Safety, Tolerability, and Immunogenicity of a Cytomegalovirus DNA Vaccine (CM04-101)
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|ClinicalTrials.gov Identifier: NCT02594566|
Recruitment Status : Withdrawn
First Posted : November 3, 2015
Last Update Posted : March 1, 2018
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|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||0 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|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|
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).
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
- 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 ]
- CMV gB antibody and CMV neutralizing antibody responses change from baseline [ Time Frame: Baseline, Days 28, 35, 56, 63, 86, 182 ]
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
|Principal Investigator:||Michael A McVoy, Ph.D.||Virginia Commonwealth University|