HIV Infections, Streptococcus Pneumoniae
Conditions
Keywords
pneumococcal conjugate vaccine, polysaccharide vaccine, PPV, PCV, Streptococcus pneumoniae, Prevnar, Pneumovax, HIV
Brief summary
Purpose: To study the immune response of the newly licensed pneumococcal conjugate vaccine (PCV) in comparison to the pneumococcal polysaccharide vaccine (PPV) to determine if a significantly better immunologic response to boosting can be elicited in patients previously vaccinated with PPV.
Interventions
BIOLOGICALpneumococcal conjugate vaccine
Prevnar is manufactured as a liquid preparation. Each 0.5 mL dose is formulated to contain: 2 μg of each saccharide for serotypes 4, 9V, 14, 18C, 19F, and 23F, and 4 μg of serotype 6B per dose (16 μg total saccharide); approximately 20 μg of CRM197 carrier protein; and 0.125 mg of aluminum per 0.5 mL dose as aluminum phosphate adjuvant. After shaking, the vaccine is a homogeneous, white suspension.
BIOLOGICALpneumococcal polysaccharide vaccine
PNEUMOVAX 23 is manufactured according to methods developed by the Merck Research Laboratories. Each 0.5 mL dose of vaccine contains 25 μg of each polysaccharide type in isotonic saline solution containing 0.25% phenol as a preservative.
Sponsors
Infectious Diseases Clinical Research Program
National Institute of Allergy and Infectious Diseases (NIAID)
US Military HIV Research Program
Uniformed Services University of the Health Sciences
Henry M. Jackson Foundation for the Advancement of Military Medicine
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
Yes
Inclusion criteria
for HIV positive subjects: 1. At least one prior PPV ≥ 3 and \< 8 years ago, while HIV positive. There is no upper limit to the number of previously received PPVs. 2. HIV-positive (except 25 HIV-negative persons as control group). 3. Age between 18 and 60 years of age. 4. Availability of patient to remain within the immediate area for the period of the study and be able to comply with protocol requirements.
Exclusion criteria
for HIV positive subjects: 1. Prior allergic reaction to the PPV 2. Allergic to components of PCV, including diphtheria toxin. 3. Pregnant or lactating females as defined by history or positive HCG urine test. 4. History of chronic viral hepatitis or biochemical evidence to include pretreatment AST or ALT values greater than 3 fold higher than upper limit of normal, or a creatinine of greater than 1.8 mg/dl 5. History of splenectomy 6. Temperature of \>38C 7. Inability to ambulate for more than 1000 meters secondary to fatigue, pain or weakness. 8. Patients in whom IM vaccination is not possible because of disease or medication. (e.g. hemophilia, coumadin therapy). 9. Patients diagnosed with HIV wasting disease 10. Viral load over 50,000 copies/ml. 11. History or evidence of recent illicit drug or alcohol abuse. 12. Use of immunosuppressive agents, to include corticosteroids and cancer chemotherapeutic agents. Inclusion Criteria for HIV negative subjects: 1. HIV-negative by HIV ELISA within the last 12 months 2. Age between 18 and 60 years of age. 3. Availability of patient to remain within the immediate area for the period of the study and be able to comply with protocol requirements.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Positive Immune Responses in the Human Immunodeficiency Virus (HIV)-Infected Pneumococcal Conjugate Vaccine (PCV) and Pneumococcal Polysaccharide Vaccine (PPV) Arms | Day 14, 60, and 180 after vaccination | The primary end point is greater than or equal to a 2-fold increase in the IgG level for at least 2 of the 4 serotypes on day 60, with levels greater than or equal to 1000 ng/mL. |
| Adverse Events (AEs) Occurring Temporally (Within 7 Days) in Association With Pneumococcal Vaccination | Day 7 after vaccination | — |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Assessment of CD4+ Cell Count Changes Caused by Vaccination With PCV and PPV. | Day 14, 60, and 180 after vaccination | The pairwise change in CD4+ cell count from the time of screening to each time frame (day 14, day 60 and day 180 post-vaccination) (CD4+ cell count at day 14/60/180 \[minus\] CD4+ cell count at screening). Analysis Population Description (further details): not all participants completed each follow-up visit. Therefore, a different number of participants analyzed is noted for each visit day. For example, in Group 1, 131 participants completed the screening visit but only 129 completed Day 14, and only 123 completed Day 60, etc. |
| Assessment of the Importance of the Host Immune Status (CD4+ Count) on the PCV and PPV Immunologic Response. | Day 60 after vaccination | Number with ≥ Successes, which is defined as: Success = 2-fold increase on Log10 scale -- if log10(Day 60) - log10(Screening) \> log10(2) |
| Assessment of Viral Load Changes Caused by Vaccination With PCV and PPV. | Day 14, 60, and 180 after vaccination | The pairwise change in viral load from the time of screening to each time frame (day 14, day 60 and day 180 post-vaccination), similar to CD4 change above. |
Countries
United States
Participant flow
Pre-assignment details
345 is the number of potential subjects that was approved for enrollment by the IRB (Group 1 PCV = 210; Group 2 PPV = 110; Group 3 HIV-negative = 25). 275 is the total number of subjects who actually consented to participate. 229 is the number of subject who were vaccinated. In 2008, the DSMB voted unanimously to recommend no further enrollment.
