Trial Outcomes & Findings for Study of a Live Attenuated Chikungunya Vaccine in a Previously Epidemic Area (NCT NCT03101111)

Last Updated: 2021-07-19

Results Overview

Number of solicited and unsolicited adverse events and number of grade 2 and higher solicited and unsolicited adverse events including clinically significant abnormal safety laboratory results, vital signs, and physical examination findings in previously exposed versus unexposed individuals.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

34 participants

Primary outcome timeframe

Throughout the whole study period (until day 392 after first dose)

Results posted on

2021-07-19

Participant Flow

Participant milestones

Participant milestones
Measure	MV-CHIK and Placebo Subjects will receive two injections on study day 0 and one injection on day 28. On both days they will receive a 5E+05 (+/- 0.5 log) TCID50 intramuscularly in the deltoid muscle of one arm. On day 0 they will receive a dummy injection of placebo (physiological saline) subcutaneously in the contralateral arm. MV-CHIK: Lyophilized, life attenuated, measles vectored Chikungunya vaccine; 5E+05 TCID50 (+/- 0.5 log) per dose	MMR-vaccine and Placebo Subjects will receive two injections on study day 0 and one injection on day 28. On both days they will receive dummy injections of placebo (physiological saline) in the deltoid muscle of one arm. On day 0 they will receive MMR-vaccine subcutaneously in the contralateral arm. MMR-vaccine: Lyophilized mixture of life attenuated Measles, Mumps, and Rubella viruses; 1000, 12500, and 1000, respectively, TCID50 per dose
Overall Study STARTED	26	8
Overall Study COMPLETED	23	7
Overall Study NOT COMPLETED	3	1

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Study of a Live Attenuated Chikungunya Vaccine in a Previously Epidemic Area

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	MV-CHIK-Placebo n=26 Participants 2 MV-CHIK injections (day 0+day 28); 1 Placebo injection (day 0)	MMR-Placebo n=8 Participants 2 Placebo injections (day 0+day 28); 1 MMR injection (day 0)	Total n=34 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	26 Participants n=5 Participants	8 Participants n=7 Participants	34 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Continuous	33.2 years STANDARD_DEVIATION 8.27 • n=5 Participants	33.2 years STANDARD_DEVIATION 8.27 • n=7 Participants	33.2 years STANDARD_DEVIATION 8.27 • n=5 Participants
Sex: Female, Male Female	11 Participants n=5 Participants	3 Participants n=7 Participants	14 Participants n=5 Participants
Sex: Female, Male Male	15 Participants n=5 Participants	5 Participants n=7 Participants	20 Participants n=5 Participants
Race/Ethnicity, Customized Hispanic or Latino	26 Participants n=5 Participants	8 Participants n=7 Participants	34 Participants n=5 Participants
Region of Enrollment Puerto Rico	26 Participants n=5 Participants	8 Participants n=7 Participants	34 Participants n=5 Participants

PRIMARY outcome

Timeframe: Throughout the whole study period (until day 392 after first dose)

Population: The intent-to-treat (ITT) population included all subjects who were randomized and received at least 1 dose of IVP. The ITT population was used for the safety analyses. Subjects were reported based on actual vaccine received.

Outcome measures

Outcome measures
Measure	MV-CHIK-Placebo/Seropositive n=12 Participants baseline seropositive cohort; received MV-CHIK-Placebo	MV-CHIK-Placebo/Seronegative n=14 Participants baseline seronegative cohort; received MV-CHIK-Placebo	MMR-Placebo/Seropositive n=4 Participants baseline seropositive cohort; received MMR-Placebo	MMR-Placebo/Seronegative n=4 Participants baseline seronegative cohort; received MMR-Placebo
Number of Participants With AEs and Abnormal Lab Values, Vital Signs, and PE Findings All AEs	11 subjects	13 subjects	4 subjects	4 subjects
Number of Participants With AEs and Abnormal Lab Values, Vital Signs, and PE Findings Severity: Severe	0 subjects	2 subjects	0 subjects	1 subjects
Number of Participants With AEs and Abnormal Lab Values, Vital Signs, and PE Findings Severity: Moderate	4 subjects	6 subjects	0 subjects	1 subjects
Number of Participants With AEs and Abnormal Lab Values, Vital Signs, and PE Findings Severity: Mild	10 subjects	13 subjects	4 subjects	4 subjects
Number of Participants With AEs and Abnormal Lab Values, Vital Signs, and PE Findings IVP related AEs	2 subjects	1 subjects	1 subjects	0 subjects
Number of Participants With AEs and Abnormal Lab Values, Vital Signs, and PE Findings (IVP Rel.AEs) Severity: Severe	0 subjects	0 subjects	0 subjects	0 subjects
Number of Participants With AEs and Abnormal Lab Values, Vital Signs, and PE Findings (IVP Rel.AEs) Severity: Moderate	1 subjects	0 subjects	0 subjects	0 subjects
Number of Participants With AEs and Abnormal Lab Values, Vital Signs, and PE Findings (IVP Rel.AEs) Severity: Mild	1 subjects	1 subjects	1 subjects	0 subjects
Number of Participants With AEs and Abnormal Lab Values, Vital Signs, and PE Findings SAEs	0 subjects	0 subjects	0 subjects	0 subjects

SECONDARY outcome

Timeframe: Days 0, 28, 56, 168, 280, and 392

Population: The per protocol (PP) population was a subset of the ITT population that included subjects who received both doses of IVP, had at least 1 post-vaccination immunogenicity assessment, and did not experience a protocol deviation that could have affected their evaluation for immunogenicity. Protocol deviations that affected evaluation of immunogenicity were determined based on a blinded data review prior to database lock.

