Pneumococcal Vaccine and Routine Pediatric Immunizations in HIV-Infected Children Receiving 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:	NCT00013871

Purpose

The purpose of this study is to determine if 2 doses of Pneumococcal Conjugate Vaccine (PCV) followed by 1 dose of Pneumococcal Polysaccharide Vaccine (PPV) in HIV-infected children on anti-HIV therapy is helpful and safe in fighting pneumococcal infections in this group of children. This study will also look at the protection provided by childhood vaccination against measles, pertussis, and hepatitis B virus.

Pneumococcal infections are the most common AIDS-related infection in HIV-infected children. PCV may help reduce the chances of HIV-infected children getting pneumococcal infections. This study will look at whether pneumococcal vaccines are safe and effective in HIV-infected children receiving HAART. It will look at whether HIV-infected children are protected by childhood vaccines received previously and if more doses are safe and improve protection.

Condition	Intervention
HIV Infections Hepatitis B Measles Pneumococcal Infections Pertussis	Biological: Diphtheria & Tetanus Toxoids & Acellular Pertussis Vaccine Adsorbed Biological: Measles-Mumps-Rubella Vaccine (Live) Biological: Pneumococcal Vaccine, Polyvalent (23-valent) Biological: Pneumococcal Conjugate Vaccine, Heptavalent Biological: Hepatitis B Vaccine (Recombinant)

Study Type:	Interventional
Study Design:	Primary Purpose: Prevention
Official Title:	Evaluation of the Immunogenicity of Pneumococcal Conjugate Vaccine and Routine Pediatric Immunizations in HIV-Infected Children Treated With Highly Active Antiretroviral Therapy (HAART)

Resource links provided by NLM:

Genetics Home Reference related topics: complement factor I deficiency

MedlinePlus related topics: Diphtheria HIV/AIDS HIV/AIDS Medicines Hepatitis Hepatitis A Hepatitis B Measles Mumps Pneumococcal Infections Rubella Tetanus Whooping Cough

Drug Information available for: Tetanus Vaccine Recombinant hepatitis B vaccine Heptavalent pneumococcal conjugate vaccine Hepatitis B Vaccines Hepatitis A Vaccines Measles-Mumps-Rubella Vaccine Pneumococcal Vaccines Rubella Vaccine

U.S. FDA Resources

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

Estimated Enrollment:	300
Study Completion Date:	January 2006
Primary Completion Date:	January 2006 (Final data collection date for primary outcome measure)

Detailed Description:

Infection by Streptococcus pneumoniae is the most frequent opportunistic infection observed in HIV-infected children. PCVs are immunogenic and efficacious in normal children and offer hope of reducing pneumococcal infections in HIV-infected children. The degree to which children on HAART are protected by prior immunizations and are responsive to new immunizations is still largely undefined. This study is designed to answer whether PCV immunizations are safe and effective. The immune responses to prior immunizations and responsiveness to booster doses of vaccines against measles, pertussis, and hepatitis B virus of children on HAART will also be examined. Answers to these questions will determine whether these children are likely to be protected against these clinically relevant pathogens and whether they should routinely receive booster doses of these vaccines after a period of HAART.

Patients are stratified on the basis of CD4 percentage and age. Patients that previously received a primary hepatitis B vaccine (HBV) series receive an HBV immunization at entry. Other vaccinations may be given (based on age and/or CD4 cell measurement, and immunization status) for PCV at entry and 2 months, and measles-mumps-rubella (MMR) vaccine and PPV at 4 months. Some patients may be administered DTaP at a 6-month visit on the basis of age, previous immunization history, and negative tetanus antibody status. Follow-up visits are done at 8, 12, and 24 months. Blood samples are collected at all clinic visits for assessment of HIV RNA, immune responses against pneumococcus, measles, pertussis, and hepatitis B virus, as well as for laboratory evaluations.

