Heterologous Effects of VaccinesNCT02765126
Heterologous Effect of Diptheria, Tetanus, Acellular Pertussis Vaccination on Influenza Challenge in the Elderly
A study testing Seasonal influenza vaccine and Diphtheria-tetanus-acellular pertussis vaccine in people with Heterologous Effects of Vaccines, run by Clifford Craig Medical Research Trust at 1 site in Australia.
Trial summary
Vaccines can have non-targeted or heterologous (also called non-specific) immunological effects on the immune system i.e. effects other than inducing an immune response against the disease targeted by the vaccine. Read more about this study
- Who is it for?
- Ages 30 to 100 yearsHealthy volunteers can take part
- Conditions the study is for
- Heterologous Effects of Vaccines
- What is being tested?
- Seasonal influenza vaccine and Diphtheria-tetanus-acellular pertussis vaccine
- Type of treatment
- Vaccines, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 450 participants
- Where
- 1 siteAustralia
- Study dates
- May 2016to Dec 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 30 to 100 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Two study groups 30-50 years old >65 years old
Who cannot join
- Unwell on day of vaccination
- Temperature >38°C
- Active cancer
- Active autoimmune disease
- Diabetes mellitus
- Taking immunosuppressive drugs including steroids
Show all 10Show fewer
- Any vaccination in last 3 months
- DT or DTaP vaccination in the last year
- Known allergy or contraindication to influenza or DTaP vaccination
- Pregnant or breastfeeding
Trial locations and contacts
1 site in 1 country.
Jane Niekamp contact
Australia1 site, 1 recruiting
- Recruiting
Clifford Craig Foundation
Launceston, Tasmania, 7250
Kathryn Ogden, MBBS, MPH, 03 6777 6010, kathryn.ogden@utas.edu.au
Jane Niekamp, 03 6777 6010
About this study
Official title: Clifford Craig Vaccine Trial Centre: Heterologous Effect of Diptheria, Tetanus, Acellular Pertussis Vaccination on Influenza Vaccine Challenge in the Elderly
Vaccines can have non-targeted or heterologous (also called non-specific) immunological effects on the immune system i.e. effects other than inducing an immune response against the disease targeted by the vaccine. This trial aims to evaluate the non-specific immunological effects of two vaccines - diphtheria-tetanus-acellular pertussis (DTP) vaccine and seasonal influenza vaccine - in a cohort of elderly humans (>65 years of age) and healthy adult control subjects (30-50 years).
Read the detailed description
This prospective randomised study aims to investigate the heterologous immunological effects of DTP and seasonal influenza (Flu) vaccination in an elderly Tasmanian population and healthy adults. The study will assess whether prior or concurrent administration of DTP with seasonal Flu vaccination affects generalised inflammation / immune homeostasis and gene expression, with a particular focus of inflammation reactive cells. It will also analyse for effects of DTP on the induction of vaccine-specific immunity to seasonal influenza vaccination (antibodies and cellular). Volunteers will be randomised to one of three vaccine groups and serial blood samples taken for immunological assays for up to 30 weeks.
The study is exploratory and will investigate vaccine effects on multiple immune parameters.
