Conventional Vaccine and Intradermal Vaccine Among HIV-infected Young Subjects

Phase 4

Completed

• Conditions: Human Influenza
• Interventions: Biological: IDflu9μg; Biological: Agripal; Biological: IDflu15μg

• Registration Number: NCT02398097
• Lead Sponsor: Korea University Guro Hospital

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 Timeline

• Study Start: 2011-11
• Primary Completion: 2011-12
• Study Completion: 2012-04
• Status Verified: 2015-03
• Study First Submitted: 2015-03-01
• Study First Submitted QC: 2015-03-24
• Last Update Submitted: 2015-03-24
• Study First Posted: 2015-03-25
• Last Update Posted: 2015-03-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 88

Inclusion Criteria

• HIV-infected individuals who were not immunized with 2011/2012 influenza vaccine

Read More

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

Read More

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
IDflu9μg	IDflu9μg	30 reduced-content intradermal split vaccine (IDflu9μg) recipients: one vaccine injection administered on Day 0
Agripal	Agripal	28 trivalent subunit inactivated intramuscular vaccine (Agripal) recipients: one vaccine injection administered on Day 0
IDflu15μg	IDflu15μg	28 standard-content intradermal split vaccine (IDflu15μg) recipients: one vaccine injection administered on Day 0

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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