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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-01-14

Study Completion Date

2020-08-27

Brief Summary

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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.

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Detailed Description

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Conditions

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Respiratory Syncytial Virus Infections

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Each enrolled subject will be allocated to 1 of 2 study groups. Group 1 will receive one dosage of the investigational RSV vaccine, and Group 2 will receive a different dosage of the same vaccine.

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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RSV Vaccine: Dosage Group #1

Participants in this group will receive a single dose of the RSV vaccine at dosage #1

Group Type EXPERIMENTAL

RSV vaccine MV-012-968 (dosage #1)

Intervention Type BIOLOGICAL

Single dose administered intranasally on Day 1

RSV Vaccine: Dosage Group #2

Participants in this group will receive a single dose of the RSV vaccine at dosage #2

Group Type EXPERIMENTAL

RSV vaccine MV-012-968 (dosage #2)

Intervention Type BIOLOGICAL

Single dose administered intranasally on Day 1

Interventions

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RSV vaccine MV-012-968 (dosage #1)

Single dose administered intranasally on Day 1

Intervention Type BIOLOGICAL

RSV vaccine MV-012-968 (dosage #2)

Single dose administered intranasally on Day 1

Intervention Type BIOLOGICAL

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

40 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes