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NCT02632578 Clinical Trial

Influenza Vaccine in HIV Study

Influenza, Human Clinical Trial

Official title:
A Comparison of Immune Responses to the Licensed Trivalent Inactivated Influenza Vaccine in HIV-positive and HIV-negative Subjects

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT02632578
Other study ID # Kent001
Secondary ID AISRF08020104183
Status Completed
Phase N/A
First received December 14, 2015
Last updated December 15, 2015
Start date February 2015
Est. completion date December 2015

Study information
Verified date December 2015
Source University of Melbourne
Contact n/a
Is FDA regulated No
Health authority Australia: Human Research Ethics Committee
Study type Observational

Clinical Trial Summary

The aims of this study are:

1. to investigate if HIV infection alters the antibody responses to influenza and

2. to assess the ability of licensed influenza vaccine to induce functional non-neutralising antibodies in HIV-infected and HIV-uninfected subjects.

Recruitment information / eligibility
Status Completed
Enrollment 57
Est. completion date December 2015
Est. primary completion date June 2015
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group 18 Years to 55 Years
Eligibility Inclusion Criteria:

- HIV-1 positive by licensed diagnostic test (for HIV-positive group only)

- Planning to receive the seasonal influenza vaccine outside the study

- Provision of written informed consent

Exclusion Criteria:

- Previous allergy to influenza vaccination

- Pregnancy or planning to become pregnant

- Unwilling or unable to provide blood samples

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

Intervention

Biological:
• 2015 Fluvax® vaccine, BioCSL (a licensed influenza vaccine)
Subjects received licensed influenza vaccine (Fluvax®), 1ml intramuscular injection.

Locations
Country Name City State
n/a

Sponsors (1)
Lead Sponsor Collaborator
University of Melbourne

Outcome
Type Measure Description Time frame Safety issue
Primary Anti-influenza antibody responses in plasma with Fc-mediated functions Four weeks after influenza vaccination No
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