Status:
COMPLETED
Persistent Readiness Through Early Prediction Immunization Study
Lead Sponsor:
Texas A&M University
Collaborating Sponsors:
Philips Healthcare
US Department of Defense - Defense Threat Reduction Agency
Conditions:
Inflammatory Response
Eligibility:
All Genders
18-40 years
Phase:
EARLY_PHASE1
Brief 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...
Detailed 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 o...
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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.
Key Trial Info
Start Date :
February 8 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 21 2022
Estimated Enrollment :
249 Patients enrolled
Trial Details
Trial ID
NCT05346302
Start Date
February 8 2022
End Date
December 21 2022
Last Update
February 14 2023
Active Locations (1)
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1
Texas A&M University - CTRAL
College Station, Texas, United States, 77845