Safety, Tolerability, and Immunogenicity of a Cytomegalovirus DNA Vaccine

NCT02594566 | Withdrawn Phase 1

• 1 other identifier: HM20004886
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

Brief 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

Keywords

Cytomegalovirus; Vaccine; Congenital Infection

Outcome Measures

Primary Outcomes (2)

• Number of participants with treatment-related adverse events

  Up to Day 182

• Number of participants with treatment-related adverse events of special interest

  Up to Day 420

Secondary Outcomes (1)

• CMV gB antibody and CMV neutralizing antibody responses change from baseline

  Baseline, Days 28, 35, 56, 63, 86, 182

Study Arms (1)

Research Subjects

EXPERIMENTAL

A total of 3 injections of the vaccine (CyMVectin) will be given at Days 0, 28 (+4 days), and 56 (+4 days).

Drug: CyMVectin

Interventions

CyMVectin DRUG

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

Also known as: VCL-6365, Vaxfectin

Research Subjects

Eligibility Criteria

• Age: 18 Years - 35 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Healthy female adults, 18 to 35 years of age
• Able and willing to be followed for approximately 15 months
• Lack serum antibodies specific for CMV
• Able to provide informed consent

You may not qualify if:

• History of receiving any previous CMV vaccine
• Pregnant, trying to become pregnant, or breastfeeding
• Receipt or donation of blood, blood products, or plasma within 30 days of the initial injection
• Clinically significant findings from clinical evaluation or laboratory tests, evidence of medical disease(s) or medical/psychiatric condition(s), or unable to participate due to occupation or other social reasons
• Use of immunomodulatory therapy (drugs that suppress the immune system) within the past 6 months or other medications or nutritional supplements as determined by the study investigators that may interfere with the vaccine response, or increase safety risks to the participant, that have been taken within 30 days prior to the initial injection on Day 0
• Antinuclear antibody (ANA) titer \>1:80
• Body mass index (BMI) \>30
• Less than 18 years of age or older than 35 years of age
• No access to a telephone

Sponsors & Collaborators

• Virginia Commonwealth University: lead
• Vical: collaborator

MeSH Terms

Conditions

Cytomegalovirus Infections

Interventions

vaxfectin

Condition Hierarchy (Ancestors)

Herpesviridae Infections; DNA Virus Infections; Virus Diseases; Infections

Study Officials

• Michael A McVoy, Ph.D.

  Virginia Commonwealth University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 16, 2015
• First Posted: November 3, 2015
• Study Start: November 1, 2015
• Primary Completion: August 1, 2016
• Study Completion: February 1, 2017
• Last Updated: March 1, 2018

Record last verified: 2018-02