Trial Outcomes & Findings for A Multicenter Study to Evaluate Safety and Immunogenicity of a Live-attenuated Chikungunya Vaccine in Adolescents (NCT NCT04650399)
NCT ID: NCT04650399
Last Updated: 2026-06-04
Results Overview
Percentage of subjects with a seroprotective CHIKV antibody level determined as µPRNT50\>= 150 (Micro Plaque Reduction Neutralization Test 50%) for baseline negative subjects 28 days post-vaccination.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
754 participants
Primary outcome timeframe
On study Day 29,which is 28 days after single vaccination
Results posted on
2026-06-04
Participant Flow
33 participants excluded from the Protocol population due to major protocol deviations.
Participant milestones
| Measure |
Active
VLA1553
Active: Single intramuscular vaccination on Day 1 with VLA1553, a lyophilized live-attenuated Chikungunya vaccine candidate 1x10E4 TCID50 per dose
|
Placebo
Placebo
Placebo: Single intramuscular vaccination on Day 1 with Phosphate-Buffered Saline (PBS) as placebo
|
|---|---|---|
|
Overall Study
STARTED
|
502
|
252
|
|
Overall Study
COMPLETED
|
488
|
246
|
|
Overall Study
NOT COMPLETED
|
14
|
6
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Serostatus result is missing for one participant
Baseline characteristics by cohort
| Measure |
Active
n=502 Participants
VLA1553
Active: Single intramuscular vaccination on Day 1 with VLA1553, a lyophilized live-attenuated Chikungunya vaccine candidate 1x10E4 TCID50 per dose
|
Placebo
n=252 Participants
Placebo
Placebo: Single intramuscular vaccination on Day 1 with Phosphate-Buffered Saline (PBS) as placebo
|
Total
n=754 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Customized
12-<15 years
|
244 Participants
n=502 Participants
|
129 Participants
n=252 Participants
|
373 Participants
n=754 Participants
|
|
Age, Customized
15 - <18 years
|
258 Participants
n=502 Participants
|
123 Participants
n=252 Participants
|
381 Participants
n=754 Participants
|
|
Sex: Female, Male
Female
|
269 Participants
n=502 Participants
|
137 Participants
n=252 Participants
|
406 Participants
n=754 Participants
|
|
Sex: Female, Male
Male
|
233 Participants
n=502 Participants
|
115 Participants
n=252 Participants
|
348 Participants
n=754 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
358 Participants
n=502 Participants
|
172 Participants
n=252 Participants
|
530 Participants
n=754 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
140 Participants
n=502 Participants
|
79 Participants
n=252 Participants
|
219 Participants
n=754 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
4 Participants
n=502 Participants
|
1 Participants
n=252 Participants
|
5 Participants
n=754 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
2 Participants
n=502 Participants
|
2 Participants
n=252 Participants
|
4 Participants
n=754 Participants
|
|
Race (NIH/OMB)
Asian
|
2 Participants
n=502 Participants
|
0 Participants
n=252 Participants
|
2 Participants
n=754 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=502 Participants
|
0 Participants
n=252 Participants
|
0 Participants
n=754 Participants
|
|
Race (NIH/OMB)
Black or African American
|
66 Participants
n=502 Participants
|
31 Participants
n=252 Participants
|
97 Participants
n=754 Participants
|
|
Race (NIH/OMB)
White
|
167 Participants
n=502 Participants
|
78 Participants
n=252 Participants
|
245 Participants
n=754 Participants
|
|
Race (NIH/OMB)
More than one race
|
120 Participants
n=502 Participants
|
72 Participants
n=252 Participants
|
192 Participants
n=754 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
145 Participants
n=502 Participants
|
69 Participants
n=252 Participants
|
214 Participants
n=754 Participants
|
|
Region of Enrollment
Brazil
|
502 Participants
n=502 Participants
|
252 Participants
n=252 Participants
|
754 Participants
n=754 Participants
|
|
BMI
|
21.63 Kg/square Meter
STANDARD_DEVIATION 4.81 • n=502 Participants
|
21.78 Kg/square Meter
STANDARD_DEVIATION 4.75 • n=252 Participants
|
21.68 Kg/square Meter
STANDARD_DEVIATION 4.79 • n=754 Participants
|
|
Serostatus (PRNT)
Seronegative μPRNT50<=40
|
408 Participants
n=502 Participants • Serostatus result is missing for one participant
|
206 Participants
n=251 Participants • Serostatus result is missing for one participant
|
614 Participants
n=753 Participants • Serostatus result is missing for one participant
|
|
Serostatus (PRNT)
Seropositive μPRNT50>40
|
94 Participants
n=502 Participants • Serostatus result is missing for one participant
|
45 Participants
n=251 Participants • Serostatus result is missing for one participant
|
139 Participants
n=753 Participants • Serostatus result is missing for one participant
|
PRIMARY outcome
Timeframe: On study Day 29,which is 28 days after single vaccinationPopulation: Per protocol population - Seronegative at baseline and without major protocol deviations that could impact the immune response
Percentage of subjects with a seroprotective CHIKV antibody level determined as µPRNT50\>= 150 (Micro Plaque Reduction Neutralization Test 50%) for baseline negative subjects 28 days post-vaccination.
