Who is sponsoring NCT03635086?

NCT03635086 is sponsored by Themis Bioscience GmbH.

What drugs are being tested in NCT03635086?

Interventions in NCT03635086: MV-CHIK lyophilised formulation, low dose, MV-CHIK liquid frozen formulation, low dose, MV-CHIK SPS® formulation, low dose, MV-CHIK liquid frozen formulation, high dose, Placebo.

What condition does NCT03635086 study?

NCT03635086 studies Chikungunya Virus Infection.

Is NCT03635086 still recruiting?

NCT03635086 is currently completed. Last updated 22 October 2021.

Are results published for NCT03635086?

Yes — primary outcome results have been posted to ClinicalTrials.gov. See the outcomes section above for details.

Last reviewed 2021-10-22 · How we verify

NCT03635086

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

Safety, Tolerability and Long-term Immunogenicity of Different Formulations of a Chikungunya Vaccine (V184-005)

Completed Phase 2 Results posted Last updated 22 October 2021

What this trial tests

Phase 2 trial testing MV-CHIK lyophilised formulation, low dose in Chikungunya Virus Infection in 60 participants. Completed in 16 November 2019.

Timeline

22 August 2018

Primary endpoint
25 January 2019

16 November 2019

Quick facts

Lead sponsor	Themis Bioscience GmbH
Phase	Phase 2
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	quadruple
Primary purpose	prevention
Enrollment	60
Start date	22 August 2018
Primary completion	25 January 2019
Estimated completion	16 November 2019
Sites	1 location across United Kingdom

Drugs / interventions tested

MV-CHIK lyophilised formulation, low dose — full drug profile →
MV-CHIK liquid frozen formulation, low dose — full drug profile →
MV-CHIK SPS® formulation, low dose — full drug profile →
MV-CHIK liquid frozen formulation, high dose — full drug profile →
Placebo

Conditions studied

Chikungunya Virus Infection — all drugs for Chikungunya Virus Infection →

Sponsor

Themis Bioscience GmbH — full company profile →

Who can join

Adults 18 to 55, any sex, with Chikungunya Virus Infection. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Geometric Mean Titer of Anti-Chikungunya Antibodies as Measured by 50% Plaque Reduction Neutralization Test 28 Days After Last MV-CHIK Vaccination Primary · 28 days after last vaccination (Up to Day 56)

Participant serum was collected for determination of antibody responses by 50% plaque reduction neutralization test (PRNT50). Geometric Mean Titer (GMT) of functional antibodies as measured by PRNT50 were assessed. Geometric mean titers and GMT ratios were estimated by applying an analysis of variance (ANOVA) including the factor treatment group. This was done using log10 transformed data and taking the anti-log of the resulting point estimates for the least squares means, least squares means differences and the corresponding 2 sided 95% confidence intervals (CI). P-values were also provided t

Group	Value	95% CI
Group A: Two MV-CHIK Lyophilized Low Dose	21.0	9.9 – 44.5
Group B: Two MV-CHIK Liquid Frozen Low Dose	19.1	9.0 – 40.5
Group C: Two MV-CHIK Liquid Low Dose Stabilizing and Protecting Solution (SPS®)	13.6	5.9 – 31.2
Group D: Two MV-CHIK Liquid Frozen High Dose	45.7	21.6 – 97.0
Group E: One MV-CHIK Liquid Frozen High Dose	8.9	4.2 – 18.8

Percentage of Participants With Solicited and Unsolicited Adverse Events Secondary · Up to Day 56

An adverse event (AE) includes any untoward medical occurrence in a participant to whom an IMP has been administered, not necessarily caused by or related to that product. An AE can therefore be any unfavourable or unintended sign, abnormal laboratory finding, symptom or disease temporally associated with the use of an IMP whether or not considered related to the IMP. The percentage of participants with solicited and unsolicited AEs was assessed.

