Trial Outcomes & Findings for Cvac as Maintenance Treatment in Patients With Epithelial Ovarian Cancer in Complete Remission Following First-line Chemotherapy or Second-line Treatment (NCT NCT01521143)
NCT ID: NCT01521143
Last Updated: 2016-12-14
Results Overview
Overall survival was defined as the number of days from Baseline to the date of death from any cause.
Recruitment status
TERMINATED
Study phase
PHASE2
Target enrollment
91 participants
Primary outcome timeframe
Baseline to the end of the study (up to 3 years, 2 months)
Results posted on
2016-12-14
Participant Flow
Different participants were enrolled in the 2 parts of the study.
Participant milestones
| Measure |
Part A - Cvac
Participants received intradermal injections of Cvac given at 4-week intervals for the first 3 doses, and then every 12 weeks for 3 additional doses, for a total of 6 doses over 44 weeks. Each injection had an approximate concentration of 60 × 10\^6 viable dendritic cells/mL.
|
Part A - Placebo
Participants received intradermal injections of placebo given at 4-week intervals for the first 3 doses, and then every 12 weeks for 3 additional doses, for a total of 6 doses over 44 weeks.
|
Part B - Cvac
Participants received intradermal injections of Cvac given at 4-week intervals for the first 3 doses, and then every 12 weeks for 3 additional doses, for a total of 6 doses over 44 weeks. Each injection had an approximate concentration of 60 × 10\^6 viable dendritic cells/mL.
|
Part B - Observational Standard of Care
Participants in this group did not receive any treatment during the study.
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
40
|
36
|
8
|
7
|
|
Overall Study
Received Treatment
|
20
|
20
|
3
|
4
|
|
Overall Study
COMPLETED
|
11
|
10
|
0
|
0
|
|
Overall Study
NOT COMPLETED
|
29
|
26
|
8
|
7
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Cvac as Maintenance Treatment in Patients With Epithelial Ovarian Cancer in Complete Remission Following First-line Chemotherapy or Second-line Treatment
Baseline characteristics by cohort
| Measure |
Part A - Cvac
n=20 Participants
Participants received intradermal injections of Cvac given at 4-week intervals for the first 3 doses, and then every 12 weeks for 3 additional doses, for a total of 6 doses over 44 weeks. Each injection had an approximate concentration of 60 × 10\^6 viable dendritic cells/mL.
|
Part A - Placebo
n=20 Participants
Participants received intradermal injections of placebo given at 4-week intervals for the first 3 doses, and then every 12 weeks for 3 additional doses, for a total of 6 doses over 44 weeks.
|
Part B - Cvac
n=3 Participants
Participants received intradermal injections of Cvac given at 4-week intervals for the first 3 doses, and then every 12 weeks for 3 additional doses, for a total of 6 doses over 44 weeks. Each injection had an approximate concentration of 60 × 10\^6 viable dendritic cells/mL.
|
Part B - Observational Standard of Care
n=4 Participants
Participants in this group did not receive any treatment during the study.
|
Total
n=47 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Customized
45-65 years of age
|
20 Participants
n=5 Participants
|
20 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
4 Participants
n=4 Participants
|
47 Participants
n=21 Participants
|
|
Gender
Female
|
20 Participants
n=5 Participants
|
20 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
4 Participants
n=4 Participants
|
47 Participants
n=21 Participants
|
|
Gender
Male
|
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
|
PRIMARY outcome
Timeframe: Baseline to the end of the study (up to 3 years, 2 months)Population: Intent-to-treat population: All participants who were randomized to a treatment group. The data for this Outcome Measure were not analyzed since the study was terminated early.
Overall survival was defined as the number of days from Baseline to the date of death from any cause.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline to the end of the study (up to 3 years, 2 months)Population: Intent-to-treat population: All participants who were randomized to a treatment group. The data for this Outcome Measure were not analyzed since the study was terminated early.
Time to next treatment was defined as the number of days from Baseline to the date when the next treatment for epithelial ovarian cancer was started.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline to the end of the study (up to 3 years, 2 months)Population: Intent-to-treat population: All participants who were randomized to a treatment group. The data for this Outcome Measure were not analyzed since the study was terminated early.
Progression-free survival was defined as the number of days from Baseline and the documented disease progression as defined by response evaluation criteria in solid tumors (RECIST) or death, whichever occurred earlier. Disease progression was defined as any measurable new lesion(s) that were accurately measured in at least 1 dimension. Any new lesion(s) with a minimum size of 20 mm were deemed as unequivocal (ie, clear or definite) progression. Any new lesion(s) with a minimum size of 15 mm but smaller than 20 mm were considered equivocal progression and had to be confirmed by a follow-up radiological procedure.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline to the end of the study (up to 3 years, 2 months)Population: Intent-to-treat population: All participants who were randomized to a treatment group. The data for this Outcome Measure were not analyzed since the study was terminated early.
Overall survival was defined as the number of days from Baseline to the date of death from any cause.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline to the end of the study (up to 3 years, 2 months)Population: Intent-to-treat population: All participants who were randomized to a treatment group. The data for this Outcome Measure were not analyzed since the study was terminated early.
Time to next treatment was defined as the number of days from Baseline to the date when the next treatment for epithelial ovarian cancer was started.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline to the end of the study (up to 3 years, 2 months)Population: Intent-to-treat population: All participants who were randomized to a treatment group. The data for this Outcome Measure were not analyzed since the study was terminated early.
Progression-free survival was defined as the number of days from Baseline and the documented disease progression as defined by response evaluation criteria in solid tumors (RECIST) or death, whichever occurred earlier. Disease progression was defined as any measurable new lesion(s) that were accurately measured in at least 1 dimension. Any new lesion(s) with a minimum size of 20 mm were deemed as unequivocal (ie, clear or definite) progression. Any new lesion(s) with a minimum size of 15 mm but smaller than 20 mm were considered equivocal progression and had to be confirmed by a follow-up radiological procedure.
Outcome measures
Outcome data not reported
Adverse Events
Part A - Cvac
Serious events: 5 serious events
Other events: 17 other events
Deaths: 0 deaths
Part A - Placebo
Serious events: 7 serious events
Other events: 13 other events
Deaths: 0 deaths
Part B - Cvac
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Part B - Observational Standard of Care
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Part A - Cvac
n=20 participants at risk
Participants received intradermal injections of Cvac given at 4-week intervals for the first 3 doses, and then every 12 weeks for 3 additional doses, for a total of 6 doses over 44 weeks. Each injection had an approximate concentration of 60 × 10\^6 viable dendritic cells/mL.
|
Part A - Placebo
n=20 participants at risk
Participants received intradermal injections of placebo given at 4-week intervals for the first 3 doses, and then every 12 weeks for 3 additional doses, for a total of 6 doses over 44 weeks.
|
Part B - Cvac
n=3 participants at risk
Participants received intradermal injections of Cvac given at 4-week intervals for the first 3 doses, and then every 12 weeks for 3 additional doses, for a total of 6 doses over 44 weeks. Each injection had an approximate concentration of 60 × 10\^6 viable dendritic cells/mL.
|
Part B - Observational Standard of Care
n=4 participants at risk
Participants in this group did not receive any treatment during the study.
|
|---|---|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
5.0%
1/20
Part A - Safety population: All randomized participants who received at least 1 dose of Cvac or placebo. Part B - Safety population: All randomized participants who received at least 1 dose of Cvac (Cvac group) or were evaluated at least once (observational standard of care group).
|
5.0%
1/20
Part A - Safety population: All randomized participants who received at least 1 dose of Cvac or placebo. Part B - Safety population: All randomized participants who received at least 1 dose of Cvac (Cvac group) or were evaluated at least once (observational standard of care group).
|
0.00%
0/3
Part A - Safety population: All randomized participants who received at least 1 dose of Cvac or placebo. Part B - Safety population: All randomized participants who received at least 1 dose of Cvac (Cvac group) or were evaluated at least once (observational standard of care group).
|
0.00%
0/4
Part A - Safety population: All randomized participants who received at least 1 dose of Cvac or placebo. Part B - Safety population: All randomized participants who received at least 1 dose of Cvac (Cvac group) or were evaluated at least once (observational standard of care group).
