A Pilot Clinical Study of PET Scanning in Evaluation of Vaccine Reactogenicity

NCT ID: NCT04515368

Last Updated: 2020-09-09

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 54 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-06-10
• Study Completion Date: 2020-09-03

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.

Conditions

Positron-Emission Tomography; Immunization Reaction

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SEQUENTIAL
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: NONE

Study Groups

Fendrix

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

Group Type: EXPERIMENTAL

Immunization

Intervention Type: BIOLOGICAL

Immunisation with one of four licensed vaccines

Bexsero

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

Group Type: EXPERIMENTAL

Immunization

Intervention Type: BIOLOGICAL

Immunisation with one of four licensed vaccines

Fluad

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

Group Type: EXPERIMENTAL

Immunization

Intervention Type: BIOLOGICAL

Immunisation with one of four licensed vaccines

Seasonal Trivalent Influenza Vaccine

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

Group Type: EXPERIMENTAL

Immunization

Intervention Type: BIOLOGICAL

Immunisation with one of four licensed vaccines

Interventions

Immunization

Immunisation with one of four licensed vaccines

Intervention Type: BIOLOGICAL

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 55 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: Yes

Sponsors

Imperial College Healthcare NHS Trust

OTHER

Sponsor Role: collaborator

Imperial College London

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

David JM Lewis, MD

Role: PRINCIPAL_INVESTIGATOR

Imperial College Healthcare NHS Trust

Other Identifiers

15/LO/2039

Identifier Type: OTHER

Identifier Source: secondary_id

191407

Identifier Type: OTHER

Identifier Source: secondary_id

PETVACC

Identifier Type: -

Identifier Source: org_study_id