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This is a phase III, randomized, controlled, open label study with two vaccine regimens. The study will assess the relative safety and immunogenicity of vaccine regimens comparing adjuvanted versus non-adjuvanted formulations of A(H1N1) inactivated influenza virus vaccine in subjects with Human Immunodeficiency Virus Type 1 (HIV-1) Infection and to compare safety and immunogenicity data with a contemporaneously enrolled control group of age-comparable, healthy subjects.
Because certain individuals may be hypo-responsive to influenza vaccination, additional studies with high-risk groups are warranted in order to determine the optimal vaccine formulation and dosing schedule for prevention of novel H1N1 virus infection.
Enrollment
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Ages
Volunteers
Inclusion criteria
For HIV-1 Infected Subjects:
Adults between 18-60 years old (inclusive)
Any sex or ethnicity
Confirmed Diagnosis of HIV-1 infection
CD4+ cells count >200 per mm3 within 3 months prior to inclusion in the study
HIV-1 viral load below 200 copies/mL within 90 days prior to inclusion in the study
Childbearing potential women must be willing to use an acceptable contraceptive method. Acceptable contraceptive methods are defined as one or more of the following:
No changes in the antiviral therapy (including HAART) for the previous 4 weeks and/or change in the predicted antiviral therapy through study Day 43 (3 weeks after the second dose of the vaccine)
No use of immunomodulatory therapy, including cyclosporine, interleukins, interferons, or systemic glucocorticoids (including inhalatory) within 3 months before study inclusion
Subjects capable of respecting all the study procedures and available for all visits scheduled to the investigation site
Subjects capable of understanding the nature and risk of the study proposed and signing the consent form
The subjects may have other underlying diseases, such as, but not limited to, hypertension, diabetes, cardiac ischemic disease, or hypothyroidism, however their symptoms/signs must be currently under control with medical treatment according to the investigator's evaluation
For Healthy Adults:
Adults between 18-60 years old (inclusive)
Any sex and ethnicity
Subjects with good health as determined by medical history, physical evaluation, and investigator's clinical opinion
Childbearing potential women must be willing to use an acceptable contraceptive method. Acceptable contraceptive methods are defined as one or more of the following:
Subjects capable of respecting all the study procedures and available for all the visits scheduled at the investigation site
Subjects capable of understanding the nature and risk of the study proposed and signing the consent form
There will be NO blood sample collection of healthy volunteers viewing the determination of their serological status regarding the HIV virus.
Exclusion criteria
For HIV-1-Infected Subjects:
For Healthy Adults:
Primary purpose
Allocation
Interventional model
Masking
154 participants in 4 patient groups
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Data sourced from clinicaltrials.gov
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