Chikungunya Virus Infection
Conditions
Keywords
Chikungunya fever
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.
Interventions
BIOLOGICALMV-CHIK lyophilised formulation, low dose
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.
BIOLOGICALMV-CHIK liquid frozen formulation, low dose
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.
BIOLOGICALMV-CHIK SPS® formulation, low dose
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.
BIOLOGICALMV-CHIK liquid frozen formulation, high dose
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.
OTHERPlacebo
Sterile physiological saline solution (0.9% sodium chloride \[NaCl\]), administered by IM injection.
Sponsors
Themis Bioscience GmbH
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 55 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Geometric Mean Titer of Anti-Chikungunya Antibodies as Measured by 50% Plaque Reduction Neutralization Test 28 Days After Last MV-CHIK Vaccination | 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 to compare GMTs between treatment groups adjusted for multiple comparisons according to Tukey Kramer. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants With at Least 1 Serious Adverse Event | 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. |
| Geometric Mean Titer of Anti-Chikungunya Antibodies as Measured by PRNT50 | 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). |
| Percentage of CD4+CD69+ Chikungunya Virus Specific T-Cells | 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. |
| Percentage of CD4+CD69+CD137+ Chikungunya Virus Specific T-Cells | 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. |
| Percentage of CD4+CD137+ Chikungunya Virus Specific T-Cells | 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. |
| Percentage of CD4+CD69+OX40+ Chikungunya Virus Specific T-Cells | 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. |
| Percentage of CD4+OX40+ Chikungunya Virus Specific T-Cells | 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. |
| Percentage of Participants With Solicited and Unsolicited Adverse Events | 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. |
| Percentage of CD8+CD69+CD137+ Chikungunya Virus Specific T-Cells | 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. |
| Percentage of CD8+CD137+ Chikungunya Virus Specific T-Cells | 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. |
| Geometric Mean Titer of Anti-Chikungunya Antibodies Determined by Enzyme Linked Immunosorbent Assay | Up to Day 365 | 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 | Up to Day 56 | 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 | Up to Day 56 | 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 | Up to Day 56 | 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. |
| Percentage of CD8+CD69+ Chikungunya Virus Specific T-Cells | 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. |
Countries
United Kingdom
Participant flow
Pre-assignment details
After completion of screening procedures, participants will be randomized to one of five treatment groups (A, B, C, D or E).
Participants by arm
| Arm | Count |
|---|---|
| Group A: Two MV-CHIK Lyophilized Low Dose Participants received two vaccinations (Day 0 and Day 28) with 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. | 12 |
| Group B: Two MV-CHIK Liquid Frozen Low Dose Participants received two vaccinations (Day 0 and Day 28) with 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. | 12 |
| Group C: Two MV-CHIK Liquid Low Dose Stabilizing and Protecting Solution (SPS®) Participants received two vaccinations (Day 0 and Day 28) with 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. | 12 |
| Group D: Two MV-CHIK Liquid Frozen High Dose Participants received two vaccinations (Day 0 and Day 28) with 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. | 12 |
| Group E: One MV-CHIK Liquid Frozen High Dose Participants received one vaccination (Day 0) with 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 and placebo (Day 28), a sterile physiological saline solution (0.9% sodium chloride \[NaCl\]), administered by IM injection. | 12 |
| Total | 60 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 | FG004 |
|---|---|---|---|---|---|---|
| Overall Study | Adverse Event | 0 | 1 | 0 | 0 | 0 |
| Overall Study | Lost to Follow-up | 1 | 0 | 0 | 0 | 0 |
| Overall Study | Withdrawal of consent | 0 | 0 | 1 | 0 | 0 |
Baseline characteristics
| Characteristic | Group A: Two MV-CHIK Lyophilized Low Dose | Total | Group E: One MV-CHIK Liquid Frozen High Dose | Group D: Two MV-CHIK Liquid Frozen High Dose | Group B: Two MV-CHIK Liquid Frozen Low Dose | Group C: Two MV-CHIK Liquid Low Dose Stabilizing and Protecting Solution (SPS®) |
|---|---|---|---|---|---|---|
| Age, Continuous | 37.9 years STANDARD_DEVIATION 9.52 | 36.9 years STANDARD_DEVIATION 9.9 | 36.8 years STANDARD_DEVIATION 7.52 | 36.3 years STANDARD_DEVIATION 9.62 | 34.6 years STANDARD_DEVIATION 11.79 | 39.0 years STANDARD_DEVIATION 11.6 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 12 Participants | 60 Participants | 12 Participants | 12 Participants | 12 Participants | 12 Participants |
| Sex: Female, Male Female | 3 Participants | 23 Participants | 6 Participants | 6 Participants | 4 Participants | 4 Participants |
| Sex: Female, Male Male | 9 Participants | 37 Participants | 6 Participants | 6 Participants | 8 Participants | 8 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk | EG004 affected / at risk |
|---|---|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 12 | 0 / 12 | 0 / 12 | 0 / 12 | 0 / 12 |
| other Total, other adverse events | 10 / 12 | 11 / 12 | 7 / 12 | 10 / 12 | 11 / 12 |
| serious Total, serious adverse events | 0 / 12 | 0 / 12 | 0 / 12 | 0 / 12 | 0 / 12 |
Outcome results
Primary
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.
Time frame: 28 days after last vaccination (Up to Day 56)
Population: The analysis population included all randomized participants who received at least one investigational medicinal product (IMP) administration and had no major protocol deviation that could have had an impact on their immune response.
