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

August 1, 2022 updated by: Meissa Vaccines, Inc.

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

63

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Arizona
      • Phoenix, Arizona, United States, 85015
        • Recruiting
        • MedPharmics
        • Contact:
        • Principal Investigator:
          • Charles S Plimpton, MD
    • California
      • La Mesa, California, United States, 91942
    • Georgia
      • Atlanta, Georgia, United States, 30322
        • Recruiting
        • The Emory Children's Center
        • Contact:
        • Principal Investigator:
          • Evan J Anderson, MD
    • Idaho
      • Idaho Falls, Idaho, United States, 83404
        • Not yet recruiting
        • Clinical Research Prime
        • Principal Investigator:
          • Jeffrey B Baker, MD
        • Contact:
        • Contact:
    • Louisiana
      • Metairie, Louisiana, United States, 70006
        • Recruiting
        • MedPharmics
        • Contact:
        • Principal Investigator:
          • Robert J Jeanfreau, MD
    • Nebraska
      • Hastings, Nebraska, United States, 68901
        • Not yet recruiting
        • Meridian Clinical Research
        • Contact:
        • Contact:
        • Principal Investigator:
          • Daniel J Leonard, MD
      • Omaha, Nebraska, United States, 68134
        • Recruiting
        • Meridian Clinical Research
        • Principal Investigator:
          • Brandon Essink, MD
        • Contact:
    • New York
      • Binghamton, New York, United States, 41348
        • Recruiting
        • Meridian Clinical Research
        • Principal Investigator:
          • Frank Eder, MD
        • Contact:
    • Ohio
      • Columbus, Ohio, United States, 43213
    • South Carolina
      • Summerville, South Carolina, United States, 29486
        • Not yet recruiting
        • Coastal Pediatric Research
        • Contact:
        • Contact:
        • Principal Investigator:
          • Stephen W Stripling, MD
    • Texas

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

10 months to 1 year (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Sequential Assignment
  • Masking: Single

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Immediate post-vaccination period
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.
Immediate post-vaccination period
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.
Full study duration, an average of 1 year
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.
Full study duration, an average of 1 year
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.
Baseline through Day 28, an average of six (6) weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Baseline through Day 28, an average of six (6) weeks
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
Baseline through Day 28, an average of six (6) weeks
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.
Intranasal inoculation through Day 22, an average of three (3) weeks
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
Intranasal inoculation through Day 22, an average of three (3) weeks
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.
Intranasal inoculation through Day 22, an average of three (3) weeks

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Approximately five (5) months duration during peak RSV season, adjusted for local epidemiology
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.
Approximately five (5) months duration during peak RSV season, adjusted for local epidemiology

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Meissa Vaccines, Inc.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 3, 2021

Primary Completion (Anticipated)

October 1, 2023

Study Completion (Anticipated)

October 1, 2023

Study Registration Dates

First Submitted

May 26, 2021

First Submitted That Met QC Criteria

May 26, 2021

First Posted (Actual)

June 1, 2021

Study Record Updates

Last Update Posted (Actual)

August 2, 2022

Last Update Submitted That Met QC Criteria

August 1, 2022

Last Verified

August 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MV-006

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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