Trial Outcomes & Findings for Immune Responses to Pneumococcal Vaccination Among HIV-infected Subjects (NCT NCT00706550)
NCT ID: NCT00706550
Last Updated: 2014-04-24
Results Overview
Immunoglobulins are antibodies or special proteins that the immune system produces to protect the body against infections. IgG is the most common antibody. We measure baseline levels (before the vaccine is administered) to know how much antibody the subject has at the start point to be able to evaluate how much antibody is produced after the vaccine is administered.
COMPLETED
NA
107 participants
Baseline
2014-04-24
Participant Flow
A total of 107 patients were enrolled on the study (11/2008-2/2011 at the Michael E. DeBakey VA Medical Center, at Thomas Street Clinic and at Legacy Clinic, in Houston, TX. Only the patients that completed the 1 month post-PV visit are included in the analysis (N=36 for each arm for a total of 72 out of the 107 initially enrolled).
Participant milestones
| Measure |
Immediate: PV Before Starting Antiretroviral Therapy
Immediate group (Arm 1) received PV prior to starting antiretroviral treatment.
PV (23-valent pneumococcal polysaccharide vaccine): Currently commercially available pneumococcal polysaccharide vaccine.
|
Delayed: PV After >6 Months of Antiretroviral Therapy
Delayed group (Arm 2) received PV after at least 6 months of antiretroviral treatment
PV (23-valent pneumococcal polysaccharide vaccine): Currently commercially available pneumococcal polysaccharide vaccine.
|
|---|---|---|
|
Overall Study
STARTED
|
43
|
64
|
|
Overall Study
COMPLETED
|
36
|
36
|
|
Overall Study
NOT COMPLETED
|
7
|
28
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Immune Responses to Pneumococcal Vaccination Among HIV-infected Subjects
Baseline characteristics by cohort
| Measure |
Arm 1: PV Before Starting Antiretroviral Therapy
n=43 Participants
Arm 1 received PV prior to starting antiretroviral treatment.
PV (23-valent pneumococcal polysaccharide vaccine): Currently commercially available pneumococcal polysaccharide vaccine
|
Arm 2: PV After >6 Months of Antiretroviral Therapy
n=64 Participants
Arm 2 received PV after at least 6 months of antiretroviral treatment.
PV (23-valent pneumococcal polysaccharide vaccine): Currently commercially available pneumococcal polysaccharide vaccine
|
Total
n=107 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
42 Participants
n=93 Participants
|
63 Participants
n=4 Participants
|
105 Participants
n=27 Participants
|
|
Age, Categorical
>=65 years
|
1 Participants
n=93 Participants
|
1 Participants
n=4 Participants
|
2 Participants
n=27 Participants
|
|
Age, Continuous
|
43.4 years
STANDARD_DEVIATION 12.9 • n=93 Participants
|
40.8 years
STANDARD_DEVIATION 11.6 • n=4 Participants
|
41.8 years
STANDARD_DEVIATION 12.1 • n=27 Participants
|
|
Sex: Female, Male
Female
|
6 Participants
n=93 Participants
|
15 Participants
n=4 Participants
|
21 Participants
n=27 Participants
|
|
Sex: Female, Male
Male
|
37 Participants
n=93 Participants
|
49 Participants
n=4 Participants
|
86 Participants
n=27 Participants
|
|
Region of Enrollment
United States
|
43 participants
n=93 Participants
|
64 participants
n=4 Participants
|
107 participants
n=27 Participants
|
PRIMARY outcome
Timeframe: BaselineImmunoglobulins are antibodies or special proteins that the immune system produces to protect the body against infections. IgG is the most common antibody. We measure baseline levels (before the vaccine is administered) to know how much antibody the subject has at the start point to be able to evaluate how much antibody is produced after the vaccine is administered.
Outcome measures
| Measure |
Immediate: PV Before Starting Antiretroviral Therapy
n=36 Participants
Immediate group (Arm 1) received PV prior to starting antiretroviral treatment.
PV (23-valent pneumococcal polysaccharide vaccine): Currently commercially available pneumococcal polysaccharide vaccine
|
Delayed: PV After >6 Months of Antiretroviral Therapy
n=36 Participants
Delayed group (Arm 2) received PV after at least 6 months of antiretroviral treatment
PV (23-valent pneumococcal polysaccharide vaccine): Currently commercially available pneumococcal polysaccharide vaccine.
|
|---|---|---|
|
Immunoglobulin G (IgG) Levels
IgG levels against CPS 6B
|
5.12 Micrograms/ml
Full Range 1.0 • Interval 0.71 to 27.6
|
5.17 Micrograms/ml
Full Range 1.0 • Interval 1.1 to 22.87
|
|
Immunoglobulin G (IgG) Levels
IgG levels against CPS 23F
|
1.80 Micrograms/ml
Full Range 1.0 • Interval 0.44 to 9.35
|
1.83 Micrograms/ml
Full Range 1.0 • Interval 0.74 to 4.71
|
PRIMARY outcome
Timeframe: One-month post-vaccineImmunoglobulins are antibodies or special proteins that the immune system produces to protect the body against infections. IgG is the most common antibody. This point of time (one-month after vaccine), gives the information about how much antibody was produced by the participant's immune system in response to the vaccine.