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
5.0%
1/20
Part A - Safety population: All randomized participants who received at least 1 dose of Cvac or placebo. Part B - Safety population: All randomized participants who received at least 1 dose of Cvac (Cvac group) or were evaluated at least once (observational standard of care group).
|
5.0%
1/20
Part A - Safety population: All randomized participants who received at least 1 dose of Cvac or placebo. Part B - Safety population: All randomized participants who received at least 1 dose of Cvac (Cvac group) or were evaluated at least once (observational standard of care group).
|
0.00%
0/3
Part A - Safety population: All randomized participants who received at least 1 dose of Cvac or placebo. Part B - Safety population: All randomized participants who received at least 1 dose of Cvac (Cvac group) or were evaluated at least once (observational standard of care group).
|
0.00%
0/4
Part A - Safety population: All randomized participants who received at least 1 dose of Cvac or placebo. Part B - Safety population: All randomized participants who received at least 1 dose of Cvac (Cvac group) or were evaluated at least once (observational standard of care group).
|
|
Gastrointestinal disorders
Ascites
|
5.0%
1/20
Part A - Safety population: All randomized participants who received at least 1 dose of Cvac or placebo. Part B - Safety population: All randomized participants who received at least 1 dose of Cvac (Cvac group) or were evaluated at least once (observational standard of care group).
|
0.00%
0/20
Part A - Safety population: All randomized participants who received at least 1 dose of Cvac or placebo. Part B - Safety population: All randomized participants who received at least 1 dose of Cvac (Cvac group) or were evaluated at least once (observational standard of care group).
|
0.00%
0/3
Part A - Safety population: All randomized participants who received at least 1 dose of Cvac or placebo. Part B - Safety population: All randomized participants who received at least 1 dose of Cvac (Cvac group) or were evaluated at least once (observational standard of care group).
|
0.00%
0/4
Part A - Safety population: All randomized participants who received at least 1 dose of Cvac or placebo. Part B - Safety population: All randomized participants who received at least 1 dose of Cvac (Cvac group) or were evaluated at least once (observational standard of care group).
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/20
Part A - Safety population: All randomized participants who received at least 1 dose of Cvac or placebo. Part B - Safety population: All randomized participants who received at least 1 dose of Cvac (Cvac group) or were evaluated at least once (observational standard of care group).
|
5.0%
1/20
Part A - Safety population: All randomized participants who received at least 1 dose of Cvac or placebo. Part B - Safety population: All randomized participants who received at least 1 dose of Cvac (Cvac group) or were evaluated at least once (observational standard of care group).
|
0.00%
0/3
Part A - Safety population: All randomized participants who received at least 1 dose of Cvac or placebo. Part B - Safety population: All randomized participants who received at least 1 dose of Cvac (Cvac group) or were evaluated at least once (observational standard of care group).
|
0.00%
0/4
Part A - Safety population: All randomized participants who received at least 1 dose of Cvac or placebo. Part B - Safety population: All randomized participants who received at least 1 dose of Cvac (Cvac group) or were evaluated at least once (observational standard of care group).
|
|
Gastrointestinal disorders
Nausea
|
5.0%
1/20
Part A - Safety population: All randomized participants who received at least 1 dose of Cvac or placebo. Part B - Safety population: All randomized participants who received at least 1 dose of Cvac (Cvac group) or were evaluated at least once (observational standard of care group).
|
0.00%
0/20
Part A - Safety population: All randomized participants who received at least 1 dose of Cvac or placebo. Part B - Safety population: All randomized participants who received at least 1 dose of Cvac (Cvac group) or were evaluated at least once (observational standard of care group).
|
0.00%
0/3
Part A - Safety population: All randomized participants who received at least 1 dose of Cvac or placebo. Part B - Safety population: All randomized participants who received at least 1 dose of Cvac (Cvac group) or were evaluated at least once (observational standard of care group).
|
0.00%
0/4
Part A - Safety population: All randomized participants who received at least 1 dose of Cvac or placebo. Part B - Safety population: All randomized participants who received at least 1 dose of Cvac (Cvac group) or were evaluated at least once (observational standard of care group).
|
|
Gastrointestinal disorders
Small intestinal perforation
|
5.0%
1/20
Part A - Safety population: All randomized participants who received at least 1 dose of Cvac or placebo. Part B - Safety population: All randomized participants who received at least 1 dose of Cvac (Cvac group) or were evaluated at least once (observational standard of care group).
|
0.00%
0/20
Part A - Safety population: All randomized participants who received at least 1 dose of Cvac or placebo. Part B - Safety population: All randomized participants who received at least 1 dose of Cvac (Cvac group) or were evaluated at least once (observational standard of care group).
|
0.00%
0/3
Part A - Safety population: All randomized participants who received at least 1 dose of Cvac or placebo. Part B - Safety population: All randomized participants who received at least 1 dose of Cvac (Cvac group) or were evaluated at least once (observational standard of care group).
|
0.00%
0/4
Part A - Safety population: All randomized participants who received at least 1 dose of Cvac or placebo. Part B - Safety population: All randomized participants who received at least 1 dose of Cvac (Cvac group) or were evaluated at least once (observational standard of care group).
|
|
General disorders
Fat necrosis
|
5.0%
1/20
Part A - Safety population: All randomized participants who received at least 1 dose of Cvac or placebo. Part B - Safety population: All randomized participants who received at least 1 dose of Cvac (Cvac group) or were evaluated at least once (observational standard of care group).
|
0.00%
0/20
Part A - Safety population: All randomized participants who received at least 1 dose of Cvac or placebo. Part B - Safety population: All randomized participants who received at least 1 dose of Cvac (Cvac group) or were evaluated at least once (observational standard of care group).
|
0.00%
0/3
Part A - Safety population: All randomized participants who received at least 1 dose of Cvac or placebo. Part B - Safety population: All randomized participants who received at least 1 dose of Cvac (Cvac group) or were evaluated at least once (observational standard of care group).
|
0.00%
0/4
Part A - Safety population: All randomized participants who received at least 1 dose of Cvac or placebo. Part B - Safety population: All randomized participants who received at least 1 dose of Cvac (Cvac group) or were evaluated at least once (observational standard of care group).
|
|
General disorders
Hernia
|
5.0%
1/20
Part A - Safety population: All randomized participants who received at least 1 dose of Cvac or placebo. Part B - Safety population: All randomized participants who received at least 1 dose of Cvac (Cvac group) or were evaluated at least once (observational standard of care group).
|
5.0%
1/20
Part A - Safety population: All randomized participants who received at least 1 dose of Cvac or placebo. Part B - Safety population: All randomized participants who received at least 1 dose of Cvac (Cvac group) or were evaluated at least once (observational standard of care group).
|
0.00%
0/3
Part A - Safety population: All randomized participants who received at least 1 dose of Cvac or placebo. Part B - Safety population: All randomized participants who received at least 1 dose of Cvac (Cvac group) or were evaluated at least once (observational standard of care group).
|
0.00%
0/4
Part A - Safety population: All randomized participants who received at least 1 dose of Cvac or placebo. Part B - Safety population: All randomized participants who received at least 1 dose of Cvac (Cvac group) or were evaluated at least once (observational standard of care group).
|
|
Hepatobiliary disorders
Cholecystitis
|
0.00%
0/20
Part A - Safety population: All randomized participants who received at least 1 dose of Cvac or placebo. Part B - Safety population: All randomized participants who received at least 1 dose of Cvac (Cvac group) or were evaluated at least once (observational standard of care group).
|
5.0%
1/20
Part A - Safety population: All randomized participants who received at least 1 dose of Cvac or placebo. Part B - Safety population: All randomized participants who received at least 1 dose of Cvac (Cvac group) or were evaluated at least once (observational standard of care group).
|
0.00%
0/3
Part A - Safety population: All randomized participants who received at least 1 dose of Cvac or placebo. Part B - Safety population: All randomized participants who received at least 1 dose of Cvac (Cvac group) or were evaluated at least once (observational standard of care group).
|
0.00%
0/4
Part A - Safety population: All randomized participants who received at least 1 dose of Cvac or placebo. Part B - Safety population: All randomized participants who received at least 1 dose of Cvac (Cvac group) or were evaluated at least once (observational standard of care group).
|
|
Infections and infestations
Clostridial infection
|
0.00%
0/20
Part A - Safety population: All randomized participants who received at least 1 dose of Cvac or placebo. Part B - Safety population: All randomized participants who received at least 1 dose of Cvac (Cvac group) or were evaluated at least once (observational standard of care group).
|
0.00%
0/20
Part A - Safety population: All randomized participants who received at least 1 dose of Cvac or placebo. Part B - Safety population: All randomized participants who received at least 1 dose of Cvac (Cvac group) or were evaluated at least once (observational standard of care group).
|
0.00%
0/3
Part A - Safety population: All randomized participants who received at least 1 dose of Cvac or placebo. Part B - Safety population: All randomized participants who received at least 1 dose of Cvac (Cvac group) or were evaluated at least once (observational standard of care group).
|
0.00%
0/4
Part A - Safety population: All randomized participants who received at least 1 dose of Cvac or placebo. Part B - Safety population: All randomized participants who received at least 1 dose of Cvac (Cvac group) or were evaluated at least once (observational standard of care group).
|
|
Infections and infestations
Herpes dermatitis
|
5.0%
1/20
Part A - Safety population: All randomized participants who received at least 1 dose of Cvac or placebo. Part B - Safety population: All randomized participants who received at least 1 dose of Cvac (Cvac group) or were evaluated at least once (observational standard of care group).
|
0.00%
0/20
Part A - Safety population: All randomized participants who received at least 1 dose of Cvac or placebo. Part B - Safety population: All randomized participants who received at least 1 dose of Cvac (Cvac group) or were evaluated at least once (observational standard of care group).
|
0.00%
0/3
Part A - Safety population: All randomized participants who received at least 1 dose of Cvac or placebo. Part B - Safety population: All randomized participants who received at least 1 dose of Cvac (Cvac group) or were evaluated at least once (observational standard of care group).
|
0.00%
0/4
Part A - Safety population: All randomized participants who received at least 1 dose of Cvac or placebo. Part B - Safety population: All randomized participants who received at least 1 dose of Cvac (Cvac group) or were evaluated at least once (observational standard of care group).
|
|
Injury, poisoning and procedural complications
Poisoning
|
5.0%
1/20
Part A - Safety population: All randomized participants who received at least 1 dose of Cvac or placebo. Part B - Safety population: All randomized participants who received at least 1 dose of Cvac (Cvac group) or were evaluated at least once (observational standard of care group).
|
0.00%
0/20
Part A - Safety population: All randomized participants who received at least 1 dose of Cvac or placebo. Part B - Safety population: All randomized participants who received at least 1 dose of Cvac (Cvac group) or were evaluated at least once (observational standard of care group).
|
0.00%
0/3
Part A - Safety population: All randomized participants who received at least 1 dose of Cvac or placebo. Part B - Safety population: All randomized participants who received at least 1 dose of Cvac (Cvac group) or were evaluated at least once (observational standard of care group).
|
0.00%
0/4
Part A - Safety population: All randomized participants who received at least 1 dose of Cvac or placebo. Part B - Safety population: All randomized participants who received at least 1 dose of Cvac (Cvac group) or were evaluated at least once (observational standard of care group).
|
|
Investigations
Biopsy liver
|
0.00%
0/20
Part A - Safety population: All randomized participants who received at least 1 dose of Cvac or placebo. Part B - Safety population: All randomized participants who received at least 1 dose of Cvac (Cvac group) or were evaluated at least once (observational standard of care group).
|
5.0%
1/20
Part A - Safety population: All randomized participants who received at least 1 dose of Cvac or placebo. Part B - Safety population: All randomized participants who received at least 1 dose of Cvac (Cvac group) or were evaluated at least once (observational standard of care group).
|
0.00%
0/3
Part A - Safety population: All randomized participants who received at least 1 dose of Cvac or placebo. Part B - Safety population: All randomized participants who received at least 1 dose of Cvac (Cvac group) or were evaluated at least once (observational standard of care group).
|
0.00%
0/4
Part A - Safety population: All randomized participants who received at least 1 dose of Cvac or placebo. Part B - Safety population: All randomized participants who received at least 1 dose of Cvac (Cvac group) or were evaluated at least once (observational standard of care group).
|
|
Investigations
Blood creatinine increased
|
0.00%
0/20
Part A - Safety population: All randomized participants who received at least 1 dose of Cvac or placebo. Part B - Safety population: All randomized participants who received at least 1 dose of Cvac (Cvac group) or were evaluated at least once (observational standard of care group).
|
5.0%
1/20
Part A - Safety population: All randomized participants who received at least 1 dose of Cvac or placebo. Part B - Safety population: All randomized participants who received at least 1 dose of Cvac (Cvac group) or were evaluated at least once (observational standard of care group).
|
0.00%
0/3
Part A - Safety population: All randomized participants who received at least 1 dose of Cvac or placebo. Part B - Safety population: All randomized participants who received at least 1 dose of Cvac (Cvac group) or were evaluated at least once (observational standard of care group).
|
0.00%
0/4
Part A - Safety population: All randomized participants who received at least 1 dose of Cvac or placebo. Part B - Safety population: All randomized participants who received at least 1 dose of Cvac (Cvac group) or were evaluated at least once (observational standard of care group).
|
|
Metabolism and nutrition disorders
Dehydration
|
0.00%
0/20
Part A - Safety population: All randomized participants who received at least 1 dose of Cvac or placebo. Part B - Safety population: All randomized participants who received at least 1 dose of Cvac (Cvac group) or were evaluated at least once (observational standard of care group).
|
5.0%
1/20
Part A - Safety population: All randomized participants who received at least 1 dose of Cvac or placebo. Part B - Safety population: All randomized participants who received at least 1 dose of Cvac (Cvac group) or were evaluated at least once (observational standard of care group).
|
0.00%
0/3
Part A - Safety population: All randomized participants who received at least 1 dose of Cvac or placebo. Part B - Safety population: All randomized participants who received at least 1 dose of Cvac (Cvac group) or were evaluated at least once (observational standard of care group).
|
0.00%
0/4
Part A - Safety population: All randomized participants who received at least 1 dose of Cvac or placebo. Part B - Safety population: All randomized participants who received at least 1 dose of Cvac (Cvac group) or were evaluated at least once (observational standard of care group).
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
5.0%
1/20
Part A - Safety population: All randomized participants who received at least 1 dose of Cvac or placebo. Part B - Safety population: All randomized participants who received at least 1 dose of Cvac (Cvac group) or were evaluated at least once (observational standard of care group).
|
0.00%
0/20
Part A - Safety population: All randomized participants who received at least 1 dose of Cvac or placebo. Part B - Safety population: All randomized participants who received at least 1 dose of Cvac (Cvac group) or were evaluated at least once (observational standard of care group).
|
0.00%
0/3
Part A - Safety population: All randomized participants who received at least 1 dose of Cvac or placebo. Part B - Safety population: All randomized participants who received at least 1 dose of Cvac (Cvac group) or were evaluated at least once (observational standard of care group).
|
0.00%
0/4
Part A - Safety population: All randomized participants who received at least 1 dose of Cvac or placebo. Part B - Safety population: All randomized participants who received at least 1 dose of Cvac (Cvac group) or were evaluated at least once (observational standard of care group).
|
|
Surgical and medical procedures
Stoma care
|
5.0%
1/20
Part A - Safety population: All randomized participants who received at least 1 dose of Cvac or placebo. Part B - Safety population: All randomized participants who received at least 1 dose of Cvac (Cvac group) or were evaluated at least once (observational standard of care group).
|
0.00%
0/20
Part A - Safety population: All randomized participants who received at least 1 dose of Cvac or placebo. Part B - Safety population: All randomized participants who received at least 1 dose of Cvac (Cvac group) or were evaluated at least once (observational standard of care group).
|
0.00%
0/3
Part A - Safety population: All randomized participants who received at least 1 dose of Cvac or placebo. Part B - Safety population: All randomized participants who received at least 1 dose of Cvac (Cvac group) or were evaluated at least once (observational standard of care group).
|
0.00%
0/4
Part A - Safety population: All randomized participants who received at least 1 dose of Cvac or placebo. Part B - Safety population: All randomized participants who received at least 1 dose of Cvac (Cvac group) or were evaluated at least once (observational standard of care group).
|
|
Vascular disorders
Lymphocele
|
0.00%
0/20
Part A - Safety population: All randomized participants who received at least 1 dose of Cvac or placebo. Part B - Safety population: All randomized participants who received at least 1 dose of Cvac (Cvac group) or were evaluated at least once (observational standard of care group).
|
5.0%
1/20
Part A - Safety population: All randomized participants who received at least 1 dose of Cvac or placebo. Part B - Safety population: All randomized participants who received at least 1 dose of Cvac (Cvac group) or were evaluated at least once (observational standard of care group).
|
0.00%
0/3
Part A - Safety population: All randomized participants who received at least 1 dose of Cvac or placebo. Part B - Safety population: All randomized participants who received at least 1 dose of Cvac (Cvac group) or were evaluated at least once (observational standard of care group).
|
0.00%
0/4
Part A - Safety population: All randomized participants who received at least 1 dose of Cvac or placebo. Part B - Safety population: All randomized participants who received at least 1 dose of Cvac (Cvac group) or were evaluated at least once (observational standard of care group).
|
Other adverse events
| Measure |
Part A - Cvac
n=20 participants at risk
Participants received intradermal injections of Cvac given at 4-week intervals for the first 3 doses, and then every 12 weeks for 3 additional doses, for a total of 6 doses over 44 weeks. Each injection had an approximate concentration of 60 × 10\^6 viable dendritic cells/mL.
|
Part A - Placebo
n=20 participants at risk
Participants received intradermal injections of placebo given at 4-week intervals for the first 3 doses, and then every 12 weeks for 3 additional doses, for a total of 6 doses over 44 weeks.
|
Part B - Cvac
n=3 participants at risk
Participants received intradermal injections of Cvac given at 4-week intervals for the first 3 doses, and then every 12 weeks for 3 additional doses, for a total of 6 doses over 44 weeks. Each injection had an approximate concentration of 60 × 10\^6 viable dendritic cells/mL.
