Clinical trial NCT05346302: Persistent Readiness Through Early Prediction Immunization Study
Official title: Persistent Readiness Through Early Prediction Immunization Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: EARLY_PHASE1
Conditions: Inflammatory Response
Keywords: commercial off the shelf wearable devices
large-scale machine learning
biomarkers
early warning of infection
predictive model of illness severity
predictive model of recovery
Lead sponsor: Texas A&M University
Sponsor class: OTHER
Collaborators: name: Philips Healthcare
name: US Department of Defense - Defense Threat Reduction Agency
First posted: 2022-04-26
Enrollment: 249
Sex: ALL
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Double-blind randomized placebo-controlled vaccine administration (pneumococcal (PPSV23), typhoid (inactivated), or saline)
Primary purpose: OTHER

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 of parameters to predict emergent cases of infection via an early warning score, along with actionable personalized information.

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 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.

Eligibility criteria: Inclusion Criteria:

* 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 Criteria:

* 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.

Primary outcomes:
measure: Questionnaires, self-reported changes in general physical health, and physiological measurements to predict of type of vaccine administered
timeFrame: up to 4 weeks
Secondary outcomes:
measure: Electrocardiography Morphology
timeFrame: up to 4 weeks
measure: Heart Rate
timeFrame: up to 4 weeks
measure: Heart Rate Variability
timeFrame: up to 4 weeks
measure: Body Temperature
timeFrame: up to 4 weeks
measure: Blood pressure (systolic and diastolic)
timeFrame: up to 4 weeks
measure: Respiratory Rate
timeFrame: up to 4 weeks
measure: Amount of End-tidal Carbon Dioxide
timeFrame: up to 4 weeks
measure: Oxygen Saturation
timeFrame: up to 4 weeks
measure: Assessment of the type and relative abundance of protein and lipids contained in Exhaled Breath Condensate
timeFrame: at enrollment, and +7, +14, +16, +21, +28 days of enrollment
measure: Assessment of the type and relative abundance of Volatile Organic Compounds contained in exhaled breath
timeFrame: at enrollment, and +7, +14, +16, +21, +28 days of enrollment
measure: Digital photo of the face to assess changes in general facial features
timeFrame: up to 4 weeks
measure: Digital photo of the face to assess changes in eyes
timeFrame: up to 4 weeks
measure: Digital photo of the face to assess changes in other facial components
timeFrame: up to 4 weeks
measure: Digital audio recording of vocal expressions to assess changes in vowel components
timeFrame: up to 4 weeks
measure: Digital audio recording of vocal expressions to assess frequency changes in speech prosody components
timeFrame: up to 4 weeks
measure: Digital audio recording of vocal expressions to assess variation changes in speech prosody components
timeFrame: up to 4 weeks
measure: Digital audio recording of vocal expressions to assess time domain changes in speech prosody components
timeFrame: up to 4 weeks
measure: Continuous Glucose Monitoring
timeFrame: up to 2 weeks
measure: Changes in physical health as measured by the Medical Symptoms Questionnaire (MSQ)
timeFrame: +7, +14, +16, +21, +28 days of enrollment
measure: Changes in gut function as measured by Gastrointestinal Symptom Rating Scale (GSRS)
timeFrame: +7, +14, +16, +21, +28 days of enrollment
measure: Changes in physical activity as measured by the short International Physical Activity Questionnaire (IPAQ)
timeFrame: +7, +14, +21, +28 days of enrollment
measure: Changes in daily dietary intake as measure by the Food Frequency Questionnaire (FFQ)
timeFrame: +7, +28 days of enrollment
measure: Changes in duration and quality of sleep as measured by Pittsburgh Sleep Quality Index (PSQI)
timeFrame: +7, +28 days of enrollment
measure: Changes in physical activity as measured by the Baecke Physical Activity Questionnaire
timeFrame: +7, +28 days of enrollment
measure: Changes in quality of life as measured by Short Form (SF) Health Survey (SF36)
timeFrame: +7, +28 days of enrollment
measure: Renal function panel Albumin
timeFrame: +14, +16, +21 days of enrollment
measure: Renal function panel BUN/Creatinine Ratio
