Persistent Readiness Through Early Prediction Immunization Study (PREP DOD)

Texas A&M University

Status and phase: Completed; Early Phase 1

Conditions: Inflammatory Response

Treatments: Drug: Typhim VI; Other: Saline; Drug: Pneumovax 23

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT05346302

PREP DOD

Details and patient eligibility

About

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.

Full 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.

Enrollment: 249 patients

Sex: All

Ages: 18 to 40 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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249 participants in 3 patient groups, including a placebo group

Pneumococcal (PPSV23) vaccine

Active Comparator group

Description:

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.

Treatment:

Drug: Pneumovax 23

Typhoid (inactivated) vaccine

Active Comparator group

Description:

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.

Treatment:

Drug: Typhim VI

Saline

Placebo Comparator group

Description:

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

Treatment:

Other: Saline