Participants by arm
| Arm | Count |
|---|---|
| Group 1 PCV, 210 patients
pneumococcal conjugate vaccine: Prevnar is manufactured as a liquid preparation. Each 0.5 mL dose is formulated to contain: 2 μg of each saccharide for serotypes 4, 9V, 14, 18C, 19F, and 23F, and 4 μg of serotype 6B per dose (16 μg total saccharide); approximately 20 μg of CRM197 carrier protein; and 0.125 mg of aluminum per 0.5 mL dose as aluminum phosphate adjuvant. After shaking, the vaccine is a homogeneous, white suspension. | 131 |
| Group 2 PPV, 110 patients
pneumococcal polysaccharide vaccine: PNEUMOVAX 23 is manufactured according to methods developed by the Merck Research Laboratories. Each 0.5 mL dose of vaccine contains 25 μg of each polysaccharide type in isotonic saline solution containing 0.25% phenol as a preservative. | 73 |
| Group 3 PCV, HIV-negative, 25 patients
pneumococcal conjugate vaccine: Prevnar is manufactured as a liquid preparation. Each 0.5 mL dose is formulated to contain: 2 μg of each saccharide for serotypes 4, 9V, 14, 18C, 19F, and 23F, and 4 μg of serotype 6B per dose (16 μg total saccharide); approximately 20 μg of CRM197 carrier protein; and 0.125 mg of aluminum per 0.5 mL dose as aluminum phosphate adjuvant. After shaking, the vaccine is a homogeneous, white suspension. | 25 |
| Total | 229 |
Baseline characteristics
| Characteristic | Group 1 | Group 2 | Group 3 | Total |
|---|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 131 Participants | 73 Participants | 25 Participants | 229 Participants |
| CD4 T cell count | 533 cells/mm^3 | 513 cells/mm^3 | — | 533 cells/mm^3 |
| CDC stage A | 91 Participants | 55 Participants | — | 146 Participants |
| CDC stage B | 25 Participants | 9 Participants | — | 34 Participants |
| CDC stage C | 15 Participants | 9 Participants | — | 24 Participants |
| Current receipt of HAART | 111 Participants | 56 Participants | — | 167 Participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 12 Participants | 11 Participants | 3 Participants | 26 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 119 Participants | 62 Participants | 22 Participants | 203 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| IgG levels at baseline Serotype 14 | 860 ng/mL | 771 ng/mL | 254 ng/mL | 765 ng/mL |
| IgG levels at baseline Serotype 19F | 723 ng/mL | 480 ng/mL | 737 ng/mL | 647 ng/mL |
| IgG levels at baseline Serotype 4 | 293 ng/mL | 254 ng/mL | 264 ng/mL | 277 ng/mL |
| IgG levels at baseline Serotype 9V | 556 ng/mL | 425 ng/mL | 746 ng/mL | 535 ng/mL |
| Race (NIH/OMB) American Indian or Alaska Native | 2 Participants | 0 Participants | 0 Participants | 2 Participants |
| Race (NIH/OMB) Asian | 3 Participants | 3 Participants | 2 Participants | 8 Participants |
