Double blinded, randomized, Priorix- and placebo-controlled, trial to evaluate the optimal dose of MV-CHIK vaccine (against Chikungunya virus) in regard to immunogenicity, safety and tolerability in healthy volunteers
Latest Information Update: 05 May 2022
At a glance
- Drugs Chikungunya virus vaccine (Primary) ; Measles mumps and rubella virus vaccine-(Priorix)
- Indications Chikungunya virus infections
- Focus Pharmacodynamics
- Sponsors Themis Bioscience
- 12 Dec 2019 Results of an analysis of humoral immune responses in chikungunya virus infected patients and healthy individuals from this study vaccinated with a candidate CHIKV vaccine published in the Journal of Infectious Diseases.
- 05 Nov 2018 Primary endpoint (Immunogenicity on day 56 confirmed by plaque reduction neutralization test (PRNT50)) has been met across all treatment group, according to a Themis Bioscience media release.
- 05 Nov 2018 Results presented in the Themis Bioscience media release.
Most Recent Events
Trial Overview
Outcome
Purpose
To investigate the immunogenicity and safety of MV-CHIK 28 days after primary immunization regime, comprising one or two vaccinations.
Primary Endpoints
Functional Anti-chikungunya Antibody Titers on Day 56 (28 Days Post Immunisation) Confirmed by Plaque Reduction Neutralization Test (PRNT50)
description: Immunogenicity on day 56 confirmed by the presence of functional anti-chikungunya antibodies as determined by the plaque reduction neutralization test (PRNT50). This means immunogenicity 28 days after primary immunization regime, comprising one or two vaccinations.
time_frame: Study day 56 (28 days after one or two vaccinations depending on treatment group).
Other Endpoints
Functional Anti-Chikungunya Antibody Titers on Days 0, 28, 196 and 224 (M1/M2 Groups Day 168) Confirmed by Plaque Reduction Neutralization Test (PRNT50)
description: Evaluation of immunogenicity on day 0, 28, 196 and 224; additionally for group M1 and M2 on day 168 as confirmed by the presence of functional anti-chikungunya antibodies, determined by the plaque reduction neutralization test (PRNT50). time_frame: Baseline until study day 224
Measurement of Anti-measles Antibody Titer by Enzyme Linked Immunosorbent Assay
description: Determination of anti-measles antibodies on day 0, 28, and 56; additionally for group M1 and M2 on day -28 by enzyme linked immunosorbent assay (ELISA). time_frame: Baseline until study day 56
Number of Participants With Solicited Local and Systemic Adverse Events
description: Evaluation of solicited local and systemic adverse events as recorded in the subjects' diaries for 7 days after each vaccination. As per the protocol, adverse events were analyzed per treatment group but were not assessed with respect to individual vaccinations. time_frame: Solicited adverse events were recorded for 7 days after each vaccination
Number of Participants Who Experienced Treatment Emergent Adverse Events
description: Evaluation of all treatment emergent adverse events (TEAEs) occurred throughout the clinical study. Clinically relevant abnormal safety laboratory values were recorded as TEAEs. As per the protocol, adverse events were analyzed per treatment group but were not assessed with respect to individual vaccinations. time_frame: First vaccination until study day 224
Number of Participants With Shedding of Live Recombinant Virus in Urine Until Day 196
description: Shedding was observed in a subset of subjects at one Austrian study site, by qualitative determination of live recombinant measles virus in urine by polymerase chain reaction (PCR). time_frame: Baseline until study day 196; assessed on days 0, 7, 10, 14, 28 and 196
Number of Participants With Shedding of Live Recombinant Virus in Saliva Until Day 196
description: Shedding was observed in a subset of subjects at one Austrian study site, by qualitative determination of live recombinant measles virus in saliva by polymerase chain reaction (PCR). time_frame: Baseline until study day 196; assessed on days 0, 7, 10, 14, 28 and 196
Chikungunya Virus Specific T Cell Responses
