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

Primary Purpose

Chikungunya Virus Infection

Status
Completed
Phase
Phase 2
Locations
United Kingdom
Study Type
Interventional
Intervention
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
Sponsored by
Themis Bioscience GmbH
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Chikungunya Virus Infection focused on measuring Chikungunya fever

Eligibility Criteria

18 Years - 55 Years (Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • Is able 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 study
  • Has a negative serum pregnancy test at screening (for female participants)
  • Has a willingness not to become pregnant or to father a child during the entire study period by practicing reliable methods of contraception
  • Has availability during the duration of the trial

Exclusion Criteria:

  • Has participated in another clinical study (including exposure to an investigational medicinal product or device) within one month before the screening visit or planned concurrent participation in another clinical study before completion of the treatment period
  • Has a history of immunodeficiency, known human immunodeficiency virus (HIV) infection or current hepatitis B/C infection
  • Has a history of drug addiction including alcohol dependence within the last 2 years
  • Has an inability or unwillingness to avoid intake of more than around 20 grams alcohol per day during 48 hours after each vaccination (equals roughly 0.5 liter beer or 0.25 liter of wine)
  • Has had a vaccination within 4 weeks prior to first vaccination or planning to receive any non-study vaccine until end of treatment period
  • Has had a prior receipt of any Chikungunya vaccine
  • Has a history of moderate or severe arthritis or arthralgia within the past 3 months prior to screening
  • Has had a recent infection within 1 week prior to screening
  • Has made blood donations including plasma donations, 90 days prior to screening visit and anticipated blood, plasma, tissue, sperm or organ donation, throughout the study until end of treatment period
  • Has clinically relevant history of renal, hepatic, gastrointestinal, cardiovascular, respiratory, skin, hematological, endocrine, inflammatory, autoimmune or neurological diseases or clinically relevant abnormal laboratory values, that in the opinion of the investigator may interfere with the aim of the study
  • Has a 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
  • Has behavioral, cognitive, or psychiatric condition that in the opinion of the investigator affects the ability of the participant to understand and cooperate with the study protocol
  • Has a 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
  • Has a history of anaphylaxis to drugs or other allergic reactions, which the investigator considers compromising the safety of the participant.
  • Use of medication during 2 weeks before the first vaccination and throughout the study, which the investigator considers affecting the validity of the study, except hormonal contraception or hormonal replacement therapy in female participants.
  • Use of immunosuppressive drugs like corticosteroids (excluding topical preparations) within 30 days prior to the first vaccination or anticipated use before completion of the treatment period
  • Has receipt of blood products or immunoglobulins within 120 days prior to the screening visit or anticipated receipt of any blood product or immunoglobulin before completion of the treatment period
  • Has pregnancy (positive pregnancy test at screening or during the treatment period) or lactation at screening, or planning to become pregnant during the treatment period
  • Has unreliable contraception methods
  • Is a person in a direct relationship with the sponsor, an investigator or other study team members. Direct dependent relationships include close relatives (i.e. children, parents, partner/spouse, siblings) as well as employees of the study site or the sponsor

Sites / Locations

  • Celerion Belfast

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm Type

Experimental

Experimental

Experimental

Experimental

Experimental

Arm Label

Group A: Two MV-CHIK lyophilized low dose

Group B: Two MV-CHIK liquid frozen low dose

Group C: Two MV-CHIK liquid low dose stabilizing and protecting solution (SPS®)

Group D: Two MV-CHIK liquid frozen high dose

Group E: One MV-CHIK liquid frozen high dose/placebo

Arm Description

Participants received two vaccinations with MV-CHIK lyophilized formulation, low dose, on day 0 and day 28.

Participants received two vaccinations with MV-CHIK liquid frozen low dose formulation on day 0 and day 28.

Participants received two vaccinations with MV-CHIK liquid low dose SPS® formulation on day 0 and day 28.

Participants received two vaccinations with MV-CHIK liquid frozen high dose formulation on day 0 and day 28.

Participants received one vaccination with MV-CHIK liquid frozen high dose formulation on day 0 and placebo on day 28.

