Trial record 13 of 34 for:    " June 16, 2010":" July 16, 2010"[FIRST-RECEIVED-DATE]AND HIV[CONDITION]

Safety of and Immunogenicity to an H1N1 Influenza Vaccine in HIV-infected Adults (VIP-H1N1)

The recruitment status of this study is unknown because the information has not been verified recently.
Verified March 2012 by Oswaldo Cruz Foundation.
Recruitment status was  Active, not recruiting
Sponsor:
Collaborator:
Ministry of Health, Brazil
Information provided by (Responsible Party):
Marilia Santini de Oliveira, Oswaldo Cruz Foundation
ClinicalTrials.gov Identifier:
NCT01155037
First received: June 29, 2010
Last updated: March 22, 2012
Last verified: March 2012
  Purpose

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.


Condition Intervention Phase
HIV Infection
Biological: Adjuvanted vaccine against H1N1 influenza virus (GSK)
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: Phase 2 Study to Evaluate the Safety of and the Immunogenicity to an Adjuvanted A(H1N1)v Influenza Vaccine in HIV-Infected Adults

Resource links provided by NLM:


Further study details as provided by Oswaldo Cruz Foundation:

Primary Outcome Measures:
  • proportions of seroconversion [ Time Frame: 21 days after vaccination regimen ] [ Designated as safety issue: No ]
    proportions of seroconversion for influenza A H1N1 in each of the four subsets of HIV-positive patients, and in the control group

  • proportions of seroprotection [ Time Frame: 21 days after vaccination regimen ] [ Designated as safety issue: No ]
    proportions of seroprotection 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 ] [ Designated as safety issue: Yes ]
    Safety and tolerability of the vaccine against H1N1 virus in different doses and administration regimens in IV-infected adults


Secondary Outcome Measures:
  • Prevalence of A H1N1 influenza symptomatic disease in the study population [ Time Frame: 12 months after vaccination ] [ Designated as safety issue: No ]
    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 [ Time Frame: 12 months after vaccination ] [ Designated as safety issue: No ]
    Evaluate the persistence of antibody titers against H1N1 virus after the vaccine series in HIV-infected patients and control group

  • Changes in HIV viral load and CD4 [ Time Frame: 12 months after vaccination ] [ Designated as safety issue: No ]
    Assess changes in HIV-1 viral load and CD4+ counts after the vaccine series.

  • Cellular immune responses to H1N1 vaccination in HIV-infected patients [ Time Frame: 12 months after vaccination ] [ Designated as safety issue: No ]
    Determine the cellular immune responses and their correlation to the development and magnitude of responses to H1N1 virus, and compare the cellular immune responses


Estimated Enrollment: 450
Study Start Date: March 2010
Estimated Study Completion Date: April 2012
Estimated Primary Completion Date: March 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 3.75 µg of the vaccine on days 0 and 21
Patients infected with HIV will receive 3.75 µg of an adjuvanted A H1N1 vaccine in two applications 21 days apart.
Biological: 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.
Experimental: 7.5 µg of the vaccine on days 0 and 21
Patients infected with HIV will receive 7.5µg of an adjuvanted A H1N1 vaccine in two applications 21 days apart.
Biological: Adjuvanted vaccine against H1N1 influenza virus (GSK)
Patients infected with HIV will receive 7.5 µg of an adjuvanted A H1N1 vaccine in two applications 21 days apart.
Active Comparator: 3.75 µg of the vaccine on day 0
The volunteers in the control group will receive a single application of 3.75 µg dose of the vaccine.
Biological: Adjuvanted vaccine against H1N1 influenza virus (GSK)
Control group will receive 3.75 µg of an adjuvanted A H1N1 vaccine in one single application.

  Eligibility

Ages Eligible for Study:   18 Years to 59 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria - for all participants

  • Both genders, aged between 18 and 59 years;
  • Capacity to give informed consent voluntarily to participate in the study;
  • Study participants with reproductive potential (defined as girls after menarche or women who have not reached menopause at least during 24 consecutive months, or who menstruated during the past 24 months, or have not undergone surgical sterilization) must have pregnancy test negative results, in blood or urine, at screening and in the vaccine application days. If they have sexual practices likely to promote pregnancy, the participants must use some form of contraception during the study period. At least one of the following methods MUST be properly used: Condoms (male or female, Hormonal contraceptive.
  • Laboratory results in the study screening: hemoglobin > 8.0 g/dL; Direct bilirubin < 2.5 x the upper limit of normal; Alanine aminotransferase, ALT (SGPT) and aspartate aminotransferase, AST (SGOT) < 3 x the upper limit of normal; Platelet count > 100.000/mm3

Inclusion Criteria - unique to the participants with HIV infection:

  • HIV-1 infection (as evidenced by rapid HIV testing or ELISA kit approved and confirmed by repeating the ELISA, IFA, Western blot, HIV-1 plasma viral load) at any time before entering the study.
  • Without changing the antiretroviral treatment within 8 weeks prior to the screening for the study: If the volunteer is receiving HAART he/she is required to be using the same regimen within at least 8 weeks before screening. Changes in antiretroviral dosage within 8 weeks prior to entering the study are permitted. In addition, the exchange of pharmacological formulation (eg. the conventional formulation for combination formulations) is allowed. If the volunteer is not on regular antiretroviral treatment, he/she should not have received any dose of any antiretroviral within 8 weeks prior to screening, including for the prevention of HIV vertical transmission (previous prophylactic and therapeutic regimens are allowed)
  • Without planning to change or start HAART in the next 6 months.

Inclusion criteria - unique to the participants without HIV infection (control group):

  • HIV-negative test result documented by rapid test approved in Brazil
  • Health professionals with indication of receiving H1N1 virus vaccine

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.

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01155037

Locations
Brazil
Instituto de Pesquisa Clinica Evandro Chagas (IPEC) - Fiocruz
Rio de Janeiro, Brazil
Sponsors and Collaborators
Oswaldo Cruz Foundation
Ministry of Health, Brazil
  More Information

No publications provided by Oswaldo Cruz Foundation

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Marilia Santini de Oliveira, Medical doctor, Oswaldo Cruz Foundation
ClinicalTrials.gov Identifier: NCT01155037     History of Changes
Other Study ID Numbers: VIP-H1N1
Study First Received: June 29, 2010
Last Updated: March 22, 2012
Health Authority: Brazil: National Committee of Ethics in Research

Keywords provided by Oswaldo Cruz Foundation:
HIV, influenza A H1N1, vaccine

Additional relevant MeSH terms:
HIV Infections
Acquired Immunodeficiency Syndrome
Influenza, Human
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases
Slow Virus Diseases
Orthomyxoviridae Infections
Respiratory Tract Infections
Respiratory Tract Diseases

ClinicalTrials.gov processed this record on August 21, 2014