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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

Primary Purpose

HIV Infections, Measles

Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
Attenuvax
M-M-R-II
Sponsored by
National Institute of Allergy and Infectious Diseases (NIAID)
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for HIV Infections focused on measuring Acquired Immunodeficiency Syndrome, AIDS-Related Complex, Measles-Mumps-Rubella Vaccine, Vaccines, Attenuated, Measles Vaccine, Immunization Schedule, Measles Virus, Measles

Eligibility Criteria

6 Months - 7 Months (Child)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • UAB, Dept. of Ped., Div. of Infectious Diseases
  • Long Beach Memorial Med. Ctr., Miller Children's Hosp.
  • Usc La Nichd Crs
  • UCLA-Los Angeles/Brazil AIDS Consortium (LABAC) CRS
  • Children's Hosp. & Research Ctr. Oakland, Ped. Clinical Research Ctr. & Research Lab.
  • UCSD Maternal, Child, and Adolescent HIV CRS
  • Harbor - UCLA Med. Ctr. - Dept. of Peds., Div. of Infectious Diseases
  • Univ. of Colorado Denver NICHD CRS
  • Yale Univ. School of Medicine - Dept. of Peds., Div. of Infectious Disease
  • Children's National Med. Ctr., ACTU
  • Howard Univ. Washington DC NICHD CRS
  • Univ. of Florida Jacksonville NICHD CRS
  • Emory Univ. School of Medicine, Dept. of Peds., Div. of Infectious Diseases
  • Cook County Hosp.
  • Chicago Children's CRS
  • Univ. of Chicago - Dept. of Peds., Div. of Infectious Disease
  • Univ. of Illinois College of Medicine at Chicago, Dept. of Peds.
  • Tulane/LSU Maternal/Child CRS
  • Johns Hopkins Hosp. & Health System - Dept. of Peds., Div. of Infectious Diseases
  • Univ. of Maryland Med. Ctr., Div. of Ped. Immunology & Rheumatology
  • HMS - Children's Hosp. Boston, Div. of Infectious Diseases
  • Children's Hospital of Michigan NICHD CRS
  • UMDNJ - Robert Wood Johnson
  • NJ Med. School CRS
  • St. Joseph's Hosp. & Med. Ctr. of New Jersey
  • Children's Hospital at Albany Medical Center, Dept. of Peds.
  • North Shore-Long Island Jewish Health System, Dept. of Peds.
  • Schneider Children's Hosp., Div. of Infectious Diseases
  • NYU Med. Ctr., Dept. of Medicine
  • Metropolitan Hosp. Ctr.
  • Metropolitan Hosp. NICHD CRS
  • Columbia IMPAACT CRS
  • Incarnation Children's Ctr.
  • Harlem Hosp. Ctr. NY NICHD CRS
  • Strong Memorial Hospital Rochester NY NICHD CRS
  • SUNY Stony Brook NICHD CRS
  • SUNY Upstate Med. Univ., Dept. of Peds.
  • DUMC Ped. CRS
  • The Children's Hosp. of Philadelphia IMPAACT CRS
  • Med. Univ. of South Carolina, Div. of Ped. Infectious Diseases
  • Texas Children's Hosp. CRS
  • Childrens Hosp. of the Kings Daughters
  • UW School of Medicine - CHRMC
  • Univ. Hosp. Ramón Ruiz Arnau, Dept. of Peds.
  • San Juan City Hosp. PR NICHD CRS
  • Univ. of Puerto Rico Ped. HIV/AIDS Research Program CRS

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

1

2

Arm Description

Participants who receive vaccination at 6 and 12 months of age

Participants who receive vaccination only at 12 months of age

Outcomes

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
Comparison of seroconversion rates at 13 months of age (following second vaccination) of HIV-uninfected children with HIV-infected children.
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

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
Assessment of measles antibody decay and persistence in HIV-infected and HIV-unifected vaccinees
Evaluation of adverse effects and immune reactions to vaccine in HIV-infected children and HIV-uninfected vaccinees

Full Information

First Posted
November 2, 1999
Last Updated
October 27, 2021
Sponsor
National Institute of Allergy and Infectious Diseases (NIAID)
Collaborators
Merck Sharp & Dohme LLC
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1. Study Identification

Unique Protocol Identification Number
NCT00000815
Brief 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
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
Study Type
Interventional

