.edu   
Principal Investigator: Evan J Anderson, MD         
United States, Idaho
Clinical Research Prime Not yet recruiting
Idaho Falls, Idaho, United States, 83404
Contact: Mireya Martinez    208-497-0600 ext 124    mireya@crprime.com   
Contact: Karley Morgan    208-497-0600    karley@crprime.com   
Principal Investigator: Jeffrey B Baker, MD         
United States, Louisiana
MedPharmics Recruiting
Metairie, Louisiana, United States, 70006
Contact: Katelyn Jackson    504-304-7197    katelynvinet@medpharmics.com   
Principal Investigator: Robert J Jeanfreau, MD         
United States, Nebraska
Meridian Clinical Research Not yet recruiting
Hastings, Nebraska, United States, 68901
Contact: Miranda D Stahr    402-407-2800    mstahr@mcrmed.com   
Contact: Kristine Johnson    402-407-2800    krjohnson@mcrmed.com   
Principal Investigator: Daniel J Leonard, MD         
Meridian Clinical Research Recruiting
Omaha, Nebraska, United States, 68134
Contact: Amy Nichols    402-933-6500    ANichols@mcrmed.com   
Principal Investigator: Brandon Essink, MD         
United States, New York
Meridian Clinical Research Recruiting
Binghamton, New York, United States, 41348
Contact: Kathe Olmstead    607-771-1064 ext 41348    KOlmstead@mcrmed.com   
Principal Investigator: Frank Eder, MD         
United States, Ohio
Aventiv Research Not yet recruiting
Columbus, Ohio, United States, 43213
Contact: Cheyanne Wilson    614-501-6164 ext 2022    cwilson@aventivresearch.com   
Contact: Logan Aldrich    614-501-6164 ext 3009    sgaines@aventivresearch.co   
Principal Investigator: Samir Arora, MD         
United States, South Carolina
Coastal Pediatric Research Not yet recruiting
Summerville, South Carolina, United States, 29486
Contact: Mathew Thomas    843-518-5646    mthomas@cpakids.com   
Contact: Emily McCoy    843-737-9471    emccoy@cpakids.com   
Principal Investigator: Stephen W Stripling, MD         
United States, Texas
PanAmerican Clinical Research Not yet recruiting
Brownsville, Texas, United States, 78520
Contact: Luis E Magana    956-443-0016    lmagana@panamclinicalresearch.com   
Contact: Patricia Garza    956-443-0016    pgarza@panamclinicalresearch.com   
Principal Investigator: Christopher Romero, MD         
Benchmark Research Recruiting
San Antonio, Texas, United States, 78240
Contact: Jaudohn Hicks    210-697-3600 ext 6    jaudohnhicks@benchmarkresearch.net   
Contact: April Valdvieso    210-697-3600 ext 6    aprilvaldvieso@benchmarkresearch.net   
Principal Investigator: Olutola Adetona, MD         
Sponsors and Collaborators
Meissa Vaccines, Inc.
Investigators
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Study Director: Jay Lieberman, MD Meissa Vaccines, Inc.
More Information
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Publications:

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Responsible Party: Meissa Vaccines, Inc.
ClinicalTrials.gov Identifier: NCT04909021    
Other Study ID Numbers: MV-006
First Posted: June 1, 2021    Key Record Dates
Last Update Posted: August 2, 2022
Last Verified: August 2022

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Meissa Vaccines, Inc.:
live attenuated vaccine
safety
immunogenicity
Phase 1 clinical trial
 Pediatric
seronegative
children
Additional relevant MeSH terms:
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Virus Diseases
Infections
Vaccines
Immunologic Factors
Physiological Effects of Drugs