Group	Value	95% CI
Group A: Two MV-CHIK Lyophilized Low Dose	83.3
Group B: Two MV-CHIK Liquid Frozen Low Dose	91.7
Group C: Two MV-CHIK Liquid Low Dose Stabilizing and Protecting Solution (SPS®)	58.3
Group D: Two MV-CHIK Liquid Frozen High Dose	83.3
Group E: One MV-CHIK Liquid Frozen High Dose	91.7

Percentage of Participants With at Least 1 Serious Adverse Event Secondary · Up to Day 56

A serious adverse event (SAE) is any untoward medical occurrence that results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, and consists of a congenital anomaly, birth defect or other important medical events. As per the protocol, adverse events were analyzed per treatment group but were not assessed with respect to individual vaccinations.

Group	Value	95% CI
Group A: Two MV-CHIK Lyophilized Low Dose	0.0
Group B: Two MV-CHIK Liquid Frozen Low Dose	0.0
Group C: Two MV-CHIK Liquid Low Dose Stabilizing and Protecting Solution (SPS®)	0.0
Group D: Two MV-CHIK Liquid Frozen High Dose	0.0
Group E: One MV-CHIK Liquid Frozen High Dose	0.0

Geometric Mean Titer of Anti-Chikungunya Antibodies as Measured by PRNT50 Secondary · Up to Day 365

Participant serum was collected at each visit (Day 0, 28, 56, 182, and 365) for determination of antibody response by PRNT50. These results represent geometric mean titers (titers \<10 were set to 5 for protocol-specified analysis).

Day 0

Group	Value	95% CI
Group A: Two MV-CHIK Lyophilized Low Dose	5.0	3.0 – 8.2
Group B: Two MV-CHIK Liquid Frozen Low Dose	8.6	5.3 – 14.2
Group C: Two MV-CHIK Liquid Low Dose Stabilizing and Protecting Solution (SPS®)	5.0	3.0 – 8.4
Group D: Two MV-CHIK Liquid Frozen High Dose	5.0	3.0 – 8.2
Group E: One MV-CHIK Liquid Frozen High Dose	5.0	3.0 – 8.2

Day 28

Group	Value	95% CI
Group A: Two MV-CHIK Lyophilized Low Dose	7.2	3.9 – 13.2
Group B: Two MV-CHIK Liquid Frozen Low Dose	14.0	7.6 – 25.6
Group C: Two MV-CHIK Liquid Low Dose Stabilizing and Protecting Solution (SPS®)	6.3	3.4 – 11.9
Group D: Two MV-CHIK Liquid Frozen High Dose	11.3	6.2 – 20.8
Group E: One MV-CHIK Liquid Frozen High Dose	8.9	4.8 – 16.2

Day 56

Group	Value	95% CI
Group A: Two MV-CHIK Lyophilized Low Dose	21.0	10.1 – 43.7
Group B: Two MV-CHIK Liquid Frozen Low Dose	19.1	9.2 – 39.7
Group C: Two MV-CHIK Liquid Low Dose Stabilizing and Protecting Solution (SPS®)	13.6	6.0 – 30.5
Group D: Two MV-CHIK Liquid Frozen High Dose	45.7	22.0 – 95.2
Group E: One MV-CHIK Liquid Frozen High Dose	6.9	3.3 – 14.3

Day 182

Group	Value	95% CI
Group A: Two MV-CHIK Lyophilized Low Dose	13.8	7.0 – 27.2
Group B: Two MV-CHIK Liquid Frozen Low Dose	18.2	9.2 – 35.9
Group C: Two MV-CHIK Liquid Low Dose Stabilizing and Protecting Solution (SPS®)	10.5	5.1 – 21.5
Group D: Two MV-CHIK Liquid Frozen High Dose	11.8	6.0 – 23.4
Group E: One MV-CHIK Liquid Frozen High Dose	6.8	3.4 – 13.5

