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NCT Number: NCT02398097

Conventional Vaccine and Intradermal Vaccine Among HIV-infected Young Subjects

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.

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Key information

Conditions

Human Influenza Infections Influenza, Human Orthomyxoviridae Infections RNA Virus Infections Respiratory Tract Diseases Respiratory Tract Infections Virus Diseases

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Agripal

Biological

2011/2012 influenza season standard dose trivalent subunit inactivated intramuscular vaccine, single dose

IDflu9μg

Biological

2011/2012 influenza season reduced-content intradermal split vaccine, single dose

IDflu15μg

Biological

2011/2012 influenza season standard-content intradermal split vaccine, single dose

Primary outcomes

  1. 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

  1. Percentage of subjects with a post-vaccination titer ≥1:40

    Time frame: Outcome measure was assessed 4 weeks after vaccination

  2. 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)

Other outcomes

  1. 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

Sponsors and collaborators

Lead sponsor

Korea University Guro Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2011
Primary completion
2011
Study completion
2012
First posted
Mar 25, 2015
Registry last updated
Mar 25, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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