Trial Outcomes & Findings for Study to Demonstrate Consistency of Three Lots of a Live-attenuated Chikungunya Virus Vaccine Candidate in Healthy Adults (NCT NCT04786444)

NCT ID: NCT04786444

Last Updated: 2023-09-28

Results Overview

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

409 participants

Primary outcome timeframe

On Day 29 after single vaccination

Results posted on

2023-09-28

Participant Flow

Participant milestones

Participant milestones
Measure	VLA1553 Lot 1 Biological Vaccine VLA1553: Single intramuscular vaccination on Day 1 with one of three Lots of VLA1553, a lyophilized live-attenuated Chikungunya vaccine candidate	VLA1553 Lot 2 Biological Vaccine VLA1553: Single intramuscular vaccination on Day 1 with one of three Lots of VLA1553, a lyophilized live-attenuated Chikungunya vaccine candidate	VLA1553 Lot 3 Biological Vaccine VLA1553: Single intramuscular vaccination on Day 1 with one of three Lots of VLA1553, a lyophilized live-attenuated Chikungunya vaccine candidate
Overall Study STARTED	136	137	135
Overall Study COMPLETED	121	120	123
Overall Study NOT COMPLETED	15	17	12

Reasons for withdrawal

Reasons for withdrawal
Measure	VLA1553 Lot 1 Biological Vaccine VLA1553: Single intramuscular vaccination on Day 1 with one of three Lots of VLA1553, a lyophilized live-attenuated Chikungunya vaccine candidate	VLA1553 Lot 2 Biological Vaccine VLA1553: Single intramuscular vaccination on Day 1 with one of three Lots of VLA1553, a lyophilized live-attenuated Chikungunya vaccine candidate	VLA1553 Lot 3 Biological Vaccine VLA1553: Single intramuscular vaccination on Day 1 with one of three Lots of VLA1553, a lyophilized live-attenuated Chikungunya vaccine candidate
Overall Study Withdrawal by Subject	4	7	2
Overall Study Lost to Follow-up	11	9	10
Overall Study Subject would like to become pregnant	0	1	0

Baseline Characteristics

Study to Demonstrate Consistency of Three Lots of a Live-attenuated Chikungunya Virus Vaccine Candidate in Healthy Adults

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	VLA1553 Lot 1 n=136 Participants Biological Vaccine VLA1553: Single intramuscular vaccination on Day 1 with one of three Lots of VLA1553, a lyophilized live-attenuated Chikungunya vaccine candidate	VLA1553 Lot 2 n=137 Participants Biological Vaccine VLA1553: Single intramuscular vaccination on Day 1 with one of three Lots of VLA1553, a lyophilized live-attenuated Chikungunya vaccine candidate	VLA1553 Lot 3 n=135 Participants Biological Vaccine VLA1553: Single intramuscular vaccination on Day 1 with one of three Lots of VLA1553, a lyophilized live-attenuated Chikungunya vaccine candidate	Total n=408 Participants Total of all reporting groups
Age, Continuous	33.2 years STANDARD_DEVIATION 7.03 • n=5 Participants	33.2 years STANDARD_DEVIATION 7.78 • n=7 Participants	33.2 years STANDARD_DEVIATION 7.43 • n=5 Participants	33.2 years STANDARD_DEVIATION 7.40 • n=4 Participants
Sex: Female, Male Female	75 Participants n=5 Participants	76 Participants n=7 Participants	72 Participants n=5 Participants	223 Participants n=4 Participants
Sex: Female, Male Male	61 Participants n=5 Participants	61 Participants n=7 Participants	63 Participants n=5 Participants	185 Participants n=4 Participants
Race/Ethnicity, Customized American, Indian or Alaska Native	4 Participants n=5 Participants	1 Participants n=7 Participants	0 Participants n=5 Participants	5 Participants n=4 Participants
Race/Ethnicity, Customized Asian	6 Participants n=5 Participants	5 Participants n=7 Participants	7 Participants n=5 Participants	18 Participants n=4 Participants
Race/Ethnicity, Customized Black or African American	21 Participants n=5 Participants	22 Participants n=7 Participants	19 Participants n=5 Participants	62 Participants n=4 Participants
Race/Ethnicity, Customized Native Hawaiian or other Pacific Islander	0 Participants n=5 Participants	1 Participants n=7 Participants	0 Participants n=5 Participants	1 Participants n=4 Participants
Race/Ethnicity, Customized White	103 Participants n=5 Participants	106 Participants n=7 Participants	106 Participants n=5 Participants	315 Participants n=4 Participants
Race/Ethnicity, Customized Other	2 Participants n=5 Participants	2 Participants n=7 Participants	3 Participants n=5 Participants	7 Participants n=4 Participants

PRIMARY outcome

Timeframe: On Day 29 after single vaccination

Population: The Per-Protocol population used for immunogenicity analyses, is based on participants without major protocol deviations that could impact the immune response.

