Conventional Vaccine and Intradermal Vaccine Among HIV-infected Young Subjects

Study Overview
=================
Brief 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.

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.

Official Title
-----------------
Safety and Immunogenicity of Influenza Vaccine Among HIV-infected Young Subjects: Conventional Vaccine Versus Intradermal Vaccine

Conditions
-----------------
Human Influenza

Intervention / Treatment
-----------------
* Biological: Agripal
* Biological: IDflu9μg
* Biological: IDflu15μg


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: HIV-infected individuals who were not immunized with 2011/2012 influenza vaccine Exclusion Criteria: 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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 60 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Agripal<br>28 trivalent subunit inactivated intramuscular vaccine (Agripal) recipients: one vaccine injection administered on Day 0 | Biological: Agripal<br>* 2011/2012 influenza season standard dose trivalent subunit inactivated intramuscular vaccine, single dose<br>|
| Active Comparator: IDflu9μg<br>30 reduced-content intradermal split vaccine (IDflu9μg) recipients: one vaccine injection administered on Day 0 | Biological: IDflu9μg<br>* 2011/2012 influenza season reduced-content intradermal split vaccine, single dose<br>|
| Active Comparator: IDflu15μg<br>28 standard-content intradermal split vaccine (IDflu15μg) recipients: one vaccine injection administered on Day 0 | Biological: IDflu15μg<br>* 2011/2012 influenza season standard-content intradermal split vaccine, single dose<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 |  | Outcome measure was assessed at two points (baseline and 4 weeks after vaccination) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of subjects with a post-vaccination titer ≥1:40 |  | Outcome measure was assessed 4 weeks after vaccination | 
| GMT ratio of the post-vaccination titer to pre-vaccination titer |  | Outcome measure was assessed at two points (baseline and 4 weeks after vaccination) |