drugset
drugset / Trial / NCT04515368

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

NCT04515368 ↗

Completed 54 enrolled Imperial College London Imperial College Healthcare NHS Trust · collab
Non-randomizedSequentialOpen-labelBasic science

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.

Timeline

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

Drugs

EvaluationDrugModalityDoseRoute
Subject Bexsero Vaccine 0.5 ml Intramuscular
Subject Fendrix Vaccine 0.5 ml Intramuscular
Subject Fluad Vaccine 0.5 ml Intramuscular
Subject Seasonal Trivalent Influenza Vaccine Vaccine 0.5 ml Intramuscular

Indications

No indication recorded.