Human Influenza
Conditions
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.
Interventions
BIOLOGICALAgripal
2011/2012 influenza season standard dose trivalent subunit inactivated intramuscular vaccine, single dose
BIOLOGICALIDflu9μg
2011/2012 influenza season reduced-content intradermal split vaccine, single dose
BIOLOGICALIDflu15μg
2011/2012 influenza season standard-content intradermal split vaccine, single dose
Sponsors
Korea University Guro Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | 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
| Measure | 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) |
Other
| Measure | Time frame | Description |
|---|---|---|
| Frequency and duration of local and systemic adverse events | Adverse events were recorded for 7 days. | The diary was made based on the Food and Drug Association (FDA) Toxicity Grading Scale for Healthy Adult and Adolescent Volunteers Enrolled in Preventive Vaccine Clinical Trials |
Outcome results
None listed