Outcome measures
| Measure |
Active
n=251 Participants
VLA1553
Active: Single intramuscular vaccination on Day 1 with VLA1553, a lyophilized live-attenuated Chikungunya vaccine candidate 1x10E4 TCID50 per dose
|
Placebo
n=42 Participants
Placebo
Placebo: Single intramuscular vaccination on Day 1 with Phosphate-Buffered Saline (PBS) as placebo
|
|---|---|---|
|
Seroprotection
|
248 participants
|
1 participants
|
SECONDARY outcome
Timeframe: On study Day 1, Day 8, Day 29, Day 85, Day 180 (Month 6) and Day 365 (Month 12) post vaccinationPopulation: Only participants with no major protocol deviations out of the immunogenicity population (per protocol population) seronegative at baseline (µPRNT50\<= 40) were analysed: Active arm N= 251 Placebo arm N=42
Immune response as measured by CHIKV-specific neutralizing antibody titers on Day 1, Day 8, Day 29, Day 85, Day 180 (Month 6) and Day 365 (Month 12) post vaccination as determined by μPRNT
Outcome measures
| Measure |
Active
n=251 Participants
VLA1553
Active: Single intramuscular vaccination on Day 1 with VLA1553, a lyophilized live-attenuated Chikungunya vaccine candidate 1x10E4 TCID50 per dose
|
Placebo
n=42 Participants
Placebo
Placebo: Single intramuscular vaccination on Day 1 with Phosphate-Buffered Saline (PBS) as placebo
|
|---|---|---|
|
CHIKV-specific Antibody Titers as GMTs up to 1 Year
Month 12 GMT
|
1283.9 titer
Interval 1145.99 to 1438.45
|
10.0 titer
Interval 10.0 to 10.0
|
|
CHIKV-specific Antibody Titers as GMTs up to 1 Year
Day 8 GMT
|
17.6 titer
Interval 15.41 to 20.06
|
10.6 titer
Interval 9.75 to 11.44
|
|
CHIKV-specific Antibody Titers as GMTs up to 1 Year
Day 29 GMT
|
3855.9 titer
Interval 3432.05 to 4331.98
|
12.3 titer
Interval 9.63 to 15.79
|
|
CHIKV-specific Antibody Titers as GMTs up to 1 Year
Day 85 GMT
|
1704.3 titer
Interval 1547.68 to 1876.82
|
10.0 titer
Interval 10.0 to 10.0
|
|
CHIKV-specific Antibody Titers as GMTs up to 1 Year
Day 180 GMT
|
1359.9 titer
Interval 1222.34 to 1512.87
|
10.0 titer
Interval 10.0 to 10.0
|
|
CHIKV-specific Antibody Titers as GMTs up to 1 Year
Day 1 GMT
|
10.6 titer
Interval 10.31 to 10.89
|
11.7 titer
Interval 10.46 to 13.17
|
SECONDARY outcome
Timeframe: On the study Day 8, Day 85, Day 180, and Day 365 (Month 12) after vaccinationPopulation: Only participants with no major protocol deviations out of the immunogenicity population (per protocol population) seronegative at baseline (µPRNT50\<= 40) were analysed: Active arm N= 251 Placebo arm N=42
Percentage of subjects with seroprotective levels defined as μPRNT50 ≥ 150 for μPRNT baseline negative subjects on Day 8, Day 85, Day 180 and Month 12 post-vaccination as determined by μPRNT.
Outcome measures
| Measure |
Active
n=251 Participants
VLA1553
Active: Single intramuscular vaccination on Day 1 with VLA1553, a lyophilized live-attenuated Chikungunya vaccine candidate 1x10E4 TCID50 per dose
|
Placebo
n=42 Participants
Placebo
Placebo: Single intramuscular vaccination on Day 1 with Phosphate-Buffered Saline (PBS) as placebo
|
|---|---|---|
|
Seroprotection up to 1 Year
Day 8 · Seroprotected
|
14 Participants
|
0 Participants
|
|
Seroprotection up to 1 Year
Day 85 · Seroprotected
|
239 Participants
|
0 Participants
|
|
Seroprotection up to 1 Year
Day 85 · Non-seroprotected
|
2 Participants
|
41 Participants
|
|
Seroprotection up to 1 Year
Day 180 · Seroprotected
|
242 Participants
|
0 Participants
|
|
Seroprotection up to 1 Year
Day 180 · Non-seroprotected
|
3 Participants
|
42 Participants
|
|
Seroprotection up to 1 Year
Month12 · Seroprotected
|
232 Participants
|
0 Participants
|
|
Seroprotection up to 1 Year
Month12 · Non-seroprotected
|
4 Participants
|
41 Participants
|
|
Seroprotection up to 1 Year
Day 8 · Non-seroprotected
|
231 Participants
|
42 Participants
|
SECONDARY outcome
Timeframe: On study Day 29, Day 180 and Month 12 after vaccinationPopulation: Only participants with no major protocol deviations out of the immunogenicity population (per protocol population) seronegative at baseline (µPRNT50\<= 40) were analysed: Active arm N= 251 Placebo arm N=42
Percentage of subjects with seroconversion defined as \> 4-fold increase of μPRNT50 compared to baseline at Day 29, Month 6 and Month 12 as determined by μPRNT assay
Outcome measures
| Measure |
Active
n=251 Participants
VLA1553
Active: Single intramuscular vaccination on Day 1 with VLA1553, a lyophilized live-attenuated Chikungunya vaccine candidate 1x10E4 TCID50 per dose
|
Placebo
n=42 Participants
Placebo
Placebo: Single intramuscular vaccination on Day 1 with Phosphate-Buffered Saline (PBS) as placebo
|
|---|---|---|
|
Seroconversion up to 1 Year Defined as > 4-fold Increase of μPRNT50 Compared to Baseline
Day 29 · Seroconversion
|
248 Participants
|
1 Participants
|
|
Seroconversion up to 1 Year Defined as > 4-fold Increase of μPRNT50 Compared to Baseline
Day 29 · Non seroconversion
