NCT02398097

Conventional Vaccine and Intradermal Vaccine Among HIV-infected Young Subjects

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

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 88 (actual)
• Sponsor: Korea University Guro Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 60 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Human Influenza

Interventions

Type	Name	Description
BIOLOGICAL	Agripal	2011/2012 influenza season standard dose trivalent subunit inactivated intramuscular vaccine, single dose
BIOLOGICAL	IDflu9μg	2011/2012 influenza season reduced-content intradermal split vaccine, single dose
BIOLOGICAL	IDflu15μg	2011/2012 influenza season standard-content intradermal split vaccine, single dose

Timeline

• Start date: 2011-11-01
• Primary completion: 2011-12-01
• Completion: 2012-04-01
• First posted: 2015-03-25
• Last updated: 2015-03-25