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Safety, Tolerability, and Immunogenicity of a Cytomegalovirus DNA Vaccine

NCT02594566 · Status: WITHDRAWN · Phase: PHASE1 · Type: INTERVENTIONAL

Last updated 2018-03-01

No results posted yet for this study

Summary

If the participant decides to take part in the study, the participant will need to do the following:

Visit the study clinic up to 10 times and be available for a reasonable amount of follow up phone calls to see how the participant is doing.

The participant will receive three doses of vaccine injected into the muscle of the upper arm. After each injection the participant will be asked to remain at the study site for at least 30 minutes after the participant receives the study vaccine.

The results of all of the participants blood tests, just like all other laboratory test results, will be provided to the Investigators, Sponsor, and vaccine developer. Positive HIV and viral hepatitis test results will be reportable to local health authorities according to local laws.

The participant will be asked to refrain from excessive physical activities and alcohol consumption within 2 days before each clinic visit to avoid possible confusing effects on laboratory tests.

Conditions

  • Congenital Cytomegalovirus Infection

Interventions

DRUG

CyMVectin

CyMVectin will be delivered by unilateral intramuscular (IM) injection at Day 0, Day 28(+4 days), and Day 56 (+4 days) in alternating arms. Each dose of CyMVectin will be administered in a 1.0-mL volume

Sponsors & Collaborators

  • Vical

    collaborator INDUSTRY

  • Virginia Commonwealth University

    lead OTHER

Principal Investigators

  • Michael A McVoy, Ph.D. · Virginia Commonwealth University

Study Design

Allocation
NA
Purpose
DIAGNOSTIC
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
35 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2015-11-30
Primary Completion
2016-08-31
Completion
2017-02-28

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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 NCT02594566 on ClinicalTrials.gov