HIV Infections
Conditions
Keywords
pneumococcal polysaccharide vaccine
Brief summary
The purpose of this study is to evaluate the best timing for administering pneumococcal vaccine (PV) to HIV-infected adults that have CD4 cell counts of more than 200 and are not yet receiving combination antiretroviral treatment (ART). Participants in this study will be assigned by chance to receive vaccination with PV prior to starting ART or after at least 6 months of ART. Antibody levels to components of the PV will be measured at 6 months and 12 months after vaccination. The results will tell us if patients that receive PV after 6 months of ART have better response to the vaccine than those that get vaccinated prior to treatment.
Interventions
BIOLOGICAL(PV) 23-valent pneumococcal polysaccharide vaccine
Currently commercially available pneumococcal polysaccharide vaccine
BIOLOGICALPlacebo
Placebo
Sponsors
Albert Einstein College of Medicine
Montefiore Medical Center
US Department of Veterans Affairs
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
DOUBLE (Subject, Caregiver)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* HIV infected * CD4 count \>200 * no acute illness * no pneumococcal vaccination within 3 years * naive to treatment or if previously on treatment, no antiretroviral treatment for at least 6 months * willingness to start antiretroviral treatment as recommended by current guidelines
Exclusion criteria
* prior pneumococcal vaccination within 3 years * prior AIDS diagnosis based on opportunistic disease * acute illness
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Immunoglobulin G (IgG) Levels | Baseline | 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. |
| IgG Levels | One-month post-vaccine | Immunoglobulins 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. |
| Immunoglobulin M (IgM) Levels | Baseline | Immunoglobulins 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. |
| IgM Levels | One-month post-vaccine | Immunoglobulins 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. |
| Opsonophagocytic Killing Activity (OPA) | Baseline | This 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. |
Countries
United States
Participant flow
Recruitment details
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).
Participants by arm
| Arm | Count |
|---|---|
| Arm 1: PV Before Starting Antiretroviral Therapy Arm 1 received PV prior to starting antiretroviral treatment.
PV (23-valent pneumococcal polysaccharide vaccine): Currently commercially available pneumococcal polysaccharide vaccine | 43 |
| Arm 2: PV After >6 Months of Antiretroviral Therapy Arm 2 received PV after at least 6 months of antiretroviral treatment.
PV (23-valent pneumococcal polysaccharide vaccine): Currently commercially available pneumococcal polysaccharide vaccine | 64 |
| Total | 107 |
Baseline characteristics
| Characteristic | Arm 2: PV After >6 Months of Antiretroviral Therapy | Arm 1: PV Before Starting Antiretroviral Therapy | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 1 Participants | 1 Participants | 2 Participants |
| Age, Categorical Between 18 and 65 years | 63 Participants | 42 Participants | 105 Participants |
| Age, Continuous | 40.8 years STANDARD_DEVIATION 11.6 | 43.4 years STANDARD_DEVIATION 12.9 | 41.8 years STANDARD_DEVIATION 12.1 |
| Region of Enrollment United States | 64 participants | 43 participants | 107 participants |
| Sex: Female, Male Female | 15 Participants | 6 Participants | 21 Participants |
| Sex: Female, Male Male | 49 Participants | 37 Participants | 86 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 2 / 43 | 1 / 64 |
| serious Total, serious adverse events | 6 / 43 | 8 / 64 |
Outcome results
Primary
IgG Levels
Immunoglobulins 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.
Time frame: One-month post-vaccine
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|---|
| Immediate: PV Before Starting Antiretroviral Therapy | IgG Levels | IgG levels against CPS 6B | 7.85 Micrograms/ml | Full Range 1 |
| Immediate: PV Before Starting Antiretroviral Therapy | IgG Levels | IgG levels against CPS 23F | 2.50 Micrograms/ml | Full Range 1 |
| Delayed: PV After >6 Months of Antiretroviral Therapy | IgG Levels | IgG levels against CPS 6B | 5.79 Micrograms/ml | Full Range 1 |
| Delayed: PV After >6 Months of Antiretroviral Therapy | IgG Levels | IgG levels against CPS 23F | 2.41 Micrograms/ml | Full Range 1 |
Primary
IgM Levels
Immunoglobulins 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.