| Race (NIH/OMB) Black or African American | 50 Participants | 27 Participants | 2 Participants | 79 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 1 Participants | 0 Participants | 0 Participants | 1 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 4 Participants | 3 Participants | 0 Participants | 7 Participants |
| Race (NIH/OMB) White | 71 Participants | 40 Participants | 21 Participants | 132 Participants |
| Region of Enrollment United States | 131 Participants | 73 Participants | 25 Participants | 229 Participants |
| Sex: Female, Male Female | 11 Participants | 3 Participants | 7 Participants | 21 Participants |
| Sex: Female, Male Male | 120 Participants | 70 Participants | 18 Participants | 208 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 131 | 0 / 73 | 0 / 25 |
| other Total, other adverse events | 51 / 131 | 23 / 73 | 24 / 25 |
| serious Total, serious adverse events | 0 / 131 | 0 / 73 | 0 / 25 |
Outcome results
Primary
Adverse Events (AEs) Occurring Temporally (Within 7 Days) in Association With Pneumococcal Vaccination
Time frame: Day 7 after vaccination
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Group 1 - PCV | Adverse Events (AEs) Occurring Temporally (Within 7 Days) in Association With Pneumococcal Vaccination | Number of AEs =1 | 36 Participants |
| Group 1 - PCV | Adverse Events (AEs) Occurring Temporally (Within 7 Days) in Association With Pneumococcal Vaccination | Number of AEs = 0 | 80 Participants |
| Group 1 - PCV | Adverse Events (AEs) Occurring Temporally (Within 7 Days) in Association With Pneumococcal Vaccination | Number of AEs >/= 2 | 15 Participants |
| Group 2 - PPV | Adverse Events (AEs) Occurring Temporally (Within 7 Days) in Association With Pneumococcal Vaccination | Number of AEs =1 | 17 Participants |
| Group 2 - PPV | Adverse Events (AEs) Occurring Temporally (Within 7 Days) in Association With Pneumococcal Vaccination | Number of AEs = 0 | 50 Participants |
| Group 2 - PPV | Adverse Events (AEs) Occurring Temporally (Within 7 Days) in Association With Pneumococcal Vaccination | Number of AEs >/= 2 | 6 Participants |
| Group 3 - HIV-negative | Adverse Events (AEs) Occurring Temporally (Within 7 Days) in Association With Pneumococcal Vaccination | Number of AEs = 0 | 1 Participants |
| Group 3 - HIV-negative | Adverse Events (AEs) Occurring Temporally (Within 7 Days) in Association With Pneumococcal Vaccination | Number of AEs >/= 2 | 11 Participants |
| Group 3 - HIV-negative | Adverse Events (AEs) Occurring Temporally (Within 7 Days) in Association With Pneumococcal Vaccination | Number of AEs =1 | 13 Participants |
Primary
Positive Immune Responses in the Human Immunodeficiency Virus (HIV)-Infected Pneumococcal Conjugate Vaccine (PCV) and Pneumococcal Polysaccharide Vaccine (PPV) Arms
The primary end point is greater than or equal to a 2-fold increase in the IgG level for at least 2 of the 4 serotypes on day 60, with levels greater than or equal to 1000 ng/mL.
