Influenza, HumanNCT02632578
Influenza Vaccine in HIV Study
An observational study of Influenza, Human, run by University of Melbourne.
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. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Influenza, Human
- What is being tested?
- 2015 Fluvax® vaccine, BioCSL (a licensed influenza vaccine)
- Type of treatment
- Vaccines, Injection or infusion
- How many people
- 57 participants
- Where
- No sites listed yet
- Study dates
- Feb 2015to Dec 2015
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 55 years
- All sexes
- Healthy volunteers accepted
- 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)
Who may be able to join
- 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
Who cannot join
- Previous allergy to influenza vaccination
- Pregnancy or planning to become pregnant
- Unwilling or unable to provide blood samples
About this study
Official title: A Comparison of Immune Responses to the Licensed Trivalent Inactivated Influenza Vaccine in HIV-positive and HIV-negative Subjects
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.
- Conditions
- Influenza, Human
- Being tested
- 2015 Fluvax® vaccine, BioCSL (a licensed influenza vaccine)
- Medical subject headings
- Influenza, Human
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
2015 Fluvax® vaccine, BioCSL (a licensed influenza vaccine)Biological
Subjects received licensed influenza vaccine (Fluvax®), 1ml intramuscular injection.
| Study group | Role | What they receive |
|---|---|---|
| HIV-positive | Not described Receives: Biological: 2015 Fluvax® vaccine, BioCSL (a licensed influenza vaccine) | |
| HIV-negative | Not described Receives: Biological: 2015 Fluvax® vaccine, BioCSL (a licensed influenza vaccine) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Anti-influenza antibody responses in plasma with Fc-mediated functions
Measured: Four weeks after influenza vaccination
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Dec 2015 (estimated)
- Study startFeb 2015
- Primary completionJun 2015
- Study completionDec 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Influenza, HumanStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 57 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Melbourne
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Prof Stephen Kent, University of Melbourne
- Investigators
- Stephen Kent, Professor, Principal investigator, University of Melbourne
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02632578
- Sponsor's protocol ID
- Kent001
- Other IDs
- AISRF08020, 1041832, 1042634, 1052979
- Status last verified
- Dec 2015
- First submitted
- 14 Dec 2015
- Last updated
- 16 Dec 2015
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Dec 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Comparison of Immune Responses to the Licensed Trivalent Inactivated Influenza Vaccine in HIV-positive and HIV-negative Subjects
- ClinicalTrials.gov ID
- NCT02632578
- Acronym / sponsor ID
- Kent001
- Conditions
- Influenza, Human
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 57 participants (actual)
- Lead sponsor
- University of MelbourneUniversity, hospital or other
- Study start
- Feb 2015
- Primary completion
- Jun 2015 (actual)
- Study completion
- Dec 2015 (actual)
- First posted
- 16 Dec 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| HIV-positive | – | Biological: 2015 Fluvax® vaccine, BioCSL (a licensed influenza vaccine) |
| HIV-negative | – | Biological: 2015 Fluvax® vaccine, BioCSL (a licensed influenza vaccine) |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- 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)
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (3 listed)
- Previous allergy to influenza vaccination
- Pregnancy or planning to become pregnant
- Unwilling or unable to provide blood samples
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 2015 Fluvax® vaccine, BioCSL (a licensed influenza vaccine)Subjects received licensed influenza vaccine (Fluvax®), 1ml intramuscular injection. | Biological | HIV-negative, HIV-positive |
Primary outcome
Anti-influenza antibody responses in plasma with Fc-mediated functions
Time frame: Four weeks after influenza vaccination
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Dec 2015.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Stephen Kent, Professor principal investigator
University of Melbourne
Questions about this trial
What is this clinical trial studying?
An observational study of Influenza, Human, run by University of Melbourne.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Dec 2015. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Anti-influenza antibody responses in plasma with Fc-mediated functions (time frame: Four weeks after influenza vaccination). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Dec 2015.