Outcomes

Primary Outcome Measures

Geometric Mean Titer of Anti-Chikungunya Antibodies as Measured by 50% Plaque Reduction Neutralization Test 28 Days After Last MV-CHIK Vaccination
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 to compare GMTs between treatment groups adjusted for multiple comparisons according to Tukey Kramer.

Secondary Outcome Measures

Percentage of Participants With Solicited and Unsolicited Adverse Events
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.
Percentage of Participants With at Least 1 Serious Adverse Event
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.
Geometric Mean Titer of Anti-Chikungunya Antibodies as Measured by PRNT50
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).
Percentage of CD4+CD69+ Chikungunya Virus Specific T-Cells
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.
Percentage of CD4+CD69+CD137+ Chikungunya Virus Specific T-Cells
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.
Percentage of CD4+CD137+ Chikungunya Virus Specific T-Cells
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.
Percentage of CD4+CD69+OX40+ Chikungunya Virus Specific T-Cells
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.
Percentage of CD4+OX40+ Chikungunya Virus Specific T-Cells
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.
Percentage of CD8+CD69+ Chikungunya Virus Specific T-Cells
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.
Percentage of CD8+CD69+CD137+ Chikungunya Virus Specific T-Cells
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.
Percentage of CD8+CD137+ Chikungunya Virus Specific T-Cells
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.
Geometric Mean Titer of Anti-Chikungunya Antibodies Determined by Enzyme Linked Immunosorbent Assay
Participant serum was collected at each visit (Day 0, 28, 56, 182, and 365) for determination of Chikungunya antibody response by enzyme linked immunosorbent assay (ELISA). The analysis of variance GMT of Chikungunya-ELISA antibodies between treatment groups is summarized.
Geometric Mean Titer of Anti-Measles Antibodies Determined by ELISA
Participant serum was collected at each visit (Day 0, 28, and 56) for determination of antibody responses by ELISA.
Number of Participants With Abnormal Laboratory Hematology Values Reported as an AE
An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure, that occurs during the course of the study. Abnormal laboratory hematology value was any AE reported under the System Organ Class of Investigations that was related to an abnormal laboratory hematology value.
Number of Participants With Abnormal Laboratory Chemistry Values Reported as an AE
An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure, that occurs during the course of the study. Abnormal laboratory chemistry value was any AE reported under the System Organ Class of Investigations that was related to an abnormal laboratory chemistry value.

Full Information

First Posted
July 24, 2018
Last Updated
October 21, 2021
Sponsor
Themis Bioscience GmbH
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1. Study Identification

Unique Protocol Identification Number
NCT03635086
Brief Title
Safety, Tolerability and Long-term Immunogenicity of Different Formulations of a Chikungunya Vaccine (V184-005)
Official Title
Observer Blinded, Randomised Study to Investigate Safety, Tolerability and Long-term Immunogenicity of Different Dose Regimens and Formulations of MV-CHIK in Healthy Volunteers
Study Type
Interventional

2. Study Status

Record Verification Date
October 2021
Overall Recruitment Status
Completed
Study Start Date
August 22, 2018 (Actual)
Primary Completion Date
January 25, 2019 (Actual)
Study Completion Date
November 16, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Themis Bioscience GmbH

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chikungunya Virus Infection
Keywords
Chikungunya fever

