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

• Register: ClinicalTrials.gov
• Last refreshed on: 17 October 2012
• Main ID: NCT01484522
• Date of registration: 29/09/2011
• Primary sponsor: International Maternal Pediatric Adolescent AIDS Clinical Trials Group
• Public title: Laboratory Study of Licensed H1N1 Influenza Vaccines in HIV-1 Perinatally Infected Children and Youth
• Scientific 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
• Date of first enrolment: October 2009
• Target sample size: 149
• Recruitment status: Completed
• URL: http://clinicaltrials.gov/show/NCT01484522
• Study type: Observational
• Study design: Observational Model: Cohort, Time Perspective: Prospective

Countries of recruitment

Puerto Rico, United States

Contacts

• Name: Patricia M. Flynn, M.D.
• Affiliation: St. Jude Childrens Research Hospital

Key inclusion & exclusion 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).



Age minimum: 6 Months
Age maximum: 25 Years
Gender: Both

Health Condition(s) or Problem(s) studied

Flu

H1N1

HIV-1 Infection

Influenza

Intervention(s)

Biological: FluMist

Biological: Fluvirin

Biological: Fluzone

Primary Outcome(s)

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]

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]

Secondary Outcome(s)

Immune responses with ARV use and timing of seasonal trivalent influenza vaccine (TIV). [Time Frame: 8 months]

Immune responses with CD4 percent and timing of seasonal trivalent influenza vaccine (TIV). [Time Frame: 8 months]

Immune responses with CD4+ cell count and timing of seasonal trivalent influenza vaccine (TIV). [Time Frame: 8 months]

Immune responses with plasma HIV-1 RNA concentration and timing of seasonal trivalent influenza vaccine (TIV). [Time Frame: 8 months]

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]

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]

Secondary ID(s)

IMPAACT P1089

U01AI068632

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

National Institute of Allergy and Infectious Disease (NIAID)