Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Infectious Diseases Clinical Research Program | OTHER |
| National Institute of Allergy and Infectious Diseases (NIAID) | NIH |
| US Military HIV Research Program | NETWORK |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group 1 | Experimental | PCV, 210 patients |
|
| Group 2 | Active Comparator | PPV, 110 patients |
|
| Group 3 | Active Comparator | PCV, HIV-negative, 25 patients |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| pneumococcal conjugate vaccine | Biological | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Day 14, 60, and 180 after vaccination |
| Adverse Events (AEs) Occurring Temporally (Within 7 Days) in Association With Pneumococcal Vaccination | Day 7 after vaccination |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
Not provided
Inclusion Criteria for HIV positive subjects:
Exclusion Criteria for HIV positive subjects:
Inclusion Criteria for HIV negative subjects:
Exclusion Criteria for HIV negative subjects:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Brian Agan, MD | Uniformed Services University of the Health Sciences | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Naval Medical Center San Diego | San Diego | California | 92134 | United States | ||
| Walter Reed Army Medical Center |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 20887830 | Result | Crum-Cianflone NF, Roediger M, Huppler Hullsiek K, Ganesan A, Landrum M, Weintrob A, Agan B, Medina S, Rahkola J, Hale B, Janoff EN; Infectious Disease Clinical Research Program HIV Working Group. The association of ethnicity with antibody responses to pneumococcal vaccination among adults with HIV infection. Vaccine. 2010 Nov 10;28(48):7583-8. doi: 10.1016/j.vaccine.2010.09.056. Epub 2010 Sep 29. | |
| 20795819 |
Not provided
Not provided
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.
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
| Uniformed Services University of the Health Sciences |
| FED |
Not provided
Not provided
Not provided
Not provided
Not provided
|
|
| pneumococcal polysaccharide vaccine | Biological | 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. |
|
|
| Day 14, 60, and 180 after vaccination |
| 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) | Day 60 after vaccination |
| 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. | Day 14, 60, and 180 after vaccination |
| Washington D.C. |
| District of Columbia |
| 20307 |
| United States |
| Tripler Army Medical Center | Tripler AMC | Hawaii | 96859 | United States |
| National Naval Medical Center | Bethesda | Maryland | 20814 | United States |
| San Antonio Military Medical Center | Lackland Air Force Base | Texas | 78236 | United States |
| Naval Medical Center Portsmouth | Portsmouth | Virginia | 23708 | United States |
| Result |
| Crum-Cianflone NF, Huppler Hullsiek K, Roediger M, Ganesan A, Patel S, Landrum ML, Weintrob A, Agan BK, Medina S, Rahkola J, Hale BR, Janoff EN; Infectious Disease Clinical Research Program HIV Working Group. A randomized clinical trial comparing revaccination with pneumococcal conjugate vaccine to polysaccharide vaccine among HIV-infected adults. J Infect Dis. 2010 Oct 1;202(7):1114-25. doi: 10.1086/656147. |
| FG001 | 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. |
| FG002 | 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. |
| COMPLETED |
|
| NOT COMPLETED |
|
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| BG001 | 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. |
| BG002 | 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. |
| BG003 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | |||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants | Participants |
| |||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| |||||||||||
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
| |||||||||||
| Race (NIH/OMB) | Count of Participants | Participants |
| |||||||||||
| Region of Enrollment | Count of Participants | Participants |
| |||||||||||
| CDC stage | Centers for Disease Control and Prevention (CDC) stage of human immunodeficiency virus (HIV) infection. HIV infection stage, based on age-specific CD4+ T-lymphocyte count or CD4+ T-lymphocyte percentage of total lymphocytes. 6 years through adult: A = asymptomatic, acute (primary) HIV or persistent generalized lymphadenopathy (PGL), ≥500 cells/µL (≥26%); B = symptomatic, not (A) or (C) conditions, 200-499 cells/µL (14-25%); C = acquired immunodeficiency syndrome (AIDS) indicator conditions, <200 cells/µL (<14%) | CDC stage only applies to the HIV-infected arms of the study. This baseline measure is not applicable to the HIV-negative arm. | Count of Participants | Participants |
| |||||||||
| CD4 T cell count | 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. | Median | Inter-Quartile Range | cells/mm^3 |
| |||||||||
| Current receipt of HAART | Highly active antiretroviral therapy (HAART) | HAART only applies to the HIV-infected arms of the study. This baseline measure is not applicable to the HIV-negative arm. | Count of Participants | Participants |
| |||||||||
| IgG levels at baseline | For the Total column, the medians and IQRs reported are weighted averages of the median, IQR1, and IQR3 from the three groups. | Median | Inter-Quartile Range | ng/mL |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | The number of participants analyzed represents the number of participants who were actually vaccinated from those who consented to participate. | Posted | Count of Participants | Participants | Day 14, 60, and 180 after vaccination |
|
|
| ||||||||||||||||||||||||||||||||||
| Primary | Adverse Events (AEs) Occurring Temporally (Within 7 Days) in Association With Pneumococcal Vaccination | Posted | Count of Participants | Participants | Day 7 after vaccination |
| ||||||||||||||||||||||||||||||||||||||
| 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. | 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. | Posted | Mean | Standard Error | cells/mm^3 | Day 14, 60, and 180 after vaccination |
| |||||||||||||||||||||||||||||||||||
| 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) | 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. | Posted | Count of Participants | Participants | Day 60 after vaccination |
| ||||||||||||||||||||||||||||||||||||
| 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. | 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. | Posted | Mean | Standard Error | log10 copies/mL | Day 14, 60, and 180 after vaccination |
|
Baseline to 180 days post vaccination.