Immunogenicity on days 0, 28, 56, 168, 280, and at the end of the study measured as geometric mean titer (GMT) of neutralizing antibodies to chikungunya in previously exposed versus unexposed individuals.

Outcome measures

Outcome measures
Measure	MV-CHIK-Placebo/Seropositive n=11 Participants baseline seropositive cohort; received MV-CHIK-Placebo	MV-CHIK-Placebo/Seronegative n=14 Participants baseline seronegative cohort; received MV-CHIK-Placebo	MMR-Placebo/Seropositive n=4 Participants baseline seropositive cohort; received MMR-Placebo	MMR-Placebo/Seronegative n=3 Participants baseline seronegative cohort; received MMR-Placebo
Immunogenicity Day 0	1059.52 Titer Interval 762.0 to 1473.3	5.0 Titer Interval 3.6 to 6.9	1280.0 Titer Interval 740.9 to 2211.3	5.0 Titer Interval 2.7 to 9.4
Immunogenicity Day 28	1290.19 Titer Interval 919.8 to 1809.8	17.82 Titer Interval 13.0 to 24.4	1280.0 Titer Interval 740.9 to 2211.3	5.0 Titer Interval 2.7 to 9.4
Immunogenicity Day 56	1280.0 Titer Interval 920.5 to 1779.9	339.03 Titer Interval 247.3 to 464.9	1280.0 Titer Interval 740.9 to 2211.3	5.0 Titer Interval 2.7 to 9.4
Immunogenicity Day 168	1280.0 Titer Interval 920.5 to 1779.9	63.5 Titer Interval 46.3 to 87.1	1280.0 Titer Interval 740.9 to 2211.3	5.0 Titer Interval 2.7 to 9.4
Immunogenicity Day 280	1114.3 Titer Interval 792.2 to 1567.3	35.64 Titer Interval 26.0 to 48.9	1280.0 Titer Interval 740.9 to 2211.3	5.0 Titer Interval 2.5 to 10.2
Immunogenicity End of Study	1280.00 Titer Interval 907.0 to 1806.0	29.97 Titer Interval 21.9 to 41.1	1280.00 Titer Interval 740.9 to 2211.3	5.00 Titer Interval 2.7 to 9.4

