Primary Immune Deficiency Disorder
Conditions
Keywords
PIDD, PID, humoral immunity, antibody deficiency
Brief summary
This is a Phase III, multicenter, open-label study of RI-002 administered as an intravenous infusion of RI-002 (IGIV) every 21 or 28 days in approximately 60 subjects with Primary Immunodeficiency Diseases (PIDD).
Detailed description
Primary immunodeficiency diseases (PIDDs) are genetically determined disorders of the immune system resulting in greatly enhanced susceptibility to infectious disease, autoimmunity and malignancy. As most subjects with PIDDs present with infections, the differential diagnosis and initial investigations for an underlying immune defect are typically guided by the clinical presentation. In subjects with PIDDs, individual infections are not necessarily more severe than those that occur in a normal host. Rather, the clinical features suggestive of an immune defect may be the recurring and/or chronic nature of infections with common pathogens that may result in end organ damage, such as bronchiectasis. Several immune globulin products have already been approved by the FDA.
Interventions
BIOLOGICALRI-002
Immune Globulin Intravenous (IGIV)
Sponsors
ADMA Biologics, Inc.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
2 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
To be eligible to participate in this study, the subjects must meet the following criteria: 1. Signed a written informed consent or a specific assent form for minors. 2. Have a diagnosis of primary immunodeficiency disease. 3. Be ≥ 2 years and ≤ 75 years. 4. Have body weight ≥ 12 kg at screening. 5. Have been receiving IGIV at a dose that has not been changed by \>50% of the mean dose on a mg/kg basis for at least 3 months prior to study entry and have maintained a trough serum Immunoglobulin G (IgG) level ≥ 500 mg/dL on the previous 2 assessments prior to receiving RI 002. The trough level must be at least 300 mg/dL above the pre-treatment serum IgG level. 6. For female subjects, be of non-childbearing potential or have a negative pregnancy test prior to study start and be deemed not at risk of becoming pregnant by adherence to a reliable contraceptive method for the duration of the study.
Exclusion criteria
Subjects must be excluded if they meet any of the following criteria: 1. Have a known hypersensitivity to immunoglobulin or any excipient in RI-002. 2. Have a history of a severe anaphylactic or anaphylactoid reaction to blood or any blood-derived product. 3. Have a specific Immunoglobulin A (IgA) deficiency, history of allergic reaction to products containing IgA or has demonstrable antibodies to IgA. 4. Have uncompensated hemodynamically significant congenital or other heart disease. 5. Have a medical condition that is known to cause secondary immune deficiency. 6. Have a significant T-cell deficiency or deficiency of granulocyte number or function. 7. Have significant renal impairment or have a history of acute renal failure. 8. Have abnormal liver function. 9. Be receiving chronic anti-coagulation therapy. 10. Have a history of deep vein thrombosis (DVT), thrombotic or thrombo-embolic event, or are at increased risk for thrombotic events. 11. Current daily use of the following medications: * corticosteroids (\> 7.5 mg (or equivalent dose on a mg/kg basis) of prednisone equivalent per day for \> 30 days) * immunomodulatory drugs * immunosuppressive drugs (excluding topical pimecrolimus (Elidel) and tacrolimus (Protopic)) 12. Administration of a hyperimmune or specialty high titer immunoglobulin product. 13. Have uncontrollable arterial hypertension. 14. Have a history of hemolysis or positive Coombs test while undergoing treatment with IGIV therapy. 15. Be morbidly obese as indicated by a Body Mass Index (BMI) ≥ 40 16. Have received any blood product (other than Immunoglobulin G) within 3 months prior to screening. 17. Have received any Respiratory Syncytial Virus (RSV) specific products, including palivizumab (Synagis®) within 3 months prior to screening. 18. Have abused alcohol, opiates, psychotropic agents, or other chemicals or drugs within the past 12 months. 19. Have any condition or abnormal laboratory assessment judged by the investigator to preclude participation in the study. 20. Are currently pregnant or nursing. 21. Have hepatitis A, B, or C.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Serious Bacterial Infections (SBIs) Per Subject Per Year (FDA Guidance for Industry (2008)) | One year | The primary objective of this study was to demonstrate that RI-002 (IGIV) reduces the frequency of serious bacterial infections (SBIs), as defined by the Diagnostic Criteria for Serious Infection Types guideline, in subjects with primary humoral immunodeficiency. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Time to Resolution of Infections - Duration Per Infection | Up to 1 year | — |
| Time to Resolution of Infections - Infection Days Per Subject | Up to 1 year | — |
| Number of Hospitalizations Due to Infections | Up to 1 year | — |
| Number of Hospitalizations Due to Infections - Per Subject-Year | Up to 1 year | — |
| Days of Hospitalization Due to Infections | Up to 1 year | — |
| Incidence of All Infections (Serious and Non-serious) | Up to 1 Year | — |
| Number of Days Lost From Work/School/Daycare and Usual Activities Due to Infections and Their Treatment - Combined Days Lost | Up to 1 year | — |
| Number of Days Lost From Work/School/Daycare and Usual Activities Due to Infections and Their Treatment - Per Subject-Year | Up to 1 year | — |
| Number of Unscheduled Visits to Physician/ER Due to Infections - Total Number of Visits | Up to 1 year | — |
| Days of Hospitalization Due to Infections - Per Subject-Year | Up to 1 year | — |
| Number of Days of Antibiotic Therapy (Prophylaxis and Treatment of Infection) | Up to 1 year | Summary of the days of antibiotic therapy in the study for prophylaxis, as treatment for infections, and combined |
