Human Immunodeficiency Virus (HIV)Phase 2QLAIVNCT02474901
Shedding, Immunogenicity and Safety of Quadrivalent Live Intranasal Influenza Vaccine (QLAIV) in HIV-infected Children and Young Adults
A Phase 2 study testing Quadrivalent Live Attenuated Influenza Vaccine in people with Human Immunodeficiency Virus (HIV), run by University of Colorado, Denver at 1 site in United States.
Trial summary
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). Read more about this study
- Who is it for?
- Ages 2 to 25 yearsHealthy volunteers can take part
- Conditions the study is for
- Human Immunodeficiency Virus (HIV)
- What is being tested?
- Quadrivalent Live Attenuated Influenza Vaccine
- Type of treatment
- Vaccines
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 101 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2013to Dec 2016
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 2 to 25 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- 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:
- HIV-infection documented by 2 tests such as positive serology, positive HIV DNA or positive HIV RNA;
- must thave a CD4>25% or 500, or
Show all 11Show fewer
- must have CD4>15% or 200 and be on HAART
- Healthy controls: no major medical problems affecting the immune system
- Recruited among:
- HIV-unifected clients of the Children's Immunodeficiency Program(CHIP),
- Children's Hospital Colorado Child Health Clinic and Adolescent Clinics.
Who cannot join
- History of:
- reactive airway disease,
- recurrent wheezing, or
- asthma
- 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
Show all 20Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Colorado Denver
Denver, Colorado, 80045
About this study
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).
Read the detailed description
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.
- Conditions
- Human Immunodeficiency Virus (HIV)
- Being tested
- Quadrivalent Live Attenuated Influenza Vaccine
- Keywords
- Shedding, Immunogenicity, Safety, HIV infected, Children, Young adults
- Medical subject headings
- Acquired Immunodeficiency Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Quadrivalent Live Attenuated Influenza VaccineBiological
Also called FluMist Quadrivalent, QLAIV
| Study group | Role | What they receive |
|---|---|---|
| QLAIV, HIV-infected | Active comparator | QLAIV administered to HIV-infected individuals 2 to 25 yoa Receives: Biological: Quadrivalent Live Attenuated Influenza Vaccine |
| QLAIV, HIV-uninfected | Active comparator | QLAIV administered to HIV-uninfected individuals 2 to 25 yoa Receives: Biological: Quadrivalent Live Attenuated Influenza Vaccine |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.)
Measured: day 0-21 post-vaccine
Secondary outcomes (2)
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.
Measured: 14 days after vaccination for AEs; up to 30 days for unscheduled visits
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.
Measured: 14-21 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jun 2015 (estimated)
- Study startJul 2013
- Primary completionMar 2016
- Study completionDec 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Human Immunodeficiency Virus (HIV)Studies of the same condition, open and under way.
- More trials run by University of Colorado, DenverThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Health services research
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 101 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Colorado, Denver
- Sponsor type
- University, hospital or other
- Collaborators
- MedImmune LLC
- Responsible party
- Sponsor
- Investigators
- Adriana Weinberg, MD, Principal investigator, University of Colorado, DenverMyron Levin, MD, Study chair, University of Colorado, DenverDonna Curtis, MD,MPH, Study director, University of Colorado, Denver
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02474901
- Sponsor's protocol ID
- 13-1752
- Acronym
- QLAIV
- Status last verified
- Oct 2017
- First submitted
- 15 Jun 2015
- Last updated
- 20 Nov 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 20 Nov 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Shedding, Immunogenicity and Safety of Quadrivalent Live Intranasal Influenza Vaccine (QLAIV) in HIV-infected Children and Young Adults
- ClinicalTrials.gov ID
- NCT02474901
- Acronym / sponsor ID
- QLAIV / 13-1752
- Conditions
- Human Immunodeficiency Virus (HIV)
- Keywords
- Shedding, Immunogenicity, Safety, HIV infected, Children, Young adults
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 101 participants (actual)
- Lead sponsor
- University of Colorado, DenverUniversity, hospital or other
- Collaborators
- MedImmune LLC
- Study start
- Jul 2013 (actual)
- Primary completion
- Mar 2016 (actual)
- Study completion
- Dec 2016 (actual)
- First posted
- 18 Jun 2015 (estimated)
- Results
- Posted 16 Oct 2017
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Detailed description
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.
Study design
- Primary purpose
- Health services research
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| QLAIV, HIV-infected | Active comparator | Biological: Quadrivalent Live Attenuated Influenza VaccineQLAIV administered to HIV-infected individuals 2 to 25 yoa |
| QLAIV, HIV-uninfected | Active comparator | Biological: Quadrivalent Live Attenuated Influenza VaccineQLAIV administered to HIV-uninfected individuals 2 to 25 yoa |
Who may qualify
- Ages
- 2 to 25 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (11 listed)
- 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
Key exclusion criteria (20 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Quadrivalent Live Attenuated Influenza VaccineAlso: FluMist Quadrivalent, QLAIV | Biological | QLAIV, HIV-infected, QLAIV, HIV-uninfected |
Primary outcome
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.
Time frame: 21 days
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.
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.
Time frame: day 0-21 post-vaccine
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.)
2 secondary outcomes
Number of Participants With Adverse Events Within 14 Days After Vaccination
Time frame: 14 days after vaccination for AEs; up to 30 days for unscheduled visits
Number of Participants Reaching Seroprotection (HAI ≥ 40) Within the HIV-positive and Control Groups.
Time frame: 14-21 days
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Nov 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Adriana Weinberg, MD principal investigator
University of Colorado, Denver
Myron Levin, MD study chair
University of Colorado, Denver
Donna Curtis, MD,MPH study director
University of Colorado, Denver
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Quadrivalent Live Attenuated Influenza Vaccine in people with Human Immunodeficiency Virus (HIV), run by University of Colorado, Denver at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 20 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Nov 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 16 Oct 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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. (time frame: 21 days). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Nov 2017; AzTrials last refreshed its copy on 8 Nov 2026.