|
3 Participants
|
41 Participants
|
|
Seroconversion up to 1 Year Defined as > 4-fold Increase of μPRNT50 Compared to Baseline
Day 180 · Seroconversion
|
243 Participants
|
0 Participants
|
|
Seroconversion up to 1 Year Defined as > 4-fold Increase of μPRNT50 Compared to Baseline
Day 180 · Non seroconversion
|
2 Participants
|
42 Participants
|
|
Seroconversion up to 1 Year Defined as > 4-fold Increase of μPRNT50 Compared to Baseline
Month 12 · Seroconversion
|
234 Participants
|
0 Participants
|
|
Seroconversion up to 1 Year Defined as > 4-fold Increase of μPRNT50 Compared to Baseline
Month 12 · Non seroconversion
|
2 Participants
|
41 Participants
|
SECONDARY outcome
Timeframe: On study Day 8, 29, 85, 180 and Month 12 after vaccinationPopulation: Only participants with no major protocol deviations out of the immunogenicity population (per protocol population) seronegative at baseline (µPRNT50\<= 40) were analysed: Active arm N= 251 Placebo arm N=42
Fold change of CHIKV-specific neutralizing antibody titers determined by μPRNT assay at Days 8, 29, 85, 180 and at Month 12 post-vaccination as compared to baseline
Outcome measures
| Measure |
Active
n=251 Participants
VLA1553
Active: Single intramuscular vaccination on Day 1 with VLA1553, a lyophilized live-attenuated Chikungunya vaccine candidate 1x10E4 TCID50 per dose
|
Placebo
n=42 Participants
Placebo
Placebo: Single intramuscular vaccination on Day 1 with Phosphate-Buffered Saline (PBS) as placebo
|
|---|---|---|
|
Fold Change in Neutralizing Antibodies Compared to Baseline
Day 8
|
8.18 fold change
Standard Deviation 49.483
|
0.93 fold change
Standard Deviation 0.201
|
|
Fold Change in Neutralizing Antibodies Compared to Baseline
Day 85
|
202.73 fold change
Standard Deviation 141.663
|
0.90 fold change
Standard Deviation 0.235
|
|
Fold Change in Neutralizing Antibodies Compared to Baseline
Day 180
|
177.17 fold change
Standard Deviation 180.146
|
0.90 fold change
Standard Deviation 0.232
|
|
Fold Change in Neutralizing Antibodies Compared to Baseline
Month 12
|
165.51 fold change
Standard Deviation 147.792
|
0.91 fold change
Standard Deviation 0.215
|
|
Fold Change in Neutralizing Antibodies Compared to Baseline
Day 29
|
495.60 fold change
Standard Deviation 379.063
|
4.05 fold change
Standard Deviation 19.660
|
SECONDARY outcome
Timeframe: 365 days (12 months) after vaccinationPopulation: Only participants with no major protocol deviations out of the immunogenicity population (per protocol population) seronegative at baseline (µPRNT50\<= 40) were analysed: Active arm N= 251 Placebo arm N=42
Percentage of subjects reaching an at least 4-fold, 8-fold, 16-fold or 64-fold change in CHIKV-specific neutralizing antibody titer compared to baseline as measured by μPRNT assay
Outcome measures
| Measure |
Active
n=251 Participants
VLA1553
Active: Single intramuscular vaccination on Day 1 with VLA1553, a lyophilized live-attenuated Chikungunya vaccine candidate 1x10E4 TCID50 per dose
|
Placebo
n=42 Participants
Placebo
Placebo: Single intramuscular vaccination on Day 1 with Phosphate-Buffered Saline (PBS) as placebo
|
|---|---|---|
|
X-fold Change in Neutralizing Antibody Titers at Month 12 Compared to Baseline
8-fold change - GMT · reached
|
233 Participants
|
0 Participants
|
|
X-fold Change in Neutralizing Antibody Titers at Month 12 Compared to Baseline
8-fold change - GMT · not reached
|
3 Participants
|
41 Participants
|
|
X-fold Change in Neutralizing Antibody Titers at Month 12 Compared to Baseline
16-fold change - GMT · reached
|
232 Participants
|
0 Participants
|
|
X-fold Change in Neutralizing Antibody Titers at Month 12 Compared to Baseline
4-fold change - GMT · not reached
|
2 Participants
|
41 Participants
|
|
X-fold Change in Neutralizing Antibody Titers at Month 12 Compared to Baseline
16-fold change - GMT · not reached
|
4 Participants
|
41 Participants
|
|
X-fold Change in Neutralizing Antibody Titers at Month 12 Compared to Baseline
64-fold change - GMT · reached
|
194 Participants
|
0 Participants
|
|
X-fold Change in Neutralizing Antibody Titers at Month 12 Compared to Baseline
64-fold change - GMT · not reached
|
42 Participants
|
41 Participants
|
|
X-fold Change in Neutralizing Antibody Titers at Month 12 Compared to Baseline
4-fold change - GMT · reached
|
234 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: On study Day 1, 8, 29, 85, 180 and Month 12 after vaccinationPopulation: Only participants without major protocol deviations out of the immunogenicity population (= per protocol population) seronegative at baseline (µPRNT50\<= 40) or seropositive at baseline (μPRNT50\>40) were analysed: Active seropositive arm N= 52 Active seronegative arm N=251
CHIKV-specific neutralizing antibodies, determined by μPRNT assay at Days 1, 8, 29, 85, 180, and Month 12 post-vaccination stratified by μPRNT baseline serostatus.
