Positron-Emission TomographyPETVACCNCT04515368
A Pilot Clinical Study of PET Scanning in Evaluation of Vaccine Reactogenicity
A study testing Immunization in people with Positron-Emission Tomography and Immunization Reaction, run by Imperial College London.
Trial summary
This study forms part of an integrated, multi-study effort to identify potential biomarkers of reactogenicity to vaccines. We have selected PET-CT as it is in routine clinical use and has been serendipitously shown to image lymph nodes and injection site inflammation after immunisation.The study's objectives are… Read more about this study
- Who is it for?
- Ages 18 to 55 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Positron-Emission Tomography, Immunization Reaction
- What is being tested?
- Immunization
- Type of treatment
- Vaccines, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 54 participants
- Where
- No sites listed yet
- Study dates
- 10 Jun 2016to 3 Sep 2020
- Phase
- Interventional
- 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 55 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Able to read and understand the informed consent form (ICF), and understand study procedures
- Signed the ICF
- Healthy male aged 18'Äì55 years inclusive
- BMI 19'Äì27 kg/m2
- Pre-immunised with hepatitis B vaccine on the basis of immunisation history if Fendrix or Engerix B is to be the study vaccine
- Available for follow-up for the duration of the study
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- Is, in the opinion of the investigator, healthy on the basis of a medical history, symptom directed medical examination and vital signs
- Have not undergone research radiation exposures, and agree to avoid such exposures, for 12 months before/after this study
- Be willing to avoid vigorous exercise or contact sports between vaccination and PET scan (e.g. gym workouts, prolonged cycling, rowing, martial arts or rugby)
Who cannot join
- History of hypersensitivity to any of the vaccine components or a history of any allergy that in the opinion of the investigator would contraindicate participant participation
- Use of steroids or immunosuppressive/immunomodulating drugs either orally or parenterally within 3 months of the PET scan. (Topical/ocular/nasal/inhaled steroids are allowed.)
- Expression of only TSPO with low-affinity to PBR28, on the basis of TSPO genotype
- Currently participating in a clinical study with a drug or device
- Any condition that, in the investigator'Äôs opinion, compromises the participant'Äôs ability to meet protocol requirements or to complete the study
- Unable to read and speak English to a fluency level adequate for the full comprehension of procedures required in participation and consent
About this study
This study forms part of an integrated, multi-study effort to identify potential biomarkers of reactogenicity to vaccines. We have selected PET-CT as it is in routine clinical use and has been serendipitously shown to image lymph nodes and injection site inflammation after immunisation.The study's objectives are exploratory:
- To methodically characterise relative anatomical distribution and intensity of post-immunisation innate immune activation visualised by PET-CT after immunisation with adjuvanted and non-adjuvanted vaccines.
- To correlate PET/CT changes with diary card recorded symptoms of reactogenicity.
- Being tested
- Immunization
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ImmunizationBiological
Immunisation with one of four licensed vaccines
| Study group | Role | What they receive |
|---|---|---|
| Fendrix | Experimental | Fendrix (Hepatitis B surface antigen adjuvanted by AS04C containing 3­O­desacyl­4'­ monophosphoryl lipid A adsorbed on aluminium phosphate, GlaxoSmithKline; 0.5 mL. intramuscular. stat. Receives: Biological: Immunization |
| Bexsero | Experimental | Bexsero (Meningococcal group B subunit / Outer Membrane Vesicles, GlaxoSmithKline); 0.5 mL. intramuscular. stat. Receives: Biological: Immunization |
| Fluad | Experimental | Fluad (split virion inactivated seasonal trivalent influenza vaccine adjuvanted with MF59C, Northern Hemisphere 2016-17, Seqirus Vaccines and Diagnostics) 0.5 mL. intramuscular. stat. Receives: Biological: Immunization |
| Seasonal Trivalent Influenza Vaccine | Experimental | Seasonal Trivalent Influenza Vaccine ('ÄòSTIV'Äô, split virion inactivated, Northern Hemisphere 2016-17, Sanofi Pasteur); 0.5 mL. intramuscular. stat. Receives: Biological: Immunization |
What is being measured
The primary outcome is the main question the study is designed to answer.
18FDG-PET/CT imaging
Quantification of PET activity at injection site and draining lymph nodes
Measured: 4 hours
18FDG- or 11C-PBR28-PET/CT imaging
Quantification of PET activity at injection site and draining lymph nodes
Measured: 1 day
18FDG- or 11C-PBR28-PET/CT imaging
Quantification of PET activity at injection site and draining lymph nodes
Measured: 3 days
18FDG- or 11C-PBR28-PET/CT imaging
Quantification of PET activity at injection site and draining lymph nodes
Measured: 5 days
18FDG- or 11C-PBR28-PET/CT imaging
Quantification of PET activity at injection site and draining lymph nodes
Measured: 7 days
18FDG-PET/CT imaging
Quantification of PET activity at injection site and draining lymph nodes
Measured: 10 days
Secondary outcomes (1)
Diary card of reactogenicity
Recording of solicited and unsolicited adverse events after immunisation
Measured: 0 to 10 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Aug 2020
- Study start10 Jun 2016
- Primary completion3 Sep 2020
- Study completion3 Sep 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Positron-Emission TomographyStudies of the same condition, open and under way.
- More trials run by Imperial College LondonThe sponsor's other registered studies.