description: Peripheral blood mononuclear cells (PBMCs) were isolated from whole blood to determine functional IL-2-producing T cells on day 0, 28, 56 and 224 in a subset of subjects. ELISpots were performed using peptides covering the CHIK proteins E1, E2 and C for re-stimulation, thereby producing three values per sample representing the number of spots per 1 x 10^6 PBMCs. If one or more of the three values was greater than 50, the sample was considered positive and the highest of the three values was used in the analysis. If all three values were below 50, the sample was considered negative and a value of 0.0 was used for analysis. time_frame: Baseline until study day 224
Immunogenicity Confirmed by the Presence of Humoral Anti-chikungunya Antibodies, Determined by Enzyme Linked Immunosorbent Assay (ELISA)
description: Evaluation of immunogenicity mediated by serum IgG antibodies against Chikungunya on days 0, 28, 196 and 224; additionally for group M1 and M2 on day 168, determined by enzyme linked immunosorbent assay (ELISA). time_frame: Baseline until study day 224; assessed on days 0, 28, 168, 196 and 224
Functional Anti-chikungunya Antibody Titers on Day 56 (28 Days Post Immunization) by Baseline Measles Titer
description: To determine the potential impact of pre-existing antibodies against measles on MV-CHIK immunogenicity, participants from treatment Groups A to D were divided into quartiles according to serum IgG concentrations against measles virus on Day 0. Functional anti-chikungunya antibodies as determined by PRNT50 were compared between groups. time_frame: Study day 56 (28 days after one or two vaccinations depending on treatment group) [1]
Diseases Treated
| Indication | Qualifiers | Patient Segments |
|---|---|---|
| Chikungunya virus infections | prevention | - |
Biomarker
| NCT Number | Biomarker Name | Biomarker Function |
|---|---|---|
| NCT02861586 | Alkaline phosphatase (ALPL) | Eligibility Criteria |
| Bilirubin | Eligibility Criteria | |
| Fibrinogen | Eligibility Criteria | |
| Interleukin-2 (IL-2) | Outcome Measure | |
| Prothrombin (PT) | Eligibility Criteria |
Subjects
- Subject Type patients
-
Number
Planned: 320
Actual: 263
- Sex male & female
- Age Group 18-55 years; adult
Patient Inclusion Criteria
1. Signed informed consent obtained before any trial-related activities. (Trial activities are any procedures that would not have been performed during normal management of the subject).2. Ability to comprehend the full nature and purpose of the study, including possible risks and side effects; ability to cooperate with the investigator and to comply with the requirements of the entire study3. Available for the duration of the trial4. Healthy men or women aged >18 and <55 years5. In female subjects either childbearing potential terminated by surgery or one year post-menopausal, or a negative urine pregnancy test during screening and the willingness not to become pregnant during the entire study and up to 6 months after the last vaccination by practicing reliable methods of contraception as specified in protocol section 8.3.6.6. Normal findings in medical history and physical examination or the investigator considers all abnormalities to be clinically irrelevant7. Normal laboratory values or the investigator considers all abnormalities to be clinically irrelevant (unless otherwise specified in exclusion criteria)
Patient Exclusion Criteria
) 1. Participation in another clinical study within the past month in which the subject has been exposed to an investigational product (pharmaceutical product or placebo or device) or planned concurrent participation in another clinical study during the study period 2. History of immunodeficiency, known human immunodeficiency virus (HIV) infection, current hepatitis B/C infection, 3. Drug addiction including alcohol dependence 4. Inability or unwillingness to avoid more than the usual intake of alcohol during the 48 hours after vaccination (not more than 20g alcohol per day, which equals 0.5 L beer or 0.25 L of wine) 5. Persons who are accommodated in an institution on court or official order. 6. Persons in direct relationship with the sponsor, an Investigator or other study site staff. Direct relationship includes relatives or close dependents (children, spouse/partner, siblings or parents), as well as employees (site or sponsor). 7. Non-study licensed vaccines: vaccination within 4 weeks prior to first vaccination or planning to receive any non-study vaccine during the study period. 8. Measles vaccination or booster within the last 5 years or during the clinical study 9. Prior receipt of any Chikungunya vaccine 10. Blood donations during 1 month prior to Screening Visit and throughout the study 11. Recent infection (within 1 week prior to Screening Visit) (If non-serious, can be basis for temporary deferral) 12. Relevant history of renal, hepatic, gastrointestinal, cardiovascular, respiratory, skin, hematological, endocrine, inflammatory or neurological diseases, that in the opinion of the investigator may interfere with the aim of the study 13. History of neoplastic disease (excluding non-melanoma skin cancer that was successfully treated) within the past 5 years or a history of any hematological malignancy. 14. History of autoimmune disease (e.g. rheumatoid arthritis, systemic lupus erythematosus (SLE), autoimmune thyroid disease). 15. History of moderate or severe arthritis or arthralgia within the past 3 months prior to Screening Visit. 16. Behavioral, cognitive, or psychiatric disease that in the opinion of the investigator affects the ability of the participant to understand and cooperate with the study protocol. 17. History of severe adverse reactions to vaccine administration, including anaphylaxis and related symptoms, such as urticaria, respiratory difficulty, angioedema and abdominal pain to vaccines, or history of allergic reaction likely to be exacerbated by any component of the vaccine. 18. History of anaphylaxis to drugs or major allergic reactions in general, which the investigator considers may compromise the safety of the volunteers 19. Clinically relevant abnormal laboratory values indicative of physical illness - Hematology: hemoglobin, hematocrit, erythrocyte count, differential white blood count, platelets - Chemistry: creatinine (≥1.7 mg/dL), potassium, sodium, calcium, aspartate transaminase/alanine aminotransferase (AST/ALT) ≥ 2.6 upper limit of normal (ULN), alkaline phosphatase, bilirubin - Coagulation parameter: prothrombin time (PT), activated partial thromboplastin time (aPTT), fibrinogen according to the evaluation of the principle investigator - Urinalysis according to the evaluation of the principle investigator 20. Use of medication during 2 weeks before the first vaccination and throughout the study, which the investigator considers may affect the validity of the study except hormonal contraception in female subjects; prior to taking any medication during 72 h prior to the first vaccination, the study center should be consulted. 21. Immunosuppressive drugs: use of corticosteroids (excluding topical preparations) or immunosuppressive drugs within 30 days prior to vaccination, or anticipated use during the trial. 22. Receipt of blood products or immunoglobulins within 120 days prior to Screening Visit or anticipated receipt of any blood products or immunoglobulin during the trial. 23. Pregnancy (positive pregnancy test at screening or during study phase), lactation or unreliable contraception in female subjects with child-bearing potential (for details please refer to section 8.3.6) 24. Subjects with any condition which in the opinion of the investigator makes the subject unsuitable for inclusion 25. Individuals who are living and/or working with severely immunocompromised people, children under 15 months old or pregnant women. 26. Inability or unwillingness to provide informed consent and to abide by the requirements of the study 27. Refusal to allow storage of specimens for future research. 28. Regular blood plasma donations
Trial Details
Identifiers
| Identifier | Owner |
|---|---|
| NCT02861586 | ClinicalTrials.gov: US National Institutes of Health |
| EudraCT2015-004037-26 | European Clinical Trials Database |
| MV-CHIK202 | - |
| V184-002 | - |
Organisations
- Sponsors Themis Bioscience
- Affiliations Batavia Biosciences; Biofabri; Themis Bioscience
Trial Dates
-
Initiation Dates
Planned : 01 Aug 2016
Actual : 17 Aug 2016
-
Primary Completion Dates
Planned : 01 Mar 2018
Actual : 01 Sep 2017
-
End Dates
Planned : 01 Jun 2018
Actual : 16 Apr 2018
Substudies/Extensions
Samples for shedding will only be collected from a subset of study subjects (of treatment groups A-D) that are enrolled at the study site in Vienna. Body fluids including saliva, urine and whole blood will be collected at Visits 1, 2, and 5. In addition, the subjects will be asked to return to the study site on days 7, 10 and 14 after the first immunization for collection of saliva, urine and whole blood. The participating subjects will sign a separate informed consent that describes the additional visits and procedures of sample collection.
