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Inflammatory ResponseEarly Phase 1PREP DODNCT05346302

Persistent Readiness Through Early Prediction Immunization Study

A Early Phase 1 study testing Pneumovax 23, Typhim VI and Saline in people with Inflammatory Response, run by Texas A&M University at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 18 to 40 yearsHealthy volunteers can take part
Conditions the study is for
Inflammatory Response
What is being tested?
Pneumovax 23, Typhim VI and Saline
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
249 participants
Where
1 siteUnited States
Study dates
8 Feb 2022to 21 Dec 2022
Phase
Early Phase 1
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 40 years
  • All sexes
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • 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

Who cannot join

  • 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)
Show all 19Show fewer
  • 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.

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Texas A&M University - CTRAL

    College Station, Texas, 77845

Other trials in United States

About this 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.

Read the 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.

Being tested
Pneumovax 23, Typhim VI, Saline
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

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • 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.

Study groups in NCT05346302
Study groupRoleWhat they receive
Pneumococcal (PPSV23) vaccineActive comparatorPNEUMOVAX 23 is a clear, colorless solution. Each 0.5-mL dose of vaccine contains 25 micrograms of each polysaccharide type in isotonic saline solution containing 0.25% phenol as a preservative under the supervision of a licensed pharmacist.
Receives: Drug: Pneumovax 23
Typhoid (inactivated) vaccineActive comparatorTyphoid vaccine is a clear, colorless solution. Each dose of 0.5 mL is formulated to contain 25 mcg of purified Vi polysaccharide in a colorless isotonic phosphate buffered saline (pH 7 ± 0.3), 4.150 mg of Sodium Chloride, 0.065 mg of Disodium Phosphate, 0.023 mg of Monosodium Phosphate, and 0.5 mL of Sterile Water for Injection under the supervision of a licensed pharmacist.
Receives: Drug: Typhim VI
SalinePlacebo comparatorSaline will be purchased commercially and compounded under the supervision of a licensed pharmacist in sterile syringes for administration of the placebo group.
Receives: Other: Saline

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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

    Measured: up to 4 weeks

Secondary outcomes (65)

  1. 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)

    Measured: up to 4 weeks

  2. Heart Rate

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

    Measured: up to 4 weeks

  3. Heart Rate Variability

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

    Measured: up to 4 weeks

  4. Body Temperature

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

    Measured: up to 4 weeks

  5. Blood pressure (systolic and diastolic)

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

    Measured: up to 4 weeks

  6. Respiratory Rate

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

    Measured: up to 4 weeks

  7. Amount of End-tidal Carbon Dioxide

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

    Measured: up to 4 weeks

  8. Oxygen Saturation

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

    Measured: up to 4 weeks

  9. 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

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

  10. 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)

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

  11. 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]

    Measured: up to 4 weeks

  12. 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

    Measured: up to 4 weeks

  13. 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

    Measured: up to 4 weeks

  14. 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).

    Measured: up to 4 weeks

  15. 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).

    Measured: up to 4 weeks

  16. 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 (%).

    Measured: up to 4 weeks

  17. 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).

    Measured: up to 4 weeks

  18. Continuous Glucose Monitoring

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

    Measured: up to 2 weeks

  19. 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.

    Measured: +7, +14, +16, +21, +28 days of enrollment

  20. 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.

    Measured: +7, +14, +16, +21, +28 days of enrollment

  21. 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.

    Measured: +7, +14, +21, +28 days of enrollment

  22. 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.

    Measured: +7, +28 days of enrollment

  23. 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.

    Measured: +7, +28 days of enrollment

  24. 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

    Measured: +7, +28 days of enrollment

  25. 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)

    Measured: +7, +28 days of enrollment

  26. Renal function panel Albumin

    Blood sample taken to measure Albumin

    Measured: +14, +16, +21 days of enrollment

  27. Renal function panel BUN/Creatinine Ratio

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

    Measured: +14, +16, +21 days of enrollment

  28. Renal function panel Calcium

    Blood sample taken to measure Calcium

    Measured: +14, +16, +21 days of enrollment

  29. Renal function panel Carbon Dioxide

    Blood sample taken to measure Carbon Dioxide

    Measured: +14, +16, +21 days of enrollment

  30. Renal function panel Chloride

    Blood sample taken to measure Chloride

    Measured: +14, +16, +21 days of enrollment

  31. Renal function panel Creatinine

    Blood sample taken to measure Creatinine

    Measured: +14, +16, +21 days of enrollment

  32. Renal function panel Estimated Glomerular Filtration Rate

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

    Measured: +14, +16, +21 days of enrollment

  33. Renal function panel Glucose

    Blood sample taken to measure Glucose

    Measured: +14, +16, +21 days of enrollment

  34. Renal function panel Phosphate

    Blood sample taken to measure Phosphate (as Phosphorus)

    Measured: +14, +16, +21 days of enrollment

  35. Renal function panel Potassium

    Blood sample taken to measure Potassium

    Measured: +14, +16, +21 days of enrollment

  36. Renal function panel Sodium

    Blood sample taken to measure Sodium

    Measured: +14, +16, +21 days of enrollment

  37. Renal function panel Urea Nitrogen

    Blood sample taken to measure Urea Nitrogen

    Measured: +14, +16, +21 days of enrollment

  38. Hepatic function panel Total Protein

    Blood sample taken to measure Total Protein

    Measured: +14, +16, +21 days of enrollment

  39. Hepatic function panel Albumin

    Blood sample taken to measure Albumin

    Measured: +14, +16, +21 days of enrollment

  40. Hepatic function panel Globulin (calculated)

    Blood sample taken to measure Globulin (calculated)

