Hematologic MalignancyNCT05384288
Response to Influenza Vaccination in Pediatric Oncology Patients
An observational study of Hematologic Malignancy and Pediatric Cancer, run by St. Jude Children's Research Hospital at 1 site in United States.
Trial summary
Influenza infection occurring during oncologic treatment or following hematopoietic cell transplantation (HCT) is associated with increased risk of morbidity in the form of lower respiratory tract infection (LRTI) and mortality relative to otherwise healthy patients. Read more about this study
- Who is it for?
- Ages Up to 18 years
- Conditions the study is for
- Hematologic Malignancy, Pediatric Cancer, Transplant-Related Cancer
- Type of treatment
- Vaccines
- How many people
- 150 participants
- Where
- 1 siteUnited States
- Study dates
- 7 Oct 2022to 1 Dec 2029
- Phase
- Observational
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 Up to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Study population: All participants who meet eligible criteria and consent to enrollment on the study.
Who may be able to join
- Patient ≤ 18 years old at the time of consent receiving care at St. Jude Children's Research Hospital
- Diagnosed with a hematological malignancy
- Eligible to receive the current seasonal influenza vaccine
Who cannot join
- Previously received at least one dose of the current seasonal influenza vaccine.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
St. Jude Children's Research Hospital
Memphis, Tennessee, 38105
Ravilo Octavio, MD, 866-278-5833, referralinfo@stjude.org
Ramilo Octavio, MD
About this study
Influenza infection occurring during oncologic treatment or following hematopoietic cell transplantation (HCT) is associated with increased risk of morbidity in the form of lower respiratory tract infection (LRTI) and mortality relative to otherwise healthy patients. The study participants have been diagnosed with a hematological malignancy and are eligible to receive the current seasonal influenza (Flu) vaccine.
Primary Objective
Read more
- To determine the feasibility of opening a longitudinal prospective study of IIV immunogenicity in pediatric leukemia patients.
- To describe the immunogenicity, as measured by the development of cell- and/or antibody-mediated influenza specific responses 3 to 5 weeks following vaccination, in a cohort of pediatric leukemia patients.
Secondary Objectives
- To describe whether an immune response, as measured by development of cell- and/or antibody-mediated influenza specific responses, is detectable 1-2 weeks following vaccination in a cohort of pediatric leukemia patients.
- To describe the durability of immunogenicity by measuring cell - and antibody- mediated influenza specific responses at 6 months and 1 year following vaccination in a cohort of pediatric leukemia patients.
Exploratory Objectives
- To estimate the clinical effectiveness of influenza vaccine in this cohort by monitoring for the development of clinical diagnosis of influenza in the cohort of enrolled pediatric oncology patients.
- To correlate results of immune cell frequency in blood, as measured by complete blood count with differential, with development of an immune response to IIV.
Read the detailed description
This is a prospective, 2-stage, non-therapeutic study to characterize the immunogenicity of influenza vaccination among pediatric oncology patients at St. Jude. The first stage of the study will consist of a feasibility phase to assess the feasibility of opening a longitudinal prospective study of IIV immunogenicity in pediatric leukemia patients. The second stage will assess the immunogenicity of IIV among pediatric leukemia patients in a larger samples size. The investigator will collect about one teaspoon of blood from the study participant up to 6 times over a year for a total of 6 teaspoons a year. The investigator will also collect some information about the study participant's underlying condition, flu testing and overall health from the medical record during this time.
- Keywords
- Influenza infection
- Medical subject headings
- Hematologic Neoplasms, Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Pediatric Influenza Vaccine Recipients | Pediatric patients eligible to receive seasonal influenza vaccine. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of evaluable participants.
Feasibility is estimated as the proportion of evaluable patients who provide a baseline and Day +35 sample. A 95% confidence interval will be provided.
Measured: 3 years
Proportion of participants with immunogenicity 3 to 5 weeks following vaccination.
Immunogenecity will be measured by the development of cell- and antibody-mediated influenza specific responses 3 to 5 weeks following vaccination. Immunogenicity is estimated as the proportion of evaluable patients whose cell- (as measured by development of any detectable specific T cell responses) and antibody-mediated influenza specific responses (as measured by detectable post vaccination antibody titers) 3 to 5 weeks following vaccination. 95% confidence intervals will be provided.
Measured: 3 years
Secondary outcomes (2)
Proportion of participants with an immune response 1 to 2 weeks following vaccination.
The proportion of patients who have detectable cell- and antibody-mediated influenza specific responses 1-2 weeks following vaccination will be estimated along with a 95% confidence interval.
Measured: 3 years
Proportion of participants with durability of immunogenicity at 6 months and 1 year post-vaccination.
The proportion of patients who still have detectable cell- and antibody-mediated influenza specific responses 6 months and 1 year following vaccination will be estimated, respectively. 95% confidence intervals will be provided
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 May 2022
- Study start7 Oct 2022
- Primary completion1 Dec 2027 (estimated)
- Study completion1 Dec 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hematologic MalignancyStudies 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
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- St. Jude Children's Research Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Ramilo Octavio, MD, Principal investigator, St. Jude Children's Research Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05384288
- Sponsor's protocol ID
- RIVIPOP
- Other IDs
- NCI-2022-05167
- Status last verified
- Jun 2026
- First submitted
- 17 May 2022
- Last updated
- 12 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No