Status:
COMPLETED
A Pilot Clinical Study of PET Scanning in Evaluation of Vaccine Reactogenicity
Lead Sponsor:
Imperial College London
Collaborating Sponsors:
Imperial College Healthcare NHS Trust
Conditions:
Positron-Emission Tomography
Immunization Reaction
Eligibility:
MALE
18-55 years
Phase:
NA
Brief 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 serendi...
Eligibility Criteria
Inclusion
- 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
- 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)
Exclusion
- 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
Key Trial Info
Start Date :
June 10 2016
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 3 2020
Estimated Enrollment :
54 Patients enrolled
Trial Details
Trial ID
NCT04515368
Start Date
June 10 2016
End Date
September 3 2020
Last Update
September 9 2020
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