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OpenTrials
Completed

NCT Number: NCT05346302

Persistent Readiness Through Early Prediction Immunization Study

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.

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Key information

Conditions

Inflammatory Response

Age range

18 year–40 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Early Phase 1

Primary location

Texas A&M University - CTRAL

College Station, Texas, 77845, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Pneumovax 23

Drug

At +14 days from enrollment in the trial, participants will receive a vaccine administered via intramuscular route only.

Typhim VI

Drug

At +14 days from enrollment in the trial, participants will receive a vaccine administered via intramuscular route only.

Saline

Other

At +14 days from enrollment in the trial, participants will receive a vaccine administered via intramuscular route only.

Primary outcomes

  1. Questionnaires, self-reported changes in general physical health, and physiological measurements to predict of type of vaccine administered

    Time frame: up to 4 weeks

    Using a daily electronic questionnaire to collect data that self-reporting changes in general physical health and physiological measurements to identify the type of intervention

Secondary outcomes

  1. Electrocardiography Morphology

    Time frame: up to 4 weeks

    Comparison of signals from standard electrocardiography (ECG) and wearable devices measuring the time elapsed between features of the electrical activity of the heart (e.g., P-wave, PR interval, PR segment, QRS complex, QRS duration, ST segment, J point, TP interval, T-wave, U-wave, QT duration, QTc interval)

  2. Heart Rate

    Time frame: up to 4 weeks

    Comparison of signals from standard electrocardiography (ECG) and wearable devices measuring beats per minute of the heart

  3. Heart Rate Variability

    Time frame: up to 4 weeks

    Comparison of signals from standard electrocardiography (ECG) and wearable devices measuring variation in the time interval between consecutive heartbeats in milliseconds

  4. Body Temperature

    Time frame: up to 4 weeks

    Comparison of signals from contact infrared forehead thermometer and wearable devices measuring body surface temperature

  5. Blood pressure (systolic and diastolic)

    Time frame: up to 4 weeks

    Comparison of signals from standard upper arm cuff and wearable devices measuring bloodpressure

  6. Respiratory Rate

    Time frame: up to 4 weeks

    Comparison of signals from nasal cannula and wearable devices measuring number of breaths per minute

  7. Amount of End-tidal Carbon Dioxide

    Time frame: up to 4 weeks

    Collection from nasal cannula to measure amount of EtCO2 in exhaled breath

  8. Oxygen Saturation

    Time frame: up to 4 weeks

    Comparison of signals from fingertip pulse oximeter and wearable devices measuring level of oxygen saturation in blood

  9. Assessment of the type and relative abundance of protein and lipids contained in Exhaled Breath Condensate

    Time frame: at enrollment, and +7, +14, +16, +21, +28 days of enrollment

    Measurement of presence and amount of components (e.g., protein, lipids) in exhaled breath condensate as determined by liquid chromatography tandem chromatography mass spectrometry

  10. Assessment of the type and relative abundance of Volatile Organic Compounds contained in exhaled breath

    Time frame: at enrollment, and +7, +14, +16, +21, +28 days of enrollment

    Measurement of presence and amount of volatile organic compounds (e.g., ethanol, acetone, etc) in breath by comprehensive gas chromatography mass spectrometry (GCxGC-MS)

  11. Digital photo of the face to assess changes in general facial features

    Time frame: up to 4 weeks

    Comparison of facial features taken with on-site digital camera and mobile device to compare general facial features such as 2-D facial landmarks, 3-D head pose, Deeply embedded facial expression features, and facial expressions via tools like Mediapipe face mesh or deepface and skin tone histograms at [RGB, HSV and YCbCr]

  12. Digital photo of the face to assess changes in eyes

    Time frame: up to 4 weeks

    Comparison of facial features taken with on-site digital camera and mobile device to compare general features of the eye such as 2-D eyes and iris landmarks and shapes, Gaze directions of two eyes, Pixel histograms of Iris, pupil, and sclera at [RGB, HSV and YCbCr], Deeply embedded iris recognition features (via tools like irisRecognition), or eye texture features (Gabor filter banks, Haralick features) using tools like Mediapipe Iris

  13. Digital photo of the face to assess changes in other facial components

    Time frame: up to 4 weeks

    Comparison of facial features taken with on-site digital camera and mobile device to compare general features Pixel histograms of: nose, forehead, left cheek, right cheek, mouth and lips at [RGB, HSV and YCbCr] using part segmentation done with Mediapipe facemesh

  14. Digital audio recording of vocal expressions to assess changes in vowel components

    Time frame: up to 4 weeks

    Comparison of vocal features taken with on-site digital microphone and mobile device to compare vowel components of: mean frequency (Hz), variation coefficient (%), jitter factor (%), mean intensity (dB), shimmer factor (%), and noise to harmony ratio (dB).