Outcome measures

Outcome measures
Measure	VLA1553 Lot 1 n=122 Participants Biological Vaccine VLA1553: Single intramuscular vaccination on Day 1 with one of three Lots of VLA1553, a lyophilized live-attenuated Chikungunya vaccine candidate	VLA1553 Lot 2 n=118 Participants Biological Vaccine VLA1553: Single intramuscular vaccination on Day 1 with one of three Lots of VLA1553, a lyophilized live-attenuated Chikungunya vaccine candidate	VLA1553 Lot 3 n=122 Participants Biological Vaccine VLA1553: Single intramuscular vaccination on Day 1 with one of three Lots of VLA1553, a lyophilized live-attenuated Chikungunya vaccine candidate
Geometric Mean Titer (GMT) of CHIKV-specific Neutralizing Antibodies as Determined by Microneutralization (μPRNT) Assay in Subjects Who Tested Negative for CHIKV Antibodies at Baseline	2556.7 Geometric Mean Titer Interval 2055.63 to 3179.8	2767.7 Geometric Mean Titer Interval 2310.25 to 3315.65	2613.7 Geometric Mean Titer Interval 2128.06 to 3210.17

SECONDARY outcome

Timeframe: on Day 8, 85 and Month 6

Population: The Per-Protocol population used for immunogenicity analyses, is based on participants without major protocol deviations that could impact the immune response.

Outcome measures

Outcome measures
Measure	VLA1553 Lot 1 n=121 Participants Biological Vaccine VLA1553: Single intramuscular vaccination on Day 1 with one of three Lots of VLA1553, a lyophilized live-attenuated Chikungunya vaccine candidate	VLA1553 Lot 2 n=118 Participants Biological Vaccine VLA1553: Single intramuscular vaccination on Day 1 with one of three Lots of VLA1553, a lyophilized live-attenuated Chikungunya vaccine candidate	VLA1553 Lot 3 n=122 Participants Biological Vaccine VLA1553: Single intramuscular vaccination on Day 1 with one of three Lots of VLA1553, a lyophilized live-attenuated Chikungunya vaccine candidate
Immune Response as Measured by CHIKV-specific Neutralizing Antibody Titers Visit 2 - Day 8	13.0 Geometric Mean Titer Interval 11.72 to 14.38	12.0 Geometric Mean Titer Interval 11.04 to 13.03	11.4 Geometric Mean Titer Interval 10.52 to 12.4
Immune Response as Measured by CHIKV-specific Neutralizing Antibody Titers Visit 4 - Day 85	832.3 Geometric Mean Titer Interval 696.51 to 994.59	829.0 Geometric Mean Titer Interval 688.88 to 997.51	875.8 Geometric Mean Titer Interval 730.45 to 1050.12
Immune Response as Measured by CHIKV-specific Neutralizing Antibody Titers Visit 5 - Day 180	666.4 Geometric Mean Titer Interval 546.33 to 812.97	777.6 Geometric Mean Titer Interval 663.4 to 911.43	688.3 Geometric Mean Titer Interval 573.46 to 826.25

SECONDARY outcome

Timeframe: on Day 8, 29, 85 and Month 6

Population: The Per-Protocol population used for immunogenicity analyses, is based on participants who have available Day 1 and Day 29 samples and without major protocol deviations that could impact the immune response

Outcome measures

Outcome measures
Measure	VLA1553 Lot 1 n=122 Participants Biological Vaccine VLA1553: Single intramuscular vaccination on Day 1 with one of three Lots of VLA1553, a lyophilized live-attenuated Chikungunya vaccine candidate	VLA1553 Lot 2 n=118 Participants Biological Vaccine VLA1553: Single intramuscular vaccination on Day 1 with one of three Lots of VLA1553, a lyophilized live-attenuated Chikungunya vaccine candidate	VLA1553 Lot 3 n=122 Participants Biological Vaccine VLA1553: Single intramuscular vaccination on Day 1 with one of three Lots of VLA1553, a lyophilized live-attenuated Chikungunya vaccine candidate
Proportion of Subjects With Seroprotective Levels for Baseline Negative Subjects Visit 2 - Day 8	0 Participants	0 Participants	0 Participants
Proportion of Subjects With Seroprotective Levels for Baseline Negative Subjects Visit 3 - Day 29	117 Participants	114 Participants	117 Participants
Proportion of Subjects With Seroprotective Levels for Baseline Negative Subjects Visit 4 - Day 85	106 Participants	104 Participants	111 Participants
Proportion of Subjects With Seroprotective Levels for Baseline Negative Subjects Visit 5 - Day 180	103 Participants	106 Participants	107 Participants

SECONDARY outcome

Timeframe: on Day 29, Day 85 and Month 6

Population: At the specified time point the number of subjects with non-missing titers is stated.

Outcome measures

Outcome measures
Measure	VLA1553 Lot 1 n=122 Participants Biological Vaccine VLA1553: Single intramuscular vaccination on Day 1 with one of three Lots of VLA1553, a lyophilized live-attenuated Chikungunya vaccine candidate	VLA1553 Lot 2 n=118 Participants Biological Vaccine VLA1553: Single intramuscular vaccination on Day 1 with one of three Lots of VLA1553, a lyophilized live-attenuated Chikungunya vaccine candidate	VLA1553 Lot 3 n=122 Participants Biological Vaccine VLA1553: Single intramuscular vaccination on Day 1 with one of three Lots of VLA1553, a lyophilized live-attenuated Chikungunya vaccine candidate
Proportion of Subjects With Seroconversion Visit 5 - Day 180	107 Participants	108 Participants	112 Participants
Proportion of Subjects With Seroconversion Visit 3 - Day 29	118 Participants	116 Participants	119 Participants
Proportion of Subjects With Seroconversion Visit 4 - Day 85	107 Participants	106 Participants	115 Participants

SECONDARY outcome

Timeframe: on Day 8, 29, 85 and Month 6

Outcome measures

Outcome measures
Measure	VLA1553 Lot 1 n=122 Participants Biological Vaccine VLA1553: Single intramuscular vaccination on Day 1 with one of three Lots of VLA1553, a lyophilized live-attenuated Chikungunya vaccine candidate	VLA1553 Lot 2 n=118 Participants Biological Vaccine VLA1553: Single intramuscular vaccination on Day 1 with one of three Lots of VLA1553, a lyophilized live-attenuated Chikungunya vaccine candidate	VLA1553 Lot 3 n=122 Participants Biological Vaccine VLA1553: Single intramuscular vaccination on Day 1 with one of three Lots of VLA1553, a lyophilized live-attenuated Chikungunya vaccine candidate
Fold Increase of CHIKV-specific Neutralizing Antibody Titers Compared to Baseline Visit 3 - Day 29	379.56 Fold increase Standard Deviation 319.179	371.37 Fold increase Standard Deviation 294.164	399.91 Fold increase Standard Deviation 523.539
Fold Increase of CHIKV-specific Neutralizing Antibody Titers Compared to Baseline Visit 4 - Day 85	110.92 Fold increase Standard Deviation 79.788	109.81 Fold increase Standard Deviation 76.375	123.20 Fold increase Standard Deviation 100.725
Fold Increase of CHIKV-specific Neutralizing Antibody Titers Compared to Baseline Visit 5 - Day 180	96.20 Fold increase Standard Deviation 79.639	98.57 Fold increase Standard Deviation 71.635	97.24 Fold increase Standard Deviation 83.274
Fold Increase of CHIKV-specific Neutralizing Antibody Titers Compared to Baseline Visit 2 - Day 8	1.58 Fold increase Standard Deviation 1.570	1.37 Fold increase Standard Deviation 1.048	1.32 Fold increase Standard Deviation 1.460

