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NCT00000815

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

Last Updated: 2021-10-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

270 participants

Study Classification

INTERVENTIONAL

Study Completion Date

2001-08-31

Brief Summary

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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

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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.

Conditions

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HIV Infections Measles

Keywords

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

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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1

Participants who receive vaccination at 6 and 12 months of age

Group Type EXPERIMENTAL

Attenuvax

Intervention Type BIOLOGICAL

Measles virus vaccine (attenuate)administered subcutaneously at a single dose of 0.5 mL at 6 months of age

M-M-R-II

Intervention Type BIOLOGICAL

Measles-Mumps-Rubella vaccine (attenuated)administered subcutaneously as a single dose of 0.5 mL at 12 months of age

2

Participants who receive vaccination only at 12 months of age

Group Type EXPERIMENTAL

M-M-R-II

Intervention Type BIOLOGICAL

Measles-Mumps-Rubella vaccine (attenuated)administered subcutaneously as a single dose of 0.5 mL at 12 months of age

Interventions

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Attenuvax

Measles virus vaccine (attenuate)administered subcutaneously at a single dose of 0.5 mL at 6 months of age

Intervention Type 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

Intervention Type BIOLOGICAL

Eligibility Criteria

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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.

Minimum Eligible Age

6 Months

Maximum Eligible Age

7 Months

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Chandwani S

Role: STUDY_CHAIR

Krasinski K

Role: STUDY_CHAIR

Locations

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UAB, Dept. of Ped., Div. of Infectious Diseases

Birmingham, Alabama, United States

Site Status

Long Beach Memorial Med. Ctr., Miller Children's Hosp.

Long Beach, California, United States

Site Status

Usc La Nichd Crs

Los Angeles, California, United States

Site Status

UCLA-Los Angeles/Brazil AIDS Consortium (LABAC) CRS

Los Angeles, California, United States

Site Status

Children's Hosp. & Research Ctr. Oakland, Ped. Clinical Research Ctr. & Research Lab.

Oakland, California, United States

Site Status

UCSD Maternal, Child, and Adolescent HIV CRS

San Diego, California, United States

Site Status

Harbor - UCLA Med. Ctr. - Dept. of Peds., Div. of Infectious Diseases

Torrance, California, United States

Site Status

Univ. of Colorado Denver NICHD CRS

Aurora, Colorado, United States

Site Status

Yale Univ. School of Medicine - Dept. of Peds., Div. of Infectious Disease

New Haven, Connecticut, United States

Site Status

Children's National Med. Ctr., ACTU

Washington D.C., District of Columbia, United States

Site Status

Howard Univ. Washington DC NICHD CRS

Washington D.C., District of Columbia, United States

Site Status

Univ. of Florida Jacksonville NICHD CRS

Jacksonville, Florida, United States

Site Status

Emory Univ. School of Medicine, Dept. of Peds., Div. of Infectious Diseases

Atlanta, Georgia, United States

Site Status

Cook County Hosp.

Chicago, Illinois, United States

Site Status

Chicago Children's CRS

Chicago, Illinois, United States

Site Status

Univ. of Chicago - Dept. of Peds., Div. of Infectious Disease

Chicago, Illinois, United States

Site Status

Univ. of Illinois College of Medicine at Chicago, Dept. of Peds.

Chicago, Illinois, United States

Site Status

Tulane/LSU Maternal/Child CRS

New Orleans, Louisiana, United States

Site Status

Johns Hopkins Hosp. & Health System - Dept. of Peds., Div. of Infectious Diseases

Baltimore, Maryland, United States

Site Status

Univ. of Maryland Med. Ctr., Div. of Ped. Immunology & Rheumatology

Baltimore, Maryland, United States

Site Status

HMS - Children's Hosp. Boston, Div. of Infectious Diseases

Boston, Massachusetts, United States

Site Status

Children's Hospital of Michigan NICHD CRS

Detroit, Michigan, United States

Site Status

UMDNJ - Robert Wood Johnson

New Brunswick, New Jersey, United States

Site Status

NJ Med. School CRS

Newark, New Jersey, United States

Site Status

St. Joseph's Hosp. & Med. Ctr. of New Jersey

Paterson, New Jersey, United States

Site Status

Children's Hospital at Albany Medical Center, Dept. of Peds.

Albany, New York, United States

Site Status

North Shore-Long Island Jewish Health System, Dept. of Peds.

Great Neck, New York, United States

Site Status