Persistent Readiness Through Early Prediction Immunization Study

NCT05346302 | Completed Early Phase 1 FDA Drug

• 1 other identifier: PREP DOD
• Study Type: interventional
• Target: 249
• Locations: 1 country
• Sites: 1

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.

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

Outcome Measures

Primary Outcomes (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

  up to 4 weeks

Secondary Outcomes (65)

• Electrocardiography Morphology

  up to 4 weeks

• Heart Rate

  up to 4 weeks

• Heart Rate Variability

  up to 4 weeks

• Body Temperature

  up to 4 weeks

• Blood pressure (systolic and diastolic)

  up to 4 weeks

Other Outcomes (4)

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

  through study completion, up to 4 weeks

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

  through study completion, up to 4 weeks

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

  through study completion, up to 4 weeks

Study Arms (3)

Pneumococcal (PPSV23) vaccine

ACTIVE COMPARATOR

PNEUMOVAX 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.

Drug: Pneumovax 23

Typhoid (inactivated) vaccine

ACTIVE COMPARATOR

Typhoid 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.

Drug: Typhim VI

Saline

PLACEBO COMPARATOR

Saline will be purchased commercially and compounded under the supervision of a licensed pharmacist in sterile syringes for administration of the placebo group.

Other: Saline

Interventions

Pneumovax 23 DRUG

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

Pneumococcal (PPSV23) vaccine

Typhim VI DRUG

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

Typhoid (inactivated) vaccine

Saline OTHER

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

Saline

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Texas A&M University: lead
• Philips Healthcare: collaborator
• US Department of Defense - Defense Threat Reduction Agency: collaborator

Study Sites (1)

Texas A&M University - CTRAL

College Station, Texas, 77845, United States

Location

Related Publications (2)

• 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.

  PMID: 40701160 DERIVED

• 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.

  PMID: 39245584 DERIVED

MeSH Terms

Interventions

23-valent pneumococcal capsular polysaccharide vaccine; Vi polysaccharide vaccine, typhoid; Sodium Chloride

Intervention Hierarchy (Ancestors)

Chlorides; Hydrochloric Acid; Chlorine Compounds; Inorganic Chemicals; Sodium Compounds

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: Double-blind randomized placebo-controlled vaccine administration (pneumococcal (PPSV23), typhoid (inactivated), or saline)

Study Record Dates

• First Submitted: February 1, 2022
• First Posted: April 26, 2022
• Study Start: February 8, 2022
• Primary Completion: December 21, 2022
• Study Completion: December 21, 2022
• Last Updated: February 14, 2023

Record last verified: 2023-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)