Persistent Readiness Through Early Prediction Immunization Study
Completed · Early Phase 1 · Has a placebo group
Conditions studied: Inflammatory Response
In brief
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.
Key facts
- Study ID
- NCT05346302
- Run by
- Texas A&M University
- People needed
- 249
- Starts
- 2022-02-08
- Expected to finish
- 2022-12-21
- Last updated by the study team
- 2023-02-14
Who can join
Age: 18 and older, up to 40. Sex: any. Healthy volunteers: accepted.
You may qualify if…
- Ages 18-40 (inclusive)
- Subject is judged to be in satisfactory health based on medical history, physical examination
- Ability to walk, sit down and stand up independently
- Willingness and ability to comply with the protocol
- ownership and use of smartphone
- ownership and use of laptop
You may not qualify if…
- Subject has planned elective surgery requiring 2 or more days of hospitalization during the entire study
- Active dependence of alcohol or drugs (self-reported)
- Known allergy to any of the following:
- Components of the vaccine/placebo
- Diagnosed and active treatment of chronic disease:
- Diabetes (Type 1 or 2)
- Active malignancy
- Heart disease
- Kidney disease
- Liver disease
- HIV/AIDS
- Hepatitis A, B, or C
- Asthma (moderate to severe)
- (possible/desire to be) pregnancy (confirmed via urine pregnancy test)
- Subject is currently enrolled in a study with an investigational compound or device
- Subject has already received the pneumococcal (PPSV23) vaccine
- Subject has already received the typhoid (inactivated) vaccine
- Subject has received any other investigational vaccination within 4 weeks of enrollment
- Any other condition that interfere with the definition 'healthy" based on self-report and according to the PI/study physician's judgement based on medical history, use of medication, and physical exam.
Where it is running
- Texas A&M University - CTRAL — College Station, Texas, United States
Full record on ClinicalTrials.gov
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