Trial Outcomes & Findings for Study of Live Attenuated ChimeriVax™-Japanese Encephalitis Vaccine (NCT NCT00981630)
NCT ID: NCT00981630
Last Updated: 2012-12-05
Results Overview
Antibodies were measured using 50% plaque reduction neutralization test (PRNT50) for measurement of neutralizing antibodies against homologous ChimeriVax™-JE and wild type JE virus strains. Seroconversion was defined as a titer ≥ 1:20 at post vaccination timepoints for subjects who were seronegative at baseline, or ≥ 4 fold rise from baseline.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
128 participants
Primary outcome timeframe
Day 11 and Day 30 post-vaccination
Results posted on
2012-12-05
Participant Flow
Participants were enrolled from 01 December 2004 to 31 January 2005 at 2 clinical centers in Australia.
A total of 128 participants who met all of the inclusion criteria and none of the exclusion criteria were enrolled and vaccinated.
Participant milestones
| Measure |
ChimeriVax™-JE 3 log10 PFU
All participants received a single dose of ChimeriVax™-JE 3 log10 Plaque-forming units (PFU) vaccine on Day 0.
|
ChimeriVax™-JE 4 log10 PFU
All participants received a single dose of ChimeriVax™-JE 4 log10 Plaque-forming units (PFU) vaccine on Day 0.
|
ChimeriVax™-JE 5 log10 PFU
All participants received a single dose of ChimeriVax™-JE 5 log10 Plaque-forming units (PFU) vaccine on Day 0
|
Placebo
All participants received a single dose of Placebo (diluent) on Day 0.
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
32
|
32
|
32
|
32
|
|
Overall Study
COMPLETED
|
32
|
32
|
32
|
32
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Study of Live Attenuated ChimeriVax™-Japanese Encephalitis Vaccine
Baseline characteristics by cohort
| Measure |
ChimeriVax™-JE 3 log10 PFU
n=32 Participants
All participants received a single dose of ChimeriVax™-JE 3 log10 Plaque-forming units (PFU) vaccine on Day 0.
|
ChimeriVax™-JE 4 log10 PFU
n=32 Participants
All participants received a single dose of ChimeriVax™-JE 4 log10 Plaque-forming units (PFU) vaccine on Day 0.
|
ChimeriVax™-JE 5 log10 PFU
n=32 Participants
All participants received a single dose of ChimeriVax™-JE 5 log10 Plaque-forming units (PFU) vaccine on Day 0
|
Placebo
n=32 Participants
All participants received a single dose of Placebo (diluent) on Day 0.
|
Total
n=128 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
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
32 Participants
n=5 Participants
|
32 Participants
n=7 Participants
|
32 Participants
n=5 Participants
|
32 Participants
n=4 Participants
|
128 Participants
n=21 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Age Continuous
|
29.3 Years
STANDARD_DEVIATION 7.62 • n=5 Participants
|
26.7 Years
STANDARD_DEVIATION 9.17 • n=7 Participants
|
27.4 Years
STANDARD_DEVIATION 8.31 • n=5 Participants
|
29.4 Years
STANDARD_DEVIATION 8.43 • n=4 Participants
|
28.2 Years
STANDARD_DEVIATION 8.38 • n=21 Participants
|
|
Sex: Female, Male
Female
|
15 Participants
n=5 Participants
|
18 Participants
n=7 Participants
|
15 Participants
n=5 Participants
|
16 Participants
n=4 Participants
|
64 Participants
n=21 Participants
|
|
Sex: Female, Male
Male
|
17 Participants
n=5 Participants
|
14 Participants
n=7 Participants
|
17 Participants
n=5 Participants
|
16 Participants
n=4 Participants
|
64 Participants
n=21 Participants
|
|
Region of Enrollment
Australia
|
32 Participants
n=5 Participants
|
32 Participants
n=7 Participants
|
32 Participants
n=5 Participants
|
32 Participants
n=4 Participants
|
128 Participants
n=21 Participants
|
PRIMARY outcome
Timeframe: Day 11 and Day 30 post-vaccinationPopulation: Seroconversion was assessed in all participants who were negative for homologous and all wild type JE antibodies at Day 0 and had no protocol violations that might have interfered with evaluation of primary criterion.
Antibodies were measured using 50% plaque reduction neutralization test (PRNT50) for measurement of neutralizing antibodies against homologous ChimeriVax™-JE and wild type JE virus strains. Seroconversion was defined as a titer ≥ 1:20 at post vaccination timepoints for subjects who were seronegative at baseline, or ≥ 4 fold rise from baseline.
Outcome measures
| Measure |
ChimeriVax™-JE 3 log10 PFU
n=31 Participants
All participants received a single dose of ChimeriVax™-JE 3 log10 Plaque-forming units (PFU) vaccine on Day 0.
|
ChimeriVax™-JE 4 log10 PFU
n=32 Participants
All participants received a single dose of ChimeriVax™-JE 4 log10 Plaque-forming units (PFU) vaccine on Day 0.
|
ChimeriVax™-JE 5 log10 PFU
n=31 Participants
All participants received a single dose of ChimeriVax™-JE 5 log10 Plaque-forming units (PFU) vaccine on Day 0
|
Placebo
n=32 Participants
All participants received a single dose of Placebo (diluent) on Day 0.
|
|---|---|---|---|---|
|
Number of Participants Who Seroconverted to the Respective Homologous JE Vaccine Strain, 28 Days After Completion of the Primary Immunization Schedule With One of 3 Doses of ChimeriVax™-JE Vaccine or A Placebo
Day 11
|
1 Participants
|
10 Participants
|
8 Participants
|
0 Participants
|
|
Number of Participants Who Seroconverted to the Respective Homologous JE Vaccine Strain, 28 Days After Completion of the Primary Immunization Schedule With One of 3 Doses of ChimeriVax™-JE Vaccine or A Placebo
Day 30
|
31 Participants
|
30 Participants
|
29 Participants
|
1 Participants
|
PRIMARY outcome
Timeframe: Day 30 post-vaccinationPopulation: Seroconversion was assessed in all participants who were negative for homologous and all wild type JE antibodies at Day 0 and had no protocol violations that might have interfered with evaluation of primary criterion.
Antibodies were measured using 50% plaque reduction neutralization test (PRNT50) for measurement of neutralizing antibodies against homologous ChimeriVax™-JE and wild type JE virus strains. Seroconversion was defined as a titer ≥ 1:20 at post vaccination time points for subjects who were seronegative at baseline, or ≥ 4 fold rise from baseline.
Outcome measures
| Measure |
ChimeriVax™-JE 3 log10 PFU
n=31 Participants
All participants received a single dose of ChimeriVax™-JE 3 log10 Plaque-forming units (PFU) vaccine on Day 0.
|
ChimeriVax™-JE 4 log10 PFU
n=32 Participants
All participants received a single dose of ChimeriVax™-JE 4 log10 Plaque-forming units (PFU) vaccine on Day 0.
|
ChimeriVax™-JE 5 log10 PFU
n=31 Participants
All participants received a single dose of ChimeriVax™-JE 5 log10 Plaque-forming units (PFU) vaccine on Day 0
|
Placebo
n=32 Participants
All participants received a single dose of Placebo (diluent) on Day 0.
|
|---|---|---|---|---|
|
Number of Participants Who Seroconverted to Wild Type JE Virus Strains After Primary Immunization Schedule With One of 3 Doses of ChimeriVax™-JE Vaccine or a Placebo
Genotype III Beijing
|
31 Participants
|
30 Participants
|
30 Participants
|
1 Participants
|
|
Number of Participants Who Seroconverted to Wild Type JE Virus Strains After Primary Immunization Schedule With One of 3 Doses of ChimeriVax™-JE Vaccine or a Placebo
Genotype I
|
31 Participants
|
28 Participants
|
30 Participants
|
1 Participants
|
|
Number of Participants Who Seroconverted to Wild Type JE Virus Strains After Primary Immunization Schedule With One of 3 Doses of ChimeriVax™-JE Vaccine or a Placebo
Genotype II
|
25 Participants
|
25 Participants
|
25 Participants
|
0 Participants
|
|
Number of Participants Who Seroconverted to Wild Type JE Virus Strains After Primary Immunization Schedule With One of 3 Doses of ChimeriVax™-JE Vaccine or a Placebo
Genotype III P3
|
30 Participants
|
29 Participants
|
29 Participants
|
0 Participants
|
|
Number of Participants Who Seroconverted to Wild Type JE Virus Strains After Primary Immunization Schedule With One of 3 Doses of ChimeriVax™-JE Vaccine or a Placebo
Genotype III Nakayama
|
31 Participants
|
27 Participants
|
27 Participants
|
1 Participants
|
|
Number of Participants Who Seroconverted to Wild Type JE Virus Strains After Primary Immunization Schedule With One of 3 Doses of ChimeriVax™-JE Vaccine or a Placebo
Genotype IV
|
25 Participants
|
28 Participants
|
26 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: Day 0 (post-vaccination) up to Day 30 post-vaccinationPopulation: Adverse events were assessed in all randomized participants who received one injection of study treatment, according to the treatment actually received (Safety Population).
Local Injection Site Adverse Events (AEs): Pain, Erythema, Reaction, Hemorrhage, Induration, Paresthesia. Treatment Related Systemic AEs: Fever, Chills, Malaise, Fatigue, Headache, Myalgia, Arthralgia, Nausea, Vomiting, Diarrhea, Rash. Other AEs as reported spontaneously.
Outcome measures
| Measure |
ChimeriVax™-JE 3 log10 PFU
n=32 Participants
All participants received a single dose of ChimeriVax™-JE 3 log10 Plaque-forming units (PFU) vaccine on Day 0.
|
ChimeriVax™-JE 4 log10 PFU
n=32 Participants
All participants received a single dose of ChimeriVax™-JE 4 log10 Plaque-forming units (PFU) vaccine on Day 0.
|
ChimeriVax™-JE 5 log10 PFU
n=32 Participants
All participants received a single dose of ChimeriVax™-JE 5 log10 Plaque-forming units (PFU) vaccine on Day 0
|
Placebo
n=32 Participants
All participants received a single dose of Placebo (diluent) on Day 0.
