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

NCT01484522 | Completed DMC

• 2 other identifiers: IMPAACT P1089U01AI068632
• Study Type: observational
• Target: 149
• Locations: 2 countries
• Sites: 17

Brief Summary

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.

Conditions

HIV-1 Infection; H1N1; Influenza; Flu

Keywords

Influenza; Perinatal; immunogenicity; Monovalent vaccine; Children; Youth; H1N1; Adolescent; Flu

Outcome Measures

Primary Outcomes (2)

• 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.

  8 months

• 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.

  8 months

Secondary Outcomes (6)

• 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.

  8 months

• Persistence of antibody responses 7 months after receipt of the first immunization with a licensed Influenza A (H1N1) 2009 monovalent vaccine.

  8 months

• Immune responses with CD4+ cell count and timing of seasonal trivalent influenza vaccine (TIV).

  8 months

• Immune responses with CD4 percent and timing of seasonal trivalent influenza vaccine (TIV).

  8 months

• Immune responses with ARV use and timing of seasonal trivalent influenza vaccine (TIV).

  8 months

Study Arms (3)

Group A

Influenza A 2009 Monovalent vaccine

Biological: FluMist

Group B

Influenza A 2009 monovalent vaccine

Biological: Fluvirin

Group C

Influenza A 2009 monovalent vaccine

Biological: Fluzone

Interventions

FluMist BIOLOGICAL

Administered at the manufacture's recommended dose

Group A

Fluvirin BIOLOGICAL

Vaccine administered at the manufacturer's recommended dose.

Group B

Fluzone BIOLOGICAL

Vaccine administered at manufacturer's recommended dose

Group C

Eligibility Criteria

• Age: 6 Months - 25 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)
• 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.

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).

Sponsors & Collaborators

• International Maternal Pediatric Adolescent AIDS Clinical Trials Group: lead
• National Institute of Allergy and Infectious Diseases (NIAID): collaborator

Study Sites (17)

Univ. of Alabama Birmingham NICHD CRS (5096)

Birmingham, Alabama, 35294, United States

Location

USC/Los Angeles County Medical Center NICHD CRS

Los Angeles, California, 90033, United States

Location

University of California San Francisco NICHD CRS (5091)

San Francisco, California, 94143, United States

Location

University of Colorado Denver NICHD CRS (5052)

Aurora, Colorado, 80045, United States

Location

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

Miami, Florida, 33136, United States

Location

University of South Florida Tampa (5018)

Tampa, Florida, 33620, United States

Location

Chicago Children's CRS (4001)

Chicago, Illinois, 60614, United States

Location

Children's Hospital of Boston NICHD CRS (5009)

Boston, Massachusetts, 02115, United States

Location

WNE Maternal Pediatric Adolescent AIDS CRS

Worcester, Massachusetts, 01605, United States

Location

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

Detroit, Michigan, 48201, United States

Location

NJ Med School CRS (2802)

Newark, New Jersey, 07103, United States

Location

New York University NY (5012)

New York, New York, 10016, United States

Location

SUNY Stony Brook (5040)

Stony Brook, New York, 11794-8111, United States

Location

Jacobi Medical Center Bronx (5013)

The Bronx, New York, 10461, United States

Location

The Children's Hospital of Philadelphia (6701)

Philadelphia, Pennsylvania, 19104, United States

Location

St. Jude/UTHSC CRS (6501)

Memphis, Tennessee, 38105-2794, United States

Location

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

San Juan, 00936-5067, Puerto Rico

Location

MeSH Terms

Conditions

Influenza, Human

Interventions

FluMist; Influenza Vaccines

Condition Hierarchy (Ancestors)

Respiratory Tract Infections; Infections; Orthomyxoviridae Infections; RNA Virus Infections; Virus Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Viral Vaccines; Vaccines; Biological Products; Complex Mixtures

Study Officials

• Patricia M. Flynn, M.D.

  St. Jude Childrens Research Hospital

  STUDY CHAIR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: NETWORK
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 29, 2011
• First Posted: December 2, 2011
• Study Start: October 1, 2009
• Primary Completion: January 1, 2010
• Study Completion: September 1, 2010
• Last Updated: December 2, 2011

Record last verified: 2011-11

Locations

US (16); PR (1)