Trial Outcomes & Findings for Pneumococcal Conjugate Vaccination in HIV in Comparison to Polysaccharide Vaccine Boosting (NCT NCT00622843)
NCT ID: NCT00622843
Last Updated: 2025-06-08
Results Overview
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.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
275 participants
Primary outcome timeframe
Day 14, 60, and 180 after vaccination
Results posted on
2025-06-08
Participant Flow
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.
Participant milestones
| Measure |
Group 1 - PCV
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.
|
Group 2 - PPV
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.
|
Group 3 - HIV-negative
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.
|
|---|---|---|---|
|
Overall Study
STARTED
|
131
|
73
|
25
|
|
Overall Study
COMPLETED
|
131
|
73
|
25
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
CDC stage only applies to the HIV-infected arms of the study. This baseline measure is not applicable to the HIV-negative arm.
Baseline characteristics by cohort
| Measure |
Group 1
n=131 Participants
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.
|
Group 2
n=73 Participants
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.
|
Group 3
n=25 Participants
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.
|
Total
n=229 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=131 Participants
|
0 Participants
n=73 Participants
|
0 Participants
n=25 Participants
|
0 Participants
n=229 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
131 Participants
n=131 Participants
|
73 Participants
n=73 Participants
|
25 Participants
n=25 Participants
|
229 Participants
n=229 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=131 Participants
|
0 Participants
n=73 Participants
|
0 Participants
n=25 Participants
|
0 Participants
n=229 Participants
|
|
Sex: Female, Male
Female
|
11 Participants
n=131 Participants
|
3 Participants
n=73 Participants
|
7 Participants
n=25 Participants
|
21 Participants
n=229 Participants
|
|
Sex: Female, Male
Male
|
120 Participants
n=131 Participants
|
70 Participants
n=73 Participants
|
18 Participants
n=25 Participants
|
208 Participants
n=229 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
12 Participants
n=131 Participants
|
11 Participants
n=73 Participants
|
3 Participants
n=25 Participants
|
26 Participants
n=229 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
119 Participants
n=131 Participants
|
62 Participants
n=73 Participants
|
22 Participants
n=25 Participants
|
203 Participants
n=229 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=131 Participants
|
0 Participants
n=73 Participants
|
0 Participants
n=25 Participants
|
0 Participants
n=229 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
2 Participants
n=131 Participants
|
0 Participants
n=73 Participants
|
0 Participants
n=25 Participants
|
2 Participants
n=229 Participants
|
|
Race (NIH/OMB)
Asian
|
3 Participants
n=131 Participants
|
3 Participants
n=73 Participants
|
2 Participants
n=25 Participants
|
8 Participants
n=229 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
1 Participants
n=131 Participants
|
0 Participants
n=73 Participants
|
0 Participants
n=25 Participants
|
1 Participants
n=229 Participants
|
|
Race (NIH/OMB)
Black or African American
|
50 Participants
n=131 Participants
|
27 Participants
n=73 Participants
|
2 Participants
n=25 Participants
|
79 Participants
n=229 Participants
|
|
Race (NIH/OMB)
White
|
71 Participants
n=131 Participants
|
40 Participants
n=73 Participants
|
21 Participants
n=25 Participants
|
132 Participants
n=229 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=131 Participants
|
0 Participants
n=73 Participants
|
0 Participants
n=25 Participants
|
0 Participants
n=229 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
4 Participants
n=131 Participants
|
3 Participants
n=73 Participants
|
0 Participants
n=25 Participants
|
7 Participants
n=229 Participants
|
|
Region of Enrollment
United States
|
131 Participants
n=131 Participants
|
73 Participants
n=73 Participants
|
25 Participants
n=25 Participants
|
229 Participants
n=229 Participants
|
|
CDC stage
A
|
91 Participants
n=131 Participants • CDC stage only applies to the HIV-infected arms of the study. This baseline measure is not applicable to the HIV-negative arm.
