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

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
International Maternal Pediatric Adolescent AIDS Clinical Trials Group
ClinicalTrials.gov Identifier:
NCT01484522
First received: September 29, 2011
Last updated: November 30, 2011
Last verified: November 2011
  Purpose

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.


Condition Intervention
HIV-1 Infection
H1N1
Influenza
Flu
Biological: FluMist
Biological: Fluvirin
Biological: Fluzone

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: A Laboratory Study to Assess the Immunogenicity of Three Licensed Influenza A (H1N1) 2009 Monovalent Vaccines in HIV-1 Perinatally Infected Children and Youth

Resource links provided by NLM:


Further study details as provided by International Maternal Pediatric Adolescent AIDS Clinical Trials Group:

Primary Outcome Measures:
  • The short term immune response following immunization with a licensed Influenza A (H1N1) 2009 Monovalent Vaccine administered as a single dose in perinatally HIV-1 infected children and youth aged >10 to <25 years. [ Time Frame: 8 months ] [ Designated as safety issue: No ]
  • The short term immune response following second immunization with a licensed Influenza A (H1N1) 2009 Monovalent Vaccine in perinatally HIV-1 infected children > 6 months to < 10 years of age. [ Time Frame: 8 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • The immune response following first immunization with a licensed Influenza A (H1N1) 2009 monovalent vaccine in children aged > 6 months to < 10 years of age. [ Time Frame: 8 months ] [ Designated as safety issue: No ]
  • Persistence of antibody responses 7 months after receipt of the first immunization with a licensed Influenza A (H1N1) 2009 monovalent vaccine. [ Time Frame: 8 months ] [ Designated as safety issue: No ]
  • Immune responses with CD4+ cell count and timing of seasonal trivalent influenza vaccine (TIV). [ Time Frame: 8 months ] [ Designated as safety issue: No ]
  • Immune responses with CD4 percent and timing of seasonal trivalent influenza vaccine (TIV). [ Time Frame: 8 months ] [ Designated as safety issue: No ]
  • Immune responses with ARV use and timing of seasonal trivalent influenza vaccine (TIV). [ Time Frame: 8 months ] [ Designated as safety issue: No ]
  • Immune responses with plasma HIV-1 RNA concentration and timing of seasonal trivalent influenza vaccine (TIV). [ Time Frame: 8 months ] [ Designated as safety issue: No ]

Enrollment: 149
Study Start Date: October 2009
Study Completion Date: September 2010
Primary Completion Date: January 2010 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Group A
Influenza A 2009 Monovalent vaccine
Biological: FluMist
Administered at the manufacture's recommended dose
Group B
Influenza A 2009 monovalent vaccine
Biological: Fluvirin
Vaccine administered at the manufacturer's recommended dose.
Group C
Influenza A 2009 monovalent vaccine
Biological: Fluzone
Vaccine administered at manufacturer's recommended dose

Detailed Description:

HIV-infected children typically respond poorer to vaccines as compared to normal children. The FDA has currently approved several Influenza A 2009 monovalent vaccines to be used in children and adults. However, little data is available in perinatally infected youth. Therefore, knowledge of the immunogenicity of several of the licensed Influenza A 2009 monovalent vaccines in HIV-infected children and youth is critically important to address the health care needs of this vulnerable population. Efforts are currently underway to evaluate Influenza A 2009 monovalent vaccines in healthy children as well as other populations. This study will assess the immune response following receipt of three Influenza A monovalent vaccines in HIV-1 infected children and youth. Protection of HIV-1 infected children and youth from 2009 H1N1 Influenza A will require knowledge of immunogenicity of these new products in this population. The 2009 (H1N1) Influenza A virus is likely to infect a significant proportion of HIV-1 infected children and youth. Immunogenicity of licensed and commercially available Influenza A 2009 monovalent vaccines must be established in HIV-1 infected children in order to assure that this population is protected. Lack of a protective immune response would support the need for additional measures to protect this high risk population.

  Eligibility

Ages Eligible for Study:   6 Months to 25 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

HIV-1 perinatally infected children and youth 6 months to 25 years of age.