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
60 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Group A: Two MV-CHIK lyophilized low dose
Arm Type
Experimental
Arm Description
Participants received two vaccinations with MV-CHIK lyophilized formulation, low dose, on day 0 and day 28.
Arm Title
Group B: Two MV-CHIK liquid frozen low dose
Arm Type
Experimental
Arm Description
Participants received two vaccinations with MV-CHIK liquid frozen low dose formulation on day 0 and day 28.
Arm Title
Group C: Two MV-CHIK liquid low dose stabilizing and protecting solution (SPS®)
Arm Type
Experimental
Arm Description
Participants received two vaccinations with MV-CHIK liquid low dose SPS® formulation on day 0 and day 28.
Arm Title
Group D: Two MV-CHIK liquid frozen high dose
Arm Type
Experimental
Arm Description
Participants received two vaccinations with MV-CHIK liquid frozen high dose formulation on day 0 and day 28.
Arm Title
Group E: One MV-CHIK liquid frozen high dose/placebo
Arm Type
Experimental
Arm Description
Participants received one vaccination with MV-CHIK liquid frozen high dose formulation on day 0 and placebo on day 28.
Intervention Type
Biological
Intervention Name(s)
MV-CHIK lyophilised formulation, low dose
Intervention Description
MV-CHIK, a live-attenuated recombinant measles vaccine expressing Chikungunya virus antigens, lyophilized low dose (powder for suspension in water for intramuscular [IM] injection): 5x10^4 ±0.5 log tissue culture infectious dose 50 (TCID50)/dose.
Intervention Type
Biological
Intervention Name(s)
MV-CHIK liquid frozen formulation, low dose
Intervention Description
MV-CHIK, a live-attenuated recombinant measles vaccine expressing Chikungunya virus antigens, liquid frozen low dose (suspension for IM injection): 1x10^5 ±0.5 log TCID50/dose.
Intervention Type
Biological
Intervention Name(s)
MV-CHIK SPS® formulation, low dose
Intervention Description
MV-CHIK, a live-attenuated recombinant measles vaccine expressing Chikungunya virus antigens, liquid SPS® low dose (suspension for IM injection): 1x10^5 ±0.5 log TCID50/dose.
Intervention Type
Biological
Intervention Name(s)
MV-CHIK liquid frozen formulation, high dose
Intervention Description
MV-CHIK, a live-attenuated recombinant measles vaccine expressing Chikungunya virus antigens, liquid frozen high dose (suspension for IM injection): 1x10^6 ±0.5 log TCID50/dose.
Intervention Type
Other
Intervention Name(s)
Placebo
Intervention Description
Sterile physiological saline solution (0.9% sodium chloride [NaCl]), administered by IM injection.
Primary Outcome Measure Information:
Title
Geometric Mean Titer of Anti-Chikungunya Antibodies as Measured by 50% Plaque Reduction Neutralization Test 28 Days After Last MV-CHIK Vaccination
Description
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 to compare GMTs between treatment groups adjusted for multiple comparisons according to Tukey Kramer.
Time Frame
28 days after last vaccination (Up to Day 56)
Secondary Outcome Measure Information:
Title
Percentage of Participants With Solicited and Unsolicited Adverse Events
Description
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.
Time Frame
Up to Day 56
Title
Percentage of Participants With at Least 1 Serious Adverse Event
Description
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.
Time Frame
Up to Day 56
Title
Geometric Mean Titer of Anti-Chikungunya Antibodies as Measured by PRNT50
Description
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).
Time Frame
Up to Day 365
Title
Percentage of CD4+CD69+ Chikungunya Virus Specific T-Cells
Description
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.
Time Frame
Up to Day 56
Title
Percentage of CD4+CD69+CD137+ Chikungunya Virus Specific T-Cells
Description
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.
Time Frame
Up to Day 56
Title
Percentage of CD4+CD137+ Chikungunya Virus Specific T-Cells
Description
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.
Time Frame
Up to Day 56
Title
Percentage of CD4+CD69+OX40+ Chikungunya Virus Specific T-Cells
Description
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.
Time Frame
Up to Day 56
Title
Percentage of CD4+OX40+ Chikungunya Virus Specific T-Cells
Description
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.
Time Frame
Up to Day 56
Title
Percentage of CD8+CD69+ Chikungunya Virus Specific T-Cells
Description
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.
Time Frame
Up to Day 56
Title
Percentage of CD8+CD69+CD137+ Chikungunya Virus Specific T-Cells
Description
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.
Time Frame
Up to Day 56
Title
Percentage of CD8+CD137+ Chikungunya Virus Specific T-Cells
Description
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.
Time Frame
Up to Day 56
Title
Geometric Mean Titer of Anti-Chikungunya Antibodies Determined by Enzyme Linked Immunosorbent Assay
Description
Participant serum was collected at each visit (Day 0, 28, 56, 182, and 365) for determination of Chikungunya antibody response by enzyme linked immunosorbent assay (ELISA). The analysis of variance GMT of Chikungunya-ELISA antibodies between treatment groups is summarized.
Time Frame
Up to Day 365
Title
Geometric Mean Titer of Anti-Measles Antibodies Determined by ELISA
Description
Participant serum was collected at each visit (Day 0, 28, and 56) for determination of antibody responses by ELISA.
Time Frame
Up to Day 56
Title
Number of Participants With Abnormal Laboratory Hematology Values Reported as an AE
Description
An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure, that occurs during the course of the study. Abnormal laboratory hematology value was any AE reported under the System Organ Class of Investigations that was related to an abnormal laboratory hematology value.
Time Frame
Up to Day 56
Title
Number of Participants With Abnormal Laboratory Chemistry Values Reported as an AE
Description
An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure, that occurs during the course of the study. Abnormal laboratory chemistry value was any AE reported under the System Organ Class of Investigations that was related to an abnormal laboratory chemistry value.
Time Frame
Up to Day 56

