A Pilot Clinical Study of PET Scanning in Evaluation of Vaccine Reactogenicity
- Conditions
- Positron-Emission TomographyImmunization Reaction
- Interventions
- Biological: Immunization
- Registration Number
- NCT04515368
- Lead Sponsor
- Imperial College London
- 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 serendipitously shown to image lymph nodes and injection site inflammation after immunisation.The study's objectives are exploratory:
1. 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.
2. To correlate PET/CT changes with diary card recorded symptoms of reactogenicity.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Male
- Target Recruitment
- 54
- 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)
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SEQUENTIAL
- Arm && Interventions
Group Intervention Description Bexsero Immunization Bexsero (Meningococcal group B subunit / Outer Membrane Vesicles, GlaxoSmithKline); 0.5 mL. intramuscular. stat. Fluad Immunization Fluad (split virion inactivated seasonal trivalent influenza vaccine adjuvanted with MF59C, Northern Hemisphere 2016-17, Seqirus Vaccines and Diagnostics) 0.5 mL. intramuscular. stat. Fendrix Immunization Fendrix (Hepatitis B surface antigen adjuvanted by AS04C containing 3¬≠O¬≠desacyl¬≠4'¬≠ monophosphoryl lipid A adsorbed on aluminium phosphate, GlaxoSmithKline; 0.5 mL. intramuscular. stat. Seasonal Trivalent Influenza Vaccine Immunization Seasonal Trivalent Influenza Vaccine ('ÄòSTIV'Äô, split virion inactivated, Northern Hemisphere 2016-17, Sanofi Pasteur); 0.5 mL. intramuscular. stat.
- Primary Outcome Measures
Name Time Method 18FDG-PET/CT imaging 10 days Quantification of PET activity at injection site and draining lymph nodes
18FDG- or 11C-PBR28-PET/CT imaging 7 days Quantification of PET activity at injection site and draining lymph nodes
- Secondary Outcome Measures
Name Time Method Diary card of reactogenicity 0 to 10 days Recording of solicited and unsolicited adverse events after immunisation