Outcome measures
| Measure |
Immediate: PV Before Starting Antiretroviral Therapy
n=36 Participants
Immediate group (Arm 1) received PV prior to starting antiretroviral treatment.
PV (23-valent pneumococcal polysaccharide vaccine): Currently commercially available pneumococcal polysaccharide vaccine
|
Delayed: PV After >6 Months of Antiretroviral Therapy
n=36 Participants
Delayed group (Arm 2) received PV after at least 6 months of antiretroviral treatment
PV (23-valent pneumococcal polysaccharide vaccine): Currently commercially available pneumococcal polysaccharide vaccine.
|
|---|---|---|
|
IgG Levels
IgG levels against CPS 6B
|
7.85 Micrograms/ml
Full Range 1.0 • Interval 2.94 to 43.58
|
5.79 Micrograms/ml
Full Range 1.0 • Interval 1.23 to 21.42
|
|
IgG Levels
IgG levels against CPS 23F
|
2.50 Micrograms/ml
Full Range 1.0 • Interval 0.62 to 23.37
|
2.41 Micrograms/ml
Full Range 1.0 • Interval 0.8 to 7.94
|
PRIMARY outcome
Timeframe: BaselineImmunoglobulins are antibodies or special proteins that the immune system produces to protect the body against infections. IgM is the first antibody produced by the immune system to fight a new infection. We measure baseline levels (before the vaccine is administered) to know how much antibody the subject has at the start point to be able to evaluate how much antibody is produced after the vaccine is administered.
Outcome measures
| Measure |
Immediate: PV Before Starting Antiretroviral Therapy
n=36 Participants
Immediate group (Arm 1) received PV prior to starting antiretroviral treatment.
PV (23-valent pneumococcal polysaccharide vaccine): Currently commercially available pneumococcal polysaccharide vaccine
|
Delayed: PV After >6 Months of Antiretroviral Therapy
n=36 Participants
Delayed group (Arm 2) received PV after at least 6 months of antiretroviral treatment
PV (23-valent pneumococcal polysaccharide vaccine): Currently commercially available pneumococcal polysaccharide vaccine.
|
|---|---|---|
|
Immunoglobulin M (IgM) Levels
IgM levels against CPS 6B
|
1.89 Micrograms/ml
Interval 0.4 to 7.56
|
1.85 Micrograms/ml
Interval 0.39 to 4.86
|
|
Immunoglobulin M (IgM) Levels
IgM levels against CPS 23F
|
0.59 Micrograms/ml
Interval 0.01 to 4.29
|
0.78 Micrograms/ml
Interval 0.09 to 3.18
|
PRIMARY outcome
Timeframe: One-month post-vaccineImmunoglobulins are antibodies or special proteins that the immune system produces to protect the body against infections. IgM is the first antibody produced by the immune system to fight a new infection. This point of time (one-month after vaccine), gives the information about how much antibody was produced by the participant's immune system in response to the vaccine.
Outcome measures
| Measure |
Immediate: PV Before Starting Antiretroviral Therapy
n=36 Participants
Immediate group (Arm 1) received PV prior to starting antiretroviral treatment.
PV (23-valent pneumococcal polysaccharide vaccine): Currently commercially available pneumococcal polysaccharide vaccine
|
Delayed: PV After >6 Months of Antiretroviral Therapy
n=36 Participants
Delayed group (Arm 2) received PV after at least 6 months of antiretroviral treatment
PV (23-valent pneumococcal polysaccharide vaccine): Currently commercially available pneumococcal polysaccharide vaccine.
|
|---|---|---|
|
IgM Levels
IgM levels against CPS 6B
|
2.18 Micrograms/ml
Interval 0.42 to 9.0
|
2.26 Micrograms/ml
Interval 0.59 to 6.29
|
|
IgM Levels
IgM levels against CPS 23F
|
0.65 Micrograms/ml
Interval 0.02 to 3.2
|
0.84 Micrograms/ml
Interval 0.23 to 2.86
|
PRIMARY outcome
Timeframe: BaselineThis assay helps us to know how the antibody produced by the body are working to kill the bacteria against which the antibody is produced. As explained previously for the immunoglobulins' assays, we measure the baseline point to be able to determine the increase after the vaccine is administered.
Outcome measures
| Measure |
Immediate: PV Before Starting Antiretroviral Therapy
n=23 Participants
Immediate group (Arm 1) received PV prior to starting antiretroviral treatment.
