PTEN Hamartoma Tumor SyndromeRIPSNCT03630523
Response of Immune System to Flu Vaccination in PHTS
A study testing Influvac Tetra in people with PTEN Hamartoma Tumor Syndrome, run by Radboud University Medical Center.
Trial summary
this study evaluates the cellular and humoral immune response to seasonal influenze vaccination in PTEN Hamartoma Tumor Syndrome. All subjects will be administered flu vaccination, half of the subjects will be control subjects. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- PTEN Hamartoma Tumor Syndrome
- What is being tested?
- Influvac Tetra
- Type of treatment
- Vaccines
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- No sites listed yet
- Study dates
- Oct 2018to Jan 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Must be diagnosed with PHTS based on genetic testing
- Must be a Radboudumc patient
- Must be 18 years or older
- Must be mentally competent
- Must have provided written informed consent to participate in the study
- Must be able to adhere to visit schedule and available to complete the study
Who cannot join
- • Known history of significant medical disorder, which in the investigator's judgment might confound the results of the study or pose additional risk to the subject by participation in the study
- Known hypersensitivity to previous influenza vaccinations (Anaphylaxis)
- Must not be allergic to chicken eggwhite
- Pregnancy at start of study
- Immunocompromised patients and those receiving concomitant immunosuppressive therapy or other immune modulating drugs including chronic steroid treatment.
- Bleeding disorders including haemophilia and thrombocytopenia or treatment with anticoagulants(Due to risk of intramuscular hematoma after injection)
- Must not have received vaccination with attenuated pathogens in the 4 weeks leading up to study. (Measles, mumps, rubella, yellow fever, rotavirus, BCG, typhoid)
About this study
Official title: Registering the Immune Response to a Flu Vaccination Challenge in PTEN Hamartoma Tumour Syndrome
this study evaluates the cellular and humoral immune response to seasonal influenze vaccination in PTEN Hamartoma Tumor Syndrome. All subjects will be administered flu vaccination, half of the subjects will be control subjects.
- Conditions
- PTEN Hamartoma Tumor Syndrome
- Being tested
- Influvac Tetra
- Keywords
- PHTS, PTEN, Vaccination
- Medical subject headings
- Hamartoma Syndrome, Multiple
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Influvac TetraBiological
Tetravalent seasonal flu vaccination 2018/2019
| Study group | Role | What they receive |
|---|---|---|
| Vaccination | Other | Arm contains all subjects; vaccination with Influvac Tetra will be administered at start of study, response will be measured in 7 and 21 days. Receives: Biological: Influvac Tetra |
What is being measured
The primary outcome is the main question the study is designed to answer.
Hemagglutination inhibition assay titre
Measured: 7 days
Secondary outcomes (2)
Proliferation assay
Measured: 21 days
interleukin profile
Measured: 21 days, 7 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Aug 2018
- Study startOct 2018 (estimated)
- Primary completionJan 2019 (estimated)
- Study completionJan 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PTEN Hamartoma Tumor SyndromeStudies of the same condition, open and under way.
- More trials run by Radboud University Medical CenterThe 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 N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Radboud University Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03630523
- Sponsor's protocol ID
- NL66559.091.18
- Acronym
- RIPS
- Status last verified
- Aug 2018
- First submitted
- 10 Aug 2018
- Last updated
- 15 Aug 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Registering the Immune Response to a Flu Vaccination Challenge in PTEN Hamartoma Tumour Syndrome
- ClinicalTrials.gov ID
- NCT03630523
- Acronym / sponsor ID
- RIPS / NL66559.091.18
- Conditions
- PTEN Hamartoma Tumor Syndrome
- Keywords
- PHTS, PTEN, Vaccination
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Radboud University Medical CenterUniversity, hospital or other
- Study start
- Oct 2018 (estimated)
- Primary completion
- Jan 2019 (estimated)
- Study completion
- Jan 2019 (estimated)
- First posted
- 15 Aug 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
this study evaluates the cellular and humoral immune response to seasonal influenze vaccination in PTEN Hamartoma Tumor Syndrome. All subjects will be administered flu vaccination, half of the subjects will be control subjects.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Vaccination | Other | Biological: Influvac TetraArm contains all subjects; vaccination with Influvac Tetra will be administered at start of study, response will be measured in 7 and 21 days. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Must be diagnosed with PHTS based on genetic testing
- Must be a Radboudumc patient
- Must be 18 years or older
- Must be mentally competent
- Must have provided written informed consent to participate in the study
Key exclusion criteria (7 listed)
- • Known history of significant medical disorder, which in the investigator's judgment might confound the results of the study or pose additional risk to the subject by participation in the study
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 |
|---|---|---|
| Influvac TetraTetravalent seasonal flu vaccination 2018/2019 | Biological | Vaccination |
Primary outcome
Hemagglutination inhibition assay titre
Time frame: 7 days
2 secondary outcomes
Proliferation assay
Time frame: 21 days
interleukin profile
Time frame: 21 days, 7 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Aug 2018.
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PTEN Hamartoma Syndrome
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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Influvac Tetra in people with PTEN Hamartoma Tumor Syndrome, run by Radboud University Medical Center.
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 6 inclusion and 7 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: status not confirmed, as of the sponsor's last update on 15 Aug 2018. Status can change between updates, so confirm with the study contact before making plans.
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.
Are results available for this study?
Results are not available in the source record.
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?
Hemagglutination inhibition assay titre (time frame: 7 days). 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 15 Aug 2018.