Time frame: Day 14, 60, and 180 after vaccination
Population: The number of participants analyzed represents the number of participants who were actually vaccinated from those who consented to participate.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Group 1 - PCV | Positive Immune Responses in the Human Immunodeficiency Virus (HIV)-Infected Pneumococcal Conjugate Vaccine (PCV) and Pneumococcal Polysaccharide Vaccine (PPV) Arms | Day 14 : Serotype 14 | 57 Participants |
| Group 1 - PCV | Positive Immune Responses in the Human Immunodeficiency Virus (HIV)-Infected Pneumococcal Conjugate Vaccine (PCV) and Pneumococcal Polysaccharide Vaccine (PPV) Arms | Day 14 : At least 3 of 4 serotypes | 37 Participants |
| Group 1 - PCV | Positive Immune Responses in the Human Immunodeficiency Virus (HIV)-Infected Pneumococcal Conjugate Vaccine (PCV) and Pneumococcal Polysaccharide Vaccine (PPV) Arms | Day 14 : Serotype 4 | 54 Participants |
| Group 1 - PCV | Positive Immune Responses in the Human Immunodeficiency Virus (HIV)-Infected Pneumococcal Conjugate Vaccine (PCV) and Pneumococcal Polysaccharide Vaccine (PPV) Arms | Day 14 : Serotype 9V | 68 Participants |
| Group 1 - PCV | Positive Immune Responses in the Human Immunodeficiency Virus (HIV)-Infected Pneumococcal Conjugate Vaccine (PCV) and Pneumococcal Polysaccharide Vaccine (PPV) Arms | Day 14 : At least 2 of 4 serotypes | 67 Participants |
| Group 1 - PCV | Positive Immune Responses in the Human Immunodeficiency Virus (HIV)-Infected Pneumococcal Conjugate Vaccine (PCV) and Pneumococcal Polysaccharide Vaccine (PPV) Arms | Day 14 : Serotype 419F | 37 Participants |
| Group 1 - PCV | Positive Immune Responses in the Human Immunodeficiency Virus (HIV)-Infected Pneumococcal Conjugate Vaccine (PCV) and Pneumococcal Polysaccharide Vaccine (PPV) Arms | Day 60 : At least 2 of 4 serotypes | 68 Participants |
| Group 1 - PCV | Positive Immune Responses in the Human Immunodeficiency Virus (HIV)-Infected Pneumococcal Conjugate Vaccine (PCV) and Pneumococcal Polysaccharide Vaccine (PPV) Arms | Day 60 : At least 3 of 4 serotypes | 37 Participants |
| Group 1 - PCV | Positive Immune Responses in the Human Immunodeficiency Virus (HIV)-Infected Pneumococcal Conjugate Vaccine (PCV) and Pneumococcal Polysaccharide Vaccine (PPV) Arms | Day 60 : Serotype 4 | 48 Participants |
| Group 1 - PCV | Positive Immune Responses in the Human Immunodeficiency Virus (HIV)-Infected Pneumococcal Conjugate Vaccine (PCV) and Pneumococcal Polysaccharide Vaccine (PPV) Arms | Day 60 : Serotype 9V | 63 Participants |
| Group 1 - PCV | Positive Immune Responses in the Human Immunodeficiency Virus (HIV)-Infected Pneumococcal Conjugate Vaccine (PCV) and Pneumococcal Polysaccharide Vaccine (PPV) Arms | Day 60 : Serotype 14 | 61 Participants |
| Group 1 - PCV | Positive Immune Responses in the Human Immunodeficiency Virus (HIV)-Infected Pneumococcal Conjugate Vaccine (PCV) and Pneumococcal Polysaccharide Vaccine (PPV) Arms | Day 60 : Serotype 419F | 42 Participants |
| Group 1 - PCV | Positive Immune Responses in the Human Immunodeficiency Virus (HIV)-Infected Pneumococcal Conjugate Vaccine (PCV) and Pneumococcal Polysaccharide Vaccine (PPV) Arms | Day 180 : At least 2 of 4 serotypes | 47 Participants |
| Group 1 - PCV | Positive Immune Responses in the Human Immunodeficiency Virus (HIV)-Infected Pneumococcal Conjugate Vaccine (PCV) and Pneumococcal Polysaccharide Vaccine (PPV) Arms | Day 180 : At least 3 of 4 serotypes | 26 Participants |
| Group 1 - PCV | Positive Immune Responses in the Human Immunodeficiency Virus (HIV)-Infected Pneumococcal Conjugate Vaccine (PCV) and Pneumococcal Polysaccharide Vaccine (PPV) Arms | Day 180 : Serotype 4 | 37 Participants |