- 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 N/A
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 54 participants (actual)
Sponsor and investigators
- Lead sponsor
- Imperial College London
- Sponsor type
- University, hospital or other
- Collaborators
- Imperial College Healthcare NHS Trust
- Responsible party
- Sponsor
- Investigators
- David JM Lewis, MD, Principal investigator, Imperial College Healthcare NHS Trust
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04515368
- Sponsor's protocol ID
- PETVACC
- Other IDs
- 15/LO/2039, 191407
- Acronym
- PETVACC
- Status last verified
- Sep 2020
- First submitted
- 13 Aug 2020
- Last updated
- 9 Sep 2020
- 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 9 Sep 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot Clinical Study of PET Scanning in Evaluation of Vaccine Reactogenicity
- ClinicalTrials.gov ID
- NCT04515368
- Acronym / sponsor ID
- PETVACC / PETVACC
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 54 participants (actual)
- Lead sponsor
- Imperial College LondonUniversity, hospital or other
- Collaborators
- Imperial College Healthcare NHS Trust
- Study start
- 10 Jun 2016 (actual)
- Primary completion
- 3 Sep 2020 (actual)
- Study completion
- 3 Sep 2020 (actual)
- First posted
- 17 Aug 2020 (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.
This study forms part of an integrated, multi-study effort to identify potential biomarkers of reactogenicity to vaccines. We have selected PET-CT as it is in routine clinical use and has been serendipitously shown to image lymph nodes and injection site inflammation after immunisation.The study's objectives are exploratory:
- To methodically characterise relative anatomical distribution and intensity of post-immunisation innate immune activation visualised by PET-CT after immunisation with adjuvanted and non-adjuvanted vaccines.
- To correlate PET/CT changes with diary card recorded symptoms of reactogenicity.
Study design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Fendrix | Experimental | Biological: ImmunizationFendrix (Hepatitis B surface antigen adjuvanted by AS04C containing 3­O­desacyl­4'­ monophosphoryl lipid A adsorbed on aluminium phosphate, GlaxoSmithKline; 0.5 mL. intramuscular. stat. |
| Bexsero | Experimental | Biological: ImmunizationBexsero (Meningococcal group B subunit / Outer Membrane Vesicles, GlaxoSmithKline); 0.5 mL. intramuscular. stat. |
| Fluad | Experimental | Biological: ImmunizationFluad (split virion inactivated seasonal trivalent influenza vaccine adjuvanted with MF59C, Northern Hemisphere 2016-17, Seqirus Vaccines and Diagnostics) 0.5 mL. intramuscular. stat. |
| Seasonal Trivalent Influenza Vaccine | Experimental | Biological: ImmunizationSeasonal Trivalent Influenza Vaccine ('ÄòSTIV'Äô, split virion inactivated, Northern Hemisphere 2016-17, Sanofi Pasteur); 0.5 mL. intramuscular. stat. |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (9 listed)
- Able to read and understand the informed consent form (ICF), and understand study procedures
- Signed the ICF
- Healthy male aged 18'Äì55 years inclusive
- BMI 19'Äì27 kg/m2
- Pre-immunised with hepatitis B vaccine on the basis of immunisation history if Fendrix or Engerix B is to be the study vaccine
Key exclusion criteria (6 listed)
- History of hypersensitivity to any of the vaccine components or a history of any allergy that in the opinion of the investigator would contraindicate participant participation
- Use of steroids or immunosuppressive/immunomodulating drugs either orally or parenterally within 3 months of the PET scan. (Topical/ocular/nasal/inhaled steroids are allowed.)
- Expression of only TSPO with low-affinity to PBR28, on the basis of TSPO genotype
- Currently participating in a clinical study with a drug or device
- Any condition that, in the investigator'Äôs opinion, compromises the participant'Äôs ability to meet protocol requirements or to complete the study
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 |
|---|---|---|
| ImmunizationImmunisation with one of four licensed vaccines | Biological | Bexsero, Fendrix, Fluad, Seasonal Trivalent Influenza Vaccine |
Primary outcome
18FDG-PET/CT imaging
Time frame: 4 hours
Quantification of PET activity at injection site and draining lymph nodes
18FDG- or 11C-PBR28-PET/CT imaging
Time frame: 1 day
Quantification of PET activity at injection site and draining lymph nodes
18FDG- or 11C-PBR28-PET/CT imaging
Time frame: 3 days
Quantification of PET activity at injection site and draining lymph nodes
18FDG- or 11C-PBR28-PET/CT imaging
Time frame: 5 days
Quantification of PET activity at injection site and draining lymph nodes
18FDG- or 11C-PBR28-PET/CT imaging
Time frame: 7 days
Quantification of PET activity at injection site and draining lymph nodes
18FDG-PET/CT imaging
Time frame: 10 days
Quantification of PET activity at injection site and draining lymph nodes
1 secondary outcome
Diary card of reactogenicity
Time frame: 0 to 10 days
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 9 Sep 2020.
- 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.
David JM Lewis, MD principal investigator
Imperial College Healthcare NHS Trust
Questions about this trial
What is this clinical trial studying?
A study testing Immunization in people with Positron-Emission Tomography and Immunization Reaction, run by Imperial College London.
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 6 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 9 Sep 2020. Status can change between updates, so confirm with the study contact before making plans.
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.
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?
18FDG-PET/CT imaging (time frame: 4 hours). The study lists 6 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 9 Sep 2020.