|
Part B - Observational Standard of Care
n=4 participants at risk
Participants in this group did not receive any treatment during the study.
|
|---|---|---|---|---|
|
Eye disorders
Visual impairment
|
5.0%
1/20
Part A - Safety population: All randomized participants who received at least 1 dose of Cvac or placebo. Part B - Safety population: All randomized participants who received at least 1 dose of Cvac (Cvac group) or were evaluated at least once (observational standard of care group).
|
0.00%
0/20
Part A - Safety population: All randomized participants who received at least 1 dose of Cvac or placebo. Part B - Safety population: All randomized participants who received at least 1 dose of Cvac (Cvac group) or were evaluated at least once (observational standard of care group).
|
0.00%
0/3
Part A - Safety population: All randomized participants who received at least 1 dose of Cvac or placebo. Part B - Safety population: All randomized participants who received at least 1 dose of Cvac (Cvac group) or were evaluated at least once (observational standard of care group).
|
0.00%
0/4
Part A - Safety population: All randomized participants who received at least 1 dose of Cvac or placebo. Part B - Safety population: All randomized participants who received at least 1 dose of Cvac (Cvac group) or were evaluated at least once (observational standard of care group).
|
|
Endocrine disorders
Autoimmune thyroiditis
|
0.00%
0/20
Part A - Safety population: All randomized participants who received at least 1 dose of Cvac or placebo. Part B - Safety population: All randomized participants who received at least 1 dose of Cvac (Cvac group) or were evaluated at least once (observational standard of care group).
|
0.00%
0/20
Part A - Safety population: All randomized participants who received at least 1 dose of Cvac or placebo. Part B - Safety population: All randomized participants who received at least 1 dose of Cvac (Cvac group) or were evaluated at least once (observational standard of care group).
|
33.3%
1/3
Part A - Safety population: All randomized participants who received at least 1 dose of Cvac or placebo. Part B - Safety population: All randomized participants who received at least 1 dose of Cvac (Cvac group) or were evaluated at least once (observational standard of care group).
|
0.00%
0/4
Part A - Safety population: All randomized participants who received at least 1 dose of Cvac or placebo. Part B - Safety population: All randomized participants who received at least 1 dose of Cvac (Cvac group) or were evaluated at least once (observational standard of care group).
|
|
Blood and lymphatic system disorders
Lymphopenia
|
0.00%
0/20
Part A - Safety population: All randomized participants who received at least 1 dose of Cvac or placebo. Part B - Safety population: All randomized participants who received at least 1 dose of Cvac (Cvac group) or were evaluated at least once (observational standard of care group).
|
5.0%
1/20
Part A - Safety population: All randomized participants who received at least 1 dose of Cvac or placebo. Part B - Safety population: All randomized participants who received at least 1 dose of Cvac (Cvac group) or were evaluated at least once (observational standard of care group).
|
0.00%
0/3
Part A - Safety population: All randomized participants who received at least 1 dose of Cvac or placebo. Part B - Safety population: All randomized participants who received at least 1 dose of Cvac (Cvac group) or were evaluated at least once (observational standard of care group).
|
0.00%
0/4
Part A - Safety population: All randomized participants who received at least 1 dose of Cvac or placebo. Part B - Safety population: All randomized participants who received at least 1 dose of Cvac (Cvac group) or were evaluated at least once (observational standard of care group).
|
|
Cardiac disorders
Atrioventricular block second degree
|
0.00%
0/20
Part A - Safety population: All randomized participants who received at least 1 dose of Cvac or placebo. Part B - Safety population: All randomized participants who received at least 1 dose of Cvac (Cvac group) or were evaluated at least once (observational standard of care group).
|
5.0%
1/20
Part A - Safety population: All randomized participants who received at least 1 dose of Cvac or placebo. Part B - Safety population: All randomized participants who received at least 1 dose of Cvac (Cvac group) or were evaluated at least once (observational standard of care group).
|
0.00%
0/3
Part A - Safety population: All randomized participants who received at least 1 dose of Cvac or placebo. Part B - Safety population: All randomized participants who received at least 1 dose of Cvac (Cvac group) or were evaluated at least once (observational standard of care group).
|
0.00%
0/4
Part A - Safety population: All randomized participants who received at least 1 dose of Cvac or placebo. Part B - Safety population: All randomized participants who received at least 1 dose of Cvac (Cvac group) or were evaluated at least once (observational standard of care group).
|
|
Cardiac disorders
Palpitations
|
0.00%
0/20
Part A - Safety population: All randomized participants who received at least 1 dose of Cvac or placebo. Part B - Safety population: All randomized participants who received at least 1 dose of Cvac (Cvac group) or were evaluated at least once (observational standard of care group).
|
0.00%
0/20
Part A - Safety population: All randomized participants who received at least 1 dose of Cvac or placebo. Part B - Safety population: All randomized participants who received at least 1 dose of Cvac (Cvac group) or were evaluated at least once (observational standard of care group).
|
33.3%
1/3
Part A - Safety population: All randomized participants who received at least 1 dose of Cvac or placebo. Part B - Safety population: All randomized participants who received at least 1 dose of Cvac (Cvac group) or were evaluated at least once (observational standard of care group).
|
0.00%
0/4
Part A - Safety population: All randomized participants who received at least 1 dose of Cvac or placebo. Part B - Safety population: All randomized participants who received at least 1 dose of Cvac (Cvac group) or were evaluated at least once (observational standard of care group).
|
|
Ear and labyrinth disorders
Tinnitus
|
0.00%
0/20
Part A - Safety population: All randomized participants who received at least 1 dose of Cvac or placebo. Part B - Safety population: All randomized participants who received at least 1 dose of Cvac (Cvac group) or were evaluated at least once (observational standard of care group).
|
5.0%
1/20
Part A - Safety population: All randomized participants who received at least 1 dose of Cvac or placebo. Part B - Safety population: All randomized participants who received at least 1 dose of Cvac (Cvac group) or were evaluated at least once (observational standard of care group).
|
0.00%
0/3
Part A - Safety population: All randomized participants who received at least 1 dose of Cvac or placebo. Part B - Safety population: All randomized participants who received at least 1 dose of Cvac (Cvac group) or were evaluated at least once (observational standard of care group).
|
0.00%
0/4
Part A - Safety population: All randomized participants who received at least 1 dose of Cvac or placebo. Part B - Safety population: All randomized participants who received at least 1 dose of Cvac (Cvac group) or were evaluated at least once (observational standard of care group).
|
|
Gastrointestinal disorders
Abdomianl pain lower
|
5.0%
1/20
Part A - Safety population: All randomized participants who received at least 1 dose of Cvac or placebo. Part B - Safety population: All randomized participants who received at least 1 dose of Cvac (Cvac group) or were evaluated at least once (observational standard of care group).
|
0.00%
0/20
Part A - Safety population: All randomized participants who received at least 1 dose of Cvac or placebo. Part B - Safety population: All randomized participants who received at least 1 dose of Cvac (Cvac group) or were evaluated at least once (observational standard of care group).
|
0.00%
0/3
Part A - Safety population: All randomized participants who received at least 1 dose of Cvac or placebo. Part B - Safety population: All randomized participants who received at least 1 dose of Cvac (Cvac group) or were evaluated at least once (observational standard of care group).
|
0.00%
0/4
Part A - Safety population: All randomized participants who received at least 1 dose of Cvac or placebo. Part B - Safety population: All randomized participants who received at least 1 dose of Cvac (Cvac group) or were evaluated at least once (observational standard of care group).
|
|
Gastrointestinal disorders
Abdominal adhesions
|
5.0%
1/20
Part A - Safety population: All randomized participants who received at least 1 dose of Cvac or placebo. Part B - Safety population: All randomized participants who received at least 1 dose of Cvac (Cvac group) or were evaluated at least once (observational standard of care group).
|
0.00%
0/20
Part A - Safety population: All randomized participants who received at least 1 dose of Cvac or placebo. Part B - Safety population: All randomized participants who received at least 1 dose of Cvac (Cvac group) or were evaluated at least once (observational standard of care group).
|
0.00%
0/3
Part A - Safety population: All randomized participants who received at least 1 dose of Cvac or placebo. Part B - Safety population: All randomized participants who received at least 1 dose of Cvac (Cvac group) or were evaluated at least once (observational standard of care group).
|
0.00%
0/4
Part A - Safety population: All randomized participants who received at least 1 dose of Cvac or placebo. Part B - Safety population: All randomized participants who received at least 1 dose of Cvac (Cvac group) or were evaluated at least once (observational standard of care group).