|
|---|---|---|---|---|
|
Number of Participants Reporting Solicited Local Injection Site and Treatment Related Adverse Events Post Vaccination With One of 3 Doses of ChimeriVax™-JE Vaccine or Placebo
Pharyngitis
|
2 Participants
|
3 Participants
|
3 Participants
|
4 Participants
|
|
Number of Participants Reporting Solicited Local Injection Site and Treatment Related Adverse Events Post Vaccination With One of 3 Doses of ChimeriVax™-JE Vaccine or Placebo
Diarrhea Infectious
|
0 Participants
|
2 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants Reporting Solicited Local Injection Site and Treatment Related Adverse Events Post Vaccination With One of 3 Doses of ChimeriVax™-JE Vaccine or Placebo
Rhinorrhea
|
2 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
|
Number of Participants Reporting Solicited Local Injection Site and Treatment Related Adverse Events Post Vaccination With One of 3 Doses of ChimeriVax™-JE Vaccine or Placebo
Pruritus
|
0 Participants
|
1 Participants
|
1 Participants
|
2 Participants
|
|
Number of Participants Reporting Solicited Local Injection Site and Treatment Related Adverse Events Post Vaccination With One of 3 Doses of ChimeriVax™-JE Vaccine or Placebo
Neutropenia
|
4 Participants
|
0 Participants
|
2 Participants
|
0 Participants
|
|
Number of Participants Reporting Solicited Local Injection Site and Treatment Related Adverse Events Post Vaccination With One of 3 Doses of ChimeriVax™-JE Vaccine or Placebo
Leukopenia
|
2 Participants
|
3 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants Reporting Solicited Local Injection Site and Treatment Related Adverse Events Post Vaccination With One of 3 Doses of ChimeriVax™-JE Vaccine or Placebo
Lymphadenopathy
|
0 Participants
|
2 Participants
|
1 Participants
|
1 Participants
|
|
Number of Participants Reporting Solicited Local Injection Site and Treatment Related Adverse Events Post Vaccination With One of 3 Doses of ChimeriVax™-JE Vaccine or Placebo
Injection Site Pain
|
1 Participants
|
2 Participants
|
4 Participants
|
2 Participants
|
|
Number of Participants Reporting Solicited Local Injection Site and Treatment Related Adverse Events Post Vaccination With One of 3 Doses of ChimeriVax™-JE Vaccine or Placebo
Injection Site Erythema
|
2 Participants
|
2 Participants
|
4 Participants
|
0 Participants
|
|
Number of Participants Reporting Solicited Local Injection Site and Treatment Related Adverse Events Post Vaccination With One of 3 Doses of ChimeriVax™-JE Vaccine or Placebo
Injection Site Reaction
|
1 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Number of Participants Reporting Solicited Local Injection Site and Treatment Related Adverse Events Post Vaccination With One of 3 Doses of ChimeriVax™-JE Vaccine or Placebo
Injection Site Hemorrhage
|
0 Participants
|
3 Participants
|
2 Participants
|
1 Participants
|
|
Number of Participants Reporting Solicited Local Injection Site and Treatment Related Adverse Events Post Vaccination With One of 3 Doses of ChimeriVax™-JE Vaccine or Placebo
Injection Site Induration
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants Reporting Solicited Local Injection Site and Treatment Related Adverse Events Post Vaccination With One of 3 Doses of ChimeriVax™-JE Vaccine or Placebo
Injection Site Paresthesia
|
0 Participants
|
1 Participants
|
2 Participants
|
1 Participants
|
|
Number of Participants Reporting Solicited Local Injection Site and Treatment Related Adverse Events Post Vaccination With One of 3 Doses of ChimeriVax™-JE Vaccine or Placebo
Headache
|
11 Participants
|
9 Participants
|
13 Participants
|
11 Participants
|
|
Number of Participants Reporting Solicited Local Injection Site and Treatment Related Adverse Events Post Vaccination With One of 3 Doses of ChimeriVax™-JE Vaccine or Placebo
Lethargy
|
0 Participants
|
4 Participants
|
2 Participants
|
2 Participants
|
|
Number of Participants Reporting Solicited Local Injection Site and Treatment Related Adverse Events Post Vaccination With One of 3 Doses of ChimeriVax™-JE Vaccine or Placebo
Fatigue
|
6 Participants
|
11 Participants
|
7 Participants
|
6 Participants
|
|
Number of Participants Reporting Solicited Local Injection Site and Treatment Related Adverse Events Post Vaccination With One of 3 Doses of ChimeriVax™-JE Vaccine or Placebo
Malaise
|
4 Participants
|
7 Participants
|
5 Participants
|
2 Participants
|
|
Number of Participants Reporting Solicited Local Injection Site and Treatment Related Adverse Events Post Vaccination With One of 3 Doses of ChimeriVax™-JE Vaccine or Placebo
Feeling Hot
|
0 Participants
|
2 Participants
|
2 Participants
|
3 Participants
|
|
Number of Participants Reporting Solicited Local Injection Site and Treatment Related Adverse Events Post Vaccination With One of 3 Doses of ChimeriVax™-JE Vaccine or Placebo
Chills
|
0 Participants
|
2 Participants
|
2 Participants
|
1 Participants
|
|
Number of Participants Reporting Solicited Local Injection Site and Treatment Related Adverse Events Post Vaccination With One of 3 Doses of ChimeriVax™-JE Vaccine or Placebo
Myalgia
|
2 Participants
|
6 Participants
|
9 Participants
|
2 Participants
|
|
Number of Participants Reporting Solicited Local Injection Site and Treatment Related Adverse Events Post Vaccination With One of 3 Doses of ChimeriVax™-JE Vaccine or Placebo
Arthralgia
|
0 Participants
|
2 Participants
|
2 Participants
|
0 Participants
|
|
Number of Participants Reporting Solicited Local Injection Site and Treatment Related Adverse Events Post Vaccination With One of 3 Doses of ChimeriVax™-JE Vaccine or Placebo
Nausea
|
0 Participants
|
6 Participants
|
3 Participants
|
2 Participants
|
|
Number of Participants Reporting Solicited Local Injection Site and Treatment Related Adverse Events Post Vaccination With One of 3 Doses of ChimeriVax™-JE Vaccine or Placebo
Diarrhea
|
0 Participants
|
1 Participants
|
4 Participants
|
2 Participants
|
|
Number of Participants Reporting Solicited Local Injection Site and Treatment Related Adverse Events Post Vaccination With One of 3 Doses of ChimeriVax™-JE Vaccine or Placebo
Abdominal Pain
|
0 Participants
|
4 Participants
|
1 Participants
|
1 Participants
|
SECONDARY outcome
Timeframe: Day 11 and Day 30 post-vaccinationPopulation: Geometric Mean Titers were assessed in all participants who were negative for homologous and all wild type JE antibodies at Day 0 and had no protocol violations that might have interfered with evaluation of primary criterion (Per-Protocol Population).
Antibodies were measured using 50% plaque reduction neutralization test (PRNT50) for measurement of neutralizing antibodies against homologous ChimeriVax™-JE virus strains.
Outcome measures
| Measure |
ChimeriVax™-JE 3 log10 PFU
n=31 Participants
All participants received a single dose of ChimeriVax™-JE 3 log10 Plaque-forming units (PFU) vaccine on Day 0.
|
ChimeriVax™-JE 4 log10 PFU
n=32 Participants
All participants received a single dose of ChimeriVax™-JE 4 log10 Plaque-forming units (PFU) vaccine on Day 0.
|
ChimeriVax™-JE 5 log10 PFU
n=31 Participants
All participants received a single dose of ChimeriVax™-JE 5 log10 Plaque-forming units (PFU) vaccine on Day 0
|
Placebo
n=32 Participants
All participants received a single dose of Placebo (diluent) on Day 0.
|
|---|---|---|---|---|
|
Geometric Mean Titers to Japanese Encephalitis (Homologous Virus) Following Primary Immunization Schedule With One of 3 Doses of ChimeriVax™-JE Vaccine or a Placebo
Day 11
|
5.2 Titers
Interval 4.8 to 5.7
|
11.4 Titers
Interval 7.0 to 18.7
|
10.2 Titers
Interval 6.3 to 16.5
|
5.0 Titers
Interval 5.0 to 5.0
|
|
Geometric Mean Titers to Japanese Encephalitis (Homologous Virus) Following Primary Immunization Schedule With One of 3 Doses of ChimeriVax™-JE Vaccine or a Placebo
Day 30
|
1829.6 Titers
Interval 916.6 to 3651.9
|
2151.5 Titers
Interval 994.1 to 4656.8
|
1956.5 Titers
Interval 913.4 to 4190.9
|
5.8 Titers
Interval 4.3 to 7.9
|
SECONDARY outcome
Timeframe: Day 30 post-vaccinationPopulation: Geometric mean titers were assessed in all participants who were negative for homologous and all wild type JE antibodies at Day 0 and had no protocol violations that might have interfered with evaluation of primary criterion (Per-Protocol Population).
The Japanese Encephalitis (Wild Type JE Virus Strains) antibodies were measured using PRNT50 for measurement of neutralizing antibodies against homologous ChimeriVax™-JE and wild type JE virus strains.
Outcome measures
| Measure |
ChimeriVax™-JE 3 log10 PFU
n=31 Participants
All participants received a single dose of ChimeriVax™-JE 3 log10 Plaque-forming units (PFU) vaccine on Day 0.
|
ChimeriVax™-JE 4 log10 PFU
n=32 Participants
All participants received a single dose of ChimeriVax™-JE 4 log10 Plaque-forming units (PFU) vaccine on Day 0.
|
ChimeriVax™-JE 5 log10 PFU
n=31 Participants
All participants received a single dose of ChimeriVax™-JE 5 log10 Plaque-forming units (PFU) vaccine on Day 0
|
Placebo
n=32 Participants
All participants received a single dose of Placebo (diluent) on Day 0.
|
|---|---|---|---|---|
|
Geometric Mean Titers to Japanese Encephalitis (Wild Type JE Virus Strains) Following Primary Immunization Schedule With One of 3 Doses of ChimeriVax™-JE Vaccine or a Placebo
Genotype I
|
208.6 Titers
Interval 134.8 to 322.9
|
193.0 Titers
Interval 109.4 to 340.5
|
188.3 Titers
Interval 122.1 to 290.6
|
5.3 Titers
Interval 4.7 to 5.9
|
|
Geometric Mean Titers to Japanese Encephalitis (Wild Type JE Virus Strains) Following Primary Immunization Schedule With One of 3 Doses of ChimeriVax™-JE Vaccine or a Placebo
Genotype II
|
50.9 Titers
Interval 33.8 to 76.5
|
69.2 Titers
Interval 41.4 to 115.7
|
49.6 Titers
Interval 32.2 to 76.3
|
5.0 Titers
Interval 5.0 to 5.0
|
|
Geometric Mean Titers to Japanese Encephalitis (Wild Type JE Virus Strains) Following Primary Immunization Schedule With One of 3 Doses of ChimeriVax™-JE Vaccine or a Placebo
Genotype III (Beijing)
|
232.6 Titers
Interval 147.0 to 368.1
|
162.3 Titers
Interval 91.0 to 289.6
|
253.4 Titers
Interval 152.8 to 420.1
|
5.4 Titers
Interval 4.7 to 6.2
|
|
Geometric Mean Titers to Japanese Encephalitis (Wild Type JE Virus Strains) Following Primary Immunization Schedule With One of 3 Doses of ChimeriVax™-JE Vaccine or a Placebo
Genotype III (P3)
|
223.6 Titers
Interval 147.3 to 339.4
|
238.7 Titers
Interval 125.7 to 453.2
|
315.5 Titers
Interval 182.0 to 547.0
|
5.3 Titers
Interval 4.9 to 5.9
|
|
Geometric Mean Titers to Japanese Encephalitis (Wild Type JE Virus Strains) Following Primary Immunization Schedule With One of 3 Doses of ChimeriVax™-JE Vaccine or a Placebo
Genotype III (Nakayama)
|
192.3 Titers
Interval 127.3 to 290.6
|
180.6 Titers
Interval 95.4 to 341.7
|
155.0 Titers
Interval 83.6 to 287.3
|
5.6 Titers
Interval 4.7 to 6.6
|
|
Geometric Mean Titers to Japanese Encephalitis (Wild Type JE Virus Strains) Following Primary Immunization Schedule With One of 3 Doses of ChimeriVax™-JE Vaccine or a Placebo
Genotype IV
|
70.4 Titers
Interval 42.4 to 117.1
|
80.4 Titers
Interval 47.1 to 137.2
|
67.1 Titers
Interval 41.3 to 108.8
|
5.0 Titers
Interval 5.0 to 5.0
|
SECONDARY outcome
Timeframe: Day 30 up to 12 months post-vaccinationPopulation: Seropositivity was assessed in all participants who were negative for homologous and all wild type JE antibodies at Day 0 and had no protocol violations that might have interfered with evaluation of primary criterion (Per-Protocol Population).
Antibodies were measured using 50% plaque reduction neutralization test (PRNT50) for measurement of neutralizing antibodies against homologous ChimeriVax™-JE virus strains. Seropositivity was defined as a titer \< 1:10.