For inclusion into the study, if perinatal acquisition of HIV infection cannot be confirmed based on the child's medical record, it is acceptable to enroll the child if the investigator's assessment is that the most likely route of infection was perinatal.

Criteria

Inclusion Criteria:

  1. Children and youth 6 months to <25 years of age at study entry.
  2. 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
  3. In the opinion of the investigator, the route of HIV-1 transmission is perinatally acquired.
  4. Parent or legal guardian, youth of legal age, or subjects who are emancipated minors, who are willing and able to provide signed informed consent.
  5. 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.

Exclusion Criteria:

  1. Has a history of probable or proven pandemic 2009 H1N1 Influenza A virus infection prior to study entry.
  2. Has received seasonal FluMist vaccine within 2 weeks prior to study entry.
  3. Has received any 2009 H1N1 vaccines prior to the day of entry.
  4. Has received any immunoglobulin or blood products within 3 months prior to study entry.
  5. 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.
  6. 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).
  7. Has an active neoplastic disease.
  8. 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).
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01484522

Locations
United States, Alabama
Univ. of Alabama Birmingham NICHD CRS (5096)
Birmingham, Alabama, United States, 35294
United States, California
USC/Los Angeles County Medical Center NICHD CRS
Los Angeles, California, United States, 90033
University of California San Francisco NICHD CRS (5091)
San Francisco, California, United States, 94143
United States, Colorado
University of Colorado Denver NICHD CRS (5052)
Aurora, Colorado, United States, 80045
United States, Florida
University of Miami Pediatric/Perinatal HIV/AIDS (4201)
Miami, Florida, United States, 33136
University of South Florida Tampa (5018)
Tampa, Florida, United States, 33620
United States, Illinois
Chicago Children's CRS (4001)
Chicago, Illinois, United States, 60614
United States, Massachusetts
Children's Hospital of Boston NICHD CRS (5009)
Boston, Massachusetts, United States, 02115
WNE Maternal Pediatric Adolescent AIDS CRS
Worcester, Massachusetts, United States, 01605
United States, Michigan
Wayne State University/Children's Hospital of Michigan NICHD CRS
Detroit, Michigan, United States, 48201
United States, New Jersey
NJ Med School CRS (2802)
Newark, New Jersey, United States, 07103
United States, New York
Jacobi Medical Center Bronx (5013)
Bronx, New York, United States, 10461
New York University NY (5012)
New York, New York, United States, 10016
SUNY Stony Brook (5040)
Stony Brook, New York, United States, 11794-8111
United States, Pennsylvania
The Children's Hospital of Philadelphia (6701)
Philadelphia, Pennsylvania, United States, 19104
United States, Tennessee
St. Jude/UTHSC CRS (6501)
Memphis, Tennessee, United States, 38105-2794
Puerto Rico
University of Puerto Rico Pediatric HIV/AIDS Research (6601)
San Juan, Puerto Rico, 00936-5067
Sponsors and Collaborators
International Maternal Pediatric Adolescent AIDS Clinical Trials Group
Investigators
Study Chair: Patricia M. Flynn, M.D. St. Jude Childrens Research Hospital
  More Information

No publications provided

Responsible Party: International Maternal Pediatric Adolescent AIDS Clinical Trials Group
ClinicalTrials.gov Identifier: NCT01484522     History of Changes
Other Study ID Numbers: IMPAACT P1089, U01AI068632
Study First Received: September 29, 2011
Last Updated: November 30, 2011
Health Authority: United States: Federal Government

Keywords provided by International Maternal Pediatric Adolescent AIDS Clinical Trials Group:
Influenza
Perinatal
immunogenicity
Monovalent vaccine
Children
Youth
H1N1
Adolescent
Flu

Additional relevant MeSH terms:
Influenza, Human
HIV Infections
Orthomyxoviridae Infections
RNA Virus Infections
Virus Diseases
Respiratory Tract Infections
Respiratory Tract Diseases
Lentivirus Infections
Retroviridae Infections
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases

ClinicalTrials.gov processed this record on July 20, 2014