A Study of Human Cytomegalovirus (HCMV) Vaccine SPYVLP01 With and Without Adjuvants (SPYVAC01)

SpyBiotech

Status and phase: Completed; Phase 1

Conditions: Cytomegalovirus Infections

Treatments: Biological: SPYVAC01

Study type: Interventional

Funder types: Industry

Identifiers

NCT06145178

SPYVAC01

Details and patient eligibility

About

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.

Enrollment: 120 patients

Sex: All

Ages: 18 to 50 years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion criteria

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, hypersensitivity, or intolerance to the planned Investigational Medicinal Product (IMP), adjuvants, and including any excipients of the IMP
• Have any medical condition or any major surgery within the past 5 years which could compromise their well-being if they participate in the study, or that could prevent, limit, or confound the protocol-specified assessments
• Have any surgery planned during the study, starting after screening and continuously until at least 90 days after receiving the last immunization
• Any confirmed or suspected immunosuppressive or immunodeficient state and chronic immunosuppressant medication within the past 6 months
• Received any live or inactivated vaccination within 6 months prior to screening or other vaccinations within the 28 days prior to screening
• Have a history of hypersensitivity or serious reactions to previous vaccinations or a history of Guillain-Barré Syndrome within 6 weeks following a previous vaccination
• Had administration of any immunoglobulins and/or any blood products within the 3 months prior to screening
• Had administration of another IMP including vaccines within 90 days or 5 half-lives prior to screening (Visit 1)
• Hepatitis B surface antigen detected in serum at screening
• Seropositive for hepatitis C virus at screening
• Have a history of or suspected immunosuppressive condition, acquired or congenital
• Symptoms of COVID-19 within 30 days prior to screening
• Alcohol or substance abuse that might interfere with the study conduct or completion
• Consume more than 25 units of alcohol per week
• Concurrent involvement in another clinical study or planned involvement during the study period
• Prior receipt of an investigational vaccine
• History of narcolepsy
• Any abnormality or permanent body art (e.g., tattoo) that would obstruct the ability to observe local reactions at the injection site
• Have had any blood loss > 450 mL within the 3 months (90 days) prior to screening or plan to donate blood during the study
• Anticipating the need for immunosuppressive treatment within the next 6 months
• Inability to contact the participant's general practitioner to confirm medical history

Trial design

Primary purpose: Prevention

Allocation: Non-Randomized

Interventional model: Sequential Assignment

Masking: None (Open label)

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120 participants in 6 patient groups

Group 1

Experimental group

Description:

Low dose SPYVLP01 alone

Treatment:

Biological: SPYVAC01

Group 2

Experimental group

Description:

High dose SPYVLP01 alone

Treatment:

Biological: SPYVAC01

Group 3

Experimental group

Description:

Low dose + Alhydrogel

Treatment:

Biological: SPYVAC01

Group 4

Experimental group

Description:

High dose + Alhydrogel

Treatment:

Biological: SPYVAC01

Group 5

Experimental group

Description:

Low dose + Matrix-M

Treatment:

Biological: SPYVAC01

Group 6

Experimental group

Description:

High dose + Matrix-M

Treatment:

Biological: SPYVAC01