Human InfluenzaPhase 4NCT02398097
Conventional Vaccine and Intradermal Vaccine Among HIV-infected Young Subjects
A Phase 4 study testing Agripal, IDflu9μg and IDflu15μg in people with Human Influenza, run by Korea University Guro Hospital.
Trial summary
Several studies have shown poor immune response to conventional influenza vaccines in HIV-infected individuals. This study was conducted expecting the more potent immunogenicity of intradermal vaccine compared with conventional intramuscular vaccine in HIV-infected adults. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Human Influenza
- What is being tested?
- Agripal, IDflu9μg and IDflu15μg
- Type of treatment
- Vaccines, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 88 participants
- Where
- No sites listed yet
- Study dates
- Nov 2011to Apr 2012
- Phase
- Phase 4
- 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 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- HIV-infected individuals who were not immunized with 2011/2012 influenza vaccine
Who cannot join
- known allergy to egg
- presentation of any febrile illness ≥37.5°C on the day of vaccination
- any history of hypersensitivity reaction to previous influenza vaccination
- any other vaccinations within the past one month
- use of immunosuppressive agent
- recipient of blood product or immunoglobulins during the previous three months
- any other conditions that might interfere with the study results
About this study
Official title: Safety and Immunogenicity of Influenza Vaccine Among HIV-infected Young Subjects: Conventional Vaccine Versus Intradermal Vaccine
Several studies have shown poor immune response to conventional influenza vaccines in HIV-infected individuals. This study was conducted expecting the more potent immunogenicity of intradermal vaccine compared with conventional intramuscular vaccine in HIV-infected adults.
Read the detailed description
During the 2011/2012 pre-influenza season, three vaccines were used in HIV-infected adults (18 to 60 years): inactivated intramuscular vaccine (Agripal), reduced-content intradermal vaccine (IDflu9μg) and standard-content intradermal vaccine (IDflu15μg). Serum hemagglutination-inhibiting (HI) antibodies and INF-γ ELISpot assay were measured at the time of vaccination and 1 month after vaccination. Adverse events were recorded for 7 days.
- Conditions
- Human Influenza
- Being tested
- Agripal, IDflu9μg, IDflu15μg
- Medical subject headings
- Influenza, Human
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AgripalBiological
2011/2012 influenza season standard dose trivalent subunit inactivated intramuscular vaccine, single dose
IDflu9μgBiological
2011/2012 influenza season reduced-content intradermal split vaccine, single dose
IDflu15μgBiological
2011/2012 influenza season standard-content intradermal split vaccine, single dose
| Study group | Role | What they receive |
|---|---|---|
| Agripal | Active comparator | 28 trivalent subunit inactivated intramuscular vaccine (Agripal) recipients: one vaccine injection administered on Day 0 Receives: Biological: Agripal |
| IDflu9μg | Active comparator | 30 reduced-content intradermal split vaccine (IDflu9μg) recipients: one vaccine injection administered on Day 0 Receives: Biological: IDflu9μg |
| IDflu15μg | Active comparator | 28 standard-content intradermal split vaccine (IDflu15μg) recipients: one vaccine injection administered on Day 0 Receives: Biological: IDflu15μg |
What is being measured
The primary outcome is the main question the study is designed to answer.
The proportion of participants with a post-vaccination titer ≥1:40 in subjects with a pre-vaccination titer of <1:10 or a ≥4-fold titer increase in subjects with a pre-vaccination titer of ≥1:10
Measured: Outcome measure was assessed at two points (baseline and 4 weeks after vaccination)
Secondary outcomes (2)
Percentage of subjects with a post-vaccination titer ≥1:40
Measured: Outcome measure was assessed 4 weeks after vaccination
GMT ratio of the post-vaccination titer to pre-vaccination titer
Measured: Outcome measure was assessed at two points (baseline and 4 weeks after vaccination)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Mar 2015 (estimated)
- Study startNov 2011
- Primary completionDec 2011
- Study completionApr 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Human InfluenzaStudies 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
- Interventional
- Phase
- Phase 4
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 88 participants (actual)
Sponsor and investigators
- Lead sponsor
- Korea University Guro Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hee Jin Cheong, Korea University Guro Hospital
- Investigators
- Hee Jin Cheong, MD, PhD, Principal investigator, Korea University Guro Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02398097
- Sponsor's protocol ID
- FLUHIV
- Status last verified
- Mar 2015
- First submitted
- 1 Mar 2015
- Last updated
- 25 Mar 2015
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Seo YB, Lee J, Song JY, Choi HJ, Cheong HJ, Kim WJ. Safety and immunogenicity of influenza vaccine among HIV-infected adults: Conventional vaccine vs. intradermal vaccine. Hum Vaccin Immunother. 2016;12(2):478-84. doi: 10.1080/21645515.2015.1076599.
