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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Agripal | Active Comparator | 28 trivalent subunit inactivated intramuscular vaccine (Agripal) recipients: one vaccine injection administered on Day 0 |
|
| IDflu9μg | Active Comparator | 30 reduced-content intradermal split vaccine (IDflu9μg) recipients: one vaccine injection administered on Day 0 |
|
| IDflu15μg | Active Comparator | 28 standard-content intradermal split vaccine (IDflu15μg) recipients: one vaccine injection administered on Day 0 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Agripal | Biological | 2011/2012 influenza season standard dose trivalent subunit inactivated intramuscular vaccine, single dose |
|
| Measure | Description | 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 | Outcome measure was assessed at two points (baseline and 4 weeks after vaccination) |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of subjects with a post-vaccination titer ≥1:40 | Outcome measure was assessed 4 weeks after vaccination | |
| GMT ratio of the post-vaccination titer to pre-vaccination titer | Outcome measure was assessed at two points (baseline and 4 weeks after vaccination) |
| Measure | Description | Time Frame |
|---|---|---|
| Frequency and duration of local and systemic adverse events | 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. |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Hee Jin Cheong, MD, PhD | Korea University Guro Hospital | Principal Investigator |
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 26431466 | Derived | Seo YB, Lee J, Song JY, Choi HJ, Cheong HJ, Kim WJ. Safety and immunogenicity of influenza vaccine among HIV-infected adults: Conventional vaccine vs. intradermal vaccine. Hum Vaccin Immunother. 2016;12(2):478-84. doi: 10.1080/21645515.2015.1076599. |
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| ID | Term |
|---|---|
| D007251 | Influenza, Human |
| ID | Term |
|---|---|
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
| D009976 | Orthomyxoviridae Infections |
| D012327 | RNA Virus Infections |
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| 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 |
|
| D014777 | Virus Diseases |
| D012140 | Respiratory Tract Diseases |