Conventional Vaccine and Intradermal Vaccine Among HIV-infected Young Subjects

March 24, 2015 updated by: Hee Jin Cheong, Korea University Guro Hospital

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

88

Phase

  • Phase 4

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 60 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Agripal
28 trivalent subunit inactivated intramuscular vaccine (Agripal) recipients: one vaccine injection administered on Day 0
Biological: Agripal
2011/2012 influenza season standard dose trivalent subunit inactivated intramuscular vaccine, single dose
Active Comparator: IDflu9μg
30 reduced-content intradermal split vaccine (IDflu9μg) recipients: one vaccine injection administered on Day 0
Biological: IDflu9μg
2011/2012 influenza season reduced-content intradermal split vaccine, single dose
Active Comparator: IDflu15μg
28 standard-content intradermal split vaccine (IDflu15μg) recipients: one vaccine injection administered on Day 0
Biological: IDflu15μg
2011/2012 influenza season standard-content intradermal split vaccine, single dose

What is the study measuring?

Primary Outcome Measures

Outcome 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
Time Frame: Outcome measure was assessed at two points (baseline and 4 weeks after vaccination)
Outcome measure was assessed at two points (baseline and 4 weeks after vaccination)

Secondary Outcome Measures

Outcome Measure
Time Frame
Percentage of subjects with a post-vaccination titer ≥1:40
Time Frame: Outcome measure was assessed 4 weeks after vaccination
Outcome measure was assessed 4 weeks after vaccination
GMT ratio of the post-vaccination titer to pre-vaccination titer
Time Frame: Outcome measure was assessed at two points (baseline and 4 weeks after vaccination)
Outcome measure was assessed at two points (baseline and 4 weeks after vaccination)

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Frequency and duration of local and systemic adverse events
Time Frame: 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
Adverse events were recorded for 7 days.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Korea University Guro Hospital

Investigators

  • Principal Investigator: Hee Jin Cheong, MD, PhD, Korea University Guro Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2011

Primary Completion (Actual)

December 1, 2011

Study Completion (Actual)

April 1, 2012

Study Registration Dates

First Submitted

March 1, 2015

First Submitted That Met QC Criteria

March 24, 2015

First Posted (Estimate)

March 25, 2015

Study Record Updates

Last Update Posted (Estimate)

March 25, 2015

Last Update Submitted That Met QC Criteria

March 24, 2015

Last Verified

March 1, 2015

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • FLUHIV

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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