SECONDARY outcome

Timeframe: up to Month 6

Outcome measures

Outcome measures
Measure	VLA1553 Lot 1 n=122 Participants Biological Vaccine VLA1553: Single intramuscular vaccination on Day 1 with one of three Lots of VLA1553, a lyophilized live-attenuated Chikungunya vaccine candidate	VLA1553 Lot 2 n=118 Participants Biological Vaccine VLA1553: Single intramuscular vaccination on Day 1 with one of three Lots of VLA1553, a lyophilized live-attenuated Chikungunya vaccine candidate	VLA1553 Lot 3 n=122 Participants Biological Vaccine VLA1553: Single intramuscular vaccination on Day 1 with one of three Lots of VLA1553, a lyophilized live-attenuated Chikungunya vaccine candidate
Proportion of Subjects Reaching an at Least 4-fold, 8-fold, 16-fold or 64-fold Increase in CHIKV-specific Neutralizing Antibody Titer Compared to Baseline Visit 2 - Day 8: subjects reaching 4-fold increase	8 Participants	6 Participants	3 Participants
Proportion of Subjects Reaching an at Least 4-fold, 8-fold, 16-fold or 64-fold Increase in CHIKV-specific Neutralizing Antibody Titer Compared to Baseline Visit 2 - Day 8: subjects reaching 8-fold increase	1 Participants	0 Participants	1 Participants
Proportion of Subjects Reaching an at Least 4-fold, 8-fold, 16-fold or 64-fold Increase in CHIKV-specific Neutralizing Antibody Titer Compared to Baseline Visit 2 - Day 8: subjects reaching 16-fold increase	0 Participants	0 Participants	0 Participants
Proportion of Subjects Reaching an at Least 4-fold, 8-fold, 16-fold or 64-fold Increase in CHIKV-specific Neutralizing Antibody Titer Compared to Baseline Visit 2 - Day 8: subjects reaching 64-fold increase	0 Participants	0 Participants	0 Participants
Proportion of Subjects Reaching an at Least 4-fold, 8-fold, 16-fold or 64-fold Increase in CHIKV-specific Neutralizing Antibody Titer Compared to Baseline Visit 4 - Day 85: subjects reaching 8-fold increase	107 Participants	106 Participants	114 Participants
Proportion of Subjects Reaching an at Least 4-fold, 8-fold, 16-fold or 64-fold Increase in CHIKV-specific Neutralizing Antibody Titer Compared to Baseline Visit 4 - Day 85: subjects reaching 16-fold increase	107 Participants	106 Participants	113 Participants
Proportion of Subjects Reaching an at Least 4-fold, 8-fold, 16-fold or 64-fold Increase in CHIKV-specific Neutralizing Antibody Titer Compared to Baseline Visit 4 - Day 85: subjects reaching 64-fold increase	75 Participants	71 Participants	77 Participants
Proportion of Subjects Reaching an at Least 4-fold, 8-fold, 16-fold or 64-fold Increase in CHIKV-specific Neutralizing Antibody Titer Compared to Baseline Visit 5 - Day 180: subjects reaching 4-fold increase	107 Participants	108 Participants	112 Participants
Proportion of Subjects Reaching an at Least 4-fold, 8-fold, 16-fold or 64-fold Increase in CHIKV-specific Neutralizing Antibody Titer Compared to Baseline Visit 5 - Day 180: subjects reaching 8-fold increase	107 Participants	108 Participants	110 Participants
Proportion of Subjects Reaching an at Least 4-fold, 8-fold, 16-fold or 64-fold Increase in CHIKV-specific Neutralizing Antibody Titer Compared to Baseline Visit 5 - Day 180: subjects reaching 16-fold increase	103 Participants	108 Participants	109 Participants
Proportion of Subjects Reaching an at Least 4-fold, 8-fold, 16-fold or 64-fold Increase in CHIKV-specific Neutralizing Antibody Titer Compared to Baseline Visit 5 - Day 180: subjects reaching 64-fold increase	69 Participants	69 Participants	64 Participants
Proportion of Subjects Reaching an at Least 4-fold, 8-fold, 16-fold or 64-fold Increase in CHIKV-specific Neutralizing Antibody Titer Compared to Baseline Visit 3 - Day 29: subjects reaching 4-fold increase	118 Participants	116 Participants	119 Participants
Proportion of Subjects Reaching an at Least 4-fold, 8-fold, 16-fold or 64-fold Increase in CHIKV-specific Neutralizing Antibody Titer Compared to Baseline Visit 3 - Day 29: subjects reaching 8-fold increase	118 Participants	116 Participants	119 Participants
Proportion of Subjects Reaching an at Least 4-fold, 8-fold, 16-fold or 64-fold Increase in CHIKV-specific Neutralizing Antibody Titer Compared to Baseline Visit 3 - Day 29: subjects reaching 16-fold increase	117 Participants	116 Participants	119 Participants
Proportion of Subjects Reaching an at Least 4-fold, 8-fold, 16-fold or 64-fold Increase in CHIKV-specific Neutralizing Antibody Titer Compared to Baseline Visit 3 - Day 29: subjects reaching 64-fold increase	116 Participants	116 Participants	116 Participants
Proportion of Subjects Reaching an at Least 4-fold, 8-fold, 16-fold or 64-fold Increase in CHIKV-specific Neutralizing Antibody Titer Compared to Baseline Visit 4 - Day 85: subjects reaching 4-fold increase	107 Participants	106 Participants	115 Participants

