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

Sponsor

Imperial College London (Other)

Overall Status

Completed

CT.gov ID

NCT04515368

Collaborator

Imperial College Healthcare NHS Trust (Other)

Enrollment

Arms

50.8

Actual Duration (Months)

Study Details

Study Description

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:

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

Condition or Disease	Intervention/Treatment	Phase
Positron-Emission Tomography Immunization Reaction	Biological: Immunization	N/A

Study Design

Study Type:

Interventional

Actual Enrollment :

54 participants

Allocation:

Non-Randomized

Intervention Model:

Sequential Assignment

Masking:

None (Open Label)

Primary Purpose:

Basic Science

Official Title:

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

Actual Study Start Date :

Jun 10, 2016

Actual Primary Completion Date :

Sep 3, 2020

Actual Study Completion Date :

Sep 3, 2020

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Fendrix 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.	Biological: Immunization Immunisation with one of four licensed vaccines
Experimental: Bexsero Bexsero (Meningococcal group B subunit / Outer Membrane Vesicles, GlaxoSmithKline); 0.5 mL. intramuscular. stat.	Biological: Immunization Immunisation with one of four licensed vaccines
Experimental: 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.	Biological: Immunization Immunisation with one of four licensed vaccines
Experimental: Seasonal Trivalent Influenza Vaccine Seasonal Trivalent Influenza Vaccine ('ÄòSTIV'Äô, split virion inactivated, Northern Hemisphere 2016-17, Sanofi Pasteur); 0.5 mL. intramuscular. stat.	Biological: Immunization Immunisation with one of four licensed vaccines

Outcome Measures

Primary Outcome Measures

18FDG-PET/CT imaging [4 hours]
Quantification of PET activity at injection site and draining lymph nodes
18FDG- or 11C-PBR28-PET/CT imaging [1 day]
Quantification of PET activity at injection site and draining lymph nodes
18FDG- or 11C-PBR28-PET/CT imaging [3 days]
Quantification of PET activity at injection site and draining lymph nodes
18FDG- or 11C-PBR28-PET/CT imaging [5 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
18FDG-PET/CT imaging [10 days]
Quantification of PET activity at injection site and draining lymph nodes

Secondary Outcome Measures

Diary card of reactogenicity [0 to 10 days]
Recording of solicited and unsolicited adverse events after immunisation

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 55 Years

Sexes Eligible for Study:

Male

Accepts Healthy Volunteers:

Yes

Inclusion Criteria:

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 Criteria:

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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

Imperial College London
Imperial College Healthcare NHS Trust

Investigators

Principal Investigator: David JM Lewis, MD, Imperial College Healthcare NHS Trust

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Imperial College London

ClinicalTrials.gov Identifier:

NCT04515368

Other Study ID Numbers:

PETVACC
15/LO/2039
191407

First Posted:

Aug 17, 2020

Last Update Posted:

Sep 9, 2020

Last Verified:

Sep 1, 2020

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Study Results

No Results Posted as of Sep 9, 2020