| Number of Days of Antibiotic Therapy (Prophylaxis and Treatment of Infection) - Per Subject-Year | Up to 1 year | Summary of the days of antibiotic therapy in the study for prophylaxis, as treatment for infections, and combined, per subject-year of treatment with RI-002 |
| Correlation Between Trough Level of RI-002 and Serious and Non-serious Infections | Up to 1 year | The relationship between trough IgG concentrations and the number of infections of any kind/seriousness was evaluated using Pearson linear correlation coefficients using forward analysis (outcomes after infusion) and backward analysis (outcomes prior to infusion; outcomes post last infusion were excluded) |
| Trough Total IgG and Specific Antibody Levels - IgG | Up to 1 year | Summary of trough total IgG concentration prior to specified infusion |
| Number of Unscheduled Visits to Physician/ER Due to Infections - Per Subject-Year | Up to 1 year | — |
| Trough Total IgG and Specific Antibody Levels - Respiratory Syncytial Virus (RSV) | Up to 1 year | Summary of trough antibody concentrations prior to specified infusion for Respiratory Syncytial Virus (RSV) |
| Trough Total IgG and Specific Antibody Levels - Tetanus | Up to 1 year | Summary of trough antibody concentrations prior to specified infusion for Tetanus |
| Trough Total IgG and Specific Antibody Levels - Streptococcus Pneumoniae, Serotype 1 | Up to 1 year | Summary of trough antibody concentrations prior to specified infusion for Streptococcus Pneumoniae, Serotype 1 |
| Trough Total IgG and Specific Antibody Levels - Streptococcus Pneumoniae, Serotype 3 | Up to 1 year | Summary of trough antibody concentrations prior to specified infusion for Streptococcus Pneumoniae, Serotype 3 |
| Trough Total IgG and Specific Antibody Levels - Streptococcus Pneumoniae, Serotype 4 | Up to 1 year | Summary of trough antibody concentrations prior to specified infusion for Streptococcus Pneumoniae, Serotype 4 |
| Trough Total IgG and Specific Antibody Levels - Streptococcus Pneumoniae, Serotype 5 | Up to 1 year | Summary of trough antibody concentrations prior to specified infusion for Streptococcus Pneumoniae, Serotype 5 |
| Trough Total IgG and Specific Antibody Levels - Streptococcus Pneumoniae, Serotype 6B | Up to 1 year | Summary of trough antibody concentrations prior to specified infusion for Streptococcus Pneumoniae, Serotype 6B |
| Trough Total IgG and Specific Antibody Levels - Streptococcus Pneumoniae, Serotype 7F | Up to 1 year | Summary of trough antibody concentrations prior to specified infusion for Streptococcus Pneumoniae, Serotype 7F |
| Trough Total IgG and Specific Antibody Levels - Streptococcus Pneumoniae, Serotype 9V | Up to 1 year | Summary of trough antibody concentrations prior to specified infusion for Streptococcus Pneumoniae, Serotype 9V |
| Trough Total IgG and Specific Antibody Levels - Streptococcus Pneumoniae, Serotype 14 | Up to 1 year | Summary of trough antibody concentrations prior to specified infusion for Streptococcus Pneumoniae, Serotype 14 |
| Trough Total IgG and Specific Antibody Levels - Streptococcus Pneumoniae, Serotype 18C | Up to 1 year | Summary of trough antibody concentrations prior to specified infusion for Streptococcus Pneumoniae, Serotype 18C |
| Trough Total IgG and Specific Antibody Levels - Streptococcus Pneumoniae, Serotype 19A | Up to 1 year | Summary of trough antibody concentrations prior to specified infusion for Streptococcus Pneumoniae, Serotype 19A |
| Trough Total IgG and Specific Antibody Levels - Streptococcus Pneumoniae, Serotype 19F | Up to 1 year | Summary of trough antibody concentrations prior to specified infusion for Streptococcus Pneumoniae, Serotype 19F |
| Trough Total IgG and Specific Antibody Levels - Streptococcus Pneumoniae, Serotype 23F | Up to 1 year | Summary of trough antibody concentrations prior to specified infusion for Streptococcus Pneumoniae, Serotype 23F |
| Trough Total IgG and Specific Antibody Levels - Haemophilus Influenzae Type B | Up to 1 year | Summary of trough antibody concentrations prior to specified infusion for Haemophilus influenzae type B |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| RI-002 Treatment Drug: RI-002 Dose: 300-800 mg/kg infusion
RI-002 | 59 |
| Total | 59 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Adverse Event | 2 |
| Overall Study | Pregnancy | 1 |
| Overall Study | Sponsor decision | 1 |
| Overall Study | Subject relocation | 1 |
Baseline characteristics
| Characteristic | RI-002 Treatment |
|---|---|
| Age, Categorical <=18 years | 13 Participants |
| Age, Categorical >=65 years | 11 Participants |
| Age, Categorical Between 18 and 65 years | 35 Participants |
| Age, Continuous | 41.8 years |
| Ethnicity (NIH/OMB) Hispanic or Latino | 3 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 56 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants |
| PIDD Type Antibody Deficiencies | 4 participants |
| PIDD Type Common Variable Immunodeficiency | 45 participants |
| PIDD Type Other | 4 participants |
| PIDD Type X-Linked Agammaglobulinemia | 6 participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 1 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 | 0 Participants |
| Race (NIH/OMB) White | 58 Participants |
| Region of Enrollment United States | 59 participants |
| Sex: Female, Male Female | 31 Participants |
| Sex: Female, Male Male | 28 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 58 / 59 |
| serious Total, serious adverse events | 2 / 59 |
Outcome results
Primary
Number of Serious Bacterial Infections (SBIs) Per Subject Per Year (FDA Guidance for Industry (2008))
The primary objective of this study was to demonstrate that RI-002 (IGIV) reduces the frequency of serious bacterial infections (SBIs), as defined by the Diagnostic Criteria for Serious Infection Types guideline, in subjects with primary humoral immunodeficiency.
