Persistent Readiness Through Early Prediction Immunization Study

Early Phase 1CompletedNCT05346302

Texas A&M University249 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

OTHER

Masking

DOUBLE

Enrollment

249

Conditions

Inflammatory Response

Interventions

Pneumovax 23DRUG

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

Typhim VIDRUG

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

SalineOTHER

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

Eligibility

Sex: ALLMin age: 18 YearsMax age: 40 YearsHealthy volunteers:

Medical Language ↔ Plain English

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.

Locations (1)

Texas A&M University - CTRAL

College Station, Texas, United States

Outcomes

Primary Outcomes

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

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

Time frame: up to 4 weeks

Secondary Outcomes

Electrocardiography Morphology

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)

Time frame: up to 4 weeks

Heart Rate

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

Time frame: up to 4 weeks

Heart Rate Variability

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

Time frame: up to 4 weeks

Body Temperature

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

Time frame: up to 4 weeks

Blood pressure (systolic and diastolic)

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

Time frame: up to 4 weeks

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.

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

Time frame: up to 4 weeks

Amount of End-tidal Carbon Dioxide

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

Time frame: up to 4 weeks

Oxygen Saturation

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

Time frame: up to 4 weeks

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

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

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

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

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

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

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

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 \[RGB, HSV and YCbCr\]

Time frame: up to 4 weeks

Digital photo of the face to assess changes in eyes

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

Time frame: up to 4 weeks

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

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

Time frame: up to 4 weeks

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

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).

Time frame: up to 4 weeks

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

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).

Time frame: up to 4 weeks

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

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 (%).

Time frame: up to 4 weeks

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

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).

Time frame: up to 4 weeks

Continuous Glucose Monitoring

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

Time frame: up to 2 weeks

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

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.

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

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

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.

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

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

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.

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

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

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

Time frame: +7, +28 days of enrollment

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

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.

Time frame: +7, +28 days of enrollment

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

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

Time frame: +7, +28 days of enrollment

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

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)

Time frame: +7, +28 days of enrollment

Renal function panel Albumin

Blood sample taken to measure Albumin