A Phase II, Comparative Study of Seroconversion of Single-Dose and Two-Dose Measles Vaccination in HIV-Infected and HIV-Uninfected Children: A Multicenter Trial of the Pediatric AIDS Clinical Trials Group - Full Text View

Sponsor:	National Institute of Allergy and Infectious Diseases (NIAID)
Collaborator:	Merck
Information provided by:	National Institute of Allergy and Infectious Diseases (NIAID)
ClinicalTrials.gov Identifier:	NCT00000815

Purpose

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.

Condition	Intervention	Phase
HIV Infections Measles	Biological: Attenuvax Biological: M-M-R-II	Phase II

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Parallel Assignment
Official Title:	A Phase II, Comparative Study of Seroconversion of Single-Dose and Two-Dose Measles Vaccination in HIV-Infected and HIV-Uninfected Children: A Multicenter Trial of the Pediatric AIDS Clinical Trials Group

Resource links provided by NLM:

MedlinePlus related topics: AIDS Childhood Immunization Measles Mumps Rubella

Drug Information available for: Measles Vaccine Rubella Vaccine

U.S. FDA Resources

Further study details as provided by National Institute of Allergy and Infectious Diseases (NIAID):

Primary Outcome Measures:

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 [ Time Frame: Throughout study ] [ Designated as safety issue: No ]
Comparison of seroconversion rates at 13 months of age (following second vaccination) of HIV-uninfected children with HIV-infected children. [ Time Frame: Throughout study ] [ Designated as safety issue: No ]
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 [ Time Frame: Throughout study ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

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 [ Time Frame: Throughout study ] [ Designated as safety issue: No ]
Assessment of measles antibody decay and persistence in HIV-infected and HIV-unifected vaccinees [ Time Frame: Throughout study ] [ Designated as safety issue: No ]
Evaluation of adverse effects and immune reactions to vaccine in HIV-infected children and HIV-uninfected vaccinees [ Time Frame: Throughout study ] [ Designated as safety issue: No ]

Estimated Enrollment:	270
Study Start Date:	November 1999
Study Completion Date:	November 2000
Primary Completion Date:	November 2000 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental Participants who receive vaccination at 6 and 12 months of age	Biological: Attenuvax Measles virus vaccine (attenuate)administered subcutaneously at a single dose of 0.5 mL at 6 months of age Biological: M-M-R-II Measles-Mumps-Rubella vaccine (attenuated)administered subcutaneously as a single dose of 0.5 mL at 12 months of age
2: Experimental Participants who receive vaccination only at 12 months of age	Biological: M-M-R-II Measles-Mumps-Rubella vaccine (attenuated)administered subcutaneously as a single dose of 0.5 mL at 12 months of age

Detailed Description:

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.

Eligibility

Ages Eligible for Study:	6 Months to 7 Months
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

Criteria

Inclusion Criteria

Patients must have:

Willing to have and receive results of HIV test
Been born to mothers with HIV infection or history of AIDS-defining condition by CDC criteria.
No history of opportunistic infection.
No known exposure to measles within 14 days prior to study entry.
CD4+ lymphocyte count >= 750 cells/mm3 or more than 15% at 6 months of age.
Parent or legal guardian available to give written informed consent and be willing to comply with all study requirements.
Childhood immunizations (other than measles) according to current recommendations of the Immunization Practice Advisory Committee and American Academy of Pediatrics.

NOTE:

Coenrollment on other therapeutic protocols (except for ACTG 185) is permitted.

NOTE:

Patients must be located in a geographical area where measles immunization at 12 months is standard of care.

Recommended:

Childhood immunizations other than measles according to current guidelines.

Exclusion Criteria

Co-existing Condition:

Patients with the following symptoms or conditions are excluded:

Intercurrent illness and/or fever for 7 days.
Known sensitivity or allergy to neomycin or eggs.

Concurrent Medication:

Excluded:

IVIG.
Uninterrupted or anticipated steroid therapy (>= 2 mg/kg/day) for more than 2 weeks duration.

Patients with the prior condition are excluded:

Platelet count < 50,000/mm3 at any time prior to study entry.

Prior Medication:

Excluded:

Any IgG preparation within the past 6 months.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00000815