  15. Digital audio recording of vocal expressions to assess frequency changes in speech prosody components

    Time frame: up to 4 weeks

    Comparison of vocal features taken with on-site digital microphone and mobile device to compare speech prosody components of: mean frequency (Hz), minimal frequency (Hz), maximal frequency (Hz), dynamic (Hz).

  16. Digital audio recording of vocal expressions to assess variation changes in speech prosody components

    Time frame: up to 4 weeks

    Comparison of vocal features taken with on-site digital microphone and mobile device to compare speech prosody components of: median frequency variation coefficient (%), percentage of pauses (%), percentage of pauses within words (%), fragmentation of vowels (%), and stop-consonant spirantization (%).

  17. Digital audio recording of vocal expressions to assess time domain changes in speech prosody components

    Time frame: up to 4 weeks

    Comparison of vocal features taken with on-site digital microphone and mobile device to compare speech prosody components of: mean duration of speech between two pauses (seconds), total amount of syllables (syllables/s), total amount of pure speech (syllables/s), articulation rate (syllables/s), time between pauses (s), SPIR index of rhythmicity (words/min), voice onset time (s).

  18. Continuous Glucose Monitoring

    Time frame: up to 2 weeks

    Using the DexCom G6 continuous glucose monitoring will be done for the week prior to and following the vaccination

  19. Changes in physical health as measured by the Medical Symptoms Questionnaire (MSQ)

    Time frame: +7, +14, +16, +21, +28 days of enrollment

    The MSQ is administered by study staff for self-reporting of presence and severity of changes in symptoms in body symptoms: digestive tract, ears, emotions, energy/activity, eyes, head, heart, joint/muscles, lungs, mind, mouth/throat, nose, skin, weight, other.

  20. Changes in gut function as measured by Gastrointestinal Symptom Rating Scale (GSRS)

    Time frame: +7, +14, +16, +21, +28 days of enrollment

    The GSRS is self-administered questionnaire regarding gut function and associated symptoms. It is composed of 15 items (7-Point Likert Scale) assessing Reflux, Abdominal pain, Indigestion, Diarrhoea and Constipation. Scores range from 15 to 105 with a higher score indicating more discomfort.

  21. Changes in physical activity as measured by the short International Physical Activity Questionnaire (IPAQ)

    Time frame: +7, +14, +21, +28 days of enrollment

    The IPAQ is a self-administered questionnaire to provide a set of well-developed instruments that can be used internationally to obtain comparable estimates of physical activity.

  22. Changes in daily dietary intake as measure by the Food Frequency Questionnaire (FFQ)

    Time frame: +7, +28 days of enrollment

    The FFQ is a self-administered questionnaire to provide an estimation of dietary protein intake.

  23. Changes in duration and quality of sleep as measured by Pittsburgh Sleep Quality Index (PSQI)

    Time frame: +7, +28 days of enrollment

    The PSQI is a self-administered questionnaire to assesses sleep quality and disturbances. 19 individual items generate seven "component" scores: subjective sleep quality, sleep latency, sleep duration, habitual sleep efficiency, sleep disturbances, use of sleeping medication, and daytime dysfunction.