Day 365

Group	Value	95% CI
Group A: Two MV-CHIK Lyophilized Low Dose	7.2	3.9 – 13.6
Group B: Two MV-CHIK Liquid Frozen Low Dose	11.8	6.5 – 21.5
Group C: Two MV-CHIK Liquid Low Dose Stabilizing and Protecting Solution (SPS®)	8.9	4.6 – 17.2
Group D: Two MV-CHIK Liquid Frozen High Dose	8.3	4.6 – 15.0
Group E: One MV-CHIK Liquid Frozen High Dose	5.0	2.8 – 9.1

Percentage of CD4+CD69+ Chikungunya Virus Specific T-Cells Secondary · Up to Day 56

Cellular immunogenicity was determined by the evaluation of T cell immune response. Blood was collected for the isolation of peripheral blood mononuclear cells (PBMCs). PBMCs were isolated from whole blood to determine functional Interleukin 2 (IL-2)-producing T cells on day 0, 14, 28, 42, and 56 and in a subset of participants.

CD4+CD69+ (Day 0)

Group	Value	95% CI
Group D: Two MV-CHIK Liquid Frozen High Dose	0.0194	± 0.0446

CD4+CD69+ (Day 14)

Group	Value	95% CI
Group D: Two MV-CHIK Liquid Frozen High Dose	0.1430	± 0.1589

CD4+CD69+ (Day 28)

Group	Value	95% CI
Group D: Two MV-CHIK Liquid Frozen High Dose	0.1077	± 0.2060

CD4+CD69+ (Day 42)

Group	Value	95% CI
Group D: Two MV-CHIK Liquid Frozen High Dose	0.2050	± 0.2316

CD4+CD69+ (Day 56)

Group	Value	95% CI
Group D: Two MV-CHIK Liquid Frozen High Dose	0.1935	± 0.2036

Percentage of CD4+CD69+CD137+ Chikungunya Virus Specific T-Cells Secondary · Up to Day 56

CD4+CD69+CD137+ (Day 0)

Group	Value	95% CI
Group D: Two MV-CHIK Liquid Frozen High Dose	0.0061	± 0.0112

CD4+CD69+CD137+ (Day 14)

Group	Value	95% CI
Group D: Two MV-CHIK Liquid Frozen High Dose	0.0174	± 0.0313

CD4+CD69+CD137+ (Day 28)

Group	Value	95% CI
Group D: Two MV-CHIK Liquid Frozen High Dose	0.0120	± 0.0168

CD4+CD69+CD137+ (Day 42)

Group	Value	95% CI
Group D: Two MV-CHIK Liquid Frozen High Dose	0.0317	± 0.0438

CD4+CD69+CD137+ (Day 56)

Group	Value	95% CI
Group D: Two MV-CHIK Liquid Frozen High Dose	0.0393	± 0.0476

Percentage of CD4+CD137+ Chikungunya Virus Specific T-Cells Secondary · Up to Day 56

CD4+CD137+ (Day 0)

Group	Value	95% CI
Group D: Two MV-CHIK Liquid Frozen High Dose	0.0528	± 0.0509

CD4+CD137+ (Day 14)

Group	Value	95% CI
Group D: Two MV-CHIK Liquid Frozen High Dose	0.1595	± 0.2105

CD4+CD137+ (Day 28)

Group	Value	95% CI
Group D: Two MV-CHIK Liquid Frozen High Dose	0.1492	± 0.0932

CD4+CD137+ (Day 42)

Group	Value	95% CI
Group D: Two MV-CHIK Liquid Frozen High Dose	0.3484	± 0.3428

CD4+CD137+ (Day 56)

Group	Value	95% CI
Group D: Two MV-CHIK Liquid Frozen High Dose	0.3994	± 0.2713

Percentage of CD4+CD69+OX40+ Chikungunya Virus Specific T-Cells Secondary · Up to Day 56

CD4+CD69+OX40+ (Day 0)

Group	Value	95% CI
Group D: Two MV-CHIK Liquid Frozen High Dose	0.0033	± 0.0048

CD4+CD69+OX40+ (Day 14)

Group	Value	95% CI
Group D: Two MV-CHIK Liquid Frozen High Dose	0.0265	± 0.0522

CD4+CD69+OX40+ (Day 28)

Group	Value	95% CI
Group D: Two MV-CHIK Liquid Frozen High Dose	0.0095	± 0.0070

CD4+CD69+OX40+ (Day 42)

Group	Value	95% CI
Group D: Two MV-CHIK Liquid Frozen High Dose	0.0267	± 0.0408

CD4+CD69+OX40+ (Day 56)

Group	Value	95% CI
Group D: Two MV-CHIK Liquid Frozen High Dose	0.0337	± 0.0386

Percentage of CD4+OX40+ Chikungunya Virus Specific T-Cells Secondary · Up to Day 56

Cellular immunogenicity will be determined by the evaluation of T cell immune response. Blood was collected for the isolation of peripheral blood mononuclear cells (PBMCs). PBMCs were isolated from whole blood to determine functional Interleukin 2 (IL-2)-producing T cells on day 0, 14, 28, 42, and 56 and in a subset of subjects.

CD4+OX40+ (Day 0)

Group	Value	95% CI
Group D: Two MV-CHIK Liquid Frozen High Dose	0.0062	± 0.0158

CD4+OX40+ (Day 14)

Group	Value	95% CI
Group D: Two MV-CHIK Liquid Frozen High Dose	0.0745	± 0.1007

CD4+OX40+ (Day 28)

Group	Value	95% CI
Group D: Two MV-CHIK Liquid Frozen High Dose	0.0269	± 0.0280

CD4+OX40+ (Day 42)

Group	Value	95% CI
Group D: Two MV-CHIK Liquid Frozen High Dose	0.0492	± 0.1012

CD4+OX40+ (Day 56)

Group	Value	95% CI
Group D: Two MV-CHIK Liquid Frozen High Dose	0.0698	± 0.0997

Percentage of CD8+CD69+ Chikungunya Virus Specific T-Cells Secondary · Up to Day 56

CD8+CD69+ (Day 0)

Group	Value	95% CI
Group D: Two MV-CHIK Liquid Frozen High Dose	0.1919	± 0.2329

CD8+CD69+ (Day 14)

Group	Value	95% CI
Group D: Two MV-CHIK Liquid Frozen High Dose	0.3319	± 0.6046

CD8+CD69+ (Day 28)

Group	Value	95% CI
Group D: Two MV-CHIK Liquid Frozen High Dose	0.4242	± 0.6330

CD8+CD69+ (Day 42)

Group	Value	95% CI
Group D: Two MV-CHIK Liquid Frozen High Dose	0.1961	± 0.2496

CD8+CD69+ (Day 56)

Group	Value	95% CI
Group D: Two MV-CHIK Liquid Frozen High Dose	0.2375	± 0.2902

Percentage of CD8+CD69+CD137+ Chikungunya Virus Specific T-Cells Secondary · Up to Day 56

CD8+CD69+CD137+ (Day 0)

Group	Value	95% CI
Group D: Two MV-CHIK Liquid Frozen High Dose	0.0005	± 0.0018

CD8+CD69+CD137+ (Day 14)

Group	Value	95% CI
Group D: Two MV-CHIK Liquid Frozen High Dose	0.0139	± 0.0229

CD8+CD69+CD137+ (Day 28)

Group	Value	95% CI
Group D: Two MV-CHIK Liquid Frozen High Dose	0.0184	± 0.0454

CD8+CD69+CD137+ (Day 42)

Group	Value	95% CI
Group D: Two MV-CHIK Liquid Frozen High Dose	0.0148	± 0.0171

CD8+CD69+CD137+ (Day 56)

Group	Value	95% CI
Group D: Two MV-CHIK Liquid Frozen High Dose	0.0380	± 0.0392

Percentage of CD8+CD137+ Chikungunya Virus Specific T-Cells Secondary · Up to Day 56

CD8+CD137+ (Day 0)

Group	Value	95% CI
Group D: Two MV-CHIK Liquid Frozen High Dose	0.0194	± 0.0334

CD8+CD137+ (Day 14)

Group	Value	95% CI
Group D: Two MV-CHIK Liquid Frozen High Dose	0.0294	± 0.0366

CD8+CD137+ (Day 28)

Group	Value	95% CI
Group D: Two MV-CHIK Liquid Frozen High Dose	0.0224	± 0.0377

CD8+CD137+ (Day 42)

Group	Value	95% CI
Group D: Two MV-CHIK Liquid Frozen High Dose	0.0341	± 0.0595

CD8+CD137+ (Day 56)

Group	Value	95% CI
Group D: Two MV-CHIK Liquid Frozen High Dose	0.0607	± 0.0557

Adverse events — posted to ClinicalTrials.gov

Time frame: Serious and non-serious adverse events: Up to ~Day 56. All cause mortality: Up to ~Day 365.. Reporting threshold: 5%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Group A: Two MV-CHIK Lyophilized Low Dose

Serious: 0/12 (0%)

Deaths: 0/12

Group B: Two MV-CHIK Liquid Frozen Low Dose

Serious: 0/12 (0%)

Deaths: 0/12

Group C: Two MV-CHIK Liquid Low Dose Stabilizing and Protecting Solution (SPS®)

Serious: 0/12 (0%)

Deaths: 0/12

Group D: Two MV-CHIK Liquid Frozen High Dose

Serious: 0/12 (0%)

Deaths: 0/12

Group E: One MV-CHIK Liquid Frozen High Dose

Serious: 0/12 (0%)

Deaths: 0/12

Other adverse events (43 terms — click to expand)

Reaction	System	Group A: Two MV-CHIK Lyoph…	Group B: Two MV-CHIK Liqui…	Group C: Two MV-CHIK Liqui…	Group D: Two MV-CHIK Liqui…	Group E: One MV-CHIK Liqui…
Injection site pain	General disorders	—	—	—	—	—
Headache	Nervous system disorders	—	—	—	—	—
Nausea	Gastrointestinal disorders	—	—	—	—	—
Fatigue	General disorders	—	—	—	—	—
Injection site induration	General disorders	—	—	—	—	—
Injection site pruritus	General disorders	—	—	—	—	—
Injection site swelling	General disorders	—	—	—	—	—
Cough	Respiratory, thoracic and mediastinal disorders	—	—	—	—	—
Influenza like illness	General disorders	—	—	—	—	—
Injection site erythema	General disorders	—	—	—	—	—
White blood cell count decreased	Investigations	—	—	—	—	—
Arthralgia	Musculoskeletal and connective tissue disorders	—	—	—	—	—
Myalgia	Musculoskeletal and connective tissue disorders	—	—	—	—	—
Dizziness	Nervous system disorders	—	—	—	—	—
Rhinorrhoea	Respiratory, thoracic and mediastinal disorders	—	—	—	—	—
Anaemia	Blood and lymphatic system disorders	—	—	—	—	—
Eosinophilia	Blood and lymphatic system disorders	—	—	—	—	—
Excessive cerumen production	Ear and labyrinth disorders	—	—	—	—	—
Lacrimation increased	Eye disorders	—	—	—	—	—
Diarrhoea	Gastrointestinal disorders	—	—	—	—	—
Vomiting	Gastrointestinal disorders	—	—	—	—	—
Chills	General disorders	—	—	—	—	—
Pain	General disorders	—	—	—	—	—
Pyrexia	General disorders	—	—	—	—	—
Nasopharyngitis	Infections and infestations	—	—	—	—	—
Urinary tract infection	Infections and infestations	—	—	—	—	—
Limb injury	Injury, poisoning and procedural complications	—	—	—	—	—
Muscle strain	Injury, poisoning and procedural complications	—	—	—	—	—
Alanine aminotransferase increased	Investigations	—	—	—	—	—
Aspartate aminotransferase increased	Investigations	—	—	—	—	—
Back pain	Musculoskeletal and connective tissue disorders	—	—	—	—	—
Limb discomfort	Musculoskeletal and connective tissue disorders	—	—	—	—	—
Musculoskeletal stiffness	Musculoskeletal and connective tissue disorders	—	—	—	—	—
Paraesthesia	Nervous system disorders	—	—	—	—	—
Syncope	Nervous system disorders	—	—	—	—	—
Vulvovaginal pain	Reproductive system and breast disorders	—	—	—	—	—
Nasal congestion	Respiratory, thoracic and mediastinal disorders	—	—	—	—	—
Oropharyngeal pain	Respiratory, thoracic and mediastinal disorders	—	—	—	—	—
Productive cough	Respiratory, thoracic and mediastinal disorders	—	—	—	—	—
Sinus pain	Respiratory, thoracic and mediastinal disorders	—	—	—	—	—

