Clinical Trial: Safety, Tolerability, and Immunogenicity of a Cytomegalovirus DNA Vaccine
Study Status: Withdrawn
Recruit Status: Withdrawn
Study Type: Interventional
Official Title: A Phase 1 Study to Evaluate the Safety, Tolerability, and Immunogenicity of a Prophylactic Cytomegalovirus Plasmid DNA Vaccine in Healthy Adults
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 Summary:
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.
Sponsor: Virginia Commonwealth University
Current Primary Outcome:
- Number of participants with treatment-related adverse events [ Time Frame: Up to Day 182 ]
- Number of participants with treatment-related adverse events of special interest [ Time Frame: Up to Day 420 ]
Original Primary Outcome: Same as current
Current Secondary Outcome: CMV gB antibody and CMV neutralizing antibody responses change from baseline [ Time Frame: Baseline, Days 28, 35, 56, 63, 86, 182 ]
Original Secondary Outcome: Same as current
Information By: Virginia Commonwealth University
Dates:
Date Received: October 16, 2015
Date Started: November 2015
Date Completion: February 2017
Last Updated: September 19, 2016
Last Verified: September 2016
