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

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.

Study Overview

• Status: Completed
• Conditions: HIV Infections; Measles
• Intervention / Treatment: Biological: Attenuvax; Biological: M-M-R-II

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.

• Study Type: Interventional
• Enrollment (Anticipated): 270
• Phase: Phase 2

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 6 months to 7 months (Child)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 1; 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
Experimental: 2; 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Secondary Outcome Measures

Outcome Measure	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	Throughout study
Evaluation of adverse effects and immune reactions to vaccine in HIV-infected children and HIV-uninfected vaccinees	Throughout study

Collaborators and Investigators

• Sponsor: National Institute of Allergy and Infectious Diseases (NIAID)
• Collaborators: Merck Sharp & Dohme LLC
• Investigators: Study Chair: Chandwani S; Study Chair: Krasinski K

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Completion (Actual): August 1, 2001

Study Registration Dates

• First Submitted: November 2, 1999
• First Submitted That Met QC Criteria: August 30, 2001
• First Posted (Estimate): August 31, 2001

Study Record Updates

• Last Update Posted (Actual): October 28, 2021
• Last Update Submitted That Met QC Criteria: October 27, 2021
• Last Verified: October 1, 2021

More Information

Terms related to this study

• Keywords: Measles-Mumps-Rubella Vaccine; Acquired Immunodeficiency Syndrome; AIDS-Related Complex; Measles; Immunization Schedule; Vaccines, Attenuated; Measles Vaccine; Measles Virus
• Additional Relevant MeSH Terms: RNA Virus Infections; Virus Diseases; Infections; Morbillivirus Infections; Paramyxoviridae Infections; Mononegavirales Infections; Measles
• Other Study ID Numbers: ACTG 225; 11202 (Registry Identifier: DAIDS ES Registry Number)