  24. Changes in physical activity as measured by the Baecke Physical Activity Questionnaire

    Time frame: +7, +28 days of enrollment

    Self-administered, 16-item questionnaire measuring physical activities in 3 categories: occupational, sport, recreational/leisure

  25. Changes in quality of life as measured by Short Form (SF) Health Survey (SF36)

    Time frame: +7, +28 days of enrollment

    Self administered questionnaire that measures each of the following eight health concepts: Physical Functioning (PF); Role-Physical (RP); Bodily Pain (BP); General Health (GH); Vitality (VT); Social Functioning (SF); Role-Emotional (RE); Mental Health (MH) as well as a reported Health Transition item (HT)

  26. Renal function panel Albumin

    Time frame: +14, +16, +21 days of enrollment

    Blood sample taken to measure Albumin

  27. Renal function panel BUN/Creatinine Ratio

    Time frame: +14, +16, +21 days of enrollment

    Blood sample taken to measure BUN/Creatinine Ratio (calculated)

  28. Renal function panel Calcium

    Time frame: +14, +16, +21 days of enrollment

    Blood sample taken to measure Calcium

  29. Renal function panel Carbon Dioxide

    Time frame: +14, +16, +21 days of enrollment

    Blood sample taken to measure Carbon Dioxide

  30. Renal function panel Chloride

    Time frame: +14, +16, +21 days of enrollment

    Blood sample taken to measure Chloride

  31. Renal function panel Creatinine

    Time frame: +14, +16, +21 days of enrollment

    Blood sample taken to measure Creatinine

  32. Renal function panel Estimated Glomerular Filtration Rate

    Time frame: +14, +16, +21 days of enrollment

    Blood sample taken to measure Estimated Glomerular Filtration Rate (calculated)

  33. Renal function panel Glucose

    Time frame: +14, +16, +21 days of enrollment

    Blood sample taken to measure Glucose

  34. Renal function panel Phosphate

    Time frame: +14, +16, +21 days of enrollment

    Blood sample taken to measure Phosphate (as Phosphorus)

  35. Renal function panel Potassium

    Time frame: +14, +16, +21 days of enrollment

    Blood sample taken to measure Potassium

  36. Renal function panel Sodium

    Time frame: +14, +16, +21 days of enrollment

    Blood sample taken to measure Sodium

  37. Renal function panel Urea Nitrogen

    Time frame: +14, +16, +21 days of enrollment

    Blood sample taken to measure Urea Nitrogen

  38. Hepatic function panel Total Protein

    Time frame: +14, +16, +21 days of enrollment

    Blood sample taken to measure Total Protein

  39. Hepatic function panel Albumin

    Time frame: +14, +16, +21 days of enrollment

    Blood sample taken to measure Albumin

  40. Hepatic function panel Globulin (calculated)

    Time frame: +14, +16, +21 days of enrollment

    Blood sample taken to measure Globulin (calculated)

  41. Hepatic function panel Albumin/Globulin Ratio

    Time frame: +14, +16, +21 days of enrollment

    Blood sample taken to measure Albumin/Globulin Ratio (calculated)

  42. Hepatic function panel Total Bilirubin

    Time frame: +14, +16, +21 days of enrollment

    Blood sample taken to measure Total Bilirubin

  43. Hepatic function panel Direct Bilirubin

    Time frame: +14, +16, +21 days of enrollment

    Blood sample taken to measure Direct Bilirubin

  44. Hepatic function panel Indirect Bilirubin

    Time frame: +14, +16, +21 days of enrollment

    Blood sample taken to measure Indirect Bilirubin (calculated)

  45. Hepatic function panel Alkaline Phosphatase

    Time frame: +14, +16, +21 days of enrollment

    Blood sample taken to measure Alkaline Phosphatase

  46. Hepatic function panel Aspartate transaminase

    Time frame: +14, +16, +21 days of enrollment

    Blood sample taken to measure Aspartate transaminase

  47. Hepatic function panel Alanine Aminotransferase

    Time frame: +14, +16, +21 days of enrollment

    Blood sample taken to measure Alanine Aminotransferase

  48. Lipid panel

    Time frame: +14, +16, +21 days of enrollment

    Blood sample taken to measure Total Cholesterol, HDL Cholesterol, LDL Cholesterol, Triglycerides, VLDL Cholesterol