- Conditions
- Heterologous Effects of Vaccines
- Being tested
- Seasonal influenza vaccine, Diphtheria-tetanus-acellular pertussis vaccine
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Seasonal influenza vaccineBiological
Also called Quadrivalent Influenza Vaccine
Intramuscular standard seasonal influenza vaccine
Diphtheria-tetanus-acellular pertussis vaccineBiological
Also called Boostrix vaccine
Intramuscular DTaP vaccine
| Study group | Role | What they receive |
|---|---|---|
| Group 1 | Active comparator | Diphtheria-tetanus-acellular pertussis vaccine administered day 0, followed by seasonal influenza vaccination four weeks later. Blood testing to occur day 0 (prior to vaccine administration), 24 hours, 1 week, 4 weeks, 4 weeks + 24 hours, 5 weeks, 8 weeks and 30 weeks. Stool samples to be taken at day 0 and 1 week post-vaccination. Receives: Biological: Seasonal influenza vaccine; Biological: Diphtheria-tetanus-acellular pertussis vaccine |
| Group 2 | Active comparator | Seasonal influenza vaccine administered on day 0, to be offered DTP vaccine at week 26. Blood testing to occur day 0 (prior to vaccine administration), 24 hours, 1 week 1, 4 weeks and 26 weeks. Stool samples to be taken at day 0 and 1 week post-vaccination. Receives: Biological: Seasonal influenza vaccine; Biological: Diphtheria-tetanus-acellular pertussis vaccine |
| Group 3 | Active comparator | Seasonal influenza vaccine and DTP vaccine administered together on day 0. Blood testing to occur day 0 (prior to vaccine administration), 24 hours, 1 week 1, 4 weeks and 26 weeks. Stool samples to be taken at day 0 and 1 week post-vaccination. Receives: Biological: Seasonal influenza vaccine; Biological: Diphtheria-tetanus-acellular pertussis vaccine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of inflammation reactive TNFR2+ regulatory T cells per mL of blood
Change over time in different vaccine groups of Tregs measured by flow cytometry.
Measured: 24 hours, 1 week, 4 weeks and 26 weeks
Secondary outcomes (4)
Whole human genome transcription profile by next generation sequencing in log2 expression levels
Differential gene expression 24 hours after vaccination compared to baseline, and vaccine groups compared to see which genes / pathways are affected. Differential transcription determined for each gene, then analysed using modular analysis tools to determine vaccine effects.
Measured: 24 hours
Influenza-specific antibody titres to seasonal influenza vaccination
Change over time in the different vaccine groups of titres measured by haemagglutination inhibition assay.
Measured: 4 weeks and 26 weeks
Pro-inflammatory (TNF) to anti-inflammatory (IL-10) cytokine ratio in stimulated blood in pg/mL
Change in TNF:IL-10 ratio post-vaccination over time as measured by cytokine multiplex assay of anti-CD3 stimulated PBMC.
Measured: 24 hours, 1 week, 4 weeks and 26 weeks
Influenza-specific IFN-g CD4 T cell responses to seasonal influenza vaccination in pg/mL
Change over time in the different vaccine groups of IFN-g levels in supernatants from CD4 T cells cultured with live influenza virus
Measured: 4 weeks and 26 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 May 2016 (estimated)
- Study startMay 2016
- Primary completionDec 2019 (estimated)
- Study completionDec 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (28)Papers the sponsor has linked to this study.
- Other trials for Heterologous Effects of VaccinesStudies of the same condition, open and under way.
- 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
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 450 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Clifford Craig Medical Research Trust
- Sponsor type
- University, hospital or other
- Collaborators
- Monash University, The Peter Doherty Institute for Infection and Immunity, University of Sao Paulo, Johns Hopkins Bloomberg School of Public Health
- Responsible party
- Sponsor
- Investigators
- Katie Flanagan, PhD FRACP, Principal investigator, Clifford Craig Medical Research Trust
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02765126
- Sponsor's protocol ID
- H0015460
- Status last verified
- Jul 2017
- First submitted
- 3 May 2016
- Last updated
- 27 Jul 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Yes: The transcriptome data will be de-identified and deposited in a pubic database. The de-identified microbiome data may well also be made publically available.
Publications
Meeting of the Strategic Advisory Group of Experts on immunization, April 2014 -- conclusions and recommendations. Wkly Epidemiol Rec. 2014 May 23;89(21):221-36. No abstract available. English, French.
PubMed 24864348Aaby P, Martins CL, Garly ML, Bale C, Andersen A, Rodrigues A, Ravn H, Lisse IM, Benn CS, Whittle HC. Non-specific effects of standard measles vaccine at 4.5 and 9 months of age on childhood mortality: randomised controlled trial. BMJ. 2010 Nov 30;341:c6495. doi: 10.1136/bmj.c6495.