Outcome measures
| Measure |
ChimeriVax™-JE 3 log10 PFU
n=31 Participants
All participants received a single dose of ChimeriVax™-JE 3 log10 Plaque-forming units (PFU) vaccine on Day 0.
|
ChimeriVax™-JE 4 log10 PFU
n=32 Participants
All participants received a single dose of ChimeriVax™-JE 4 log10 Plaque-forming units (PFU) vaccine on Day 0.
|
ChimeriVax™-JE 5 log10 PFU
n=31 Participants
All participants received a single dose of ChimeriVax™-JE 5 log10 Plaque-forming units (PFU) vaccine on Day 0
|
Placebo
n=32 Participants
All participants received a single dose of Placebo (diluent) on Day 0.
|
|---|---|---|---|---|
|
Participants With Japanese Encephalitis (Homologous Virus) Seropositivity Over Time Following Primary Immunization Schedule With One of 3 Doses of ChimeriVax™-JE Vaccine or Placebo
Day 30 [N = 31; 32; 31; 32]
|
31 Participants
|
30 Participants
|
29 Participants
|
1 Participants
|
|
Participants With Japanese Encephalitis (Homologous Virus) Seropositivity Over Time Following Primary Immunization Schedule With One of 3 Doses of ChimeriVax™-JE Vaccine or Placebo
Month 6 [N = 31; 30; 28; 32]
|
30 Participants
|
28 Participants
|
27 Participants
|
0 Participants
|
|
Participants With Japanese Encephalitis (Homologous Virus) Seropositivity Over Time Following Primary Immunization Schedule With One of 3 Doses of ChimeriVax™-JE Vaccine or Placebo
Month 12 [N = 31; 30; 30; 29]
|
27 Participants
|
26 Participants
|
29 Participants
|
0 Participants
|
Adverse Events
ChimeriVax™-JE 3 log10 PFU
Serious events: 2 serious events
Other events: 16 other events
Deaths: 0 deaths
ChimeriVax™-JE 4 log10 PFU
Serious events: 1 serious events
Other events: 16 other events
Deaths: 0 deaths
ChimeriVax™-JE 5 log10 PFU
Serious events: 0 serious events
Other events: 16 other events
Deaths: 0 deaths
Placebo
Serious events: 2 serious events
Other events: 17 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
ChimeriVax™-JE 3 log10 PFU
n=32 participants at risk
All participants received a single dose of ChimeriVax™-JE 3 log10 Plaque-forming units (PFU) vaccine on Day 0.
|
ChimeriVax™-JE 4 log10 PFU
n=32 participants at risk
All participants received a single dose of ChimeriVax™-JE 4 log10 Plaque-forming units (PFU) vaccine on Day 0.
|
ChimeriVax™-JE 5 log10 PFU
n=32 participants at risk
All participants received a single dose of ChimeriVax™-JE 5 log10 Plaque-forming units (PFU) vaccine on Day 0
|
Placebo
n=32 participants at risk
All participants received a single dose of Placebo (diluent) on Day 0.
|
|---|---|---|---|---|
|
Infections and infestations
Gastroenteritis
|
0.00%
0/32 • Adverse events data were collected from Day 0 (post-vaccination) up to Month 12 post-vaccination.
|
3.1%
1/32 • Number of events 1 • Adverse events data were collected from Day 0 (post-vaccination) up to Month 12 post-vaccination.
|
0.00%
0/32 • Adverse events data were collected from Day 0 (post-vaccination) up to Month 12 post-vaccination.
|
0.00%
0/32 • Adverse events data were collected from Day 0 (post-vaccination) up to Month 12 post-vaccination.
|
|
Infections and infestations
Cellulitis
|
0.00%
0/32 • Adverse events data were collected from Day 0 (post-vaccination) up to Month 12 post-vaccination.
|
0.00%
0/32 • Adverse events data were collected from Day 0 (post-vaccination) up to Month 12 post-vaccination.
|
0.00%
0/32 • Adverse events data were collected from Day 0 (post-vaccination) up to Month 12 post-vaccination.
|
3.1%
1/32 • Number of events 1 • Adverse events data were collected from Day 0 (post-vaccination) up to Month 12 post-vaccination.
|
|
Infections and infestations
Peritonsillar Abscess
|
3.1%
1/32 • Number of events 1 • Adverse events data were collected from Day 0 (post-vaccination) up to Month 12 post-vaccination.
|
0.00%
0/32 • Adverse events data were collected from Day 0 (post-vaccination) up to Month 12 post-vaccination.
|
0.00%
0/32 • Adverse events data were collected from Day 0 (post-vaccination) up to Month 12 post-vaccination.
|
0.00%
0/32 • Adverse events data were collected from Day 0 (post-vaccination) up to Month 12 post-vaccination.
|
|
Musculoskeletal and connective tissue disorders
Intervertebral Disc Protrusion
|
0.00%
0/32 • Adverse events data were collected from Day 0 (post-vaccination) up to Month 12 post-vaccination.
|
0.00%
0/32 • Adverse events data were collected from Day 0 (post-vaccination) up to Month 12 post-vaccination.
|
0.00%
0/32 • Adverse events data were collected from Day 0 (post-vaccination) up to Month 12 post-vaccination.
|
3.1%
1/32 • Number of events 1 • Adverse events data were collected from Day 0 (post-vaccination) up to Month 12 post-vaccination.
|
|
Reproductive system and breast disorders
Pregnancy
|
3.1%
1/32 • Number of events 1 • Adverse events data were collected from Day 0 (post-vaccination) up to Month 12 post-vaccination.
|
0.00%
0/32 • Adverse events data were collected from Day 0 (post-vaccination) up to Month 12 post-vaccination.
|
0.00%
0/32 • Adverse events data were collected from Day 0 (post-vaccination) up to Month 12 post-vaccination.
|
0.00%
0/32 • Adverse events data were collected from Day 0 (post-vaccination) up to Month 12 post-vaccination.
|
Other adverse events
| Measure |
ChimeriVax™-JE 3 log10 PFU
n=32 participants at risk
All participants received a single dose of ChimeriVax™-JE 3 log10 Plaque-forming units (PFU) vaccine on Day 0.
|
ChimeriVax™-JE 4 log10 PFU
n=32 participants at risk
All participants received a single dose of ChimeriVax™-JE 4 log10 Plaque-forming units (PFU) vaccine on Day 0.