| Arm | Measure | Value (GEOMETRIC_MEAN) |
|---|---|---|
| Group A: Two MV-CHIK Lyophilized Low Dose | Geometric Mean Titer of Anti-Chikungunya Antibodies as Measured by 50% Plaque Reduction Neutralization Test 28 Days After Last MV-CHIK Vaccination | 21.0 Titer |
| Group B: Two MV-CHIK Liquid Frozen Low Dose | Geometric Mean Titer of Anti-Chikungunya Antibodies as Measured by 50% Plaque Reduction Neutralization Test 28 Days After Last MV-CHIK Vaccination | 19.1 Titer |
| Group C: Two MV-CHIK Liquid Low Dose Stabilizing and Protecting Solution (SPS®) | Geometric Mean Titer of Anti-Chikungunya Antibodies as Measured by 50% Plaque Reduction Neutralization Test 28 Days After Last MV-CHIK Vaccination | 13.6 Titer |
| Group D: Two MV-CHIK Liquid Frozen High Dose | Geometric Mean Titer of Anti-Chikungunya Antibodies as Measured by 50% Plaque Reduction Neutralization Test 28 Days After Last MV-CHIK Vaccination | 45.7 Titer |
| Group E: One MV-CHIK Liquid Frozen High Dose | Geometric Mean Titer of Anti-Chikungunya Antibodies as Measured by 50% Plaque Reduction Neutralization Test 28 Days After Last MV-CHIK Vaccination | 8.9 Titer |
Comparison: 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.p-value: 0.999895% CI: [0.2, 4.9]Tukey-Kramer
Comparison: 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.p-value: 0.934595% CI: [0.3, 7.5]Tukey-Kramer
Comparison: 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.p-value: 0.583695% CI: [0.1, 2.1]Tukey-Kramer
Comparison: 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.p-value: 0.484495% CI: [0.5, 10.6]Tukey-Kramer
Comparison: 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.p-value: 0.972595% CI: [0.3, 6.8]Tukey-Kramer
Comparison: 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.p-value: 0.471595% CI: [0.1, 1.9]Tukey-Kramer
Comparison: 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.p-value: 0.596995% CI: [0.5, 9.6]Tukey-Kramer
Comparison: 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.p-value: 0.204395% CI: [0.1, 1.4]Tukey-Kramer
Comparison: 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.p-value: 0.938895% CI: [0.3, 7.4]Tukey-Kramer
Comparison: 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.p-value: 0.025195% CI: [1.2, 23.1]Tukey-Kramer
Secondary
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).
Time frame: Up to Day 365
Population: The analysis population included all randomized participants who received at least one investigational medicinal product (IMP) administration and had no major protocol deviation that could have had an impact on their immune response.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Group A: Two MV-CHIK Lyophilized Low Dose | Geometric Mean Titer of Anti-Chikungunya Antibodies as Measured by PRNT50 | Day 182 | 13.8 Titer |
| Group A: Two MV-CHIK Lyophilized Low Dose | Geometric Mean Titer of Anti-Chikungunya Antibodies as Measured by PRNT50 | Day 0 | 5.0 Titer |
| Group A: Two MV-CHIK Lyophilized Low Dose | Geometric Mean Titer of Anti-Chikungunya Antibodies as Measured by PRNT50 | Day 365 | 7.2 Titer |
| Group A: Two MV-CHIK Lyophilized Low Dose | Geometric Mean Titer of Anti-Chikungunya Antibodies as Measured by PRNT50 | Day 28 | 7.2 Titer |
| Group A: Two MV-CHIK Lyophilized Low Dose | Geometric Mean Titer of Anti-Chikungunya Antibodies as Measured by PRNT50 | Day 56 | 21.0 Titer |
| Group B: Two MV-CHIK Liquid Frozen Low Dose | Geometric Mean Titer of Anti-Chikungunya Antibodies as Measured by PRNT50 | Day 182 | 18.2 Titer |
| Group B: Two MV-CHIK Liquid Frozen Low Dose | Geometric Mean Titer of Anti-Chikungunya Antibodies as Measured by PRNT50 | Day 56 | 19.1 Titer |
| Group B: Two MV-CHIK Liquid Frozen Low Dose | Geometric Mean Titer of Anti-Chikungunya Antibodies as Measured by PRNT50 | Day 28 | 14.0 Titer |
| Group B: Two MV-CHIK Liquid Frozen Low Dose | Geometric Mean Titer of Anti-Chikungunya Antibodies as Measured by PRNT50 | Day 365 | 11.8 Titer |
| Group B: Two MV-CHIK Liquid Frozen Low Dose | Geometric Mean Titer of Anti-Chikungunya Antibodies as Measured by PRNT50 | Day 0 | 8.6 Titer |
| Group C: Two MV-CHIK Liquid Low Dose Stabilizing and Protecting Solution (SPS®) | Geometric Mean Titer of Anti-Chikungunya Antibodies as Measured by PRNT50 | Day 56 | 13.6 Titer |
| Group C: Two MV-CHIK Liquid Low Dose Stabilizing and Protecting Solution (SPS®) | Geometric Mean Titer of Anti-Chikungunya Antibodies as Measured by PRNT50 | Day 0 | 5.0 Titer |
| Group C: Two MV-CHIK Liquid Low Dose Stabilizing and Protecting Solution (SPS®) | Geometric Mean Titer of Anti-Chikungunya Antibodies as Measured by PRNT50 | Day 28 | 6.3 Titer |