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Locations

United States, Alabama
Univ of Alabama at Birmingham - Pediatric
Birmingham, Alabama, United States, 35233
United States, California
UCSD Med Ctr / Pediatrics / Clinical Sciences
La Jolla, California, United States, 920930672
Harbor - UCLA Med Ctr / UCLA School of Medicine
Los Angeles, California, United States, 905022004
AIDS Clinical Research Ctr / UCLA Med Ctr
Los Angeles, California, United States, 900951793
Long Beach Memorial (Pediatric)
Long Beach, California, United States, 90801
UCLA Med Ctr / Pediatric
Los Angeles, California, United States, 900951752
Harbor UCLA Med Ctr
Torrance, California, United States, 90502
Los Angeles County - USC Med Ctr
Los Angeles, California, United States, 90033
United States, Colorado
Children's Hosp of Denver
Denver, Colorado, United States, 802181088
United States, Connecticut
Yale Univ Med School
New Haven, Connecticut, United States, 06504
United States, District of Columbia
Howard Univ Hosp
Washington, District of Columbia, United States, 20060
Children's Hosp of Washington DC
Washington, District of Columbia, United States, 200102916
United States, Florida
Univ of Florida Health Science Ctr / Pediatrics
Jacksonville, Florida, United States, 32209
United States, Georgia
Emory Univ Hosp / Pediatrics
Atlanta, Georgia, United States, 30306
United States, Illinois
Chicago Children's Memorial Hosp
Chicago, Illinois, United States, 606143394
Cook County Hosp
Chicago, Illinois, United States, 60612
Univ of Illinois College of Medicine / Pediatrics
Chicago, Illinois, United States, 60612
Univ of Chicago Children's Hosp
Chicago, Illinois, United States, 606371470
United States, Louisiana
Tulane Univ / Charity Hosp of New Orleans
New Orleans, Louisiana, United States, 701122699
United States, Maryland
Univ of Maryland at Baltimore / Univ Med Ctr
Baltimore, Maryland, United States, 21201
Johns Hopkins Hosp - Pediatric
Baltimore, Maryland, United States, 212874933
United States, Massachusetts
Children's Hosp of Boston
Boston, Massachusetts, United States, 021155724
United States, Michigan
Children's Hosp of Michigan
Detroit, Michigan, United States, 48201
United States, New Jersey
Univ of Medicine & Dentistry of New Jersey / Univ Hosp
Newark, New Jersey, United States, 071032714
UMDNJ - Robert Wood Johnson Med School / Pediatrics
New Brunswick, New Jersey, United States, 089030019
Children's Hosp of New Jersey / UMDNJ - New Jersey Med Schl
Newark, New Jersey, United States, 071072198
Saint Joseph's Hosp and Med Ctr/UMDNJ - New Jersey Med Schl
Newark, New Jersey, United States, 07103
United States, New York
King's County Hosp Ctr / Pediatrics
Brooklyn, New York, United States, 11203
Harlem Hosp Ctr
New York, New York, United States, 10037
North Shore Univ Hosp
Great Neck, New York, United States, 11021
Westchester Hosp
Valhalla, New York, United States, 10595
Schneider Children's Hosp
New Hyde Park, New York, United States, 11040
SUNY Health Sciences Ctr at Syracuse / Pediatrics
Syracuse, New York, United States, 13210
Columbia Presbyterian Med Ctr
New York, New York, United States, 10032
Mount Sinai Med Ctr / Pediatrics
New York, New York, United States, 10029
Metropolitan Hosp Ctr
New York, New York, United States, 10029
Children's Hosp at Albany Med Ctr
Albany, New York, United States, 12208
Bellevue Hosp / New York Univ Med Ctr
New York, New York, United States, 10016
Incarnation Children's Ctr / Columbia Presbyterian Med Ctr
New York, New York, United States, 10032
State Univ of New York at Stony Brook
Stony Brook, New York, United States, 117948111
Univ of Rochester Med Ctr
Rochester, New York, United States, 146420001
United States, North Carolina
Duke Univ Med Ctr
Durham, North Carolina, United States, 277103499
United States, Ohio
Case Western Reserve Univ - Pediatric
Cleveland, Ohio, United States, 44106
United States, Pennsylvania
Children's Hosp of Philadelphia
Philadelphia, Pennsylvania, United States, 191044318
United States, South Carolina
Med Univ of South Carolina
Charleston, South Carolina, United States, 294253312
United States, Texas
Texas Children's Hosp / Baylor Univ
Houston, Texas, United States, 77030
United States, Virginia
Children's Hosp of the King's Daughters
Norfolk, Virginia, United States, 23507
United States, Washington
Children's Hospital & Medical Center / Seattle ACTU
Seattle, Washington, United States, 981050371
Puerto Rico
San Juan City Hosp
San Juan, Puerto Rico, 009367344
Univ of Puerto Rico / Univ Children's Hosp AIDS
San Juan, Puerto Rico, 009365067
Ramon Ruiz Arnau Univ Hosp / Pediatrics
Bayamon, Puerto Rico, 00956

Sponsors and Collaborators

National Institute of Allergy and Infectious Diseases (NIAID)

Merck

Investigators

Study Chair:	Chandwani S
Study Chair:	Krasinski K

More Information

No publications provided

Responsible Party:	DAIDS ( Rona Siskind )
Study ID Numbers:	ACTG 225
Study First Received:	November 2, 1999
Last Updated:	September 8, 2009
ClinicalTrials.gov Identifier:	NCT00000815 History of Changes
Health Authority:	United States: Food and Drug Administration

Keywords provided by National Institute of Allergy and Infectious Diseases (NIAID):

Acquired Immunodeficiency Syndrome
AIDS-Related Complex
Measles-Mumps-Rubella Vaccine
Vaccines, Attenuated

Measles Vaccine
Immunization Schedule
Measles Virus
Measles

Additional relevant MeSH terms:

RNA Virus Infections
Sexually Transmitted Diseases, Viral
Paramyxoviridae Infections
Morbillivirus Infections
Slow Virus Diseases
Immune System Diseases
Measles
Acquired Immunodeficiency Syndrome

Infection
Immunologic Deficiency Syndromes
Virus Diseases
HIV Infections
Sexually Transmitted Diseases
Lentivirus Infections
Retroviridae Infections
Mononegavirales Infections

ClinicalTrials.gov processed this record on November 25, 2009