Other Details
- Design double-blind; multicentre; parallel; prospective; randomised
- Phase of Trial Phase II
- Location Austria; Germany
- Focus Pharmacodynamics
Interventions
| Drugs | Route | Formulation |
|---|---|---|
| Chikungunya virus vaccinePrimary Drug | Intramuscular | Injection |
| Measles mumps and rubella virus vaccine-(Priorix) | Intramuscular | Injection |
Measles Booster Group 1
20 subjects will receive i.m. vaccinations with Priorix® on study day -28, MV-CHIK on day 0 and 28 and placebo on day 168 and 196. Physical examinations, vital signs, pregnancy tests for females, inquiry of adverse events and collection of immunogenicity blood samples will be performed during all visits. Biological: MV-CHIK low dose (recombinant measles virus vaccine expressing Chikungunya virus antigens, powder for suspension for injection, 5xE4 (± 0.5 log) TCID50/dose) Other Name: vaccine against Chikungunya Biological: Priorix® (lyophilized mixed preparation containing the attenuated Schwarz measles virus strain, the RIT 4385 strain of mumps virus (derived from the Jeryl Lynn strain) and the Wistar RA 27/3 rubella virus strain. Powder and solvent for suspension for injection) Other Name: vaccine against Measles, Mumps and Rubella Biological: physiological saline solution (sterile physiological saline solution 0.9% used as placebo) Other Name: 0.9% sodium chloride (NaCl)
Measles Booster Group 2
20 subjects will receive i.m. vaccinations with Priorix® on study day -28, placebo on day 0 and 28 and MV-CHIK on day 168 and 196. Physical examinations, vital signs, pregnancy tests for females, inquiry of adverse events and collection of immunogenicity blood samples will be performed during all visits. Biological: MV-CHIK low dose (recombinant measles virus vaccine expressing Chikungunya virus antigens, powder for suspension for injection, 5xE4 (± 0.5 log) TCID50/dose) Other Name: vaccine against Chikungunya Biological: Priorix® (lyophilized mixed preparation containing the attenuated Schwarz measles virus strain, the RIT 4385 strain of mumps virus (derived from the Jeryl Lynn strain) and the Wistar RA 27/3 rubella virus strain. Powder and solvent for suspension for injection) Other Name: vaccine against Measles, Mumps and Rubella Biological: physiological saline solution (sterile physiological saline solution 0.9% used as placebo) Other Name: 0.9% sodium chloride (NaCl)
Treatment Group A; MV-CHIK low
60 subjects will receive i.m. vaccinations with MV-CHIK low dose (5xE4 (± 0.5 log) TCID50 per 0.3 mL) on study day 0 and 28, placebo on day 196. Physical examinations, vital signs, pregnancy tests for females, inquiry of adverse events and collection of immunogenicity blood samples will be performed during all visits. Biological: MV-CHIK low dose (recombinant measles virus vaccine expressing Chikungunya virus antigens, powder for suspension for injection, 5xE4 (± 0.5 log) TCID50/dose) Other Name: vaccine against Chikungunya Biological: physiological saline solution (sterile physiological saline solution 0.9% used as placebo) Other Name: 0.9% sodium chloride (NaCl)
Treatment Group B; MV-CHIK low
60 subjects will receive i.m. vaccinations with placebo on study day 0. MV-CHIK low dose (5xE4 (± 0.5 log) TCID50 per 0.3 mL) on day 28 and MV-CHIK boosting dose on day 196. Physical examinations, vital signs, pregnancy tests for females, inquiry of adverse events and collection of immunogenicity blood samples will be performed during all visits. Biological: MV-CHIK low dose (recombinant measles virus vaccine expressing Chikungunya virus antigens, powder for suspension for injection, 5xE4 (± 0.5 log) TCID50/dose) Other Name: vaccine against Chikungunya Biological: physiological saline solution (sterile physiological saline solution 0.9% used as placebo) Other Name: 0.9% sodium chloride (NaCl)
Treatment Group C; MV-CHIK high
60 subjects will receive i.m. vaccinations with MV-CHIK high dose (5xE5 (± 0.5 log) TCID50 per 0.3 mL) on study day 0 and 28, placebo on day 196. Physical examinations, vital signs, pregnancy tests for females, inquiry of adverse events and collection of immunogenicity blood samples will be performed during all visits. Biological: MV-CHIK high dose (recombinant measles virus vaccine expressing Chikungunya virus antigens, powder for suspension for injection; 5xE5 (± 0.5 log) TCID50/dose) Other Name: vaccine against Chikungunya Biological: physiological saline solution (sterile physiological saline solution 0.9% used as placebo) Other Name: 0.9% sodium chloride (NaCl)
Treatment Group D; MV-CHIK high
60 subjects will receive i.m. vaccinations with placebo on study day 0, MV-CHIK high dose (5xE5 (± 0.5 log) TCID50 per 0.3 mL) on study day 28 and MV-CHIK boosting dose on day 196. Physical examinations, vital signs, pregnancy tests for females, inquiry of adverse events and collection of immunogenicity blood samples will be performed during all visits. Biological: MV-CHIK high dose (recombinant measles virus vaccine expressing Chikungunya virus antigens, powder for suspension for injection; 5xE5 (± 0.5 log) TCID50/dose) Other Name: vaccine against Chikungunya Biological: physiological saline solution (sterile physiological saline solution 0.9% used as placebo) Other Name: 0.9% sodium chloride (NaCl)
Treatment Group A/C; Priorix®
20 subjects will receive i.m. vaccinations with Priorix® on study day 0 and 28, placebo on day 196. Physical examinations, vital signs, pregnancy tests for females, inquiry of adverse events and collection of immunogenicity blood samples will be performed during all visits. Biological: Priorix® (lyophilized mixed preparation containing the attenuated Schwarz measles virus strain, the RIT 4385 strain of mumps virus (derived from the Jeryl Lynn strain) and the Wistar RA 27/3 rubella virus strain. Powder and solvent for suspension for injection) Other Name: vaccine against Measles, Mumps and Rubella Biological: physiological saline solution (sterile physiological saline solution 0.9% used as placebo) Other Name: 0.9% sodium chloride (NaCl)
Treatment Group B/D; Priorix®
20 subjects will receive i.m. vaccinations with placebo on study day 0, Priorix® on day 28 and one boosting dose with Priorix® on day 196. Physical examinations, vital signs, pregnancy tests for females, inquiry of adverse events and collection of immunogenicity blood samples will be performed during all visits. Biological: Priorix® (lyophilized mixed preparation containing the attenuated Schwarz measles virus strain, the RIT 4385 strain of mumps virus (derived from the Jeryl Lynn strain) and the Wistar RA 27/3 rubella virus strain. Powder and solvent for suspension for injection) Other Name: vaccine against Measles, Mumps and Rubella Biological: physiological saline solution (sterile physiological saline solution 0.9% used as placebo) Other Name: 0.9% sodium chloride (NaCl)
Results
Adverse events
In a phase II trial of Chikungunya virus vaccine demonstrated excellent safety and tolerability profile. Adverse events related to the vaccine were highly similar between groups with no serious effects reported [2] .
Immunogenicity
In the phase II trial of the Chikungunya virus vaccine elicited a potent immune response by generating neutralizing antibodies against Chikungunya, in all treatment groups after two injections, with seroconversion rates ranging from 86.4% to 100.0%, depending on dose and administration schedule. pre-existing antibodies against the measles vaccine virus did not affect immunogenicity against Chikungunya and pre-existing antibodies against the measles vaccine virus did not affect immunogenicity against Chikungunya [2] .
Publications
-
Themis Bioscience. Themis Bioscience Publishes Compelling Phase 2 Results for Lead Vaccine Candidate against Chikungunya Fever in The Lancet. Media-Rel 2018;.
Media Release -
Prof Emil C Reisinger MD, Roland Tschismarov PhD, Prof Eckhard Beubler PhD, Prof Ursula Wiedermann MD, Christa Firbas MD, Micha Loebermann MD, et al. Immunogenicity, safety, and tolerability of the measles-vectored chikungunya virus vaccine MV-CHIK: a double-blind, randomised, placebo-controlled and active-controlled phase 2 trial. Lancet 2018;.
PubMed | CrossRef Fulltext -
Henss L, Yue C, von Rhein C, Tschismarov R, Lewis-Ximenez LL, Dolle A, et al. Analysis of humoral immune responses in chikungunya virus (CHIKV) infected patients and individuals vaccinated with a candidate CHIKV vaccine. J-Infect-Dis 2019;.
