Asthma
Conditions
Keywords
Vaccine, Pneumococcal, Pneumonia
Brief summary
Investigators are assessing if patients with asthma respond better to the Pneumovax vaccine if they are given Prevnar initially.
Detailed description
Patients will be randomized into either PCV13 and PPSV23 (Experimental) or PPSV23 alone (Active comparator). At the Week 0 time point, the patients will receive either PCV13 (Experimental) or PPSV23 (Active comparator) and undergo a blood draw of 5ml for assessment of pre-vacation serotype titers. The Active Comparator group will undergo a 5ml draw of blood for assessment of titers at week 8, 16, and 24 following vaccination. The Experimental group will undergo vaccination with PPSV23 at week 8 with 5 ml blood draw for pneumococcal serotype titers as well as a blood draw at week 16 and week 24.
Interventions
BIOLOGICALPCV13
Single 0.5 ml dose of PCV13 administered via intramuscular injection
BIOLOGICALPPSV23
Single 0.5 ml dose of PPSV23 administered via intramuscularly or subcutaneously
Sponsors
Mayo Clinic
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
19 Years to 64 Years
Healthy volunteers
No
Inclusion criteria
\- Diagnosis of asthma
Exclusion criteria
* Research exemption requested * History of PCV-13 vaccination * History of cochlear implant * Cerebrospinal Fluid (CSF) leak * Congestive Heart Failure (CHF) * Diabetes Mellitus (DM) * Chronic Kidney Disease (CKD) * Human Immunodeficiency Virus (HIV) * Common Variable Immune Deficiency (CVID) * Patients who have received the PPSV23 vaccine in the last 5 years * Women who are pregnant will also be excluded from the study by performing 2 point of care urine pregnancy tests ( prior to vaccinations)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Total Anti-pneumococcal IgG Levels at Baseline, Week 0, Week 8 and Week 16 | Baseline, week 0, week 8, week 16 | 5 ml blood draw for assessment of pneumococcal specific titer IgG. Measured as mcg/dL. |
| Sum of Anti-pneumococcal IgG to All Serotypes at Baseline, Week 0, Week 8 and Week 16 | Baseline, week 0, week 8, week 16 | 5 ml blood draw for assessment of IgG specific Antibody titers to all 23 serotypes. Measured as mcg/mL. |
| Sum of Anti-pneumococcal IgG to Serotypes Common to PCV13 and PPSV23 at Baseline, Week 0, Week 8, Week 16 | Baseline, week 0, week 8, week 16 | 5 ml blood draw for assessment of IgG specific Antibody titers for serotypes common PCV13 & PPSV23. Measured as mcg/mL. |
| Sum of Anti-pneumococcal IgG to Serotypes Unique to PPSV23 at Baseline, Week 0, Week 8 and Week 16. | Baseline, week 0, week 8, week 16 | 5 ml blood draw for assessment of IgG specific Antibody titers for serotypes unique to PPSV23. Measured as mcg/mL. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| PCV13 and PPSV23 Participants received PPSV23 primed with PCV13. Participants received PCV13 8 weeks prior to receiving PPSV23
PCV13: Single 0.5 ml dose of PCV13 administered via intramuscular injection
PPSV23: Single 0.5 ml dose of PPSV23 administered 8 weeks after receiving PCV13 via intramuscularly or subcutaneously | 8 |
| PPSV23 Participants received PPSV23 alone
PPSV23: Single 0.5 ml dose of PPSV23 administered via intramuscularly or subcutaneously | 9 |
| Total | 17 |
Baseline characteristics
| Characteristic | PCV13 and PPSV23 | PPSV23 | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 1 Participants | 1 Participants |
| Age, Categorical Between 18 and 65 years | 8 Participants | 8 Participants | 16 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 1 Participants | 1 Participants |
| Race (NIH/OMB) White | 8 Participants | 8 Participants | 16 Participants |
| Region of Enrollment United States | 8 participants | 9 participants | 17 participants |
| Sex: Female, Male Female | 7 Participants | 8 Participants | 15 Participants |
| Sex: Female, Male Male | 1 Participants | 1 Participants | 2 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 8 | 0 / 9 |
| other Total, other adverse events | 0 / 8 | 0 / 9 |
| serious Total, serious adverse events | 0 / 8 | 0 / 9 |
Outcome results
Primary
Sum of Anti-pneumococcal IgG to All Serotypes at Baseline, Week 0, Week 8 and Week 16
5 ml blood draw for assessment of IgG specific Antibody titers to all 23 serotypes. Measured as mcg/mL.