| Group C: Two MV-CHIK Liquid Low Dose Stabilizing and Protecting Solution (SPS®) | Geometric Mean Titer of Anti-Chikungunya Antibodies as Measured by PRNT50 | Day 182 | 10.5 Titer |
| Group C: Two MV-CHIK Liquid Low Dose Stabilizing and Protecting Solution (SPS®) | Geometric Mean Titer of Anti-Chikungunya Antibodies as Measured by PRNT50 | Day 365 | 8.9 Titer |
| Group D: Two MV-CHIK Liquid Frozen High Dose | Geometric Mean Titer of Anti-Chikungunya Antibodies as Measured by PRNT50 | Day 365 | 8.3 Titer |
| Group D: Two MV-CHIK Liquid Frozen High Dose | Geometric Mean Titer of Anti-Chikungunya Antibodies as Measured by PRNT50 | Day 0 | 5.0 Titer |
| Group D: Two MV-CHIK Liquid Frozen High Dose | Geometric Mean Titer of Anti-Chikungunya Antibodies as Measured by PRNT50 | Day 182 | 11.8 Titer |
| Group D: Two MV-CHIK Liquid Frozen High Dose | Geometric Mean Titer of Anti-Chikungunya Antibodies as Measured by PRNT50 | Day 56 | 45.7 Titer |
| Group D: Two MV-CHIK Liquid Frozen High Dose | Geometric Mean Titer of Anti-Chikungunya Antibodies as Measured by PRNT50 | Day 28 | 11.3 Titer |
| Group E: One MV-CHIK Liquid Frozen High Dose | Geometric Mean Titer of Anti-Chikungunya Antibodies as Measured by PRNT50 | Day 56 | 6.9 Titer |
| Group E: One MV-CHIK Liquid Frozen High Dose | Geometric Mean Titer of Anti-Chikungunya Antibodies as Measured by PRNT50 | Day 182 | 6.8 Titer |
| Group E: One MV-CHIK Liquid Frozen High Dose | Geometric Mean Titer of Anti-Chikungunya Antibodies as Measured by PRNT50 | Day 0 | 5.0 Titer |
| Group E: One MV-CHIK Liquid Frozen High Dose | Geometric Mean Titer of Anti-Chikungunya Antibodies as Measured by PRNT50 | Day 365 | 5.0 Titer |
| Group E: One MV-CHIK Liquid Frozen High Dose | Geometric Mean Titer of Anti-Chikungunya Antibodies as Measured by PRNT50 | Day 28 | 8.9 Titer |
Comparison: Day 0p-value: 0.526395% CI: [0.2, 1.6]ANOVA
Comparison: Day 0p-value: 195% CI: [0.4, 2.8]ANOVA
Comparison: Day 0p-value: 195% CI: [0.4, 2.7]ANOVA
Comparison: Day 0p-value: 195% CI: [0.4, 2.7]ANOVA
Comparison: Day 0p-value: 0.5595% CI: [0.6, 4.7]ANOVA
Comparison: Day 0p-value: 0.526395% CI: [0.6, 4.6]ANOVA
Comparison: Day 0p-value: 0.526395% CI: [0.6, 4.6]ANOVA
Comparison: Day 0p-value: 195% CI: [0.4, 2.8]ANOVA
Comparison: Day 0p-value: 195% CI: [0.4, 2.8]ANOVA
Comparison: Day 0p-value: 195% CI: [0.4, 2.7]ANOVA
Comparison: Day 28p-value: 0.532195% CI: [0.2, 1.7]ANOVA
Comparison: Day 28p-value: 0.998395% CI: [0.3, 3.9]ANOVA
Comparison: Day 28p-value: 0.823495% CI: [0.2, 2.1]ANOVA
Comparison: Day 28p-value: 0.988295% CI: [0.2, 2.7]ANOVA
Comparison: Day 28p-value: 0.377895% CI: [0.6, 7.6]ANOVA
Comparison: Day 28p-value: 0.987895% CI: [0.4, 4.1]ANOVA
Comparison: Day 28p-value: 0.821395% CI: [0.5, 5.3]ANOVA
Comparison: Day 28p-value: 0.671695% CI: [0.2, 1.9]ANOVA
Comparison: Day 28p-value: 0.93895% CI: [0.2, 2.5]ANOVA
Comparison: Day 28p-value: 0.977795% CI: [0.4, 4.3]ANOVA
Comparison: Day 56p-value: 0.999795% CI: [0.3, 4.7]ANOVA
Comparison: Day 56p-value: 0.928795% CI: [0.3, 7.2]ANOVA
Comparison: Day 56p-value: 0.559895% CI: [0.1, 2]ANOVA
Comparison: Day 56p-value: 0.211795% CI: [0.7, 13.1]ANOVA
Comparison: Day 56p-value: 0.969995% CI: [0.3, 6.6]ANOVA
Comparison: Day 56p-value: 0.44695% CI: [0.1, 1.8]ANOVA
Comparison: Day 56p-value: 0.29295% CI: [0.6, 11.9]ANOVA
Comparison: Day 56p-value: 0.18495% CI: [0.1, 1.4]ANOVA
Comparison: Day 56p-value: 0.722995% CI: [0.4, 9.2]ANOVA
Comparison: Day 56p-value: 0.005295% CI: [1.5, 28.6]ANOVA
Comparison: Day 182p-value: 0.977795% CI: [0.2, 3]ANOVA
Comparison: Day 182p-value: 0.981295% CI: [0.3, 5.3]ANOVA
Comparison: Day 182p-value: 0.997995% CI: [0.3, 4.5]ANOVA
Comparison: Day 182p-value: 0.58895% CI: [0.5, 7.9]ANOVA
Comparison: Day 182p-value: 0.797395% CI: [0.4, 7]ANOVA
Comparison: Day 182p-value: 0.899295% CI: [0.4, 6]ANOVA
Comparison: Day 182p-value: 0.260295% CI: [0.7, 10.4]ANOVA
Comparison: Day 182p-value: 0.999195% CI: [0.2, 3.6]ANOVA
Comparison: Day 182p-value: 0.902895% CI: [0.4, 6.2]ANOVA
Comparison: Day 182p-value: 0.776195% CI: [0.4, 6.8]ANOVA
Comparison: Day 365p-value: 0.783395% CI: [0.2, 2.1]ANOVA
Comparison: Day 365p-value: 0.991595% CI: [0.2, 2.9]ANOVA
Comparison: Day 365p-value: 0.99895% CI: [0.3, 3]ANOVA
Comparison: Day 365p-value: 0.90995% CI: [0.4, 4.9]ANOVA
Comparison: Day 365p-value: 0.965195% CI: [0.4, 4.7]ANOVA
Comparison: Day 365p-value: 0.911295% CI: [0.4, 4.7]ANOVA
Comparison: Day 365p-value: 0.25795% CI: [0.7, 7.8]ANOVA
Comparison: Day 365p-value: 0.999995% CI: [0.3, 3.8]ANOVA
Comparison: Day 365p-value: 0.695395% CI: [0.5, 6.2]ANOVA
Comparison: Day 365p-value: 0.752395% CI: [0.5, 5.4]ANOVA
Secondary
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.
