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| ID | Type | Description | Link |
|---|---|---|---|
| 11202 | Registry Identifier | DAIDS ES Registry Number |
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| Name | Class |
|---|---|
| Merck Sharp & Dohme LLC | INDUSTRY |
To compare measles seroconversion rates (development of antibodies) at 13 months of age in HIV-infected and uninfected children on one of two immunization schedules: attenuated measles/mumps/rubella virus (M-M-R II) vaccine at 12 months versus attenuated measles vaccine (Attenuvax) at 6 months plus M-M-R II vaccine at 12 months.
Recommendations for the age at vaccination should balance the need to minimize the risk of morbidity and mortality with the benefit of achieving the highest seroconversion rates. Immunizing a more intact immune system at an earlier stage of HIV infection may in turn achieve better and long-lasting measles protection. This study will help define a more effective measles vaccine regimen for children diagnosed with HIV infection and will provide greater insight into the functional status of the HIV-infected children's humoral immune system.
Recommendations for the age at vaccination should balance the need to minimize the risk of morbidity and mortality with the benefit of achieving the highest seroconversion rates. Immunizing a more intact immune system at an earlier stage of HIV infection may in turn achieve better and long-lasting measles protection. This study will help define a more effective measles vaccine regimen for children diagnosed with HIV infection and will provide greater insight into the functional status of the HIV-infected children's humoral immune system.
Patients, HIV infected and uninfected, are randomized to one of two attenuated measles vaccine schedules: at 6 and 12 months of age, or at 12 months of age only. Attenuvax is administered as the month 6 vaccine and M-M-R II as the month 12 vaccine. Patients are followed for 24 months after the last vaccination.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Experimental | Participants who receive vaccination at 6 and 12 months of age |
|
| 2 | Experimental | Participants who receive vaccination only at 12 months of age |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Attenuvax | Biological | Measles virus vaccine (attenuate)administered subcutaneously at a single dose of 0.5 mL at 6 months of age |
|
| Measure | Description | Time Frame |
|---|---|---|
| Comparison of measles seroconversion rates at 13 months of age between HIV-infected children vaccinated at 12 months of age and HIV-infected children vaccinated at 6 and 12 months of age | Throughout study | |
| Comparison of seroconversion rates at 13 months of age (following second vaccination) of HIV-uninfected children with HIV-infected children. | Throughout study | |
| Comparison of seroconversion rates at 13 months of age (following single vaccination) of HIV-uninfected children with HIV-infected children following vaccination at 12 months of age | Throughout study |
| Measure | Description | Time Frame |
|---|---|---|
| Comparison of measles seroconversion rates in HIV-infected children vaccinated at 6 months of age with HIV-infected children vaccinated at 12 months of age | Throughout study | |
| Assessment of measles antibody decay and persistence in HIV-infected and HIV-unifected vaccinees |
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Inclusion Criteria
Patients must have:
NOTE:
NOTE:
Recommended:
Exclusion Criteria
Co-existing Condition:
Patients with the following symptoms or conditions are excluded:
Concurrent Medication:
Excluded:
Patients with the prior condition are excluded:
Prior Medication:
Excluded:
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| Name | Affiliation | Role |
|---|---|---|
| Chandwani S | Study Chair | |
| Krasinski K | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| UAB, Dept. of Ped., Div. of Infectious Diseases | Birmingham | Alabama | 35233 | United States | ||
| Long Beach Memorial Med. Ctr., Miller Children's Hosp. |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 21666159 | Result | Chandwani S, Beeler J, Li H, Audet S, Smith B, Moye J, Nalin D, Krasinski K; PACTG 225 Study Team. Safety and immunogenicity of early measles vaccination in children born to HIV-infected mothers in the United States: results of Pediatric AIDS Clinical Trials Group (PACTG) protocol 225. J Infect Dis. 2011 Jul;204 Suppl 1(Suppl 1):S179-89. doi: 10.1093/infdis/jir089. |
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| M-M-R-II | Biological | Measles-Mumps-Rubella vaccine (attenuated)administered subcutaneously as a single dose of 0.5 mL at 12 months of age |
|
| Throughout study |
| Evaluation of adverse effects and immune reactions to vaccine in HIV-infected children and HIV-uninfected vaccinees | Throughout study |