Time frame: Baseline, week 0, week 8, week 16
Population: Baseline = For arm PPSV23 baseline is 8 weeks prior to receiving PPSV-23. For arm PCV13 and PPSV23 baseline is day of receiving PCV-13. Week 0 = day of receiving PPSV-23 for both arms. Week 8 = eight weeks after receiving PPSV-23 for both arms. Week 16 = sixteen weeks after receiving PPSV-23 for both arms.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| PCV13 and PPSV23 | Sum of Anti-pneumococcal IgG to All Serotypes at Baseline, Week 0, Week 8 and Week 16 | baseline | 228.0 mcg/mL. |
| PCV13 and PPSV23 | Sum of Anti-pneumococcal IgG to All Serotypes at Baseline, Week 0, Week 8 and Week 16 | week 8 | 502.9 mcg/mL. |
| PCV13 and PPSV23 | Sum of Anti-pneumococcal IgG to All Serotypes at Baseline, Week 0, Week 8 and Week 16 | week 0 | 506.3 mcg/mL. |
| PCV13 and PPSV23 | Sum of Anti-pneumococcal IgG to All Serotypes at Baseline, Week 0, Week 8 and Week 16 | week 16 | 534.8 mcg/mL. |
| PPSV23 | Sum of Anti-pneumococcal IgG to All Serotypes at Baseline, Week 0, Week 8 and Week 16 | week 0 | 206.8 mcg/mL. |
| PPSV23 | Sum of Anti-pneumococcal IgG to All Serotypes at Baseline, Week 0, Week 8 and Week 16 | baseline | 206.8 mcg/mL. |
| PPSV23 | Sum of Anti-pneumococcal IgG to All Serotypes at Baseline, Week 0, Week 8 and Week 16 | week 16 | 485.7 mcg/mL. |
| PPSV23 | Sum of Anti-pneumococcal IgG to All Serotypes at Baseline, Week 0, Week 8 and Week 16 | week 8 | 449.4 mcg/mL. |
Primary
Sum of Anti-pneumococcal IgG to Serotypes Common to PCV13 and PPSV23 at Baseline, Week 0, Week 8, Week 16
5 ml blood draw for assessment of IgG specific Antibody titers for serotypes common PCV13 & PPSV23. Measured as mcg/mL.
Time frame: Baseline, week 0, week 8, week 16
Population: Baseline = For arm PPSV23 baseline is 8 weeks prior to receiving PPSV-23. For arm PCV13 and PPSV23 baseline is day of receiving PCV-13. Week 0 = day of receiving PPSV-23 for both arms. Week 8 = eight weeks after receiving PPSV-23 for both arms. Week 16 = sixteen weeks after receiving PPSV-23 for both arms.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| PCV13 and PPSV23 | Sum of Anti-pneumococcal IgG to Serotypes Common to PCV13 and PPSV23 at Baseline, Week 0, Week 8, Week 16 | baseline | 142.4 mcg/mL |
| PCV13 and PPSV23 | Sum of Anti-pneumococcal IgG to Serotypes Common to PCV13 and PPSV23 at Baseline, Week 0, Week 8, Week 16 | week 0 | 418.9 mcg/mL |
| PCV13 and PPSV23 | Sum of Anti-pneumococcal IgG to Serotypes Common to PCV13 and PPSV23 at Baseline, Week 0, Week 8, Week 16 | week 8 | 362.8 mcg/mL |
| PCV13 and PPSV23 | Sum of Anti-pneumococcal IgG to Serotypes Common to PCV13 and PPSV23 at Baseline, Week 0, Week 8, Week 16 | week 16 | 343.7 mcg/mL |
| PPSV23 | Sum of Anti-pneumococcal IgG to Serotypes Common to PCV13 and PPSV23 at Baseline, Week 0, Week 8, Week 16 | week 16 | 230.5 mcg/mL |
| PPSV23 | Sum of Anti-pneumococcal IgG to Serotypes Common to PCV13 and PPSV23 at Baseline, Week 0, Week 8, Week 16 | baseline | 107.4 mcg/mL |
| PPSV23 | Sum of Anti-pneumococcal IgG to Serotypes Common to PCV13 and PPSV23 at Baseline, Week 0, Week 8, Week 16 | week 8 | 229.4 mcg/mL |
| PPSV23 | Sum of Anti-pneumococcal IgG to Serotypes Common to PCV13 and PPSV23 at Baseline, Week 0, Week 8, Week 16 | week 0 | 107.4 mcg/mL |
Primary
Sum of Anti-pneumococcal IgG to Serotypes Unique to PPSV23 at Baseline, Week 0, Week 8 and Week 16.