|
55 Participants
n=73 Participants • CDC stage only applies to the HIV-infected arms of the study. This baseline measure is not applicable to the HIV-negative arm.
|
—
|
146 Participants
n=204 Participants • CDC stage only applies to the HIV-infected arms of the study. This baseline measure is not applicable to the HIV-negative arm.
|
|
CDC stage
B
|
25 Participants
n=131 Participants • CDC stage only applies to the HIV-infected arms of the study. This baseline measure is not applicable to the HIV-negative arm.
|
9 Participants
n=73 Participants • CDC stage only applies to the HIV-infected arms of the study. This baseline measure is not applicable to the HIV-negative arm.
|
—
|
34 Participants
n=204 Participants • CDC stage only applies to the HIV-infected arms of the study. This baseline measure is not applicable to the HIV-negative arm.
|
|
CDC stage
C
|
15 Participants
n=131 Participants • CDC stage only applies to the HIV-infected arms of the study. This baseline measure is not applicable to the HIV-negative arm.
|
9 Participants
n=73 Participants • CDC stage only applies to the HIV-infected arms of the study. This baseline measure is not applicable to the HIV-negative arm.
|
—
|
24 Participants
n=204 Participants • CDC stage only applies to the HIV-infected arms of the study. This baseline measure is not applicable to the HIV-negative arm.
|
|
CD4 T cell count
|
533 cells/mm^3
n=131 Participants • CD4 T cell count only applies to the HIV-infected arms of the study. This baseline measure is not applicable to the HIV-negative arm.
|
513 cells/mm^3
n=73 Participants • CD4 T cell count only applies to the HIV-infected arms of the study. This baseline measure is not applicable to the HIV-negative arm.
|
—
|
533 cells/mm^3
n=204 Participants • CD4 T cell count only applies to the HIV-infected arms of the study. This baseline measure is not applicable to the HIV-negative arm.
|
|
Current receipt of HAART
|
111 Participants
n=131 Participants • HAART only applies to the HIV-infected arms of the study. This baseline measure is not applicable to the HIV-negative arm.
|
56 Participants
n=73 Participants • HAART only applies to the HIV-infected arms of the study. This baseline measure is not applicable to the HIV-negative arm.
|
—
|
167 Participants
n=204 Participants • HAART only applies to the HIV-infected arms of the study. This baseline measure is not applicable to the HIV-negative arm.
|
|
IgG levels at baseline
Serotype 4
|
293 ng/mL
n=131 Participants
|
254 ng/mL
n=73 Participants
|
264 ng/mL
n=25 Participants
|
277 ng/mL
n=229 Participants
|
|
IgG levels at baseline
Serotype 9V
|
556 ng/mL
n=131 Participants
|
425 ng/mL
n=73 Participants
|
746 ng/mL
n=25 Participants
|
535 ng/mL
n=229 Participants
|
|
IgG levels at baseline
Serotype 14
|
860 ng/mL
n=131 Participants
|
771 ng/mL
n=73 Participants
|
254 ng/mL
n=25 Participants
|
765 ng/mL
n=229 Participants
|
|
IgG levels at baseline
Serotype 19F
|
723 ng/mL
n=131 Participants
|
480 ng/mL
n=73 Participants
|
737 ng/mL
n=25 Participants
|
647 ng/mL
n=229 Participants
|
PRIMARY outcome
Timeframe: Day 14, 60, and 180 after vaccinationPopulation: The number of participants analyzed represents the number of participants who were actually vaccinated from those who consented to participate.
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.
