Immune System Function Following Vaccination in HIV Infected Children Taking Anti-HIV Drugs - Full Text View

Sponsor:	National Institute of Allergy and Infectious Diseases (NIAID)
Collaborator:	Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Information provided by:	National Institute of Allergy and Infectious Diseases (NIAID)
ClinicalTrials.gov Identifier:	NCT00257127

Purpose

The purpose of this study is to determine immune system function following vaccination in HIV-infected children currently taking anti-HIV drugs. To test the effectiveness of prior vaccination, patients in this study will receive booster shots of one of two pneumococcal vaccines, a hepatitis B vaccine, and a measles vaccine.

Condition	Intervention
HIV Infections	Biological: Pneumococcal 7-valent conjugate vaccine Biological: Pneumococcal polysaccharide vaccine Biological: Hepatitis B vaccine Biological: Measles, mumps, and rubella virus vaccine, live

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Uncontrolled, Parallel Assignment, Safety/Efficacy Study
Official Title:	Evaluation of Immunologic Memory Following Pneumococcal, Hepatitis B, and Measles Vaccination in HIV Infected Children Treated With Highly Active Antiretroviral Therapy (HAART)

Resource links provided by NLM:

MedlinePlus related topics: AIDS AIDS Medicines Hepatitis Hepatitis B Measles Memory

Drug Information available for: Heptavalent pneumococcal conjugate vaccine Hepatitis B Vaccines Pneumococcal Vaccines Rubella Vaccine

U.S. FDA Resources

Further study details as provided by National Institute of Allergy and Infectious Diseases (NIAID):

Primary Outcome Measures:

Grade 3 or greater hematologic and chemistry laboratory values, signs, or symptoms not present, as specified by the protocol [ Time Frame: At study entry ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

Seropositivity, as determined by antibody levels [ Time Frame: At study entry and Days 7 and 28 ] [ Designated as safety issue: No ]
Immunologic memory, as determined by primary and secondary responses, antibody levels, and additional measures of immunologic memory [ Time Frame: Throughout study ] [ Designated as safety issue: No ]

Enrollment:	101
Study Start Date:	February 2006
Study Completion Date:	December 2006
Primary Completion Date:	December 2006 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental Patients will receive PCV, HBV, and MMR at study entry	Biological: Pneumococcal 7-valent conjugate vaccine 0.5 mL administered intramuscularly Biological: Hepatitis B vaccine 0.5 mL administered intramuscularly Biological: Measles, mumps, and rubella virus vaccine, live 0.5 mL administered subcutaneously
2: Experimental Patients will receive PPV, HBV, and MMR at study entry	Biological: Pneumococcal polysaccharide vaccine 0.5 mL administered intramuscularly Biological: Hepatitis B vaccine 0.5 mL administered intramuscularly Biological: Measles, mumps, and rubella virus vaccine, live 0.5 mL administered subcutaneously

Detailed Description:

With their immunocompromised status, HIV-infected children are at especially high risk for opportunistic infections, including infection by Streptococcus pneumoniae, hepatitis B, and measles. In PACTG P1024, HIV-infected children taking highly active antiretroviral therapy (HAART) received 2 doses of the pneumococcal conjugate vaccine (PCV), 1 dose of the pneumococcal polysaccharide vaccine (PPV), and booster shots of the hepatitis B vaccine (HBV) and measles, mumps, and rubella vaccine (MMR). Early responses to these vaccinations were favorable, but with declining antibody responses within the 18 months after vaccination. It is unknown if additional booster vaccinations in these children will result in a protective immunologic memory upon re-exposure to these pathogens. This study will determine whether HIV-infected children on HAART have evidence of specific immunologic memory 3 to 4 years after vaccination in PACTG P1024.

Patients will be randomly assigned to receive PCV or PPV at study entry. All eligible patients will also receive HBV and MMR at study entry. Patients will be monitored in the clinic for 1 hour after vaccination for any adverse effects. Study staff will contact patients by phone around Day 3 after study entry to ask patients if they have experienced any adverse effects to the vaccinations; patients who received MMR at study entry will be contacted again around Day 21. Some patients may be asked to return to the clinic for further evaluation if they experience side effects.

There will be study visits at study entry and Days 7 and 28. Medical history, a physical exam, blood collection, and an assessment of HIV-related symptoms will occur at all visits. HAART will not be provided by this study.