| Group 1 - PCV | Positive Immune Responses in the Human Immunodeficiency Virus (HIV)-Infected Pneumococcal Conjugate Vaccine (PCV) and Pneumococcal Polysaccharide Vaccine (PPV) Arms | Day 180 : Serotype 9V | 49 Participants |
| Group 1 - PCV | Positive Immune Responses in the Human Immunodeficiency Virus (HIV)-Infected Pneumococcal Conjugate Vaccine (PCV) and Pneumococcal Polysaccharide Vaccine (PPV) Arms | Day 180 : Serotype 14 | 47 Participants |
| Group 1 - PCV | Positive Immune Responses in the Human Immunodeficiency Virus (HIV)-Infected Pneumococcal Conjugate Vaccine (PCV) and Pneumococcal Polysaccharide Vaccine (PPV) Arms | Day 180 : Serotype 419F | 38 Participants |
| Group 2 - PPV | Positive Immune Responses in the Human Immunodeficiency Virus (HIV)-Infected Pneumococcal Conjugate Vaccine (PCV) and Pneumococcal Polysaccharide Vaccine (PPV) Arms | Day 180 : Serotype 419F | 13 Participants |
| Group 2 - PPV | Positive Immune Responses in the Human Immunodeficiency Virus (HIV)-Infected Pneumococcal Conjugate Vaccine (PCV) and Pneumococcal Polysaccharide Vaccine (PPV) Arms | Day 14 : At least 2 of 4 serotypes | 23 Participants |
| Group 2 - PPV | Positive Immune Responses in the Human Immunodeficiency Virus (HIV)-Infected Pneumococcal Conjugate Vaccine (PCV) and Pneumococcal Polysaccharide Vaccine (PPV) Arms | Day 60 : Serotype 9V | 25 Participants |
| Group 2 - PPV | Positive Immune Responses in the Human Immunodeficiency Virus (HIV)-Infected Pneumococcal Conjugate Vaccine (PCV) and Pneumococcal Polysaccharide Vaccine (PPV) Arms | Day 180 : At least 2 of 4 serotypes | 30 Participants |
| Group 2 - PPV | Positive Immune Responses in the Human Immunodeficiency Virus (HIV)-Infected Pneumococcal Conjugate Vaccine (PCV) and Pneumococcal Polysaccharide Vaccine (PPV) Arms | Day 14 : At least 3 of 4 serotypes | 11 Participants |
| Group 2 - PPV | Positive Immune Responses in the Human Immunodeficiency Virus (HIV)-Infected Pneumococcal Conjugate Vaccine (PCV) and Pneumococcal Polysaccharide Vaccine (PPV) Arms | Day 180 : Serotype 4 | 16 Participants |
| Group 2 - PPV | Positive Immune Responses in the Human Immunodeficiency Virus (HIV)-Infected Pneumococcal Conjugate Vaccine (PCV) and Pneumococcal Polysaccharide Vaccine (PPV) Arms | Day 180 : Serotype 9V | 24 Participants |
| Group 2 - PPV | Positive Immune Responses in the Human Immunodeficiency Virus (HIV)-Infected Pneumococcal Conjugate Vaccine (PCV) and Pneumococcal Polysaccharide Vaccine (PPV) Arms | Day 14 : Serotype 4 | 17 Participants |
| Group 2 - PPV | Positive Immune Responses in the Human Immunodeficiency Virus (HIV)-Infected Pneumococcal Conjugate Vaccine (PCV) and Pneumococcal Polysaccharide Vaccine (PPV) Arms | Day 60 : Serotype 14 | 28 Participants |
| Group 2 - PPV | Positive Immune Responses in the Human Immunodeficiency Virus (HIV)-Infected Pneumococcal Conjugate Vaccine (PCV) and Pneumococcal Polysaccharide Vaccine (PPV) Arms | Day 180 : Serotype 14 | 22 Participants |
| Group 2 - PPV | Positive Immune Responses in the Human Immunodeficiency Virus (HIV)-Infected Pneumococcal Conjugate Vaccine (PCV) and Pneumococcal Polysaccharide Vaccine (PPV) Arms | Day 14 : Serotype 9V | 22 Participants |
| Group 2 - PPV | Positive Immune Responses in the Human Immunodeficiency Virus (HIV)-Infected Pneumococcal Conjugate Vaccine (PCV) and Pneumococcal Polysaccharide Vaccine (PPV) Arms | Day 60 : Serotype 4 | 15 Participants |
| Group 2 - PPV | Positive Immune Responses in the Human Immunodeficiency Virus (HIV)-Infected Pneumococcal Conjugate Vaccine (PCV) and Pneumococcal Polysaccharide Vaccine (PPV) Arms | Day 180 : At least 3 of 4 serotypes | 11 Participants |
