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Ensayos clínicos

Ensayos clínicos

Safety of and Immune Response to an H1N1 Influenza Virus Vaccine in HIV Infected Children and Youth

Patrocinador(es) del estudio: National Institute of Allergy and Infectious Diseases (NIAID)
Números de identificación: NCT00992836, IMPAACT P1088
  • Concluido

Propósito del estudio

Children and people infected with HIV are particularly susceptible to influenza infections. This study will test the safety and effectiveness of a vaccine for the new H1N1 influenza virus in children and youth infected with HIV.

Afección:Fase:
Infecciones por el VIH
Influenza H1N1
Fase 2

Detalles del estudio

The new H1N1 influenza virus seen in 2009 has been designated a pandemic by the World Health

Organization, due to the sustained community outbreaks seen in the United States and Mexico.

Based on preliminary data, it appears children and young adults are particularly at risk of

the H1N1 virus. People infected with HIV are also more susceptible to severe influenza

infections than those who are uninfected. Children with HIV infection, then, have a

compounded risk of H1N1 infection. Higher doses of influenza vaccines are associated with

the development of higher levels of serum antibodies, which are needed to resist infection.

Higher vaccine doses can be used to improve vaccine effectiveness in at-risk populations.

This study will test the safety and immune response of HIV infected children and youth to a

high dose of a vaccine for the new H1N1 influenza virus.



Participation in this study will last 7 months and have two steps. The first step involves

receiving the first dose of H1N1 virus vaccine, and the second step, occurring 21 days

later, involves receiving the second dose of vaccine. Each dose of vaccine will be delivered

via two intramuscular shots (four total injections). After receiving each dose of the

vaccine, participants will be given a diary to record any symptoms or reactions.

Participants will be stratified into three groups by age, including 4 to 9 years, 9 to 18

years, and 18 to 25 years.



Participants will complete five scheduled visits, taking place at screening, study entry,

Days 21 and 31, and after 7 months. Measurements taken on these visits will include a

medical history, physical and neurological exams, a blood draw, and, when applicable, a

pregnancy test. In addition to these visits, participants may receive up to three additional

phone calls or visits occurring 2 and 10 days after the first dose of vaccine and 2 days

after the second dose of vaccine to check for reactions to the vaccine.The new H1N1 influenza virus seen in 2009 has been designated a pandemic by the World Health

Organization, due to the sustained community outbreaks seen in the United States and Mexico.

Based on preliminary data, it appears children and young adults are particularly at risk of

the H1N1 virus. People infected with HIV are also more susceptible to severe influenza

infections than those who are uninfected. Children with HIV infection, then, have a

compounded risk of H1N1 infection. Higher doses of influenza vaccines are associated with

the development of higher levels of serum antibodies, which are needed to resist infection.

Higher vaccine doses can be used to improve vaccine effectiveness in at-risk populations.

This study will test the safety and immune response of HIV infected children and youth to a

high dose of a vaccine for the new H1N1 influenza virus.



Participation in this study will last 7 months and have two steps. The first step involves

receiving the first dose of H1N1 virus vaccine, and the second step, occurring 21 days

later, involves receiving the second dose of vaccine. Each dose of vaccine will be delivered

via two intramuscular shots (four total injections). After receiving each dose of the

vaccine, participants will be given a diary to record any symptoms or reactions.

Participants will be stratified into three groups by age, including 4 to 9 years, 9 to 18

years, and 18 to 25 years.



Participants will complete five scheduled visits, taking place at screening, study entry,

Days 21 and 31, and after 7 months. Measurements taken on these visits will include a

medical history, physical and neurological exams, a blood draw, and, when applicable, a

pregnancy test. In addition to these visits, participants may receive up to three additional

phone calls or visits occurring 2 and 10 days after the first dose of vaccine and 2 days

after the second dose of vaccine to check for reactions to the vaccine.

Criterios de inclusión

    for Step I:
    • HIV infected
    • HIV-1 was perinatally acquired, in the opinion of the investigator
    • Participants receiving antiretrovirals (ARVs) must have been receiving a stable
    regimen for 90 days prior to entry with no intention to modify their regimen within 60 days following study entry
    • Participants not receiving ARVs at entry must not have received ARVs within 90 days
    prior to entry and must NOT plan to initiate ARVs within 60 days following study entry
    • Ability to complete all study immunizations and evaluations, in the opinion of the
    investigator
    • Agrees to use contraception, if necessary
    • Documented platelet count of more than 50,000 per mm3 and an absolute neutrophil
    count (ANC) of more than 500 per mm3 within the 30 days prior to study entry
    • Youth of legal age (from 18 to 25 years of age), parent or legal guardian, or
    participants who are emancipated minors must provide informed consent for Step II:
    • Received the first dose of Influenza A (H1N1) 2009 monovalent vaccine at least 21
    days ago
    • Documented platelet count of more than 50,000 per mm3 and an ANC of more than 500 per
    mm3 within the 30 days prior to Step II entry
    • If a woman became pregnant after Dose #1, she must be at more than 14 weeks of
    gestation and have her obstetrician's permission to receive the vaccine