Outcome measures
| Measure |
Active
n=52 Participants
VLA1553
Active: Single intramuscular vaccination on Day 1 with VLA1553, a lyophilized live-attenuated Chikungunya vaccine candidate 1x10E4 TCID50 per dose
|
Placebo
n=251 Participants
Placebo
Placebo: Single intramuscular vaccination on Day 1 with Phosphate-Buffered Saline (PBS) as placebo
|
|---|---|---|
|
Immunogenicity (GMT) Per Baseline Serostatus
Day 1
|
3097.1 Titer
Interval 2324.9 to 4125.89
|
10.6 Titer
Interval 10.31 to 10.89
|
|
Immunogenicity (GMT) Per Baseline Serostatus
Day 8
|
3251.2 Titer
Interval 2458.75 to 4298.98
|
17.6 Titer
Interval 15.41 to 20.06
|
|
Immunogenicity (GMT) Per Baseline Serostatus
Day 29
|
3886.5 Titer
Interval 3063.4 to 4930.87
|
3855.9 Titer
Interval 3432.05 to 4331.98
|
|
Immunogenicity (GMT) Per Baseline Serostatus
Day 85
|
3913.4 Titer
Interval 3015.95 to 5077.91
|
1704.3 Titer
Interval 1547.68 to 1876.82
|
|
Immunogenicity (GMT) Per Baseline Serostatus
Day 180
|
3736.8 Titer
Interval 2848.17 to 4902.71
|
1359.9 Titer
Interval 1222.34 to 1512.87
|
|
Immunogenicity (GMT) Per Baseline Serostatus
Month 12
|
5048.2 Titer
Interval 3931.03 to 6482.89
|
1283.9 Titer
Interval 1145.99 to 1438.45
|
SECONDARY outcome
Timeframe: On study Day 29 and Day 180 after vaccinationPopulation: Safety Population
Frequency of unsolicited AEs at Day 29 and Day 180 (6 months) post-vaccination
Outcome measures
| Measure |
Active
n=502 Participants
VLA1553
Active: Single intramuscular vaccination on Day 1 with VLA1553, a lyophilized live-attenuated Chikungunya vaccine candidate 1x10E4 TCID50 per dose
|
Placebo
n=252 Participants
Placebo
Placebo: Single intramuscular vaccination on Day 1 with Phosphate-Buffered Saline (PBS) as placebo
|
|---|---|---|
|
Number of Participants With Unsolicited Adverse Events
Day 180
|
309 Participants
|
148 Participants
|
|
Number of Participants With Unsolicited Adverse Events
Day 29
|
196 Participants
|
81 Participants
|
SECONDARY outcome
Timeframe: up to 10 days after vaccinationPopulation: Safety Population
Frequency of solicited injection site and systemic adverse events within ten days post-vaccination
Outcome measures
| Measure |
Active
n=502 Participants
VLA1553
Active: Single intramuscular vaccination on Day 1 with VLA1553, a lyophilized live-attenuated Chikungunya vaccine candidate 1x10E4 TCID50 per dose
|
Placebo
n=252 Participants
Placebo
Placebo: Single intramuscular vaccination on Day 1 with Phosphate-Buffered Saline (PBS) as placebo
|
|---|---|---|
|
Number of Participants With Solicited Adverse Events
Any solicited systemic adverse event
|
319 Participants
|
107 Participants
|
|
Number of Participants With Solicited Adverse Events
Headache (Solicited Systemic AE
|
256 Participants
|
87 Participants
|
|
Number of Participants With Solicited Adverse Events
Myalgia (Solicited Systemic AE)
|
135 Participants
|
31 Participants
|
|
Number of Participants With Solicited Adverse Events
Fatigue (Solicited Systemic AE)
|
112 Participants
|
24 Participants
|
|
Number of Participants With Solicited Adverse Events
Fever (Solicited Systemic AE)
|
121 Participants
|
9 Participants
|
|
Number of Participants With Solicited Adverse Events
Nausea (Solicited Systemic AE)
|
80 Participants
|
31 Participants
|
|
Number of Participants With Solicited Adverse Events
Arthralgia (Solicited Systemic AE)
|
65 Participants
|
14 Participants
|
|
Number of Participants With Solicited Adverse Events
Vomiting (Solicited Systemic AE)
|
13 Participants
|
9 Participants
|
|
Number of Participants With Solicited Adverse Events
Rash (Solicited Systemic AE)
|
18 Participants
|
2 Participants
|
|
Number of Participants With Solicited Adverse Events
Any solicited injection site adverse event
|
160 Participants
|
62 Participants
|
|
Number of Participants With Solicited Adverse Events
Tenderness (Solicited Local AE)
|
100 Participants
|
37 Participants
|
|
Number of Participants With Solicited Adverse Events
Pain (Solicited Local AE)
|
97 Participants
|
34 Participants
|
|
Number of Participants With Solicited Adverse Events
Induration (Solicited Local AE)
|
21 Participants
|
11 Participants
|
|
Number of Participants With Solicited Adverse Events
Redness (Solicited Local AE)
|
11 Participants
|
3 Participants
|
|
Number of Participants With Solicited Adverse Events
Swelling (Solicited Local AE)
|
7 Participants
|
7 Participants
|
SECONDARY outcome
Timeframe: until 365 days (12 months) after vaccinationPopulation: Safety population
