Influenza Vaccine in HIV Study | NCT02632578

Studies
Influenza Vaccine in HIV Study

NCT02632578

Sponsor

University of Melbourne

Status

Completed

Last Update Posted

Dec 16, 2015Estimated

Enrollment

57Actual

Phase

Not provided

Conditions

Influenza, Human

Interventions

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

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

ID	Type	Description	Link
AISRF08020	Other Grant/Funding Number	The Australia-India Strategic Research Fund
1041832, 1042634, 1052979	Other Grant/Funding Number	The Australian National Health and Medical Research Council

Status Module

Record Verification Date

Dec 2015

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Feb 2015

Primary Completion Date

Jun 2015Actual

Completion Date

Dec 2015Actual

First Submitted Date

Dec 14, 2015

First Submission Date that Met QC Criteria

Dec 15, 2015

First Posted Date

Dec 16, 2015Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Dec 15, 2015

Last Update Posted Date

Dec 16, 2015Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

The aims of this study are:

to investigate if HIV infection alters the antibody responses to influenza and
to assess the ability of licensed influenza vaccine to induce functional non-neutralising antibodies in HIV-infected and HIV-uninfected subjects.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

Retention

Enrollment

57Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
HIV-positive			Biological: 2015 Fluvax® vaccine, BioCSL (a licensed influenza vaccine)
HIV-negative			Biological: 2015 Fluvax® vaccine, BioCSL (a licensed influenza vaccine)

Interventions

Name	Type	Description	Arm Group Labels	Other Names
2015 Fluvax® vaccine, BioCSL (a licensed influenza vaccine)	Biological	Subjects received licensed influenza vaccine (Fluvax®), 1ml intramuscular injection.	HIV-negative

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Anti-influenza antibody responses in plasma with Fc-mediated functions		Four weeks after influenza vaccination

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

55 Years

Standard Ages

Adult

Study Population

Subjects are recruited from two sites in Melbourne, Australia:

Melbourne Sexual Health Centre (HIV-positive and HIV-negative subjects)
The University of Melbourne at the Peter Doherty Institute for Infection and Immunity (HIV-negative subjects only)

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Stephen Kent, Professor	University of Melbourne	Principal Investigator

Locations

Not provided

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D007251	Influenza, Human

Ancestor Terms

ID	Term
D012141	Respiratory Tract Infections
D007239	Infections
D009976	Orthomyxoviridae Infections
D012327	RNA Virus Infections

Browse Leaves

Not provided

Browse Branches

Not provided