HIV Infection
Conditions
Keywords
HIV, Flu vaccination, HIV infected individuals, Fluzone SD, Fluzone HD
Brief summary
The overall goal of this study is to compare the safety and immunogenicity of trivalent Fluzone® High-Dose vaccine vs the regular standard-dose (SD) in HIV infected individuals. Our hypothesis is that Fluzone® HD will be safe and more immunogenic than the currently used vaccine
Interventions
BIOLOGICALFluzone®
Fluzone® Standard dose in a blinded manner as single-0.5mL injection intramuscularly into one of the subject's deltoid muscles.
Sponsors
University of Pennsylvania
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. A confirmed diagnosis of HIV-1 infection as documented by any licensed ELISA test kit and confirmed by Western blot at any time prior to study entry or any measurable HIV RNA viral load in the chart. Serum HIV-1 antigen, plasma HIV-1 RNA, or a second antibody test by a method other than ELISA is acceptable as an alternative confirmatory test. 2. \> 18 years 3. Able to understand and comply with planned study procedures. 4. Provides written informed consent prior to initiation of any study procedures. 5. Subject should be 1) on stable antiretroviral therapy as outlined in the DHHS treatment guidelines for HIV-1 infected individuals OR 2) not on antiretroviral therapy and not intending to start treatment within the next 30 days.
Exclusion criteria
1. Has a known allergy to eggs or other components in the vaccines (these may include, but are not limited to: gelatin, formaldehyde, octoxinol and chicken protein). 2. Has a history, in the opinion of the site investigator, of severe reactions following previous immunization with seasonal TIV. 3. Participation in a novel H1N1 influenza vaccine study in the past two years. 4. Proven history, by RT-PCR, of novel influenza H1N1 infection, or, has a positive influenza diagnostic testing since June 2009 (specificity to H1N1 not required) prior to study entry. 5. Received any other live licensed vaccine within 4 weeks or inactivated licensed vaccine within 1 week prior to study entry. 6. Scheduled administration of any live virus vaccine or inactivated vaccine at or between entry and the Day 21 visit. NOTE: Live or inactivated vaccines expected to be administered between study entry and the Day 21 visit should be excluded to prevent potential interference with immunogenicity responses and confounding safety results. 7. Received a non-licensed agent (vaccine, drug, biologic, device, blood product, or medication) within 4 weeks prior to vaccination in this study with the exception of new antiretroviral medications as part of a phase 3 trial. 8. An acute illness and/or an oral temperature greater than or equal to 100.0 degrees F within 24 hours prior to study entry. 9. Use of anti-cancer chemotherapy or radiation therapy within the preceding 36 months of study enrollment, or has immunosuppression as a result of an underlying illness or treatment (other than HIV-1 infection). 10. Active neoplastic disease (excluding non-melanoma skin cancer, and HPV-related cervical dysplasia, CIN grades 1, 2 or 3). 11. Use of immunomodulators (e.g., interleukins, interferons, cyclosporine), HIV vaccine, systemic cytotoxic chemotherapy, or investigational therapy within 30 days prior to study entry. NOTE: Subjects receiving stable physiologic glucocorticoid doses, defined as prednisone ≤10 mg/day, will not be excluded. Subjects receiving corticosteroids for acute therapy for an opportunistic infection such as Pneumocystis jiroveci pneumonia (PCP), or receiving a short course (defined as ≤2 weeks) of pharmacologic glucocorticoid therapy will not be excluded. 12. Received immunoglobulin or other blood products 13. Current diagnosis of uncontrolled major psychiatric disorder. 14. History of Guillain-Barré Syndrome in the subject or subject's family (parents, siblings, half siblings, or children). 15. Any condition that would, in the opinion of the site investigator, place the subject at an unacceptable risk of injury or render the subject unable to meet the requirements of the protocol.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Immunogenicity | Baseline to 21 days | To compare the immunogenicity of trivalent Fluzone® High-Dose vaccine vs the regular standard-dose (SD) in HIV infected individuals. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Fluzone SD Fluzone® Standard dose
Fluzone®: Fluzone® Standard dose in a blinded manner as single-0.5mL injection intramuscularly into one of the subject's deltoid muscles. | 95 |
| Fluzone® High Dose Fluzone® High dose in a blinded manner as single-0.5mL injection intramuscularly into one of the subject's deltoid muscles.
Fluzone®: Fluzone® High dose or Standard dose in a blinded manner as single-0.5mL injection intramuscularly into one of the subject's deltoid muscles. | 100 |
| Total | 195 |
Baseline characteristics
| Characteristic | Fluzone® High Dose | Total | Fluzone SD |
|---|---|---|---|
| Age, Continuous | 44 years | 45 years | 46 years |
| Ethnicity (NIH/OMB) Hispanic or Latino | 3 Participants | 10 Participants | 7 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 97 Participants | 185 Participants | 88 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 1 Participants | 1 Participants |
| Race (NIH/OMB) Black or African American | 78 Participants | 136 Participants | 58 Participants |
| Race (NIH/OMB) More than one race | 00 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 22 Participants | 58 Participants | 36 Participants |
| Sex: Female, Male Female | 36 Participants | 58 Participants | 22 Participants |
| Sex: Female, Male Male | 64 Participants | 137 Participants | 73 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 73 / 95 | 90 / 100 |
| serious Total, serious adverse events | 3 / 95 | 0 / 100 |
Outcome results
Primary
Immunogenicity
To compare the immunogenicity of trivalent Fluzone® High-Dose vaccine vs the regular standard-dose (SD) in HIV infected individuals.
Time frame: Baseline to 21 days
Population: All participants except 5 participants with missing data at day 21
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| SD Recipients | Immunogenicity | Baseline H1N1 (A/California/07/2009 X-179 A) | 22 Geometric Mean antibody titer |
| SD Recipients | Immunogenicity | Week 3 H1N1 (A/California/07/2009 X-179 A) | 344 Geometric Mean antibody titer |
| SD Recipients | Immunogenicity | Baseline H3N2 A/Victoria/210/2009 X-187 | 25 Geometric Mean antibody titer |
| SD Recipients | Immunogenicity | Week 3 H3N2 A/Victoria/210/2009 X-187 | 324 Geometric Mean antibody titer |
| SD Recipients | Immunogenicity | Baseline B/Brisbane/60/2008 (influenza B) | 17 Geometric Mean antibody titer |
| SD Recipients | Immunogenicity | Week 3 B/Brisbane/60/2008 (influenza B) | 64 Geometric Mean antibody titer |
| HD Recipients | Immunogenicity | Baseline B/Brisbane/60/2008 (influenza B) | 20 Geometric Mean antibody titer |
| HD Recipients | Immunogenicity | Baseline H1N1 (A/California/07/2009 X-179 A) | 25 Geometric Mean antibody titer |
| HD Recipients | Immunogenicity | Week 3 H3N2 A/Victoria/210/2009 X-187 | 739 Geometric Mean antibody titer |
| HD Recipients | Immunogenicity | Week 3 H1N1 (A/California/07/2009 X-179 A) | 686 Geometric Mean antibody titer |
| HD Recipients | Immunogenicity | Week 3 B/Brisbane/60/2008 (influenza B) | 140 Geometric Mean antibody titer |
| HD Recipients | Immunogenicity | Baseline H3N2 A/Victoria/210/2009 X-187 | 26 Geometric Mean antibody titer |