Congenital Cytomegalovirus Infection Clinical Trial
— CM04-101Official title:
A Phase 1 Study to Evaluate the Safety, Tolerability, and Immunogenicity of a Prophylactic Cytomegalovirus Plasmid DNA Vaccine in Healthy Adults
Verified date | February 2018 |
Source | Virginia Commonwealth University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Withdrawn |
Enrollment | 0 |
Est. completion date | February 2017 |
Est. primary completion date | August 2016 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Female |
Age group | 18 Years to 35 Years |
Eligibility |
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 |
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
Virginia Commonwealth University | Vical |
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Number of participants with treatment-related adverse events | Up to Day 182 | ||
Primary | Number of participants with treatment-related adverse events of special interest | Up to Day 420 | ||
Secondary | CMV gB antibody and CMV neutralizing antibody responses change from baseline | Baseline, Days 28, 35, 56, 63, 86, 182 |
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