timeFrame: +14, +16, +21 days of enrollment
measure: Renal function panel Calcium
timeFrame: +14, +16, +21 days of enrollment
measure: Renal function panel Carbon Dioxide
timeFrame: +14, +16, +21 days of enrollment
measure: Renal function panel Chloride
timeFrame: +14, +16, +21 days of enrollment
measure: Renal function panel Creatinine
timeFrame: +14, +16, +21 days of enrollment
measure: Renal function panel Estimated Glomerular Filtration Rate
timeFrame: +14, +16, +21 days of enrollment
measure: Renal function panel Glucose
timeFrame: +14, +16, +21 days of enrollment
measure: Renal function panel Phosphate
timeFrame: +14, +16, +21 days of enrollment
measure: Renal function panel Potassium
timeFrame: +14, +16, +21 days of enrollment
measure: Renal function panel Sodium
timeFrame: +14, +16, +21 days of enrollment
measure: Renal function panel Urea Nitrogen
timeFrame: +14, +16, +21 days of enrollment
measure: Hepatic function panel Total Protein
timeFrame: +14, +16, +21 days of enrollment
measure: Hepatic function panel Albumin
timeFrame: +14, +16, +21 days of enrollment
measure: Hepatic function panel Globulin (calculated)
timeFrame: +14, +16, +21 days of enrollment
measure: Hepatic function panel Albumin/Globulin Ratio
timeFrame: +14, +16, +21 days of enrollment
measure: Hepatic function panel Total Bilirubin
timeFrame: +14, +16, +21 days of enrollment
measure: Hepatic function panel Direct Bilirubin
timeFrame: +14, +16, +21 days of enrollment
measure: Hepatic function panel Indirect Bilirubin
timeFrame: +14, +16, +21 days of enrollment
measure: Hepatic function panel Alkaline Phosphatase
timeFrame: +14, +16, +21 days of enrollment
measure: Hepatic function panel Aspartate transaminase
timeFrame: +14, +16, +21 days of enrollment
measure: Hepatic function panel Alanine Aminotransferase
timeFrame: +14, +16, +21 days of enrollment
measure: Lipid panel
timeFrame: +14, +16, +21 days of enrollment
measure: CBC (DIFF/PLT) White blood cell count
timeFrame: +14, +16, +21 days of enrollment
measure: CBC (DIFF/PLT) red blood cell count
timeFrame: +14, +16, +21 days of enrollment
measure: CBC (DIFF/PLT) Hemoglobin
timeFrame: +14, +16, +21 days of enrollment
measure: CBC (DIFF/PLT) Hematocrit
timeFrame: +14, +16, +21 days of enrollment
measure: CBC (DIFF/PLT) mean corpuscular volume
timeFrame: +14, +16, +21 days of enrollment
measure: CBC (DIFF/PLT) mean corpuscular hemoglobin
timeFrame: +14, +16, +21 days of enrollment
measure: CBC (DIFF/PLT) corpuscular hemoglobin concentration
timeFrame: +14, +16, +21 days of enrollment
measure: CBC (DIFF/PLT) red cell distribution width
timeFrame: +14, +16, +21 days of enrollment
measure: CBC (DIFF/PLT) Platelet Count
timeFrame: +14, +16, +21 days of enrollment
measure: CBC (DIFF/PLT) mean platelet volume
timeFrame: +14, +16, +21 days of enrollment
measure: CBC (DIFF/PLT) Differential
timeFrame: +14, +16, +21 days of enrollment
measure: Highly Sensitive CRP
timeFrame: +14, +16, +21 days of enrollment
measure: Hemoglobin A1C
timeFrame: +14 days of enrollment
measure: Body Composition using Dual Energy X-Ray Absorptiometry bone density
timeFrame: at enrollment
measure: Body Composition using Dual Energy X-Ray Absorptiometry Muscle
timeFrame: at enrollment
measure: Body Composition using Dual Energy X-Ray Absorptiometry Fat
timeFrame: at enrollment
measure: Measurement of daily physical activity using accelerometry sensors
timeFrame: up to 4 weeks
Other outcomes:
measure: Development of personalized algorithm to provide an estimate of probability of onset of infection using activity and physiological measures
timeFrame: through study completion, up to 4 weeks
measure: Development of personalized algorithm to provide an estimated index of severity of infection using activity and physiological measures
timeFrame: through study completion, up to 4 weeks
measure: Development of personalized algorithm to provide an estimated score related to time until recovery of infection using activity and physiological measures
timeFrame: through study completion, up to 4 weeks
measure: Development of personalized algorithm to provide detect the systems involved (respiratory vs gastrointestinal vs other) in infection using activity and physiological measures
timeFrame: through study completion, up to 4 weeks
Locations:
city: College Station
country: United States
facility: Texas A&M University - CTRAL
state: Texas
Study officials:
References: