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

A Phase I First in Human Study to Assess Safety and Immunogenicity of the Human Cytomegalovirus Vaccine Candidate SPYVLP01 With and Without Adjuvants in Healthy Adult Volunteers

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.

Study Overview

• Status: Completed
• Conditions: Cytomegalovirus Infections
• Intervention / Treatment: Biological: SPYVAC01

• Study Type: Interventional
• Enrollment (Actual): 120
• Phase: Phase 1

Contacts and Locations

Study Locations

• United Kingdom
  • Bristol, United Kingdom
    • Velocity Bristol
  • Manchester, United Kingdom
    • Medicines Evaluation Unit

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Non-Randomized
• Interventional Model: Sequential Assignment
• Masking: None (Open Label)

Number of Arms

6

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Group 1; Low dose SPYVLP01 alone	Biological: SPYVAC01; Novel vaccine SPYVLP01
Experimental: Group 2; High dose SPYVLP01 alone	Biological: SPYVAC01; Novel vaccine SPYVLP01
Experimental: Group 3; Low dose + Alhydrogel	Biological: SPYVAC01; Novel vaccine SPYVLP01
Experimental: Group 4; High dose + Alhydrogel	Biological: SPYVAC01; Novel vaccine SPYVLP01
Experimental: Group 5; Low dose + Matrix-M	Biological: SPYVAC01; Novel vaccine SPYVLP01
Experimental: Group 6; High dose + Matrix-M	Biological: SPYVAC01; Novel vaccine SPYVLP01

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
To assess the safety profile of the vaccine with and without adjuvants	The specific endpoints for safety will be actively and passively collected data on Adverse Events (AEs). The following parameters will be assessed: Occurrence of solicited local and systemic reactogenicity signs and symptoms for 7 days following each vaccination; Occurrence of unsolicited AEs for 28 days following each vaccination; Change from baseline for safety laboratory measures for 28 days following each vaccination; Occurrence of Serious Adverse Events (SAEs) during the whole study duration; Occurrence of Adverse events of special interest (AESIs) during the whole study duration	ongoing for 12 months
To assess the reactogenicity profile of the vaccine with and without adjuvants	The specific endpoints for reactogenicity will be actively and passively collected data on AEs. The following parameters will be assessed: Occurrence of solicited local and systemic reactogenicity signs and symptoms for 7 days following each vaccination; Occurrence of unsolicited AEs for 28 days following each vaccination; Change from baseline for safety laboratory measures for 28 days following each vaccination; Occurrence of SAEs during the whole study duration; Occurrence of AESIs during the whole study Duration	ongoing for 12 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
To investigate the pentamer specific binding antibodies and neutralizing antibodies solicited by each arm in seropositive and seronegative healthy male and female adult volunteers	Pentamer-specific immunogenicity will be assessed by a variety of immunological assays.	ongoing for 12 months

Collaborators and Investigators

• Sponsor: SpyBiotech Limited

Study record dates

Study Major Dates

• Study Start (Actual): November 22, 2023
• Primary Completion (Actual): June 20, 2025
• Study Completion (Actual): July 9, 2025

Study Registration Dates

• First Submitted: November 14, 2023
• First Submitted That Met QC Criteria: November 20, 2023
• First Posted (Actual): November 24, 2023

Study Record Updates

• Last Update Posted (Actual): September 22, 2025
• Last Update Submitted That Met QC Criteria: September 16, 2025
• Last Verified: September 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Infections; Virus Diseases; DNA Virus Infections; Herpesviridae Infections; Cytomegalovirus Infections
• Other Study ID Numbers: SPYVAC01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No