A Pilot Clinical Study of PET Scanning in Evaluation of Vaccine Reactogenicity (PETVACC)

Imperial College London

Status: Completed

Conditions: Immunization Reaction; Positron-Emission Tomography

Treatments: Biological: Immunization

Study type: Interventional

Funder types: Other

Identifiers

NCT04515368

PETVACC

191407

15/LO/2039 (Other Identifier)

Details and patient eligibility

About

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.

Enrollment: 54 patients

Sex: Male

Ages: 18 to 55 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

1. Able to read and understand the informed consent form (ICF), and understand study procedures
2. Signed the ICF
3. Healthy male aged 18'Äì55 years inclusive
4. BMI 19'Äì27 kg/m2
5. Pre-immunised with hepatitis B vaccine on the basis of immunisation history if Fendrix or Engerix B is to be the study vaccine
6. Available for follow-up for the duration of the study
7. Is, in the opinion of the investigator, healthy on the basis of a medical history, symptom directed medical examination and vital signs
8. Have not undergone research radiation exposures, and agree to avoid such exposures, for 12 months before/after this study
9. 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 criteria

1. 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
2. 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.)
3. Expression of only TSPO with low-affinity to PBR28, on the basis of TSPO genotype
4. Currently participating in a clinical study with a drug or device
5. Any condition that, in the investigator'Äôs opinion, compromises the participant'Äôs ability to meet protocol requirements or to complete the study
6. Unable to read and speak English to a fluency level adequate for the full comprehension of procedures required in participation and consent

Trial design

Primary purpose: Basic Science

Allocation: Non-Randomized

Interventional model: Sequential Assignment

Masking: None (Open label)

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54 participants in 4 patient groups

Fendrix

Experimental group

Description:

Fendrix (Hepatitis B surface antigen adjuvanted by AS04C containing 3­O­desacyl­4'­ monophosphoryl lipid A adsorbed on aluminium phosphate, GlaxoSmithKline; 0.5 mL. intramuscular. stat.

Treatment:

Biological: Immunization

Bexsero

Experimental group

Description:

Bexsero (Meningococcal group B subunit / Outer Membrane Vesicles, GlaxoSmithKline); 0.5 mL. intramuscular. stat.

Treatment:

Biological: Immunization

Fluad

Experimental group

Description:

Fluad (split virion inactivated seasonal trivalent influenza vaccine adjuvanted with MF59C, Northern Hemisphere 2016-17, Seqirus Vaccines and Diagnostics) 0.5 mL. intramuscular. stat.

Treatment:

Biological: Immunization

Seasonal Trivalent Influenza Vaccine

Experimental group

Description:

Seasonal Trivalent Influenza Vaccine ('ÄòSTIV'Äô, split virion inactivated, Northern Hemisphere 2016-17, Sanofi Pasteur); 0.5 mL. intramuscular. stat.

Treatment:

Biological: Immunization