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Trial record 32 of 46 for:    congenital CMV

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02594566
Recruitment Status : Withdrawn
First Posted : November 3, 2015
Last Update Posted : March 1, 2018
Sponsor:
Collaborator:
Vical
Information provided by (Responsible Party):
Virginia Commonwealth University

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.


Condition or disease Intervention/treatment Phase
Congenital Cytomegalovirus Infection Drug: CyMVectin Phase 1

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.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: A Phase 1 Study to Evaluate the Safety, Tolerability, and Immunogenicity of a Prophylactic Cytomegalovirus Plasmid DNA Vaccine in Healthy Adults
Study Start Date : November 2015
Estimated Primary Completion Date : August 2016
Estimated Study Completion Date : February 2017


Arm Intervention/treatment
Experimental: Research Subjects
A total of 3 injections of the vaccine (CyMVectin) will be given at Days 0, 28 (+4 days), and 56 (+4 days).
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
Other Names:
  • VCL-6365
  • Vaxfectin




Primary Outcome Measures :
  1. Number of participants with treatment-related adverse events [ Time Frame: Up to Day 182 ]
  2. Number of participants with treatment-related adverse events of special interest [ Time Frame: Up to Day 420 ]

Secondary Outcome Measures :
  1. CMV gB antibody and CMV neutralizing antibody responses change from baseline [ Time Frame: Baseline, Days 28, 35, 56, 63, 86, 182 ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 35 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02594566


Sponsors and Collaborators
Virginia Commonwealth University
Vical
Investigators
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Principal Investigator: Michael A McVoy, Ph.D. Virginia Commonwealth University

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Responsible Party: Virginia Commonwealth University
ClinicalTrials.gov Identifier: NCT02594566     History of Changes
Other Study ID Numbers: HM20004886
First Posted: November 3, 2015    Key Record Dates
Last Update Posted: March 1, 2018
Last Verified: February 2018
Keywords provided by Virginia Commonwealth University:
Cytomegalovirus
Vaccine
Congenital Infection
Additional relevant MeSH terms:
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Cytomegalovirus Infections
Herpesviridae Infections
DNA Virus Infections
Virus Diseases
Vaccines
Immunologic Factors
Physiological Effects of Drugs