TuberculosisPhase 1TBCOX2NCT02503839
Therapeutic Vaccination and Immune Modulation - New Treatment Strategies for the MDR Tuberculosis Pandemic
A Phase 1 study testing etoricoxib and H56:IC31 in people with Tuberculosis, run by Anne Margarita Dyrhol Riise at 2 sites in Norway.
Trial summary
Tuberculosis (TB) is a global challenge and for the increasing epidemic of multi-drug resistant (MDR)-TB there is restricted treatment options. This calls for research of new immune-modulating treatment strategies that can strengthen the patients immune system to better fight the TB bacteria. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Tuberculosis
- What is being tested?
- etoricoxib and H56:IC31
- Type of treatment
- Vaccines
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 39 participants
- Where
- 2 sitesNorway
- Study dates
- Nov 2015to 23 Mar 2020
- Phase
- Phase 1
- 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 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age between 18 to 70 years at the time of randomization.
- Microbiologically confirmed pulmonary TB (culture and/or PCR + susceptibility testing) and/or microbiologically confirmed extra-pulmonary TB (culture and/or PCR + susceptibility testing).
- Drug sensitive Mtb strains (except single resistance where fully adequate anti-TB chemotherapy regimen could be provided).
- Is willing and likely to comply with the trial procedures and is prepared to grant authorized persons access to their medical record.
- Has completed the written informed consent process prior to the start of screening evaluations.
- Females: Ability to avoid pregnancy during the trial.
Show all 10Show fewer
- Subjects may receive H56:IC31 vaccination (arm#2 and #4) if they meet the following criteria:
- Sputum obtained prior to 1th immunization (day 84) must be Mtb negative evaluated by at least two consecutive AFS or GeneXpert/PCR at least 7 days apart.
- Documented reduction in the extent of TB disease at the infectious site(s) within day 84 evaluated by physical and/or radiological examination.
- Clinical improvement with normal vital signs (blood pressure, temperature and pulse), improvement of any TB related symptoms to Grade 1-3, stable or increased body-weight and reduced inflammatory blood parameters (CRP, ESR and WBC counts) compared to baseline.
Who cannot join
- Main exclusion criteria:
- Study-specific: Disseminated TB. Evidence of a new acute illness that may compromise the safety of the subject in the trial on study day 0. History of autoimmune disease or immunosuppression. History or laboratory evidence of any possible immunodeficiency state. Anemia (<9 g/100 ml). HIV sero-positivity. Chronic hepatitis B (HBs antigen positive) with increased liver transaminases (ASAT, ALAT) or chronic hepatitis C (HCV RNA positive). Concomitant or sporadic use of NSAID or corticosteroids (>2 times per week). Other immune modulating therapies including DMARDS. Total cholesterol > 7 mmol/L. Hypertension >140/90 mm Hg (treated or untreated) or treated with >1 antihypertensive drug at any blood pressure. Cardiovascular events or stroke in parents, siblings or off-springs occurring < 55 years of age. Serum creatinine above reference levels (females > 90 µmol/L; males > 105 µmol/L). Known diabetes mellitus type I or diabetes mellitus type II with HbA1c >7%. Pregnancy (S-hCG >5 IU/l for females at childbearing age). Breastfeeding.
- 2. Exclusion criteria for etoricoxib according to SPC: Known hypersensitivity for etoricoxib or etoricoxib tablet substances. Known hypersensitivity for sulphonamides. Active peptic ulcer or gastrointestinal haemorrhage. History of asthma, acute rhinitis, nasal polyps, angioneurotic oedema, urticaria or other allergic reactions after taking acetyl salicylic acid or NSAID including COX-2 inhibitors. Moderate/severe deranged liver function (Child-Pugh >7). Serum-creatinine clearance < 30 ml/min. Inflammatory bowel disease. Heart failure (NYHA II-IV). Established ischaemic heart disease, peripheral arteriosclerosis and/or cerebrovascular disease, including previous myocardial infarction, angina pectoris, unstable angina, PCI or coronary bypass, previous transitory ischemic attack or apoplexia/stroke.
- 3. Exclusion criteria for H56:IC31: Known hypersensitivity for vaccines or vaccine adjuvants.
Trial locations and contacts
2 sites in 1 country.
Norway2 sites
Haukeland University Hospital
Bergen, 5020
Oslo University Hospital
Oslo, 0424
About this study
Official title: Therapeutic Vaccination and Immune Modulation - New Treatment Strategies for the Multidrug-resistant Tuberculosis Pandemic; an Open Label Phase I Clinical Trial of the Therapeutic TB H56:IC31 Vaccine and Cyclooxygenase-inhibitors
Tuberculosis (TB) is a global challenge and for the increasing epidemic of multi-drug resistant (MDR)-TB there is restricted treatment options. This calls for research of new immune-modulating treatment strategies that can strengthen the patients immune system to better fight the TB bacteria. The pro-inflammatory, but still immunosuppressive mediator prostaglandin E2 (PGE2) is produced by cyclooxygenase-2 (COX-2) in inflamed infected tissue. Studies from both human and animal models show that COX-2 inhibitors (COX-2i) can improve the immune system and strengthen vaccines responses.
Hypothesis
Read more
- A hyperactive COX-2/PGE2 signal system in active TB causes down-regulated immune responses that favour TB survival, but this can be abrogated by COX-2i.
- TB-specific immunisation with targeted antigens presented as a therapeutic TB vaccine and enhanced by COX-2i will improve immune-mediated host clearance of TB.
- Combinations of COX-2i and a therapeutic TB vaccine to conventional anti-TB chemotherapy offer new treatment modalities for TB, including MDR/XDR-TB.
Approach to test the hypothesis
- Study design: 4-arm, open and randomized clinical intervention trial of patients starting treatment for active TB in specialized Norwegian TB centres and where two arms will receive the COX-2i etoricoxib with and without a TB vaccine, one arm vaccine only and the last arm serve as control receiving only standard anti-TB therapy. For safety precautions, only patients bearing sensitive TB strains are included and study arms will be sequentially introduced.
- In a mouse model examine in more detail the effects of reversion of chronic inflammation with COX-2i locally in tissue and the interplay with TB vaccine responses, immune regulation, correlates of protection and survival in a well-characterized model for TB-exposed mice.
Read the detailed description
The hypothesis is that treating TB patients with a therapeutic TB vaccine and COX-2 inhibiting drugs in addition to standard antibiotic TB therapy will improve the patients immune system and boost TB vaccine responses.
The project will provide safety and immunogenicity data from a Norwegian phase 1 clinical trial of the therapeutic TB vaccine candidate H56:IC31 and the COX-2i etoricoxib given to TB patients together with standard TB antibiotics.
The investigators will also perform exploratory in-depth studies of immune regulatory mechanisms and try to identify biomarkers for efficacy of treatment both in humans and in a parallel mouse model. These results may further optimize the therapeutic strategy and prepare for larger clinical trials and finally contribute to new treatment options for MDR-TB.
Objectives:
- Study the safety and tolerability of etoricoxib given for 20 weeks (day 0-140) alone and in combination with the therapeutic TB vaccine H56:IC31 given as two immunizations at day 84 and day 140 in patients with active TB disease treated with conventional 26-week anti-TB chemotherapy.
- Study the immune effects of etoricoxib given for 20 weeks (day 0-140) on immune regulation and TB vaccine (H56:IC31) immunogenicity in patients with active TB disease treated with conventional 26-week anti-TB chemotherapy.
- Conditions
- Tuberculosis
- Being tested
- etoricoxib, H56:IC31
- Keywords
- Host-modulating therapy, Vaccine, Cyclooxygenase inhibitors
- Medical subject headings
- Tuberculosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
etoricoxibDrug
Also called Arcoxia®
cyclooxygenase-2 inhibitor. Anti-inflammatory
H56:IC31Biological
Therapeutic and prophylactic TB vaccine
| Study group | Role | What they receive |
|---|---|---|
| Arm#1 | Experimental | arm#1 (n=10) receiving etoricoxib from inclusion day 0 and in 140 days.