Frequency of any Adverse Event of Special Interest: The following cluster of symptoms with or without remissions or exacerbations received particular consideration and were defined as early onset AESI: 1. Fever (≥37.8°C measured axillary); and 2. Acute (poly)arthralgia/arthritis, myalgia, neurological symptoms (e.g., meningoencephalitis, acute encephalitis, headache, seizures), retinitis/uveitis; or one or more of the following signs and symptoms: macular to maculopapular rash (sometimes with cutaneous pruritus (foot plant)), pigmentary changes, bullous rash/skin blistering, purpura and ecchymosis; and 3. Onset of symptoms 2 to 21 days after vaccination (i.e., Day 3 to Day 22); and 4. Duration of event ≥3 days, Onset of symptoms 22 days post vaccination or later (Day 23 - study end) was defined as late onset AESI.
Outcome measures
| Measure |
Active
n=502 Participants
VLA1553
Active: Single intramuscular vaccination on Day 1 with VLA1553, a lyophilized live-attenuated Chikungunya vaccine candidate 1x10E4 TCID50 per dose
|
Placebo
n=252 Participants
Placebo
Placebo: Single intramuscular vaccination on Day 1 with Phosphate-Buffered Saline (PBS) as placebo
|
|---|---|---|
|
Number of Participants With Adverse Event of Special Interest
Early Onset AESI
|
17 Participants
|
2 Participants
|
|
Number of Participants With Adverse Event of Special Interest
Late Onset AESI
|
38 Participants
|
17 Participants
|
SECONDARY outcome
Timeframe: until 365 days (12 months) after vaccinationPopulation: Safety population
Frequency and relatedness of any Serious Adverse Event (SAE) during the entire study period
Outcome measures
| Measure |
Active
n=502 Participants
VLA1553
Active: Single intramuscular vaccination on Day 1 with VLA1553, a lyophilized live-attenuated Chikungunya vaccine candidate 1x10E4 TCID50 per dose
|
Placebo
n=252 Participants
Placebo
Placebo: Single intramuscular vaccination on Day 1 with Phosphate-Buffered Saline (PBS) as placebo
|
|---|---|---|
|
Number of Participants With Serious Adverse Events
Frequency of related SAE
|
1 Participants
|
0 Participants
|
|
Number of Participants With Serious Adverse Events
Frequency of SAE
|
11 Participants
|
5 Participants
|
Adverse Events
Active
Serious events: 11 serious events
Other events: 396 other events
Deaths: 0 deaths
Placebo
Serious events: 5 serious events
Other events: 171 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Active
n=502 participants at risk
VLA1553
Active: Single intramuscular vaccination on Day 1 with VLA1553, a lyophilized live-attenuated Chikungunya vaccine candidate 1x10E4 TCID50 per dose
|
Placebo
n=252 participants at risk
Placebo
Placebo: Single intramuscular vaccination on Day 1 with Phosphate-Buffered Saline (PBS) as placebo
|
|---|---|---|
|
Psychiatric disorders
Suicidal ideation
|
0.00%
0/502 • up to 10 days after vaccination - Solicited Adverse Events up to 6 months after vaccinattion - Unsolicited Adverse Events up to 12 months after vaccination - Serious Adverse Events and Adverse Event of Special Interest
|
0.40%
1/252 • Number of events 1 • up to 10 days after vaccination - Solicited Adverse Events up to 6 months after vaccinattion - Unsolicited Adverse Events up to 12 months after vaccination - Serious Adverse Events and Adverse Event of Special Interest
|
|
Infections and infestations
Pneumonia
|
0.20%
1/502 • Number of events 1 • up to 10 days after vaccination - Solicited Adverse Events up to 6 months after vaccinattion - Unsolicited Adverse Events up to 12 months after vaccination - Serious Adverse Events and Adverse Event of Special Interest
|
0.40%
1/252 • Number of events 1 • up to 10 days after vaccination - Solicited Adverse Events up to 6 months after vaccinattion - Unsolicited Adverse Events up to 12 months after vaccination - Serious Adverse Events and Adverse Event of Special Interest
|
|
Infections and infestations
Dengue fever
|
0.00%
0/502 • up to 10 days after vaccination - Solicited Adverse Events up to 6 months after vaccinattion - Unsolicited Adverse Events up to 12 months after vaccination - Serious Adverse Events and Adverse Event of Special Interest
|
0.40%
1/252 • Number of events 1 • up to 10 days after vaccination - Solicited Adverse Events up to 6 months after vaccinattion - Unsolicited Adverse Events up to 12 months after vaccination - Serious Adverse Events and Adverse Event of Special Interest
|
|
Investigations
Prothrombin time prolonged
|
0.00%
0/502 • up to 10 days after vaccination - Solicited Adverse Events up to 6 months after vaccinattion - Unsolicited Adverse Events up to 12 months after vaccination - Serious Adverse Events and Adverse Event of Special Interest
|
0.40%
1/252 • Number of events 1 • up to 10 days after vaccination - Solicited Adverse Events up to 6 months after vaccinattion - Unsolicited Adverse Events up to 12 months after vaccination - Serious Adverse Events and Adverse Event of Special Interest
|
|
Infections and infestations
Pharyngitis
|
0.00%
0/502 • up to 10 days after vaccination - Solicited Adverse Events up to 6 months after vaccinattion - Unsolicited Adverse Events up to 12 months after vaccination - Serious Adverse Events and Adverse Event of Special Interest
