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

NCT04515368 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 54

Last updated 2020-09-09

No results posted yet for this study

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

Interventions

BIOLOGICAL

Immunization

Immunisation with one of four licensed vaccines

Sponsors & Collaborators

  • Imperial College Healthcare NHS Trust

    collaborator OTHER

  • Imperial College London

    lead OTHER

Principal Investigators

  • David JM Lewis, MD · Imperial College Healthcare NHS Trust

Study Design

Allocation
NON_RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Max Age
55 Years
Sex
MALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2016-06-10
Primary Completion
2020-09-03
Completion
2020-09-03

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04515368 on ClinicalTrials.gov