PubMed | CrossRef Fulltext
Trial Centres
Investigators
| Investigator | Centre Name | Trial Centre Country |
|---|---|---|
|
Andrea Pfeiffer, MSc
+43-1-236-7151 Ext: 20 andrea.pfeiffer@themisbio.com
show details
|
-
|
|
|
Birgit Brodacz
+43 316 380 4309 birgit.brodacz@medunigraz.at
show details
|
Hansa Sanatorium GmbH | Austria |
| Carlos Jürgen Fritzsche, MD | Medicinal University Rostock, Department for Tropical Medicin and infectious diseases | Germany |
| Christa Firbas, MD | Medicinal University Vienna |
-
|
| Christian Schörgenhofer, MD | Medical University Vienna, Department of Clinical Pharmacology | Austria |
|
Diana Wachholz
+49 30 96060 940 wachholz@bcrt.de
show details
|
Berliner Center for Travel- and Tropical Medicine | Germany |
| Doris Partosch, MD | Berliner Center for Travel- and Tropical Medicine | Germany |
| Emil Reisinger, MD | Medical University Rostock |
-
|
| Eva-Luise Hobl, MD | Medical University Vienna, Department of Clinical Pharmacology | Austria |
| Fritz Pinl, MD | Hansa Sanatorium GmbH, Graz |
-
|
|
Head of Clinical Development
Muthgasse 11/2
show details
Wien Postcode: 1190 Austria Telephone: 00431236715120 Fax: 00431236715176 andrea.pfeiffer@themisbio.com |
Themis Bioscience GmbH | Austria |
| Hilte Geerdes-Fenge, MD | Medicinal University Rostock, Department for Tropical Medicin and infectious diseases | Germany |
| Josef Donnerer, MD | Hansa Sanatorium GmbH | Austria |
| Julia Karstädt, MD | Berliner Center for Travel- and Tropical Medicine | Germany |
|
Katrin Schmidt
+49 381 4947 337 katrin.schmidt2@uni-rostock.de
show details
|
Medicinal University Rostock, Department for Tropical Medicin and infectious diseases | Germany |
| Micha Löbermann, MD | Medicinal University Rostock, Department for Tropical Medicin and infectious diseases | Germany |
| Michael Schwameis, MD | Medical University Vienna, Department of Clinical Pharmacology | Austria |
|
Raimund M Vielnascher, MSc
+43-1-236-7151 Ext: 18 raimund.vielnascher@themisbio.com
show details
|
-
|
|
|
Sabine Schranz
+43 1 40400 29970 sabine.schranz@meduniwien.ac.at
show details
|
Medical University Vienna, Department of Clinical Pharmacology | Austria |
| Simone Fuchs, MD | Hansa Sanatorium GmbH | Austria |
| Thomas Jelinek, MD | Berliner Centrum für Reise- und Tropenmedizin |
-
|
| Wolf Groth, MD | Berliner Center for Travel- and Tropical Medicine | Germany |
Centres
| Centre Name | Location | Trial Centre Country |
|---|---|---|
| - |
-
|
-
|
| ABF Pharmaceutical Services GmbH |
-
|
-
|
| Assign Clinical Research GmbH |
-
|
-
|
| Batavia Biosciences |
-
|
-
|
| Berliner Center for Travel- and Tropical Medicine | Berlin | Germany |
| Berliner Centrum für Reise- und Tropenmedizin |
-
|
-
|
| Biofabri, S.L |
-
|
-
|
| Envigo |
-
|
-
|
| Hansa Sanatorium GmbH | Graz | Austria |
| Hansa Sanatorium GmbH, Graz |
-
|
-
|
| Medical University of Vienna |
-
|
-
|
| Medical University Rostock |
-
|
-
|
| Medical University Vienna, Department of Clinical Pharmacology | Vienna | Austria |
| Medicinal University Rostock, Department for Tropical Medicin and infectious diseases | Rostock | Germany |
| Medicinal University Vienna |
-
|
-
|
| SRI International |
-
|
-
|
| Themis Bioscience GmbH | Wien | Austria |
Trial History
| Event Date | Event Type | Comment |
|---|---|---|
| 05 May 2022 | Other trial event | Last checked against ClinicalTrials.gov record. Updated 05 May 2022 |
| 08 Jun 2021 | Biomarker Update | Biomarkers information updated Updated 17 Sep 2021 |
