Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 1:44 AM
Ignite Modification Date:
2025-12-25 @ 1:44 AM
NCT ID:
NCT03802994
Eligibility Criteria:
Inclusion Criteria:
Inclusion criteria are group specific. HBV, HCV and HIV testing are not necessary in the RT groups as all RT recipients are tested prior to transplant. The investigators will not restrict volunteers with respect to gender, ethnic or racial group.
Groups 1 (65-75 yrs) and 2 (35-45 yrs) Renal Transplant populations
* End stage renal disease cause either DM2 and/or hypertension (HTN)
* Renal transplant \>12 months ago
Group 3: Diabetic/hypertensive 65-75 year old controls
* With DM2 and/or HTN
* Previous immunization with PPV23 \>1 year prior
* Willingness to be tested for HIV, HBV and HCV
* "normal kidney function" defined as glomerular filtration rate (GFR) of 60% or above
Group 4: Healthy Control 65-75 yr old
* Without DM2
* May have high blood pressure (systolic\>140 and/or diastolic\>90) as long as it is well controlled (systolic\<140 and/or diastolic \<90) and has not affected kidney function.
* Previous receipt of PPV23 \> 1 year prior
* Willingness to be tested for HIV, HBV and HCV
Group 5: Healthy Control 35-45 yr old
* Without DM2.
* May have high blood pressure (systolic\>140 and/or diastolic\>90) as long as it is well controlled (systolic\<140 and/or diastolic \<90) and has not affected kidney function.
* Willingness to be tested for HIV, HBV and HCV and filling out a medical questionnaire that will include diabetes screening.
Exclusion Criteria:
Exclusion criteria are either applicable to all groups or group specific. Therefore we have listed the exclusion criteria applicable to ALL groups first. Group specific criteria are listed under each group.
Exclusion Criteria common to all groups
* Previous immunization with PCV13.
* Pregnancy, no contraceptive practice in women of childbearing age, or breastfeeding
* Known anaphylaxis, hypersensitivity or "bad allergic reaction" to the pneumonia vaccine. This does not include egg allergy or previous Guillan Barre syndrome.
* Those who received blood products or gamma globulin within 3 months.
* Inability to comprehend or sign the informed consent form
* Previous/present illness that may affect immune response to the vaccine
* previous pneumococcal disease
* disease
* removal of the spleen
* auto-immune disease such as lupus or rheumatoid arthritis
* end-stage liver disease
* cancer
* Significant abnormalities (3xULN and all those considered to be critical values) in CBC, chemistries including glucose.
* HIV, HBsAg or HCV positivity
* Receipt of PPV23 within 1 year
Groups 1 (65-75 yrs) and 2 (35-45 yrs) Renal Transplant populations
* Medications that are known to affect immune function (chemotherapy, anti-TNF agents) with the exception of anti-rejection medication.
* Episode of acute rejection within the last 6 month period
Group 3: Diabetic/hypertensive 65-75 year old controls
* Medications that are known to affect immune function (chemotherapy, anti-TNF agents).
* The inclusion/exclusion criteria will be determined by chart review.
Group 4: Healthy Control 65-75 yr old
* Medications that are known to affect immune function (chemotherapy, anti-TNF agents).
* The inclusion/exclusion criteria will be determined by chart review and pregnancy test for females of child bearing potential.
Group 5: Healthy Control 35-45 yr old
* Medications that are known to affect immune function (chemotherapy, anti-TNF agents).
* The inclusion/exclusion criteria will be determined by chart review and pregnancy test for females of child bearing potential.
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
35 Years
Maximum Age:
75 Years
Study:
NCT03802994
Study Brief:
Protocol Section:
NCT03802994