Safety and Immune Response to an Investigational Vaccine Against Respiratory Syncytial Virus in Healthy Adults

September 13, 2020 updated by: Meissa Vaccines, Inc.

A Phase 1 Study to Evaluate the Safety and Immunogenicity of an Intranasal Live Attenuated Respiratory Syncytial Virus (RSV) Vaccine in Healthy Adults

This study evaluates an investigational vaccine designed to protect humans against infection with respiratory syncytial virus (RSV). The investigational vaccine (MV-012-968) is administered as drops in the nose. This study specifically analyzes the safety of, and the immune response to, the vaccine when administered to healthy non-pregnant adults between the ages of 18 and 40 years.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

20

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
    • Kansas
      • Lenexa, Kansas, United States, 66219
        • Johnson County Clin-Trials

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

18 years to 40 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Key Inclusion Criteria:

  • Adult 18-40 years of age
  • In good health based on review of the medical record, history, and physical examination, without evidence of chronic disease
  • RSV 'sero-low' from a pre-vaccination serum sample
  • Signed informed consent form

Exclusion Criteria:

  • Occupational or household exposure to children < 5 years of age, or to immunocompromised individuals
  • Prior receipt of an investigational RSV vaccine
  • Women who are pregnant, lactating, or unwilling to take effective measures to prevent pregnancy for at least 3 months after vaccination
  • Any other reason the Investigator considers exclusionary

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: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: RSV Vaccine: Dosage Group #1
Participants in this group will receive a single dose of the RSV vaccine at dosage #1
Biological: RSV vaccine MV-012-968 (dosage #1)
Single dose administered intranasally on Day 1
Experimental: RSV Vaccine: Dosage Group #2
Participants in this group will receive a single dose of the RSV vaccine at dosage #2
Biological: RSV vaccine MV-012-968 (dosage #2)
Single dose administered intranasally on Day 1

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
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 can occur after vaccine administration.
Immediate post-vaccination period
Serious adverse events (SAEs)
Time Frame: Vaccination through study completion, 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.
Vaccination through study completion, an average of 6 months
Medically attended adverse events (MAEs)
Time Frame: Vaccination through study completion, 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.
Vaccination through study completion, an average of 6 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in serum RSV-specific neutralizing antibody (nAb) titers
Time Frame: Baseline through study completion, an average of 6 months
Post-vaccination change in serum RSV-specific nAb titers will be measured per participant.
Baseline through study completion, an average of 6 months
Change in serum RSV F-specific binding antibody titers
Time Frame: Baseline through study completion, an average of 6 months
Post-vaccination change in serum RSV F-specific binding antibody titers will be measured per participant.
Baseline through study completion, an average of 6 months
Change in mucosal RSV F-specific binding antibody titers
Time Frame: Baseline through study completion, an average of 6 months
Post-vaccination change in mucosal RSV F-specific binding antibody titers will be measured per participant.
Baseline through study completion, an average of 6 months
Potential vaccine virus shedding
Time Frame: Baseline through 2 months
The presence and, if detected, quantity and duration of any shed vaccine virus will be measured per participant.
Baseline through 2 months

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)

January 14, 2020

Primary Completion (Actual)

August 27, 2020

Study Completion (Actual)

August 27, 2020

Study Registration Dates

First Submitted

January 6, 2020

First Submitted That Met QC Criteria

January 9, 2020

First Posted (Actual)

January 13, 2020

Study Record Updates

Last Update Posted (Actual)

September 16, 2020

Last Update Submitted That Met QC Criteria

September 13, 2020

Last Verified

September 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MV-003

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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