SECONDARY outcome

Timeframe: 10 days post vaccination

Outcome measures

Outcome measures
Measure	VLA1553 Lot 1 n=136 Participants Biological Vaccine VLA1553: Single intramuscular vaccination on Day 1 with one of three Lots of VLA1553, a lyophilized live-attenuated Chikungunya vaccine candidate	VLA1553 Lot 2 n=137 Participants Biological Vaccine VLA1553: Single intramuscular vaccination on Day 1 with one of three Lots of VLA1553, a lyophilized live-attenuated Chikungunya vaccine candidate	VLA1553 Lot 3 n=135 Participants Biological Vaccine VLA1553: Single intramuscular vaccination on Day 1 with one of three Lots of VLA1553, a lyophilized live-attenuated Chikungunya vaccine candidate
Frequency of Solicited Injection Site number of subjects experiencing any solicited injection site adverse events	23 Participants	30 Participants	26 Participants
Frequency of Solicited Injection Site Tenderness	19 Participants	22 Participants	17 Participants
Frequency of Solicited Injection Site Pain	7 Participants	10 Participants	9 Participants
Frequency of Solicited Injection Site Erythema/Redness	4 Participants	2 Participants	5 Participants
Frequency of Solicited Injection Site Induration	3 Participants	1 Participants	3 Participants
Frequency of Solicited Injection Site Swelling	2 Participants	0 Participants	2 Participants

SECONDARY outcome

Timeframe: 10 days post vaccination

Outcome measures

Outcome measures
Measure	VLA1553 Lot 1 n=136 Participants Biological Vaccine VLA1553: Single intramuscular vaccination on Day 1 with one of three Lots of VLA1553, a lyophilized live-attenuated Chikungunya vaccine candidate	VLA1553 Lot 2 n=137 Participants Biological Vaccine VLA1553: Single intramuscular vaccination on Day 1 with one of three Lots of VLA1553, a lyophilized live-attenuated Chikungunya vaccine candidate	VLA1553 Lot 3 n=135 Participants Biological Vaccine VLA1553: Single intramuscular vaccination on Day 1 with one of three Lots of VLA1553, a lyophilized live-attenuated Chikungunya vaccine candidate
Frequency of Solicited Systemic Reactions number of subjects experiencing any solicited systemic adverse events	73 Participants	78 Participants	82 Participants
Frequency of Solicited Systemic Reactions Fatigue	53 Participants	49 Participants	53 Participants
Frequency of Solicited Systemic Reactions Headache	49 Participants	42 Participants	55 Participants
Frequency of Solicited Systemic Reactions Myalgia	31 Participants	35 Participants	30 Participants
Frequency of Solicited Systemic Reactions Arthralgia	19 Participants	21 Participants	23 Participants
Frequency of Solicited Systemic Reactions Nausea	16 Participants	20 Participants	17 Participants
Frequency of Solicited Systemic Reactions Fever	16 Participants	18 Participants	18 Participants
Frequency of Solicited Systemic Reactions Rash	1 Participants	6 Participants	6 Participants
Frequency of Solicited Systemic Reactions Vomiting	2 Participants	6 Participants	2 Participants

SECONDARY outcome

Timeframe: 10 days post vaccination

Outcome measures

Outcome measures
Measure	VLA1553 Lot 1 n=136 Participants Biological Vaccine VLA1553: Single intramuscular vaccination on Day 1 with one of three Lots of VLA1553, a lyophilized live-attenuated Chikungunya vaccine candidate	VLA1553 Lot 2 n=137 Participants Biological Vaccine VLA1553: Single intramuscular vaccination on Day 1 with one of three Lots of VLA1553, a lyophilized live-attenuated Chikungunya vaccine candidate	VLA1553 Lot 3 n=135 Participants Biological Vaccine VLA1553: Single intramuscular vaccination on Day 1 with one of three Lots of VLA1553, a lyophilized live-attenuated Chikungunya vaccine candidate
Severity of Solicited Injection Site Mild	21 Participants	29 Participants	26 Participants
Severity of Solicited Injection Site Moderate	2 Participants	1 Participants	0 Participants
Severity of Solicited Injection Site Severe	0 Participants	0 Participants	0 Participants

SECONDARY outcome

Timeframe: 10 days post vaccination

Outcome measures

Outcome measures
Measure	VLA1553 Lot 1 n=136 Participants Biological Vaccine VLA1553: Single intramuscular vaccination on Day 1 with one of three Lots of VLA1553, a lyophilized live-attenuated Chikungunya vaccine candidate	VLA1553 Lot 2 n=137 Participants Biological Vaccine VLA1553: Single intramuscular vaccination on Day 1 with one of three Lots of VLA1553, a lyophilized live-attenuated Chikungunya vaccine candidate	VLA1553 Lot 3 n=135 Participants Biological Vaccine VLA1553: Single intramuscular vaccination on Day 1 with one of three Lots of VLA1553, a lyophilized live-attenuated Chikungunya vaccine candidate
Severity of Solicited Systemic Reactions Mild	56 Participants	60 Participants	61 Participants
Severity of Solicited Systemic Reactions Moderate	12 Participants	15 Participants	18 Participants
Severity of Solicited Systemic Reactions Severe	5 Participants	3 Participants	3 Participants