Step-wise inclusion starting with arm#1,arm#2 and arm#3 (first group) randomized (2:2:1) and if safety data are satisfactory proceeding with arm #4 and the rest of arm#3 randomized (2:2:1). Receives: Drug: etoricoxib |
| Arm#2 | Experimental | arm#2 (n=10) receiving H56:IC31 vaccine at day 84 and 140 and no etoricoxib. Receives: Biological: H56:IC31 |
| Arm#3 | No intervention | arm#3 (n=10), the first group (n=5) serving as control to arm#1 and arm#2, the next group (n=5) serving as control to arm#4. |
| Arm#4 | Experimental | arm#4 (n=10) receiving etoricoxib from inclusion day 0 and in 140 days and H56:IC31 vaccine at day 84 and 140. Receives: Drug: etoricoxib; Biological: H56:IC31 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety of etoricoxib (arm#1) assessed by the number of participants with adverse events
Number and % of study patients with AE or SAE
Measured: From day 0 until day 238 (14 weeks after the last dose of etoricoxib)
Safety of H56:IC31 vaccine (arm#2) assessed by the number of participants with adverse events
Number and % of study patients with AE or SAE
Measured: From day 0 until day 238. For vaccine related adverse events; immunisation (day 84 and day 140) and 14 days post-immunisation (day 98 and day 154).
Safety of combined etoricoxib and H56:IC31 vaccine (arm#4) assessed by the number of participants with adverse events
Number and % of study patients with AE or SAE
Measured: From day 0 until day 238 (14 weeks after the last dose of etoricoxib). For vaccine related adverse events; from immunisation (day 84 and day 140) and 14 days post-immunisation (day 98 and day 154).
Immunogenicity of etoricoxib (arm#1)
Total CD4+ T cell cytokine (IFN-γ, IL-2, TNF-α) responses to sum TB peptides.
Measured: Day 0 (baseline) to day 84
Immunogenicity of H56:IC31 vaccine (arm#2)
Total CD4+ T cell cytokine (IFN-γ, IL-2, TNF-α) responses to sum TB peptides.
Measured: From before first immunisation (day 84) to 14 days after second immunisation (day 154).
Immunogenicity of combined etoricoxib and H56:IC31 vaccine (arm#4)
Total CD4+ T cell cytokine (IFN-γ, IL-2, TNF-α) responses to sum TB peptides.
Measured: From before first immunisation (day 84) to 14 days after second immunisation (day 154).
Secondary outcomes (1)
Exploratory immune studies
Study in depth the effect of etoricoxib on immune activation, regulation and TB vaccine immunogenicity measured by the percentage of innate cells (monocytes/MDSC) and CD4+ and CD8+ T cells expressing various activation, supression and regulation markers in response to stimulation with TB antigenic peptide pools (Ag85B, ESAT-6, Rv2660c). Serologi to H56 and gene signature analyses.
Measured: From day 0 (baseline) until day 238 (study end); 14, 28, 56, 84, 98, 140, 154, 182, 210, 238 days from baseline (selected timepoints for various analysis).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jul 2015 (estimated)
- Study startNov 2015
- Primary completionSep 2019
- Study completion23 Mar 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for TuberculosisStudies 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 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 39 participants (actual)
Sponsor and investigators
- Lead sponsor
- Anne Margarita Dyrhol Riise
- Sponsor type
- University, hospital or other
- Collaborators
- University of Oslo, Statens Serum Institut, Haukeland University Hospital
- Responsible party
- Sponsor-investigator, Anne Margarita Dyrhol Riise, Oslo University Hospital
- Investigators
- Anne Margarita Dyrhol-Riise, PhD, Principal investigator, Oslo University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02503839
- Sponsor's protocol ID
- 2015/692
- Other IDs
- 2014-004986-26, 2014
- Acronym
- TBCOX2
- Status last verified
- Apr 2022
- First submitted
- 10 Jul 2015
- Last updated
- 8 Apr 2022
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Yes: The study is published. https://doi.org/10.1038/s41467-021-27029-6
Publications
Nore KG, Louet C, Bugge M, Gidon A, Jorgensen MJ, Jenum S, Dyrhol-Riise AM, Tonby K, Flo TH. The Cyclooxygenase 2 Inhibitor Etoricoxib as Adjunctive Therapy in Tuberculosis Impairs Macrophage Control of Mycobacterial Growth. J Infect Dis. 2024 Mar 14;229(3):888-897. doi: 10.1093/infdis/jiad390.
