Safety of and Immunogenicity to an H1N1 Influenza Vaccine in HIV-infected Adults
- Conditions
- HIV Infection
- Interventions
- Biological: Adjuvanted vaccine against H1N1 influenza virus (GSK)
- Registration Number
- NCT01155037
- Lead Sponsor
- Oswaldo Cruz Foundation
- Brief Summary
This is a randomized, open label, phase II trial to evaluate the safety and immunogenicity of two different schedules of vaccination against influenza A H1N1 in HIV-infected individuals, in which each of the randomized groups will be compared with HIV-negative volunteers vaccinated with the regimen indicated by the Brazilian National Immunization Program. Will be included in the study HIV-infected patients, stratified by CD4 count (\< 200 cells/mm3 or \> 200 cells/mm3) at the time of screening for the study, not receiving antiretroviral therapy treatment or receiving stable treatment for at least 8 weeks, with no plans to change over the next 6 months, eligible to receive vaccine against influenza A H1N1. The control group will be formed by HIV-negative individuals, confirmed by serology performed at screening, eligible to receive vaccine against influenza A H1N1. Patients infected with HIV will receive one of two possible vaccination regimens: 1) 3.75 µg in two applications 21 days apart, 2) 7.5 µg in two applications 21 days apart. The volunteers in the control group will receive a single application of 3.75 µg dose of the vaccine. The study's hypotheses are: 1) The vaccine against the H1N1 virus promotes antibody titers above the level specified for protection (seroconversion), being as safe and well tolerated in patients HIV-1 infected as in non HIV-infected volunteers; 2) The proportion of seroconversion for H1N1 virus vaccine at a dose of 3.75 µg in HIV-1-infected patients is similar to the proportion of seroconversion induced by the same vaccine at a dose of 7.5 µg; 3)The proportion of seroconversion with one dose of the vaccine against H1N1 virus is similar to the proportion after the second dose.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 450
Not provided
- Use of any systemic anticancer or immunomodulator treatment, corticosteroid, experimental vaccines, interleukins, interferons, growth factors or intravenous immunoglobulin (IVIG) within 45 days prior to entry into the study.
- Pregnancy or lactation.
- Allergy and/or sensitivity or any known hypersensitivity to residues present in the vaccine (egg, chicken protein, egg albumin, formaldehyde, gentamicin sulphate and sodium deoxycholate) and/or thimerosal.
- Use of alcohol or addiction or other conditions which in the opinion of the site's investigator, may interfere with compliance to the study requirements.
D5. Serious illness requiring systemic treatment and/or hospitalization within 45 days prior to entry into the study
- Severe febrile illness or acute infection at the time of screening for the study and/or days of vaccination
- Vaccination against seasonal influenza in the last 12 months prior to study entry
- Previous vaccination against influenza A H1N1
- History or family history of Guillain-Barré Syndrome (parents, siblings, half-siblings or children).
- Diagnosis of neurological condition including (but not limited to) the absence of deep tendon reflexes, Achilles and patellar, in both legs (four missing) in the last six months.
- Disproportionate force loss in lower limb(s) compared to the upper limbs in the last six months.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description 7.5 µg of the vaccine on days 0 and 21 Adjuvanted vaccine against H1N1 influenza virus (GSK) Patients infected with HIV will receive 7.5µg of an adjuvanted A H1N1 vaccine in two applications 21 days apart. 3.75 µg of the vaccine on days 0 and 21 Adjuvanted vaccine against H1N1 influenza virus (GSK) Patients infected with HIV will receive 3.75 µg of an adjuvanted A H1N1 vaccine in two applications 21 days apart. 3.75 µg of the vaccine on day 0 Adjuvanted vaccine against H1N1 influenza virus (GSK) The volunteers in the control group will receive a single application of 3.75 µg dose of the vaccine.
- Primary Outcome Measures
Name Time Method proportions of seroconversion 21 days after vaccination regimen proportions of seroconversion for influenza A H1N1 in each of the four subsets of HIV-positive patients, and in the control group
Safety of the A H1N1 vaccine at two different regimens in HIV-infected adults 1 months after vaccination Safety and tolerability of the vaccine against H1N1 virus in different doses and administration regimens in IV-infected adults
proportions of seroprotection 21 days after vaccination regimen proportions of seroprotection for influenza A H1N1 in each of the four subsets of HIV-positive patients and in the control group
- Secondary Outcome Measures
Name Time Method Cellular immune responses to H1N1 vaccination in HIV-infected patients 12 months after vaccination Determine the cellular immune responses and their correlation to the development and magnitude of responses to H1N1 virus, and compare the cellular immune responses
Changes in HIV viral load and CD4 12 months after vaccination Assess changes in HIV-1 viral load and CD4+ counts after the vaccine series.
Prevalence of A H1N1 influenza symptomatic disease in the study population 12 months after vaccination proportions of the vaccine's protective factor against influenza A H1N1 in each of the four subsets of HIV-positive patients and in the control group
Persistence of antibodies against H1N1 virus 12 months after vaccination Evaluate the persistence of antibody titers against H1N1 virus after the vaccine series in HIV-infected patients and control group
Trial Locations
- Locations (1)
Instituto de Pesquisa Clinica Evandro Chagas (IPEC) - Fiocruz
🇧🇷Rio de Janeiro, Brazil