Persistent Readiness Through Early Prediction Immunization Study

• Status: Recruiting
• Trial end date: 2022-12-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Early Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Texas A&M University
• Collaborators: Philips Healthcare; US Department of Defense - Defense Threat Reduction Agency
• Treatments: Heptavalent Pneumococcal Conjugate Vaccine

Criteria

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.