Study of the Safety and Immunogenicity of an Intranasal Vaccine for Respiratory Syncytial Virus in Seropositive Children

June 26, 2021 updated by: Meissa Vaccines, Inc.

A Randomized, Single-Blind, Placebo-Controlled, Dose-Escalation Phase 1b Study to Evaluate the Safety and Immunogenicity of an Intranasal Live Attenuated Respiratory Syncytial Virus (RSV) Vaccine in Seropositive Young Children

This study evaluates an investigational vaccine that is designed to protect humans against infection with respiratory syncytial virus (RSV) and is administered as drops in the nose. Specifically, the study analyzes the safety of, and the immune response to, the vaccine when administered to healthy children between the ages of 15 and 59 months who are seropositive to RSV.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

34

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
    • Nebraska
      • Norfolk, Nebraska, United States, 68701
        • Meridian Clinical Research
      • Omaha, Nebraska, United States, 68134
        • Meridian Clinical Research
    • Ohio
      • Cincinnati, Ohio, United States, 45229
        • Cincinnati Children's Hospital Medical Center

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

1 year to 4 years (CHILD)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Key Inclusion Criteria:

  1. Children aged 15-59 months
  2. Good health based on history, physical examination and medical record review, without evidence or suspicion of chronic disease
  3. Seropositive to RSV, as defined by serum neutralizing antibody titer above the threshold described in the study Analytical Plan
  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), metabolic, hepatic, renal, or infectious (including recurrent or chronic sinusitis)
  2. Known or suspected immunodeficiency
  3. Household or close contact with anyone ≤ 6 months of age or with immunocompromised individual(s)
  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 3 months prior to study inoculation, or planned 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 participant'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
  • 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
PLACEBO_COMPARATOR: Dosage Group 1: Placebo
Participants in this arm will receive a single intranasal dose of placebo.
Other: Placebo
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
PLACEBO_COMPARATOR: Dosage Group 2: Placebo
Participants in this arm will receive a single intranasal dose of placebo.
Other: Placebo
Single dose administered intranasally on Day 1
EXPERIMENTAL: Dosage Group 3: RSV Vaccine Dosage 3
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 administered intranasally on Day 1

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 6 months
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 6 months
Medically attended adverse events (MAEs)
Time Frame: Full study duration, an average of 6 months
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 6 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in serum RSV-specific neutralizing antibody titers
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
Change in serum binding (RSV F-specific) antibody titers
Time Frame: Baseline through Day 28, an average of six (6) weeks
Change in serum binding (RSV F-specific) antibody titers will be measured per participant.
Baseline through Day 28, an average of six (6) weeks
Change in nasal mucosal binding (RSV F-specific) antibody titers
Time Frame: Baseline through Day 28, an average of six (6) weeks
Change in mucosal binding (RSV F-specific) antibody titers will be measured per participant.
Baseline through Day 28, an average of six (6) weeks
Potential vaccine virus shedding: frequency
Time Frame: Baseline through Day 28, an average of four (4) weeks
Frequency of any post-vaccination shedding of vaccine virus (as detected by viral culture) will be measured per dosage group and overall.
Baseline through Day 28, an average of four (4) weeks
Potential vaccine virus shedding: magnitude
Time Frame: Baseline through Day 28, an average of four (4) weeks
If post-vaccination shedding of vaccine virus is detected by culture, peak viral titer (measured in plaque forming units, PFU) will be measured per dosage group and overall.
Baseline through Day 28, an average of four (4) weeks
Potential vaccine virus shedding: duration
Time Frame: Baseline through Day 28, an average of four (4) weeks
If post-vaccination shedding of vaccine virus is detected by culture, duration of shedding (in days) will be measured per dosage group and overall.
Baseline through Day 28, an average of four (4) weeks

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 9, 2020

Primary Completion (ACTUAL)

May 7, 2021

Study Completion (ACTUAL)

May 7, 2021

Study Registration Dates

First Submitted

June 12, 2020

First Submitted That Met QC Criteria

June 20, 2020

First Posted (ACTUAL)

June 23, 2020

Study Record Updates

Last Update Posted (ACTUAL)

June 29, 2021

Last Update Submitted That Met QC Criteria

June 26, 2021

Last Verified

June 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MV-005

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.

Clinical Trials on Respiratory Syncytial Virus Infections

Clinical Trials on Investigational RSV vaccine MV-012-968 (Dosage 1)

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Gabon

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe