Chikungunya virus vaccine - Themis Bioscience
Alternative Names: Measles-vectored Chikungunya vaccine; MV-CHIK; MV-CHIK/DP; V-184Latest Information Update: 01 Dec 2022
At a glance
- Originator Themis Bioscience
- Developer National Institute of Allergy and Infectious Diseases; Themis Bioscience
- Class Viral vaccines
- Mechanism of Action Immunostimulants
-
Orphan Drug Status
No
Orphan designation is assigned by a regulatory body to encourage companies to develop drugs for rare diseases.
- New Molecular Entity No
Highest Development Phases
- Phase II Chikungunya virus infections
Most Recent Events
- 30 Nov 2022 Chikungunya virus vaccine is still in phase II trials for Chikungunya virus infection (Prevention)(Merck pipeline, November 2022)
- 13 May 2021 Themis Bioscience completes a phase II trial in Chikungunya virus infection (Prevention) in Puerto Rico (IM (NCT03807843)
- 28 Jun 2020 No recent reports of development identified for phase-I development in Chikungunya-virus-infections(Prevention) in USA (IM, Injection)
Development Overview
Introduction
A vaccine to prevent Chikungunya virus infections (V 184) is being developed by Themis Bioscience (a subsidiary of Merck and Co). The vaccine is designed using Themaxyn™ vector technology licensed from Institut Pasteur, and intended for use in travellers as well as for individuals in endemic developing countries. The Themaxyn™ platform is based on an attenuated measles virus vector, which carries difficult-to-present antigens as transgenes. Themaxyn™ vaccines are designed to target the antigens directly to macrophages and dendritic cells, resulting in a potent antigen-specific immune responses, whilst avoiding immune responses to the vector. Clinical development is underway in Austria, Germany, Puerto Rico and the UK.
Phase I development for prevention of Chikungunya virus infections was conducted in the US. As at June 2020, no recent reports of development were identified.
In June 2020, Themis Bioscience was acquired by Merck & Co [1] .
Key Development Milestones
The US FDA, in February 2019 granted fast track designation to Themis Bioscience's Chikungunya virus vaccine to prevent chikungunya virus infections [2] .
Prior to November 2018, chikungunya fever was added to the US FDA Tropical Disease Priority Review Voucher Program [3] .
In June 2018, the European Medicines Agency (EMA) granted PRIority MEdicines (PRIME) designation to Themis Bioscience's Chikungunya virus vaccine to prevent chikungunya virus infections (chikungunya fever) [4] .
In May 2021, Themis Bioscience and Walter Reed Army Institute of Research completed a phase II trial that evaluated the safety and immunogenicity of live attenuated measles virus-vectored chikungunya virus vaccine in healthy volunteers (NCT03807843; MV-CHIK206). The open-label trial was initiated in July 2019 and completed enrolment of 41 volunteers with history of chikungunya infection in Puerto Rico [5] .
In October 2019, Themis Bioscience completed a phase II trial that investigated the safety, tolerability and long-term immunogenicity of different dose regimens and formulations (lyophilised, liquid frozen and liquid SPS) of chikungunya virus vaccine in healthy volunteers (NCT03635086; MV-CHIK-205; EudraCT2018-000211-25). The observer blinded, randomized trial was initiated in September 2018 and enrolled 60 participants in the UK [6] .
In April 2019, Themis Bioscience, in collaboration with Walter Reed Army Institute of Research, completed a phase II trial to assess the safety of live attenuated measles virus-vectored chikungunya virus vaccine in a previously epidemic area in healthy volunteers (NCT03101111; MV-CHIK204). Secondarily, immune response and viremia will be assessed. The randomised, double-blinded trial enrolled 34 participants in Puerto Rico [7] .
In April 2018, Themis Bioscience completed a phase II trial that evaluated the safety, tolerability and immunogenicity of the chikungunya virus vaccine in healthy adult subjects (MV-CHIK-202; EudraCT2015-004037-26; NCT02861586). The double-blind, randomised, Priorix®- and placebo-controlled trial was initiated in August 2016, and enrolled 263 subjects in Austria and Germany. IN November 2018, company released the results from the study and trail met its primary endpoint [3] [8] .
In June 2014, Themis Bioscience reported that it had received positive interim results from a phase I trial of its chikungunya fever vaccine. The trial was completed as at January 2016, and was carried out at the Vienna General Hospital in 42 subjects. The vaccine was shown to be safe and well tolerated, and dose-dependent immune responses were achieved [9] [10] . The results were published in "The Lancet Infectious Diseases" in March 2015 [11] .
In May 2017, National Institute of Allergy and Infectious Diseases (NIAID) initiated a phase I trial to assess the safety, immunogenicity and schedule of chikungunya virus vaccine (15-0038; HHSN272201300015I; NCT03028441). The trial will evaluate two dosage levels and three immunisation schedules over a period of 22 months. The randomised, double-blinded, placebo-controlled, dose-comparison trial is recruiting 180 healthy adults (aged 18-45 years) in the US [12] .
Financing information
In September 2019, Themis Bioscience raised $US40 million in a Series D financing. The company intends to use the funds for phase III trials for chikungunya virus vaccine as well as to support further expansion into oncology indications [see Adis Insight Drug Profile800053174] using the proprietary measles vaccine vector platform [13] .
In June 2019, Themis Bioscience announced that the Coalition for Epidemic Preparedness Innovations (CEPI) will provide up to $US 21 million of non-dilutive capital for Chikungunya vaccine (MV-CHIK). The funding will underwrite a collaborative effort to accelerate regulatory approval of Themis’ Chikungunya vaccine and provide a significant portion of the capital required for initiation of phase III clinical trial [14] .
In January 2018, Themis Bioscience closed a Series C round totalling €10 million. The proceeds will be used to advance Themis’ clinical and preclinical vaccine development programmes, including chikungunya virus vaccine [15] .
Themis Bioscience closed a Series B financing round of €10 million in November 2016. The funds will be used to complete a phase II trial for chickungunya vaccine and for the preparation of phase III trials [16] .
In May 2015, Themis Bioscience closed the first €7 million Series B financing round of up to €10 million led by Wellington Partners. Existing investors Ventech and Omnes Capital also participated in the round. Earlier in 2011, Themis raised €5 million in Series A financing round following a seed financing from Austria Wirtschaftsservice in 2009, and other substantial funding from Austrian national funding agencies (FFG and Inits) [11] .
Patent Information
Themis Bioscience has patent-protection for its Themaxyn™ vaccine technology.
Drug Properties & Chemical Synopsis
- Route of administration IM
- Formulation Injection
- Class Viral vaccines
- Mechanism of Action Immunostimulants
-
WHO ATC code
J07B-X (Other viral vaccines)
-
EPhMRA code
J7A9 (Other specified single component)
Biomarkers Sourced From Trials
| Indication | Biomarker Function | Biomarker Name | Number of Trials |
|---|---|---|---|
|
Chikungunya virus infections |
Detailed Description |
PD-1/CD279 PAF1 Ferritin C-reactive protein (CRP) |
|
|
Chikungunya virus infections |
Eligibility Criteria |
Prothrombin (PT) Fibrinogen Bilirubin Alkaline phosphatase (ALPL) |
|
|
Chikungunya virus infections |
Outcome Measure |
tumor necrosis factor receptor superfamily, member 4 tumor necrosis factor receptor superfamily member 9 T-cell surface antigen CD4 T-Cell differentiation antigen CD8 prion protein (testis specific) Interleukin-2 (IL-2) CD69 |
Biomarker
| Drug Name | Biomarker Name | Biomarker Function |
|---|---|---|
| Chikungunya virus vaccine - Themis Bioscience | Alkaline phosphatase (ALPL) | Eligibility Criteria |
| Bilirubin | Eligibility Criteria | |
| C-reactive protein (CRP) | Detailed Description | |
| CD69 | Outcome Measure | |
| Ferritin | Detailed Description | |
| Fibrinogen | Eligibility Criteria | |
| Interleukin-2 (IL-2) | Outcome Measure | |
| prion protein (testis specific) | Outcome Measure | |
| Prothrombin (PT) | Eligibility Criteria | |
| T-Cell differentiation antigen CD8 | Outcome Measure | |
| T-cell surface antigen CD4 | Outcome Measure | |
| tumor necrosis factor receptor superfamily member 9 | Outcome Measure | |
| tumor necrosis factor receptor superfamily, member 4 | Outcome Measure |
Development Status
Summary Table
| Indication | Qualifier | Patient Segment | Phase | Countries | Route / Formulation | Developers | Event Date |
|---|---|---|---|---|---|---|---|
| Chikungunya virus infections | - | Prevention | Phase II | Austria, Germany, Puerto Rico, United Kingdom | IM / Injection | Themis Bioscience | 17 Sep 2018 |
| Chikungunya virus infections | - | Prevention | No development reported (I) | USA (fast track) | IM / Injection | National Institute of Allergy and Infectious Diseases | 28 Jun 2020 |
Priority Development Status
| Type | Region | Indication |
|---|---|---|
| Fast Track | USA | Chikungunya virus infections |
| PRIME | European Union | Chikungunya virus infections |
Commercial Information
Involved Organisations
| Organisation | Involvement | Countries |
|---|---|---|
| Themis Bioscience | Originator | Austria |
| Themis Bioscience | Owner | Austria |
| Institut Pasteur | Technology Provider | France |
| Coalition for Epidemic Preparedness Innovations | Funder | Norway |
| Vienna General Hospital | Collaborator | Austria |
| National Institute of Allergy and Infectious Diseases | Collaborator | USA |
Scientific Summary
Adverse Events
The chikungunya virus vaccine was safe and well tolerated in 42 volunteers in a phase I trial [9] .
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 [3] [8] .
Immunogenicity
Summary
The chikungunya virus vaccine induced immune responses, in the form of neutralising antibodies, in a phase I trial that included 42 volunteers. Immune responses were more potent at higher doses of the vaccine [9] .
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 [3] [8] .
Future Events
| Expected Date | Event Type | Description | Updated |
|---|---|---|---|
| 31 Dec 2019 | Trial Update | Themis Bioscience plans a phase III trial for Chikungunya virus infection (Prevention) in 2019 [2] | 28 Feb 2019 |
| 31 Dec 2019 | Regulatory Status | Themis Bioscience announces intention to submit clinical trial application to regulatory authorities for Chikungunya virus infections in second half of 2019 [14] | 13 Jun 2019 |
| 04 Mar 2019 | Trial Update | Themis Bioscience plans a phase II trial for Chikungunya virus infection (Prevention) in Puerto Rico in March 2019 (NCT03807843) | 12 Nov 2019 |
| 17 Sep 2018 | Trial Update | Themis Bioscience plans a phase II trial for Chikungunya Virus Infection (Prevention) in United Kingdom (NCT03635086) (700298938) | 27 Dec 2018 |