|
ChimeriVax™-JE 5 log10 PFU
n=32 participants at risk
All participants received a single dose of ChimeriVax™-JE 5 log10 Plaque-forming units (PFU) vaccine on Day 0
|
Placebo
n=32 participants at risk
All participants received a single dose of Placebo (diluent) on Day 0.
|
|---|---|---|---|---|
|
Nervous system disorders
Headache
|
50.0%
16/32 • Adverse events data were collected from Day 0 (post-vaccination) up to Month 12 post-vaccination.
|
50.0%
16/32 • Adverse events data were collected from Day 0 (post-vaccination) up to Month 12 post-vaccination.
|
50.0%
16/32 • Adverse events data were collected from Day 0 (post-vaccination) up to Month 12 post-vaccination.
|
53.1%
17/32 • Adverse events data were collected from Day 0 (post-vaccination) up to Month 12 post-vaccination.
|
|
Nervous system disorders
Lethargy
|
0.00%
0/32 • Adverse events data were collected from Day 0 (post-vaccination) up to Month 12 post-vaccination.
|
12.5%
4/32 • Adverse events data were collected from Day 0 (post-vaccination) up to Month 12 post-vaccination.
|
6.2%
2/32 • Adverse events data were collected from Day 0 (post-vaccination) up to Month 12 post-vaccination.
|
6.2%
2/32 • Adverse events data were collected from Day 0 (post-vaccination) up to Month 12 post-vaccination.
|
|
General disorders
Fatigue
|
18.8%
6/32 • Adverse events data were collected from Day 0 (post-vaccination) up to Month 12 post-vaccination.
|
50.0%
16/32 • Adverse events data were collected from Day 0 (post-vaccination) up to Month 12 post-vaccination.
|
31.2%
10/32 • Adverse events data were collected from Day 0 (post-vaccination) up to Month 12 post-vaccination.
|
21.9%
7/32 • Adverse events data were collected from Day 0 (post-vaccination) up to Month 12 post-vaccination.
|
|
General disorders
Injection Site Pain
|
3.1%
1/32 • Adverse events data were collected from Day 0 (post-vaccination) up to Month 12 post-vaccination.
|
6.2%
2/32 • Adverse events data were collected from Day 0 (post-vaccination) up to Month 12 post-vaccination.
|
12.5%
4/32 • Adverse events data were collected from Day 0 (post-vaccination) up to Month 12 post-vaccination.
|
6.2%
2/32 • Adverse events data were collected from Day 0 (post-vaccination) up to Month 12 post-vaccination.
|
|
General disorders
Injection Site Erythema
|
6.2%
2/32 • Adverse events data were collected from Day 0 (post-vaccination) up to Month 12 post-vaccination.
|
6.2%
2/32 • Adverse events data were collected from Day 0 (post-vaccination) up to Month 12 post-vaccination.
|
12.5%
4/32 • Adverse events data were collected from Day 0 (post-vaccination) up to Month 12 post-vaccination.
|
0.00%
0/32 • Adverse events data were collected from Day 0 (post-vaccination) up to Month 12 post-vaccination.
|
|
General disorders
Injection Site Hemorrhage
|
0.00%
0/32 • Adverse events data were collected from Day 0 (post-vaccination) up to Month 12 post-vaccination.
|
9.4%
3/32 • Adverse events data were collected from Day 0 (post-vaccination) up to Month 12 post-vaccination.
|
6.2%
2/32 • Adverse events data were collected from Day 0 (post-vaccination) up to Month 12 post-vaccination.
|
3.1%
1/32 • Adverse events data were collected from Day 0 (post-vaccination) up to Month 12 post-vaccination.
|
|
General disorders
Injection Site Paresthesia
|
0.00%
0/32 • Adverse events data were collected from Day 0 (post-vaccination) up to Month 12 post-vaccination.
|
3.1%
1/32 • Adverse events data were collected from Day 0 (post-vaccination) up to Month 12 post-vaccination.
|
6.2%
2/32 • Adverse events data were collected from Day 0 (post-vaccination) up to Month 12 post-vaccination.
|
3.1%
1/32 • Adverse events data were collected from Day 0 (post-vaccination) up to Month 12 post-vaccination.
|
|
General disorders
Malaise
|
21.9%
7/32 • Adverse events data were collected from Day 0 (post-vaccination) up to Month 12 post-vaccination.
|
21.9%
7/32 • Adverse events data were collected from Day 0 (post-vaccination) up to Month 12 post-vaccination.
|
18.8%
6/32 • Adverse events data were collected from Day 0 (post-vaccination) up to Month 12 post-vaccination.
|
21.9%
7/32 • Adverse events data were collected from Day 0 (post-vaccination) up to Month 12 post-vaccination.
|
|
General disorders
Feeling Hot
|
0.00%
0/32 • Adverse events data were collected from Day 0 (post-vaccination) up to Month 12 post-vaccination.
|
6.2%
2/32 • Adverse events data were collected from Day 0 (post-vaccination) up to Month 12 post-vaccination.
|
6.2%
2/32 • Adverse events data were collected from Day 0 (post-vaccination) up to Month 12 post-vaccination.
|
9.4%
3/32 • Adverse events data were collected from Day 0 (post-vaccination) up to Month 12 post-vaccination.
|
|
General disorders
Chills
|
0.00%
0/32 • Adverse events data were collected from Day 0 (post-vaccination) up to Month 12 post-vaccination.
|
6.2%
2/32 • Adverse events data were collected from Day 0 (post-vaccination) up to Month 12 post-vaccination.
|
6.2%
2/32 • Adverse events data were collected from Day 0 (post-vaccination) up to Month 12 post-vaccination.
|
3.1%
1/32 • Adverse events data were collected from Day 0 (post-vaccination) up to Month 12 post-vaccination.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
6.2%
2/32 • Adverse events data were collected from Day 0 (post-vaccination) up to Month 12 post-vaccination.
|
18.8%
6/32 • Adverse events data were collected from Day 0 (post-vaccination) up to Month 12 post-vaccination.
