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| ID | Type | Description | Link |
|---|---|---|---|
| 10132 | Registry Identifier | DAIDS ES Registry Number | |
| PACTG P1061s |
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| Name | Class |
|---|---|
| Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) | NIH |
The purpose of this study is to determine immune system function following vaccination in HIV-infected children currently taking anti-HIV drugs. To test the effectiveness of prior vaccination, patients in this study will receive booster shots of one of two pneumococcal vaccines, a hepatitis B vaccine, and a measles vaccine.
With their immunocompromised status, HIV-infected children are at especially high risk for opportunistic infections, including infection by Streptococcus pneumoniae, hepatitis B, and measles. In PACTG P1024, HIV-infected children taking highly active antiretroviral therapy (HAART) received 2 doses of the pneumococcal conjugate vaccine (PCV), 1 dose of the pneumococcal polysaccharide vaccine (PPV), and booster shots of the hepatitis B vaccine (HBV) and measles, mumps, and rubella vaccine (MMR). Early responses to these vaccinations were favorable, but with declining antibody responses within the 18 months after vaccination. It is unknown if additional booster vaccinations in these children will result in a protective immunologic memory upon re-exposure to these pathogens. This study will determine whether HIV-infected children on HAART have evidence of specific immunologic memory 3 to 4 years after vaccination in PACTG P1024.
Patients will be randomly assigned to receive PCV or PPV at study entry. All eligible patients will also receive HBV and MMR at study entry. Patients will be monitored in the clinic for 1 hour after vaccination for any adverse effects. Study staff will contact patients by phone around Day 3 after study entry to ask patients if they have experienced any adverse effects to the vaccinations; patients who received MMR at study entry will be contacted again around Day 21. Some patients may be asked to return to the clinic for further evaluation if they experience side effects.
There will be study visits at study entry and Days 7 and 28. Medical history, a physical exam, blood collection, and an assessment of HIV-related symptoms will occur at all visits. HAART will not be provided by this study.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Experimental | Patients will receive PCV, HBV, and MMR at study entry |
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| 2 | Experimental | Patients will receive PPV, HBV, and MMR at study entry |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Pneumococcal 7-valent conjugate vaccine | Biological | 0.5 mL administered intramuscularly |
|
| Measure | Description | Time Frame |
|---|---|---|
| Grade 3 or greater hematologic and chemistry laboratory values, signs, or symptoms not present, as specified by the protocol | At study entry |
| Measure | Description | Time Frame |
|---|---|---|
| Seropositivity, as determined by antibody levels | At study entry and Days 7 and 28 | |
| Immunologic memory, as determined by primary and secondary responses, antibody levels, and additional measures of immunologic memory | Throughout study |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Mark Abzug, MD | The Children's Hospital, Denver, CO | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| UAB, Dept. of Ped., Div. of Infectious Diseases | Birmingham | Alabama | 35233 | United States | ||
| Usc La Nichd Crs |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 15288824 | Background | Obaro SK, Pugatch D, Luzuriaga K. Immunogenicity and efficacy of childhood vaccines in HIV-1-infected children. Lancet Infect Dis. 2004 Aug;4(8):510-8. doi: 10.1016/S1473-3099(04)01106-5. | |
| 23954381 | Derived | Abzug MJ, Song LY, Levin MJ, Nachman SA, Borkowsky W, Pelton SI; International Maternal Pediatric Adolescent AIDS Clinical Trials Group P1024 and P1061s Protocol Teams. Antibody persistence and immunologic memory after sequential pneumococcal conjugate and polysaccharide vaccination in HIV-infected children on highly active antiretroviral therapy. Vaccine. 2013 Oct 1;31(42):4782-90. doi: 10.1016/j.vaccine.2013.08.002. Epub 2013 Aug 14. |
| Label | URL |
|---|---|
| Click here for more information about PACTG P1024 | View source |
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| Pneumococcal polysaccharide vaccine | Biological | 0.5 mL administered intramuscularly |
|
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| Hepatitis B vaccine | Biological | 0.5 mL administered intramuscularly |
|
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| Measles, mumps, and rubella virus vaccine, live | Biological | 0.5 mL administered subcutaneously |
|
|
| Alhambra |
| California |
| 91803 |
| United States |
| Long Beach Memorial Med. Ctr., Miller Children's Hosp. | Long Beach | California | 90806 | United States |
| UCSD Mother-Child-Adolescent Program CRS | San Diego | California | 92103 | United States |
| Univ. of Colorado Denver NICHD CRS | Aurora | Colorado | 80045 | United States |
| Yale Univ. School of Medicine - Dept. of Peds., Div. of Infectious Disease | New Haven | Connecticut | 06510 | United States |
| South Florida CDTC Ft Lauderdale NICHD CRS | Fort Lauderdale | Florida | 33316 | United States |
| Univ. of Florida College of Medicine-Dept of Peds, Div. of Immunology, Infectious Diseases & Allergy | Gainesville | Florida | 32610-0296 | United States |
| Univ. of Florida Jacksonville NICHD CRS | Jacksonville | Florida | 32209 | United States |
| Chicago Children's CRS | Chicago | Illinois | 60614 | United States |
| Univ. of Chicago - Dept. of Peds., Div. of Infectious Disease | Chicago | Illinois | 60637 | United States |
| Children's Hosp. | New Orleans | Louisiana | 70118 | United States |
| HMS - Children's Hosp. Boston, Div. of Infectious Diseases | Boston | Massachusetts | 02115 | United States |
| BMC, Div. of Ped Infectious Diseases | Boston | Massachusetts | 02118 | United States |
| WNE Maternal Pediatric Adolescent AIDS CRS | Worcester | Massachusetts | 01605 | United States |
| Rutgers - New Jersey Medical School CRS | Newark | New Jersey | 07103 | United States |
| SUNY Downstate Med. Ctr., Children's Hosp. at Downstate NICHD CRS | Brooklyn | New York | 11203 | United States |
| Nyu Ny Nichd Crs | New York | New York | 10016 | United States |
| Metropolitan Hosp. Ctr. | New York | New York | 10029 | United States |
| Harlem Hosp. Ctr. NY NICHD CRS | New York | New York | 10037 | United States |
| Strong Memorial Hospital Rochester NY NICHD CRS | Rochester | New York | 14642 | United States |
| SUNY Stony Brook NICHD CRS | Stony Brook | New York | 11794-8111 | United States |
| Bronx-Lebanon Hosp. IMPAACT CRS | The Bronx | New York | 10457 | United States |
| St. Christopher's Hosp. for Children | Philadelphia | Pennsylvania | 19134 | United States |
| Univ. of Puerto Rico Ped. HIV/AIDS Research Program CRS | San Juan | 00935 | Puerto Rico |
| San Juan City Hosp. PR NICHD CRS | San Juan | 00936 | Puerto Rico |
| 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 |
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| ID | Term |
|---|---|
| D022242 | Pneumococcal Vaccines |
| D017325 | Hepatitis B Vaccines |
| D022542 | Measles-Mumps-Rubella Vaccine |
| ID | Term |
|---|---|
| D022541 | Streptococcal Vaccines |
| D001428 | Bacterial Vaccines |
| D014612 | Vaccines |
| D001688 | Biological Products |
| D045424 | Complex Mixtures |
| D014761 | Viral Hepatitis Vaccines |
| D014765 | Viral Vaccines |
| D017778 | Vaccines, Combined |
| D008458 | Measles Vaccine |
| D009108 | Mumps Vaccine |
| D012411 | Rubella Vaccine |
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