SECONDARY outcome

Timeframe: up to Day 29

Outcome measures

Outcome measures
Measure	VLA1553 Lot 1 n=136 Participants Biological Vaccine VLA1553: Single intramuscular vaccination on Day 1 with one of three Lots of VLA1553, a lyophilized live-attenuated Chikungunya vaccine candidate	VLA1553 Lot 2 n=137 Participants Biological Vaccine VLA1553: Single intramuscular vaccination on Day 1 with one of three Lots of VLA1553, a lyophilized live-attenuated Chikungunya vaccine candidate	VLA1553 Lot 3 n=135 Participants Biological Vaccine VLA1553: Single intramuscular vaccination on Day 1 with one of three Lots of VLA1553, a lyophilized live-attenuated Chikungunya vaccine candidate
Severity of Unsolicited Adverse Events (AEs) Within 28 Days Post-vaccination Mild	25 Participants	17 Participants	32 Participants
Severity of Unsolicited Adverse Events (AEs) Within 28 Days Post-vaccination Moderate	10 Participants	5 Participants	10 Participants
Severity of Unsolicited Adverse Events (AEs) Within 28 Days Post-vaccination Severe	3 Participants	0 Participants	0 Participants

SECONDARY outcome

Timeframe: up to Day 29

Outcome measures

Outcome measures
Measure	VLA1553 Lot 1 n=136 Participants Biological Vaccine VLA1553: Single intramuscular vaccination on Day 1 with one of three Lots of VLA1553, a lyophilized live-attenuated Chikungunya vaccine candidate	VLA1553 Lot 2 n=137 Participants Biological Vaccine VLA1553: Single intramuscular vaccination on Day 1 with one of three Lots of VLA1553, a lyophilized live-attenuated Chikungunya vaccine candidate	VLA1553 Lot 3 n=135 Participants Biological Vaccine VLA1553: Single intramuscular vaccination on Day 1 with one of three Lots of VLA1553, a lyophilized live-attenuated Chikungunya vaccine candidate
Frequency of Unsolicited Adverse Events (AEs) Within 28 Days Post-vaccination	38 Participants	22 Participants	42 Participants

SECONDARY outcome

Timeframe: up to Month 6

Outcome measures

Outcome measures
Measure	VLA1553 Lot 1 n=136 Participants Biological Vaccine VLA1553: Single intramuscular vaccination on Day 1 with one of three Lots of VLA1553, a lyophilized live-attenuated Chikungunya vaccine candidate	VLA1553 Lot 2 n=137 Participants Biological Vaccine VLA1553: Single intramuscular vaccination on Day 1 with one of three Lots of VLA1553, a lyophilized live-attenuated Chikungunya vaccine candidate	VLA1553 Lot 3 n=135 Participants Biological Vaccine VLA1553: Single intramuscular vaccination on Day 1 with one of three Lots of VLA1553, a lyophilized live-attenuated Chikungunya vaccine candidate
Severity of Any Adverse Event During the Entire Study Period Mild	64 Participants	66 Participants	61 Participants
Severity of Any Adverse Event During the Entire Study Period Moderate	26 Participants	27 Participants	36 Participants
Severity of Any Adverse Event During the Entire Study Period Severe	8 Participants	4 Participants	4 Participants

SECONDARY outcome

Timeframe: up to Month 6

Outcome measures

Outcome measures
Measure	VLA1553 Lot 1 n=136 Participants Biological Vaccine VLA1553: Single intramuscular vaccination on Day 1 with one of three Lots of VLA1553, a lyophilized live-attenuated Chikungunya vaccine candidate	VLA1553 Lot 2 n=137 Participants Biological Vaccine VLA1553: Single intramuscular vaccination on Day 1 with one of three Lots of VLA1553, a lyophilized live-attenuated Chikungunya vaccine candidate	VLA1553 Lot 3 n=135 Participants Biological Vaccine VLA1553: Single intramuscular vaccination on Day 1 with one of three Lots of VLA1553, a lyophilized live-attenuated Chikungunya vaccine candidate
Frequency of Any Adverse Event During the Entire Study Period	98 Participants	97 Participants	101 Participants

SECONDARY outcome

Timeframe: up to Month 6

Outcome measures

Outcome measures
Measure	VLA1553 Lot 1 n=136 Participants Biological Vaccine VLA1553: Single intramuscular vaccination on Day 1 with one of three Lots of VLA1553, a lyophilized live-attenuated Chikungunya vaccine candidate	VLA1553 Lot 2 n=137 Participants Biological Vaccine VLA1553: Single intramuscular vaccination on Day 1 with one of three Lots of VLA1553, a lyophilized live-attenuated Chikungunya vaccine candidate	VLA1553 Lot 3 n=135 Participants Biological Vaccine VLA1553: Single intramuscular vaccination on Day 1 with one of three Lots of VLA1553, a lyophilized live-attenuated Chikungunya vaccine candidate
Frequency of Any Serious Adverse Event (SAE) During the Entire Study Period	3 Participants	2 Participants	0 Participants