Time frame: One year
Population: Analysis included 59 treated subjects, with a total of 55.88 subject-years of treatment with RI-002
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| RI-002 Treatment | Number of Serious Bacterial Infections (SBIs) Per Subject Per Year (FDA Guidance for Industry (2008)) | 0 SBIs/subject/year |
Secondary
Correlation Between Trough Level of RI-002 and Serious and Non-serious Infections
The relationship between trough IgG concentrations and the number of infections of any kind/seriousness was evaluated using Pearson linear correlation coefficients using forward analysis (outcomes after infusion) and backward analysis (outcomes prior to infusion; outcomes post last infusion were excluded)
Time frame: Up to 1 year
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| RI-002 Treatment | Correlation Between Trough Level of RI-002 and Serious and Non-serious Infections | Forward analysis | -0.0453 Linear Correlation Coefficients |
| RI-002 Treatment | Correlation Between Trough Level of RI-002 and Serious and Non-serious Infections | Backward analysis | -0.0045 Linear Correlation Coefficients |
Secondary
Days of Hospitalization Due to Infections
Time frame: Up to 1 year
Population: Analysis included 59 treated subjects, with a total of 55.88 subject-years of treatment with RI-002
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| RI-002 Treatment | Days of Hospitalization Due to Infections | 5 Days |
Secondary
Days of Hospitalization Due to Infections - Per Subject-Year
Time frame: Up to 1 year
Population: Analysis included 59 treated subjects, with a total of 55.88 subject-years of treatment with RI-002
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| RI-002 Treatment | Days of Hospitalization Due to Infections - Per Subject-Year | 0.089 Days per subject-year |
Secondary
Incidence of All Infections (Serious and Non-serious)
Time frame: Up to 1 Year
Population: Analysis included 59 treated subjects, with a total of 55.88 subject-years of treatment with RI-002
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| RI-002 Treatment | Incidence of All Infections (Serious and Non-serious) | Number of Infections (All) per subject-year | 3.436 events per subject-year |
| RI-002 Treatment | Incidence of All Infections (Serious and Non-serious) | Number of Serious Infections per subject-year | 0.018 events per subject-year |
Secondary
Number of Days Lost From Work/School/Daycare and Usual Activities Due to Infections and Their Treatment - Combined Days Lost
Time frame: Up to 1 year
Population: Analysis included 59 treated subjects, with a total of 55.88 subject-years of treatment with RI-002
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| RI-002 Treatment | Number of Days Lost From Work/School/Daycare and Usual Activities Due to Infections and Their Treatment - Combined Days Lost | 243 Days |
Secondary
Number of Days Lost From Work/School/Daycare and Usual Activities Due to Infections and Their Treatment - Per Subject-Year
Time frame: Up to 1 year
Population: Analysis included 59 treated subjects, with a total of 55.88 subject-years of treatment with RI-002
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| RI-002 Treatment | Number of Days Lost From Work/School/Daycare and Usual Activities Due to Infections and Their Treatment - Per Subject-Year | 4.349 Days per subject-year |
Secondary
Number of Days of Antibiotic Therapy (Prophylaxis and Treatment of Infection)
Summary of the days of antibiotic therapy in the study for prophylaxis, as treatment for infections, and combined
Time frame: Up to 1 year
Population: Analysis included 59 treated subjects, with a total of 55.88 subject-years of treatment with RI-002
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| RI-002 Treatment | Number of Days of Antibiotic Therapy (Prophylaxis and Treatment of Infection) | Total days of antibiotic use COMBINED | 2969 Days |
| RI-002 Treatment | Number of Days of Antibiotic Therapy (Prophylaxis and Treatment of Infection) | Total days of antibiotic use for INFECTION | 1839 Days |
| RI-002 Treatment | Number of Days of Antibiotic Therapy (Prophylaxis and Treatment of Infection) | Total days of antibiotic use for PROPHYLAXIS | 1130 Days |
Secondary
Number of Days of Antibiotic Therapy (Prophylaxis and Treatment of Infection) - Per Subject-Year
Summary of the days of antibiotic therapy in the study for prophylaxis, as treatment for infections, and combined, per subject-year of treatment with RI-002
Time frame: Up to 1 year
Population: Analysis included 59 treated subjects, with a total of 55.88 subject-years of treatment with RI-002
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| RI-002 Treatment | Number of Days of Antibiotic Therapy (Prophylaxis and Treatment of Infection) - Per Subject-Year | Days of antibiotic use per subject-year COMBINED | 53.135 Days per subject-year |
| RI-002 Treatment | Number of Days of Antibiotic Therapy (Prophylaxis and Treatment of Infection) - Per Subject-Year | Days of antibiotic per subject-year for INFECTION | 32.912 Days per subject-year |