2. Study Status

Record Verification Date
October 2021
Overall Recruitment Status
Completed
Study Start Date
undefined (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
August 2001 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
National Institute of Allergy and Infectious Diseases (NIAID)
Collaborators
Merck Sharp & Dohme LLC

4. Oversight

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
HIV Infections, Measles
Keywords
Acquired Immunodeficiency Syndrome, AIDS-Related Complex, Measles-Mumps-Rubella Vaccine, Vaccines, Attenuated, Measles Vaccine, Immunization Schedule, Measles Virus, Measles

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
270 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Experimental
Arm Description
Participants who receive vaccination at 6 and 12 months of age
Arm Title
2
Arm Type
Experimental
Arm Description
Participants who receive vaccination only at 12 months of age
Intervention Type
Biological
Intervention Name(s)
Attenuvax
Intervention Description
Measles virus vaccine (attenuate)administered subcutaneously at a single dose of 0.5 mL at 6 months of age
Intervention Type
Biological
Intervention Name(s)
M-M-R-II
Intervention Description
Measles-Mumps-Rubella vaccine (attenuated)administered subcutaneously as a single dose of 0.5 mL at 12 months of age
Primary Outcome Measure Information:
Title
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
Title
Comparison of seroconversion rates at 13 months of age (following second vaccination) of HIV-uninfected children with HIV-infected children.
Time Frame
Throughout study
Title
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
Secondary Outcome Measure Information:
Title
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
Title
Assessment of measles antibody decay and persistence in HIV-infected and HIV-unifected vaccinees
Time Frame
Throughout study
Title
Evaluation of adverse effects and immune reactions to vaccine in HIV-infected children and HIV-uninfected vaccinees
Time Frame
Throughout study