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. | 0 | 131 | 0 | 131 | 51 | 131 |
| EG001 | 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. | 0 | 73 | 0 | 73 | 23 | 73 |
| EG002 | 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. | 0 | 25 | 0 | 25 | 24 | 25 |
Not provided
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Local tenderness | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
| ||
| Malaise | General disorders | Non-systematic Assessment |
| ||
| Myalgia | General disorders | Non-systematic Assessment |
| ||
| Headache | General disorders | Non-systematic Assessment |
| ||
| Erythema | Skin and subcutaneous tissue disorders | Non-systematic Assessment |
| ||
| Local swelling | Skin and subcutaneous tissue disorders | Non-systematic Assessment |
| ||
| Local site reaction | Skin and subcutaneous tissue disorders | Non-systematic Assessment |
| ||
| Injection site, other | General disorders | Non-systematic Assessment |
| ||
| Pyrexia | General disorders | Non-systematic Assessment |
| ||
| Diarrhea | Gastrointestinal disorders | Non-systematic Assessment |
| ||
| Dizziness | General disorders | Non-systematic Assessment |
| ||
| Other related | General disorders | Non-systematic Assessment |
|
Limitations include: enrollment halted before full recruitment, no defined correlate of protective pneumococcal immunity in adults, prior pneumococcal vaccination may result in blunted responses to subsequent vaccination, and limiting to 4 serotypes.
Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Brian Agan, Deputy Science Director | Infectious Disease Clinical Research Program, Uniformed Services University and HJF | 240-694-2946 | bagan@idcrp.org |
| ID | Term |
|---|---|
| D015658 | HIV Infections |
| ID | Term |
|---|---|
| D000086982 | Blood-Borne Infections |
| D003141 | Communicable Diseases |
| D007239 | Infections |
| D015229 | Sexually Transmitted Diseases, Viral |
| D012749 | Sexually Transmitted Diseases |
| D016180 | Lentivirus Infections |
| D012192 | Retroviridae Infections |
| D012327 | RNA Virus Infections |
| D014777 | Virus Diseases |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D007153 | Immunologic Deficiency Syndromes |
| D007154 | Immune System Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D022242 | Pneumococcal Vaccines |
| ID | Term |
|---|---|
| D022541 | Streptococcal Vaccines |
| D001428 | Bacterial Vaccines |
| D014612 | Vaccines |
| D001688 | Biological Products |
| D045424 | Complex Mixtures |
Not provided
Not provided
|
|
|
|
|
|
|
|
|
| Serotype 9V |
|
|
| Serotype 14 |
|
|
| Serotype 19F |
|
|
|
| Day 14 : Serotype 4 |
|
| Day 14 : Serotype 9V |
|
| Day 14 : Serotype 14 |
|
| Day 14 : Serotype 419F |
|
| Day 60 : At least 2 of 4 serotypes |
|
| Day 60 : At least 3 of 4 serotypes |
|
| Day 60 : Serotype 4 |
|
| Day 60 : Serotype 9V |
|
| Day 60 : Serotype 14 |
|
| Day 60 : Serotype 419F |
|
| Day 180 : At least 2 of 4 serotypes |
|
| Day 180 : At least 3 of 4 serotypes |
|
| Day 180 : Serotype 4 |
|
| Day 180 : Serotype 9V |
|
| Day 180 : Serotype 14 |
|
| Day 180 : Serotype 419F |
|
|
|
| OG002 | 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. |
|
|
| 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. |
|
|
| 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. |
|
|