| RI-002 Treatment | Number of Days of Antibiotic Therapy (Prophylaxis and Treatment of Infection) - Per Subject-Year | Days of antibiotic per subject-yr for PROPHYLAXIS | 20.223 Days per subject-year |
Secondary
Number of Hospitalizations Due to Infections
Time frame: Up to 1 year
Population: Analysis included 59 treated subjects, with a total of 55.88 subject-years of treatment with RI-002
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| RI-002 Treatment | Number of Hospitalizations Due to Infections | 1 Number of hospitalizations |
Secondary
Number of Hospitalizations Due to Infections - Per Subject-Year
Time frame: Up to 1 year
Population: Analysis included 59 treated subjects, with a total of 55.88 subject-years of treatment with RI-002
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| RI-002 Treatment | Number of Hospitalizations Due to Infections - Per Subject-Year | 0.018 Hospitalizations per subject-year |
Secondary
Number of Unscheduled Visits to Physician/ER Due to Infections - Per Subject-Year
Time frame: Up to 1 year
Population: Analysis included 59 treated subjects, with a total of 55.88 subject-years of treatment with RI-002
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| RI-002 Treatment | Number of Unscheduled Visits to Physician/ER Due to Infections - Per Subject-Year | 0.966 Number of Visits per subject-year |
Secondary
Number of Unscheduled Visits to Physician/ER Due to Infections - Total Number of Visits
Time frame: Up to 1 year
Population: Analysis included 59 treated subjects, with a total of 55.88 subject-years of treatment with RI-002
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| RI-002 Treatment | Number of Unscheduled Visits to Physician/ER Due to Infections - Total Number of Visits | 54 Number of Visits |
Secondary
Time to Resolution of Infections - Duration Per Infection
Time frame: Up to 1 year
Population: Analysis included 59 treated subjects, with a total of 55.88 subject-years of treatment with RI-002
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| RI-002 Treatment | Time to Resolution of Infections - Duration Per Infection | 16.7 Days | Standard Deviation 27.83 |
Secondary
Time to Resolution of Infections - Infection Days Per Subject
Time frame: Up to 1 year
Population: Analysis included 59 treated subjects, with a total of 55.88 subject-years of treatment with RI-002
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| RI-002 Treatment | Time to Resolution of Infections - Infection Days Per Subject | 62.7 Days per subject | Standard Deviation 86.8 |
Secondary
Trough Total IgG and Specific Antibody Levels - Haemophilus Influenzae Type B
Summary of trough antibody concentrations prior to specified infusion for Haemophilus influenzae type B
Time frame: Up to 1 year
Population: Number available for analysis varied by infusion; 53-59 subjects
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| RI-002 Treatment | Trough Total IgG and Specific Antibody Levels - Haemophilus Influenzae Type B | Infusion 1 (n=59) | 3.25 ug/mL | Standard Error 0.417 |
| RI-002 Treatment | Trough Total IgG and Specific Antibody Levels - Haemophilus Influenzae Type B | Infusion 4 (n=56) | 3.12 ug/mL | Standard Error 0.454 |
| RI-002 Treatment | Trough Total IgG and Specific Antibody Levels - Haemophilus Influenzae Type B | Infusion 8 (n=56) | 2.93 ug/mL | Standard Error 0.364 |
| RI-002 Treatment | Trough Total IgG and Specific Antibody Levels - Haemophilus Influenzae Type B | Infusion 12 (n=54) | 3.11 ug/mL | Standard Error 0.442 |
| RI-002 Treatment | Trough Total IgG and Specific Antibody Levels - Haemophilus Influenzae Type B | End of Study (Infusion 13 / 17) (n=53) | 3.31 ug/mL | Standard Error 0.404 |
Secondary
Trough Total IgG and Specific Antibody Levels - IgG
Summary of trough total IgG concentration prior to specified infusion
Time frame: Up to 1 year
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| RI-002 Treatment | Trough Total IgG and Specific Antibody Levels - IgG | Infusion 1 (n=59) | 1000 mg/dL | Standard Error 36.32 |
| RI-002 Treatment | Trough Total IgG and Specific Antibody Levels - IgG | Infusion 2 (n=57) | 1024.3 mg/dL | Standard Error 33.38 |
| RI-002 Treatment | Trough Total IgG and Specific Antibody Levels - IgG | Infusion 3 (n=55) | 1007.5 mg/dL | Standard Error 33.26 |
| RI-002 Treatment | Trough Total IgG and Specific Antibody Levels - IgG | Infusion 6 (n=56) | 1016.1 mg/dL | Standard Error 34.18 |
| RI-002 Treatment | Trough Total IgG and Specific Antibody Levels - IgG | Infusion 7 (n=55) | 1039.5 mg/dL | Standard Error 37.5 |
| RI-002 Treatment | Trough Total IgG and Specific Antibody Levels - IgG | Infusion 8 (n=56) | 957.7 mg/dL | Standard Error 35.49 |
| RI-002 Treatment | Trough Total IgG and Specific Antibody Levels - IgG | Infusion 9 (n=56) | 1030.5 mg/dL | Standard Error 36.77 |
| RI-002 Treatment | Trough Total IgG and Specific Antibody Levels - IgG | Infusion 12 (n=54) | 1000.6 mg/dL | Standard Error 33.62 |
