Persistent Readiness Through Early Prediction Immunization Study
试验速览
- 阶段
- 早期 1 期
- 状态
- 已完成
- 入组人数
- 249
- 试验地点
- 1
- 主要终点
- Questionnaires, self-reported changes in general physical health, and physiological measurements to predict of type of vaccine administered
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 40 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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
排除标准
- •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
- •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.
研究组 & 干预措施
Saline
Saline will be purchased commercially and compounded under the supervision of a licensed pharmacist in sterile syringes for administration of the placebo group.
干预措施: Saline (Other)
Pneumococcal (PPSV23) vaccine
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.
干预措施: Pneumovax 23 (Drug)
Typhoid (inactivated) vaccine
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.
干预措施: Typhim VI (Drug)
结局指标
主要结局
Questionnaires, self-reported changes in general physical health, and physiological measurements to predict of type of vaccine administered
时间窗: up to 4 weeks
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
次要结局
- Renal function panel Albumin(+14, +16, +21 days of enrollment)
- Respiratory Rate(up to 4 weeks)
- CBC (DIFF/PLT) Differential(+14, +16, +21 days of enrollment)
- Body Composition using Dual Energy X-Ray Absorptiometry Fat(at enrollment)
- Electrocardiography Morphology(up to 4 weeks)
- Amount of End-tidal Carbon Dioxide(up to 4 weeks)
- Body Temperature(up to 4 weeks)
- Oxygen Saturation(up to 4 weeks)
- Digital photo of the face to assess changes in eyes(up to 4 weeks)
- Heart Rate(up to 4 weeks)
- Changes in daily dietary intake as measure by the Food Frequency Questionnaire (FFQ)(+7, +28 days of enrollment)
- Changes in quality of life as measured by Short Form (SF) Health Survey (SF36)(+7, +28 days of enrollment)
- Renal function panel Estimated Glomerular Filtration Rate(+14, +16, +21 days of enrollment)
- Heart Rate Variability(up to 4 weeks)
- Blood pressure (systolic and diastolic)(up to 4 weeks)
- Assessment of the type and relative abundance of protein and lipids contained in Exhaled Breath Condensate(at enrollment, and +7, +14, +16, +21, +28 days of enrollment)
- Assessment of the type and relative abundance of Volatile Organic Compounds contained in exhaled breath(at enrollment, and +7, +14, +16, +21, +28 days of enrollment)
- Digital photo of the face to assess changes in general facial features(up to 4 weeks)
- Digital photo of the face to assess changes in other facial components(up to 4 weeks)
- Digital audio recording of vocal expressions to assess frequency changes in speech prosody components(up to 4 weeks)
- Renal function panel Creatinine(+14, +16, +21 days of enrollment)
- Digital audio recording of vocal expressions to assess changes in vowel components(up to 4 weeks)
- Digital audio recording of vocal expressions to assess time domain changes in speech prosody components(up to 4 weeks)
- Changes in physical health as measured by the Medical Symptoms Questionnaire (MSQ)(+7, +14, +16, +21, +28 days of enrollment)
- Changes in physical activity as measured by the short International Physical Activity Questionnaire (IPAQ)(+7, +14, +21, +28 days of enrollment)
- Changes in physical activity as measured by the Baecke Physical Activity Questionnaire(+7, +28 days of enrollment)
- Digital audio recording of vocal expressions to assess variation changes in speech prosody components(up to 4 weeks)
- Continuous Glucose Monitoring(up to 2 weeks)
- Changes in gut function as measured by Gastrointestinal Symptom Rating Scale (GSRS)(+7, +14, +16, +21, +28 days of enrollment)
- Changes in duration and quality of sleep as measured by Pittsburgh Sleep Quality Index (PSQI)(+7, +28 days of enrollment)
- Hepatic function panel Albumin(+14, +16, +21 days of enrollment)
- Hepatic function panel Total Bilirubin(+14, +16, +21 days of enrollment)
- Hepatic function panel Direct Bilirubin(+14, +16, +21 days of enrollment)
- Renal function panel BUN/Creatinine Ratio(+14, +16, +21 days of enrollment)
- Renal function panel Calcium(+14, +16, +21 days of enrollment)
- Renal function panel Urea Nitrogen(+14, +16, +21 days of enrollment)
- Hepatic function panel Albumin/Globulin Ratio(+14, +16, +21 days of enrollment)
- Hepatic function panel Indirect Bilirubin(+14, +16, +21 days of enrollment)
- Hepatic function panel Alkaline Phosphatase(+14, +16, +21 days of enrollment)
- Renal function panel Carbon Dioxide(+14, +16, +21 days of enrollment)
- Renal function panel Chloride(+14, +16, +21 days of enrollment)
- Renal function panel Glucose(+14, +16, +21 days of enrollment)
- Renal function panel Phosphate(+14, +16, +21 days of enrollment)
- Renal function panel Potassium(+14, +16, +21 days of enrollment)
- Renal function panel Sodium(+14, +16, +21 days of enrollment)
- Hepatic function panel Total Protein(+14, +16, +21 days of enrollment)
- Hepatic function panel Globulin (calculated)(+14, +16, +21 days of enrollment)
- Hepatic function panel Alanine Aminotransferase(+14, +16, +21 days of enrollment)
- CBC (DIFF/PLT) red blood cell count(+14, +16, +21 days of enrollment)
- CBC (DIFF/PLT) Hemoglobin(+14, +16, +21 days of enrollment)
- CBC (DIFF/PLT) corpuscular hemoglobin concentration(+14, +16, +21 days of enrollment)
- CBC (DIFF/PLT) red cell distribution width(+14, +16, +21 days of enrollment)
- Hepatic function panel Aspartate transaminase(+14, +16, +21 days of enrollment)
- CBC (DIFF/PLT) mean corpuscular volume(+14, +16, +21 days of enrollment)
- CBC (DIFF/PLT) mean corpuscular hemoglobin(+14, +16, +21 days of enrollment)
- CBC (DIFF/PLT) White blood cell count(+14, +16, +21 days of enrollment)
- CBC (DIFF/PLT) mean platelet volume(+14, +16, +21 days of enrollment)
- CBC (DIFF/PLT) Platelet Count(+14, +16, +21 days of enrollment)
- Body Composition using Dual Energy X-Ray Absorptiometry bone density(at enrollment)
- Highly Sensitive CRP(+14, +16, +21 days of enrollment)
- Hemoglobin A1C(+14 days of enrollment)
- Measurement of daily physical activity using accelerometry sensors(up to 4 weeks)
- Body Composition using Dual Energy X-Ray Absorptiometry Muscle(at enrollment)
- Lipid panel(+14, +16, +21 days of enrollment)
- CBC (DIFF/PLT) Hematocrit(+14, +16, +21 days of enrollment)
研究者
Marielle PKJ Engelen, PhD
Professor
Texas A&M University