| Group 2 - PPV | Positive Immune Responses in the Human Immunodeficiency Virus (HIV)-Infected Pneumococcal Conjugate Vaccine (PCV) and Pneumococcal Polysaccharide Vaccine (PPV) Arms | Day 14 : Serotype 14 | 27 Participants |
| Group 2 - PPV | Positive Immune Responses in the Human Immunodeficiency Virus (HIV)-Infected Pneumococcal Conjugate Vaccine (PCV) and Pneumococcal Polysaccharide Vaccine (PPV) Arms | Day 60 : At least 3 of 4 serotypes | 9 Participants |
| Group 2 - PPV | Positive Immune Responses in the Human Immunodeficiency Virus (HIV)-Infected Pneumococcal Conjugate Vaccine (PCV) and Pneumococcal Polysaccharide Vaccine (PPV) Arms | Day 60 : Serotype 419F | 12 Participants |
| Group 2 - PPV | Positive Immune Responses in the Human Immunodeficiency Virus (HIV)-Infected Pneumococcal Conjugate Vaccine (PCV) and Pneumococcal Polysaccharide Vaccine (PPV) Arms | Day 14 : Serotype 419F | 12 Participants |
| Group 2 - PPV | Positive Immune Responses in the Human Immunodeficiency Virus (HIV)-Infected Pneumococcal Conjugate Vaccine (PCV) and Pneumococcal Polysaccharide Vaccine (PPV) Arms | Day 60 : At least 2 of 4 serotypes | 23 Participants |
| Group 3 - HIV-negative | Positive Immune Responses in the Human Immunodeficiency Virus (HIV)-Infected Pneumococcal Conjugate Vaccine (PCV) and Pneumococcal Polysaccharide Vaccine (PPV) Arms | Day 14 : Serotype 419F | 14 Participants |
| Group 3 - HIV-negative | Positive Immune Responses in the Human Immunodeficiency Virus (HIV)-Infected Pneumococcal Conjugate Vaccine (PCV) and Pneumococcal Polysaccharide Vaccine (PPV) Arms | Day 60 : At least 2 of 4 serotypes | 22 Participants |
| Group 3 - HIV-negative | Positive Immune Responses in the Human Immunodeficiency Virus (HIV)-Infected Pneumococcal Conjugate Vaccine (PCV) and Pneumococcal Polysaccharide Vaccine (PPV) Arms | Day 60 : At least 3 of 4 serotypes | 16 Participants |
| Group 3 - HIV-negative | Positive Immune Responses in the Human Immunodeficiency Virus (HIV)-Infected Pneumococcal Conjugate Vaccine (PCV) and Pneumococcal Polysaccharide Vaccine (PPV) Arms | Day 180 : Serotype 4 | 18 Participants |
| Group 3 - HIV-negative | Positive Immune Responses in the Human Immunodeficiency Virus (HIV)-Infected Pneumococcal Conjugate Vaccine (PCV) and Pneumococcal Polysaccharide Vaccine (PPV) Arms | Day 60 : Serotype 4 | 18 Participants |
| Group 3 - HIV-negative | Positive Immune Responses in the Human Immunodeficiency Virus (HIV)-Infected Pneumococcal Conjugate Vaccine (PCV) and Pneumococcal Polysaccharide Vaccine (PPV) Arms | Day 180 : Serotype 419F | 12 Participants |
| Group 3 - HIV-negative | Positive Immune Responses in the Human Immunodeficiency Virus (HIV)-Infected Pneumococcal Conjugate Vaccine (PCV) and Pneumococcal Polysaccharide Vaccine (PPV) Arms | Day 60 : Serotype 9V | 21 Participants |
| Group 3 - HIV-negative | Positive Immune Responses in the Human Immunodeficiency Virus (HIV)-Infected Pneumococcal Conjugate Vaccine (PCV) and Pneumococcal Polysaccharide Vaccine (PPV) Arms | Day 60 : Serotype 14 | 18 Participants |
| Group 3 - HIV-negative | Positive Immune Responses in the Human Immunodeficiency Virus (HIV)-Infected Pneumococcal Conjugate Vaccine (PCV) and Pneumococcal Polysaccharide Vaccine (PPV) Arms | Day 180 : Serotype 9V | 22 Participants |
| Group 3 - HIV-negative | Positive Immune Responses in the Human Immunodeficiency Virus (HIV)-Infected Pneumococcal Conjugate Vaccine (PCV) and Pneumococcal Polysaccharide Vaccine (PPV) Arms | Day 60 : Serotype 419F | 20 Participants |
| Group 3 - HIV-negative | Positive Immune Responses in the Human Immunodeficiency Virus (HIV)-Infected Pneumococcal Conjugate Vaccine (PCV) and Pneumococcal Polysaccharide Vaccine (PPV) Arms | Day 14 : At least 2 of 4 serotypes | 22 Participants |