| 12 Dec 2019 | Results | Results of an analysis of humoral immune responses in chikungunya virus infected patients and healthy individuals from this study vaccinated with a candidate CHIKV vaccine published in the Journal of Infectious Diseases. Updated 02 Jan 2020 |
| 05 Nov 2018 | Endpoint met | Primary endpoint (Immunogenicity on day 56 confirmed by plaque reduction neutralization test (PRNT50)) has been met across all treatment group, according to a Themis Bioscience media release. Updated 03 Dec 2018 |
| 05 Nov 2018 | Results | Results presented in the Themis Bioscience media release. Updated 03 Dec 2018 |
| 05 Nov 2018 | Results | Results published in the Lancet. Updated 03 Dec 2018 |
| 30 Jun 2018 | Other trial event | Last checked against European Clinical Trials Database record. Updated 30 Jun 2018 |
| 19 Jun 2018 | Status change - completed | Status changed from active, no longer recruiting to completed. Updated 28 Jun 2018 |
| 11 Jun 2018 | Other trial event | According to a Themis Bioscience media release, final results from this trial are expected in mid-2018. Updated 18 Jun 2018 |
| 08 Jun 2018 | Other trial event | This trial has been completed in Austria (end date: 2018-04-16) Updated 11 Jun 2018 |
| 10 Oct 2017 | Completion date | Planned End Date changed from 1 Aug 2017 to 1 Jun 2018. Updated 13 Oct 2017 |
| 10 Oct 2017 | Other trial event | Planned primary completion date changed from 1 Aug 2017 to 1 Mar 2018. Updated 13 Oct 2017 |
| 10 Oct 2017 | Status change - active, no longer recruiting | Status changed from recruiting to active, no longer recruiting. Updated 13 Oct 2017 |
| 21 Dec 2016 | Status change - recruiting | Status changed from not yet recruiting to recruiting. Updated 26 Dec 2016 |
| 12 Aug 2016 | Status change - not yet recruiting | Status changed from planning to not yet recruiting. Updated 19 Feb 2018 |
| 12 Aug 2016 | Other trial event | New source identified and integrated (ClinicalTrials.gov: US National Institutes of Health NCT02861586). Updated 12 Aug 2016 |
| 12 Aug 2016 | New trial record | New trial record Updated 12 Aug 2016 |
| 05 May 2015 | Other trial event | According to a Themis Bioscience media release, company plans to initiate Phase II trials for Chikungunya fever vaccine. Updated 19 Feb 2018 |
Table of Contents
References
-
ClinicalTrials.gov: US National Institutes of Health. Trial-Reg 2023;.
Available from: URL: http://clinicaltrials.gov -
Themis Bioscience. Themis Bioscience Publishes Compelling Phase 2 Results for Lead Vaccine Candidate against Chikungunya Fever in The Lancet. Media-Rel 2018;.
Media Release -
Themis Bioscience. Themis Receives EMA PRIME Designation for Chikungunya Vaccine. Media-Rel 2018;.
Media Release -
European Clinical Trials Database. Trial-Reg 2023;.
Available from: URL: https://www.clinicaltrialsregister.eu -
Themis Bioscience. Themis Bioscience's Raises up to EUR 10 Million in Series B. Media-Rel 2015;.
Media Release -
Prof Emil C Reisinger MD, Roland Tschismarov PhD, Prof Eckhard Beubler PhD, Prof Ursula Wiedermann MD, Christa Firbas MD, Micha Loebermann MD, et al. Immunogenicity, safety, and tolerability of the measles-vectored chikungunya virus vaccine MV-CHIK: a double-blind, randomised, placebo-controlled and active-controlled phase 2 trial. Lancet 2018;.
PubMed | CrossRef Fulltext -
Henss L, Yue C, von Rhein C, Tschismarov R, Lewis-Ximenez LL, Dolle A, et al. Analysis of humoral immune responses in chikungunya virus (CHIKV) infected patients and individuals vaccinated with a candidate CHIKV vaccine. J-Infect-Dis 2019;.
PubMed | CrossRef Fulltext
Adis International Ltd. Part of Springer Science+Business Media
© Springer Nature Switzerland AG