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| ID | Type | Description | Link |
|---|---|---|---|
| Control # 078760 | |||
| File # 9427-C1574-34C |
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| Name | Class |
|---|---|
| Wyeth is now a wholly owned subsidiary of Pfizer | INDUSTRY |
The purpose of this study is to determine whether people who are HIV-positive respond better to a vaccine for pneumonia-related disease when they are immunized immediately, or when immunization is delayed until the immune system has improved to a certain level. The study will also compare the effectiveness of polysaccharide and heptavalent vaccines.
A multicentre, randomized controlled trial using a two factorial design. Eighty patients will be randomly assigned to receive either Pneumovax (or Pneumo23 according to standard use at site) or heptavalent pneumococcal conjugate vaccine (Prevnar) prior to reconstitution of the immune system or will have immunization delayed until their CD4 count is greater than 200 cells/mm3 after the introduction of antiretroviral therapy. Randomization will be stratified by study centre. Variable block sizes will be used to try to prevent study personnel from guessing the next allocation. Random allocation lists will be generated by computer.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Pneumovax/immediate | Experimental |
| |
| Pneumovax/delayed | Experimental |
| |
| Prevnar/immediate | Experimental |
| |
| Prevnar/delayed | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Pneumovax | Biological |
| ||
| Prevnar |
| Measure | Description | Time Frame |
|---|---|---|
| Number of serotypes to which a response is found | ||
| A response is defined as a doubling in antibody titer at 1 month compared to baseline. |
| Measure | Description | Time Frame |
|---|---|---|
| Antibody response at 6 months and one year | ||
| Changes in viral load 3 months post immunization | ||
| Adverse events |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Walter Schlech, MD | Victoria General Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Medical Arts Health Research Group | Kelowna | British Columbia | V1Y 1T2 | Canada | ||
| Downtown IDC |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 23535358 | Result | Slayter KL, Singer J, Lee TC, Kayhty H, Schlech WF. Immunization against pneumococcal disease in HIV-infected patients: conjugate versus polysaccharide vaccine before or after reconstitution of the immune system (CTN-147). Int J STD AIDS. 2013 Mar;24(3):227-31. doi: 10.1177/0956462412472450. Epub 2013 May 6. | |
| 39883948 | Derived |
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| ID | Term |
|---|---|
| D011008 | Pneumococcal Infections |
| D015658 | HIV Infections |
| ID | Term |
|---|---|
| D013290 | Streptococcal Infections |
| D016908 | Gram-Positive Bacterial Infections |
| D001424 | Bacterial Infections |
| D001423 | Bacterial Infections and Mycoses |
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| ID | Term |
|---|---|
| D022242 | Pneumococcal Vaccines |
| D000069443 | Heptavalent Pneumococcal Conjugate Vaccine |
| ID | Term |
|---|---|
| D022541 | Streptococcal Vaccines |
| D001428 | Bacterial Vaccines |
| D014612 | Vaccines |
| D001688 | Biological Products |
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| Biological |
|
| Overall incidence of invasive pneumococcal disease |
| Incidence of invasive pneumococcal disease between vaccines |
| Vancouver |
| British Columbia |
| Canada |
| St. Paul's Hospital | Vancouver | British Columbia | Canada |
| St. Boniface General Hospital | Winnipeg | Manitoba | Canada |
| Moncton Hospital | Windsor | New Brunswick | Canada |
| Victoria General | Halifax | Nova Scotia | Canada |
| McMaster University | Hamilton | Ontario | Canada |
| St. Joseph's Hospital | London | Ontario | Canada |
| Sunnybrook | Toronto | Ontario | Canada |
| Toronto General | Toronto | Ontario | Canada |
| Metropolitan Hospital | Windsor | Ontario | Canada |
| Montreal Chest/Royal-Victoria | Montreal | Quebec | Canada |
| Centre Hospitalier Universitaire de Sherbrooke | Sherbrooke | Quebec | Canada |
| Centre Hospitalier Universitaire de Laval | Ste-Foy | Quebec | Canada |
| Kimby E, Schar S, Pirosa MC, Vanazzi A, Mey UM, Rauch D, Wahlin BE, Hitz F, Hernberg M, Johansson AS, de Nully Brown P, Hagberg H, Ferreri AJM, Krasniqi F, Voegeli M, Novak U, Zander T, Bersvendsen H, Mamot C, Mingrone W, Stathis A, Dirnhofer S, Hayoz S, Ostenstad B, Zucca E. Six-month rituximab-lenalidomide regimen in advanced untreated follicular lymphoma: SAKK 35/10 trial 10-year update. Blood Adv. 2025 Apr 8;9(7):1712-1719. doi: 10.1182/bloodadvances.2024014840. |
| D007239 | Infections |
| D000086982 | Blood-Borne Infections |
| D003141 | Communicable Diseases |
| 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 |
| D045424 |
| Complex Mixtures |
| D017778 | Vaccines, Combined |