Outcome measures
| Measure |
Group 1 - PCV
n=131 Participants
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.
|
Group 2 - PPV
n=73 Participants
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.
|
Group 3 - HIV-negative
n=25 Participants
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.
|
|---|---|---|---|
|
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
|
17 Participants
|
17 Participants
|
|
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
|
23 Participants
|
22 Participants
|
|
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
|
11 Participants
|
16 Participants
|
|
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
|
22 Participants
|
22 Participants
|
|
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
|
27 Participants
|
18 Participants
|
|
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
|
12 Participants
|
14 Participants
|
|
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
|
23 Participants
|
22 Participants
|
|
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
|
9 Participants
|
16 Participants
|
|
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
|
15 Participants
|
18 Participants
|
|
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
|
25 Participants
|
21 Participants
|
|
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
|
28 Participants
|
18 Participants
|
|
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
|
12 Participants
|
20 Participants
|
|
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
|
30 Participants
|
21 Participants
|
|
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
|
11 Participants
|
16 Participants
|
|
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
|
16 Participants
|
18 Participants
|
|
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
|
24 Participants
|
22 Participants
|
|
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
|
22 Participants
|
18 Participants
|
|
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
|
13 Participants
|
12 Participants
|
PRIMARY outcome
Timeframe: Day 7 after vaccinationOutcome measures
| Measure |
Group 1 - PCV
n=131 Participants
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.
|
Group 2 - PPV
n=73 Participants
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.
|
Group 3 - HIV-negative
n=25 Participants
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.
|
|---|---|---|---|
|
Adverse Events (AEs) Occurring Temporally (Within 7 Days) in Association With Pneumococcal Vaccination
Number of AEs =1
|
36 Participants
|
17 Participants
|
13 Participants
|
|
Adverse Events (AEs) Occurring Temporally (Within 7 Days) in Association With Pneumococcal Vaccination
Number of AEs = 0
|
80 Participants
|
50 Participants
|
1 Participants
|
|
Adverse Events (AEs) Occurring Temporally (Within 7 Days) in Association With Pneumococcal Vaccination
Number of AEs >/= 2
|
15 Participants
|
6 Participants
|
11 Participants
|
SECONDARY outcome
Timeframe: Day 14, 60, and 180 after vaccinationPopulation: 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.
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.
Outcome measures
| Measure |
Group 1 - PCV
n=131 Participants
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.
|
Group 2 - PPV
n=73 Participants
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.
|
Group 3 - HIV-negative
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.
|
|---|---|---|---|
|
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
|
14.66 cells/mm^3
Standard Error 28.08
|
—
|
|
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
|
22.57 cells/mm^3
Standard Error 30.73
|
—
|
|
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
|
12.22 cells/mm^3
Standard Error 27.81
|
—
|
SECONDARY outcome
Timeframe: Day 60 after vaccinationPopulation: 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.
Number with ≥ Successes, which is defined as: Success = 2-fold increase on Log10 scale -- if log10(Day 60) - log10(Screening) \> log10(2)
Outcome measures
| Measure |
Group 1 - PCV
n=131 Participants
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.
|
Group 2 - PPV
n=73 Participants
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.
|
Group 3 - HIV-negative
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.
|
|---|---|---|---|
|
Assessment of the Importance of the Host Immune Status (CD4+ Count) on the PCV and PPV Immunologic Response.
</= 350 cells/mm^3
|
8 Participants
|
5 Participants
|
—
|
|
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
|
13 Participants
|
—
|
|
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
|
12 Participants
|
—
|
|
Assessment of the Importance of the Host Immune Status (CD4+ Count) on the PCV and PPV Immunologic Response.
>/= 751 cells/mm^3
|
14 Participants
|
5 Participants
|
—
|
SECONDARY outcome
Timeframe: Day 14, 60, and 180 after vaccinationPopulation: 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.
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.
