Study to Evaluate Safety, Tolerability, and Immunogenicity of Candidate Human Cytomegalovirus Vac… (NCT02826798) | Clinical Trial Compass
CompletedPhase 1
Study to Evaluate Safety, Tolerability, and Immunogenicity of Candidate Human Cytomegalovirus Vaccine in Healthy Adults
Canada128 participantsStarted 2016-06-23
Plain-language summary
The purpose of this study is to compare the safety and effectiveness of four different doses of cytomegalovirus vaccines in healthy adults.
Who can participate
Age range
18 Years – 40 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. Generally healthy adult female and male 18 to 40 years of age, inclusive;
. Serologically confirmed to be CMV seronegative at screening;
. Female volunteers must agree to use an adequate contraception method as deemed appropriate by the investigator
. Sign an informed consent document indicating understanding of the purpose and procedures required for the study and willingness to participate in the study
Exclusion criteria
. History of or current clinically significant medical illness or any other illness that in the opinion of the investigator interferes with the interpretation of the study results
. Clinically significant abnormal physical examination, vital signs, or clinically significant abnormal values for hematology, clinical chemistry or urinalysis at screening as determined by the investigator
. Previous receipt of any cytomegalovirus vaccine
. History of allergic reactions or anaphylactic reaction to any vaccine component
. Pregnant or breastfeeding or plans to conceive from two weeks before the study start through six months after the last dose of study vaccine
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Number of Participants With Local and Systemic Adverse Events During Seven-Day Follow-Up Period
Timeframe: Day of vaccine administration (days 0, 56, 168) and six subsequent days
2
Number of Participants With Any Adverse Event
Timeframe: Following each of the 3 injections of study vaccine, the occurrence of adverse events was captured during a 28-day follow-up period as well as through Day 336 or early withdrawal.
3
Number of Participants With Any Serious Adverse Event
Timeframe: Through Day 336 or early withdrawal
4
Number of Participants With Any Hematological or Biochemical Laboratory Abnormality
. Known or suspected impairment of immunological function, including but not limited to autoimmune diseases, splenectomy, or HIV/AIDS
. Chronic administration (defined as more than 14 days in total) of immune-suppressive or other immune-modifying drug with six months prior to the product dose (for corticosteroids, this is defined as prednisone ≥20 mg/day or equivalent). Inhaled and topical steroids are allowed
. Participation in another clinical study within 30 days or plans to participate in another treatment based clinical study during the conduct of the present study