NCT05346302

Persistent Readiness Through Early Prediction Immunization Study

• Status: Completed
• Phase: EARLY_Phase 1
• Study type: Interventional
• Enrollment: 249 (actual)
• Sponsor: Texas A&M University · Academic / Other
• Sex: All
• Age: 18 Years – 40 Years
• Healthy volunteers: Accepted

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.

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.

Conditions

• Inflammatory Response

Interventions

Type	Name	Description
DRUG	Pneumovax 23	At +14 days from enrollment in the trial, participants will receive a vaccine administered via intramuscular route only.
DRUG	Typhim VI	At +14 days from enrollment in the trial, participants will receive a vaccine administered via intramuscular route only.
OTHER	Saline	At +14 days from enrollment in the trial, participants will receive a vaccine administered via intramuscular route only.

Timeline

• Start date: 2022-02-08
• Primary completion: 2022-12-21
• Completion: 2022-12-21
• First posted: 2022-04-26
• Last updated: 2023-02-14

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study