|
|
Gastrointestinal disorders
Abdominal discomfort
|
0.00%
0/20
Part A - Safety population: All randomized participants who received at least 1 dose of Cvac or placebo. Part B - Safety population: All randomized participants who received at least 1 dose of Cvac (Cvac group) or were evaluated at least once (observational standard of care group).
|
5.0%
1/20
Part A - Safety population: All randomized participants who received at least 1 dose of Cvac or placebo. Part B - Safety population: All randomized participants who received at least 1 dose of Cvac (Cvac group) or were evaluated at least once (observational standard of care group).
|
0.00%
0/3
Part A - Safety population: All randomized participants who received at least 1 dose of Cvac or placebo. Part B - Safety population: All randomized participants who received at least 1 dose of Cvac (Cvac group) or were evaluated at least once (observational standard of care group).
|
0.00%
0/4
Part A - Safety population: All randomized participants who received at least 1 dose of Cvac or placebo. Part B - Safety population: All randomized participants who received at least 1 dose of Cvac (Cvac group) or were evaluated at least once (observational standard of care group).
|
|
Gastrointestinal disorders
Abdominal distension
|
5.0%
1/20
Part A - Safety population: All randomized participants who received at least 1 dose of Cvac or placebo. Part B - Safety population: All randomized participants who received at least 1 dose of Cvac (Cvac group) or were evaluated at least once (observational standard of care group).
|
5.0%
1/20
Part A - Safety population: All randomized participants who received at least 1 dose of Cvac or placebo. Part B - Safety population: All randomized participants who received at least 1 dose of Cvac (Cvac group) or were evaluated at least once (observational standard of care group).
|
0.00%
0/3
Part A - Safety population: All randomized participants who received at least 1 dose of Cvac or placebo. Part B - Safety population: All randomized participants who received at least 1 dose of Cvac (Cvac group) or were evaluated at least once (observational standard of care group).
|
0.00%
0/4
Part A - Safety population: All randomized participants who received at least 1 dose of Cvac or placebo. Part B - Safety population: All randomized participants who received at least 1 dose of Cvac (Cvac group) or were evaluated at least once (observational standard of care group).
|
|
Gastrointestinal disorders
Abdominal hernia
|
10.0%
2/20
Part A - Safety population: All randomized participants who received at least 1 dose of Cvac or placebo. Part B - Safety population: All randomized participants who received at least 1 dose of Cvac (Cvac group) or were evaluated at least once (observational standard of care group).
|
5.0%
1/20
Part A - Safety population: All randomized participants who received at least 1 dose of Cvac or placebo. Part B - Safety population: All randomized participants who received at least 1 dose of Cvac (Cvac group) or were evaluated at least once (observational standard of care group).
|
0.00%
0/3
Part A - Safety population: All randomized participants who received at least 1 dose of Cvac or placebo. Part B - Safety population: All randomized participants who received at least 1 dose of Cvac (Cvac group) or were evaluated at least once (observational standard of care group).
|
0.00%
0/4
Part A - Safety population: All randomized participants who received at least 1 dose of Cvac or placebo. Part B - Safety population: All randomized participants who received at least 1 dose of Cvac (Cvac group) or were evaluated at least once (observational standard of care group).
|
|
Gastrointestinal disorders
Abdominal pain
|
5.0%
1/20
Part A - Safety population: All randomized participants who received at least 1 dose of Cvac or placebo. Part B - Safety population: All randomized participants who received at least 1 dose of Cvac (Cvac group) or were evaluated at least once (observational standard of care group).
|
10.0%
2/20
Part A - Safety population: All randomized participants who received at least 1 dose of Cvac or placebo. Part B - Safety population: All randomized participants who received at least 1 dose of Cvac (Cvac group) or were evaluated at least once (observational standard of care group).
|
0.00%
0/3
Part A - Safety population: All randomized participants who received at least 1 dose of Cvac or placebo. Part B - Safety population: All randomized participants who received at least 1 dose of Cvac (Cvac group) or were evaluated at least once (observational standard of care group).
|
0.00%
0/4
Part A - Safety population: All randomized participants who received at least 1 dose of Cvac or placebo. Part B - Safety population: All randomized participants who received at least 1 dose of Cvac (Cvac group) or were evaluated at least once (observational standard of care group).
|
|
Gastrointestinal disorders
Abdominal pain upper
|
5.0%
1/20
Part A - Safety population: All randomized participants who received at least 1 dose of Cvac or placebo. Part B - Safety population: All randomized participants who received at least 1 dose of Cvac (Cvac group) or were evaluated at least once (observational standard of care group).
|
0.00%
0/20
Part A - Safety population: All randomized participants who received at least 1 dose of Cvac or placebo. Part B - Safety population: All randomized participants who received at least 1 dose of Cvac (Cvac group) or were evaluated at least once (observational standard of care group).
|
0.00%
0/3
Part A - Safety population: All randomized participants who received at least 1 dose of Cvac or placebo. Part B - Safety population: All randomized participants who received at least 1 dose of Cvac (Cvac group) or were evaluated at least once (observational standard of care group).
|
0.00%
0/4
Part A - Safety population: All randomized participants who received at least 1 dose of Cvac or placebo. Part B - Safety population: All randomized participants who received at least 1 dose of Cvac (Cvac group) or were evaluated at least once (observational standard of care group).
|
|
Gastrointestinal disorders
Constipation
|
10.0%
2/20
Part A - Safety population: All randomized participants who received at least 1 dose of Cvac or placebo. Part B - Safety population: All randomized participants who received at least 1 dose of Cvac (Cvac group) or were evaluated at least once (observational standard of care group).
|
5.0%
1/20
Part A - Safety population: All randomized participants who received at least 1 dose of Cvac or placebo. Part B - Safety population: All randomized participants who received at least 1 dose of Cvac (Cvac group) or were evaluated at least once (observational standard of care group).
|
0.00%
0/3
Part A - Safety population: All randomized participants who received at least 1 dose of Cvac or placebo. Part B - Safety population: All randomized participants who received at least 1 dose of Cvac (Cvac group) or were evaluated at least once (observational standard of care group).
|
0.00%
0/4
Part A - Safety population: All randomized participants who received at least 1 dose of Cvac or placebo. Part B - Safety population: All randomized participants who received at least 1 dose of Cvac (Cvac group) or were evaluated at least once (observational standard of care group).
|
|
Gastrointestinal disorders
Diarrhea
|
5.0%
1/20
Part A - Safety population: All randomized participants who received at least 1 dose of Cvac or placebo. Part B - Safety population: All randomized participants who received at least 1 dose of Cvac (Cvac group) or were evaluated at least once (observational standard of care group).
|
15.0%
3/20
Part A - Safety population: All randomized participants who received at least 1 dose of Cvac or placebo. Part B - Safety population: All randomized participants who received at least 1 dose of Cvac (Cvac group) or were evaluated at least once (observational standard of care group).
|
0.00%
0/3
Part A - Safety population: All randomized participants who received at least 1 dose of Cvac or placebo. Part B - Safety population: All randomized participants who received at least 1 dose of Cvac (Cvac group) or were evaluated at least once (observational standard of care group).
|
0.00%
0/4
Part A - Safety population: All randomized participants who received at least 1 dose of Cvac or placebo. Part B - Safety population: All randomized participants who received at least 1 dose of Cvac (Cvac group) or were evaluated at least once (observational standard of care group).
|
|
Gastrointestinal disorders
Flatulence
|
5.0%
1/20
Part A - Safety population: All randomized participants who received at least 1 dose of Cvac or placebo. Part B - Safety population: All randomized participants who received at least 1 dose of Cvac (Cvac group) or were evaluated at least once (observational standard of care group).
|
0.00%
0/20
Part A - Safety population: All randomized participants who received at least 1 dose of Cvac or placebo. Part B - Safety population: All randomized participants who received at least 1 dose of Cvac (Cvac group) or were evaluated at least once (observational standard of care group).
|
0.00%
0/3
Part A - Safety population: All randomized participants who received at least 1 dose of Cvac or placebo. Part B - Safety population: All randomized participants who received at least 1 dose of Cvac (Cvac group) or were evaluated at least once (observational standard of care group).
|
0.00%
0/4
Part A - Safety population: All randomized participants who received at least 1 dose of Cvac or placebo. Part B - Safety population: All randomized participants who received at least 1 dose of Cvac (Cvac group) or were evaluated at least once (observational standard of care group).
|
|
Gastrointestinal disorders
Gastritis erosive
|
0.00%
0/20
Part A - Safety population: All randomized participants who received at least 1 dose of Cvac or placebo. Part B - Safety population: All randomized participants who received at least 1 dose of Cvac (Cvac group) or were evaluated at least once (observational standard of care group).
|
5.0%
1/20
Part A - Safety population: All randomized participants who received at least 1 dose of Cvac or placebo. Part B - Safety population: All randomized participants who received at least 1 dose of Cvac (Cvac group) or were evaluated at least once (observational standard of care group).