| Group 3 - HIV-negative | Positive Immune Responses in the Human Immunodeficiency Virus (HIV)-Infected Pneumococcal Conjugate Vaccine (PCV) and Pneumococcal Polysaccharide Vaccine (PPV) Arms | Day 14 : At least 3 of 4 serotypes | 16 Participants |
| Group 3 - HIV-negative | Positive Immune Responses in the Human Immunodeficiency Virus (HIV)-Infected Pneumococcal Conjugate Vaccine (PCV) and Pneumococcal Polysaccharide Vaccine (PPV) Arms | Day 180 : At least 2 of 4 serotypes | 21 Participants |
| Group 3 - HIV-negative | Positive Immune Responses in the Human Immunodeficiency Virus (HIV)-Infected Pneumococcal Conjugate Vaccine (PCV) and Pneumococcal Polysaccharide Vaccine (PPV) Arms | Day 14 : Serotype 4 | 17 Participants |
| Group 3 - HIV-negative | Positive Immune Responses in the Human Immunodeficiency Virus (HIV)-Infected Pneumococcal Conjugate Vaccine (PCV) and Pneumococcal Polysaccharide Vaccine (PPV) Arms | Day 14 : Serotype 9V | 22 Participants |
| Group 3 - HIV-negative | Positive Immune Responses in the Human Immunodeficiency Virus (HIV)-Infected Pneumococcal Conjugate Vaccine (PCV) and Pneumococcal Polysaccharide Vaccine (PPV) Arms | Day 14 : Serotype 14 | 18 Participants |
| Group 3 - HIV-negative | Positive Immune Responses in the Human Immunodeficiency Virus (HIV)-Infected Pneumococcal Conjugate Vaccine (PCV) and Pneumococcal Polysaccharide Vaccine (PPV) Arms | Day 180 : At least 3 of 4 serotypes | 16 Participants |
| Group 3 - HIV-negative | Positive Immune Responses in the Human Immunodeficiency Virus (HIV)-Infected Pneumococcal Conjugate Vaccine (PCV) and Pneumococcal Polysaccharide Vaccine (PPV) Arms | Day 180 : Serotype 14 | 18 Participants |
Secondary
Assessment of CD4+ Cell Count Changes Caused by Vaccination With PCV and PPV.
The pairwise change in CD4+ cell count from the time of screening to each time frame (day 14, day 60 and day 180 post-vaccination) (CD4+ cell count at day 14/60/180 \[minus\] CD4+ cell count at screening). Analysis Population Description (further details): not all participants completed each follow-up visit. Therefore, a different number of participants analyzed is noted for each visit day. For example, in Group 1, 131 participants completed the screening visit but only 129 completed Day 14, and only 123 completed Day 60, etc.
Time frame: Day 14, 60, and 180 after vaccination
Population: Number of participants analyzed for each time frame: Group 1 (Day 14=129/131; Day 60=123/131; Day 180=119/131); Group 2 (Day 14=69/73; Day 60=67/73; Day 180=67/73). Group 3 = 0 since these data are not applicable to HIV-negative subjects.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Group 1 - PCV | Assessment of CD4+ Cell Count Changes Caused by Vaccination With PCV and PPV. | Day 14 (CD4) | 40.17 cells/mm^3 | Standard Error 22.29 |
| Group 1 - PCV | Assessment of CD4+ Cell Count Changes Caused by Vaccination With PCV and PPV. | Day 60 (CD4) | 13.20 cells/mm^3 | Standard Error 21.13 |
| Group 1 - PCV | Assessment of CD4+ Cell Count Changes Caused by Vaccination With PCV and PPV. | Day 180 (CD4) | 29.65 cells/mm^3 | Standard Error 21.57 |
| Group 2 - PPV | Assessment of CD4+ Cell Count Changes Caused by Vaccination With PCV and PPV. | Day 14 (CD4) | 14.66 cells/mm^3 | Standard Error 28.08 |
| Group 2 - PPV | Assessment of CD4+ Cell Count Changes Caused by Vaccination With PCV and PPV. | Day 60 (CD4) | 22.57 cells/mm^3 | Standard Error 30.73 |
| Group 2 - PPV | Assessment of CD4+ Cell Count Changes Caused by Vaccination With PCV and PPV. | Day 180 (CD4) | 12.22 cells/mm^3 | Standard Error 27.81 |
Secondary
Assessment of the Importance of the Host Immune Status (CD4+ Count) on the PCV and PPV Immunologic Response.