Outcome measures
| Measure |
Group 1 - PCV
n=131 Participants
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.
|
Group 2 - PPV
n=72 Participants
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.
|
Group 3 - HIV-negative
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.
|
|---|---|---|---|
|
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
|
0.03 log10 copies/mL
Standard Error 0.12
|
—
|
|
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
|
0.08 log10 copies/mL
Standard Error 0.14
|
—
|
|
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
|
0.01 log10 copies/mL
Standard Error 0.13
|
—
|
Adverse Events
Group 1 - PCV
Serious events: 0 serious events
Other events: 51 other events
Deaths: 0 deaths
Group 2 - PPV
Serious events: 0 serious events
Other events: 23 other events
Deaths: 0 deaths
Group 3 - HIV-negative
Serious events: 0 serious events
Other events: 24 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Group 1 - PCV
n=131 participants at risk
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.
|
Group 2 - PPV
n=73 participants at risk
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.
|
Group 3 - HIV-negative
n=25 participants at risk
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.
|
|---|---|---|---|
|
Musculoskeletal and connective tissue disorders
Local tenderness
|
27.5%
36/131 • Baseline to 180 days post vaccination.
|
19.2%
14/73 • Baseline to 180 days post vaccination.
|
92.0%
23/25 • Baseline to 180 days post vaccination.
|
|
General disorders
Malaise
|
3.8%
5/131 • Baseline to 180 days post vaccination.
|
4.1%
3/73 • Baseline to 180 days post vaccination.
|
28.0%
7/25 • Baseline to 180 days post vaccination.
|
|
General disorders
Myalgia
|
8.4%
11/131 • Baseline to 180 days post vaccination.
|
9.6%
7/73 • Baseline to 180 days post vaccination.
|
20.0%
5/25 • Baseline to 180 days post vaccination.
|
|
General disorders
Headache
|
2.3%
3/131 • Baseline to 180 days post vaccination.
|
5.5%
4/73 • Baseline to 180 days post vaccination.
|
4.0%
1/25 • Baseline to 180 days post vaccination.
|
|
Skin and subcutaneous tissue disorders
Erythema
|
0.76%
1/131 • Baseline to 180 days post vaccination.
|
4.1%
3/73 • Baseline to 180 days post vaccination.
|
12.0%
3/25 • Baseline to 180 days post vaccination.
|
|
Skin and subcutaneous tissue disorders
Local swelling
|
0.00%
0/131 • Baseline to 180 days post vaccination.
|
0.00%
0/73 • Baseline to 180 days post vaccination.
|
12.0%
3/25 • Baseline to 180 days post vaccination.
|
|
Skin and subcutaneous tissue disorders
Local site reaction
|
5.3%
7/131 • Baseline to 180 days post vaccination.
|
1.4%
1/73 • Baseline to 180 days post vaccination.
|
12.0%
3/25 • Baseline to 180 days post vaccination.
|
|
General disorders
Injection site, other
|
2.3%
3/131 • Baseline to 180 days post vaccination.
|
1.4%
1/73 • Baseline to 180 days post vaccination.
|
0.00%
0/25 • Baseline to 180 days post vaccination.
|
|
General disorders
Pyrexia
|
0.76%
1/131 • Baseline to 180 days post vaccination.
|
0.00%
0/73 • Baseline to 180 days post vaccination.
|
16.0%
4/25 • Baseline to 180 days post vaccination.
|
|
Gastrointestinal disorders
Diarrhea
|
1.5%
2/131 • Baseline to 180 days post vaccination.
|
0.00%
0/73 • Baseline to 180 days post vaccination.
|
0.00%
0/25 • Baseline to 180 days post vaccination.
|
|
General disorders
Dizziness
|
0.00%
0/131 • Baseline to 180 days post vaccination.
|
4.1%
3/73 • Baseline to 180 days post vaccination.
|
0.00%
0/25 • Baseline to 180 days post vaccination.
|
|
General disorders
Other related
|
0.76%
1/131 • Baseline to 180 days post vaccination.
|
1.4%
1/73 • Baseline to 180 days post vaccination.
|
12.0%
3/25 • Baseline to 180 days post vaccination.
|
Additional Information
Dr. Brian Agan, Deputy Science Director
Infectious Disease Clinical Research Program, Uniformed Services University and HJF
Phone: 240-694-2946
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place