|
0.00%
0/3
Part A - Safety population: All randomized participants who received at least 1 dose of Cvac or placebo. Part B - Safety population: All randomized participants who received at least 1 dose of Cvac (Cvac group) or were evaluated at least once (observational standard of care group).
|
0.00%
0/4
Part A - Safety population: All randomized participants who received at least 1 dose of Cvac or placebo. Part B - Safety population: All randomized participants who received at least 1 dose of Cvac (Cvac group) or were evaluated at least once (observational standard of care group).
|
|
Gastrointestinal disorders
Intestinal obstruction
|
0.00%
0/20
Part A - Safety population: All randomized participants who received at least 1 dose of Cvac or placebo. Part B - Safety population: All randomized participants who received at least 1 dose of Cvac (Cvac group) or were evaluated at least once (observational standard of care group).
|
5.0%
1/20
Part A - Safety population: All randomized participants who received at least 1 dose of Cvac or placebo. Part B - Safety population: All randomized participants who received at least 1 dose of Cvac (Cvac group) or were evaluated at least once (observational standard of care group).
|
0.00%
0/3
Part A - Safety population: All randomized participants who received at least 1 dose of Cvac or placebo. Part B - Safety population: All randomized participants who received at least 1 dose of Cvac (Cvac group) or were evaluated at least once (observational standard of care group).
|
0.00%
0/4
Part A - Safety population: All randomized participants who received at least 1 dose of Cvac or placebo. Part B - Safety population: All randomized participants who received at least 1 dose of Cvac (Cvac group) or were evaluated at least once (observational standard of care group).
|
|
Gastrointestinal disorders
Lip blister
|
0.00%
0/20
Part A - Safety population: All randomized participants who received at least 1 dose of Cvac or placebo. Part B - Safety population: All randomized participants who received at least 1 dose of Cvac (Cvac group) or were evaluated at least once (observational standard of care group).
|
5.0%
1/20
Part A - Safety population: All randomized participants who received at least 1 dose of Cvac or placebo. Part B - Safety population: All randomized participants who received at least 1 dose of Cvac (Cvac group) or were evaluated at least once (observational standard of care group).
|
0.00%
0/3
Part A - Safety population: All randomized participants who received at least 1 dose of Cvac or placebo. Part B - Safety population: All randomized participants who received at least 1 dose of Cvac (Cvac group) or were evaluated at least once (observational standard of care group).
|
0.00%
0/4
Part A - Safety population: All randomized participants who received at least 1 dose of Cvac or placebo. Part B - Safety population: All randomized participants who received at least 1 dose of Cvac (Cvac group) or were evaluated at least once (observational standard of care group).
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/20
Part A - Safety population: All randomized participants who received at least 1 dose of Cvac or placebo. Part B - Safety population: All randomized participants who received at least 1 dose of Cvac (Cvac group) or were evaluated at least once (observational standard of care group).
|
20.0%
4/20
Part A - Safety population: All randomized participants who received at least 1 dose of Cvac or placebo. Part B - Safety population: All randomized participants who received at least 1 dose of Cvac (Cvac group) or were evaluated at least once (observational standard of care group).
|
0.00%
0/3
Part A - Safety population: All randomized participants who received at least 1 dose of Cvac or placebo. Part B - Safety population: All randomized participants who received at least 1 dose of Cvac (Cvac group) or were evaluated at least once (observational standard of care group).
|
0.00%
0/4
Part A - Safety population: All randomized participants who received at least 1 dose of Cvac or placebo. Part B - Safety population: All randomized participants who received at least 1 dose of Cvac (Cvac group) or were evaluated at least once (observational standard of care group).
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/20
Part A - Safety population: All randomized participants who received at least 1 dose of Cvac or placebo. Part B - Safety population: All randomized participants who received at least 1 dose of Cvac (Cvac group) or were evaluated at least once (observational standard of care group).
|
10.0%
2/20
Part A - Safety population: All randomized participants who received at least 1 dose of Cvac or placebo. Part B - Safety population: All randomized participants who received at least 1 dose of Cvac (Cvac group) or were evaluated at least once (observational standard of care group).
|
0.00%
0/3
Part A - Safety population: All randomized participants who received at least 1 dose of Cvac or placebo. Part B - Safety population: All randomized participants who received at least 1 dose of Cvac (Cvac group) or were evaluated at least once (observational standard of care group).
|
0.00%
0/4
Part A - Safety population: All randomized participants who received at least 1 dose of Cvac or placebo. Part B - Safety population: All randomized participants who received at least 1 dose of Cvac (Cvac group) or were evaluated at least once (observational standard of care group).
|
|
General disorders
Asthenia
|
5.0%
1/20
Part A - Safety population: All randomized participants who received at least 1 dose of Cvac or placebo. Part B - Safety population: All randomized participants who received at least 1 dose of Cvac (Cvac group) or were evaluated at least once (observational standard of care group).
|
5.0%
1/20
Part A - Safety population: All randomized participants who received at least 1 dose of Cvac or placebo. Part B - Safety population: All randomized participants who received at least 1 dose of Cvac (Cvac group) or were evaluated at least once (observational standard of care group).
|
0.00%
0/3
Part A - Safety population: All randomized participants who received at least 1 dose of Cvac or placebo. Part B - Safety population: All randomized participants who received at least 1 dose of Cvac (Cvac group) or were evaluated at least once (observational standard of care group).
|
0.00%
0/4
Part A - Safety population: All randomized participants who received at least 1 dose of Cvac or placebo. Part B - Safety population: All randomized participants who received at least 1 dose of Cvac (Cvac group) or were evaluated at least once (observational standard of care group).
|
|
General disorders
Chest pain
|
5.0%
1/20
Part A - Safety population: All randomized participants who received at least 1 dose of Cvac or placebo. Part B - Safety population: All randomized participants who received at least 1 dose of Cvac (Cvac group) or were evaluated at least once (observational standard of care group).
|
5.0%
1/20
Part A - Safety population: All randomized participants who received at least 1 dose of Cvac or placebo. Part B - Safety population: All randomized participants who received at least 1 dose of Cvac (Cvac group) or were evaluated at least once (observational standard of care group).
|
0.00%
0/3
Part A - Safety population: All randomized participants who received at least 1 dose of Cvac or placebo. Part B - Safety population: All randomized participants who received at least 1 dose of Cvac (Cvac group) or were evaluated at least once (observational standard of care group).
|
0.00%
0/4
Part A - Safety population: All randomized participants who received at least 1 dose of Cvac or placebo. Part B - Safety population: All randomized participants who received at least 1 dose of Cvac (Cvac group) or were evaluated at least once (observational standard of care group).
|
|
General disorders
Chills
|
10.0%
2/20
Part A - Safety population: All randomized participants who received at least 1 dose of Cvac or placebo. Part B - Safety population: All randomized participants who received at least 1 dose of Cvac (Cvac group) or were evaluated at least once (observational standard of care group).
|
5.0%
1/20
Part A - Safety population: All randomized participants who received at least 1 dose of Cvac or placebo. Part B - Safety population: All randomized participants who received at least 1 dose of Cvac (Cvac group) or were evaluated at least once (observational standard of care group).
|
0.00%
0/3
Part A - Safety population: All randomized participants who received at least 1 dose of Cvac or placebo. Part B - Safety population: All randomized participants who received at least 1 dose of Cvac (Cvac group) or were evaluated at least once (observational standard of care group).
|
0.00%
0/4
Part A - Safety population: All randomized participants who received at least 1 dose of Cvac or placebo. Part B - Safety population: All randomized participants who received at least 1 dose of Cvac (Cvac group) or were evaluated at least once (observational standard of care group).
|
|
General disorders
Edema
|
0.00%
0/20
Part A - Safety population: All randomized participants who received at least 1 dose of Cvac or placebo. Part B - Safety population: All randomized participants who received at least 1 dose of Cvac (Cvac group) or were evaluated at least once (observational standard of care group).
|
5.0%
1/20
Part A - Safety population: All randomized participants who received at least 1 dose of Cvac or placebo. Part B - Safety population: All randomized participants who received at least 1 dose of Cvac (Cvac group) or were evaluated at least once (observational standard of care group).
|
0.00%
0/3
Part A - Safety population: All randomized participants who received at least 1 dose of Cvac or placebo. Part B - Safety population: All randomized participants who received at least 1 dose of Cvac (Cvac group) or were evaluated at least once (observational standard of care group).
|
0.00%
0/4
Part A - Safety population: All randomized participants who received at least 1 dose of Cvac or placebo. Part B - Safety population: All randomized participants who received at least 1 dose of Cvac (Cvac group) or were evaluated at least once (observational standard of care group).
|
|
General disorders
Fatigue
|
0.00%
0/20
Part A - Safety population: All randomized participants who received at least 1 dose of Cvac or placebo. Part B - Safety population: All randomized participants who received at least 1 dose of Cvac (Cvac group) or were evaluated at least once (observational standard of care group).