SECONDARY outcome

Timeframe: within 2 to 21 days post-vaccination

AESI Definition: The following cluster of symptoms suggestive of CHIKV infection with or without remissions or exacerbations received particular consideration: 1. Fever (≥38.0°C \[100.4°F\] measured orally) and 2. Acute (poly)arthralgia/arthritis most frequently in the extremities (wrists, ankles, and phalanges, often symmetric), back pain and/or neurological symptoms (e.g. confusion, optic neuritis, meningoencephalitis, or polyneuropathy) and/or cardiac symptoms (e.g. myocarditis) or One or more of the following signs and symptoms: macular to maculopapular rash (sometimes with cutaneous pruritus \[foot plant\] and edema of the face and extremities), polyadenopathies; and 3. Onset of symptoms 2 to 21 days after vaccination and 4. Duration of event ≥3 days. Ongoing AESIs are monitored for entire study period

Outcome measures

Outcome measures
Measure	VLA1553 Lot 1 n=136 Participants Biological Vaccine VLA1553: Single intramuscular vaccination on Day 1 with one of three Lots of VLA1553, a lyophilized live-attenuated Chikungunya vaccine candidate	VLA1553 Lot 2 n=137 Participants Biological Vaccine VLA1553: Single intramuscular vaccination on Day 1 with one of three Lots of VLA1553, a lyophilized live-attenuated Chikungunya vaccine candidate	VLA1553 Lot 3 n=135 Participants Biological Vaccine VLA1553: Single intramuscular vaccination on Day 1 with one of three Lots of VLA1553, a lyophilized live-attenuated Chikungunya vaccine candidate
Severity of Any Adverse Event of Special Interest (AESI) Mild	0 Participants	0 Participants	0 Participants
Severity of Any Adverse Event of Special Interest (AESI) Moderate	0 Participants	0 Participants	0 Participants
Severity of Any Adverse Event of Special Interest (AESI) Severe	0 Participants	1 Participants	0 Participants

SECONDARY outcome

Timeframe: Within 2 to 21 Days Post-vaccination

Outcome measures

Outcome measures
Measure	VLA1553 Lot 1 n=136 Participants Biological Vaccine VLA1553: Single intramuscular vaccination on Day 1 with one of three Lots of VLA1553, a lyophilized live-attenuated Chikungunya vaccine candidate	VLA1553 Lot 2 n=137 Participants Biological Vaccine VLA1553: Single intramuscular vaccination on Day 1 with one of three Lots of VLA1553, a lyophilized live-attenuated Chikungunya vaccine candidate	VLA1553 Lot 3 n=135 Participants Biological Vaccine VLA1553: Single intramuscular vaccination on Day 1 with one of three Lots of VLA1553, a lyophilized live-attenuated Chikungunya vaccine candidate
Frequency of Any Adverse Event of Special Interest (AESI)	0 Participants	1 Participants	0 Participants