PubMed 26431466
Study at a glance
From the registry record, last updated by the sponsor on 25 Mar 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety and Immunogenicity of Influenza Vaccine Among HIV-infected Young Subjects: Conventional Vaccine Versus Intradermal Vaccine
- ClinicalTrials.gov ID
- NCT02398097
- Acronym / sponsor ID
- FLUHIV
- Conditions
- Human Influenza
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 88 participants (actual)
- Lead sponsor
- Korea University Guro HospitalUniversity, hospital or other
- Study start
- Nov 2011
- Primary completion
- Dec 2011 (actual)
- Study completion
- Apr 2012 (actual)
- First posted
- 25 Mar 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.
Several studies have shown poor immune response to conventional influenza vaccines in HIV-infected individuals. This study was conducted expecting the more potent immunogenicity of intradermal vaccine compared with conventional intramuscular vaccine in HIV-infected adults.
Detailed description
During the 2011/2012 pre-influenza season, three vaccines were used in HIV-infected adults (18 to 60 years): inactivated intramuscular vaccine (Agripal), reduced-content intradermal vaccine (IDflu9μg) and standard-content intradermal vaccine (IDflu15μg). Serum hemagglutination-inhibiting (HI) antibodies and INF-γ ELISpot assay were measured at the time of vaccination and 1 month after vaccination. Adverse events were recorded for 7 days.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Agripal | Active comparator | Biological: Agripal28 trivalent subunit inactivated intramuscular vaccine (Agripal) recipients: one vaccine injection administered on Day 0 |
| IDflu9μg | Active comparator | Biological: IDflu9μg30 reduced-content intradermal split vaccine (IDflu9μg) recipients: one vaccine injection administered on Day 0 |
| IDflu15μg | Active comparator | Biological: IDflu15μg28 standard-content intradermal split vaccine (IDflu15μg) recipients: one vaccine injection administered on Day 0 |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- HIV-infected individuals who were not immunized with 2011/2012 influenza vaccine
Key exclusion criteria (7 listed)
- known allergy to egg
- presentation of any febrile illness ≥37.5°C on the day of vaccination
- any history of hypersensitivity reaction to previous influenza vaccination
- any other vaccinations within the past one month
- use of immunosuppressive agent
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 |
|---|---|---|
| Agripal2011/2012 influenza season standard dose trivalent subunit inactivated intramuscular vaccine, single dose | Biological | Agripal |
| IDflu9μg2011/2012 influenza season reduced-content intradermal split vaccine, single dose | Biological | IDflu9μg |
| IDflu15μg2011/2012 influenza season standard-content intradermal split vaccine, single dose | Biological | IDflu15μg |
Primary outcome
The proportion of participants with a post-vaccination titer ≥1:40 in subjects with a pre-vaccination titer of <1:10 or a ≥4-fold titer increase in subjects with a pre-vaccination titer of ≥1:10
Time frame: Outcome measure was assessed at two points (baseline and 4 weeks after vaccination)
2 secondary outcomes
Percentage of subjects with a post-vaccination titer ≥1:40
Time frame: Outcome measure was assessed 4 weeks after vaccination
GMT ratio of the post-vaccination titer to pre-vaccination titer
Time frame: Outcome measure was assessed at two points (baseline and 4 weeks after 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 25 Mar 2015.
- Derived from this study: PubMed 26431466Seo YB, Lee J, Song JY, Choi HJ, Cheong HJ, Kim WJ. Safety and immunogenicity of influenza vaccine among HIV-infected adults: Conventional vaccine vs. intradermal vaccine. Hum Vaccin Immunother. 2016;12(2):478-84. doi: 10.1080/21645515.2015.1076599.
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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.
Hee Jin Cheong, MD, PhD principal investigator
Korea University Guro Hospital
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Agripal, IDflu9μg and IDflu15μg in people with Human Influenza, run by Korea University Guro Hospital.
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 1 inclusion and 7 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 25 Mar 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
The proportion of participants with a post-vaccination titer ≥1:40 in subjects with a pre-vaccination titer of <1:10 or a ≥4-fold titer increase in subjects with a pre-vaccination titer of ≥1:10 (time frame: Outcome measure was assessed at two points (baseline and 4 weeks after vaccination)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02398097, which also lists 1 linked publication.
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 25 Mar 2015.