Laboratory Study of Licensed H1N1 Influenza Vaccines in HIV-1 Perinatally Infected Children and Youth

Completed

Conditions studied: HIV-1 Infection, H1N1, Influenza, Flu

In brief

The purpose of this research study is to evaluate the immune response to the H1N1 influenza or "flu" vaccine. The "immune response" is how your body recognizes and defends itself against bacteria, viruses, and substances that may be harmful to the body. HIV-1 infected children typically respond more poorly to vaccines compared to uninfected, healthy children and so this study hopes to learn whether or not the body will successfully produce enough antibodies (proteins that fight infection) that will prevent or fight the H1N1 flu virus. There is no information yet on the safety or immune response to this vaccine in children infected with HIV.

Key facts

Study ID: NCT01484522
Run by: International Maternal Pediatric Adolescent AIDS Clinical Trials Group
People needed: 149
Starts: 2009-10-01
Expected to finish: 2010-09-01
Last updated by the study team: 2011-12-02

Who can join

Age: 1 and older, up to 25. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

Children and youth 6 months to <25 years of age at study entry.
HIV infection, defined as positive test results obtained from 2 different samples. Tests may include two of the same type OR two different types of tests listed below, as long as there are positive test results obtained from 2 different samples:
HIV-1 antibody (ELISA + WB), obtained at age >18 months
HIV-1 culture, any age
HIV-1 DNA PCR, any age
HIV-1 RNA PCR >10,000 copies/mL, any age
Neutralizable HIV-1 p24 antigen obtained >28 days of age
In the opinion of the investigator, the route of HIV-1 transmission is perinatally acquired.
Parent or legal guardian, youth of legal age, or subjects who are emancipated minors, who are willing and able to provide signed informed consent.
Planned receipt of one of the following FDA licensed Influenza A (H1N1) 2009 Monovalent Vaccines within 24 hours following study entry:
Group A: Influenza A (H1N1) 2009 Monovalent Vaccine (MedImmune FluMist®)
Group B: Influenza A (H1N1) 2009 Monovalent Vaccine (Novartis Fluvirin®)
Group C: Influenza A (H1N1) 2009 Monovalent Vaccine (Sanofi Pasteur Fluzone®) *OR has received one of the above vaccines within 4 hours prior to study entry.

You may not qualify if…

Has a history of probable or proven pandemic 2009 H1N1 Influenza A virus infection prior to study entry.
Has received seasonal FluMist vaccine within 2 weeks prior to study entry.
Has received any 2009 H1N1 vaccines prior to the day of entry.
Has received any immunoglobulin or blood products within 3 months prior to study entry.
Has any condition that would, in the opinion of the site investigator, place the subject at an unacceptable risk of injury or render the subject unable to meet the requirements of the study.
Use of anti-cancer chemotherapy or radiation therapy within the 36 months preceding study entry, or has immunosuppression as a result of an underlying illness or treatment (other than HIV-1 infection).
Has an active neoplastic disease.
Long term use of glucocorticoids, including oral or parenteral prednisone or equivalent (more than or equal to 2 mg/kg per day or more than or equal to 20 mg total dose) for more than 2 weeks in the past 6 months, or high-dose inhaled steroids (>800 mcg/day of beclomethasone dipropionate or equivalent) within the preceding 6 months (nasal and topical steroids are allowed).

Where it is running

Univ. of Alabama Birmingham NICHD CRS (5096) — Birmingham, Alabama, United States
USC/Los Angeles County Medical Center NICHD CRS — Los Angeles, California, United States
University of California San Francisco NICHD CRS (5091) — San Francisco, California, United States
University of Colorado Denver NICHD CRS (5052) — Aurora, Colorado, United States
University of Miami Pediatric/Perinatal HIV/AIDS (4201) — Miami, Florida, United States
University of South Florida Tampa (5018) — Tampa, Florida, United States
Chicago Children's CRS (4001) — Chicago, Illinois, United States
Children's Hospital of Boston NICHD CRS (5009) — Boston, Massachusetts, United States
WNE Maternal Pediatric Adolescent AIDS CRS — Worcester, Massachusetts, United States
Wayne State University/Children's Hospital of Michigan NICHD CRS — Detroit, Michigan, United States
NJ Med School CRS (2802) — Newark, New Jersey, United States
New York University NY (5012) — New York, New York, United States
SUNY Stony Brook (5040) — Stony Brook, New York, United States
Jacobi Medical Center Bronx (5013) — The Bronx, New York, United States
The Children's Hospital of Philadelphia (6701) — Philadelphia, Pennsylvania, United States
St. Jude/UTHSC CRS (6501) — Memphis, Tennessee, United States
University of Puerto Rico Pediatric HIV/AIDS Research (6601) — San Juan, Puerto Rico

Full record on ClinicalTrials.gov

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