Time frame: Up to Day 365
Population: The analysis population included all randomized participants who received at least one investigational medicinal product (IMP) administration and had no major protocol deviation that could have had an impact on their immune response.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|---|
| Group A: Two MV-CHIK Lyophilized Low Dose | Geometric Mean Titer of Anti-Chikungunya Antibodies Determined by Enzyme Linked Immunosorbent Assay | Day 182 | 15.6 Titer | Standard Deviation 112.9 |
| Group A: Two MV-CHIK Lyophilized Low Dose | Geometric Mean Titer of Anti-Chikungunya Antibodies Determined by Enzyme Linked Immunosorbent Assay | Day 0 | 7.4 Titer | Standard Deviation 0 |
| Group A: Two MV-CHIK Lyophilized Low Dose | Geometric Mean Titer of Anti-Chikungunya Antibodies Determined by Enzyme Linked Immunosorbent Assay | Day 365 | 11.9 Titer | Standard Deviation 112.8 |
| Group A: Two MV-CHIK Lyophilized Low Dose | Geometric Mean Titer of Anti-Chikungunya Antibodies Determined by Enzyme Linked Immunosorbent Assay | Day 28 | 9.7 Titer | Standard Deviation 46.83 |
| Group A: Two MV-CHIK Lyophilized Low Dose | Geometric Mean Titer of Anti-Chikungunya Antibodies Determined by Enzyme Linked Immunosorbent Assay | Day 56 | 54.3 Titer | Standard Deviation 306.39 |
| Group B: Two MV-CHIK Liquid Frozen Low Dose | Geometric Mean Titer of Anti-Chikungunya Antibodies Determined by Enzyme Linked Immunosorbent Assay | Day 182 | 26.9 Titer | Standard Deviation 3304.35 |
| Group B: Two MV-CHIK Liquid Frozen Low Dose | Geometric Mean Titer of Anti-Chikungunya Antibodies Determined by Enzyme Linked Immunosorbent Assay | Day 56 | 90.0 Titer | Standard Deviation 4369.43 |
| Group B: Two MV-CHIK Liquid Frozen Low Dose | Geometric Mean Titer of Anti-Chikungunya Antibodies Determined by Enzyme Linked Immunosorbent Assay | Day 28 | 17.8 Titer | Standard Deviation 4009.38 |
| Group B: Two MV-CHIK Liquid Frozen Low Dose | Geometric Mean Titer of Anti-Chikungunya Antibodies Determined by Enzyme Linked Immunosorbent Assay | Day 365 | 23.8 Titer | Standard Deviation 3087.93 |
| Group B: Two MV-CHIK Liquid Frozen Low Dose | Geometric Mean Titer of Anti-Chikungunya Antibodies Determined by Enzyme Linked Immunosorbent Assay | Day 0 | 14.5 Titer | Standard Deviation 3907.5 |
| Group C: Two MV-CHIK Liquid Low Dose Stabilizing and Protecting Solution (SPS®) | Geometric Mean Titer of Anti-Chikungunya Antibodies Determined by Enzyme Linked Immunosorbent Assay | Day 56 | 54.7 Titer | Standard Deviation 112.29 |
| Group C: Two MV-CHIK Liquid Low Dose Stabilizing and Protecting Solution (SPS®) | Geometric Mean Titer of Anti-Chikungunya Antibodies Determined by Enzyme Linked Immunosorbent Assay | Day 0 | 7.4 Titer | Standard Deviation 0 |
| Group C: Two MV-CHIK Liquid Low Dose Stabilizing and Protecting Solution (SPS®) | Geometric Mean Titer of Anti-Chikungunya Antibodies Determined by Enzyme Linked Immunosorbent Assay | Day 28 | 8.1 Titer | Standard Deviation 3.69 |
| Group C: Two MV-CHIK Liquid Low Dose Stabilizing and Protecting Solution (SPS®) | Geometric Mean Titer of Anti-Chikungunya Antibodies Determined by Enzyme Linked Immunosorbent Assay | Day 182 | 16.3 Titer | Standard Deviation 92.58 |
| Group C: Two MV-CHIK Liquid Low Dose Stabilizing and Protecting Solution (SPS®) | Geometric Mean Titer of Anti-Chikungunya Antibodies Determined by Enzyme Linked Immunosorbent Assay | Day 365 | 15.8 Titer | Standard Deviation 75.39 |
| Group D: Two MV-CHIK Liquid Frozen High Dose | Geometric Mean Titer of Anti-Chikungunya Antibodies Determined by Enzyme Linked Immunosorbent Assay | Day 365 | 18.9 Titer | Standard Deviation 18.52 |
| Group D: Two MV-CHIK Liquid Frozen High Dose | Geometric Mean Titer of Anti-Chikungunya Antibodies Determined by Enzyme Linked Immunosorbent Assay | Day 0 | 7.4 Titer | Standard Deviation 0 |
| Group D: Two MV-CHIK Liquid Frozen High Dose | Geometric Mean Titer of Anti-Chikungunya Antibodies Determined by Enzyme Linked Immunosorbent Assay | Day 182 | 26.5 Titer | Standard Deviation 17.36 |
| Group D: Two MV-CHIK Liquid Frozen High Dose | Geometric Mean Titer of Anti-Chikungunya Antibodies Determined by Enzyme Linked Immunosorbent Assay | Day 56 | 171.4 Titer | Standard Deviation 307.41 |
| Group D: Two MV-CHIK Liquid Frozen High Dose | Geometric Mean Titer of Anti-Chikungunya Antibodies Determined by Enzyme Linked Immunosorbent Assay | Day 28 | 14.1 Titer | Standard Deviation 28.47 |
| Group E: One MV-CHIK Liquid Frozen High Dose | Geometric Mean Titer of Anti-Chikungunya Antibodies Determined by Enzyme Linked Immunosorbent Assay | Day 56 | 9.8 Titer | Standard Deviation 7.69 |
| Group E: One MV-CHIK Liquid Frozen High Dose | Geometric Mean Titer of Anti-Chikungunya Antibodies Determined by Enzyme Linked Immunosorbent Assay | Day 182 | 8.1 Titer | Standard Deviation 4.66 |
| Group E: One MV-CHIK Liquid Frozen High Dose | Geometric Mean Titer of Anti-Chikungunya Antibodies Determined by Enzyme Linked Immunosorbent Assay | Day 0 | 7.4 Titer | Standard Deviation 0 |
| Group E: One MV-CHIK Liquid Frozen High Dose | Geometric Mean Titer of Anti-Chikungunya Antibodies Determined by Enzyme Linked Immunosorbent Assay | Day 365 | 9.4 Titer | Standard Deviation 10.01 |
| Group E: One MV-CHIK Liquid Frozen High Dose | Geometric Mean Titer of Anti-Chikungunya Antibodies Determined by Enzyme Linked Immunosorbent Assay | Day 28 | 13.1 Titer | Standard Deviation 8.74 |
Comparison: Day 0p-value: 0.526395% CI: [0.1, 1.7]ANOVA
Comparison: Day 0p-value: 195% CI: [0.3, 3.5]ANOVA
Comparison: Day 0p-value: 195% CI: [0.3, 3.4]ANOVA
Comparison: Day 0p-value: 195% CI: [0.3, 3.4]ANOVA
