Ignite Creation Date:
2024-05-05 @ 10:39 PM
Last Modification Date:
2024-10-26 @ 10:22 AM
Study NCT ID:
NCT01155037
Status:
COMPLETED
Last Update Posted:
2018-07-18
First Post:
2010-06-29
Brief Title:
Safety of and Immunogenicity to an H1N1 Influenza Vaccine in HIV-infected Adults
Sponsor:
Oswaldo Cruz Foundation
Organization:
Oswaldo Cruz Foundation
Study Overview
Official Title:
Phase 2 Study to Evaluate the Safety of and the Immunogenicity to an Adjuvanted AH1N1v Influenza Vaccine in HIV-Infected Adults
Status:
COMPLETED
Status Verified Date:
2018-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
VIP-H1N1
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 cellsmm3 or 200 cellsmm3 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 1 375 µg in two applications 21 days apart 2 75 µg in two applications 21 days apart The volunteers in the control group will receive a single application of 375 µg dose of the vaccine The studys 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 375 µg in HIV-1-infected patients is similar to the proportion of seroconversion induced by the same vaccine at a dose of 75 µg 3The proportion of seroconversion with one dose of the vaccine against H1N1 virus is similar to the proportion after the second dose
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None