Eligibility

Ages Eligible for Study:	6 Years to 23 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Completed the 96-week initial study period of PACTG P1024 and had enrolled into that study between June 1, 2001 and March 31, 2002
Fulfilled PACTG P1024's definition of HAART (taking 3 or more antiretrovirals [ARVs] from at least 2 of the available therapeutic drug classes) during PACTG P1024's vaccination period (Weeks 0 to 24). Patients who were taking 3 nucleoside reverse transcriptase inhibitors during that period without a non-nucleoside reverse transcriptase inhibitor or a protease inhibitor (PI) are not eligible for this study. Nontherapeutic boosting doses of ritonavir used in ritonavir-boosted PI regimens are not counted as separate ARVs.
Stable ARV regimen in the 4 weeks prior to study entry
No changes anticipated to current ARV regimen during this study
Willing to complete all study vaccinations and evaluations
Willing to use acceptable forms of contraception, if applicable
Parent or guardian willing to provide informed consent, if applicable

Exclusion Criteria:

Abnormal blood or chemistry values on most recent laboratory tests. More information on this criterion can be found in the protocol.
Received PCV, HBV, PPV, or MMR vaccines during PACTG P1024 in a sequence other than specified in PACTG P1024
Received one or more doses of each of PCV, PPV, MMR, or HBV vaccines since the end of PACTG P1024's vaccination period
Previous Grade 3 or higher adverse events or allergic reactions judged to be possibly or definitely related to the PCV, PPV, MMR, or HBV vaccines
Received any killed vaccine within the 4 weeks prior to study entry
Received any live vaccine within the 6 weeks prior to study entry
Planning to receive any killed or live vaccine other than study vaccines between the first and third study visits
Presence of an underlying condition that contraindicates use of any of the study vaccines. Patients who have a CD4% less than 15% will not be given the MMR vaccine, but such patients will not be excluded from this study.
Current immunomodulatory therapy, including IL-2, any interferon product, GM-CSF, or thalidomide. Patients taking G-CSF or erythropoietin are not excluded.
Anticipated need for immunomodulatory treatment during this study
Any intramuscular immune globulin product within the 6 months prior to study entry
Intravenous immune globulin within the 11 months prior to study entry
Platelets or plasma products within the 7 months prior to study entry
Anticipated need for immune globulin products during this study
Current systemic immunosuppressive therapy, including the equivalent of 1 mg/kg/day or greater of prednisone in the 2 weeks prior to study entry. Patients using inhaled corticosteroids only are not excluded from this study. More information on this criterion can be found in the protocol.
Anticipated need for systemic immunosuppressive therapy during this study
Other known or suspected diseases of the immune system
Cancer in the 3 months prior to study entry or treatment for cancer within the 3 months prior to study entry
Other acute or chronic medical or surgical conditions or contraindications that, in the opinion of the investigator, may interfere with the study
Known bleeding disorder
Any Grade 2 or higher clinical toxicity at study screening. More information on this criterion can be found in the protocol.
Require certain medications
Pregnancy

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00257127

Show 30 Study Locations

Sponsors and Collaborators

National Institute of Allergy and Infectious Diseases (NIAID)

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Investigators

Study Chair:

Mark Abzug, MD

The Children's Hospital, Denver, CO

More Information

Additional Information:

Click here for more information about PACTG P1024 This link exits the ClinicalTrials.gov site

Haga clic aquí para ver información sobre este ensayo clínico en español This link exits the ClinicalTrials.gov site

Publications:

Obaro SK, Pugatch D, Luzuriaga K. Immunogenicity and efficacy of childhood vaccines in HIV-1-infected children. Lancet Infect Dis. 2004 Aug;4(8):510-8. Review.

Responsible Party:	DAIDS ( Rona Siskind )
Study ID Numbers:	PACTG P1061s, DAIDS-ES ID 10132
Study First Received:	November 18, 2005
Last Updated:	August 6, 2009
ClinicalTrials.gov Identifier:	NCT00257127 History of Changes
Health Authority:	United States: Food and Drug Administration

Keywords provided by National Institute of Allergy and Infectious Diseases (NIAID):

Vaccination

Additional relevant MeSH terms:

Virus Diseases
Sexually Transmitted Diseases, Viral
RNA Virus Infections
Slow Virus Diseases
Immune System Diseases
HIV Infections

Sexually Transmitted Diseases
Acquired Immunodeficiency Syndrome
Lentivirus Infections
Infection
Retroviridae Infections
Immunologic Deficiency Syndromes

ClinicalTrials.gov processed this record on November 22, 2009