|
31.2%
10/32 • Adverse events data were collected from Day 0 (post-vaccination) up to Month 12 post-vaccination.
|
6.2%
2/32 • Adverse events data were collected from Day 0 (post-vaccination) up to Month 12 post-vaccination.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.00%
0/32 • Adverse events data were collected from Day 0 (post-vaccination) up to Month 12 post-vaccination.
|
6.2%
2/32 • Adverse events data were collected from Day 0 (post-vaccination) up to Month 12 post-vaccination.
|
6.2%
2/32 • Adverse events data were collected from Day 0 (post-vaccination) up to Month 12 post-vaccination.
|
0.00%
0/32 • Adverse events data were collected from Day 0 (post-vaccination) up to Month 12 post-vaccination.
|
|
Gastrointestinal disorders
Nausea
|
6.2%
2/32 • Adverse events data were collected from Day 0 (post-vaccination) up to Month 12 post-vaccination.
|
18.8%
6/32 • Adverse events data were collected from Day 0 (post-vaccination) up to Month 12 post-vaccination.
|
9.4%
3/32 • Adverse events data were collected from Day 0 (post-vaccination) up to Month 12 post-vaccination.
|
9.4%
3/32 • Adverse events data were collected from Day 0 (post-vaccination) up to Month 12 post-vaccination.
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/32 • Adverse events data were collected from Day 0 (post-vaccination) up to Month 12 post-vaccination.
|
6.2%
2/32 • Adverse events data were collected from Day 0 (post-vaccination) up to Month 12 post-vaccination.
|
12.5%
4/32 • Adverse events data were collected from Day 0 (post-vaccination) up to Month 12 post-vaccination.
|
9.4%
3/32 • Adverse events data were collected from Day 0 (post-vaccination) up to Month 12 post-vaccination.
|
|
Gastrointestinal disorders
Abdominal Pain
|
0.00%
0/32 • Adverse events data were collected from Day 0 (post-vaccination) up to Month 12 post-vaccination.
|
18.8%
6/32 • Adverse events data were collected from Day 0 (post-vaccination) up to Month 12 post-vaccination.
|
3.1%
1/32 • Adverse events data were collected from Day 0 (post-vaccination) up to Month 12 post-vaccination.
|
3.1%
1/32 • Adverse events data were collected from Day 0 (post-vaccination) up to Month 12 post-vaccination.
|
|
Infections and infestations
Pharyngitis
|
9.4%
3/32 • Adverse events data were collected from Day 0 (post-vaccination) up to Month 12 post-vaccination.
|
9.4%
3/32 • Adverse events data were collected from Day 0 (post-vaccination) up to Month 12 post-vaccination.
|
9.4%
3/32 • Adverse events data were collected from Day 0 (post-vaccination) up to Month 12 post-vaccination.
|
15.6%
5/32 • Adverse events data were collected from Day 0 (post-vaccination) up to Month 12 post-vaccination.
|
|
Infections and infestations
Diarrhea Infectious
|
0.00%
0/32 • Adverse events data were collected from Day 0 (post-vaccination) up to Month 12 post-vaccination.
|
6.2%
2/32 • Adverse events data were collected from Day 0 (post-vaccination) up to Month 12 post-vaccination.
|
0.00%
0/32 • Adverse events data were collected from Day 0 (post-vaccination) up to Month 12 post-vaccination.
|
0.00%
0/32 • Adverse events data were collected from Day 0 (post-vaccination) up to Month 12 post-vaccination.
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhea
|
6.2%
2/32 • Adverse events data were collected from Day 0 (post-vaccination) up to Month 12 post-vaccination.
|
6.2%
2/32 • Adverse events data were collected from Day 0 (post-vaccination) up to Month 12 post-vaccination.
|
0.00%
0/32 • Adverse events data were collected from Day 0 (post-vaccination) up to Month 12 post-vaccination.
|
3.1%
1/32 • Adverse events data were collected from Day 0 (post-vaccination) up to Month 12 post-vaccination.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
0.00%
0/32 • Adverse events data were collected from Day 0 (post-vaccination) up to Month 12 post-vaccination.
|
3.1%
1/32 • Adverse events data were collected from Day 0 (post-vaccination) up to Month 12 post-vaccination.
|
3.1%
1/32 • Adverse events data were collected from Day 0 (post-vaccination) up to Month 12 post-vaccination.
|
6.2%
2/32 • Adverse events data were collected from Day 0 (post-vaccination) up to Month 12 post-vaccination.
|
|
Blood and lymphatic system disorders
Neutropenia
|
12.5%
4/32 • Adverse events data were collected from Day 0 (post-vaccination) up to Month 12 post-vaccination.
|
0.00%
0/32 • Adverse events data were collected from Day 0 (post-vaccination) up to Month 12 post-vaccination.
|
6.2%
2/32 • Adverse events data were collected from Day 0 (post-vaccination) up to Month 12 post-vaccination.
|
0.00%
0/32 • Adverse events data were collected from Day 0 (post-vaccination) up to Month 12 post-vaccination.
|
|
Blood and lymphatic system disorders
Leukopenia
|
6.2%
2/32 • Adverse events data were collected from Day 0 (post-vaccination) up to Month 12 post-vaccination.
|
9.4%
3/32 • Adverse events data were collected from Day 0 (post-vaccination) up to Month 12 post-vaccination.
|
0.00%
0/32 • Adverse events data were collected from Day 0 (post-vaccination) up to Month 12 post-vaccination.
|
0.00%
0/32 • Adverse events data were collected from Day 0 (post-vaccination) up to Month 12 post-vaccination.
|
|
Blood and lymphatic system disorders
Lymphadenopathy
|
0.00%
0/32 • Adverse events data were collected from Day 0 (post-vaccination) up to Month 12 post-vaccination.
|
6.2%
2/32 • Adverse events data were collected from Day 0 (post-vaccination) up to Month 12 post-vaccination.
|
3.1%
1/32 • Adverse events data were collected from Day 0 (post-vaccination) up to Month 12 post-vaccination.