Adverse Events

MV-CHIK-Placebo/Seronegative

Serious events: 0 serious events

Other events: 11 other events

Deaths: 0 deaths

MV-CHIK-Placebo/Seropositive

Serious events: 0 serious events

Other events: 13 other events

Deaths: 0 deaths

MMR-Placebo/Seropositive

Serious events: 0 serious events

Other events: 4 other events

Deaths: 0 deaths

MMR-Placebo/Seronegative

Serious events: 0 serious events

Other events: 4 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	MV-CHIK-Placebo/Seronegative n=12 participants at risk baseline seronegative cohort; received MV-CHIK-Placebo	MV-CHIK-Placebo/Seropositive n=14 participants at risk baseline seropositive cohort; received MV-CHIK-Placebo	MMR-Placebo/Seropositive n=4 participants at risk baseline seropositive cohort; received MMR-Placebo	MMR-Placebo/Seronegative n=4 participants at risk baseline seronegative cohort; received MMR-Placebo
Infections and infestations Infections and infestations	25.0% 3/12 • Adverse events (AEs) were monitored throughout the study. Under protocol versions 1.0 and 2.0, nonserious AEs were recorded from the time a subject signed the ICF, Under protocol version 3.0, nonserious AEs were recorded from the time a subject received their first vaccination on Day 0 through the last follow-up visit on Day 392 (±10 days). Adverse event of special interest:The AESI for this study, persistent joint pain, was defined as nontraumatic joint pain or stiffness that persisted for more than 24 hours or was associated with objective findings of effusion or soft tissue swelling.	50.0% 7/14 • Adverse events (AEs) were monitored throughout the study. Under protocol versions 1.0 and 2.0, nonserious AEs were recorded from the time a subject signed the ICF, Under protocol version 3.0, nonserious AEs were recorded from the time a subject received their first vaccination on Day 0 through the last follow-up visit on Day 392 (±10 days). Adverse event of special interest:The AESI for this study, persistent joint pain, was defined as nontraumatic joint pain or stiffness that persisted for more than 24 hours or was associated with objective findings of effusion or soft tissue swelling.	100.0% 4/4 • Adverse events (AEs) were monitored throughout the study. Under protocol versions 1.0 and 2.0, nonserious AEs were recorded from the time a subject signed the ICF, Under protocol version 3.0, nonserious AEs were recorded from the time a subject received their first vaccination on Day 0 through the last follow-up visit on Day 392 (±10 days). Adverse event of special interest:The AESI for this study, persistent joint pain, was defined as nontraumatic joint pain or stiffness that persisted for more than 24 hours or was associated with objective findings of effusion or soft tissue swelling.	75.0% 3/4 • Adverse events (AEs) were monitored throughout the study. Under protocol versions 1.0 and 2.0, nonserious AEs were recorded from the time a subject signed the ICF, Under protocol version 3.0, nonserious AEs were recorded from the time a subject received their first vaccination on Day 0 through the last follow-up visit on Day 392 (±10 days). Adverse event of special interest:The AESI for this study, persistent joint pain, was defined as nontraumatic joint pain or stiffness that persisted for more than 24 hours or was associated with objective findings of effusion or soft tissue swelling.
Musculoskeletal and connective tissue disorders Musculoskeletal and connective tissue disorder	50.0% 6/12 • Adverse events (AEs) were monitored throughout the study. Under protocol versions 1.0 and 2.0, nonserious AEs were recorded from the time a subject signed the ICF, Under protocol version 3.0, nonserious AEs were recorded from the time a subject received their first vaccination on Day 0 through the last follow-up visit on Day 392 (±10 days). Adverse event of special interest:The AESI for this study, persistent joint pain, was defined as nontraumatic joint pain or stiffness that persisted for more than 24 hours or was associated with objective findings of effusion or soft tissue swelling.	28.6% 4/14 • Adverse events (AEs) were monitored throughout the study. Under protocol versions 1.0 and 2.0, nonserious AEs were recorded from the time a subject signed the ICF, Under protocol version 3.0, nonserious AEs were recorded from the time a subject received their first vaccination on Day 0 through the last follow-up visit on Day 392 (±10 days). Adverse event of special interest:The AESI for this study, persistent joint pain, was defined as nontraumatic joint pain or stiffness that persisted for more than 24 hours or was associated with objective findings of effusion or soft tissue swelling.	25.0% 1/4 • Adverse events (AEs) were monitored throughout the study. Under protocol versions 1.0 and 2.0, nonserious AEs were recorded from the time a subject signed the ICF, Under protocol version 3.0, nonserious AEs were recorded from the time a subject received their first vaccination on Day 0 through the last follow-up visit on Day 392 (±10 days). Adverse event of special interest:The AESI for this study, persistent joint pain, was defined as nontraumatic joint pain or stiffness that persisted for more than 24 hours or was associated with objective findings of effusion or soft tissue swelling.	50.0% 2/4 • Adverse events (AEs) were monitored throughout the study. Under protocol versions 1.0 and 2.0, nonserious AEs were recorded from the time a subject signed the ICF, Under protocol version 3.0, nonserious AEs were recorded from the time a subject received their first vaccination on Day 0 through the last follow-up visit on Day 392 (±10 days). Adverse event of special interest:The AESI for this study, persistent joint pain, was defined as nontraumatic joint pain or stiffness that persisted for more than 24 hours or was associated with objective findings of effusion or soft tissue swelling.