Number with ≥ Successes, which is defined as: Success = 2-fold increase on Log10 scale -- if log10(Day 60) - log10(Screening) \> log10(2)
Time frame: Day 60 after vaccination
Population: The number analyzed in the rows is based on the number of participants who had the CD4+ counts in each category at baseline. This data is not applicable to Group 3 since they are HIV-negative.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Group 1 - PCV | Assessment of the Importance of the Host Immune Status (CD4+ Count) on the PCV and PPV Immunologic Response. | </= 350 cells/mm^3 | 8 Participants |
| Group 1 - PCV | Assessment of the Importance of the Host Immune Status (CD4+ Count) on the PCV and PPV Immunologic Response. | 351-500 cells/mm^3 | 22 Participants |
| Group 1 - PCV | Assessment of the Importance of the Host Immune Status (CD4+ Count) on the PCV and PPV Immunologic Response. | 501-750 cells/mm^3 | 38 Participants |
| Group 1 - PCV | Assessment of the Importance of the Host Immune Status (CD4+ Count) on the PCV and PPV Immunologic Response. | >/= 751 cells/mm^3 | 14 Participants |
| Group 2 - PPV | Assessment of the Importance of the Host Immune Status (CD4+ Count) on the PCV and PPV Immunologic Response. | >/= 751 cells/mm^3 | 5 Participants |
| Group 2 - PPV | Assessment of the Importance of the Host Immune Status (CD4+ Count) on the PCV and PPV Immunologic Response. | </= 350 cells/mm^3 | 5 Participants |
| Group 2 - PPV | Assessment of the Importance of the Host Immune Status (CD4+ Count) on the PCV and PPV Immunologic Response. | 501-750 cells/mm^3 | 12 Participants |
| Group 2 - PPV | Assessment of the Importance of the Host Immune Status (CD4+ Count) on the PCV and PPV Immunologic Response. | 351-500 cells/mm^3 | 13 Participants |
Secondary
Assessment of Viral Load Changes Caused by Vaccination With PCV and PPV.
The pairwise change in viral load from the time of screening to each time frame (day 14, day 60 and day 180 post-vaccination), similar to CD4 change above.
Time frame: Day 14, 60, and 180 after vaccination
Population: Number of participants analyzed for each time frame: Group 1 (Day 14=129/131; Day 60=123/131; Day 180=117/131); Group 2 (Day 14=70/72; Day 60=68/72; Day 180=68/72). Group 3 = 0 since these data are not applicable to HIV-negative subjects.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Group 1 - PCV | Assessment of Viral Load Changes Caused by Vaccination With PCV and PPV. | Day 60 (viral load) | -0.05 log10 copies/mL | Standard Error 0.08 |
| Group 1 - PCV | Assessment of Viral Load Changes Caused by Vaccination With PCV and PPV. | Day 14 (viral load) | -0.02 log10 copies/mL | Standard Error 0.08 |
| Group 1 - PCV | Assessment of Viral Load Changes Caused by Vaccination With PCV and PPV. | Day 180 (viral load) | -0.03 log10 copies/mL | Standard Error 0.09 |
| Group 2 - PPV | Assessment of Viral Load Changes Caused by Vaccination With PCV and PPV. | Day 14 (viral load) | 0.03 log10 copies/mL | Standard Error 0.12 |
| Group 2 - PPV | Assessment of Viral Load Changes Caused by Vaccination With PCV and PPV. | Day 60 (viral load) | 0.08 log10 copies/mL | Standard Error 0.14 |
| Group 2 - PPV | Assessment of Viral Load Changes Caused by Vaccination With PCV and PPV. | Day 180 (viral load) | 0.01 log10 copies/mL | Standard Error 0.13 |