|
3.1%
1/32 • Adverse events data were collected from Day 0 (post-vaccination) up to Month 12 post-vaccination.
|
|
Nervous system disorders
Syncope vasovagal
|
3.1%
1/32 • Adverse events data were collected from Day 0 (post-vaccination) up to Month 12 post-vaccination.
|
3.1%
1/32 • Adverse events data were collected from Day 0 (post-vaccination) up to Month 12 post-vaccination.
|
3.1%
1/32 • Adverse events data were collected from Day 0 (post-vaccination) up to Month 12 post-vaccination.
|
6.2%
2/32 • Adverse events data were collected from Day 0 (post-vaccination) up to Month 12 post-vaccination.
|
|
Blood and lymphatic system disorders
Thrombocytopena
|
6.2%
2/32 • Adverse events data were collected from Day 0 (post-vaccination) up to Month 12 post-vaccination.
|
0.00%
0/32 • Adverse events data were collected from Day 0 (post-vaccination) up to Month 12 post-vaccination.
|
0.00%
0/32 • Adverse events data were collected from Day 0 (post-vaccination) up to Month 12 post-vaccination.
|
3.1%
1/32 • Adverse events data were collected from Day 0 (post-vaccination) up to Month 12 post-vaccination.
|
|
Infections and infestations
Upper respiratory tract infection
|
3.1%
1/32 • Adverse events data were collected from Day 0 (post-vaccination) up to Month 12 post-vaccination.
|
18.8%
6/32 • Adverse events data were collected from Day 0 (post-vaccination) up to Month 12 post-vaccination.
|
3.1%
1/32 • Adverse events data were collected from Day 0 (post-vaccination) up to Month 12 post-vaccination.
|
9.4%
3/32 • Adverse events data were collected from Day 0 (post-vaccination) up to Month 12 post-vaccination.
|
|
Infections and infestations
Sinusitis
|
3.1%
1/32 • Adverse events data were collected from Day 0 (post-vaccination) up to Month 12 post-vaccination.
|
6.2%
2/32 • Adverse events data were collected from Day 0 (post-vaccination) up to Month 12 post-vaccination.
|
6.2%
2/32 • Adverse events data were collected from Day 0 (post-vaccination) up to Month 12 post-vaccination.
|
6.2%
2/32 • Adverse events data were collected from Day 0 (post-vaccination) up to Month 12 post-vaccination.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
0.00%
0/32 • Adverse events data were collected from Day 0 (post-vaccination) up to Month 12 post-vaccination.
|
3.1%
1/32 • Adverse events data were collected from Day 0 (post-vaccination) up to Month 12 post-vaccination.
|
0.00%
0/32 • Adverse events data were collected from Day 0 (post-vaccination) up to Month 12 post-vaccination.
|
6.2%
2/32 • Adverse events data were collected from Day 0 (post-vaccination) up to Month 12 post-vaccination.
|
|
Investigations
Blood creatinine phosphokinase increased
|
6.2%
2/32 • Adverse events data were collected from Day 0 (post-vaccination) up to Month 12 post-vaccination.
|
6.2%
2/32 • Adverse events data were collected from Day 0 (post-vaccination) up to Month 12 post-vaccination.
|
3.1%
1/32 • Adverse events data were collected from Day 0 (post-vaccination) up to Month 12 post-vaccination.
|
3.1%
1/32 • Adverse events data were collected from Day 0 (post-vaccination) up to Month 12 post-vaccination.
|
|
Investigations
Blood bilirubin increased
|
0.00%
0/32 • Adverse events data were collected from Day 0 (post-vaccination) up to Month 12 post-vaccination.
|
0.00%
0/32 • Adverse events data were collected from Day 0 (post-vaccination) up to Month 12 post-vaccination.
|
6.2%
2/32 • Adverse events data were collected from Day 0 (post-vaccination) up to Month 12 post-vaccination.
|
0.00%
0/32 • Adverse events data were collected from Day 0 (post-vaccination) up to Month 12 post-vaccination.
|
|
Reproductive system and breast disorders
Dysmenorrhoea
|
9.4%
3/32 • Adverse events data were collected from Day 0 (post-vaccination) up to Month 12 post-vaccination.
|
9.4%
3/32 • Adverse events data were collected from Day 0 (post-vaccination) up to Month 12 post-vaccination.
|
6.2%
2/32 • Adverse events data were collected from Day 0 (post-vaccination) up to Month 12 post-vaccination.
|
3.1%
1/32 • Adverse events data were collected from Day 0 (post-vaccination) up to Month 12 post-vaccination.
|
|
Cardiac disorders
Bradycardia
|
3.1%
1/32 • Adverse events data were collected from Day 0 (post-vaccination) up to Month 12 post-vaccination.
|
6.2%
2/32 • Adverse events data were collected from Day 0 (post-vaccination) up to Month 12 post-vaccination.
|
3.1%
1/32 • Adverse events data were collected from Day 0 (post-vaccination) up to Month 12 post-vaccination.
|
3.1%
1/32 • Adverse events data were collected from Day 0 (post-vaccination) up to Month 12 post-vaccination.
|
|
Injury, poisoning and procedural complications
Muscle strain
|
6.2%
2/32 • Adverse events data were collected from Day 0 (post-vaccination) up to Month 12 post-vaccination.
|
0.00%
0/32 • Adverse events data were collected from Day 0 (post-vaccination) up to Month 12 post-vaccination.
|
0.00%
0/32 • Adverse events data were collected from Day 0 (post-vaccination) up to Month 12 post-vaccination.
|
0.00%
0/32 • Adverse events data were collected from Day 0 (post-vaccination) up to Month 12 post-vaccination.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee Sponsor must have the opportunity to review at least 60 days prior to submission for publication or presentation. If review indicates that potentially patentable subject matter would be disclosed, publication or public disclosure may be delayed for a maximum of an additional 60 days to allow for filing the necessary patent applications.
- Publication restrictions are in place
Restriction type: OTHER