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

September 16, 2025 updated by: SpyBiotech Limited

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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
120

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
To assess the safety profile of the vaccine with and without adjuvants
Time Frame: ongoing for 12 months

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
Time Frame: ongoing for 12 months

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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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
Time Frame: ongoing for 12 months
Pentamer-specific immunogenicity will be assessed by a variety of immunological assays.
ongoing for 12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
SpyBiotech Limited

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
November 22, 2023

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 20, 2025

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
July 9, 2025

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
November 14, 2023

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 20, 2023

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
November 24, 2023

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
September 22, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 16, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
September 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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