Conventional Vaccine and Intradermal Vaccine Among HIV-infected Young Subjects

Korea University

Status and phase: Completed; Phase 4

Conditions: Human Influenza

Treatments: Biological: IDflu9μg; Biological: Agripal; Biological: IDflu15μg

Study type: Interventional

Funder types: Other

Identifiers

NCT02398097

FLUHIV

Details and patient eligibility

About

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.

Full 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.

Enrollment: 88 patients

Sex: All

Ages: 18 to 60 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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88 participants in 3 patient groups

Agripal

Active Comparator group

Description:

28 trivalent subunit inactivated intramuscular vaccine (Agripal) recipients: one vaccine injection administered on Day 0

Treatment:

Biological: Agripal

IDflu9μg

Active Comparator group

Description:

30 reduced-content intradermal split vaccine (IDflu9μg) recipients: one vaccine injection administered on Day 0

Treatment:

Biological: IDflu9μg

IDflu15μg

Active Comparator group

Description:

28 standard-content intradermal split vaccine (IDflu15μg) recipients: one vaccine injection administered on Day 0

Treatment:

Biological: IDflu15μg