Eligibility

Ages Eligible for Study:	2 Years to 18 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria

Patients may be eligible for this study if they:

Are 2 to 18 years of age.
Are HIV-infected.
Have a viral load (amount of HIV in the blood) under 60,000 copies/ml within 30 days of study entry.
Have been on their current anti-HIV drugs for at least 3 months.
Have received 4 or more doses of a pertussis vaccine.
Have received 1 or more doses of measles vaccine unless a CD4 percent or CD4 number ruled out taking the vaccine. (This reflects a change in the CD4 requirement.)
Expect to be able to complete all study injections and follow-up.
Have a negative pregnancy test if able to have children and use effective methods of birth control.
Have parent or guardian's consent if under 18 years of age.
Have received an approved hepatitis B vaccine series. Not required for study entry, but children who have received this vaccine will be studied.
(This study was changed to allow patients who became HIV infected after birth, have a viral load between 30,000 and 60,000 copies/ml, and who have been on their current anti-HIV drugs for 3 to 6 months.)

Exclusion Criteria

Patients will not be eligible for this study if they:

Had a certain CD4 level before beginning anti-HIV drugs and at screening.
Have received any killed vaccine within 4 weeks, or any live vaccine within 6 weeks, of entering the study.
Have received pneumococcal vaccines or had a reaction to PPV.
Have had an allergic reaction to any measles or hepatitis B vaccines, or to other routine childhood immunizations if 13 years of age or less.
Have any other condition that would make receiving study vaccines inadvisable.
Are currently on medications that affect the immune system, except for G-CSF and erythropoietin. This includes the equivalent to more than 1 mg/kg/day of prednisone in the 2 weeks preceding study screening. Nonsteroidal anti-inflammatory agents and inhaled corticosteroids are not excluded.
Have received certain blood products within the previous 6 months.
Have other diseases of the immune system.
Have had cancer within 3 months of study screening or are being treated or have been treated for cancer within 3 months of study entry.
Are pregnant.
Have any other disease or previous surgery that would interfere with study treatment.
Are likely to have bleeding disorders.
Show certain side effects to vaccines at screening.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00013871

Show 43 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

More Information

Additional Information:

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

No publications provided by National Institute of Allergy and Infectious Diseases (NIAID)

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Abzug MJ, Warshaw M, Rosenblatt HM, Levin MJ, Nachman SA, Pelton SI, Borkowsky W, Fenton T; International Maternal Pediatric Adolescent AIDS Clinical Trials Group P1024 and P1061s Protocol Teams. Immunogenicity and immunologic memory after hepatitis B virus booster vaccination in HIV-infected children receiving highly active antiretroviral therapy. J Infect Dis. 2009 Sep 15;200(6):935-46.

Abzug MJ, Song LY, Fenton T, Nachman SA, Levin MJ, Rosenblatt HM, Pelton SI, Borkowsky W, Edwards KM, Peters J; International Maternal Pediatric Adolescent AIDS Clinical Trials Group P1024 Protocol Team. Pertussis booster vaccination in HIV-infected children receiving highly active antiretroviral therapy. Pediatrics. 2007 Nov;120(5):e1190-202. Epub 2007 Oct 15.

ClinicalTrials.gov Identifier:	NCT00013871 History of Changes
Other Study ID Numbers:	ACTG P1024, PACTG 1024, DAIDS-ES ID 10609
Study First Received:	March 31, 2001
Last Updated:	August 6, 2009
Health Authority:	United States: Food and Drug Administration

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

Measles-Mumps-Rubella Vaccine
Antibodies, Viral
Hepatitis B Vaccines
Immunization, Secondary

Pneumococcal Vaccines
Antiretroviral Therapy, Highly Active
Diphtheria-Tetanus-acellular Pertussis Vaccines

Additional relevant MeSH terms:

HIV Infections
Acquired Immunodeficiency Syndrome
Hepatitis
Hepatitis A
Hepatitis B
Measles
Whooping Cough
Pneumococcal Infections
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
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
Enterovirus Infections
Picornaviridae Infections
Hepadnaviridae Infections
DNA Virus Infections
Morbillivirus Infections
Paramyxoviridae Infections
Mononegavirales Infections
Bordetella Infections
Gram-Negative Bacterial Infections
Bacterial Infections

ClinicalTrials.gov processed this record on February 12, 2012