| RI-002 Treatment | Trough Total IgG and Specific Antibody Levels - IgG | Infusion 13 (n=53) | 992.8 mg/dL | Standard Error 35.34 |
| RI-002 Treatment | Trough Total IgG and Specific Antibody Levels - IgG | Infusion 14 (3-week cycle only) (n=16) | 1165.3 mg/dL | Standard Error 79.59 |
| RI-002 Treatment | Trough Total IgG and Specific Antibody Levels - IgG | Infusion 15 (3-week cycle only) (n=16) | 1160.9 mg/dL | Standard Error 77.96 |
| RI-002 Treatment | Trough Total IgG and Specific Antibody Levels - IgG | Infusion 16 (3-week cycle only) (n=16) | 1147.9 mg/dL | Standard Error 74.93 |
| RI-002 Treatment | Trough Total IgG and Specific Antibody Levels - IgG | Infusion 17 (3-week cycle only) (n=16) | 1136.3 mg/dL | Standard Error 70.78 |
| RI-002 Treatment | Trough Total IgG and Specific Antibody Levels - IgG | Infusion 4 (n=56) | 1017.4 mg/dL | Standard Error 34.96 |
| RI-002 Treatment | Trough Total IgG and Specific Antibody Levels - IgG | Infusion 5 (n=55) | 1008.1 mg/dL | Standard Error 32.49 |
| RI-002 Treatment | Trough Total IgG and Specific Antibody Levels - IgG | Infusion 10 (n=54) | 1021.7 mg/dL | Standard Error 37.27 |
| RI-002 Treatment | Trough Total IgG and Specific Antibody Levels - IgG | Infusion 11 (n=55) | 1018.9 mg/dL | Standard Error 34.85 |
Secondary
Trough Total IgG and Specific Antibody Levels - Respiratory Syncytial Virus (RSV)
Summary of trough antibody concentrations prior to specified infusion for Respiratory Syncytial Virus (RSV)
Time frame: Up to 1 year
Population: Number available for analysis varied by infusion; 51-56 subjects
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| RI-002 Treatment | Trough Total IgG and Specific Antibody Levels - Respiratory Syncytial Virus (RSV) | Infusion 1 (n=56) | 1211.9 titer | Standard Error 187.13 |
| RI-002 Treatment | Trough Total IgG and Specific Antibody Levels - Respiratory Syncytial Virus (RSV) | Infusion 4 (n=54) | 2220.1 titer | Standard Error 286.79 |
| RI-002 Treatment | Trough Total IgG and Specific Antibody Levels - Respiratory Syncytial Virus (RSV) | Infusion 8 (n=54) | 1936.2 titer | Standard Error 363.84 |
| RI-002 Treatment | Trough Total IgG and Specific Antibody Levels - Respiratory Syncytial Virus (RSV) | Infusion 12 (n=52) | 1632.4 titer | Standard Error 224.9 |
| RI-002 Treatment | Trough Total IgG and Specific Antibody Levels - Respiratory Syncytial Virus (RSV) | End of Study (Infusion 13 / 17) (n=51) | 1862.3 titer | Standard Error 207.94 |
Secondary
Trough Total IgG and Specific Antibody Levels - Streptococcus Pneumoniae, Serotype 1
Summary of trough antibody concentrations prior to specified infusion for Streptococcus Pneumoniae, Serotype 1
Time frame: Up to 1 year
Population: Number available for analysis varied by infusion; 53-59 subjects
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| RI-002 Treatment | Trough Total IgG and Specific Antibody Levels - Streptococcus Pneumoniae, Serotype 1 | Infusion 1 (n=59) | 3.108 ug/mL | Standard Error 0.5967 |
| RI-002 Treatment | Trough Total IgG and Specific Antibody Levels - Streptococcus Pneumoniae, Serotype 1 | Infusion 4 (n=55) | 2.900 ug/mL | Standard Error 0.4585 |
| RI-002 Treatment | Trough Total IgG and Specific Antibody Levels - Streptococcus Pneumoniae, Serotype 1 | Infusion 8 (n=56) | 2.866 ug/mL | Standard Error 0.5154 |
| RI-002 Treatment | Trough Total IgG and Specific Antibody Levels - Streptococcus Pneumoniae, Serotype 1 | Infusion 12 (n=54) | 2.788 ug/mL | Standard Error 0.6185 |
| RI-002 Treatment | Trough Total IgG and Specific Antibody Levels - Streptococcus Pneumoniae, Serotype 1 | End of Study (Infusion 13 / 17) (n=53) | 2.736 ug/mL | Standard Error 0.503 |
Secondary
Trough Total IgG and Specific Antibody Levels - Streptococcus Pneumoniae, Serotype 14
Summary of trough antibody concentrations prior to specified infusion for Streptococcus Pneumoniae, Serotype 14
Time frame: Up to 1 year
Population: Number available for analysis varied by infusion; 53-59 subjects
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| RI-002 Treatment | Trough Total IgG and Specific Antibody Levels - Streptococcus Pneumoniae, Serotype 14 | Infusion 1 (n=59) | 4.853 ug/mL | Standard Error 0.4724 |
| RI-002 Treatment | Trough Total IgG and Specific Antibody Levels - Streptococcus Pneumoniae, Serotype 14 | Infusion 4 (n=56) | 6.744 ug/mL | Standard Error 0.3984 |
| RI-002 Treatment | Trough Total IgG and Specific Antibody Levels - Streptococcus Pneumoniae, Serotype 14 | Infusion 8 (n=56) | 6.356 ug/mL | Standard Error 0.3547 |
| RI-002 Treatment | Trough Total IgG and Specific Antibody Levels - Streptococcus Pneumoniae, Serotype 14 | Infusion 12 (n=54) | 6.341 ug/mL | Standard Error 0.4275 |
| RI-002 Treatment | Trough Total IgG and Specific Antibody Levels - Streptococcus Pneumoniae, Serotype 14 | End of Study (Infusion 13 / 17) (n=53) | 6.218 ug/mL | Standard Error 0.4268 |
Secondary
