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Human Challenge Study to Evaluate the Efficacy of MV-012-968 Vaccine

NCT04690335 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2022-08-04

No results posted yet for this study

Summary

The purpose of this research study is to evaluate whether the investigational, live attenuated, intranasally delivered vaccine MV-012-968 ('study vaccine') may have prophylactic efficacy against symptomatic RSV infection when administered to adults 18-45 years of age in the Human Viral Challenge model.

Conditions

  • RSV Infection

Interventions

BIOLOGICAL

MV-012-968

MV-012-968 is a recombinant, live attenuated RSV vaccine.

OTHER

Placebo

Saline solution

Sponsors & Collaborators

  • Hvivo

    collaborator INDUSTRY

  • Meissa Vaccines, Inc.

    lead INDUSTRY

Principal Investigators

  • Mariya Kalinova, MD · hVIVO Services Ltd

  • Oliver Medzihradsky, MD MPH MS · Meissa Vaccines, Inc.

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
45 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2020-12-29
Primary Completion
2021-05-07
Completion
2021-09-09
FDA Drug
Yes

Countries

  • United Kingdom

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04690335 on ClinicalTrials.gov