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Is able 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 study Has a negative serum pregnancy test at screening (for female participants) Has a willingness not to become pregnant or to father a child during the entire study period by practicing reliable methods of contraception Has availability during the duration of the trial Exclusion Criteria: Has participated in another clinical study (including exposure to an investigational medicinal product or device) within one month before the screening visit or planned concurrent participation in another clinical study before completion of the treatment period Has a history of immunodeficiency, known human immunodeficiency virus (HIV) infection or current hepatitis B/C infection Has a history of drug addiction including alcohol dependence within the last 2 years Has an inability or unwillingness to avoid intake of more than around 20 grams alcohol per day during 48 hours after each vaccination (equals roughly 0.5 liter beer or 0.25 liter of wine) Has had a vaccination within 4 weeks prior to first vaccination or planning to receive any non-study vaccine until end of treatment period Has had a prior receipt of any Chikungunya vaccine Has a history of moderate or severe arthritis or arthralgia within the past 3 months prior to screening Has had a recent infection within 1 week prior to screening Has made blood donations including plasma donations, 90 days prior to screening visit and anticipated blood, plasma, tissue, sperm or organ donation, throughout the study until end of treatment period Has clinically relevant history of renal, hepatic, gastrointestinal, cardiovascular, respiratory, skin, hematological, endocrine, inflammatory, autoimmune or neurological diseases or clinically relevant abnormal laboratory values, that in the opinion of the investigator may interfere with the aim of the study Has a 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 Has behavioral, cognitive, or psychiatric condition that in the opinion of the investigator affects the ability of the participant to understand and cooperate with the study protocol Has a 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 Has a history of anaphylaxis to drugs or other allergic reactions, which the investigator considers compromising the safety of the participant. Use of medication during 2 weeks before the first vaccination and throughout the study, which the investigator considers affecting the validity of the study, except hormonal contraception or hormonal replacement therapy in female participants. Use of immunosuppressive drugs like corticosteroids (excluding topical preparations) within 30 days prior to the first vaccination or anticipated use before completion of the treatment period Has receipt of blood products or immunoglobulins within 120 days prior to the screening visit or anticipated receipt of any blood product or immunoglobulin before completion of the treatment period Has pregnancy (positive pregnancy test at screening or during the treatment period) or lactation at screening, or planning to become pregnant during the treatment period Has unreliable contraception methods Is a person in a direct relationship with the sponsor, an investigator or other study team members. Direct dependent relationships include close relatives (i.e. children, parents, partner/spouse, siblings) as well as employees of the study site or the sponsor
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Medical Director
Organizational Affiliation
Merck Sharp & Dohme LLC
Official's Role
Study Director
Facility Information:
Facility Name
Celerion Belfast
City
Belfast
State/Province
Northern Ireland
ZIP/Postal Code
BT9 6 AD
Country
United Kingdom

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
http://engagezone.msd.com/doc/ProcedureAccessClinicalTrialData.pdf
IPD Sharing URL
http://engagezone.msd.com/ds_documentation.php
Citations:
PubMed Identifier
25739878
Citation
Ramsauer K, Schwameis M, Firbas C, Mullner M, Putnak RJ, Thomas SJ, Despres P, Tauber E, Jilma B, Tangy F. Immunogenicity, safety, and tolerability of a recombinant measles-virus-based chikungunya vaccine: a randomised, double-blind, placebo-controlled, active-comparator, first-in-man trial. Lancet Infect Dis. 2015 May;15(5):519-27. doi: 10.1016/S1473-3099(15)70043-5. Epub 2015 Mar 2.
Results Reference
result

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

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