| Long Beach |
| California |
| 90801 |
| United States |
| Usc La Nichd Crs | Los Angeles | California | 90033 | United States |
| UCLA-Los Angeles/Brazil AIDS Consortium (LABAC) CRS | Los Angeles | California | United States |
| Children's Hosp. & Research Ctr. Oakland, Ped. Clinical Research Ctr. & Research Lab. | Oakland | California | 94609 | United States |
| UCSD Maternal, Child, and Adolescent HIV CRS | San Diego | California | United States |
| Harbor - UCLA Med. Ctr. - Dept. of Peds., Div. of Infectious Diseases | Torrance | California | United States |
| Univ. of Colorado Denver NICHD CRS | Aurora | Colorado | United States |
| Yale Univ. School of Medicine - Dept. of Peds., Div. of Infectious Disease | New Haven | Connecticut | 06504 | United States |
| Children's National Med. Ctr., ACTU | Washington D.C. | District of Columbia | 20010 | United States |
| Howard Univ. Washington DC NICHD CRS | Washington D.C. | District of Columbia | 20060 | United States |
| Univ. of Florida Jacksonville NICHD CRS | Jacksonville | Florida | United States |
| Emory Univ. School of Medicine, Dept. of Peds., Div. of Infectious Diseases | Atlanta | Georgia | 30306 | United States |
| Cook County Hosp. | Chicago | Illinois | 60612 | United States |
| Chicago Children's CRS | Chicago | Illinois | 60614 | United States |
| Univ. of Chicago - Dept. of Peds., Div. of Infectious Disease | Chicago | Illinois | United States |
| Univ. of Illinois College of Medicine at Chicago, Dept. of Peds. | Chicago | Illinois | United States |
| Tulane/LSU Maternal/Child CRS | New Orleans | Louisiana | United States |
| Johns Hopkins Hosp. & Health System - Dept. of Peds., Div. of Infectious Diseases | Baltimore | Maryland | United States |
| Univ. of Maryland Med. Ctr., Div. of Ped. Immunology & Rheumatology | Baltimore | Maryland | United States |
| HMS - Children's Hosp. Boston, Div. of Infectious Diseases | Boston | Massachusetts | United States |
| Children's Hospital of Michigan NICHD CRS | Detroit | Michigan | 48201 | United States |
| UMDNJ - Robert Wood Johnson | New Brunswick | New Jersey | United States |
| NJ Med. School CRS | Newark | New Jersey | United States |
| St. Joseph's Hosp. & Med. Ctr. of New Jersey | Paterson | New Jersey | 07503 | United States |
| Children's Hospital at Albany Medical Center, Dept. of Peds. | Albany | New York | 12208 | United States |
| North Shore-Long Island Jewish Health System, Dept. of Peds. | Great Neck | New York | 11021 | United States |
| Schneider Children's Hosp., Div. of Infectious Diseases | New Hyde Park | New York | 11040 | United States |
| NYU Med. Ctr., Dept. of Medicine | New York | New York | 10016 | United States |
| Metropolitan Hosp. Ctr. | New York | New York | 10029 | United States |
| Metropolitan Hosp. NICHD CRS | New York | New York | 10029 | United States |
| Columbia IMPAACT CRS | New York | New York | 10032 | United States |
| Incarnation Children's Ctr. | New York | New York | 10032 | 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 | United States |
| SUNY Stony Brook NICHD CRS | Stony Brook | New York | United States |
| SUNY Upstate Med. Univ., Dept. of Peds. | Syracuse | New York | 13210 | United States |
| DUMC Ped. CRS | Durham | North Carolina | 27710 | United States |
| The Children's Hosp. of Philadelphia IMPAACT CRS | Philadelphia | Pennsylvania | United States |
| Med. Univ. of South Carolina, Div. of Ped. Infectious Diseases | Charleston | South Carolina | United States |
| Texas Children's Hosp. CRS | Houston | Texas | United States |
| Childrens Hosp. of the Kings Daughters | Norfolk | Virginia | 23507 | United States |
| UW School of Medicine - CHRMC | Seattle | Washington | United States |
| Univ. Hosp. Ramón Ruiz Arnau, Dept. of Peds. | Bayamón | Puerto Rico |
| San Juan City Hosp. PR NICHD CRS | San Juan | Puerto Rico |
| Univ. of Puerto Rico Ped. HIV/AIDS Research Program CRS | San Juan | Puerto Rico |
| ID | Term |
|---|---|
| D015658 | HIV Infections |
| D008457 | Measles |
| D000163 | Acquired Immunodeficiency Syndrome |
| D000386 | AIDS-Related Complex |
| 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 |
| D018185 | Morbillivirus Infections |
| D018184 | Paramyxoviridae Infections |
| D018701 | Mononegavirales Infections |
| D012897 | Slow Virus Diseases |
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| ID | Term |
|---|---|
| D008458 | Measles Vaccine |
| D022542 | Measles-Mumps-Rubella Vaccine |
| ID | Term |
|---|---|
| D014765 | Viral Vaccines |
| D014612 | Vaccines |
| D001688 | Biological Products |
| D045424 | Complex Mixtures |
| D017778 | Vaccines, Combined |
| D009108 | Mumps Vaccine |
| D012411 | Rubella Vaccine |
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