A Study of Human Cytomegalovirus (HCMV) Vaccine SPYVLP01 With and Without Adjuvants (NCT06145178) | Clinical Trial Compass
CompletedPhase 1
A Study of Human Cytomegalovirus (HCMV) Vaccine SPYVLP01 With and Without Adjuvants
United Kingdom120 participantsStarted 2023-11-22
Plain-language summary
The main purpose of the study is to evaluate the safety and immunogenicity of SPYVLP01 in two different doses with and without adjuvants in healthy adults aged 18-50 years old.
Who can participate
Age range
18 Years – 50 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:
* Healthy male and female adult volunteers aged 18 to 50 years with a body mass index (BMI) of 19 to 32 kg/m2
* Written informed consent before initiation of any study-specific procedures
* Willing and able to understand and comply with study requirements
* Women of childbearing potential must have a negative pregnancy test at screening and prior dose 1 of vaccine.
* Women of childbearing potential must agree to practice a highly effective form of contraception continuously until 90 days after receiving the last immunization.
* Women of childbearing potential must agree not to donate eggs from screening visit and continuously until 90 days after receiving the last immunization
* Men must agree to practice a highly effective form of contraception with their female partner of childbearing potential from screening visit and continuously until 90 days after receiving the last immunization
* Men must be willing to refrain from sperm donation, from screening visit and continuously until 90 days after receiving the last immunization
* All participants must agree not to be vaccinated with any vaccine other than the study vaccine during the study, starting after screening visit and continuously until 28 days after receiving the last immunization
Exclusion Criteria
* Any acute illness, with or without fever within 72 hours prior to the first immunization
* Pregnancy, lactation, or intention to become pregnant during the study
* Have a known allergy, hypersensitiv…
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
To assess the safety profile of the vaccine with and without adjuvants
Timeframe: ongoing for 12 months
2
To assess the reactogenicity profile of the vaccine with and without adjuvants