PubMed 21118875Sorup S, Benn CS, Poulsen A, Krause TG, Aaby P, Ravn H. Live vaccine against measles, mumps, and rubella and the risk of hospital admissions for nontargeted infections. JAMA. 2014 Feb 26;311(8):826-35. doi: 10.1001/jama.2014.470.
PubMed 24570246Aaby P, Benn C, Nielsen J, Lisse IM, Rodrigues A, Ravn H. Testing the hypothesis that diphtheria-tetanus-pertussis vaccine has negative non-specific and sex-differential effects on child survival in high-mortality countries. BMJ Open. 2012 May 22;2(3):e000707. doi: 10.1136/bmjopen-2011-000707. Print 2012.
PubMed 22619263Nichol KL, Nordin JD, Nelson DB, Mullooly JP, Hak E. Effectiveness of influenza vaccine in the community-dwelling elderly. N Engl J Med. 2007 Oct 4;357(14):1373-81. doi: 10.1056/NEJMoa070844.
PubMed 17914038Goodwin K, Viboud C, Simonsen L. Antibody response to influenza vaccination in the elderly: a quantitative review. Vaccine. 2006 Feb 20;24(8):1159-69. doi: 10.1016/j.vaccine.2005.08.105. Epub 2005 Sep 19.
PubMed 16213065Sasaki S, Sullivan M, Narvaez CF, Holmes TH, Furman D, Zheng NY, Nishtala M, Wrammert J, Smith K, James JA, Dekker CL, Davis MM, Wilson PC, Greenberg HB, He XS. Limited efficacy of inactivated influenza vaccine in elderly individuals is associated with decreased production of vaccine-specific antibodies. J Clin Invest. 2011 Aug;121(8):3109-19. doi: 10.1172/JCI57834. Epub 2011 Jul 25.
PubMed 21785218Grant EJ, Chen L, Quinones-Parra S, Pang K, Kedzierska K, Chen W. T-cell immunity to influenza A viruses. Crit Rev Immunol. 2014;34(1):15-39. doi: 10.1615/critrevimmunol.2013010019.
PubMed 24579700Saurwein-Teissl M, Lung TL, Marx F, Gschosser C, Asch E, Blasko I, Parson W, Bock G, Schonitzer D, Trannoy E, Grubeck-Loebenstein B. Lack of antibody production following immunization in old age: association with CD8(+)CD28(-) T cell clonal expansions and an imbalance in the production of Th1 and Th2 cytokines. J Immunol. 2002 Jun 1;168(11):5893-9. doi: 10.4049/jimmunol.168.11.5893.
PubMed 12023394Weston WM, Friedland LR, Wu X, Howe B. Vaccination of adults 65 years of age and older with tetanus toxoid, reduced diphtheria toxoid and acellular pertussis vaccine (Boostrix((R))): results of two randomized trials. Vaccine. 2012 Feb 21;30(9):1721-8. doi: 10.1016/j.vaccine.2011.12.055. Epub 2011 Dec 31.
PubMed 22212127Solana R, Tarazona R, Gayoso I, Lesur O, Dupuis G, Fulop T. Innate immunosenescence: effect of aging on cells and receptors of the innate immune system in humans. Semin Immunol. 2012 Oct;24(5):331-41. doi: 10.1016/j.smim.2012.04.008. Epub 2012 May 4.
PubMed 22560929Panda A, Qian F, Mohanty S, van Duin D, Newman FK, Zhang L, Chen S, Towle V, Belshe RB, Fikrig E, Allore HG, Montgomery RR, Shaw AC. Age-associated decrease in TLR function in primary human dendritic cells predicts influenza vaccine response. J Immunol. 2010 Mar 1;184(5):2518-27. doi: 10.4049/jimmunol.0901022. Epub 2010 Jan 25.
