HIVPhase 2NCT01205581
Immunogenicity of Fluzone HD,A High Dose Influenza Vaccine, In Children With Cancer or HIV
A Phase 2 study testing Fluzone High Dose Vaccine and Fluzone Standard Dose Vaccine in people with HIV and Cancer, run by St. Jude Children's Research Hospital at 1 site in United States.
Trial summary
This is an open label-study of Fluzone HD, a high-dose form of trivalent, inactivated influenza vaccine (TIV), vs. Fluzone, a standard-dose form of TIV. Subjects with cancer or HIV will be vaccinated twice with one of the two vaccines and evaluated for development of immune responses. Read more about this study
- Who is it for?
- Ages 3 to 21 years
- What is being tested?
- Fluzone High Dose Vaccine and Fluzone Standard Dose Vaccine
- Type of treatment
- Vaccines
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 85 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2010to Aug 2013
- 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 3 to 21 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Age 3 years (on or past their 3rd birthday) through 21 years of age (not yet reached their 22nd birthday) at the time of entry into the study.
- Written informed consent (and assent, if applicable) obtained.
- Participant has a diagnosis of cancer or HIV.
- If subject has cancer, currently receiving chemotherapy and /or radiotherapy for the treatment of cancer or has received chemotherapy in the past 12 weeks
Who cannot join
- Severe hypersensitivity to egg proteins or any component of Fluzone, or life-threatening reactions after any previous administration of any influenza vaccine;
- History of Guillain-Barre´ syndrome in the subject or subject's family (parents, siblings, half siblings, or children);
- Not willing to agree to acceptable birth control for three months after study immunization
Trial locations and contacts
1 site in 1 country.
United States1 site
St. Jude Children's Research Hospital
Memphis, Tennessee, 38105
About this study
This is an open label-study of Fluzone HD, a high-dose form of trivalent, inactivated influenza vaccine (TIV), vs. Fluzone, a standard-dose form of TIV. Subjects with cancer or HIV will be vaccinated twice with one of the two vaccines and evaluated for development of immune responses.
Read the detailed description
The primary objectives of this study are to compare the immune response of Fluzone HD, a high-dose, trivalent influenza vaccine (TIV), to Fluzone, a standard-dose TIV, in children with cancer and in children with HIV.
The secondary objectives of this study are to:
- Describe the safety and reactogenicity of high-dose and standard-dose TIV.
- Compare the immunogenicity induced by 1 dose, compared to 2 doses, of high-dose and standard-dose TIV.
- Describe the relationship between baseline lymphocyte numbers/function and robustness/durability of the immune response.
- Being tested
- Fluzone High Dose Vaccine, Fluzone Standard Dose Vaccine
- Keywords
- Fluzone, Trivalent Influenza Vaccine
- Medical subject headings
- Neoplasms, Influenza, Human
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fluzone High Dose VaccineBiological
Also called Fluzone-HD
Two doses of Fluzone HD will be administered to children with leukemia, solid tumor, or HIV.
Fluzone Standard Dose VaccineBiological
Also called Fluzone-SD
Two doses of Fluzone Standard Dose Vaccine will be administered to children with leukemia, solid tumor, or HIV.
| Study group | Role | What they receive |
|---|---|---|
| Leukemia-HD | Active comparator | Subjects with a diagnosis of leukemia will be vaccinated twice with Fluzone High Dose Vaccine and evaluated for development of immune responses. Receives: Biological: Fluzone High Dose Vaccine |
| Leukemia-SD | Active comparator | Subjects with a diagnosis of leukemia will be vaccinated twice with Fluzone Standard Dose Vaccine and evaluated for development of immune responses. Receives: Biological: Fluzone Standard Dose Vaccine |
| Solid Tumor-HD | Active comparator | Subjects with a diagnosis of solid tumor will be vaccinated twice with Fluzone High Dose Vaccine and evaluated for development of immune responses. Receives: Biological: Fluzone High Dose Vaccine |
| Solid Tumor-SD | Active comparator | Subjects with a diagnosis of solid tumor will be vaccinated twice with Fluzone Standard Dose Vaccine and evaluated for development of immune responses. Receives: Biological: Fluzone Standard Dose Vaccine |
| HIV-HD | Active comparator | Subjects with a diagnosis of human immunodeficiency virus (HIV) will be vaccinated twice with Fluzone High Dose Vaccine and evaluated for development of immune responses. Receives: Biological: Fluzone High Dose Vaccine |
| HIV-SD | Active comparator | Subjects with a diagnosis of human immunodeficiency virus (HIV) will be vaccinated twice with Fluzone Standard Dose Vaccine and evaluated for development of immune responses. Receives: Biological: Fluzone Standard Dose Vaccine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of Seroconversion After 1 Dose of Vaccine
The immune response of Fluzone HD to Fluzone was determined using the hemagglutination-inhibition (HAI) assay to each of the 3 antigens contained in the vaccine: H1, H3 and B. Seroconversion was defined as a post-vaccine HAI titer ≥40 if baseline was <10, or a 4-fold rise in HAI titer if the baseline ≥10.