|
10.0%
2/20
Part A - Safety population: All randomized participants who received at least 1 dose of Cvac or placebo. Part B - Safety population: All randomized participants who received at least 1 dose of Cvac (Cvac group) or were evaluated at least once (observational standard of care group).
|
0.00%
0/3
Part A - Safety population: All randomized participants who received at least 1 dose of Cvac or placebo. Part B - Safety population: All randomized participants who received at least 1 dose of Cvac (Cvac group) or were evaluated at least once (observational standard of care group).
|
0.00%
0/4
Part A - Safety population: All randomized participants who received at least 1 dose of Cvac or placebo. Part B - Safety population: All randomized participants who received at least 1 dose of Cvac (Cvac group) or were evaluated at least once (observational standard of care group).
|
|
General disorders
Feeling hot
|
0.00%
0/20
Part A - Safety population: All randomized participants who received at least 1 dose of Cvac or placebo. Part B - Safety population: All randomized participants who received at least 1 dose of Cvac (Cvac group) or were evaluated at least once (observational standard of care group).
|
5.0%
1/20
Part A - Safety population: All randomized participants who received at least 1 dose of Cvac or placebo. Part B - Safety population: All randomized participants who received at least 1 dose of Cvac (Cvac group) or were evaluated at least once (observational standard of care group).
|
0.00%
0/3
Part A - Safety population: All randomized participants who received at least 1 dose of Cvac or placebo. Part B - Safety population: All randomized participants who received at least 1 dose of Cvac (Cvac group) or were evaluated at least once (observational standard of care group).
|
0.00%
0/4
Part A - Safety population: All randomized participants who received at least 1 dose of Cvac or placebo. Part B - Safety population: All randomized participants who received at least 1 dose of Cvac (Cvac group) or were evaluated at least once (observational standard of care group).
|
|
General disorders
Hernia
|
0.00%
0/20
Part A - Safety population: All randomized participants who received at least 1 dose of Cvac or placebo. Part B - Safety population: All randomized participants who received at least 1 dose of Cvac (Cvac group) or were evaluated at least once (observational standard of care group).
|
5.0%
1/20
Part A - Safety population: All randomized participants who received at least 1 dose of Cvac or placebo. Part B - Safety population: All randomized participants who received at least 1 dose of Cvac (Cvac group) or were evaluated at least once (observational standard of care group).
|
0.00%
0/3
Part A - Safety population: All randomized participants who received at least 1 dose of Cvac or placebo. Part B - Safety population: All randomized participants who received at least 1 dose of Cvac (Cvac group) or were evaluated at least once (observational standard of care group).
|
0.00%
0/4
Part A - Safety population: All randomized participants who received at least 1 dose of Cvac or placebo. Part B - Safety population: All randomized participants who received at least 1 dose of Cvac (Cvac group) or were evaluated at least once (observational standard of care group).
|
|
General disorders
Influenza like illness
|
10.0%
2/20
Part A - Safety population: All randomized participants who received at least 1 dose of Cvac or placebo. Part B - Safety population: All randomized participants who received at least 1 dose of Cvac (Cvac group) or were evaluated at least once (observational standard of care group).
|
0.00%
0/20
Part A - Safety population: All randomized participants who received at least 1 dose of Cvac or placebo. Part B - Safety population: All randomized participants who received at least 1 dose of Cvac (Cvac group) or were evaluated at least once (observational standard of care group).
|
33.3%
1/3
Part A - Safety population: All randomized participants who received at least 1 dose of Cvac or placebo. Part B - Safety population: All randomized participants who received at least 1 dose of Cvac (Cvac group) or were evaluated at least once (observational standard of care group).
|
0.00%
0/4
Part A - Safety population: All randomized participants who received at least 1 dose of Cvac or placebo. Part B - Safety population: All randomized participants who received at least 1 dose of Cvac (Cvac group) or were evaluated at least once (observational standard of care group).
|
|
General disorders
Infusion site erythema
|
0.00%
0/20
Part A - Safety population: All randomized participants who received at least 1 dose of Cvac or placebo. Part B - Safety population: All randomized participants who received at least 1 dose of Cvac (Cvac group) or were evaluated at least once (observational standard of care group).
|
5.0%
1/20
Part A - Safety population: All randomized participants who received at least 1 dose of Cvac or placebo. Part B - Safety population: All randomized participants who received at least 1 dose of Cvac (Cvac group) or were evaluated at least once (observational standard of care group).
|
0.00%
0/3
Part A - Safety population: All randomized participants who received at least 1 dose of Cvac or placebo. Part B - Safety population: All randomized participants who received at least 1 dose of Cvac (Cvac group) or were evaluated at least once (observational standard of care group).
|
0.00%
0/4
Part A - Safety population: All randomized participants who received at least 1 dose of Cvac or placebo. Part B - Safety population: All randomized participants who received at least 1 dose of Cvac (Cvac group) or were evaluated at least once (observational standard of care group).
|
|
General disorders
Infusion site pain
|
0.00%
0/20
Part A - Safety population: All randomized participants who received at least 1 dose of Cvac or placebo. Part B - Safety population: All randomized participants who received at least 1 dose of Cvac (Cvac group) or were evaluated at least once (observational standard of care group).
|
5.0%
1/20
Part A - Safety population: All randomized participants who received at least 1 dose of Cvac or placebo. Part B - Safety population: All randomized participants who received at least 1 dose of Cvac (Cvac group) or were evaluated at least once (observational standard of care group).
|
0.00%
0/3
Part A - Safety population: All randomized participants who received at least 1 dose of Cvac or placebo. Part B - Safety population: All randomized participants who received at least 1 dose of Cvac (Cvac group) or were evaluated at least once (observational standard of care group).
|
0.00%
0/4
Part A - Safety population: All randomized participants who received at least 1 dose of Cvac or placebo. Part B - Safety population: All randomized participants who received at least 1 dose of Cvac (Cvac group) or were evaluated at least once (observational standard of care group).
|
|
General disorders
Injection site discomfort
|
5.0%
1/20
Part A - Safety population: All randomized participants who received at least 1 dose of Cvac or placebo. Part B - Safety population: All randomized participants who received at least 1 dose of Cvac (Cvac group) or were evaluated at least once (observational standard of care group).
|
0.00%
0/20
Part A - Safety population: All randomized participants who received at least 1 dose of Cvac or placebo. Part B - Safety population: All randomized participants who received at least 1 dose of Cvac (Cvac group) or were evaluated at least once (observational standard of care group).
|
0.00%
0/3
Part A - Safety population: All randomized participants who received at least 1 dose of Cvac or placebo. Part B - Safety population: All randomized participants who received at least 1 dose of Cvac (Cvac group) or were evaluated at least once (observational standard of care group).
|
0.00%
0/4
Part A - Safety population: All randomized participants who received at least 1 dose of Cvac or placebo. Part B - Safety population: All randomized participants who received at least 1 dose of Cvac (Cvac group) or were evaluated at least once (observational standard of care group).
|
|
General disorders
Injection site erythema
|
25.0%
5/20
Part A - Safety population: All randomized participants who received at least 1 dose of Cvac or placebo. Part B - Safety population: All randomized participants who received at least 1 dose of Cvac (Cvac group) or were evaluated at least once (observational standard of care group).
|
20.0%
4/20
Part A - Safety population: All randomized participants who received at least 1 dose of Cvac or placebo. Part B - Safety population: All randomized participants who received at least 1 dose of Cvac (Cvac group) or were evaluated at least once (observational standard of care group).
|
0.00%
0/3
Part A - Safety population: All randomized participants who received at least 1 dose of Cvac or placebo. Part B - Safety population: All randomized participants who received at least 1 dose of Cvac (Cvac group) or were evaluated at least once (observational standard of care group).
|
0.00%
0/4
Part A - Safety population: All randomized participants who received at least 1 dose of Cvac or placebo. Part B - Safety population: All randomized participants who received at least 1 dose of Cvac (Cvac group) or were evaluated at least once (observational standard of care group).
|
|
General disorders
Injection site hematoma
|
5.0%
1/20
Part A - Safety population: All randomized participants who received at least 1 dose of Cvac or placebo. Part B - Safety population: All randomized participants who received at least 1 dose of Cvac (Cvac group) or were evaluated at least once (observational standard of care group).
|
0.00%
0/20
Part A - Safety population: All randomized participants who received at least 1 dose of Cvac or placebo. Part B - Safety population: All randomized participants who received at least 1 dose of Cvac (Cvac group) or were evaluated at least once (observational standard of care group).
|
0.00%
0/3
Part A - Safety population: All randomized participants who received at least 1 dose of Cvac or placebo. Part B - Safety population: All randomized participants who received at least 1 dose of Cvac (Cvac group) or were evaluated at least once (observational standard of care group).