Blood and lymphatic system disorders Blood and lymphatic system disorders	33.3% 4/12 • Adverse events (AEs) were monitored throughout the study. Under protocol versions 1.0 and 2.0, nonserious AEs were recorded from the time a subject signed the ICF, Under protocol version 3.0, nonserious AEs were recorded from the time a subject received their first vaccination on Day 0 through the last follow-up visit on Day 392 (±10 days). Adverse event of special interest:The AESI for this study, persistent joint pain, was defined as nontraumatic joint pain or stiffness that persisted for more than 24 hours or was associated with objective findings of effusion or soft tissue swelling.	14.3% 2/14 • Adverse events (AEs) were monitored throughout the study. Under protocol versions 1.0 and 2.0, nonserious AEs were recorded from the time a subject signed the ICF, Under protocol version 3.0, nonserious AEs were recorded from the time a subject received their first vaccination on Day 0 through the last follow-up visit on Day 392 (±10 days). Adverse event of special interest:The AESI for this study, persistent joint pain, was defined as nontraumatic joint pain or stiffness that persisted for more than 24 hours or was associated with objective findings of effusion or soft tissue swelling.	0.00% 0/4 • Adverse events (AEs) were monitored throughout the study. Under protocol versions 1.0 and 2.0, nonserious AEs were recorded from the time a subject signed the ICF, Under protocol version 3.0, nonserious AEs were recorded from the time a subject received their first vaccination on Day 0 through the last follow-up visit on Day 392 (±10 days). Adverse event of special interest:The AESI for this study, persistent joint pain, was defined as nontraumatic joint pain or stiffness that persisted for more than 24 hours or was associated with objective findings of effusion or soft tissue swelling.	25.0% 1/4 • Adverse events (AEs) were monitored throughout the study. Under protocol versions 1.0 and 2.0, nonserious AEs were recorded from the time a subject signed the ICF, Under protocol version 3.0, nonserious AEs were recorded from the time a subject received their first vaccination on Day 0 through the last follow-up visit on Day 392 (±10 days). Adverse event of special interest:The AESI for this study, persistent joint pain, was defined as nontraumatic joint pain or stiffness that persisted for more than 24 hours or was associated with objective findings of effusion or soft tissue swelling.
Nervous system disorders Nervous system disorders	25.0% 3/12 • Adverse events (AEs) were monitored throughout the study. Under protocol versions 1.0 and 2.0, nonserious AEs were recorded from the time a subject signed the ICF, Under protocol version 3.0, nonserious AEs were recorded from the time a subject received their first vaccination on Day 0 through the last follow-up visit on Day 392 (±10 days). Adverse event of special interest:The AESI for this study, persistent joint pain, was defined as nontraumatic joint pain or stiffness that persisted for more than 24 hours or was associated with objective findings of effusion or soft tissue swelling.	7.1% 1/14 • Adverse events (AEs) were monitored throughout the study. Under protocol versions 1.0 and 2.0, nonserious AEs were recorded from the time a subject signed the ICF, Under protocol version 3.0, nonserious AEs were recorded from the time a subject received their first vaccination on Day 0 through the last follow-up visit on Day 392 (±10 days). Adverse event of special interest:The AESI for this study, persistent joint pain, was defined as nontraumatic joint pain or stiffness that persisted for more than 24 hours or was associated with objective findings of effusion or soft tissue swelling.	25.0% 1/4 • Adverse events (AEs) were monitored throughout the study. Under protocol versions 1.0 and 2.0, nonserious AEs were recorded from the time a subject signed the ICF, Under protocol version 3.0, nonserious AEs were recorded from the time a subject received their first vaccination on Day 0 through the last follow-up visit on Day 392 (±10 days). Adverse event of special interest:The AESI for this study, persistent joint pain, was defined as nontraumatic joint pain or stiffness that persisted for more than 24 hours or was associated with objective findings of effusion or soft tissue swelling.	25.0% 1/4 • Adverse events (AEs) were monitored throughout the study. Under protocol versions 1.0 and 2.0, nonserious AEs were recorded from the time a subject signed the ICF, Under protocol version 3.0, nonserious AEs were recorded from the time a subject received their first vaccination on Day 0 through the last follow-up visit on Day 392 (±10 days). Adverse event of special interest:The AESI for this study, persistent joint pain, was defined as nontraumatic joint pain or stiffness that persisted for more than 24 hours or was associated with objective findings of effusion or soft tissue swelling.
Respiratory, thoracic and mediastinal disorders Respiratory, thoracic, mediastinal disorders	16.7% 2/12 • Adverse events (AEs) were monitored throughout the study. Under protocol versions 1.0 and 2.0, nonserious AEs were recorded from the time a subject signed the ICF, Under protocol version 3.0, nonserious AEs were recorded from the time a subject received their first vaccination on Day 0 through the last follow-up visit on Day 392 (±10 days). Adverse event of special interest:The AESI for this study, persistent joint pain, was defined as nontraumatic joint pain or stiffness that persisted for more than 24 hours or was associated with objective findings of effusion or soft tissue swelling.	21.4% 3/14 • Adverse events (AEs) were monitored throughout the study. Under protocol versions 1.0 and 2.0, nonserious AEs were recorded from the time a subject signed the ICF, Under protocol version 3.0, nonserious AEs were recorded from the time a subject received their first vaccination on Day 0 through the last follow-up visit on Day 392 (±10 days). Adverse event of special interest:The AESI for this study, persistent joint pain, was defined as nontraumatic joint pain or stiffness that persisted for more than 24 hours or was associated with objective findings of effusion or soft tissue swelling.	