PubMed 20100933Baylis D, Bartlett DB, Syddall HE, Ntani G, Gale CR, Cooper C, Lord JM, Sayer AA. Immune-endocrine biomarkers as predictors of frailty and mortality: a 10-year longitudinal study in community-dwelling older people. Age (Dordr). 2013 Jun;35(3):963-71. doi: 10.1007/s11357-012-9396-8. Epub 2012 Mar 3.
PubMed 22388931Franceschi C, Capri M, Monti D, Giunta S, Olivieri F, Sevini F, Panourgia MP, Invidia L, Celani L, Scurti M, Cevenini E, Castellani GC, Salvioli S. Inflammaging and anti-inflammaging: a systemic perspective on aging and longevity emerged from studies in humans. Mech Ageing Dev. 2007 Jan;128(1):92-105. doi: 10.1016/j.mad.2006.11.016. Epub 2006 Nov 20.
PubMed 17116321Bruunsgaard H, Andersen-Ranberg K, Hjelmborg Jv, Pedersen BK, Jeune B. Elevated levels of tumor necrosis factor alpha and mortality in centenarians. Am J Med. 2003 Sep;115(4):278-83. doi: 10.1016/s0002-9343(03)00329-2.
PubMed 12967692
Study at a glance
From the registry record, last updated by the sponsor on 27 Jul 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clifford Craig Vaccine Trial Centre: Heterologous Effect of Diptheria, Tetanus, Acellular Pertussis Vaccination on Influenza Vaccine Challenge in the Elderly
- ClinicalTrials.gov ID
- NCT02765126
- Acronym / sponsor ID
- H0015460
- Conditions
- Heterologous Effects of Vaccines
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 450 participants (estimated)
- Lead sponsor
- Clifford Craig Medical Research TrustUniversity, hospital or other
- Collaborators
- Monash University, The Peter Doherty Institute for Infection and Immunity, University of Sao Paulo, Johns Hopkins Bloomberg School of Public Health
- Study start
- May 2016
- Primary completion
- Dec 2019 (estimated)
- Study completion
- Dec 2019 (estimated)
- First posted
- 6 May 2016 (estimated)
- 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.
Vaccines can have non-targeted or heterologous (also called non-specific) immunological effects on the immune system i.e. effects other than inducing an immune response against the disease targeted by the vaccine. This trial aims to evaluate the non-specific immunological effects of two vaccines - diphtheria-tetanus-acellular pertussis (DTP) vaccine and seasonal influenza vaccine - in a cohort of elderly humans (>65 years of age) and healthy adult control subjects (30-50 years).
Detailed description
This prospective randomised study aims to investigate the heterologous immunological effects of DTP and seasonal influenza (Flu) vaccination in an elderly Tasmanian population and healthy adults. The study will assess whether prior or concurrent administration of DTP with seasonal Flu vaccination affects generalised inflammation / immune homeostasis and gene expression, with a particular focus of inflammation reactive cells. It will also analyse for effects of DTP on the induction of vaccine-specific immunity to seasonal influenza vaccination (antibodies and cellular). Volunteers will be randomised to one of three vaccine groups and serial blood samples taken for immunological assays for up to 30 weeks.