|
0.00%
0/4
Part A - Safety population: All randomized participants who received at least 1 dose of Cvac or placebo. Part B - Safety population: All randomized participants who received at least 1 dose of Cvac (Cvac group) or were evaluated at least once (observational standard of care group).
|
|
General disorders
Injection site nodule
|
10.0%
2/20
Part A - Safety population: All randomized participants who received at least 1 dose of Cvac or placebo. Part B - Safety population: All randomized participants who received at least 1 dose of Cvac (Cvac group) or were evaluated at least once (observational standard of care group).
|
10.0%
2/20
Part A - Safety population: All randomized participants who received at least 1 dose of Cvac or placebo. Part B - Safety population: All randomized participants who received at least 1 dose of Cvac (Cvac group) or were evaluated at least once (observational standard of care group).
|
0.00%
0/3
Part A - Safety population: All randomized participants who received at least 1 dose of Cvac or placebo. Part B - Safety population: All randomized participants who received at least 1 dose of Cvac (Cvac group) or were evaluated at least once (observational standard of care group).
|
0.00%
0/4
Part A - Safety population: All randomized participants who received at least 1 dose of Cvac or placebo. Part B - Safety population: All randomized participants who received at least 1 dose of Cvac (Cvac group) or were evaluated at least once (observational standard of care group).
|
|
General disorders
Injection site pain
|
15.0%
3/20
Part A - Safety population: All randomized participants who received at least 1 dose of Cvac or placebo. Part B - Safety population: All randomized participants who received at least 1 dose of Cvac (Cvac group) or were evaluated at least once (observational standard of care group).
|
10.0%
2/20
Part A - Safety population: All randomized participants who received at least 1 dose of Cvac or placebo. Part B - Safety population: All randomized participants who received at least 1 dose of Cvac (Cvac group) or were evaluated at least once (observational standard of care group).
|
0.00%
0/3
Part A - Safety population: All randomized participants who received at least 1 dose of Cvac or placebo. Part B - Safety population: All randomized participants who received at least 1 dose of Cvac (Cvac group) or were evaluated at least once (observational standard of care group).
|
0.00%
0/4
Part A - Safety population: All randomized participants who received at least 1 dose of Cvac or placebo. Part B - Safety population: All randomized participants who received at least 1 dose of Cvac (Cvac group) or were evaluated at least once (observational standard of care group).
|
|
General disorders
Injection site reaction
|
0.00%
0/20
Part A - Safety population: All randomized participants who received at least 1 dose of Cvac or placebo. Part B - Safety population: All randomized participants who received at least 1 dose of Cvac (Cvac group) or were evaluated at least once (observational standard of care group).
|
0.00%
0/20
Part A - Safety population: All randomized participants who received at least 1 dose of Cvac or placebo. Part B - Safety population: All randomized participants who received at least 1 dose of Cvac (Cvac group) or were evaluated at least once (observational standard of care group).
|
33.3%
1/3
Part A - Safety population: All randomized participants who received at least 1 dose of Cvac or placebo. Part B - Safety population: All randomized participants who received at least 1 dose of Cvac (Cvac group) or were evaluated at least once (observational standard of care group).
|
0.00%
0/4
Part A - Safety population: All randomized participants who received at least 1 dose of Cvac or placebo. Part B - Safety population: All randomized participants who received at least 1 dose of Cvac (Cvac group) or were evaluated at least once (observational standard of care group).
|
|
General disorders
Local swelling
|
0.00%
0/20
Part A - Safety population: All randomized participants who received at least 1 dose of Cvac or placebo. Part B - Safety population: All randomized participants who received at least 1 dose of Cvac (Cvac group) or were evaluated at least once (observational standard of care group).
|
5.0%
1/20
Part A - Safety population: All randomized participants who received at least 1 dose of Cvac or placebo. Part B - Safety population: All randomized participants who received at least 1 dose of Cvac (Cvac group) or were evaluated at least once (observational standard of care group).
|
0.00%
0/3
Part A - Safety population: All randomized participants who received at least 1 dose of Cvac or placebo. Part B - Safety population: All randomized participants who received at least 1 dose of Cvac (Cvac group) or were evaluated at least once (observational standard of care group).
|
0.00%
0/4
Part A - Safety population: All randomized participants who received at least 1 dose of Cvac or placebo. Part B - Safety population: All randomized participants who received at least 1 dose of Cvac (Cvac group) or were evaluated at least once (observational standard of care group).
|
|
General disorders
Nodule
|
0.00%
0/20
Part A - Safety population: All randomized participants who received at least 1 dose of Cvac or placebo. Part B - Safety population: All randomized participants who received at least 1 dose of Cvac (Cvac group) or were evaluated at least once (observational standard of care group).
|
5.0%
1/20
Part A - Safety population: All randomized participants who received at least 1 dose of Cvac or placebo. Part B - Safety population: All randomized participants who received at least 1 dose of Cvac (Cvac group) or were evaluated at least once (observational standard of care group).
|
0.00%
0/3
Part A - Safety population: All randomized participants who received at least 1 dose of Cvac or placebo. Part B - Safety population: All randomized participants who received at least 1 dose of Cvac (Cvac group) or were evaluated at least once (observational standard of care group).
|
0.00%
0/4
Part A - Safety population: All randomized participants who received at least 1 dose of Cvac or placebo. Part B - Safety population: All randomized participants who received at least 1 dose of Cvac (Cvac group) or were evaluated at least once (observational standard of care group).
|
|
General disorders
Pain
|
5.0%
1/20
Part A - Safety population: All randomized participants who received at least 1 dose of Cvac or placebo. Part B - Safety population: All randomized participants who received at least 1 dose of Cvac (Cvac group) or were evaluated at least once (observational standard of care group).
|
0.00%
0/20
Part A - Safety population: All randomized participants who received at least 1 dose of Cvac or placebo. Part B - Safety population: All randomized participants who received at least 1 dose of Cvac (Cvac group) or were evaluated at least once (observational standard of care group).
|
0.00%
0/3
Part A - Safety population: All randomized participants who received at least 1 dose of Cvac or placebo. Part B - Safety population: All randomized participants who received at least 1 dose of Cvac (Cvac group) or were evaluated at least once (observational standard of care group).
|
0.00%
0/4
Part A - Safety population: All randomized participants who received at least 1 dose of Cvac or placebo. Part B - Safety population: All randomized participants who received at least 1 dose of Cvac (Cvac group) or were evaluated at least once (observational standard of care group).
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
0.00%
0/20
Part A - Safety population: All randomized participants who received at least 1 dose of Cvac or placebo. Part B - Safety population: All randomized participants who received at least 1 dose of Cvac (Cvac group) or were evaluated at least once (observational standard of care group).
|
0.00%
0/20
Part A - Safety population: All randomized participants who received at least 1 dose of Cvac or placebo. Part B - Safety population: All randomized participants who received at least 1 dose of Cvac (Cvac group) or were evaluated at least once (observational standard of care group).
|
33.3%
1/3
Part A - Safety population: All randomized participants who received at least 1 dose of Cvac or placebo. Part B - Safety population: All randomized participants who received at least 1 dose of Cvac (Cvac group) or were evaluated at least once (observational standard of care group).
|
0.00%
0/4
Part A - Safety population: All randomized participants who received at least 1 dose of Cvac or placebo. Part B - Safety population: All randomized participants who received at least 1 dose of Cvac (Cvac group) or were evaluated at least once (observational standard of care group).
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
0.00%
0/20
Part A - Safety population: All randomized participants who received at least 1 dose of Cvac or placebo. Part B - Safety population: All randomized participants who received at least 1 dose of Cvac (Cvac group) or were evaluated at least once (observational standard of care group).
|
0.00%
0/20
Part A - Safety population: All randomized participants who received at least 1 dose of Cvac or placebo. Part B - Safety population: All randomized participants who received at least 1 dose of Cvac (Cvac group) or were evaluated at least once (observational standard of care group).
|
33.3%
1/3
Part A - Safety population: All randomized participants who received at least 1 dose of Cvac or placebo. Part B - Safety population: All randomized participants who received at least 1 dose of Cvac (Cvac group) or were evaluated at least once (observational standard of care group).
|
0.00%
0/4
Part A - Safety population: All randomized participants who received at least 1 dose of Cvac or placebo. Part B - Safety population: All randomized participants who received at least 1 dose of Cvac (Cvac group) or were evaluated at least once (observational standard of care group).
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee For study centers in Australia, no publication of the study results may be made until publication of the results of the study from all centers or until 2 years after study completion, whichever is sooner. For study centers in the USA, no submission for publication or public disclosure of the results by will be made until the results from all centers have been received and analyzed by the sponsor, or the multi-center study has been terminated or abandoned at all centers.
- Publication restrictions are in place
Restriction type: OTHER