Phase 2 Study to Evaluate the Safety of and the Immunogenicity to an Adjuvanted A(H1N1)v Influenza Vaccine in HIV-Infected Adults
Overview
- Phase
- Phase 2
- Intervention
- Not specified
- Conditions
- HIV Infection
- Sponsor
- Oswaldo Cruz Foundation
- Enrollment
- 450
- Locations
- 1
- Primary Endpoint
- proportions of seroconversion
- Status
- Completed
- Last Updated
- 7 years ago
Overview
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.
Investigators
Marilia Santini de Oliveira
Medical doctor
Oswaldo Cruz Foundation
Eligibility Criteria
Inclusion Criteria
- Not provided
Exclusion Criteria
- •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.
- •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.
Outcomes
Primary Outcomes
proportions of seroconversion
Time Frame: 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
Time Frame: 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
Time Frame: 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 Outcomes
- Cellular immune responses to H1N1 vaccination in HIV-infected patients(12 months after vaccination)
- Changes in HIV viral load and CD4(12 months after vaccination)
- Prevalence of A H1N1 influenza symptomatic disease in the study population(12 months after vaccination)
- Persistence of antibodies against H1N1 virus(12 months after vaccination)