Comparison: Day 0p-value: 0.5595% CI: [0.6, 7]ANOVA
Comparison: Day 0p-value: 0.526395% CI: [0.6, 6.7]ANOVA
Comparison: Day 0p-value: 0.526395% CI: [0.6, 6.7]ANOVA
Comparison: Day 0p-value: 195% CI: [0.3, 3.5]ANOVA
Comparison: Day 0p-value: 195% CI: [0.3, 3.5]ANOVA
Comparison: Day 0p-value: 195% CI: [0.3, 3.4]ANOVA
Comparison: Day 28p-value: 0.770895% CI: [0.1, 2.4]ANOVA
Comparison: Day 28p-value: 0.996695% CI: [0.3, 5.4]ANOVA
Comparison: Day 28p-value: 0.950395% CI: [0.2, 3]ANOVA
Comparison: Day 28p-value: 0.979195% CI: [0.2, 3.2]ANOVA
Comparison: Day 28p-value: 0.573995% CI: [0.5, 9.8]ANOVA
Comparison: Day 28p-value: 0.991895% CI: [0.3, 5.4]ANOVA
Comparison: Day 28p-value: 0.974895% CI: [0.3, 5.9]ANOVA
Comparison: Day 28p-value: 0.82795% CI: [0.1, 2.6]ANOVA
Comparison: Day 28p-value: 0.89395% CI: [0.1, 2.8]ANOVA
Comparison: Day 28p-value: 0.999995% CI: [0.3, 4.7]ANOVA
Comparison: Day 56p-value: 0.910595% CI: [0.1, 3.2]ANOVA
Comparison: Day 56p-value: 195% CI: [0.2, 5.5]ANOVA
Comparison: Day 56p-value: 0.304795% CI: [0.1, 1.7]ANOVA
Comparison: Day 56p-value: 0.042395% CI: [1, 29.2]ANOVA
Comparison: Day 56p-value: 0.921395% CI: [0.3, 9.1]ANOVA
Comparison: Day 56p-value: 0.809295% CI: [0.1, 2.8]ANOVA
Comparison: Day 56p-value: 0.00495% CI: [1.7, 48.5]ANOVA
Comparison: Day 56p-value: 0.334795% CI: [0.1, 1.8]ANOVA
Comparison: Day 56p-value: 0.048895% CI: [1, 30.7]ANOVA
Comparison: Day 56p-value: 0.000195% CI: [3.3, 92.2]ANOVA
Comparison: Day 182p-value: 0.883195% CI: [0.1, 3]ANOVA
Comparison: Day 182p-value: 195% CI: [0.2, 5.2]ANOVA
Comparison: Day 182p-value: 0.891695% CI: [0.1, 3.1]ANOVA
Comparison: Day 182p-value: 0.79495% CI: [0.4, 9.9]ANOVA
Comparison: Day 182p-value: 0.916995% CI: [0.3, 8.9]ANOVA
Comparison: Day 182p-value: 195% CI: [0.2, 5.2]ANOVA
Comparison: Day 182p-value: 0.256395% CI: [0.6, 17.1]ANOVA
Comparison: Day 182p-value: 0.923795% CI: [0.1, 3.3]ANOVA
Comparison: Day 182p-value: 0.770895% CI: [0.4, 10.8]ANOVA
Comparison: Day 182p-value: 0.266195% CI: [0.6, 16.9]ANOVA
Comparison: Day 365p-value: 0.761495% CI: [0.1, 2.6]ANOVA
Comparison: Day 365p-value: 0.990595% CI: [0.1, 4.3]ANOVA
Comparison: Day 365p-value: 0.93395% CI: [0.1, 3.3]ANOVA
Comparison: Day 365p-value: 0.994595% CI: [0.2, 6.7]ANOVA
Comparison: Day 365p-value: 0.959995% CI: [0.3, 8.4]ANOVA
Comparison: Day 365p-value: 0.994295% CI: [0.2, 6.4]ANOVA
Comparison: Day 365p-value: 0.493295% CI: [0.5, 12.9]ANOVA
Comparison: Day 365p-value: 0.998395% CI: [0.2, 4.6]ANOVA
Comparison: Day 365p-value: 0.911295% CI: [0.3, 9.3]ANOVA
Comparison: Day 365p-value: 0.743195% CI: [0.4, 10.2]ANOVA
Secondary
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.
Time frame: Up to Day 56
Population: The analysis population included all randomized participants who received at least one investigational medicinal product (IMP) administration and had no major protocol deviation that could have had an impact on their immune response.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|---|
| Group A: Two MV-CHIK Lyophilized Low Dose | Geometric Mean Titer of Anti-Measles Antibodies Determined by ELISA | Day 28 | 1250.8 Titer | Standard Deviation 1629.35 |
| Group A: Two MV-CHIK Lyophilized Low Dose | Geometric Mean Titer of Anti-Measles Antibodies Determined by ELISA | Day 0 | 711.6 Titer | Standard Deviation 1764.77 |
| Group A: Two MV-CHIK Lyophilized Low Dose | Geometric Mean Titer of Anti-Measles Antibodies Determined by ELISA | Day 56 | 1476.8 Titer | Standard Deviation 1672.1 |
| Group B: Two MV-CHIK Liquid Frozen Low Dose | Geometric Mean Titer of Anti-Measles Antibodies Determined by ELISA | Day 0 | 482.1 Titer | Standard Deviation 1009.4 |
| Group B: Two MV-CHIK Liquid Frozen Low Dose | Geometric Mean Titer of Anti-Measles Antibodies Determined by ELISA | Day 56 | 1158.6 Titer | Standard Deviation 1019.59 |
| Group B: Two MV-CHIK Liquid Frozen Low Dose | Geometric Mean Titer of Anti-Measles Antibodies Determined by ELISA | Day 28 | 1120.3 Titer | Standard Deviation 849.01 |
| Group C: Two MV-CHIK Liquid Low Dose Stabilizing and Protecting Solution (SPS®) | Geometric Mean Titer of Anti-Measles Antibodies Determined by ELISA | Day 0 | 750.2 Titer | Standard Deviation 1580.9 |
| Group C: Two MV-CHIK Liquid Low Dose Stabilizing and Protecting Solution (SPS®) | Geometric Mean Titer of Anti-Measles Antibodies Determined by ELISA | Day 28 | 1207.7 Titer | Standard Deviation 1642.33 |
| Group C: Two MV-CHIK Liquid Low Dose Stabilizing and Protecting Solution (SPS®) | Geometric Mean Titer of Anti-Measles Antibodies Determined by ELISA | Day 56 | 1355.4 Titer | Standard Deviation 1818.08 |
| Group D: Two MV-CHIK Liquid Frozen High Dose | Geometric Mean Titer of Anti-Measles Antibodies Determined by ELISA | Day 56 | 3009.80 Titer | Standard Deviation 1355.67 |
| Group D: Two MV-CHIK Liquid Frozen High Dose | Geometric Mean Titer of Anti-Measles Antibodies Determined by ELISA | Day 0 | 731.0 Titer | Standard Deviation 1612.98 |
| Group D: Two MV-CHIK Liquid Frozen High Dose | Geometric Mean Titer of Anti-Measles Antibodies Determined by ELISA | Day 28 | 2246.4 Titer | Standard Deviation 1515.4 |
| Group E: One MV-CHIK Liquid Frozen High Dose | Geometric Mean Titer of Anti-Measles Antibodies Determined by ELISA | Day 28 | 2116.2 Titer | Standard Deviation 1527.25 |
| Group E: One MV-CHIK Liquid Frozen High Dose | Geometric Mean Titer of Anti-Measles Antibodies Determined by ELISA | Day 0 | 888.4 Titer | Standard Deviation 1560.14 |
| Group E: One MV-CHIK Liquid Frozen High Dose | Geometric Mean Titer of Anti-Measles Antibodies Determined by ELISA | Day 56 | 2011.8 Titer | Standard Deviation 1852.26 |
Secondary
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.