25.0% 1/4 • Adverse events (AEs) were monitored throughout the study. Under protocol versions 1.0 and 2.0, nonserious AEs were recorded from the time a subject signed the ICF, Under protocol version 3.0, nonserious AEs were recorded from the time a subject received their first vaccination on Day 0 through the last follow-up visit on Day 392 (±10 days). Adverse event of special interest:The AESI for this study, persistent joint pain, was defined as nontraumatic joint pain or stiffness that persisted for more than 24 hours or was associated with objective findings of effusion or soft tissue swelling.	0.00% 0/4 • Adverse events (AEs) were monitored throughout the study. Under protocol versions 1.0 and 2.0, nonserious AEs were recorded from the time a subject signed the ICF, Under protocol version 3.0, nonserious AEs were recorded from the time a subject received their first vaccination on Day 0 through the last follow-up visit on Day 392 (±10 days). Adverse event of special interest:The AESI for this study, persistent joint pain, was defined as nontraumatic joint pain or stiffness that persisted for more than 24 hours or was associated with objective findings of effusion or soft tissue swelling.
Gastrointestinal disorders Gastrointestinal disorders	16.7% 2/12 • Adverse events (AEs) were monitored throughout the study. Under protocol versions 1.0 and 2.0, nonserious AEs were recorded from the time a subject signed the ICF, Under protocol version 3.0, nonserious AEs were recorded from the time a subject received their first vaccination on Day 0 through the last follow-up visit on Day 392 (±10 days). Adverse event of special interest:The AESI for this study, persistent joint pain, was defined as nontraumatic joint pain or stiffness that persisted for more than 24 hours or was associated with objective findings of effusion or soft tissue swelling.	14.3% 2/14 • Adverse events (AEs) were monitored throughout the study. Under protocol versions 1.0 and 2.0, nonserious AEs were recorded from the time a subject signed the ICF, Under protocol version 3.0, nonserious AEs were recorded from the time a subject received their first vaccination on Day 0 through the last follow-up visit on Day 392 (±10 days). Adverse event of special interest:The AESI for this study, persistent joint pain, was defined as nontraumatic joint pain or stiffness that persisted for more than 24 hours or was associated with objective findings of effusion or soft tissue swelling.	0.00% 0/4 • Adverse events (AEs) were monitored throughout the study. Under protocol versions 1.0 and 2.0, nonserious AEs were recorded from the time a subject signed the ICF, Under protocol version 3.0, nonserious AEs were recorded from the time a subject received their first vaccination on Day 0 through the last follow-up visit on Day 392 (±10 days). Adverse event of special interest:The AESI for this study, persistent joint pain, was defined as nontraumatic joint pain or stiffness that persisted for more than 24 hours or was associated with objective findings of effusion or soft tissue swelling.	25.0% 1/4 • Adverse events (AEs) were monitored throughout the study. Under protocol versions 1.0 and 2.0, nonserious AEs were recorded from the time a subject signed the ICF, Under protocol version 3.0, nonserious AEs were recorded from the time a subject received their first vaccination on Day 0 through the last follow-up visit on Day 392 (±10 days). Adverse event of special interest:The AESI for this study, persistent joint pain, was defined as nontraumatic joint pain or stiffness that persisted for more than 24 hours or was associated with objective findings of effusion or soft tissue swelling.
Injury, poisoning and procedural complications Injury, poisoning and procedural complications	8.3% 1/12 • Adverse events (AEs) were monitored throughout the study. Under protocol versions 1.0 and 2.0, nonserious AEs were recorded from the time a subject signed the ICF, Under protocol version 3.0, nonserious AEs were recorded from the time a subject received their first vaccination on Day 0 through the last follow-up visit on Day 392 (±10 days). Adverse event of special interest:The AESI for this study, persistent joint pain, was defined as nontraumatic joint pain or stiffness that persisted for more than 24 hours or was associated with objective findings of effusion or soft tissue swelling.	21.4% 3/14 • Adverse events (AEs) were monitored throughout the study. Under protocol versions 1.0 and 2.0, nonserious AEs were recorded from the time a subject signed the ICF, Under protocol version 3.0, nonserious AEs were recorded from the time a subject received their first vaccination on Day 0 through the last follow-up visit on Day 392 (±10 days). Adverse event of special interest:The AESI for this study, persistent joint pain, was defined as nontraumatic joint pain or stiffness that persisted for more than 24 hours or was associated with objective findings of effusion or soft tissue swelling.	0.00% 0/4 • Adverse events (AEs) were monitored throughout the study. Under protocol versions 1.0 and 2.0, nonserious AEs were recorded from the time a subject signed the ICF, Under protocol version 3.0, nonserious AEs were recorded from the time a subject received their first vaccination on Day 0 through the last follow-up visit on Day 392 (±10 days). Adverse event of special interest:The AESI for this study, persistent joint pain, was defined as nontraumatic joint pain or stiffness that persisted for more than 24 hours or was associated with objective findings of effusion or soft tissue swelling.	25.0% 1/4 • Adverse events (AEs) were monitored throughout the study. Under protocol versions 1.0 and 2.0, nonserious AEs were recorded from the time a subject signed the ICF, Under protocol version 3.0, nonserious AEs were recorded from the time a subject received their first vaccination on Day 0 through the last follow-up visit on Day 392 (±10 days). Adverse event of special interest:The AESI for this study, persistent joint pain, was defined as nontraumatic joint pain or stiffness that persisted for more than 24 hours or was associated with objective findings of effusion or soft tissue swelling.
