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

NCT ID: NCT01484522

Last Updated: 2011-12-02

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

149 participants

Study Classification

OBSERVATIONAL

Study Start Date

2009-10-31

Study Completion Date

2010-09-30

Brief Summary

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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.

Detailed Description

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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.

Conditions

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HIV-1 Infection H1N1 Influenza Flu

Keywords

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Influenza Perinatal immunogenicity Monovalent vaccine Children Youth H1N1 Adolescent Flu

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Group A

Influenza A 2009 Monovalent vaccine

FluMist

Intervention Type BIOLOGICAL

Administered at the manufacture's recommended dose

Group B

Influenza A 2009 monovalent vaccine

Fluvirin

Intervention Type BIOLOGICAL

Vaccine administered at the manufacturer's recommended dose.

Group C

Influenza A 2009 monovalent vaccine

Fluzone

Intervention Type BIOLOGICAL

Vaccine administered at manufacturer's recommended dose

Interventions

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FluMist

Administered at the manufacture's recommended dose

Intervention Type BIOLOGICAL

Fluvirin

Vaccine administered at the manufacturer's recommended dose.

Intervention Type BIOLOGICAL

Fluzone

Vaccine administered at manufacturer's recommended dose

Intervention Type BIOLOGICAL

Eligibility Criteria

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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).
Minimum Eligible Age

6 Months

Maximum Eligible Age

25 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National Institute of Allergy and Infectious Diseases (NIAID)

NIH

Sponsor Role collaborator

International Maternal Pediatric Adolescent AIDS Clinical Trials Group

NETWORK

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Patricia M. Flynn, M.D.

Role: STUDY_CHAIR

St. Jude Childrens Research Hospital

Locations

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Univ. of Alabama Birmingham NICHD CRS (5096)

Birmingham, Alabama, United States

Site Status

USC/Los Angeles County Medical Center NICHD CRS

Los Angeles, California, United States

Site Status

University of California San Francisco NICHD CRS (5091)

San Francisco, California, United States

Site Status

University of Colorado Denver NICHD CRS (5052)

Aurora, Colorado, United States

Site Status

University of Miami Pediatric/Perinatal HIV/AIDS (4201)

Miami, Florida, United States

Site Status

University of South Florida Tampa (5018)

Tampa, Florida, United States

Site Status

Chicago Children's CRS (4001)

Chicago, Illinois, United States

Site Status

Children's Hospital of Boston NICHD CRS (5009)

Boston, Massachusetts, United States

Site Status

WNE Maternal Pediatric Adolescent AIDS CRS

Worcester, Massachusetts, United States

Site Status

Wayne State University/Children's Hospital of Michigan NICHD CRS

Detroit, Michigan, United States

Site Status

NJ Med School CRS (2802)

Newark, New Jersey, United States

Site Status

New York University NY (5012)

New York, New York, United States

Site Status

SUNY Stony Brook (5040)

Stony Brook, New York, United States

Site Status

Jacobi Medical Center Bronx (5013)

The Bronx, New York, United States

Site Status

The Children's Hospital of Philadelphia (6701)

Philadelphia, Pennsylvania, United States

Site Status

St. Jude/UTHSC CRS (6501)

Memphis, Tennessee, United States

Site Status

University of Puerto Rico Pediatric HIV/AIDS Research (6601)

San Juan, , Puerto Rico

Site Status

Countries

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United States Puerto Rico

Other Identifiers

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U01AI068632

Identifier Type: NIH

Identifier Source: secondary_id

View Link

IMPAACT P1089

Identifier Type: -

Identifier Source: org_study_id