Safety and Immunogenicity of Influenza Vaccine Among HIV-infected Young Subjects: Conventional Vaccine Versus Intradermal Vaccine
Trial Snapshot
- Phase
- Phase 4
- Status
- Completed
- Enrollment
- 88
- Primary Endpoint
- 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
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Prevention
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 60 Years (Adult)
- Sex
- All
- Accepts 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
Arms & Interventions
Agripal
28 trivalent subunit inactivated intramuscular vaccine (Agripal) recipients: one vaccine injection administered on Day 0
Intervention: Agripal (Biological)
IDflu9μg
30 reduced-content intradermal split vaccine (IDflu9μg) recipients: one vaccine injection administered on Day 0
Intervention: IDflu9μg (Biological)
IDflu15μg
28 standard-content intradermal split vaccine (IDflu15μg) recipients: one vaccine injection administered on Day 0
Intervention: IDflu15μg (Biological)
Outcomes
Primary Outcomes
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)
Secondary Outcomes
- GMT ratio of the post-vaccination titer to pre-vaccination titer(Outcome measure was assessed at two points (baseline and 4 weeks after vaccination))
- Percentage of subjects with a post-vaccination titer ≥1:40(Outcome measure was assessed 4 weeks after vaccination)
Investigators
Hee Jin Cheong
Professor
Korea University Guro Hospital