Completed

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

0 criteria met from your profileSee at a glance how your profile meets each eligibility criteria.
What is being tested

Attenuvax

+ M-M-R-II

Biological
Who is being recruted

Blood-Borne Infections+18

+ Urogenital Diseases

+ Genital Diseases

From 6 to 7 Months
See all eligibility criteria
How is the trial designed

Treatment Study

Phase 2
Interventional
See protocol details

Summary

Principal SponsorNational Institute of Allergy and Infectious Diseases (NIAID)
Last updated: January 28, 2026
Sourced from a government-validated database.Claim as a partner

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.

Official TitleA 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
NCT00000815
Principal SponsorNational Institute of Allergy and Infectious Diseases (NIAID)
Last updated: January 28, 2026
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

270 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.



Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

From 6 to 7 Months

Range of ages for which participants are eligible to join.

Healthy volunteers allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Blood-Borne InfectionsUrogenital DiseasesGenital DiseasesAcquired Immunodeficiency SyndromeAIDS-Related ComplexCommunicable DiseasesImmunologic Deficiency SyndromesImmune System DiseasesInfectionsMeaslesRetroviridae InfectionsRNA Virus InfectionsSexually Transmitted DiseasesSlow Virus DiseasesVirus DiseasesSexually Transmitted Diseases, ViralHIV InfectionsLentivirus InfectionsParamyxoviridae InfectionsMorbillivirus InfectionsMononegavirales Infections

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.

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

2 intervention groups are designated in this study

This study does not include a placebo group 

Treatment Groups

Group I

Experimental
Participants who receive vaccination at 6 and 12 months of age

Group II

Experimental
Participants who receive vaccination only at 12 months of age

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 46 locations

Suspended

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

Birmingham, United StatesOpen UAB, Dept. of Ped., Div. of Infectious Diseases in Google Maps
Suspended

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

Long Beach, United States
Suspended

Usc La Nichd Crs

Los Angeles, United States
Suspended

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

Los Angeles, United States
Completed46 Study Centers