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Influenza Vaccine in HIV Study

NCT ID: NCT02632578

Last Updated: 2015-12-16

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

57 participants

Study Classification

OBSERVATIONAL

Study Start Date

2015-02-28

Study Completion Date

2015-12-31

Brief Summary

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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.

Detailed Description

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Conditions

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Influenza, Human

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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HIV-positive

2015 Fluvax® vaccine, BioCSL (a licensed influenza vaccine)

Intervention Type BIOLOGICAL

Subjects received licensed influenza vaccine (Fluvax®), 1ml intramuscular injection.

HIV-negative

2015 Fluvax® vaccine, BioCSL (a licensed influenza vaccine)

Intervention Type BIOLOGICAL

Subjects received licensed influenza vaccine (Fluvax®), 1ml intramuscular injection.

Interventions

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2015 Fluvax® vaccine, BioCSL (a licensed influenza vaccine)

Subjects received licensed influenza vaccine (Fluvax®), 1ml intramuscular injection.

Intervention Type BIOLOGICAL

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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University of Melbourne

OTHER

Sponsor Role lead

Responsible Party

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Prof Stephen Kent

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Stephen Kent, Professor

Role: PRINCIPAL_INVESTIGATOR

University of Melbourne

Other Identifiers

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AISRF08020

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

1041832, 1042634, 1052979

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

Kent001

Identifier Type: -

Identifier Source: org_study_id