Trials / Completed
CompletedNCT04515368
A Pilot Clinical Study of PET Scanning in Evaluation of Vaccine Reactogenicity
- Status
- Completed
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 54 (actual)
- Sponsor
- Imperial College London · Academic / Other
- Sex
- Male
- Age
- 18 Years – 55 Years
- Healthy volunteers
- Accepted
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
Interventions
| Type | Name | Description |
|---|---|---|
| BIOLOGICAL | Immunization | Immunisation with one of four licensed vaccines |
Timeline
- Start date
- 2016-06-10
- Primary completion
- 2020-09-03
- Completion
- 2020-09-03
- First posted
- 2020-08-17
- Last updated
- 2020-09-09
Source: ClinicalTrials.gov record NCT04515368. Inclusion in this directory is not an endorsement.