The study is exploratory and will investigate vaccine effects on multiple immune parameters.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Group 1 | Active comparator | Biological: Seasonal influenza vaccine, Biological: Diphtheria-tetanus-acellular pertussis vaccineDiphtheria-tetanus-acellular pertussis vaccine administered day 0, followed by seasonal influenza vaccination four weeks later. Blood testing to occur day 0 (prior to vaccine administration), 24 hours, 1 week, 4 weeks, 4 weeks + 24 hours, 5 weeks, 8 weeks and 30 weeks. Stool samples to be taken at day 0 and 1 week post-vaccination. |
| Group 2 | Active comparator | Biological: Seasonal influenza vaccine, Biological: Diphtheria-tetanus-acellular pertussis vaccineSeasonal influenza vaccine administered on day 0, to be offered DTP vaccine at week 26. Blood testing to occur day 0 (prior to vaccine administration), 24 hours, 1 week 1, 4 weeks and 26 weeks. Stool samples to be taken at day 0 and 1 week post-vaccination. |
| Group 3 | Active comparator | Biological: Seasonal influenza vaccine, Biological: Diphtheria-tetanus-acellular pertussis vaccineSeasonal influenza vaccine and DTP vaccine administered together on day 0. Blood testing to occur day 0 (prior to vaccine administration), 24 hours, 1 week 1, 4 weeks and 26 weeks. Stool samples to be taken at day 0 and 1 week post-vaccination. |
Who may qualify
- Ages
- 30 to 100 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Two study groups 30-50 years old >65 years old
Key exclusion criteria (10 listed)
- Unwell on day of vaccination
- Temperature >38°C
- Active cancer
- Active autoimmune disease
- Diabetes mellitus
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 |
|---|---|---|
| Seasonal influenza vaccineAlso: Quadrivalent Influenza VaccineIntramuscular standard seasonal influenza vaccine | Biological | Group 1, Group 2, Group 3 |
| Diphtheria-tetanus-acellular pertussis vaccineAlso: Boostrix vaccineIntramuscular DTaP vaccine | Biological | Group 1, Group 2, Group 3 |
Primary outcome
Number of inflammation reactive TNFR2+ regulatory T cells per mL of blood
Time frame: 24 hours, 1 week, 4 weeks and 26 weeks
Change over time in different vaccine groups of Tregs measured by flow cytometry.
4 secondary outcomes
Whole human genome transcription profile by next generation sequencing in log2 expression levels
Time frame: 24 hours
Influenza-specific antibody titres to seasonal influenza vaccination
Time frame: 4 weeks and 26 weeks
Pro-inflammatory (TNF) to anti-inflammatory (IL-10) cytokine ratio in stimulated blood in pg/mL
Time frame: 24 hours, 1 week, 4 weeks and 26 weeks
Influenza-specific IFN-g CD4 T cell responses to seasonal influenza vaccination in pg/mL
Time frame: 4 weeks and 26 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jul 2017.
- Background: PubMed 24864348Meeting of the Strategic Advisory Group of Experts on immunization, April 2014 -- conclusions and recommendations. Wkly Epidemiol Rec. 2014 May 23;89(21):221-36. No abstract available. English, French.
- Background: PubMed 21118875Aaby P, Martins CL, Garly ML, Bale C, Andersen A, Rodrigues A, Ravn H, Lisse IM, Benn CS, Whittle HC. Non-specific effects of standard measles vaccine at 4.5 and 9 months of age on childhood mortality: randomised controlled trial. BMJ. 2010 Nov 30;341:c6495. doi: 10.1136/bmj.c6495.
- Background: PubMed 24570246Sorup S, Benn CS, Poulsen A, Krause TG, Aaby P, Ravn H. Live vaccine against measles, mumps, and rubella and the risk of hospital admissions for nontargeted infections. JAMA. 2014 Feb 26;311(8):826-35. doi: 10.1001/jama.2014.470.
- Background: PubMed 22619263Aaby P, Benn C, Nielsen J, Lisse IM, Rodrigues A, Ravn H. Testing the hypothesis that diphtheria-tetanus-pertussis vaccine has negative non-specific and sex-differential effects on child survival in high-mortality countries. BMJ Open. 2012 May 22;2(3):e000707. doi: 10.1136/bmjopen-2011-000707. Print 2012.
- Background: PubMed 17914038Nichol KL, Nordin JD, Nelson DB, Mullooly JP, Hak E. Effectiveness of influenza vaccine in the community-dwelling elderly. N Engl J Med. 2007 Oct 4;357(14):1373-81. doi: 10.1056/NEJMoa070844.