PubMed 37721470Jenum S, Tonby K, Rueegg CS, Ruhwald M, Kristiansen MP, Bang P, Olsen IC, Sellaeg K, Rostad K, Mustafa T, Tasken K, Kvale D, Mortensen R, Dyrhol-Riise AM. A Phase I/II randomized trial of H56:IC31 vaccination and adjunctive cyclooxygenase-2-inhibitor treatment in tuberculosis patients. Nat Commun. 2021 Nov 22;12(1):6774. doi: 10.1038/s41467-021-27029-6.
PubMed 34811370Tonby K, Mortensen R, Ruhwald M, Dyrhol-Riise AM, Jenum S. KLRG1-Expressing CD4 T Cells Are Reduced in Tuberculosis Patients Compared to Healthy Mycobacterium tuberculosis-Infected Subjects, but Increase With Treatment. J Infect Dis. 2019 Jun 5;220(1):174-176. doi: 10.1093/infdis/jiz056. No abstract available.
PubMed 30888024
Study at a glance
From the registry record, last updated by the sponsor on 8 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Therapeutic Vaccination and Immune Modulation - New Treatment Strategies for the Multidrug-resistant Tuberculosis Pandemic; an Open Label Phase I Clinical Trial of the Therapeutic TB H56:IC31 Vaccine and Cyclooxygenase-inhibitors
- ClinicalTrials.gov ID
- NCT02503839
- Acronym / sponsor ID
- TBCOX2 / 2015/692
- Conditions
- Tuberculosis
- Keywords
- Host-modulating therapy, Vaccine, Cyclooxygenase inhibitors
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 39 participants (actual)
- Lead sponsor
- Anne Margarita Dyrhol RiiseUniversity, hospital or other
- Collaborators
- University of Oslo, Statens Serum Institut, Haukeland University Hospital
- Study start
- Nov 2015 (actual)
- Primary completion
- Sep 2019 (actual)
- Study completion
- 23 Mar 2020 (actual)
- First posted
- 21 Jul 2015 (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.
Tuberculosis (TB) is a global challenge and for the increasing epidemic of multi-drug resistant (MDR)-TB there is restricted treatment options. This calls for research of new immune-modulating treatment strategies that can strengthen the patients immune system to better fight the TB bacteria. The pro-inflammatory, but still immunosuppressive mediator prostaglandin E2 (PGE2) is produced by cyclooxygenase-2 (COX-2) in inflamed infected tissue. Studies from both human and animal models show that COX-2 inhibitors (COX-2i) can improve the immune system and strengthen vaccines responses.
Hypothesis
- A hyperactive COX-2/PGE2 signal system in active TB causes down-regulated immune responses that favour TB survival, but this can be abrogated by COX-2i.
- TB-specific immunisation with targeted antigens presented as a therapeutic TB vaccine and enhanced by COX-2i will improve immune-mediated host clearance of TB.
- Combinations of COX-2i and a therapeutic TB vaccine to conventional anti-TB chemotherapy offer new treatment modalities for TB, including MDR/XDR-TB.
Approach to test the hypothesis
- Study design: 4-arm, open and randomized clinical intervention trial of patients starting treatment for active TB in specialized Norwegian TB centres and where two arms will receive the COX-2i etoricoxib with and without a TB vaccine, one arm vaccine only and the last arm serve as control receiving only standard anti-TB therapy. For safety precautions, only patients bearing sensitive TB strains are included and study arms will be sequentially introduced.
- In a mouse model examine in more detail the effects of reversion of chronic inflammation with COX-2i locally in tissue and the interplay with TB vaccine responses, immune regulation, correlates of protection and survival in a well-characterized model for TB-exposed mice.
Detailed description
The hypothesis is that treating TB patients with a therapeutic TB vaccine and COX-2 inhibiting drugs in addition to standard antibiotic TB therapy will improve the patients immune system and boost TB vaccine responses.
The project will provide safety and immunogenicity data from a Norwegian phase 1 clinical trial of the therapeutic TB vaccine candidate H56:IC31 and the COX-2i etoricoxib given to TB patients together with standard TB antibiotics.
The investigators will also perform exploratory in-depth studies of immune regulatory mechanisms and try to identify biomarkers for efficacy of treatment both in humans and in a parallel mouse model. These results may further optimize the therapeutic strategy and prepare for larger clinical trials and finally contribute to new treatment options for MDR-TB.