Measured: at least 21 days after first dose, which is given at the time of baseline evaluation visit, and prior to second dose
Rate of Seroprotection After 1 Dose of Vaccine
The immune response of Fluzone HD to Fluzone was determined using the hemagglutination-inhibition (HAI) assay to each of the 3 antigens contained in the vaccine: H1, H3 and B. Seroprotection was defined as a post-vaccine HAI titer ≥40.
Measured: at least 21 days after first dose, which is given at the time of baseline evaluation visit, and prior to second dose
Number of Participants Achieving Seroprotection After Second Dose of Vaccine
The immune response of Fluzone HD to Fluzone was determined using the hemagglutination-inhibition (HAI) assay to each of the 3 antigens contained in the vaccine: H1, H3 and B. Seroprotection was defined as a post-vaccine HAI titer ≥40.
Measured: 21 to 42 days after second dose
Secondary outcomes (11)
Number of Participants Reporting Grade 3 and Grade 4 Adverse Events Possibly, Probably, or Definitely Attributable to Fluzone or Fluzone HD
Number of participants reporting grade 3 and grade 4 adverse events possibly, probably, or definitely attributable to Fluzone or Fluzone HD.
Measured: From initial vaccine administration through up to 8 months
Rate of Sero-conversion for 1 Dose vs. 2 Doses of Fluzone HD
The rate of seroconversion to the 3 antigens contained in the vaccine was determined by hemagglutination-inhibition test and was compared by disease.
The immune response of 1 dose vs. 2 doses of Fluzone HD was determined using the hemagglutination-inhibition (HAI) assay to each of the 3 antigens contained in the vaccine: H1, H3 and B. Seroconversion was defined as a post-vaccine HAI titer ≥40 if baseline was <10, or a 4-fold rise in HAI titer if the baseline ≥10.
Measured: at least 21 days after each dose of vaccine
Rate of Sero-conversion for 1 Dose vs. 2 Doses of Fluzone SD
The rate of seroconversion to the 3 antigens contained in the vaccine was determined by hemagglutination-inhibition test and was compared by disease.
The immune response of 1 dose vs. 2 doses of Fluzone SD was determined using the hemagglutination-inhibition (HAI) assay to each of the 3 antigens contained in the vaccine: H1, H3 and B. Seroconversion was defined as a post-vaccine HAI titer ≥40 if baseline was <10, or a 4-fold rise in HAI titer if the baseline ≥10.
Measured: at least 21 days after each dose of vaccine
Rate of Vaccine Response by Seroconversion Compared by Absolute Lymphocyte Count (ALC)
The relationship between baseline lymphocyte numbers/function and robustness of the immune response will be described through descriptive analysis of relationships between pre-defined variables.
Measured: ALC at baseline and vaccine response at least 21 days after last dose of vaccine
Rate of Vaccine Response by Seroprotection Compared by Absolute Lymphocyte Count (ALC)
The relationship between baseline lymphocyte numbers/function and robustness of the immune response will be described through descriptive analysis of relationships between pre-defined variables.
Measured: ALC at baseline and vaccine response at least 21 days after last dose of vaccine
Number of Local Reactogenicity Events After First Dose
Number of moderate or greater local reactogenicity events associated with the administration of Fluzone or FluzoneHD. Local reactions were defined as pain, redness, or induration.
Measured: First 14 days after vaccination
Number of Local Reactogenicity Events After Second Dose
Number of moderate or greater local reactogenicity events associated with the administration of Fluzone or FluzoneHD. Local reactions were defined as pain, redness, or induration.
Measured: First 14 days after vaccination
Number of Systemic Reactogenicity Events After First Dose
Number of moderate or greater systemic reactogenicity event associated with the administration of Fluzone or FluzoneHD. Systemic reactions were defined as muscle ache, fatigue, or fever.
Measured: First 14 days after vaccination
Number of Systemic Reactogenicity Events After Second Dose
Number of moderate or greater systemic reactogenicity event associated with the administration of Fluzone or FluzoneHD. Systemic reactions were defined as muscle ache, fatigue, or fever.