5 ml blood draw for assessment of IgG specific Antibody titers for serotypes unique to PPSV23. Measured as mcg/mL.
Time frame: Baseline, week 0, week 8, week 16
Population: Baseline = For arm PPSV23 baseline is 8 weeks prior to receiving PPSV-23. For arm PCV13 and PPSV23 baseline is day of receiving PCV-13. Week 0 = day of receiving PPSV-23 for both arms. Week 8 = eight weeks after receiving PPSV-23 for both arms. Week 16 = sixteen weeks after receiving PPSV-23 for both arms.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| PCV13 and PPSV23 | Sum of Anti-pneumococcal IgG to Serotypes Unique to PPSV23 at Baseline, Week 0, Week 8 and Week 16. | baseline | 89.2 mcg/mL |
| PCV13 and PPSV23 | Sum of Anti-pneumococcal IgG to Serotypes Unique to PPSV23 at Baseline, Week 0, Week 8 and Week 16. | week 0 | 82.4 mcg/mL |
| PCV13 and PPSV23 | Sum of Anti-pneumococcal IgG to Serotypes Unique to PPSV23 at Baseline, Week 0, Week 8 and Week 16. | week 8 | 174.2 mcg/mL |
| PCV13 and PPSV23 | Sum of Anti-pneumococcal IgG to Serotypes Unique to PPSV23 at Baseline, Week 0, Week 8 and Week 16. | week 16 | 179.1 mcg/mL |
| PPSV23 | Sum of Anti-pneumococcal IgG to Serotypes Unique to PPSV23 at Baseline, Week 0, Week 8 and Week 16. | week 16 | 184.1 mcg/mL |
| PPSV23 | Sum of Anti-pneumococcal IgG to Serotypes Unique to PPSV23 at Baseline, Week 0, Week 8 and Week 16. | baseline | 74.7 mcg/mL |
| PPSV23 | Sum of Anti-pneumococcal IgG to Serotypes Unique to PPSV23 at Baseline, Week 0, Week 8 and Week 16. | week 8 | 220.0 mcg/mL |
| PPSV23 | Sum of Anti-pneumococcal IgG to Serotypes Unique to PPSV23 at Baseline, Week 0, Week 8 and Week 16. | week 0 | 74.7 mcg/mL |
Primary
Total Anti-pneumococcal IgG Levels at Baseline, Week 0, Week 8 and Week 16
5 ml blood draw for assessment of pneumococcal specific titer IgG. Measured as mcg/dL.
Time frame: Baseline, week 0, week 8, week 16
Population: Baseline = For arm PPSV23 baseline is 8 weeks prior to receiving PPSV-23. For arm PCV13 and PPSV23 baseline is day of receiving PCV-13. Week 0 = day of receiving PPSV-23 for both arms. Week 8 = eight weeks after receiving PPSV-23 for both arms. Week 16 = sixteen weeks after receiving PPSV-23 for both arms.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| PCV13 and PPSV23 | Total Anti-pneumococcal IgG Levels at Baseline, Week 0, Week 8 and Week 16 | baseline | 109.8 mcg/dL |
| PCV13 and PPSV23 | Total Anti-pneumococcal IgG Levels at Baseline, Week 0, Week 8 and Week 16 | week 0 | 142.3 mcg/dL |
| PCV13 and PPSV23 | Total Anti-pneumococcal IgG Levels at Baseline, Week 0, Week 8 and Week 16 | week 8 | 211.7 mcg/dL |
| PCV13 and PPSV23 | Total Anti-pneumococcal IgG Levels at Baseline, Week 0, Week 8 and Week 16 | week 16 | 212.0 mcg/dL |
| PPSV23 | Total Anti-pneumococcal IgG Levels at Baseline, Week 0, Week 8 and Week 16 | week 16 | 224.8 mcg/dL |
| PPSV23 | Total Anti-pneumococcal IgG Levels at Baseline, Week 0, Week 8 and Week 16 | baseline | 53.9 mcg/dL |
| PPSV23 | Total Anti-pneumococcal IgG Levels at Baseline, Week 0, Week 8 and Week 16 | week 8 | 243.3 mcg/dL |
| PPSV23 | Total Anti-pneumococcal IgG Levels at Baseline, Week 0, Week 8 and Week 16 | week 0 | 53.9 mcg/dL |