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| Name | Class |
|---|---|
| MedImmune LLC | INDUSTRY |
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The goal of this study is to determine if there is a difference in shedding (primary objective) and in immunogenicity and safety (secondary objectives) between HIV-positive and HIV-negative children and young adults who are receiving the quadrivalent live-attenuated influenza vaccine (QLAIV).
QLAIV is an intranasal vaccine that works by using 4 different attenuated strains of influenza virus that will replicate in the nose and stimulate an immune response in recipients that should protect them if they are infected with one of those strains of influenza in the future. A couple of studies have shown an increase in duration that the viruses remain in the nose in immunocompromised people. Those studies were done using the trivalent vaccine, so the investigators would like to evaluate the quadrivalent vaccine, and there is still a need for additional data to help understand the duration of shedding. If shedding is prolonged in HIV-infected children and young adults, it would be important to know for contacts of those individuals who are very immunocompromised. Shedding will be measured by looking for influenza RNA in nasopharyngeal swabs taken at baseline, 2-5 days, 7-10 days and 14-21 days after the intranasal immunization.
The live-attenuated influenza vaccines have been shown to have increased effectiveness in children and they stimulate the immune system in a different way than the inactivated influenza vaccines (TIV or QIV). In this study, the investigators will have the opportunity to compare the immunogenicity of QLAIV, measured at baseline and 14-21 days post-vaccination, in HIV-infected and uninfected children, adolescents and young adults. Although prior studies of LAIV in HIV-infected and other immunocompromised children and adults have not shown any increase in serious adverse events, safety will be actively monitored for the first 30-45 days through a study-specific questionnaire administered at each clinic or phone visit and by asking the subjects to keep a diary of side effects. Safety will be monitored passively throughout the course of the study.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| QLAIV, HIV-infected | Active Comparator | QLAIV administered to HIV-infected individuals 2 to 25 yoa |
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| QLAIV, HIV-uninfected | Active Comparator | QLAIV administered to HIV-uninfected individuals 2 to 25 yoa |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Quadrivalent Live Attenuated Influenza Vaccine | Biological |
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| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Shedding for at Least One of the Influenza Strains Included in the QLAIV in the First 21 Days After Vaccine Administration Days in HIV-positive and Control Groups. | Measure PCR positivity for any of the influenza subtypes included in QLAIV between baseline (day 0) and the last study visit at 14-21 days after vaccine. Compare number of participants with PCR positivity for any of the vaccine-strain influenza virus strains in each patient group. | 21 days |
| Number of Participants With Shedding for at Least One of the Influenza Strains Included in the QLAIV Vaccine at Each of the 4 Study Visits, Days 0 (Baseline), 2-5, 7-10, and 14-21 in HIV-positive and Control Groups. | Measure PCR positivity for any of the influenza subtypes included in QLAIV at visit 1 (day 0), visit 2 (days 2-5), visit 3 (days 7-10) and visit 4 (days 14-21). Compare number of participants with shedding for any subtype in each patient group. (The study was powered based on the 7-10 day data.) | day 0-21 post-vaccine |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Adverse Events Within 14 Days After Vaccination | The investigators will compare the number of adverse events (AE) reported by AE category within 14 days after vaccination as reported by each participant. Data will reflect whether a participant ever reported the AE, and not the number of times the AE was reported. | 14 days after vaccination for AEs; up to 30 days for unscheduled visits |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With PCR-diagnosed Influenza and Clinically-diagnosed Influenza Like Illness. | Compare numbers of participants with influenza diagnosed by PCR and with clinically-diagnosed influenza between the two groups. Data was taken from Influenza Infection Questionnaires #1 and #2. The last questionnaire (#2) was administered between May 15 and June 10, 2014 (after the vaccine). Data is reported as PCR-confirmed influenza and clinically-diagnosed influenza (subject told had influenza without confirmatory testing). |
Inclusion Criteria:
Age 2-25
Only supposed to get one dose of vaccine for upcoming influenza season
No viral respiratory symptoms at time of immunization
HIV-infected group: must have:
Healthy controls: no major medical problems affecting the immune system
Recruited among:
Exclusion Criteria:
History of:
Active wheezing at time of immunization
On any antiviral agents active against influenza (amantadien/rimantadine, zanamavir, oseltamivir) at time of immunization or planned over 21 days of shedding collection