Metabolism and nutrition disorders Metabolism and nutrition disorders	0.00% 0/12 • Adverse events (AEs) were monitored throughout the study. Under protocol versions 1.0 and 2.0, nonserious AEs were recorded from the time a subject signed the ICF, Under protocol version 3.0, nonserious AEs were recorded from the time a subject received their first vaccination on Day 0 through the last follow-up visit on Day 392 (±10 days). Adverse event of special interest:The AESI for this study, persistent joint pain, was defined as nontraumatic joint pain or stiffness that persisted for more than 24 hours or was associated with objective findings of effusion or soft tissue swelling.	28.6% 4/14 • Adverse events (AEs) were monitored throughout the study. Under protocol versions 1.0 and 2.0, nonserious AEs were recorded from the time a subject signed the ICF, Under protocol version 3.0, nonserious AEs were recorded from the time a subject received their first vaccination on Day 0 through the last follow-up visit on Day 392 (±10 days). Adverse event of special interest:The AESI for this study, persistent joint pain, was defined as nontraumatic joint pain or stiffness that persisted for more than 24 hours or was associated with objective findings of effusion or soft tissue swelling.	0.00% 0/4 • Adverse events (AEs) were monitored throughout the study. Under protocol versions 1.0 and 2.0, nonserious AEs were recorded from the time a subject signed the ICF, Under protocol version 3.0, nonserious AEs were recorded from the time a subject received their first vaccination on Day 0 through the last follow-up visit on Day 392 (±10 days). Adverse event of special interest:The AESI for this study, persistent joint pain, was defined as nontraumatic joint pain or stiffness that persisted for more than 24 hours or was associated with objective findings of effusion or soft tissue swelling.	0.00% 0/4 • Adverse events (AEs) were monitored throughout the study. Under protocol versions 1.0 and 2.0, nonserious AEs were recorded from the time a subject signed the ICF, Under protocol version 3.0, nonserious AEs were recorded from the time a subject received their first vaccination on Day 0 through the last follow-up visit on Day 392 (±10 days). Adverse event of special interest:The AESI for this study, persistent joint pain, was defined as nontraumatic joint pain or stiffness that persisted for more than 24 hours or was associated with objective findings of effusion or soft tissue swelling.
Renal and urinary disorders Renal and urinary disorders	0.00% 0/12 • Adverse events (AEs) were monitored throughout the study. Under protocol versions 1.0 and 2.0, nonserious AEs were recorded from the time a subject signed the ICF, Under protocol version 3.0, nonserious AEs were recorded from the time a subject received their first vaccination on Day 0 through the last follow-up visit on Day 392 (±10 days). Adverse event of special interest:The AESI for this study, persistent joint pain, was defined as nontraumatic joint pain or stiffness that persisted for more than 24 hours or was associated with objective findings of effusion or soft tissue swelling.	28.6% 4/14 • Adverse events (AEs) were monitored throughout the study. Under protocol versions 1.0 and 2.0, nonserious AEs were recorded from the time a subject signed the ICF, Under protocol version 3.0, nonserious AEs were recorded from the time a subject received their first vaccination on Day 0 through the last follow-up visit on Day 392 (±10 days). Adverse event of special interest:The AESI for this study, persistent joint pain, was defined as nontraumatic joint pain or stiffness that persisted for more than 24 hours or was associated with objective findings of effusion or soft tissue swelling.	0.00% 0/4 • Adverse events (AEs) were monitored throughout the study. Under protocol versions 1.0 and 2.0, nonserious AEs were recorded from the time a subject signed the ICF, Under protocol version 3.0, nonserious AEs were recorded from the time a subject received their first vaccination on Day 0 through the last follow-up visit on Day 392 (±10 days). Adverse event of special interest:The AESI for this study, persistent joint pain, was defined as nontraumatic joint pain or stiffness that persisted for more than 24 hours or was associated with objective findings of effusion or soft tissue swelling.	0.00% 0/4 • Adverse events (AEs) were monitored throughout the study. Under protocol versions 1.0 and 2.0, nonserious AEs were recorded from the time a subject signed the ICF, Under protocol version 3.0, nonserious AEs were recorded from the time a subject received their first vaccination on Day 0 through the last follow-up visit on Day 392 (±10 days). Adverse event of special interest:The AESI for this study, persistent joint pain, was defined as nontraumatic joint pain or stiffness that persisted for more than 24 hours or was associated with objective findings of effusion or soft tissue swelling.