| 24 May 2017 | Trial Update | Themis Bioscience in collaboration with Walter Reed Army Institute of Research plans a phase II trial for Chikungunya virus infections in Puerto Rico (NCT03101111) | 28 Aug 2017 |
Development History
| Event Date | Update Type | Comment |
|---|---|---|
| 30 Nov 2022 | Active Status Review | Chikungunya virus vaccine is still in phase II trials for Chikungunya virus infection (Prevention)(Merck pipeline, November 2022) Updated 01 Dec 2022 |
| 20 Oct 2021 | Biomarker Update | Biomarkers information updated Updated 22 Oct 2021 |
| 13 May 2021 | Trial Update | Themis Bioscience completes a phase II trial in Chikungunya virus infection (Prevention) in Puerto Rico (IM (NCT03807843) Updated 25 Jun 2021 |
| 16 Dec 2020 | Trial Update | Themis Bioscience suspends a phase II trial for Chikungunya virus infection (Prevention) in Puerto Rico due to clinical stock recovery action (IM) (NCT03807843) Updated 01 Jan 2021 |
| 28 Jun 2020 | Phase Change - No development reported | No recent reports of development identified for phase-I development in Chikungunya-virus-infections(Prevention) in USA (IM, Injection) Updated 28 Jun 2020 |
| 19 Jun 2020 | Company Involvement | Themis Bioscience has been acquired by Merck & Co Updated 25 Jun 2020 |
| 10 Oct 2019 | Trial Update | Themis Bioscience completes a phase-II clinical trials in Chikungunya virus infections (Prevention) in United Kingdom (IM) (NCT03635086) (EudraCT2018-000211-25) Updated 14 Feb 2020 |
| 16 Jul 2019 | Trial Update | Themis Bioscience initiates enrolment in a phase II trial for Chikungunya virus infection (Prevention) in Puerto Rico (IM) (NCT03807843) Updated 09 Aug 2019 |
| 04 Jun 2019 | Regulatory Status | Themis Bioscience announces intention to submit clinical trial application to regulatory authorities for Chikungunya virus infections in second half of 2019 [14] Updated 13 Jun 2019 |
| 02 Apr 2019 | Trial Update | Themis Bioscience completes a phase II trial in Chikungunya virus infections (Prevention) in Puerto Rico (IM) (NCT03101111) Updated 08 Aug 2019 |
| 25 Feb 2019 | Regulatory Status | Chikungunya virus vaccine receives Fast Track designation for Chikungunya virus infections [IM,Injection] (Prevention) in USA [2] Updated 28 Feb 2019 |
| 25 Feb 2019 | Trial Update | Themis Bioscience plans a phase III trial for Chikungunya virus infection (Prevention) in 2019 [2] Updated 28 Feb 2019 |
| 17 Jan 2019 | Trial Update | Themis Bioscience plans a phase II trial for Chikungunya virus infection (Prevention) in Puerto Rico in March 2019 (NCT03807843) Updated 12 Nov 2019 |
| 06 Nov 2018 | Regulatory Status | Chikungunya virus vaccine receives priority review status for Chikungunya virus infection in USA before November 2018 [3] Updated 16 Nov 2018 |
| 06 Nov 2018 | Scientific Update | Immunogenicity and safety data from a phase II trial in Chikungunya virus infections released by Themis Bioscience [3] Updated 16 Nov 2018 |
| 17 Sep 2018 | Phase Change - II | Phase-II clinical trials in Chikungunya virus infections (Prevention) in United Kingdom (IM) (NCT03635086) Updated 27 Dec 2018 |
| 24 Aug 2018 | Trial Update | Themis Bioscience plans a phase II trial for Chikungunya Virus Infection (Prevention) in United Kingdom (NCT03635086) Updated 27 Dec 2018 |
| 13 Jun 2018 | Regulatory Status | Chikungunya virus vaccine - Themis Bioscience receives Priority Medicine (PRIME) status for Chikungunya virus infections (Prevention) in European Union [4] Updated 13 Jun 2018 |
| 13 Jun 2018 | Trial Update | Themis Bioscience plans a phase III trial for Chikungunya virus infections [4] Updated 13 Jun 2018 |
| 16 Apr 2018 | Trial Update | Themis Bioscience completes a phase II trial in Chikungunya virus infections (Prevention) in Austria, Germany (IM) (EudraCT2015-004037-26) (NCT02861586) Updated 02 Jul 2018 |
