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Phase I Trial of Measles Vectored Chikungungya Vaccine

NCT03028441 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 180

Last updated 2020-11-27

No results posted yet for this study

Summary

This study is a randomized, double-blinded, Phase 1, placebo- controlled, and dose comparison trial to evaluate the safety, immunogenicity and schedule of MV-CHIK. Two dosage levels and 3 immunization schedules will be evaluated. This study will enroll up to 180 healthy subjects aged 18 to 45 years.Study duration is approximately 22 months. Subject participation duration is approximately 8-13 months. The primary objectives are to evaluate the safety and tolerability of 5 x 10\^4 TCID50 and 5 x 10\^5 TCID50 MV-CHIK and placebo following two consecutive intramuscular injections and to assess the CHIKV serum plaque reduction neutralization test (PRNT50) antibody responses to 5 x 10\^4 TCID50, 5 x 10\^5 TCID50 of MV-CHIK or placebo on day 29 following the first dose.

Conditions

  • Chikungunya Virus Infection

Interventions

OTHER

Placebo

Placebo

BIOLOGICAL

VRC-CHKVLP059-00-VP

Measles-vectored Chikungunya vaccine

Sponsors & Collaborators

  • National Institute of Allergy and Infectious Diseases (NIAID)

    lead NIH

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2017-05-30
Primary Completion
2019-01-17
Completion
2019-01-17
FDA Drug
Yes

Countries

  • United States

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 NCT03028441 on ClinicalTrials.gov