Cardiac disorders Cardiac disorders	0.00% 0/12 • Adverse events (AEs) were monitored throughout the study. Under protocol versions 1.0 and 2.0, nonserious AEs were recorded from the time a subject signed the ICF, Under protocol version 3.0, nonserious AEs were recorded from the time a subject received their first vaccination on Day 0 through the last follow-up visit on Day 392 (±10 days). Adverse event of special interest:The AESI for this study, persistent joint pain, was defined as nontraumatic joint pain or stiffness that persisted for more than 24 hours or was associated with objective findings of effusion or soft tissue swelling.	0.00% 0/14 • Adverse events (AEs) were monitored throughout the study. Under protocol versions 1.0 and 2.0, nonserious AEs were recorded from the time a subject signed the ICF, Under protocol version 3.0, nonserious AEs were recorded from the time a subject received their first vaccination on Day 0 through the last follow-up visit on Day 392 (±10 days). Adverse event of special interest:The AESI for this study, persistent joint pain, was defined as nontraumatic joint pain or stiffness that persisted for more than 24 hours or was associated with objective findings of effusion or soft tissue swelling.	50.0% 2/4 • Adverse events (AEs) were monitored throughout the study. Under protocol versions 1.0 and 2.0, nonserious AEs were recorded from the time a subject signed the ICF, Under protocol version 3.0, nonserious AEs were recorded from the time a subject received their first vaccination on Day 0 through the last follow-up visit on Day 392 (±10 days). Adverse event of special interest:The AESI for this study, persistent joint pain, was defined as nontraumatic joint pain or stiffness that persisted for more than 24 hours or was associated with objective findings of effusion or soft tissue swelling.	0.00% 0/4 • Adverse events (AEs) were monitored throughout the study. Under protocol versions 1.0 and 2.0, nonserious AEs were recorded from the time a subject signed the ICF, Under protocol version 3.0, nonserious AEs were recorded from the time a subject received their first vaccination on Day 0 through the last follow-up visit on Day 392 (±10 days). Adverse event of special interest:The AESI for this study, persistent joint pain, was defined as nontraumatic joint pain or stiffness that persisted for more than 24 hours or was associated with objective findings of effusion or soft tissue swelling.
Skin and subcutaneous tissue disorders Skin and subcutaneous tissue disorders	0.00% 0/12 • Adverse events (AEs) were monitored throughout the study. Under protocol versions 1.0 and 2.0, nonserious AEs were recorded from the time a subject signed the ICF, Under protocol version 3.0, nonserious AEs were recorded from the time a subject received their first vaccination on Day 0 through the last follow-up visit on Day 392 (±10 days). Adverse event of special interest:The AESI for this study, persistent joint pain, was defined as nontraumatic joint pain or stiffness that persisted for more than 24 hours or was associated with objective findings of effusion or soft tissue swelling.	14.3% 2/14 • Adverse events (AEs) were monitored throughout the study. Under protocol versions 1.0 and 2.0, nonserious AEs were recorded from the time a subject signed the ICF, Under protocol version 3.0, nonserious AEs were recorded from the time a subject received their first vaccination on Day 0 through the last follow-up visit on Day 392 (±10 days). Adverse event of special interest:The AESI for this study, persistent joint pain, was defined as nontraumatic joint pain or stiffness that persisted for more than 24 hours or was associated with objective findings of effusion or soft tissue swelling.	0.00% 0/4 • Adverse events (AEs) were monitored throughout the study. Under protocol versions 1.0 and 2.0, nonserious AEs were recorded from the time a subject signed the ICF, Under protocol version 3.0, nonserious AEs were recorded from the time a subject received their first vaccination on Day 0 through the last follow-up visit on Day 392 (±10 days). Adverse event of special interest:The AESI for this study, persistent joint pain, was defined as nontraumatic joint pain or stiffness that persisted for more than 24 hours or was associated with objective findings of effusion or soft tissue swelling.	0.00% 0/4 • Adverse events (AEs) were monitored throughout the study. Under protocol versions 1.0 and 2.0, nonserious AEs were recorded from the time a subject signed the ICF, Under protocol version 3.0, nonserious AEs were recorded from the time a subject received their first vaccination on Day 0 through the last follow-up visit on Day 392 (±10 days). Adverse event of special interest:The AESI for this study, persistent joint pain, was defined as nontraumatic joint pain or stiffness that persisted for more than 24 hours or was associated with objective findings of effusion or soft tissue swelling.
Vascular disorders Vascular disorders	16.7% 2/12 • Adverse events (AEs) were monitored throughout the study. Under protocol versions 1.0 and 2.0, nonserious AEs were recorded from the time a subject signed the ICF, Under protocol version 3.0, nonserious AEs were recorded from the time a subject received their first vaccination on Day 0 through the last follow-up visit on Day 392 (±10 days). Adverse event of special interest:The AESI for this study, persistent joint pain, was defined as nontraumatic joint pain or stiffness that persisted for more than 24 hours or was associated with objective findings of effusion or soft tissue swelling.	0.00% 0/14 • Adverse events (AEs) were monitored throughout the study. Under protocol versions 1.0 and 2.0, nonserious AEs were recorded from the time a subject signed the ICF, Under protocol version 3.0, nonserious AEs were recorded from the time a subject received their first vaccination on Day 0 through the last follow-up visit on Day 392 (±10 days). Adverse event of special interest:The AESI for this study, persistent joint pain, was defined as nontraumatic joint pain or stiffness that persisted for more than 24 hours or was associated with objective findings of effusion or soft tissue swelling.	