Time frame: Up to Day 56
Population: The analysis population included all participants who entered in the study and received at least one IMP administration. All analyses based on the safety population were carried out using the actual treatment received.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Group A: Two MV-CHIK Lyophilized Low Dose | Number of Participants With Abnormal Laboratory Chemistry Values Reported as an AE | 0 Participants |
| Group B: Two MV-CHIK Liquid Frozen Low Dose | Number of Participants With Abnormal Laboratory Chemistry Values Reported as an AE | 1 Participants |
| Group C: Two MV-CHIK Liquid Low Dose Stabilizing and Protecting Solution (SPS®) | Number of Participants With Abnormal Laboratory Chemistry Values Reported as an AE | 0 Participants |
| Group D: Two MV-CHIK Liquid Frozen High Dose | Number of Participants With Abnormal Laboratory Chemistry Values Reported as an AE | 1 Participants |
| Group E: One MV-CHIK Liquid Frozen High Dose | Number of Participants With Abnormal Laboratory Chemistry Values Reported as an AE | 0 Participants |
Secondary
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.
Time frame: Up to Day 56
Population: The analysis population included all participants who entered in the study and received at least one IMP administration. All analyses based on the safety population were carried out using the actual treatment received.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Group A: Two MV-CHIK Lyophilized Low Dose | Number of Participants With Abnormal Laboratory Hematology Values Reported as an AE | 1 Participants |
| Group B: Two MV-CHIK Liquid Frozen Low Dose | Number of Participants With Abnormal Laboratory Hematology Values Reported as an AE | 0 Participants |
| Group C: Two MV-CHIK Liquid Low Dose Stabilizing and Protecting Solution (SPS®) | Number of Participants With Abnormal Laboratory Hematology Values Reported as an AE | 0 Participants |
| Group D: Two MV-CHIK Liquid Frozen High Dose | Number of Participants With Abnormal Laboratory Hematology Values Reported as an AE | 0 Participants |
| Group E: One MV-CHIK Liquid Frozen High Dose | Number of Participants With Abnormal Laboratory Hematology Values Reported as an AE | 4 Participants |
Secondary
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.
Time frame: Up to Day 56
Population: The analysis population included a subset of all randomized participants who received at least one investigational medicinal product (IMP) administration and had no major protocol deviation that could have had an impact on their immune response. Based on the protocol, only participants in subset Treatment Group D (MV-CHIK liquid frozen high dose formulation) were analyzed for t-cell response.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Group A: Two MV-CHIK Lyophilized Low Dose | Percentage of CD4+CD137+ Chikungunya Virus Specific T-Cells | CD4+CD137+ (Day 0) | 0.0528 Percentage of t-cells | Standard Deviation 0.0509 |
| Group A: Two MV-CHIK Lyophilized Low Dose | Percentage of CD4+CD137+ Chikungunya Virus Specific T-Cells | CD4+CD137+ (Day 14) | 0.1595 Percentage of t-cells | Standard Deviation 0.2105 |
| Group A: Two MV-CHIK Lyophilized Low Dose | Percentage of CD4+CD137+ Chikungunya Virus Specific T-Cells | CD4+CD137+ (Day 28) | 0.1492 Percentage of t-cells | Standard Deviation 0.0932 |
| Group A: Two MV-CHIK Lyophilized Low Dose | Percentage of CD4+CD137+ Chikungunya Virus Specific T-Cells | CD4+CD137+ (Day 42) | 0.3484 Percentage of t-cells | Standard Deviation 0.3428 |
| Group A: Two MV-CHIK Lyophilized Low Dose | Percentage of CD4+CD137+ Chikungunya Virus Specific T-Cells | CD4+CD137+ (Day 56) | 0.3994 Percentage of t-cells | Standard Deviation 0.2713 |
Secondary
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.
Time frame: Up to Day 56
Population: The analysis population included a subset of all randomized participants who received at least one investigational medicinal product (IMP) administration and had no major protocol deviation that could have had an impact on their immune response. Based on the protocol, a subset of the participants in treatment group D (MV-CHIK liquid frozen high dose formulation) were analyzed for t-cell response.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Group A: Two MV-CHIK Lyophilized Low Dose | Percentage of CD4+CD69+CD137+ Chikungunya Virus Specific T-Cells | CD4+CD69+CD137+ (Day 0) | 0.0061 Percentage of t-cells | Standard Deviation 0.0112 |
| Group A: Two MV-CHIK Lyophilized Low Dose | Percentage of CD4+CD69+CD137+ Chikungunya Virus Specific T-Cells | CD4+CD69+CD137+ (Day 14) | 0.0174 Percentage of t-cells | Standard Deviation 0.0313 |
| Group A: Two MV-CHIK Lyophilized Low Dose | Percentage of CD4+CD69+CD137+ Chikungunya Virus Specific T-Cells | CD4+CD69+CD137+ (Day 28) | 0.0120 Percentage of t-cells | Standard Deviation 0.0168 |
| Group A: Two MV-CHIK Lyophilized Low Dose | Percentage of CD4+CD69+CD137+ Chikungunya Virus Specific T-Cells | CD4+CD69+CD137+ (Day 42) | 0.0317 Percentage of t-cells | Standard Deviation 0.0438 |
| Group A: Two MV-CHIK Lyophilized Low Dose | Percentage of CD4+CD69+CD137+ Chikungunya Virus Specific T-Cells | CD4+CD69+CD137+ (Day 56) | 0.0393 Percentage of t-cells | Standard Deviation 0.0476 |
Secondary
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.