Measured: First 14 days after vaccination
Comparison of Geometric Mean Titer (GMT) by HAI
Serum antibody levels expressed as the reciprocal of the dilution needed to inhibit hemagglutination in vitro.
Measured: Pre-vaccination, post-vaccination and 9 months after vaccination
Comparison of Geometric Mean Ratios (GMR) by HAI
GMTs compared to each other as a ratio of the pre- and post-vaccine titers and as the ratio post-last dose to 9 months later.
GMRs were compared pre- to post-vaccination and post- vaccination to 9 months later.
Measured: Pre-vaccination, post-vaccination and 9 months after vaccination
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Sep 2010 (estimated)
- Study startSep 2010
- Primary completionAug 2013
- Study completionAug 2013
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 HIVStudies of the same condition, open and under way.
- More trials run by St. Jude Children's Research HospitalThe 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 85 participants (actual)
Sponsor and investigators
- Lead sponsor
- St. Jude Children's Research Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jonathan A McCullers, MD, Principal investigator, St. Jude Children's Research Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01205581
- Sponsor's protocol ID
- FLUHD
- Status last verified
- Jul 2016
- First submitted
- 17 Sep 2010
- Last updated
- 23 Sep 2016
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Sep 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Immunogenicity of Fluzone HD,A High Dose Influenza Vaccine, In Children With Cancer or HIV
- ClinicalTrials.gov ID
- NCT01205581
- Acronym / sponsor ID
- FLUHD
- Keywords
- Fluzone, Trivalent Influenza Vaccine
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 85 participants (actual)
- Lead sponsor
- St. Jude Children's Research HospitalUniversity, hospital or other
- Study start
- Sep 2010
- Primary completion
- Aug 2013 (actual)
- Study completion
- Aug 2013 (actual)
- First posted
- 20 Sep 2010 (estimated)
- Results
- Posted 12 Sep 2014
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is an open label-study of Fluzone HD, a high-dose form of trivalent, inactivated influenza vaccine (TIV), vs. Fluzone, a standard-dose form of TIV. Subjects with cancer or HIV will be vaccinated twice with one of the two vaccines and evaluated for development of immune responses.
Detailed description
The primary objectives of this study are to compare the immune response of Fluzone HD, a high-dose, trivalent influenza vaccine (TIV), to Fluzone, a standard-dose TIV, in children with cancer and in children with HIV.
The secondary objectives of this study are to:
- Describe the safety and reactogenicity of high-dose and standard-dose TIV.
- Compare the immunogenicity induced by 1 dose, compared to 2 doses, of high-dose and standard-dose TIV.
- Describe the relationship between baseline lymphocyte numbers/function and robustness/durability of the immune response.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| Leukemia-HD | Active comparator | Biological: Fluzone High Dose VaccineSubjects with a diagnosis of leukemia will be vaccinated twice with Fluzone High Dose Vaccine and evaluated for development of immune responses. |
| Leukemia-SD | Active comparator | Biological: Fluzone Standard Dose VaccineSubjects with a diagnosis of leukemia will be vaccinated twice with Fluzone Standard Dose Vaccine and evaluated for development of immune responses. |
| Solid Tumor-HD | Active comparator | Biological: Fluzone High Dose VaccineSubjects with a diagnosis of solid tumor will be vaccinated twice with Fluzone High Dose Vaccine and evaluated for development of immune responses. |
| Solid Tumor-SD | Active comparator | Biological: Fluzone Standard Dose VaccineSubjects with a diagnosis of solid tumor will be vaccinated twice with Fluzone Standard Dose Vaccine and evaluated for development of immune responses. |
| HIV-HD | Active comparator | Biological: Fluzone High Dose VaccineSubjects with a diagnosis of human immunodeficiency virus (HIV) will be vaccinated twice with Fluzone High Dose Vaccine and evaluated for development of immune responses. |
| HIV-SD | Active comparator | Biological: Fluzone Standard Dose VaccineSubjects with a diagnosis of human immunodeficiency virus (HIV) will be vaccinated twice with Fluzone Standard Dose Vaccine and evaluated for development of immune responses. |
Who may qualify
- Ages
- 3 to 21 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (4 listed)
- Age 3 years (on or past their 3rd birthday) through 21 years of age (not yet reached their 22nd birthday) at the time of entry into the study.
- Written informed consent (and assent, if applicable) obtained.
- Participant has a diagnosis of cancer or HIV.