|
0.40%
1/252 • Number of events 1 • up to 10 days after vaccination - Solicited Adverse Events up to 6 months after vaccinattion - Unsolicited Adverse Events up to 12 months after vaccination - Serious Adverse Events and Adverse Event of Special Interest
|
|
Metabolism and nutrition disorders
Hyperkalemia
|
0.20%
1/502 • Number of events 1 • up to 10 days after vaccination - Solicited Adverse Events up to 6 months after vaccinattion - Unsolicited Adverse Events up to 12 months after vaccination - Serious Adverse Events and Adverse Event of Special Interest
|
0.00%
0/252 • up to 10 days after vaccination - Solicited Adverse Events up to 6 months after vaccinattion - Unsolicited Adverse Events up to 12 months after vaccination - Serious Adverse Events and Adverse Event of Special Interest
|
|
Blood and lymphatic system disorders
Neutropenia
|
0.20%
1/502 • Number of events 1 • up to 10 days after vaccination - Solicited Adverse Events up to 6 months after vaccinattion - Unsolicited Adverse Events up to 12 months after vaccination - Serious Adverse Events and Adverse Event of Special Interest
|
0.00%
0/252 • up to 10 days after vaccination - Solicited Adverse Events up to 6 months after vaccinattion - Unsolicited Adverse Events up to 12 months after vaccination - Serious Adverse Events and Adverse Event of Special Interest
|
|
Infections and infestations
Gastroenteritis
|
0.20%
1/502 • Number of events 1 • up to 10 days after vaccination - Solicited Adverse Events up to 6 months after vaccinattion - Unsolicited Adverse Events up to 12 months after vaccination - Serious Adverse Events and Adverse Event of Special Interest
|
0.00%
0/252 • up to 10 days after vaccination - Solicited Adverse Events up to 6 months after vaccinattion - Unsolicited Adverse Events up to 12 months after vaccination - Serious Adverse Events and Adverse Event of Special Interest
|
|
Nervous system disorders
Juvenile Myoclonic Epilepsy
|
0.20%
1/502 • Number of events 1 • up to 10 days after vaccination - Solicited Adverse Events up to 6 months after vaccinattion - Unsolicited Adverse Events up to 12 months after vaccination - Serious Adverse Events and Adverse Event of Special Interest
|
0.00%
0/252 • up to 10 days after vaccination - Solicited Adverse Events up to 6 months after vaccinattion - Unsolicited Adverse Events up to 12 months after vaccination - Serious Adverse Events and Adverse Event of Special Interest
|
|
Investigations
Transaminase increase
|
0.00%
0/502 • up to 10 days after vaccination - Solicited Adverse Events up to 6 months after vaccinattion - Unsolicited Adverse Events up to 12 months after vaccination - Serious Adverse Events and Adverse Event of Special Interest
|
0.40%
1/252 • Number of events 1 • up to 10 days after vaccination - Solicited Adverse Events up to 6 months after vaccinattion - Unsolicited Adverse Events up to 12 months after vaccination - Serious Adverse Events and Adverse Event of Special Interest
|
|
Injury, poisoning and procedural complications
Lower limb fracture
|
0.20%
1/502 • Number of events 1 • up to 10 days after vaccination - Solicited Adverse Events up to 6 months after vaccinattion - Unsolicited Adverse Events up to 12 months after vaccination - Serious Adverse Events and Adverse Event of Special Interest
|
0.00%
0/252 • up to 10 days after vaccination - Solicited Adverse Events up to 6 months after vaccinattion - Unsolicited Adverse Events up to 12 months after vaccination - Serious Adverse Events and Adverse Event of Special Interest
|
|
Infections and infestations
Cat scratch disease
|
0.20%
1/502 • Number of events 1 • up to 10 days after vaccination - Solicited Adverse Events up to 6 months after vaccinattion - Unsolicited Adverse Events up to 12 months after vaccination - Serious Adverse Events and Adverse Event of Special Interest
|
0.00%
0/252 • up to 10 days after vaccination - Solicited Adverse Events up to 6 months after vaccinattion - Unsolicited Adverse Events up to 12 months after vaccination - Serious Adverse Events and Adverse Event of Special Interest
|
|
General disorders
Pyrexia
|
0.20%
1/502 • Number of events 1 • up to 10 days after vaccination - Solicited Adverse Events up to 6 months after vaccinattion - Unsolicited Adverse Events up to 12 months after vaccination - Serious Adverse Events and Adverse Event of Special Interest
|
0.00%
0/252 • up to 10 days after vaccination - Solicited Adverse Events up to 6 months after vaccinattion - Unsolicited Adverse Events up to 12 months after vaccination - Serious Adverse Events and Adverse Event of Special Interest
|
|
Infections and infestations
Appendicitis
|
0.20%
1/502 • Number of events 1 • up to 10 days after vaccination - Solicited Adverse Events up to 6 months after vaccinattion - Unsolicited Adverse Events up to 12 months after vaccination - Serious Adverse Events and Adverse Event of Special Interest