PV (23-valent pneumococcal polysaccharide vaccine): Currently commercially available pneumococcal polysaccharide vaccine
|
Delayed: PV After >6 Months of Antiretroviral Therapy
n=36 Participants
Delayed group (Arm 2) received PV after at least 6 months of antiretroviral treatment
PV (23-valent pneumococcal polysaccharide vaccine): Currently commercially available pneumococcal polysaccharide vaccine.
|
|---|---|---|
|
Opsonophagocytic Killing Activity (OPA)
OPA titers against CPS 6B
|
4.5 Titers
Interval 2.0 to 512.0
|
6.0 Titers
Interval 2.0 to 512.0
|
|
Opsonophagocytic Killing Activity (OPA)
OPA titers against CPS 23F
|
2.9 Titers
Interval 2.0 to 32.0
|
2.9 Titers
Interval 2.0 to 256.0
|
PRIMARY outcome
Timeframe: One-month post-vaccineThis assay helps us to know how the antibody produced by the body are working to kill the bacteria against which the antibody is produced. This point of time (one-month after vaccine), gives the information about how much the killing activity increased 1 month after the vaccine was administered.
Outcome measures
| Measure |
Immediate: PV Before Starting Antiretroviral Therapy
n=23 Participants
Immediate group (Arm 1) received PV prior to starting antiretroviral treatment.
PV (23-valent pneumococcal polysaccharide vaccine): Currently commercially available pneumococcal polysaccharide vaccine
|
Delayed: PV After >6 Months of Antiretroviral Therapy
n=36 Participants
Delayed group (Arm 2) received PV after at least 6 months of antiretroviral treatment
PV (23-valent pneumococcal polysaccharide vaccine): Currently commercially available pneumococcal polysaccharide vaccine.
|
|---|---|---|
|
Opsonophagocytic Killing Activity (OPA)
OPA titers against CPS 6B
|
23.0 Titers
Interval 2.0 to 512.0
|
13.7 Titers
Interval 2.0 to 512.0
|
|
Opsonophagocytic Killing Activity (OPA)
OPA titers against CPS 23F
|
4.7 Titers
Interval 2.0 to 128.0
|
3.3 Titers
Interval 2.0 to 64.0
|
Adverse Events
Arm 1: PV Before Starting Antiretroviral Therapy
Arm 2: PV After >6 Months of Antiretroviral Therapy
Serious adverse events
| Measure |
Arm 1: PV Before Starting Antiretroviral Therapy
n=43 participants at risk
Arm 1 received PV prior to starting antiretroviral treatment.
PV (23-valent pneumococcal polysaccharide vaccine): Currently commercially available pneumococcal polysaccharide vaccine
|
Arm 2: PV After >6 Months of Antiretroviral Therapy
n=64 participants at risk
Arm 2 received PV after at least 6 months of antiretroviral treatment.
PV (23-valent pneumococcal polysaccharide vaccine): Currently commercially available pneumococcal polysaccharide vaccine
|
|---|---|---|
|
Cardiac disorders
CHF, arrhythmia
|
2.3%
1/43 • Number of events 1
|
1.6%
1/64 • Number of events 2
|
|
Nervous system disorders
Cerebrovascular accident
|
0.00%
0/43
|
1.6%
1/64 • Number of events 1
|
|
General disorders
Death
|
2.3%
1/43 • Number of events 1
|
3.1%
2/64 • Number of events 2
|
|
General disorders
Dehydration, electrolite abnormalities
|
0.00%
0/43
|
1.6%
1/64 • Number of events 2
|
|
Surgical and medical procedures
Elective surgery
|
0.00%
0/43
|
1.6%
1/64 • Number of events 1
|
|
Gastrointestinal disorders
Gastrointestinal infections and other disorders
|
0.00%
0/43
|
3.1%
2/64 • Number of events 5
|
|
Psychiatric disorders
Mental health related
|
4.7%
2/43 • Number of events 3
|
0.00%
0/64
|
|
Infections and infestations
Other infections
|
2.3%
1/43 • Number of events 1
|
1.6%
1/64 • Number of events 2
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory infection
|
7.0%
3/43 • Number of events 3
|
6.2%
4/64 • Number of events 4
|
|
Skin and subcutaneous tissue disorders
Skin infection
|
2.3%
1/43 • Number of events 1
|
1.6%
1/64 • Number of events 1
|
Other adverse events
| Measure |
Arm 1: PV Before Starting Antiretroviral Therapy
n=43 participants at risk
Arm 1 received PV prior to starting antiretroviral treatment.
PV (23-valent pneumococcal polysaccharide vaccine): Currently commercially available pneumococcal polysaccharide vaccine
|
Arm 2: PV After >6 Months of Antiretroviral Therapy
n=64 participants at risk
Arm 2 received PV after at least 6 months of antiretroviral treatment.
PV (23-valent pneumococcal polysaccharide vaccine): Currently commercially available pneumococcal polysaccharide vaccine
|
|---|---|---|
|
Blood and lymphatic system disorders
Anemia
|
2.3%
1/43 • Number of events 1
|
0.00%
0/64
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.00%
0/43
|
1.6%
1/64 • Number of events 1
|
|
Infections and infestations
Upper respiratory infection
|
2.3%
1/43 • Number of events 1
|
1.6%
1/64 • Number of events 1
|
Additional Information
Dr. Maria C. Rodriguez-Barradas
Michael E. DeBakey Veterans Affairs Medical Center
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place