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:	Allocation: Randomized Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment
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:

Genetics Home Reference related topics: complement factor I deficiency

MedlinePlus related topics: HIV/AIDS Measles Mumps Rubella

Drug Information available for: Measles 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
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

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

Show 51 Study Locations

Sponsors and Collaborators

National Institute of Allergy and Infectious Diseases (NIAID)

Merck

Investigators

Study Chair:	Chandwani S
Study Chair:	Krasinski K

More Information

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:S179-89.

Responsible Party:	Rona Siskind, DAIDS
ClinicalTrials.gov Identifier:	NCT00000815 History of Changes
Other Study ID Numbers:	ACTG 225
Study First Received:	November 2, 1999
Last Updated:	June 23, 2011
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:

HIV Infections
Acquired Immunodeficiency Syndrome
Measles
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral

Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases
Slow Virus Diseases
Morbillivirus Infections
Paramyxoviridae Infections
Mononegavirales Infections

ClinicalTrials.gov processed this record on February 13, 2012