|
0.00%
0/252 • up to 10 days after vaccination - Solicited Adverse Events up to 6 months after vaccinattion - Unsolicited Adverse Events up to 12 months after vaccination - Serious Adverse Events and Adverse Event of Special Interest
|
|
Injury, poisoning and procedural complications
Arthropod sting
|
0.20%
1/502 • Number of events 1 • up to 10 days after vaccination - Solicited Adverse Events up to 6 months after vaccinattion - Unsolicited Adverse Events up to 12 months after vaccination - Serious Adverse Events and Adverse Event of Special Interest
|
0.00%
0/252 • up to 10 days after vaccination - Solicited Adverse Events up to 6 months after vaccinattion - Unsolicited Adverse Events up to 12 months after vaccination - Serious Adverse Events and Adverse Event of Special Interest
|
|
Nervous system disorders
Seizure
|
0.20%
1/502 • Number of events 1 • up to 10 days after vaccination - Solicited Adverse Events up to 6 months after vaccinattion - Unsolicited Adverse Events up to 12 months after vaccination - Serious Adverse Events and Adverse Event of Special Interest
|
0.00%
0/252 • up to 10 days after vaccination - Solicited Adverse Events up to 6 months after vaccinattion - Unsolicited Adverse Events up to 12 months after vaccination - Serious Adverse Events and Adverse Event of Special Interest
|
Other adverse events
| Measure |
Active
n=502 participants at risk
VLA1553
Active: Single intramuscular vaccination on Day 1 with VLA1553, a lyophilized live-attenuated Chikungunya vaccine candidate 1x10E4 TCID50 per dose
|
Placebo
n=252 participants at risk
Placebo
Placebo: Single intramuscular vaccination on Day 1 with Phosphate-Buffered Saline (PBS) as placebo
|
|---|---|---|
|
General disorders
Pyrexia
|
38.6%
194/502 • Number of events 276 • up to 10 days after vaccination - Solicited Adverse Events up to 6 months after vaccinattion - Unsolicited Adverse Events up to 12 months after vaccination - Serious Adverse Events and Adverse Event of Special Interest
|
27.0%
68/252 • Number of events 86 • up to 10 days after vaccination - Solicited Adverse Events up to 6 months after vaccinattion - Unsolicited Adverse Events up to 12 months after vaccination - Serious Adverse Events and Adverse Event of Special Interest
|
|
General disorders
Injection site pain
|
29.7%
149/502 • Number of events 198 • up to 10 days after vaccination - Solicited Adverse Events up to 6 months after vaccinattion - Unsolicited Adverse Events up to 12 months after vaccination - Serious Adverse Events and Adverse Event of Special Interest
|
21.8%
55/252 • Number of events 72 • up to 10 days after vaccination - Solicited Adverse Events up to 6 months after vaccinattion - Unsolicited Adverse Events up to 12 months after vaccination - Serious Adverse Events and Adverse Event of Special Interest
|
|
Nervous system disorders
Headache
|
56.6%
284/502 • Number of events 393 • up to 10 days after vaccination - Solicited Adverse Events up to 6 months after vaccinattion - Unsolicited Adverse Events up to 12 months after vaccination - Serious Adverse Events and Adverse Event of Special Interest
|
45.2%
114/252 • Number of events 160 • up to 10 days after vaccination - Solicited Adverse Events up to 6 months after vaccinattion - Unsolicited Adverse Events up to 12 months after vaccination - Serious Adverse Events and Adverse Event of Special Interest
|
|
General disorders
Fatigue
|
23.3%
117/502 • Number of events 123 • up to 10 days after vaccination - Solicited Adverse Events up to 6 months after vaccinattion - Unsolicited Adverse Events up to 12 months after vaccination - Serious Adverse Events and Adverse Event of Special Interest
|
11.9%
30/252 • Number of events 32 • up to 10 days after vaccination - Solicited Adverse Events up to 6 months after vaccinattion - Unsolicited Adverse Events up to 12 months after vaccination - Serious Adverse Events and Adverse Event of Special Interest
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
32.3%
162/502 • Number of events 186 • up to 10 days after vaccination - Solicited Adverse Events up to 6 months after vaccinattion - Unsolicited Adverse Events up to 12 months after vaccination - Serious Adverse Events and Adverse Event of Special Interest
|
19.4%
49/252 • Number of events 61 • up to 10 days after vaccination - Solicited Adverse Events up to 6 months after vaccinattion - Unsolicited Adverse Events up to 12 months after vaccination - Serious Adverse Events and Adverse Event of Special Interest
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
14.7%
74/502 • Number of events 75 • up to 10 days after vaccination - Solicited Adverse Events up to 6 months after vaccinattion - Unsolicited Adverse Events up to 12 months after vaccination - Serious Adverse Events and Adverse Event of Special Interest
