Pneumococcal Vaccine and Routine Pediatric Immunizations in HIV-Infected Children Receiving Anti-HIV Drugs

HIV Infections Clinical Trial

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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00013871
• Other study ID #: P1024
• Secondary ID: PACTG 102410609A
• Status: Completed
• Phase: N/A
• Est. completion date: November 2004

Study information

• Verified date: October 2021
• Source: National Institute of Allergy and Infectious Diseases (NIAID)
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 300
• Est. completion date: November 2004
• Accepts healthy volunteers: No
• Gender: All
• Age group: 2 Years to 18 Years

Eligibility

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.

Related Conditions & MeSH terms

• Communicable Diseases
• Hepatitis
• Hepatitis B
• HIV Infections
• Infections
• Measles
• Pertussis
• Pneumococcal Infections
• Whooping Cough

Intervention

Biological:
• Diphtheria & Tetanus Toxoids & Acellular Pertussis Vaccine Adsorbed

• Measles-Mumps-Rubella Vaccine (Live)

• Pneumococcal Vaccine, Polyvalent (23-valent)

• Pneumococcal Conjugate Vaccine, Heptavalent

• Hepatitis B Vaccine (Recombinant)

Locations

Country	Name	City	State
Puerto Rico	San Juan City Hosp. PR NICHD CRS	San Juan
Puerto Rico	Univ. of Puerto Rico Ped. HIV/AIDS Research Program CRS	San Juan
United States	Univ. of Colorado Denver NICHD CRS	Aurora	Colorado
United States	Johns Hopkins Hosp. & Health System - Dept. of Peds., Div. of Infectious Diseases	Baltimore	Maryland
United States	Univ. of Maryland Med. Ctr., Div. of Ped. Immunology & Rheumatology	Baltimore	Maryland
United States	UAB, Dept. of Ped., Div. of Infectious Diseases	Birmingham	Alabama
United States	BMC, Div. of Ped Infectious Diseases	Boston	Massachusetts
United States	HMS - Children's Hosp. Boston, Div. of Infectious Diseases	Boston	Massachusetts
United States	Bronx-Lebanon Hosp. IMPAACT CRS	Bronx	New York
United States	Montefiore Med. Ctr. - AECOM	Bronx	New York
United States	SUNY Downstate Med. Ctr., Children's Hosp. at Downstate NICHD CRS	Brooklyn	New York
United States	Chicago Children's CRS	Chicago	Illinois
United States	Univ. of Chicago - Dept. of Peds., Div. of Infectious Disease	Chicago	Illinois
United States	Columbus Regional HealthCare System, The Med. Ctr.	Columbus	Georgia
United States	South Florida CDTC Ft Lauderdale NICHD CRS	Fort Lauderdale	Florida
United States	Univ. of Florida College of Medicine-Dept of Peds, Div. of Immunology, Infectious Diseases & Allergy	Gainesville	Florida
United States	Connecticut Children's Med. Ctr.	Hartford	Connecticut
United States	Texas Children's Hosp. CRS	Houston	Texas
United States	Univ. of Florida Jacksonville NICHD CRS	Jacksonville	Florida
United States	Long Beach Memorial Med. Ctr., Miller Children's Hosp.	Long Beach	California
United States	Usc La Nichd Crs	Los Angeles	California
United States	Univ. of Miami Ped. Perinatal HIV/AIDS CRS	Miami	Florida
United States	Yale Univ. School of Medicine - Dept. of Peds., Div. of Infectious Disease	New Haven	Connecticut
United States	Schneider Children's Hosp., Div. of Infectious Diseases	New Hyde Park	New York
United States	Columbia IMPAACT CRS	New York	New York
United States	Cornell Univ., Div. of Ped. Infectious Diseases & Immunology	New York	New York
United States	Harlem Hosp. Ctr. NY NICHD CRS	New York	New York
United States	Metropolitan Hosp. Ctr.	New York	New York
United States	Nyu Ny Nichd Crs	New York	New York
United States	St. Luke's-Roosevelt Hosp. Ctr.	New York	New York
United States	Rutgers - New Jersey Medical School CRS	Newark	New Jersey
United States	Children's Hosp. & Research Ctr. Oakland, Ped. Clinical Research Ctr. & Research Lab.	Oakland	California
United States	St. Christopher's Hosp. for Children	Philadelphia	Pennsylvania
United States	Strong Memorial Hospital Rochester NY NICHD CRS	Rochester	New York
United States	UCSD Mother-Child-Adolescent Program CRS	San Diego	California
United States	UCSF Pediatric AIDS CRS	San Francisco	California
United States	Baystate Health, Baystate Med. Ctr.	Springfield	Massachusetts
United States	SUNY Stony Brook NICHD CRS	Stony Brook	New York
United States	Children's National Med. Ctr. Washington DC NICHD CRS	Washington	District of Columbia
United States	WNE Maternal Pediatric Adolescent AIDS CRS	Worcester	Massachusetts

Sponsors (2)

Lead Sponsor	Collaborator
National Institute of Allergy and Infectious Diseases (NIAID)	Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Countries where clinical trial is conducted

United States,  Puerto Rico, 

External Links

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