Back to results

Safety, Tolerability, and Immunogenicity of a Cytomegalovirus DNA Vaccine (CM04-101)

Primary Purpose

Congenital Cytomegalovirus Infection

Status

Withdrawn

Phase

Phase 1

Locations

Study Type

Interventional

Intervention

CyMVectin

About this trial

This is an interventional diagnostic trial for Congenital Cytomegalovirus Infection focused on measuring Cytomegalovirus, Vaccine, Congenital Infection

Eligibility Criteria

18 Years - 35 Years (Adult)FemaleAccepts Healthy Volunteers

Inclusion Criteria:

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

Exclusion Criteria:

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

Sites / Locations

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Research Subjects

Arm Description

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

Outcomes

Primary Outcome Measures

Number of participants with treatment-related adverse events

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

Secondary Outcome Measures

CMV gB antibody and CMV neutralizing antibody responses change from baseline

Full Information

NCT ID

NCT02594566

First Posted

October 16, 2015

Last Updated

February 28, 2018

Sponsor

Virginia Commonwealth University

Collaborators

Vical

1. Study Identification

Unique Protocol Identification Number

NCT02594566

Brief Title

Safety, Tolerability, and Immunogenicity of a Cytomegalovirus DNA Vaccine

Acronym

CM04-101

Official Title

A Phase 1 Study to Evaluate the Safety, Tolerability, and Immunogenicity of a Prophylactic Cytomegalovirus Plasmid DNA Vaccine in Healthy Adults

Study Type

Interventional

2. Study Status

Record Verification Date

February 2018

Overall Recruitment Status

Withdrawn

Study Start Date

November 2015 (undefined)

Primary Completion Date

August 2016 (Anticipated)

Study Completion Date

February 2017 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Virginia Commonwealth University

Collaborators

Vical

4. Oversight

Data Monitoring Committee

5. Study Description

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.

Detailed Description

Up to 10 normal healthy adult female subjects 18 to 35 years of age will be enrolled in this trial. A total of 3 injections of the vaccine will be given at Days 0, 28 (+4 days), and 56 (+4 days). There are follow-up visits 7 days after each vaccination, one follow-up visit 28 days after the 3rd (last) vaccination, and a final visit 3 months later. Blood and urine samples will be collected at each vaccination and follow-up visit. The participant will be asked to complete a telephone call follow-up at 1 year after receiving the last vaccination. Participants will be required to complete subject diary cards throughout the study until the telephone call follow-up at approximately Day 420 (i.e., 12 months following the 3rd and final dose scheduled for Day 56). Diary cards will be reviewed with the study staff at each visit and during the Day 420 telephone call.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Congenital Cytomegalovirus Infection

Keywords

Cytomegalovirus, Vaccine, Congenital Infection

7. Study Design

Primary Purpose

Diagnostic

Study Phase

Phase 1

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

0 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Research Subjects

Arm Type

Experimental

Arm Description

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

Intervention Type

Drug

Intervention Name(s)

CyMVectin

Other Intervention Name(s)

VCL-6365, Vaxfectin

Intervention Description

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

Primary Outcome Measure Information:

Title

Number of participants with treatment-related adverse events

Time Frame

Up to Day 182

Title

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

Time Frame

Up to Day 420

Secondary Outcome Measure Information:

Title

CMV gB antibody and CMV neutralizing antibody responses change from baseline

Time Frame

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

10. Eligibility

Sex

Female

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

35 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: 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 Exclusion Criteria: 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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Michael A McVoy, Ph.D.

Organizational Affiliation

Virginia Commonwealth University

Official's Role

Principal Investigator

12. IPD Sharing Statement

Learn more about this trial

Safety, Tolerability, and Immunogenicity of a Cytomegalovirus DNA Vaccine

We'll reach out to this number within 24 hrs