Trough Total IgG and Specific Antibody Levels - Streptococcus Pneumoniae, Serotype 18C
Summary of trough antibody concentrations prior to specified infusion for Streptococcus Pneumoniae, Serotype 18C
Time frame: Up to 1 year
Population: Number available for analysis varied by infusion; 53-59 subjects
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| RI-002 Treatment | Trough Total IgG and Specific Antibody Levels - Streptococcus Pneumoniae, Serotype 18C | Infusion 1 (n=59) | 7.259 ug/mL | Standard Error 0.7462 |
| RI-002 Treatment | Trough Total IgG and Specific Antibody Levels - Streptococcus Pneumoniae, Serotype 18C | Infusion 4 (n=56) | 7.461 ug/mL | Standard Error 0.6143 |
| RI-002 Treatment | Trough Total IgG and Specific Antibody Levels - Streptococcus Pneumoniae, Serotype 18C | Infusion 8 (n=55) | 6.588 ug/mL | Standard Error 0.5627 |
| RI-002 Treatment | Trough Total IgG and Specific Antibody Levels - Streptococcus Pneumoniae, Serotype 18C | Infusion 12 (n=54) | 7.146 ug/mL | Standard Error 0.7852 |
| RI-002 Treatment | Trough Total IgG and Specific Antibody Levels - Streptococcus Pneumoniae, Serotype 18C | End of Study (Infusion 13 / 17) (n=53) | 6.566 ug/mL | Standard Error 0.5452 |
Secondary
Trough Total IgG and Specific Antibody Levels - Streptococcus Pneumoniae, Serotype 19A
Summary of trough antibody concentrations prior to specified infusion for Streptococcus Pneumoniae, Serotype 19A
Time frame: Up to 1 year
Population: Number available for analysis varied by infusion; 51-54 subjects
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| RI-002 Treatment | Trough Total IgG and Specific Antibody Levels - Streptococcus Pneumoniae, Serotype 19A | Infusion 1 (n=53) | 19.090 ug/mL | Standard Error 1.6428 |
| RI-002 Treatment | Trough Total IgG and Specific Antibody Levels - Streptococcus Pneumoniae, Serotype 19A | Infusion 4 (n=52) | 17.717 ug/mL | Standard Error 1.3715 |
| RI-002 Treatment | Trough Total IgG and Specific Antibody Levels - Streptococcus Pneumoniae, Serotype 19A | Infusion 8 (n=54) | 15.450 ug/mL | Standard Error 1.2636 |
| RI-002 Treatment | Trough Total IgG and Specific Antibody Levels - Streptococcus Pneumoniae, Serotype 19A | Infusion 12 (n=51) | 11.621 ug/mL | Standard Error 1.0681 |
| RI-002 Treatment | Trough Total IgG and Specific Antibody Levels - Streptococcus Pneumoniae, Serotype 19A | End of Study (Infusion 13 / 17) (n=52) | 12.167 ug/mL | Standard Error 1.4398 |
Secondary
Trough Total IgG and Specific Antibody Levels - Streptococcus Pneumoniae, Serotype 19F
Summary of trough antibody concentrations prior to specified infusion for Streptococcus Pneumoniae, Serotype 19F
Time frame: Up to 1 year
Population: Number available for analysis varied by infusion; 53-59 subjects
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| RI-002 Treatment | Trough Total IgG and Specific Antibody Levels - Streptococcus Pneumoniae, Serotype 19F | Infusion 1 (n=59) | 6.630 ug/mL | Standard Error 1.0784 |
| RI-002 Treatment | Trough Total IgG and Specific Antibody Levels - Streptococcus Pneumoniae, Serotype 19F | Infusion 4 (n=55) | 7.876 ug/mL | Standard Error 0.8826 |
| RI-002 Treatment | Trough Total IgG and Specific Antibody Levels - Streptococcus Pneumoniae, Serotype 19F | Infusion 8 (n=56) | 7.361 ug/mL | Standard Error 0.8704 |
| RI-002 Treatment | Trough Total IgG and Specific Antibody Levels - Streptococcus Pneumoniae, Serotype 19F | Infusion 12 (n=53) | 7.042 ug/mL | Standard Error 0.761 |
| RI-002 Treatment | Trough Total IgG and Specific Antibody Levels - Streptococcus Pneumoniae, Serotype 19F | End of Study (Infusion 13 / 17) (n=53) | 7.681 ug/mL | Standard Error 0.9497 |
Secondary
Trough Total IgG and Specific Antibody Levels - Streptococcus Pneumoniae, Serotype 23F
Summary of trough antibody concentrations prior to specified infusion for Streptococcus Pneumoniae, Serotype 23F
Time frame: Up to 1 year
Population: Number available for analysis varied by infusion; 53-59 subjects
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| RI-002 Treatment | Trough Total IgG and Specific Antibody Levels - Streptococcus Pneumoniae, Serotype 23F | Infusion 1 (n=59) | 1.490 ug/mL | Standard Error 0.1453 |
| RI-002 Treatment | Trough Total IgG and Specific Antibody Levels - Streptococcus Pneumoniae, Serotype 23F | Infusion 4 (n=55) | 1.829 ug/mL | Standard Error 0.1548 |
| RI-002 Treatment | Trough Total IgG and Specific Antibody Levels - Streptococcus Pneumoniae, Serotype 23F | Infusion 8 (n=56) | 1.580 ug/mL | Standard Error 0.1128 |
| RI-002 Treatment | Trough Total IgG and Specific Antibody Levels - Streptococcus Pneumoniae, Serotype 23F | Infusion 12 (n=54) | 1.554 ug/mL | Standard Error 0.1179 |
| RI-002 Treatment | Trough Total IgG and Specific Antibody Levels - Streptococcus Pneumoniae, Serotype 23F | End of Study (Infusion 13 / 17) (n=53) | 1.681 ug/mL | Standard Error 0.1282 |
Secondary
Trough Total IgG and Specific Antibody Levels - Streptococcus Pneumoniae, Serotype 3
