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

NCT04515368 | Completed

• 3 other identifiers: PETVACC15/LO/2039191407
• Study Type: interventional
• Target: 54
• Locations: 0 countries
• Sites: N/A

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. 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. 2.To correlate PET/CT changes with diary card recorded symptoms of reactogenicity.

Conditions

Positron-Emission Tomography; Immunization Reaction

Outcome Measures

Primary Outcomes (6)

• 18FDG-PET/CT imaging

  Quantification of PET activity at injection site and draining lymph nodes

  4 hours

• 18FDG- or 11C-PBR28-PET/CT imaging

  Quantification of PET activity at injection site and draining lymph nodes

  1 day

• 18FDG- or 11C-PBR28-PET/CT imaging

  Quantification of PET activity at injection site and draining lymph nodes

  3 days

• 18FDG- or 11C-PBR28-PET/CT imaging

  Quantification of PET activity at injection site and draining lymph nodes

  5 days

• 18FDG- or 11C-PBR28-PET/CT imaging

  Quantification of PET activity at injection site and draining lymph nodes

  7 days

• 18FDG-PET/CT imaging

  Quantification of PET activity at injection site and draining lymph nodes

  10 days

Secondary Outcomes (1)

• Diary card of reactogenicity

  0 to 10 days

Study Arms (4)

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.

Biological: Immunization

Bexsero

EXPERIMENTAL

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

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.

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.

Biological: Immunization

Interventions

Immunization BIOLOGICAL

Immunisation with one of four licensed vaccines

Bexsero; Fendrix; Fluad; Seasonal Trivalent Influenza Vaccine

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Imperial College London: lead
• Imperial College Healthcare NHS Trust: collaborator

MeSH Terms

Interventions

Immunization

Intervention Hierarchy (Ancestors)

Immunotherapy; Immunomodulation; Biological Therapy; Therapeutics; Immunologic Techniques; Investigative Techniques; Primary Prevention; Preventive Health Services; Health Services; Health Care Facilities Workforce and Services; Communicable Disease Control; Public Health Practice; Public Health; Environment and Public Health

Study Officials

• David JM Lewis, MD

  Imperial College Healthcare NHS Trust

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 13, 2020
• First Posted: August 17, 2020
• Study Start: June 10, 2016
• Primary Completion: September 3, 2020
• Study Completion: September 3, 2020
• Last Updated: September 9, 2020

Record last verified: 2020-09

Data Sharing

• IPD Sharing: Will not share