- If subject has cancer, currently receiving chemotherapy and /or radiotherapy for the treatment of cancer or has received chemotherapy in the past 12 weeks
Key exclusion criteria (3 listed)
- Severe hypersensitivity to egg proteins or any component of Fluzone, or life-threatening reactions after any previous administration of any influenza vaccine;
- History of Guillain-Barre´ syndrome in the subject or subject's family (parents, siblings, half siblings, or children);
- Not willing to agree to acceptable birth control for three months after study 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 |
|---|---|---|
| Fluzone High Dose VaccineAlso: Fluzone-HDTwo doses of Fluzone HD will be administered to children with leukemia, solid tumor, or HIV. | Biological | HIV-HD, Leukemia-HD, Solid Tumor-HD |
| Fluzone Standard Dose VaccineAlso: Fluzone-SDTwo doses of Fluzone Standard Dose Vaccine will be administered to children with leukemia, solid tumor, or HIV. | Biological | HIV-SD, Leukemia-SD, Solid Tumor-SD |
Primary outcome
Rate of Seroconversion After 1 Dose of Vaccine
Time frame: at least 21 days after first dose, which is given at the time of baseline evaluation visit, and prior to second dose
The immune response of Fluzone HD to Fluzone was determined using the hemagglutination-inhibition (HAI) assay to each of the 3 antigens contained in the vaccine: H1, H3 and B. Seroconversion was defined as a post-vaccine HAI titer ≥40 if baseline was <10, or a 4-fold rise in HAI titer if the baseline ≥10.
Rate of Seroprotection After 1 Dose of Vaccine
Time frame: at least 21 days after first dose, which is given at the time of baseline evaluation visit, and prior to second dose
The immune response of Fluzone HD to Fluzone was determined using the hemagglutination-inhibition (HAI) assay to each of the 3 antigens contained in the vaccine: H1, H3 and B. Seroprotection was defined as a post-vaccine HAI titer ≥40.
Number of Participants Achieving Seroprotection After Second Dose of Vaccine
Time frame: 21 to 42 days after second dose
The immune response of Fluzone HD to Fluzone was determined using the hemagglutination-inhibition (HAI) assay to each of the 3 antigens contained in the vaccine: H1, H3 and B. Seroprotection was defined as a post-vaccine HAI titer ≥40.
11 secondary outcomes
Number of Participants Reporting Grade 3 and Grade 4 Adverse Events Possibly, Probably, or Definitely Attributable to Fluzone or Fluzone HD
Time frame: From initial vaccine administration through up to 8 months
Rate of Sero-conversion for 1 Dose vs. 2 Doses of Fluzone HD
Time frame: at least 21 days after each dose of vaccine
Rate of Sero-conversion for 1 Dose vs. 2 Doses of Fluzone SD
Time frame: at least 21 days after each dose of vaccine
Rate of Vaccine Response by Seroconversion Compared by Absolute Lymphocyte Count (ALC)
Time frame: ALC at baseline and vaccine response at least 21 days after last dose of vaccine
Rate of Vaccine Response by Seroprotection Compared by Absolute Lymphocyte Count (ALC)
Time frame: ALC at baseline and vaccine response at least 21 days after last dose of vaccine
Number of Local Reactogenicity Events After First Dose
Time frame: First 14 days after vaccination
Number of Local Reactogenicity Events After Second Dose
Time frame: First 14 days after vaccination
Number of Systemic Reactogenicity Events After First Dose
Time frame: First 14 days after vaccination
Number of Systemic Reactogenicity Events After Second Dose
Time frame: First 14 days after vaccination
Comparison of Geometric Mean Titer (GMT) by HAI
Time frame: Pre-vaccination, post-vaccination and 9 months after vaccination
Comparison of Geometric Mean Ratios (GMR) by HAI
Time frame: Pre-vaccination, post-vaccination and 9 months after vaccination
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Sep 2016.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- St. Jude Children's Research HospitalLink provided by the sponsor.
- Clinical Trials Open at St. JudeLink provided by the sponsor.
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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.
Jonathan A McCullers, MD principal investigator
St. Jude Children's Research Hospital
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 Fluzone High Dose Vaccine and Fluzone Standard Dose Vaccine in people with HIV and Cancer, run by St. Jude Children's Research Hospital 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 4 inclusion and 3 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 23 Sep 2016. 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 12 Sep 2014). 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?
Rate of Seroconversion After 1 Dose of Vaccine (time frame: at least 21 days after first dose, which is given at the time of baseline evaluation visit, and prior to second dose). The study lists 3 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 23 Sep 2016.