Time frame: Up to Day 56
Population: The analysis population included a subset of all randomized participants who received at least one investigational medicinal product (IMP) administration and had no major protocol deviation that could have had an impact on their immune response. Based on the protocol, only participants in subset Treatment Group D (MV-CHIK liquid frozen high dose formulation) were analyzed for t-cell response.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Group A: Two MV-CHIK Lyophilized Low Dose | Percentage of CD4+CD69+ Chikungunya Virus Specific T-Cells | CD4+CD69+ (Day 0) | 0.0194 Percentage of t-cells | Standard Deviation 0.0446 |
| Group A: Two MV-CHIK Lyophilized Low Dose | Percentage of CD4+CD69+ Chikungunya Virus Specific T-Cells | CD4+CD69+ (Day 14) | 0.1430 Percentage of t-cells | Standard Deviation 0.1589 |
| Group A: Two MV-CHIK Lyophilized Low Dose | Percentage of CD4+CD69+ Chikungunya Virus Specific T-Cells | CD4+CD69+ (Day 28) | 0.1077 Percentage of t-cells | Standard Deviation 0.206 |
| Group A: Two MV-CHIK Lyophilized Low Dose | Percentage of CD4+CD69+ Chikungunya Virus Specific T-Cells | CD4+CD69+ (Day 42) | 0.2050 Percentage of t-cells | Standard Deviation 0.2316 |
| Group A: Two MV-CHIK Lyophilized Low Dose | Percentage of CD4+CD69+ Chikungunya Virus Specific T-Cells | CD4+CD69+ (Day 56) | 0.1935 Percentage of t-cells | Standard Deviation 0.2036 |
Secondary
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.
Time frame: Up to Day 56
Population: The analysis population included a subset of all randomized participants who received at least one investigational medicinal product (IMP) administration and had no major protocol deviation that could have had an impact on their immune response. Based on the protocol, only participants in subset Treatment Group D (MV-CHIK liquid frozen high dose formulation) were analyzed for t-cell response.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Group A: Two MV-CHIK Lyophilized Low Dose | Percentage of CD4+CD69+OX40+ Chikungunya Virus Specific T-Cells | CD4+CD69+OX40+ (Day 0) | 0.0033 Percentage of t-cells | Standard Deviation 0.0048 |
| Group A: Two MV-CHIK Lyophilized Low Dose | Percentage of CD4+CD69+OX40+ Chikungunya Virus Specific T-Cells | CD4+CD69+OX40+ (Day 14) | 0.0265 Percentage of t-cells | Standard Deviation 0.0522 |
| Group A: Two MV-CHIK Lyophilized Low Dose | Percentage of CD4+CD69+OX40+ Chikungunya Virus Specific T-Cells | CD4+CD69+OX40+ (Day 28) | 0.0095 Percentage of t-cells | Standard Deviation 0.007 |
| Group A: Two MV-CHIK Lyophilized Low Dose | Percentage of CD4+CD69+OX40+ Chikungunya Virus Specific T-Cells | CD4+CD69+OX40+ (Day 42) | 0.0267 Percentage of t-cells | Standard Deviation 0.0408 |
| Group A: Two MV-CHIK Lyophilized Low Dose | Percentage of CD4+CD69+OX40+ Chikungunya Virus Specific T-Cells | CD4+CD69+OX40+ (Day 56) | 0.0337 Percentage of t-cells | Standard Deviation 0.0386 |
Secondary
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.
Time frame: Up to Day 56
Population: The analysis population included a subset of all randomized participants who received at least one investigational medicinal product (IMP) administration and had no major protocol deviation that could have had an impact on their immune response. Based on the protocol, only participants in subset Treatment Group D (MV-CHIK liquid frozen high dose formulation) were analyzed for t-cell response.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Group A: Two MV-CHIK Lyophilized Low Dose | Percentage of CD4+OX40+ Chikungunya Virus Specific T-Cells | CD4+OX40+ (Day 0) | 0.0062 Percentage of t-cells | Standard Deviation 0.0158 |
| Group A: Two MV-CHIK Lyophilized Low Dose | Percentage of CD4+OX40+ Chikungunya Virus Specific T-Cells | CD4+OX40+ (Day 14) | 0.0745 Percentage of t-cells | Standard Deviation 0.1007 |
| Group A: Two MV-CHIK Lyophilized Low Dose | Percentage of CD4+OX40+ Chikungunya Virus Specific T-Cells | CD4+OX40+ (Day 28) | 0.0269 Percentage of t-cells | Standard Deviation 0.028 |
| Group A: Two MV-CHIK Lyophilized Low Dose | Percentage of CD4+OX40+ Chikungunya Virus Specific T-Cells | CD4+OX40+ (Day 42) | 0.0492 Percentage of t-cells | Standard Deviation 0.1012 |
| Group A: Two MV-CHIK Lyophilized Low Dose | Percentage of CD4+OX40+ Chikungunya Virus Specific T-Cells | CD4+OX40+ (Day 56) | 0.0698 Percentage of t-cells | Standard Deviation 0.0997 |
Secondary
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.