|
7.5%
19/252 • Number of events 20 • up to 10 days after vaccination - Solicited Adverse Events up to 6 months after vaccinattion - Unsolicited Adverse Events up to 12 months after vaccination - Serious Adverse Events and Adverse Event of Special Interest
|
|
Gastrointestinal disorders
Nausea
|
19.7%
99/502 • Number of events 108 • up to 10 days after vaccination - Solicited Adverse Events up to 6 months after vaccinattion - Unsolicited Adverse Events up to 12 months after vaccination - Serious Adverse Events and Adverse Event of Special Interest
|
16.3%
41/252 • Number of events 49 • up to 10 days after vaccination - Solicited Adverse Events up to 6 months after vaccinattion - Unsolicited Adverse Events up to 12 months after vaccination - Serious Adverse Events and Adverse Event of Special Interest
|
|
Gastrointestinal disorders
Odynophagia
|
8.8%
44/502 • Number of events 52 • up to 10 days after vaccination - Solicited Adverse Events up to 6 months after vaccinattion - Unsolicited Adverse Events up to 12 months after vaccination - Serious Adverse Events and Adverse Event of Special Interest
|
10.3%
26/252 • Number of events 36 • up to 10 days after vaccination - Solicited Adverse Events up to 6 months after vaccinattion - Unsolicited Adverse Events up to 12 months after vaccination - Serious Adverse Events and Adverse Event of Special Interest
|
|
Gastrointestinal disorders
Vomiting
|
6.0%
30/502 • Number of events 34 • up to 10 days after vaccination - Solicited Adverse Events up to 6 months after vaccinattion - Unsolicited Adverse Events up to 12 months after vaccination - Serious Adverse Events and Adverse Event of Special Interest
|
9.5%
24/252 • Number of events 28 • up to 10 days after vaccination - Solicited Adverse Events up to 6 months after vaccinattion - Unsolicited Adverse Events up to 12 months after vaccination - Serious Adverse Events and Adverse Event of Special Interest
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
10.0%
50/502 • Number of events 61 • up to 10 days after vaccination - Solicited Adverse Events up to 6 months after vaccinattion - Unsolicited Adverse Events up to 12 months after vaccination - Serious Adverse Events and Adverse Event of Special Interest
|
10.3%
26/252 • Number of events 35 • up to 10 days after vaccination - Solicited Adverse Events up to 6 months after vaccinattion - Unsolicited Adverse Events up to 12 months after vaccination - Serious Adverse Events and Adverse Event of Special Interest
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
4.8%
24/502 • Number of events 25 • up to 10 days after vaccination - Solicited Adverse Events up to 6 months after vaccinattion - Unsolicited Adverse Events up to 12 months after vaccination - Serious Adverse Events and Adverse Event of Special Interest
|
6.7%
17/252 • Number of events 17 • up to 10 days after vaccination - Solicited Adverse Events up to 6 months after vaccinattion - Unsolicited Adverse Events up to 12 months after vaccination - Serious Adverse Events and Adverse Event of Special Interest
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhoea
|
3.8%
19/502 • Number of events 23 • up to 10 days after vaccination - Solicited Adverse Events up to 6 months after vaccinattion - Unsolicited Adverse Events up to 12 months after vaccination - Serious Adverse Events and Adverse Event of Special Interest
|
6.3%
16/252 • Number of events 18 • up to 10 days after vaccination - Solicited Adverse Events up to 6 months after vaccinattion - Unsolicited Adverse Events up to 12 months after vaccination - Serious Adverse Events and Adverse Event of Special Interest
|
|
Infections and infestations
Influenza
|
8.0%
40/502 • Number of events 47 • up to 10 days after vaccination - Solicited Adverse Events up to 6 months after vaccinattion - Unsolicited Adverse Events up to 12 months after vaccination - Serious Adverse Events and Adverse Event of Special Interest
|
7.1%
18/252 • Number of events 18 • up to 10 days after vaccination - Solicited Adverse Events up to 6 months after vaccinattion - Unsolicited Adverse Events up to 12 months after vaccination - Serious Adverse Events and Adverse Event of Special Interest
|
|
Infections and infestations
Rhinitis
|
3.8%
19/502 • Number of events 22 • up to 10 days after vaccination - Solicited Adverse Events up to 6 months after vaccinattion - Unsolicited Adverse Events up to 12 months after vaccination - Serious Adverse Events and Adverse Event of Special Interest
|
5.6%
14/252 • Number of events 19 • up to 10 days after vaccination - Solicited Adverse Events up to 6 months after vaccinattion - Unsolicited Adverse Events up to 12 months after vaccination - Serious Adverse Events and Adverse Event of Special Interest
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place