    Measured: +14, +16, +21 days of enrollment

  41. Hepatic function panel Albumin/Globulin Ratio

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

    Measured: +14, +16, +21 days of enrollment

  42. Hepatic function panel Total Bilirubin

    Blood sample taken to measure Total Bilirubin

    Measured: +14, +16, +21 days of enrollment

  43. Hepatic function panel Direct Bilirubin

    Blood sample taken to measure Direct Bilirubin

    Measured: +14, +16, +21 days of enrollment

  44. Hepatic function panel Indirect Bilirubin

    Blood sample taken to measure Indirect Bilirubin (calculated)

    Measured: +14, +16, +21 days of enrollment

  45. Hepatic function panel Alkaline Phosphatase

    Blood sample taken to measure Alkaline Phosphatase

    Measured: +14, +16, +21 days of enrollment

  46. Hepatic function panel Aspartate transaminase

    Blood sample taken to measure Aspartate transaminase

    Measured: +14, +16, +21 days of enrollment

  47. Hepatic function panel Alanine Aminotransferase

    Blood sample taken to measure Alanine Aminotransferase

    Measured: +14, +16, +21 days of enrollment

  48. Lipid panel

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

    Measured: +14, +16, +21 days of enrollment

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

    Blood sample taken to measure White blood cell count

    Measured: +14, +16, +21 days of enrollment

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

    Blood sample taken to measure red blood cell count

    Measured: +14, +16, +21 days of enrollment

  51. CBC (DIFF/PLT) Hemoglobin

    Blood sample taken to measure Hemoglobin

    Measured: +14, +16, +21 days of enrollment

  52. CBC (DIFF/PLT) Hematocrit

    Blood sample taken to measure Hematocrit

    Measured: +14, +16, +21 days of enrollment

  53. CBC (DIFF/PLT) mean corpuscular volume

    Blood sample taken to measure mean corpuscular volume

    Measured: +14, +16, +21 days of enrollment

  54. CBC (DIFF/PLT) mean corpuscular hemoglobin

    Blood sample taken to measure mean corpuscular hemoglobin

    Measured: +14, +16, +21 days of enrollment

  55. CBC (DIFF/PLT) corpuscular hemoglobin concentration

    Blood sample taken to measure mean corpuscular hemoglobin concentration

    Measured: +14, +16, +21 days of enrollment

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

    Blood sample taken to measure red cell distribution width

    Measured: +14, +16, +21 days of enrollment

  57. CBC (DIFF/PLT) Platelet Count

    Blood sample taken to measure Platelet Count

    Measured: +14, +16, +21 days of enrollment

  58. CBC (DIFF/PLT) mean platelet volume

    Blood sample taken to measure mean platelet volume

    Measured: +14, +16, +21 days of enrollment

  59. CBC (DIFF/PLT) Differential

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

    Measured: +14, +16, +21 days of enrollment

  60. Highly Sensitive CRP

    Blood sample taken to measure Highly Sensitive C-Reactive Protein

    Measured: +14, +16, +21 days of enrollment

  61. Hemoglobin A1C

    Blood sample taken to measure hemoglobin A1C

    Measured: +14 days of enrollment

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

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

    Measured: at enrollment

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

    Measurement of muscle mass (kg)

    Measured: at enrollment

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

    Measurement of fat mass (kg)

    Measured: at enrollment

  65. Measurement of daily physical activity using accelerometry sensors

    Changes in physical activity detected by accelerometry data of wearable devices

    Measured: up to 4 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted26 Apr 2022
  2. Study start8 Feb 2022
  3. Primary completion21 Dec 2022
  4. Study completion21 Dec 2022

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Early Phase 1
Primary purpose
Other
Allocation
Randomised
Intervention model
Parallel groups
Model description
Double-blind randomized placebo-controlled vaccine administration (pneumococcal (PPSV23), typhoid (inactivated), or saline)
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
249 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05346302
Sponsor's protocol ID
PREP DOD
Acronym
PREP DOD
Status last verified
Feb 2023
First submitted
1 Feb 2022
Last updated
14 Feb 2023
Results posted
No
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Publications

  • Schrader SE, Hansen JR, O'Bryon I, Ruebush LE, Deutz NE, Wahl JH, Deatherage Kaiser BL. Volatile organic compound and proteomics data from the same exhaled breath condensate sample. J Breath Res. 2025 Aug 4;19(4). doi: 10.1088/1752-7163/adf34d.

    PubMed 40701160

  • Wang C, Damiano RJ, Ruebush LE, Engelen MPKJ, Mariani S, Liu L, Silva I, Borhani S, Cote GL, Conroy B, McFarlane D, Deutz NEP. A randomized, triple-blinded, placebo-controlled clinical trial evaluating immune responses of Typhim Vi and PPSV23 vaccines in healthy adults: The PREP study. Vaccine. 2024 Dec 2;42(26):126292. doi: 10.1016/j.vaccine.2024.126292. Epub 2024 Sep 7.

    PubMed 39245584

Questions about this trial

What is this clinical trial studying?

A Early Phase 1 study testing Pneumovax 23, Typhim VI and Saline in people with Inflammatory Response, run by Texas A&M University at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 19 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 14 Feb 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Questionnaires, self-reported changes in general physical health, and physiological measurements to predict of type of vaccine administered (time frame: up to 4 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05346302, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Feb 2023; AzTrials last refreshed its copy on 27 Oct 2026.

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