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The overall goal of this study is to study influenza vaccine responses in HIV infected individuals. Immunocompromised individuals require special protection from influenza, but may not respond appropriately to the standard killed vaccine. Patients who receive the H1N1 flu vaccine as part of their standard of care will be asked to donate blood samples for immunologic studies. These studies will determine whether participants were able to produce the appropriate antibodies to the vaccine and possibly identify predictors of vaccine responsiveness.
Our hypothesis is that vaccine responsiveness to the new H1N1 influenza vaccine will be compromised in HIV infected patients.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Vaccine | Experimental | Novartis unadjuvanted inactivated S-OIV H1N1 influenza vaccine 15 mcg administered as single-0.5mL (15mcg) injection intramuscularly into one of the subject's deltoid muscles |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| H1N1 vaccination | Biological | Novartis unadjuvanted inactivated S-OIV H1N1 influenza vaccine 15 mcg administered as single-0.5mL (15mcg) injection intramuscularly into one of the subject's deltoid muscles |
| Measure | Description | Time Frame |
|---|---|---|
| Safety | To assess the safety of inactivated swine-origin H1N1 influenza vaccine in HIV-1 infected individuals (received as part of standard of care). Safety was assessed via
| 21-28 days |
| Immunogenicity | Immunologic response, defined as HAI titer ≥ 1:40, at 21 days after vaccine dose. | 21-28 days |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Pablo Tebas | University of Pennsylvania | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Pennsylvania. Clinical Trials Unit | Philadelphia | Pennsylvania | 19104 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 20616698 | Result | Tebas P, Frank I, Lewis M, Quinn J, Zifchak L, Thomas A, Kenney T, Kappes R, Wagner W, Maffei K, Sullivan K; Center for AIDS Research and Clinical Trials Unit of the University of Pennsylvania. Poor immunogenicity of the H1N1 2009 vaccine in well controlled HIV-infected individuals. AIDS. 2010 Sep 10;24(14):2187-92. doi: 10.1097/QAD.0b013e32833c6d5c. |
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The study was conducted at the MacGregor Clinic of the Hospital of the University of Pennsylvania in Philadelphia, Pennsylvania, USA, between the months of November and January 2009-2010. All patients signed an informed consent. The study was approved by the University of Pennsylvania institutional review board .
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| ID | Title | Description |
|---|---|---|
| FG000 | Vaccine Arm (Single Arm) | 15 µg dose of the monovalent, unadjuvanted, inactivated, split virus H1N1 vaccine (Novartis, Basel, Switzerland). |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Vaccination Group (Single Arm Study) | All participants |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Median |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Safety | To assess the safety of inactivated swine-origin H1N1 influenza vaccine in HIV-1 infected individuals (received as part of standard of care). Safety was assessed via
| Posted | Number | percentage of participants | 21-28 days |
|
|
Duration of the study (21-28 days)
Serious adverse events include all Grade 3 or greater adverse events
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Vaccine Arm (Single Arm) | 15 µg dose of the monovalent, unadjuvanted, inactivated, split virus H1N1 vaccine (Novartis, Basel, Switzerland). |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Pain at Injection Site | General disorders | MedDRA | Systematic Assessment | Administration site reaction |
Single Arm Study
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Pablo Tebas | University of Pennsylvania | 2153498092 | pablo.tebas@uphs.upenn.edu |
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| ID | Term |
|---|---|
| D015658 | HIV Infections |
| ID | Term |
|---|---|
| D000086982 | Blood-Borne Infections |
| D003141 | Communicable Diseases |
| D007239 | Infections |
| D015229 | Sexually Transmitted Diseases, Viral |
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| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Percentage of Participants at Baseline with HAI assay titers ≥ 1:40 | Number | percentage of participants |
|
|
|
| Primary | Immunogenicity | Immunologic response, defined as HAI titer ≥ 1:40, at 21 days after vaccine dose. | Among the 90 participants without evidence of previous exposure to H1N1, only 61% [95% confidence interval (CI) 51-71] developed protective titers by week 3 of the study (seroconversion rate). | Posted | Number | 95% Confidence Interval | percentage of seroconversion | 21-28 days |
|
|
|
| 0 |
| 120 |
| 31 |
| 120 |
|
| Redness at Injection Site | General disorders | MedDRA | Systematic Assessment | Administration site reaction |
|
| Tenderness at Injection Site | General disorders | MedDRA | Systematic Assessment | Administration site reaction |
|
| Headache | General disorders | MedDRA | Systematic Assessment | Systemic site reaction |
|
| Malaise | General disorders | MedDRA | Systematic Assessment | Systemic site reaction |
|
| Myalgia | General disorders | MedDRA | Systematic Assessment | Systemic site reaction |
|
| Nausea | General disorders | MedDRA | Systematic Assessment | Systemic site reaction |
|
| Chills | General disorders | MedDRA | Systematic Assessment | Systemic site reaction |
|
| Vomiting | General disorders | MedDRA | Systematic Assessment | Systemic site reaction |
|
| Fever | General disorders | MedDRA | Systematic Assessment | Systemic site reaction |
|
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| D012749 | Sexually Transmitted Diseases |
| D016180 | Lentivirus Infections |
| D012192 | Retroviridae Infections |
| D012327 | RNA Virus Infections |
| D014777 | Virus Diseases |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D007153 | Immunologic Deficiency Syndromes |
| D007154 | Immune System Diseases |