Adverse Events

VLA1553 Lot 1

Serious events: 3 serious events

Other events: 90 other events

Deaths: 0 deaths

VLA1553 Lot 2

Serious events: 2 serious events

Other events: 91 other events

Deaths: 0 deaths

VLA1553 Lot 3

Serious events: 0 serious events

Other events: 92 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	VLA1553 Lot 1 n=136 participants at risk Biological Vaccine VLA1553: Single intramuscular vaccination on Day 1 with one of three Lots of VLA1553, a lyophilized live-attenuated Chikungunya vaccine candidate	VLA1553 Lot 2 n=137 participants at risk Biological Vaccine VLA1553: Single intramuscular vaccination on Day 1 with one of three Lots of VLA1553, a lyophilized live-attenuated Chikungunya vaccine candidate	VLA1553 Lot 3 n=135 participants at risk Biological Vaccine VLA1553: Single intramuscular vaccination on Day 1 with one of three Lots of VLA1553, a lyophilized live-attenuated Chikungunya vaccine candidate
Infections and infestations Appendicitis	0.74% 1/136 • Number of events 1 • Up to Month 6 Solicited AEs are collected by systematic assessment through subject eDiaries (within 10 days postvaccination): injection site AEs (pain, tenderness, induration, swelling, erythema/redness) or systemic AEs (headache, myalgia, arthralgia, fever, vomiting, nausea, rash, fatigue). Unsolicited AEs, and SAEs are collected by non-systematic assessment up to Day 180. AESI is defined as symptoms suggestive of CHIKV infection up to 21 days after vaccination and collected by systematic assessment.	0.73% 1/137 • Number of events 1 • Up to Month 6 Solicited AEs are collected by systematic assessment through subject eDiaries (within 10 days postvaccination): injection site AEs (pain, tenderness, induration, swelling, erythema/redness) or systemic AEs (headache, myalgia, arthralgia, fever, vomiting, nausea, rash, fatigue). Unsolicited AEs, and SAEs are collected by non-systematic assessment up to Day 180. AESI is defined as symptoms suggestive of CHIKV infection up to 21 days after vaccination and collected by systematic assessment.	0.00% 0/135 • Up to Month 6 Solicited AEs are collected by systematic assessment through subject eDiaries (within 10 days postvaccination): injection site AEs (pain, tenderness, induration, swelling, erythema/redness) or systemic AEs (headache, myalgia, arthralgia, fever, vomiting, nausea, rash, fatigue). Unsolicited AEs, and SAEs are collected by non-systematic assessment up to Day 180. AESI is defined as symptoms suggestive of CHIKV infection up to 21 days after vaccination and collected by systematic assessment.
Pregnancy, puerperium and perinatal conditions Abortion spontaneous	0.74% 1/136 • Number of events 1 • Up to Month 6 Solicited AEs are collected by systematic assessment through subject eDiaries (within 10 days postvaccination): injection site AEs (pain, tenderness, induration, swelling, erythema/redness) or systemic AEs (headache, myalgia, arthralgia, fever, vomiting, nausea, rash, fatigue). Unsolicited AEs, and SAEs are collected by non-systematic assessment up to Day 180. AESI is defined as symptoms suggestive of CHIKV infection up to 21 days after vaccination and collected by systematic assessment.	0.73% 1/137 • Number of events 1 • Up to Month 6 Solicited AEs are collected by systematic assessment through subject eDiaries (within 10 days postvaccination): injection site AEs (pain, tenderness, induration, swelling, erythema/redness) or systemic AEs (headache, myalgia, arthralgia, fever, vomiting, nausea, rash, fatigue). Unsolicited AEs, and SAEs are collected by non-systematic assessment up to Day 180. AESI is defined as symptoms suggestive of CHIKV infection up to 21 days after vaccination and collected by systematic assessment.	0.00% 0/135 • Up to Month 6 Solicited AEs are collected by systematic assessment through subject eDiaries (within 10 days postvaccination): injection site AEs (pain, tenderness, induration, swelling, erythema/redness) or systemic AEs (headache, myalgia, arthralgia, fever, vomiting, nausea, rash, fatigue). Unsolicited AEs, and SAEs are collected by non-systematic assessment up to Day 180. AESI is defined as symptoms suggestive of CHIKV infection up to 21 days after vaccination and collected by systematic assessment.
Hepatobiliary disorders Cholecystitis acute	0.74% 1/136 • Number of events 1 • Up to Month 6 Solicited AEs are collected by systematic assessment through subject eDiaries (within 10 days postvaccination): injection site AEs (pain, tenderness, induration, swelling, erythema/redness) or systemic AEs (headache, myalgia, arthralgia, fever, vomiting, nausea, rash, fatigue). Unsolicited AEs, and SAEs are collected by non-systematic assessment up to Day 180. AESI is defined as symptoms suggestive of CHIKV infection up to 21 days after vaccination and collected by systematic assessment.	0.00% 0/137 • Up to Month 6 Solicited AEs are collected by systematic assessment through subject eDiaries (within 10 days postvaccination): injection site AEs (pain, tenderness, induration, swelling, erythema/redness) or systemic AEs (headache, myalgia, arthralgia, fever, vomiting, nausea, rash, fatigue). Unsolicited AEs, and SAEs are collected by non-systematic assessment up to Day 180. AESI is defined as symptoms suggestive of CHIKV infection up to 21 days after vaccination and collected by systematic assessment.	0.00% 0/135 • Up to Month 6 Solicited AEs are collected by systematic assessment through subject eDiaries (within 10 days postvaccination): injection site AEs (pain, tenderness, induration, swelling, erythema/redness) or systemic AEs (headache, myalgia, arthralgia, fever, vomiting, nausea, rash, fatigue). Unsolicited AEs, and SAEs are collected by non-systematic assessment up to Day 180. AESI is defined as symptoms suggestive of CHIKV infection up to 21 days after vaccination and collected by systematic assessment.

Other adverse events

Additional Information

Clinical Strategy Manager

Valneva Austria GmbH

Phone: +43 1 206 20

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
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