Summary of trough antibody concentrations prior to specified infusion for Streptococcus Pneumoniae, Serotype 3
Time frame: Up to 1 year
Population: Number available for analysis varied by infusion; 53-59 subjects
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| RI-002 Treatment | Trough Total IgG and Specific Antibody Levels - Streptococcus Pneumoniae, Serotype 3 | Infusion 1 (n=59) | 1.447 ug/mL | Standard Error 0.1077 |
| RI-002 Treatment | Trough Total IgG and Specific Antibody Levels - Streptococcus Pneumoniae, Serotype 3 | Infusion 4 (n=56) | 1.873 ug/mL | Standard Error 0.1263 |
| RI-002 Treatment | Trough Total IgG and Specific Antibody Levels - Streptococcus Pneumoniae, Serotype 3 | Infusion 8 (n=56) | 1.787 ug/mL | Standard Error 0.1105 |
| RI-002 Treatment | Trough Total IgG and Specific Antibody Levels - Streptococcus Pneumoniae, Serotype 3 | Infusion 12 (n=54) | 1.686 ug/mL | Standard Error 0.136 |
| RI-002 Treatment | Trough Total IgG and Specific Antibody Levels - Streptococcus Pneumoniae, Serotype 3 | End of Study (Infusion 13 / 17) (n=53) | 1.672 ug/mL | Standard Error 0.1249 |
Secondary
Trough Total IgG and Specific Antibody Levels - Streptococcus Pneumoniae, Serotype 4
Summary of trough antibody concentrations prior to specified infusion for Streptococcus Pneumoniae, Serotype 4
Time frame: Up to 1 year
Population: Number available for analysis varied by infusion; 53-58 subjects
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| RI-002 Treatment | Trough Total IgG and Specific Antibody Levels - Streptococcus Pneumoniae, Serotype 4 | Infusion 1 (n=58) | 0.530 ug/mL | Standard Error 0.0713 |
| RI-002 Treatment | Trough Total IgG and Specific Antibody Levels - Streptococcus Pneumoniae, Serotype 4 | Infusion 4 (n=56) | 0.824 ug/mL | Standard Error 0.1589 |
| RI-002 Treatment | Trough Total IgG and Specific Antibody Levels - Streptococcus Pneumoniae, Serotype 4 | Infusion 8 (n=55) | 0.610 ug/mL | Standard Error 0.0624 |
| RI-002 Treatment | Trough Total IgG and Specific Antibody Levels - Streptococcus Pneumoniae, Serotype 4 | Infusion 12 (n=53) | 0.644 ug/mL | Standard Error 0.0703 |
| RI-002 Treatment | Trough Total IgG and Specific Antibody Levels - Streptococcus Pneumoniae, Serotype 4 | End of Study (Infusion 13 / 17) (n=53) | 0.802 ug/mL | Standard Error 0.1681 |
Secondary
Trough Total IgG and Specific Antibody Levels - Streptococcus Pneumoniae, Serotype 5
Summary of trough antibody concentrations prior to specified infusion for Streptococcus Pneumoniae, Serotype 5
Time frame: Up to 1 year
Population: Number available for analysis varied by infusion; 52-58 subjects
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| RI-002 Treatment | Trough Total IgG and Specific Antibody Levels - Streptococcus Pneumoniae, Serotype 5 | Infusion 1 (n=58) | 10.843 ug/mL | Standard Error 0.7116 |
| RI-002 Treatment | Trough Total IgG and Specific Antibody Levels - Streptococcus Pneumoniae, Serotype 5 | Infusion 4 (n=54) | 12.264 ug/mL | Standard Error 0.8885 |
| RI-002 Treatment | Trough Total IgG and Specific Antibody Levels - Streptococcus Pneumoniae, Serotype 5 | Infusion 8 (n=55) | 11.235 ug/mL | Standard Error 0.8974 |
| RI-002 Treatment | Trough Total IgG and Specific Antibody Levels - Streptococcus Pneumoniae, Serotype 5 | Infusion 12 (n=54) | 11.707 ug/mL | Standard Error 0.8858 |
| RI-002 Treatment | Trough Total IgG and Specific Antibody Levels - Streptococcus Pneumoniae, Serotype 5 | End of Study (Infusion 13 / 17) (n=52) | 10.503 ug/mL | Standard Error 0.842 |
Secondary
Trough Total IgG and Specific Antibody Levels - Streptococcus Pneumoniae, Serotype 6B
Summary of trough antibody concentrations prior to specified infusion for Streptococcus Pneumoniae, Serotype 6B
Time frame: Up to 1 year
Population: Number available for analysis varied by infusion; 53-59 subjects
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| RI-002 Treatment | Trough Total IgG and Specific Antibody Levels - Streptococcus Pneumoniae, Serotype 6B | Infusion 12 (n=54) | 2.026 ug/mL | Standard Error 0.2199 |
| RI-002 Treatment | Trough Total IgG and Specific Antibody Levels - Streptococcus Pneumoniae, Serotype 6B | End of Study (Infusion 13 / 17) (n=53) | 1.862 ug/mL | Standard Error 0.2054 |
| RI-002 Treatment | Trough Total IgG and Specific Antibody Levels - Streptococcus Pneumoniae, Serotype 6B | Infusion 1 (n=59) | 2.121 ug/mL | Standard Error 0.2529 |
| RI-002 Treatment | Trough Total IgG and Specific Antibody Levels - Streptococcus Pneumoniae, Serotype 6B | Infusion 4 (n=56) | 2.496 ug/mL | Standard Error 0.2503 |
| RI-002 Treatment | Trough Total IgG and Specific Antibody Levels - Streptococcus Pneumoniae, Serotype 6B | Infusion 8 (n=56) | 2.166 ug/mL | Standard Error 0.1849 |
Secondary
Trough Total IgG and Specific Antibody Levels - Streptococcus Pneumoniae, Serotype 7F
Summary of trough antibody concentrations prior to specified infusion for Streptococcus Pneumoniae, Serotype 7F
Time frame: Up to 1 year
Population: Number available for analysis varied by infusion; 53-57 subjects
