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

Completed · Not applicable

Conditions studied: HIV Infections, Hepatitis B, Measles, Pneumococcal Infections, Pertussis

In brief

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.

Key facts

Study ID

NCT00013871

Run by

National Institute of Allergy and Infectious Diseases (NIAID)

People needed

300

Expected to finish

2004-11-01

Last updated by the study team

2021-11-01

Who can join

Age: 2 and older, up to 18. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.)

You may not qualify if…

• 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.

Where it is running

• UAB, Dept. of Ped., Div. of Infectious Diseases — Birmingham, Alabama, 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
• Children's Hosp. & Research Ctr. Oakland, Ped. Clinical Research Ctr. & Research Lab. — Oakland, California, United States
• UCSD Mother-Child-Adolescent Program CRS — San Diego, California, United States
• UCSF Pediatric AIDS CRS — San Francisco, California, United States
• Univ. of Colorado Denver NICHD CRS — Aurora, Colorado, United States
• Connecticut Children's Med. Ctr. — Hartford, Connecticut, United States
• Yale Univ. School of Medicine - Dept. of Peds., Div. of Infectious Disease — New Haven, Connecticut, United States
• Children's National Med. Ctr. Washington DC NICHD CRS — Washington D.C., District of Columbia, 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
• Univ. of Florida Jacksonville NICHD CRS — Jacksonville, Florida, United States
• Univ. of Miami Ped. Perinatal HIV/AIDS CRS — Miami, Florida, United States
• Columbus Regional HealthCare System, The Med. Ctr. — Columbus, Georgia, United States
• Univ. of Chicago - Dept. of Peds., Div. of Infectious Disease — Chicago, Illinois, United States
• Chicago Children's CRS — Chicago, Illinois, United States
• Univ. of Maryland Med. Ctr., Div. of Ped. Immunology & Rheumatology — Baltimore, Maryland, United States
• Johns Hopkins Hosp. & Health System - Dept. of Peds., Div. of Infectious Diseases — Baltimore, Maryland, United States
• HMS - Children's Hosp. Boston, Div. of Infectious Diseases — Boston, Massachusetts, United States
• BMC, Div. of Ped Infectious Diseases — Boston, Massachusetts, United States
• Baystate Health, Baystate Med. Ctr. — Springfield, Massachusetts, United States
• WNE Maternal Pediatric Adolescent AIDS CRS — Worcester, Massachusetts, United States
• Rutgers - New Jersey Medical School CRS — Newark, New Jersey, United States
• SUNY Downstate Med. Ctr., Children's Hosp. at Downstate NICHD CRS — Brooklyn, New York, United States

Full record on ClinicalTrials.gov

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