10. Eligibility

Sex
All
Minimum Age & Unit of Time
6 Months
Maximum Age & Unit of Time
7 Months
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Chandwani S
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Krasinski K
Official's Role
Study Chair
Facility Information:
Facility Name
UAB, Dept. of Ped., Div. of Infectious Diseases
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35233
Country
United States
Facility Name
Long Beach Memorial Med. Ctr., Miller Children's Hosp.
City
Long Beach
State/Province
California
ZIP/Postal Code
90801
Country
United States
Facility Name
Usc La Nichd Crs
City
Los Angeles
State/Province
California
ZIP/Postal Code
90033
Country
United States
Facility Name
UCLA-Los Angeles/Brazil AIDS Consortium (LABAC) CRS
City
Los Angeles
State/Province
California
Country
United States
Facility Name
Children's Hosp. & Research Ctr. Oakland, Ped. Clinical Research Ctr. & Research Lab.
City
Oakland
State/Province
California
ZIP/Postal Code
94609
Country
United States
Facility Name
UCSD Maternal, Child, and Adolescent HIV CRS
City
San Diego
State/Province
California
Country
United States
Facility Name
Harbor - UCLA Med. Ctr. - Dept. of Peds., Div. of Infectious Diseases
City
Torrance
State/Province
California
Country
United States
Facility Name
Univ. of Colorado Denver NICHD CRS
City
Aurora
State/Province
Colorado
Country
United States
Facility Name
Yale Univ. School of Medicine - Dept. of Peds., Div. of Infectious Disease
City
New Haven
State/Province
Connecticut
ZIP/Postal Code
06504
Country
United States
Facility Name
Children's National Med. Ctr., ACTU
City
Washington
State/Province
District of Columbia
ZIP/Postal Code
20010
Country
United States
Facility Name
Howard Univ. Washington DC NICHD CRS
City
Washington
State/Province
District of Columbia
ZIP/Postal Code
20060
Country
United States
Facility Name
Univ. of Florida Jacksonville NICHD CRS
City
Jacksonville
State/Province
Florida
Country
United States
Facility Name
Emory Univ. School of Medicine, Dept. of Peds., Div. of Infectious Diseases
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30306
Country
United States
Facility Name
Cook County Hosp.
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60612
Country
United States
Facility Name
Chicago Children's CRS
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60614
Country
United States
Facility Name
Univ. of Chicago - Dept. of Peds., Div. of Infectious Disease
City
Chicago
State/Province
Illinois
Country
United States
Facility Name
Univ. of Illinois College of Medicine at Chicago, Dept. of Peds.
City
Chicago
State/Province
Illinois
Country
United States
Facility Name
Tulane/LSU Maternal/Child CRS
City
New Orleans
State/Province
Louisiana
Country
United States
Facility Name
Johns Hopkins Hosp. & Health System - Dept. of Peds., Div. of Infectious Diseases
City
Baltimore
State/Province
Maryland
Country
United States
Facility Name
Univ. of Maryland Med. Ctr., Div. of Ped. Immunology & Rheumatology
City
Baltimore
State/Province
Maryland
Country
United States
Facility Name
HMS - Children's Hosp. Boston, Div. of Infectious Diseases
City
Boston
State/Province
Massachusetts
Country
United States
Facility Name
Children's Hospital of Michigan NICHD CRS
City
Detroit
State/Province
Michigan
ZIP/Postal Code
48201
Country
United States
Facility Name
UMDNJ - Robert Wood Johnson
City
New Brunswick
State/Province
New Jersey
Country
United States
Facility Name
NJ Med. School CRS
City
Newark
State/Province
New Jersey
Country
United States
Facility Name
St. Joseph's Hosp. & Med. Ctr. of New Jersey
City
Paterson
State/Province
New Jersey
ZIP/Postal Code
07503
Country
United States
Facility Name
Children's Hospital at Albany Medical Center, Dept. of Peds.
City
Albany
State/Province
New York
ZIP/Postal Code
12208
Country
United States
Facility Name
North Shore-Long Island Jewish Health System, Dept. of Peds.
City
Great Neck
State/Province
New York
ZIP/Postal Code
11021
Country
United States
Facility Name
Schneider Children's Hosp., Div. of Infectious Diseases
City
New Hyde Park
State/Province
New York
ZIP/Postal Code
11040
Country
United States
Facility Name
NYU Med. Ctr., Dept. of Medicine
City
New York
State/Province
New York
ZIP/Postal Code
10016
Country
United States
Facility Name
Metropolitan Hosp. Ctr.
City
New York
State/Province
New York
ZIP/Postal Code
10029
Country
United States
Facility Name
Metropolitan Hosp. NICHD CRS
City
New York
State/Province
New York
ZIP/Postal Code
10029
Country
United States
Facility Name
Columbia IMPAACT CRS
City
New York
State/Province
New York
ZIP/Postal Code
10032
Country
United States
Facility Name
Incarnation Children's Ctr.
City
New York
State/Province
New York
ZIP/Postal Code
10032
Country
United States
Facility Name
Harlem Hosp. Ctr. NY NICHD CRS
City
New York
State/Province
New York
ZIP/Postal Code
10037
Country
United States
Facility Name
Strong Memorial Hospital Rochester NY NICHD CRS
City
Rochester
State/Province
New York
Country
United States
Facility Name
SUNY Stony Brook NICHD CRS
City
Stony Brook
State/Province
New York
Country
United States
Facility Name
SUNY Upstate Med. Univ., Dept. of Peds.
City
Syracuse
State/Province
New York
ZIP/Postal Code
13210
Country
United States
Facility Name
DUMC Ped. CRS
City
Durham
State/Province
North Carolina
ZIP/Postal Code
27710
Country
United States
Facility Name
The Children's Hosp. of Philadelphia IMPAACT CRS
City
Philadelphia
State/Province
Pennsylvania
Country
United States
Facility Name
Med. Univ. of South Carolina, Div. of Ped. Infectious Diseases
City
Charleston
State/Province
South Carolina
Country
United States
Facility Name
Texas Children's Hosp. CRS
City
Houston
State/Province
Texas
Country
United States
Facility Name
Childrens Hosp. of the Kings Daughters
City
Norfolk
State/Province
Virginia
ZIP/Postal Code
23507
Country
United States
Facility Name
UW School of Medicine - CHRMC
City
Seattle
State/Province
Washington
Country
United States
Facility Name
Univ. Hosp. Ramón Ruiz Arnau, Dept. of Peds.
City
Bayamon
Country
Puerto Rico
Facility Name
San Juan City Hosp. PR NICHD CRS
City
San Juan
Country
Puerto Rico
Facility Name
Univ. of Puerto Rico Ped. HIV/AIDS Research Program CRS
City
San Juan
Country
Puerto Rico

12. IPD Sharing Statement

Citations:
PubMed Identifier
21666159
Citation
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.
Results Reference
result

Learn more about this trial

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

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