Criterios de exclusión

    for Step I:
    • Pregnancy
    • Known allergy to egg protein (egg or egg product) or other components in the vaccines
    (these may include, but are not limited to: neomycin and polymyxin)
    • History, in the opinion of the site investigator, of severe reactions following
    previous immunization with seasonal influenza vaccines that would contraindicate receipt of any influenza vaccine.
    • History of probable or proven pandemic 2009 Influenza A (H1N1) infection prior to
    study entry
    • Has received any live licensed vaccine within 4 weeks or inactivated licensed vaccine
    within 2 weeks prior to study entry
    • Has received a nonlicensed agent (vaccine, drug, biologic, device, blood product, or
    medication) within 4 weeks prior to study entry or expects to receive another nonlicensed agent during the course of the study
    • Has an acute illness or a documented temperature greater than or equal to 100.0
    degrees Fahrenheit within 24 hours prior to study entry
    • 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 (at least 2 mg/kg per day or at least 20 mg total dose) for more than 2 weeks in the past 6 months or high-dose inhaled steroids (more than 800 mcg/day of beclomethasone dipropionate or equivalent) within the preceding 6 months. Nasal and topical steroids are allowed.
    • Has received immunoglobulin or other blood products within the 3 months prior to
    study entry
    • History of Guillain-Barre syndrome in the subject or subject's family, including
    parents, siblings, half-siblings, and children
    • Onset of a neurological disorder including (but not limited to) absent ankle and
    patellar deep tendon reflexes in both legs (all four absent) within the past 6 months
    • Disproportionate loss of strength in lower extremity or extremities compared to the
    upper extremities within the past 6 months
    • Has any condition that would, in the opinion of the site investigator, place the
    participant at an unacceptable risk of injury or render the participant unable to meet the requirements of the protocol

Centros de estudio/contactos

Alabama

    UAB Pediatric Infectious Diseases CRS, Birmingham, Alabama, 35233, United States

California

    Usc La Nichd Crs, Alhambra, California, 91803, United States

    University of California, UC San Diego CRS, La Jolla, California, 92093-0672, United States

    Miller Children's Hosp. Long Beach CA NICHD CRS, Long Beach, California, 90806, United States

    UCLA-Los Angeles/Brazil AIDS Consortium (LABAC) CRS, Los Angeles, California, 90095-1752, United States

    Univ. of California San Francisco NICHD CRS, San Francisco, California, 94143, United States

    Harbor UCLA Medical Ctr. NICHD CRS, Torrance, California, 90502, United States

Colorado

    Univ. of Colorado Denver NICHD CRS, Aurora, Colorado, 80045, United States

District of Columbia

    Children's National Med. Ctr. Washington DC NICHD CRS, Washington, District of Columbia, 20010, United States

    Howard Univ. Washington DC NICHD CRS, Washington, District of Columbia, 20060, United States

Florida

    South Florida CDTC Ft Lauderdale NICHD CRS, Fort Lauderdale, Florida, 33316, United States

    Univ. of Florida Jacksonville NICHD CRS, Jacksonville, Florida, 32209, United States

    Pediatric Perinatal HIV Clinical Trials Unit CRS, Miami, Florida, 33136, United States

    USF - Tampa NICHD CRS, Tampa, Florida, 33606, United States

Illinois

    Ann & Robert H. Lurie Children's Hospital of Chicago (LCH) CRS, Chicago, Illinois, 60614-3393, United States

    Rush Univ. Cook County Hosp. Chicago NICHD CRS, Chicago, Illinois, 60612, United States

Maryland

    Johns Hopkins Univ. Baltimore NICHD CRS, Baltimore, Maryland, 21287, United States

    Univ. of Maryland Baltimore NICHD CRS, Baltimore, Maryland, 21201, United States

Massachusetts

    Children's Hosp. of Boston NICHD CRS, Boston, Massachusetts, 02115, United States

    Boston Medical Center Ped. HIV Program NICHD CRS, Boston, Massachusetts, 02118, United States

    WNE Maternal Pediatric Adolescent AIDS CRS, Worcester, Massachusetts, 01605, United States

Michigan

    Children's Hospital of Michigan NICHD CRS, Detroit, Michigan, 48201, United States

New Jersey

    Rutgers - New Jersey Medical School CRS, Newark, New Jersey, 01703, United States

New York

    Bronx-Lebanon CRS, Bronx, New York, 10457, United States

    Jacobi Med. Ctr. Bronx NICHD CRS, Bronx, New York, 10461, United States

    Columbia IMPAACT CRS, New York, New York, 10032, United States

    Metropolitan Hosp. NICHD CRS, New York, New York, 10029, United States

    Nyu Ny Nichd Crs, New York, New York, 10016, United States

    Strong Memorial Hospital Rochester NY NICHD CRS, Rochester, New York, 14642, United States

    SUNY Stony Brook NICHD CRS, Stony Brook, New York, 11794-8111, United States

North Carolina

    DUMC Ped. CRS, Durham, North Carolina, 27710, United States

Pennsylvania

    The Children's Hosp. of Philadelphia IMPAACT CRS, Philadelphia, Pennsylvania, 19104, United States

Tennessee

    St. Jude Children's Research Hospital CRS, Memphis, Tennessee, 38105-3678, United States

Texas

    Texas Children's Hospital CRS, Houston, Texas, 77030-2399, United States

Washington

    Seattle Children's Research Institute CRS, Seattle, Washington, 98101, United States

    San Juan City Hosp. PR NICHD CRS, San Juan, Washington, 00936, Puerto Rico

    University of Puerto Rico Pediatric HIV/AIDS Research Program CRS, San Juan, Washington, 00935, Puerto Rico

Actualizado: 9 de diciembre del 2009

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