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 range18 Years – 50 Years
SexALL
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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…
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