Objectives:
- Study the safety and tolerability of etoricoxib given for 20 weeks (day 0-140) alone and in combination with the therapeutic TB vaccine H56:IC31 given as two immunizations at day 84 and day 140 in patients with active TB disease treated with conventional 26-week anti-TB chemotherapy.
- Study the immune effects of etoricoxib given for 20 weeks (day 0-140) on immune regulation and TB vaccine (H56:IC31) immunogenicity in patients with active TB disease treated with conventional 26-week anti-TB chemotherapy.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Arm#1 | Experimental | Drug: etoricoxibarm#1 (n=10) receiving etoricoxib from inclusion day 0 and in 140 days. Step-wise inclusion starting with arm#1,arm#2 and arm#3 (first group) randomized (2:2:1) and if safety data are satisfactory proceeding with arm #4 and the rest of arm#3 randomized (2:2:1). |
| Arm#2 | Experimental | Biological: H56:IC31arm#2 (n=10) receiving H56:IC31 vaccine at day 84 and 140 and no etoricoxib. |
| Arm#3 | No intervention | –arm#3 (n=10), the first group (n=5) serving as control to arm#1 and arm#2, the next group (n=5) serving as control to arm#4. |
| Arm#4 | Experimental | Drug: etoricoxib, Biological: H56:IC31arm#4 (n=10) receiving etoricoxib from inclusion day 0 and in 140 days and H56:IC31 vaccine at day 84 and 140. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Age between 18 to 70 years at the time of randomization.
- Microbiologically confirmed pulmonary TB (culture and/or PCR + susceptibility testing) and/or microbiologically confirmed extra-pulmonary TB (culture and/or PCR + susceptibility testing).
- Drug sensitive Mtb strains (except single resistance where fully adequate anti-TB chemotherapy regimen could be provided).
- Is willing and likely to comply with the trial procedures and is prepared to grant authorized persons access to their medical record.
- Has completed the written informed consent process prior to the start of screening evaluations.
Key exclusion criteria (4 listed)
- Study-specific: Disseminated TB. Evidence of a new acute illness that may compromise the safety of the subject in the trial on study day 0. History of autoimmune disease or immunosuppression. History or laboratory evidence of any possible immunodeficiency state. Anemia (<9 g/100 ml). HIV sero-positivity. Chronic hepatitis B (HBs antigen positive) with increased liver transaminases (ASAT, ALAT) or chronic hepatitis C (HCV RNA positive). Concomitant or sporadic use of NSAID or corticosteroids (>2 times per week). Other immune modulating therapies including DMARDS. Total cholesterol > 7 mmol/L. Hypertension >140/90 mm Hg (treated or untreated) or treated with >1 antihypertensive drug at any blood pressure. Cardiovascular events or stroke in parents, siblings or off-springs occurring < 55 years of age. Serum creatinine above reference levels (females > 90 µmol/L; males > 105 µmol/L). Known diabetes mellitus type I or diabetes mellitus type II with HbA1c >7%. Pregnancy (S-hCG >5 IU/l for females at childbearing age). Breastfeeding.
- 2. Exclusion criteria for etoricoxib according to SPC: Known hypersensitivity for etoricoxib or etoricoxib tablet substances. Known hypersensitivity for sulphonamides. Active peptic ulcer or gastrointestinal haemorrhage. History of asthma, acute rhinitis, nasal polyps, angioneurotic oedema, urticaria or other allergic reactions after taking acetyl salicylic acid or NSAID including COX-2 inhibitors. Moderate/severe deranged liver function (Child-Pugh >7). Serum-creatinine clearance < 30 ml/min. Inflammatory bowel disease. Heart failure (NYHA II-IV). Established ischaemic heart disease, peripheral arteriosclerosis and/or cerebrovascular disease, including previous myocardial infarction, angina pectoris, unstable angina, PCI or coronary bypass, previous transitory ischemic attack or apoplexia/stroke.
- 3. Exclusion criteria for H56:IC31: Known hypersensitivity for vaccines or vaccine adjuvants.