  49. CBC (DIFF/PLT) White blood cell count

    Time frame: +14, +16, +21 days of enrollment

    Blood sample taken to measure White blood cell count

  50. CBC (DIFF/PLT) red blood cell count

    Time frame: +14, +16, +21 days of enrollment

    Blood sample taken to measure red blood cell count

  51. CBC (DIFF/PLT) Hemoglobin

    Time frame: +14, +16, +21 days of enrollment

    Blood sample taken to measure Hemoglobin

  52. CBC (DIFF/PLT) Hematocrit

    Time frame: +14, +16, +21 days of enrollment

    Blood sample taken to measure Hematocrit

  53. CBC (DIFF/PLT) mean corpuscular volume

    Time frame: +14, +16, +21 days of enrollment

    Blood sample taken to measure mean corpuscular volume

  54. CBC (DIFF/PLT) mean corpuscular hemoglobin

    Time frame: +14, +16, +21 days of enrollment

    Blood sample taken to measure mean corpuscular hemoglobin

  55. CBC (DIFF/PLT) corpuscular hemoglobin concentration

    Time frame: +14, +16, +21 days of enrollment

    Blood sample taken to measure mean corpuscular hemoglobin concentration

  56. CBC (DIFF/PLT) red cell distribution width

    Time frame: +14, +16, +21 days of enrollment

    Blood sample taken to measure red cell distribution width

  57. CBC (DIFF/PLT) Platelet Count

    Time frame: +14, +16, +21 days of enrollment

    Blood sample taken to measure Platelet Count

  58. CBC (DIFF/PLT) mean platelet volume

    Time frame: +14, +16, +21 days of enrollment

    Blood sample taken to measure mean platelet volume

  59. CBC (DIFF/PLT) Differential

    Time frame: +14, +16, +21 days of enrollment

    Blood sample taken to measure Differential (Absolute and Percent - Neutrophils, Lymphocytes, Monocytes, Eosinophils, and Basophils)

  60. Highly Sensitive CRP

    Time frame: +14, +16, +21 days of enrollment

    Blood sample taken to measure Highly Sensitive C-Reactive Protein

  61. Hemoglobin A1C

    Time frame: +14 days of enrollment

    Blood sample taken to measure hemoglobin A1C

  62. Body Composition using Dual Energy X-Ray Absorptiometry bone density

    Time frame: at enrollment

    Measurement of bone mineral density (g/cm^2)

  63. Body Composition using Dual Energy X-Ray Absorptiometry Muscle

    Time frame: at enrollment

    Measurement of muscle mass (kg)

  64. Body Composition using Dual Energy X-Ray Absorptiometry Fat

    Time frame: at enrollment

    Measurement of fat mass (kg)

  65. Measurement of daily physical activity using accelerometry sensors

    Time frame: up to 4 weeks

    Changes in physical activity detected by accelerometry data of wearable devices

Other outcomes

  1. Development of personalized algorithm to provide an estimate of probability of onset of infection using activity and physiological measures

    Time frame: through study completion, up to 4 weeks

    Apply machine learning algorithms to data collected from clinical setting and wearable devices at various time scales relative to symptoms that are represented by percent score between 0-100%.

  2. Development of personalized algorithm to provide an estimated index of severity of infection using activity and physiological measures

    Time frame: through study completion, up to 4 weeks

    Apply machine learning algorithms to data collected from clinical setting and wearable devices at various time scales relative to symptoms to estimate the acuity/intensity of care associated with infection ranging from 0-10.

  3. Development of personalized algorithm to provide an estimated score related to time until recovery of infection using activity and physiological measures

    Time frame: through study completion, up to 4 weeks

    Apply machine learning algorithms to data collected from clinical setting and wearable devices at various time scales relative to symptoms to be reported in hours.

  4. Development of personalized algorithm to provide detect the systems involved (respiratory vs gastrointestinal vs other) in infection using activity and physiological measures

    Time frame: through study completion, up to 4 weeks

    Apply machine learning algorithms to data collected from clinical setting and wearable devices at various time scales relative to symptoms to generate a probability score of systems involved in infection.

Sponsors and collaborators

Lead sponsor

Texas A&M University

Other

Collaborators

  • Philips Healthcare
  • US Department of Defense - Defense Threat Reduction Agency

Registry information

Acronym: PREP DOD

Important dates

Study start
2022
Primary completion
2022
Study completion
2022
First posted
Apr 26, 2022
Registry last updated
Feb 14, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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