Cytomegalovirus InfectionsPhase 1SPYVAC01NCT06145178
A Study of Human Cytomegalovirus (HCMV) Vaccine SPYVLP01 With and Without Adjuvants
A Phase 1 study testing SPYVAC01 in people with Cytomegalovirus Infections, run by SpyBiotech Limited at 2 sites in United Kingdom.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Cytomegalovirus Infections
- What is being tested?
- SPYVAC01
- Type of treatment
- Vaccines
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 2 sitesUnited Kingdom
- Study dates
- 22 Nov 2023to 9 Jul 2025
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
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- 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
Who cannot join
- 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
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- 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 locations and contacts
2 sites in 1 country.
United Kingdom2 sites
Velocity Bristol
Bristol
Medicines Evaluation Unit
Manchester
About this study
Official title: 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.
- Conditions
- Cytomegalovirus Infections
- Being tested
- SPYVAC01
- Medical subject headings
- Cytomegalovirus Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SPYVAC01Biological
Novel vaccine SPYVLP01
| Study group | Role | What they receive |
|---|---|---|
| Group 1 | Experimental | Low dose SPYVLP01 alone Receives: Biological: SPYVAC01 |
| Group 2 | Experimental | High dose SPYVLP01 alone Receives: Biological: SPYVAC01 |
| Group 3 | Experimental | Low dose + Alhydrogel Receives: Biological: SPYVAC01 |
| Group 4 | Experimental | High dose + Alhydrogel Receives: Biological: SPYVAC01 |
| Group 5 | Experimental | Low dose + Matrix-M Receives: Biological: SPYVAC01 |
| Group 6 | Experimental | High dose + Matrix-M Receives: Biological: SPYVAC01 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: ongoing for 12 months
Secondary outcomes (1)
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.
Measured: ongoing for 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Nov 2023
- Study start22 Nov 2023
- Primary completion20 Jun 2025
- Study completion9 Jul 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cytomegalovirus InfectionsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- SpyBiotech Limited
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06145178
- Sponsor's protocol ID
- SPYVAC01
- Acronym
- SPYVAC01
- Status last verified
- Sep 2025
- First submitted
- 14 Nov 2023
- Last updated
- 22 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT06145178
- Acronym / sponsor ID
- SPYVAC01 / SPYVAC01
- Conditions
- Cytomegalovirus Infections
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- SpyBiotech LimitedIndustry (pharma, biotech, devices)
- Study start
- 22 Nov 2023 (actual)
- Primary completion
- 20 Jun 2025 (actual)
- Study completion
- 9 Jul 2025 (actual)
- First posted
- 24 Nov 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| Group 1 | Experimental | Biological: SPYVAC01Low dose SPYVLP01 alone |
| Group 2 | Experimental | Biological: SPYVAC01High dose SPYVLP01 alone |
| Group 3 | Experimental | Biological: SPYVAC01Low dose + Alhydrogel |
| Group 4 | Experimental | Biological: SPYVAC01High dose + Alhydrogel |
| Group 5 | Experimental | Biological: SPYVAC01Low dose + Matrix-M |
| Group 6 | Experimental | Biological: SPYVAC01High dose + Matrix-M |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (9 listed)
- 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.
Key exclusion criteria (23 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SPYVAC01Novel vaccine SPYVLP01 | Biological | Group 1, Group 2, Group 3, Group 4, Group 5, Group 6 |
Primary outcome
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
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
1 secondary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Sep 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing SPYVAC01 in people with Cytomegalovirus Infections, run by SpyBiotech Limited at 2 sites in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 23 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To assess the safety profile of the vaccine with and without adjuvants (time frame: ongoing for 12 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Sep 2025; AzTrials last refreshed its copy on 8 Nov 2026.