Type 1 Diabetes
Conditions
Brief summary
The purpose of this study is to determine if children with type 1 diabetes have adequate immune response to PPSV23 vaccination and to assess factors affecting immune response.
Interventions
BIOLOGICALPneumovax 23- pneumococcal polysaccharide
PPSV23 is a vaccine to help protect against serious infection due to the Streptococcus pneumoniae bacteria. One dose administered intramuscularly or subcutaneously.
PROCEDUREBlood draw
6 ml blood draw at baseline and 6 months post immunization
Sponsors
Mayo Clinic
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
PREVENTION
Masking
NONE
Intervention model description
Will study immunological response to vaccination
Eligibility
Sex/Gender
ALL
Age
3 Years to 18 Years
Healthy volunteers
No
Inclusion criteria
* Children ages 3-18 years old. * Clinical diagnosis of Type 1 diabetes.
Exclusion criteria
* Newly diagnosed with Type 1 diabetes with in the past month of study date. * Contraindications to receiving 23 valent pneumococcal vaccines. * Other conditions associated with compromised immunity and vaccine response. * Primary or Secondary Immune deficiency. * Previous receipt of PPSV-23 vaccination.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Immunoglobulin G (IgG) Antibodies | 6 months post vaccination | Serological response. Blood draw for assessment of pneumococcal specific titer IgG. Measured as mcg/mL |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Pneumovax 23 Type 1 Diabetes subjects received Pneumovax 23-pneumococcal polysaccharide (PPSV23)
Pneumovax 23- pneumococcal polysaccharide: PPSV23 is a vaccine to help protect against serious infection due to the Streptococcus pneumoniae bacteria. One dose administered intramuscularly or subcutaneously.
Blood draw: 6 ml blood draw at baseline and 6 months post immunization | 29 |
| Total | 29 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Withdrawal by Subject | 4 |
Baseline characteristics
| Characteristic | Pneumovax 23 |
|---|---|
| Age, Continuous | 11.6 years STANDARD_DEVIATION 3.3 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 1 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 27 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 1 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 1 Participants |
| Race (NIH/OMB) White | 28 Participants |
| Region of Enrollment United States | 29 participants |
| Sex/Gender, Customized Female | 11 Participants |
| Sex/Gender, Customized Male | 17 Participants |
| Sex/Gender, Customized Unknown | 1 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 29 |
| other Total, other adverse events | 0 / 29 |
| serious Total, serious adverse events | 0 / 29 |
Outcome results
Primary
Immunoglobulin G (IgG) Antibodies
Serological response. Blood draw for assessment of pneumococcal specific titer IgG. Measured as mcg/mL
Time frame: 6 months post vaccination
Population: Three subjects withdrew prior to the 6 months post vaccination blood draw and one subject withdrew prior to receiving the vaccine.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Pneumovax 23 | Immunoglobulin G (IgG) Antibodies | 270.0 mcg/mL |