| 09 Aug 2017 | Phase Change - II | Phase-II clinical trials in Chikungunya virus infections (Prevention) in Puerto Rico (IM) (NCT03101111) Updated 28 Aug 2017 |
| 30 May 2017 | Phase Change - I | Phase-I clinical trials in Chikungunya virus infections (Prevention) in USA (IM) (NCT03028441) Updated 10 Jan 2018 |
| 05 Apr 2017 | Trial Update | Themis Bioscience in collaboration with Walter Reed Army Institute of Research plans a phase II trial for Chikungunya virus infections in Puerto Rico (NCT03101111) Updated 28 Aug 2017 |
| 29 Dec 2016 | Trial Update | National Institute of Allergy and Infectious Diseases (NIAID) plans a phase I trial in Chikungunya virus infections (Prevention) in USA (IM) (NCT03028441) Updated 02 Feb 2017 |
| 17 Aug 2016 | Phase Change - II | Phase-II clinical trials in Chikungunya virus infections (Prevention) in Germany (IM) after August 2016 (NCT02861586) Updated 10 Jan 2018 |
| 02 Aug 2016 | Phase Change - II | Phase-II clinical trials in Chikungunya virus infections (Prevention) in Austria (IM) (EudraCT2015-004037-26) Updated 09 Aug 2016 |
| 09 May 2016 | Trial Update | Themis Bioscience plans phase II development of the vaccine Updated 09 May 2016 |
| 19 Jan 2016 | Trial Update | Themis Bioscience completes a phase-I trial in Chikungunya virus infections (prevention) in Austria (Parenteral) prior to January 2016 Updated 19 May 2016 |
| 12 Jun 2014 | Scientific Update | Adverse events and immunogenicity data from a phase I trial in Chikungunya virus infections released by Themis Bioscience [9] Updated 19 Jun 2014 |
| 01 Jan 2014 | Phase Change - I | Phase-I clinical trials in Chikungunya virus infections (prevention) in Austria (IM) Updated 19 Jun 2014 |
References
-
Merck Completes Acquisition of Themis.
Media Release -
Themis Bioscience Receives FDA Fast Track Designation for Chikungunya Vaccine Candidate.
Media Release -
Themis Bioscience Publishes Compelling Phase 2 Results for Lead Vaccine Candidate against Chikungunya Fever in The Lancet.
Media Release -
Themis Receives EMA PRIME Designation for Chikungunya Vaccine.
Media Release -
Phase 2 Study of a Live Attenuated Measles Virus-Vectored Chikungunya Vaccine in Previously Exposed Adults
ctiprofile -
Observer Blinded, Randomised Study to Investigate Safety, Tolerability and Long-term Immunogenicity of Different Dose Regimens and Formulations of MV-CHIK in Healthy Volunteers
ctiprofile -
Phase 2 Study of a Live Attenuated Measles Virus-Vectored Chikungunya Vaccine in a Previously Epidemic Area
ctiprofile -
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
ctiprofile -
Threat of Emerging Virus can be Stopped: Interim results of First Clinical Trial of Themis Bioscience's Vaccine Candidate Against Chikungunya Fever Prove Successful.
Media Release -
A phase I study to assess safety and tolerability of Chikungunya fever vaccine
ctiprofile -
Themis Bioscience's Raises up to EUR 10 Million in Series B.
Media Release -
A Phase 1, Double Blinded, Placebo Controlled, Dose Comparison Trial to Evaluate the Safety, Immunogenicity and Schedule of Measles-Vectored Chikungunya Virus Vaccine (MV-CHIK) in Healthy Adults
ctiprofile -
Themis Raises EUR 40 Million in Series D Financing Round Backed by US/EU Consortium to Support Pivotal Study and Expand Clinical Pipeline.
Media Release -
CEPI Awards up to US$21 Million to Themis Bioscience for Phase 3 Chikungunya Vaccine Development.
Media Release -
Themis Raises EUR 10 Million in Series C Financing to Advance Clinical Pipeline.
Media Release -
Themis Bioscience Successfully Closes 10 M EUR Financing Round.
Media Release
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