Receipt of IVIG within 3 months prior to enrollment
Plan to receive IVIG during the 4 weeks after immunization
Moderate to severely immunocompromised individual living in the home
Pregnant
Breastfeeding
Plan to start immunosupressive medications or stop HAART over the 4 weeks following immmunization
Temperature > 100F or 37.8C
Rhinorrhea or cough not related to allergies at the time of immunization
History of fungal sinusitis
History of Guillain-Barre Syndrome
Current on antibiotics
Currently taking aspirin
On an investigational drug at the time of immunization or planned over the 28 days of shedding collection
On any experimental medication at time of immunization or planned over 21 days of shedding collection
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| Name | Affiliation | Role |
|---|---|---|
| Adriana Weinberg, MD | University of Colorado, Denver | Principal Investigator |
| Myron Levin, MD | University of Colorado, Denver | Study Chair |
| Donna Curtis, MD,MPH | University of Colorado, Denver | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Colorado Denver | Denver | Colorado | 80045 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | QLAIV, HIV-uninfected | QLAIV administered to HIV-uninfected individuals 2 to 25 yoa Quadrivalent Live Attenuated Influenza Vaccine |
| FG001 | QLAIV, HIV-infected | QLAIV administered to HIV-infected individuals 2 to 25 yoa Quadrivalent Live Attenuated Influenza Vaccine |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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Open label
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| Number of Participants Reaching Seroprotection (HAI ≥ 40) Within the HIV-positive and Control Groups. | The investigators will measure hemagglutinin inhibition (HAI) on blood samples #2 (14-21 days after vaccination) for all participants. The investigators will also compare the number of participants reaching HAI ≥ 40 for each virus sub-type contained in the vaccine. | 14-21 days |
| up to 11 months post-vaccination |
| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | QLAIV, HIV-infected | QLAIV administered to HIV-infected individuals 2 to 25 yoa Quadrivalent Live Attenuated Influenza Vaccine |
| BG001 | QLAIV, HIV-uninfected | QLAIV administered to HIV-uninfected individuals 2 to 25 yoa Quadrivalent Live Attenuated Influenza Vaccine |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants | Participants |
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| Age, Continuous | Median | Inter-Quartile Range | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| 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 | Number of Participants With Shedding for at Least One of the Influenza Strains Included in the QLAIV in the First 21 Days After Vaccine Administration Days in HIV-positive and Control Groups. | Measure PCR positivity for any of the influenza subtypes included in QLAIV between baseline (day 0) and the last study visit at 14-21 days after vaccine. Compare number of participants with PCR positivity for any of the vaccine-strain influenza virus strains in each patient group. | HIV-infected and uninfected recipients of QLAIV; one HIV-uninfected subject was lost-to-follow-up after the first follow-up visit following vaccination. | Posted | Count of Participants | Participants | 21 days |
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| Primary | Number of Participants With Shedding for at Least One of the Influenza Strains Included in the QLAIV Vaccine at Each of the 4 Study Visits, Days 0 (Baseline), 2-5, 7-10, and 14-21 in HIV-positive and Control Groups. | Measure PCR positivity for any of the influenza subtypes included in QLAIV at visit 1 (day 0), visit 2 (days 2-5), visit 3 (days 7-10) and visit 4 (days 14-21). Compare number of participants with shedding for any subtype in each patient group. (The study was powered based on the 7-10 day data.) | Subjects with data for any of the visits | Posted | Count of Participants | Participants | day 0-21 post-vaccine |
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| Secondary | Number of Participants With Adverse Events Within 14 Days After Vaccination | The investigators will compare the number of adverse events (AE) reported by AE category within 14 days after vaccination as reported by each participant. Data will reflect whether a participant ever reported the AE, and not the number of times the AE was reported. | Posted | Count of Participants | Participants | 14 days after vaccination for AEs; up to 30 days for unscheduled visits |
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| Secondary | Number of Participants Reaching Seroprotection (HAI ≥ 40) Within the HIV-positive and Control Groups. | The investigators will measure hemagglutinin inhibition (HAI) on blood samples #2 (14-21 days after vaccination) for all participants. The investigators will also compare the number of participants reaching HAI ≥ 40 for each virus sub-type contained in the vaccine. | The total number of participants analyzed reflect the number of subjects for whom there was a blood sample from the 4th visit at day 14-21. | Posted | Count of Participants | Participants | 14-21 days |