0.00% 0/4 • Adverse events (AEs) were monitored throughout the study. Under protocol versions 1.0 and 2.0, nonserious AEs were recorded from the time a subject signed the ICF, Under protocol version 3.0, nonserious AEs were recorded from the time a subject received their first vaccination on Day 0 through the last follow-up visit on Day 392 (±10 days). Adverse event of special interest:The AESI for this study, persistent joint pain, was defined as nontraumatic joint pain or stiffness that persisted for more than 24 hours or was associated with objective findings of effusion or soft tissue swelling.	0.00% 0/4 • Adverse events (AEs) were monitored throughout the study. Under protocol versions 1.0 and 2.0, nonserious AEs were recorded from the time a subject signed the ICF, Under protocol version 3.0, nonserious AEs were recorded from the time a subject received their first vaccination on Day 0 through the last follow-up visit on Day 392 (±10 days). Adverse event of special interest:The AESI for this study, persistent joint pain, was defined as nontraumatic joint pain or stiffness that persisted for more than 24 hours or was associated with objective findings of effusion or soft tissue swelling.
Investigations Investigations	8.3% 1/12 • Adverse events (AEs) were monitored throughout the study. Under protocol versions 1.0 and 2.0, nonserious AEs were recorded from the time a subject signed the ICF, Under protocol version 3.0, nonserious AEs were recorded from the time a subject received their first vaccination on Day 0 through the last follow-up visit on Day 392 (±10 days). Adverse event of special interest:The AESI for this study, persistent joint pain, was defined as nontraumatic joint pain or stiffness that persisted for more than 24 hours or was associated with objective findings of effusion or soft tissue swelling.	0.00% 0/14 • Adverse events (AEs) were monitored throughout the study. Under protocol versions 1.0 and 2.0, nonserious AEs were recorded from the time a subject signed the ICF, Under protocol version 3.0, nonserious AEs were recorded from the time a subject received their first vaccination on Day 0 through the last follow-up visit on Day 392 (±10 days). Adverse event of special interest:The AESI for this study, persistent joint pain, was defined as nontraumatic joint pain or stiffness that persisted for more than 24 hours or was associated with objective findings of effusion or soft tissue swelling.	0.00% 0/4 • Adverse events (AEs) were monitored throughout the study. Under protocol versions 1.0 and 2.0, nonserious AEs were recorded from the time a subject signed the ICF, Under protocol version 3.0, nonserious AEs were recorded from the time a subject received their first vaccination on Day 0 through the last follow-up visit on Day 392 (±10 days). Adverse event of special interest:The AESI for this study, persistent joint pain, was defined as nontraumatic joint pain or stiffness that persisted for more than 24 hours or was associated with objective findings of effusion or soft tissue swelling.	0.00% 0/4 • Adverse events (AEs) were monitored throughout the study. Under protocol versions 1.0 and 2.0, nonserious AEs were recorded from the time a subject signed the ICF, Under protocol version 3.0, nonserious AEs were recorded from the time a subject received their first vaccination on Day 0 through the last follow-up visit on Day 392 (±10 days). Adverse event of special interest:The AESI for this study, persistent joint pain, was defined as nontraumatic joint pain or stiffness that persisted for more than 24 hours or was associated with objective findings of effusion or soft tissue swelling.
Psychiatric disorders Psychiatric disorders	0.00% 0/12 • Adverse events (AEs) were monitored throughout the study. Under protocol versions 1.0 and 2.0, nonserious AEs were recorded from the time a subject signed the ICF, Under protocol version 3.0, nonserious AEs were recorded from the time a subject received their first vaccination on Day 0 through the last follow-up visit on Day 392 (±10 days). Adverse event of special interest:The AESI for this study, persistent joint pain, was defined as nontraumatic joint pain or stiffness that persisted for more than 24 hours or was associated with objective findings of effusion or soft tissue swelling.	7.1% 1/14 • Adverse events (AEs) were monitored throughout the study. Under protocol versions 1.0 and 2.0, nonserious AEs were recorded from the time a subject signed the ICF, Under protocol version 3.0, nonserious AEs were recorded from the time a subject received their first vaccination on Day 0 through the last follow-up visit on Day 392 (±10 days). Adverse event of special interest:The AESI for this study, persistent joint pain, was defined as nontraumatic joint pain or stiffness that persisted for more than 24 hours or was associated with objective findings of effusion or soft tissue swelling.	0.00% 0/4 • Adverse events (AEs) were monitored throughout the study. Under protocol versions 1.0 and 2.0, nonserious AEs were recorded from the time a subject signed the ICF, Under protocol version 3.0, nonserious AEs were recorded from the time a subject received their first vaccination on Day 0 through the last follow-up visit on Day 392 (±10 days). Adverse event of special interest:The AESI for this study, persistent joint pain, was defined as nontraumatic joint pain or stiffness that persisted for more than 24 hours or was associated with objective findings of effusion or soft tissue swelling.	0.00% 0/4 • Adverse events (AEs) were monitored throughout the study. Under protocol versions 1.0 and 2.0, nonserious AEs were recorded from the time a subject signed the ICF, Under protocol version 3.0, nonserious AEs were recorded from the time a subject received their first vaccination on Day 0 through the last follow-up visit on Day 392 (±10 days). Adverse event of special interest:The AESI for this study, persistent joint pain, was defined as nontraumatic joint pain or stiffness that persisted for more than 24 hours or was associated with objective findings of effusion or soft tissue swelling.

Additional Information

Christiane Thomasser

Themis Bioscience

Phone: 01 236 7151

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place