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 |
|---|---|---|
| etoricoxibAlso: Arcoxia®cyclooxygenase-2 inhibitor. Anti-inflammatory | Drug | Arm#1, Arm#4 |
| H56:IC31Therapeutic and prophylactic TB vaccine | Biological | Arm#2, Arm#4 |
Primary outcome
Safety of etoricoxib (arm#1) assessed by the number of participants with adverse events
Time frame: From day 0 until day 238 (14 weeks after the last dose of etoricoxib)
Number and % of study patients with AE or SAE
Safety of H56:IC31 vaccine (arm#2) assessed by the number of participants with adverse events
Time frame: From day 0 until day 238. For vaccine related adverse events; immunisation (day 84 and day 140) and 14 days post-immunisation (day 98 and day 154).
Number and % of study patients with AE or SAE
Safety of combined etoricoxib and H56:IC31 vaccine (arm#4) assessed by the number of participants with adverse events
Time frame: From day 0 until day 238 (14 weeks after the last dose of etoricoxib). For vaccine related adverse events; from immunisation (day 84 and day 140) and 14 days post-immunisation (day 98 and day 154).
Number and % of study patients with AE or SAE
Immunogenicity of etoricoxib (arm#1)
Time frame: Day 0 (baseline) to day 84
Total CD4+ T cell cytokine (IFN-γ, IL-2, TNF-α) responses to sum TB peptides.
Immunogenicity of H56:IC31 vaccine (arm#2)
Time frame: From before first immunisation (day 84) to 14 days after second immunisation (day 154).
Total CD4+ T cell cytokine (IFN-γ, IL-2, TNF-α) responses to sum TB peptides.
Immunogenicity of combined etoricoxib and H56:IC31 vaccine (arm#4)
Time frame: From before first immunisation (day 84) to 14 days after second immunisation (day 154).
Total CD4+ T cell cytokine (IFN-γ, IL-2, TNF-α) responses to sum TB peptides.
1 secondary outcome
Exploratory immune studies
Time frame: From day 0 (baseline) until day 238 (study end); 14, 28, 56, 84, 98, 140, 154, 182, 210, 238 days from baseline (selected timepoints for various analysis).
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Apr 2022.
- Derived from this study: PubMed 37721470Nore KG, Louet C, Bugge M, Gidon A, Jorgensen MJ, Jenum S, Dyrhol-Riise AM, Tonby K, Flo TH. The Cyclooxygenase 2 Inhibitor Etoricoxib as Adjunctive Therapy in Tuberculosis Impairs Macrophage Control of Mycobacterial Growth. J Infect Dis. 2024 Mar 14;229(3):888-897. doi: 10.1093/infdis/jiad390.
- Derived from this study: PubMed 34811370Jenum S, Tonby K, Rueegg CS, Ruhwald M, Kristiansen MP, Bang P, Olsen IC, Sellaeg K, Rostad K, Mustafa T, Tasken K, Kvale D, Mortensen R, Dyrhol-Riise AM. A Phase I/II randomized trial of H56:IC31 vaccination and adjunctive cyclooxygenase-2-inhibitor treatment in tuberculosis patients. Nat Commun. 2021 Nov 22;12(1):6774. doi: 10.1038/s41467-021-27029-6.
- Derived from this study: PubMed 30888024Tonby K, Mortensen R, Ruhwald M, Dyrhol-Riise AM, Jenum S. KLRG1-Expressing CD4 T Cells Are Reduced in Tuberculosis Patients Compared to Healthy Mycobacterium tuberculosis-Infected Subjects, but Increase With Treatment. J Infect Dis. 2019 Jun 5;220(1):174-176. doi: 10.1093/infdis/jiz056. No abstract available.
- Individual participant dataSharing planned: Yes. The study is published. https://doi.org/10.1038/s41467-021-27029-6
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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.
Anne Margarita Dyrhol-Riise, PhD principal investigator
Oslo University Hospital
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing etoricoxib and H56:IC31 in people with Tuberculosis, run by Anne Margarita Dyrhol Riise at 2 sites in Norway.
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 10 inclusion and 4 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 8 Apr 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Norway. 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Safety of etoricoxib (arm#1) assessed by the number of participants with adverse events (time frame: From day 0 until day 238 (14 weeks after the last dose of etoricoxib)). The study lists 6 primary outcomes in all. 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 NCT02503839, which also lists 3 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 8 Apr 2022.