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| Other Pre-specified | Number of Participants With PCR-diagnosed Influenza and Clinically-diagnosed Influenza Like Illness. | Compare numbers of participants with influenza diagnosed by PCR and with clinically-diagnosed influenza between the two groups. Data was taken from Influenza Infection Questionnaires #1 and #2. The last questionnaire (#2) was administered between May 15 and June 10, 2014 (after the vaccine). Data is reported as PCR-confirmed influenza and clinically-diagnosed influenza (subject told had influenza without confirmatory testing). | Number of participants analyzed reflects the number of subjects who participated in the end-of-season interview. | Posted | Count of Participants | Participants | up to 11 months post-vaccination |
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1 year
HIV-infected and HIV-uninfected individuals
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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 | QLAIV, HIV-infected | Quadrivalent Live Attenuated Influenza Vaccine (QLAIV) administered to HIV-infected individuals 2 to 25 yoa | 0 | 45 | 1 | 45 | 17 | 45 |
| EG001 | QLAIV, HIV-uninfected | Quadrivalent Live Attenuated Influenza Vaccine (QLAIV) administered to HIV-uninfected individuals 2 to 25 yoa | 0 | 55 | 0 | 55 | 16 | 55 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| bleeding | Respiratory, thoracic and mediastinal disorders | Systematic Assessment | nose |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Temperature >100F | General disorders | Systematic Assessment | Temperature >100F reported at any of the 3 follow-up visits after vaccine. |
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| Runny nose | Respiratory, thoracic and mediastinal disorders | Systematic Assessment | Runny nose reported at any of the 3 follow-up visits after vaccine. |
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| Nasal congestion | Respiratory, thoracic and mediastinal disorders | Systematic Assessment | Nasal congestion reported at any of the 3 follow-up visits after vaccine. |
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| Sore throat | Respiratory, thoracic and mediastinal disorders | Systematic Assessment | Sore throat reported at any of the 3 follow-up visits after vaccine. |
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| Headache | Nervous system disorders | Systematic Assessment | Headache reported at any of the 3 follow-up visits after vaccine. |
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| Muscle aches | General disorders | Systematic Assessment | Muscle aches reported at any of the 3 follow-up visits after vaccine. |
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| Decrease in energy | General disorders | Systematic Assessment | Decrease in energy reported at any of the 3 follow-up visits after vaccine. |
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| Decreased appetite | Gastrointestinal disorders | Systematic Assessment | Decreased appetite reported at any of the 3 follow-up visits after vaccine. |
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| Any other symptoms | General disorders | Systematic Assessment | Any other symptoms reported at any of the 3 follow-up visits after vaccine. |
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Data on influenza diagnosis from the end-of-season questionnaire is limited by the number of subjects who were available to answer the questionnaire (17/45 in HIV-infected group, 53/55 in HIV-uninfected group).
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Adriana Weinberg, MD | University of Colorado | 3037244480 | adriana.weinberg@ucdenver.edu |
| ID | Term |
|---|---|
| D000163 | Acquired Immunodeficiency Syndrome |
| ID | Term |
|---|---|
| D015658 | HIV Infections |
| D000086982 | Blood-Borne Infections |
| D003141 | Communicable Diseases |
| D007239 | Infections |
| D015229 | Sexually Transmitted Diseases, Viral |
| D012749 | Sexually Transmitted Diseases |
| D016180 | Lentivirus Infections |
| D012192 | Retroviridae Infections |
| D012327 | RNA Virus Infections |
| D014777 | Virus Diseases |
| D012897 | Slow Virus Diseases |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D007153 | Immunologic Deficiency Syndromes |
| D007154 | Immune System Diseases |
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| >=65 years |
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| Male |
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| Not Hispanic or Latino |
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| Unknown or Not Reported |
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| Asian |
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| Native Hawaiian or Other Pacific Islander |
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| Black or African American |
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| White |
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| More than one race |
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| Unknown or Not Reported |
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