- Background: PubMed 16213065Goodwin K, Viboud C, Simonsen L. Antibody response to influenza vaccination in the elderly: a quantitative review. Vaccine. 2006 Feb 20;24(8):1159-69. doi: 10.1016/j.vaccine.2005.08.105. Epub 2005 Sep 19.
- Background: PubMed 21785218Sasaki S, Sullivan M, Narvaez CF, Holmes TH, Furman D, Zheng NY, Nishtala M, Wrammert J, Smith K, James JA, Dekker CL, Davis MM, Wilson PC, Greenberg HB, He XS. Limited efficacy of inactivated influenza vaccine in elderly individuals is associated with decreased production of vaccine-specific antibodies. J Clin Invest. 2011 Aug;121(8):3109-19. doi: 10.1172/JCI57834. Epub 2011 Jul 25.
- Background: PubMed 24579700Grant EJ, Chen L, Quinones-Parra S, Pang K, Kedzierska K, Chen W. T-cell immunity to influenza A viruses. Crit Rev Immunol. 2014;34(1):15-39. doi: 10.1615/critrevimmunol.2013010019.
- Background: PubMed 12023394Saurwein-Teissl M, Lung TL, Marx F, Gschosser C, Asch E, Blasko I, Parson W, Bock G, Schonitzer D, Trannoy E, Grubeck-Loebenstein B. Lack of antibody production following immunization in old age: association with CD8(+)CD28(-) T cell clonal expansions and an imbalance in the production of Th1 and Th2 cytokines. J Immunol. 2002 Jun 1;168(11):5893-9. doi: 10.4049/jimmunol.168.11.5893.
- Background: PubMed 22212127Weston WM, Friedland LR, Wu X, Howe B. Vaccination of adults 65 years of age and older with tetanus toxoid, reduced diphtheria toxoid and acellular pertussis vaccine (Boostrix((R))): results of two randomized trials. Vaccine. 2012 Feb 21;30(9):1721-8. doi: 10.1016/j.vaccine.2011.12.055. Epub 2011 Dec 31.
- Background: PubMed 22560929Solana R, Tarazona R, Gayoso I, Lesur O, Dupuis G, Fulop T. Innate immunosenescence: effect of aging on cells and receptors of the innate immune system in humans. Semin Immunol. 2012 Oct;24(5):331-41. doi: 10.1016/j.smim.2012.04.008. Epub 2012 May 4.
- Background: PubMed 20100933Panda A, Qian F, Mohanty S, van Duin D, Newman FK, Zhang L, Chen S, Towle V, Belshe RB, Fikrig E, Allore HG, Montgomery RR, Shaw AC. Age-associated decrease in TLR function in primary human dendritic cells predicts influenza vaccine response. J Immunol. 2010 Mar 1;184(5):2518-27. doi: 10.4049/jimmunol.0901022. Epub 2010 Jan 25.
- Individual participant dataSharing planned: Yes. The transcriptome data will be de-identified and deposited in a pubic database. The de-identified microbiome data may well also be made publically available.
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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.
Jane Niekamp contact
Katie Flanagan, PhD FRACP principal investigator
Clifford Craig Medical Research Trust
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Seasonal influenza vaccine and Diphtheria-tetanus-acellular pertussis vaccine in people with Heterologous Effects of Vaccines, run by Clifford Craig Medical Research Trust at 1 site in Australia.
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 1 inclusion and 10 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 27 Jul 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 Australia. 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.
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?
Contact Kathryn Ogden, MPH FRACGP (+61 3 6777 8790, kathryn.ogden@utas.edu.au), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of inflammation reactive TNFR2+ regulatory T cells per mL of blood (time frame: 24 hours, 1 week, 4 weeks and 26 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02765126, which also lists 28 linked publications.
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 27 Jul 2017.