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| RI-002 Treatment | Trough Total IgG and Specific Antibody Levels - Streptococcus Pneumoniae, Serotype 7F | Infusion 1 (n=57) | 3.413 ug/mL | Standard Error 0.4009 |
| RI-002 Treatment | Trough Total IgG and Specific Antibody Levels - Streptococcus Pneumoniae, Serotype 7F | Infusion 4 (n=55) | 3.457 ug/mL | Standard Error 0.393 |
| RI-002 Treatment | Trough Total IgG and Specific Antibody Levels - Streptococcus Pneumoniae, Serotype 7F | Infusion 8 (n=55) | 2.633 ug/mL | Standard Error 0.1971 |
| RI-002 Treatment | Trough Total IgG and Specific Antibody Levels - Streptococcus Pneumoniae, Serotype 7F | Infusion 12 (n=54) | 2.492 ug/mL | Standard Error 0.2703 |
| RI-002 Treatment | Trough Total IgG and Specific Antibody Levels - Streptococcus Pneumoniae, Serotype 7F | End of Study (Infusion 13 / 17) (n=53) | 3.191 ug/mL | Standard Error 0.404 |
Secondary
Trough Total IgG and Specific Antibody Levels - Streptococcus Pneumoniae, Serotype 9V
Summary of trough antibody concentrations prior to specified infusion for Streptococcus Pneumoniae, Serotype 9V
Time frame: Up to 1 year
Population: Number available for analysis varied by infusion; 53-59 subjects
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| RI-002 Treatment | Trough Total IgG and Specific Antibody Levels - Streptococcus Pneumoniae, Serotype 9V | Infusion 1 (n=59) | 1.473 ug/mL | Standard Error 0.1063 |
| RI-002 Treatment | Trough Total IgG and Specific Antibody Levels - Streptococcus Pneumoniae, Serotype 9V | Infusion 4 (n=56) | 1.938 ug/mL | Standard Error 0.1566 |
| RI-002 Treatment | Trough Total IgG and Specific Antibody Levels - Streptococcus Pneumoniae, Serotype 9V | Infusion 8 (n=56) | 2.010 ug/mL | Standard Error 0.2842 |
| RI-002 Treatment | Trough Total IgG and Specific Antibody Levels - Streptococcus Pneumoniae, Serotype 9V | Infusion 12 (n=53) | 1.902 ug/mL | Standard Error 0.1579 |
| RI-002 Treatment | Trough Total IgG and Specific Antibody Levels - Streptococcus Pneumoniae, Serotype 9V | End of Study (Infusion 13 / 17) (n=53) | 2.223 ug/mL | Standard Error 0.3123 |
Secondary
Trough Total IgG and Specific Antibody Levels - Tetanus
Summary of trough antibody concentrations prior to specified infusion for Tetanus
Time frame: Up to 1 year
Population: Number available for analysis varied by infusion; 53-59 subjects
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| RI-002 Treatment | Trough Total IgG and Specific Antibody Levels - Tetanus | Infusion 1 (n=59) | 5.98 IU/mL | Standard Error 0.573 |
| RI-002 Treatment | Trough Total IgG and Specific Antibody Levels - Tetanus | Infusion 4 (n=56) | 7.57 IU/mL | Standard Error 0.586 |
| RI-002 Treatment | Trough Total IgG and Specific Antibody Levels - Tetanus | Infusion 8 (n=56) | 7.07 IU/mL | Standard Error 0.523 |
| RI-002 Treatment | Trough Total IgG and Specific Antibody Levels - Tetanus | Infusion 12 (n=54) | 6.97 IU/mL | Standard Error 0.47 |
| RI-002 Treatment | Trough Total IgG and Specific Antibody Levels - Tetanus | End of Study (Infusion 13 / 17) (n=53) | 6.50 IU/mL | Standard Error 0.531 |
Post Hoc
Number of Days Lost From Work/School/Daycare Due to Infections and Their Treatment
Additional analysis performed to separate the number of days lost from work, school and/or daycare from the days missed from normal activities, due to infection
Time frame: Up to 1 year
Population: Analysis includes 59 treated subjects, with a total of 55.88 subject-years of treatment with RI-002
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| RI-002 Treatment | Number of Days Lost From Work/School/Daycare Due to Infections and Their Treatment | 93 Days |
Post Hoc
Number of Days Lost From Work/School/Daycare Due to Infections and Their Treatment - Per Subject-Year
Additional analysis performed to separate the number of days lost from work, school and/or daycare from the days missed from normal activities, due to infection
Time frame: Up to 1 year
Population: Analysis includes 59 treated subjects, with a total of 55.88 subject-years of treatment with RI-002
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| RI-002 Treatment | Number of Days Lost From Work/School/Daycare Due to Infections and Their Treatment - Per Subject-Year | 1.66 Days per subject-year |
Post Hoc
Number of Participants With No Days Lost From Work/School/Daycare Due to Infections and Their Treatment
Additional analysis performed to separate the number of days lost from work, school and/or daycare from the days missed from normal activities, due to infection. Presenting the number of subjects with no (0) days lost from work/school/daycare due to infection
Time frame: Up to 1 year
Population: Analysis includes 59 treated subjects, with a total of 55.88 subject-years of treatment with RI-002
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| RI-002 Treatment | Number of Participants With No Days Lost From Work/School/Daycare Due to Infections and Their Treatment | 36 participants |