Time frame: Up to Day 56
Population: The analysis population included a subset of all randomized participants who received at least one investigational medicinal product (IMP) administration and had no major protocol deviation that could have had an impact on their immune response. Based on the protocol, only participants in subset Treatment Group D (MV-CHIK liquid frozen high dose formulation) were analyzed for t-cell response.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Group A: Two MV-CHIK Lyophilized Low Dose | Percentage of CD8+CD137+ Chikungunya Virus Specific T-Cells | CD8+CD137+ (Day 0) | 0.0194 Percentage of t-cells | Standard Deviation 0.0334 |
| Group A: Two MV-CHIK Lyophilized Low Dose | Percentage of CD8+CD137+ Chikungunya Virus Specific T-Cells | CD8+CD137+ (Day 14) | 0.0294 Percentage of t-cells | Standard Deviation 0.0366 |
| Group A: Two MV-CHIK Lyophilized Low Dose | Percentage of CD8+CD137+ Chikungunya Virus Specific T-Cells | CD8+CD137+ (Day 28) | 0.0224 Percentage of t-cells | Standard Deviation 0.0377 |
| Group A: Two MV-CHIK Lyophilized Low Dose | Percentage of CD8+CD137+ Chikungunya Virus Specific T-Cells | CD8+CD137+ (Day 42) | 0.0341 Percentage of t-cells | Standard Deviation 0.0595 |
| Group A: Two MV-CHIK Lyophilized Low Dose | Percentage of CD8+CD137+ Chikungunya Virus Specific T-Cells | CD8+CD137+ (Day 56) | 0.0607 Percentage of t-cells | Standard Deviation 0.0557 |
Secondary
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.
Time frame: Up to Day 56
Population: The analysis population included a subset of all randomized participants who received at least one investigational medicinal product (IMP) administration and had no major protocol deviation that could have had an impact on their immune response. Based on the protocol, only participants in subset Treatment Group D (MV-CHIK liquid frozen high dose formulation) were analyzed for t-cell response.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Group A: Two MV-CHIK Lyophilized Low Dose | Percentage of CD8+CD69+CD137+ Chikungunya Virus Specific T-Cells | CD8+CD69+CD137+ (Day 0) | 0.0005 Percentage of t-cells | Standard Deviation 0.0018 |
| Group A: Two MV-CHIK Lyophilized Low Dose | Percentage of CD8+CD69+CD137+ Chikungunya Virus Specific T-Cells | CD8+CD69+CD137+ (Day 14) | 0.0139 Percentage of t-cells | Standard Deviation 0.0229 |
| Group A: Two MV-CHIK Lyophilized Low Dose | Percentage of CD8+CD69+CD137+ Chikungunya Virus Specific T-Cells | CD8+CD69+CD137+ (Day 28) | 0.0184 Percentage of t-cells | Standard Deviation 0.0454 |
| Group A: Two MV-CHIK Lyophilized Low Dose | Percentage of CD8+CD69+CD137+ Chikungunya Virus Specific T-Cells | CD8+CD69+CD137+ (Day 42) | 0.0148 Percentage of t-cells | Standard Deviation 0.0171 |
| Group A: Two MV-CHIK Lyophilized Low Dose | Percentage of CD8+CD69+CD137+ Chikungunya Virus Specific T-Cells | CD8+CD69+CD137+ (Day 56) | 0.0380 Percentage of t-cells | Standard Deviation 0.0392 |
Secondary
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.
Time frame: Up to Day 56
Population: The analysis population included a subset of all randomized participants who received at least one investigational medicinal product (IMP) administration and had no major protocol deviation that could have had an impact on their immune response. Based on the protocol, only participants in subset Treatment Group D (MV-CHIK liquid frozen high dose formulation) were analyzed for t-cell response.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Group A: Two MV-CHIK Lyophilized Low Dose | Percentage of CD8+CD69+ Chikungunya Virus Specific T-Cells | CD8+CD69+ (Day 0) | 0.1919 Percentage of t-cells | Standard Deviation 0.2329 |
| Group A: Two MV-CHIK Lyophilized Low Dose | Percentage of CD8+CD69+ Chikungunya Virus Specific T-Cells | CD8+CD69+ (Day 14) | 0.3319 Percentage of t-cells | Standard Deviation 0.6046 |
| Group A: Two MV-CHIK Lyophilized Low Dose | Percentage of CD8+CD69+ Chikungunya Virus Specific T-Cells | CD8+CD69+ (Day 28) | 0.4242 Percentage of t-cells | Standard Deviation 0.633 |
| Group A: Two MV-CHIK Lyophilized Low Dose | Percentage of CD8+CD69+ Chikungunya Virus Specific T-Cells | CD8+CD69+ (Day 42) | 0.1961 Percentage of t-cells | Standard Deviation 0.2496 |
| Group A: Two MV-CHIK Lyophilized Low Dose | Percentage of CD8+CD69+ Chikungunya Virus Specific T-Cells | CD8+CD69+ (Day 56) | 0.2375 Percentage of t-cells | Standard Deviation 0.2902 |
Secondary
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.
Time frame: Up to Day 56
Population: The analysis population included all participants who entered in the study and received at least one IMP administration. All analyses based on the safety population were carried out using the actual treatment received.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Group A: Two MV-CHIK Lyophilized Low Dose | Percentage of Participants With at Least 1 Serious Adverse Event | 0.0 Percentage of Participants |
| Group B: Two MV-CHIK Liquid Frozen Low Dose | Percentage of Participants With at Least 1 Serious Adverse Event | 0.0 Percentage of Participants |
| Group C: Two MV-CHIK Liquid Low Dose Stabilizing and Protecting Solution (SPS®) | Percentage of Participants With at Least 1 Serious Adverse Event | 0.0 Percentage of Participants |
| Group D: Two MV-CHIK Liquid Frozen High Dose | Percentage of Participants With at Least 1 Serious Adverse Event | 0.0 Percentage of Participants |
| Group E: One MV-CHIK Liquid Frozen High Dose | Percentage of Participants With at Least 1 Serious Adverse Event | 0.0 Percentage of Participants |
Secondary
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.
Time frame: Up to Day 56
Population: The analysis population included all participants who entered in the study and received at least one IMP administration. All analyses based on the safety population were carried out using the actual treatment received.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Group A: Two MV-CHIK Lyophilized Low Dose | Percentage of Participants With Solicited and Unsolicited Adverse Events | 83.3 Percentage of Participants |
| Group B: Two MV-CHIK Liquid Frozen Low Dose | Percentage of Participants With Solicited and Unsolicited Adverse Events | 91.7 Percentage of Participants |
| Group C: Two MV-CHIK Liquid Low Dose Stabilizing and Protecting Solution (SPS®) | Percentage of Participants With Solicited and Unsolicited Adverse Events | 58.3 Percentage of Participants |
| Group D: Two MV-CHIK Liquid Frozen High Dose | Percentage of Participants With Solicited and Unsolicited Adverse Events | 83.3 Percentage of Participants |
| Group E: One MV-CHIK Liquid Frozen High Dose | Percentage of Participants With Solicited and Unsolicited Adverse Events | 91.7 Percentage of Participants |