Data from ClinicalTrials.gov NCT03635086 adverse events section.

Sponsor's own description

The purpose of this study is to investigate immunogenicity and safety of Measles Virus-Chikungunya (MV-CHIK) vaccine in different dose regimens, 28 days after one or two vaccinations.

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

Engineering and combining oncolytic measles virus for cancer therapy.
Leber MF, Neault S, Jirovec E, Barkley R, et al · · 2020 · cited 47× · PMID 32718830 · DOI 10.1016/j.cytogfr.2020.07.005
Current Efforts in the Development of Vaccines for the Prevention of Zika and Chikungunya Virus Infections.
Schrauf S, Tschismarov R, Tauber E, Ramsauer K. · · 2020 · cited 37× · PMID 32373111 · DOI 10.3389/fimmu.2020.00592
Chikungunya Vaccine Candidates: Current Landscape and Future Prospects.
Schmidt C, Schnierle BS. · · 2022 · cited 22× · PMID 36277603 · DOI 10.2147/dddt.s366112
Recent development in the strategies projected for chikungunya vaccine in humans.
Goyal M, Chauhan A, Goyal V, Jaiswal N, et al · · 2018 · cited 21× · PMID 30573950 · DOI 10.2147/dddt.s181574
Developing a Prototype Pathogen Plan and Research Priorities for the Alphaviruses.
Powers AM, Williamson LE, Carnahan RH, Crowe JE, et al · · 2023 · cited 12× · PMID 37849399 · DOI 10.1093/infdis/jiac326
Prophylactic strategies to control chikungunya virus infection.
Hucke FIL, Bestehorn-Willmann M, Bugert JJ. · · 2021 · cited 11× · PMID 33590406 · DOI 10.1007/s11262-020-01820-x
Versatility of live-attenuated measles viruses as platform technology for recombinant vaccines.
Ebenig A, Lange MV, Mühlebach MD. · · 2022 · cited 10× · PMID 36243743 · DOI 10.1038/s41541-022-00543-4
Immunogenicity and Safety of Chikungunya Vaccines: A Systematic Review and Meta-Analysis.
Rosso A, Flacco ME, Cioni G, Cioni G, et al · · 2024 · cited 4× · PMID 39340001 · DOI 10.3390/vaccines12090969

Verify or expand the search:

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Other Themis Bioscience GmbH trials

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Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT03635086 (US National Library of Medicine, public domain)
Publications: Europe PMC API search by NCT ID, retrieved 9 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Themis Bioscience GmbH
Last refreshed: 22 October 2021

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03635086.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing

NCT03635086

Quick facts

Drugs / interventions tested

Conditions studied

Sponsor

Who can join

Results — posted to ClinicalTrials.gov

Adverse events — posted to ClinicalTrials.gov

Sponsor's own description

Publications & conference data

Related trials

Other recruiting trials for Chikungunya Virus Infection

Other Themis Bioscience GmbH trials

Verify against primary sources