Time frame: One-month post-vaccine
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Immediate: PV Before Starting Antiretroviral Therapy | IgM Levels | IgM levels against CPS 6B | 2.18 Micrograms/ml |
| Immediate: PV Before Starting Antiretroviral Therapy | IgM Levels | IgM levels against CPS 23F | 0.65 Micrograms/ml |
| Delayed: PV After >6 Months of Antiretroviral Therapy | IgM Levels | IgM levels against CPS 6B | 2.26 Micrograms/ml |
| Delayed: PV After >6 Months of Antiretroviral Therapy | IgM Levels | IgM levels against CPS 23F | 0.84 Micrograms/ml |
Primary
Immunoglobulin G (IgG) Levels
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.
Time frame: Baseline
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|---|
| Immediate: PV Before Starting Antiretroviral Therapy | Immunoglobulin G (IgG) Levels | IgG levels against CPS 6B | 5.12 Micrograms/ml | Full Range 1 |
| Immediate: PV Before Starting Antiretroviral Therapy | Immunoglobulin G (IgG) Levels | IgG levels against CPS 23F | 1.80 Micrograms/ml | Full Range 1 |
| Delayed: PV After >6 Months of Antiretroviral Therapy | Immunoglobulin G (IgG) Levels | IgG levels against CPS 23F | 1.83 Micrograms/ml | Full Range 1 |
| Delayed: PV After >6 Months of Antiretroviral Therapy | Immunoglobulin G (IgG) Levels | IgG levels against CPS 6B | 5.17 Micrograms/ml | Full Range 1 |
Primary
Immunoglobulin M (IgM) Levels
Immunoglobulins 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.
Time frame: Baseline
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Immediate: PV Before Starting Antiretroviral Therapy | Immunoglobulin M (IgM) Levels | IgM levels against CPS 6B | 1.89 Micrograms/ml |
| Immediate: PV Before Starting Antiretroviral Therapy | Immunoglobulin M (IgM) Levels | IgM levels against CPS 23F | 0.59 Micrograms/ml |
| Delayed: PV After >6 Months of Antiretroviral Therapy | Immunoglobulin M (IgM) Levels | IgM levels against CPS 6B | 1.85 Micrograms/ml |
| Delayed: PV After >6 Months of Antiretroviral Therapy | Immunoglobulin M (IgM) Levels | IgM levels against CPS 23F | 0.78 Micrograms/ml |
Primary
Opsonophagocytic Killing Activity (OPA)
This 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.
Time frame: Baseline
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Immediate: PV Before Starting Antiretroviral Therapy | Opsonophagocytic Killing Activity (OPA) | OPA titers against CPS 6B | 4.5 Titers |
| Immediate: PV Before Starting Antiretroviral Therapy | Opsonophagocytic Killing Activity (OPA) | OPA titers against CPS 23F | 2.9 Titers |
| Delayed: PV After >6 Months of Antiretroviral Therapy | Opsonophagocytic Killing Activity (OPA) | OPA titers against CPS 6B | 6.0 Titers |
| Delayed: PV After >6 Months of Antiretroviral Therapy | Opsonophagocytic Killing Activity (OPA) | OPA titers against CPS 23F | 2.9 Titers |
Primary
Opsonophagocytic Killing Activity (OPA)
This 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.
Time frame: One-month post-vaccine
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Immediate: PV Before Starting Antiretroviral Therapy | Opsonophagocytic Killing Activity (OPA) | OPA titers against CPS 6B | 23.0 Titers |
| Immediate: PV Before Starting Antiretroviral Therapy | Opsonophagocytic Killing Activity (OPA) | OPA titers against CPS 23F | 4.7 Titers |
| Delayed: PV After >6 Months of Antiretroviral Therapy | Opsonophagocytic Killing Activity (OPA) | OPA titers against CPS 6B | 13.7 Titers |
| Delayed: PV After >6 Months of Antiretroviral Therapy | Opsonophagocytic Killing Activity (OPA) | OPA titers against CPS 23F | 3.3 Titers |