Persistent Readiness Through Early Prediction Immunization Study — PREP DOD  

Inflammatory Response Clinical Trial

Official title: Persistent Readiness Through Early Prediction Immunization Study

Status Completed

Clinical Trial Summary

This study will enroll volunteers in an open-format (outside hospital) setting, to complete novel data collection/analysis of biomarkers, facial images, and audio-recording to establish an optimal set of parameters to predict emergent cases of infection via an early warning score, along with actionable personalized information.

Clinical Trial Description

The objective of the study is to collect data from participants for a period of 4 weeks. These data will be used for developing and testing an algorithm for early detection of infection.

At the end of week two, subjects will receive an immunization in a double-blind randomized placebo-controlled fashion. Vaccines to be administered will be pneumococcal (PPSV23), typhoid (inactivated), or saline. Administration of these vaccines often cause mild 'infection-like' inflammation response. Pneumococcal infection causes pneumonia and can lead to sepsis and the PPSV23 vaccination will induce mild symptoms related to the immune system activation including local reaction in 50% of the cases and fever and malaise in 1% of the cases. Typhoid fever is caused by salmonella Typhi bacteria and its effects can range from gastrointestinal symptoms to sepsis. Injectable typhoid vaccine (inactivated) side effects will induce mild symptoms related to the immune system activation and can include local reaction in 6% of the cases and fever, malaise, headache and sometimes diarrhea in 1% of the cases. ;

Related Conditions & MeSH terms

• Inflammatory Response

• NCT number: NCT05346302
• Study type: Interventional
• Source: Texas A&M University
• Status: Completed
• Phase: Early Phase 1
• Start date: February 8, 2022
• Completion date: December 21, 2022