Trial Outcomes & Findings for Booster Dose (50 µg) of Recombinant Ricin Toxin Vaccine (RVEc™) in Previously Vaccinated Healthy Adults (NCT NCT01846104)
NCT ID: NCT01846104
Last Updated: 2019-12-27
Results Overview
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
4 participants
Primary outcome timeframe
Six months
Results posted on
2019-12-27
Participant Flow
Participant milestones
| Measure |
50-μg Booster Dose RVEc
Subjects will be receive one 50-μg dose of RVEc
50-μg booster dose RVEc: Subjects will be recruited from the 10 subjects who received three 50-μg doses of RVEc during the Phase 1 trial (NCT01317667). Subjects will receive a single booster dose only and will be followed for 6 months after vaccination.
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|---|---|
|
Overall Study
STARTED
|
4
|
|
Overall Study
COMPLETED
|
3
|
|
Overall Study
NOT COMPLETED
|
1
|
Reasons for withdrawal
| Measure |
50-μg Booster Dose RVEc
Subjects will be receive one 50-μg dose of RVEc
50-μg booster dose RVEc: Subjects will be recruited from the 10 subjects who received three 50-μg doses of RVEc during the Phase 1 trial (NCT01317667). Subjects will receive a single booster dose only and will be followed for 6 months after vaccination.
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|---|---|
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Overall Study
Withdrawal by Subject
|
1
|
Baseline Characteristics
Booster Dose (50 µg) of Recombinant Ricin Toxin Vaccine (RVEc™) in Previously Vaccinated Healthy Adults
Baseline characteristics by cohort
| Measure |
50-μg Booster Dose RVEc
n=4 Participants
Subjects will be receive one 50-μg dose of RVEc
50-μg booster dose RVEc: Subjects will be recruited from the 10 subjects who received three 50-μg doses of RVEc during the Phase 1 trial. Subjects will receive a single booster dose only and will be followed for 6 months after vaccination.
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|---|---|
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Age, Continuous
|
39 years
STANDARD_DEVIATION 10.03 • n=5 Participants
|
|
Sex: Female, Male
Female
|
2 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
4 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Six monthsPopulation: All statistical analysis of safety data was conducted using 4 subjects at every time point except Day 180 (for which there were 3 subjects).
Outcome measures
| Measure |
50-μg Booster Dose RVEc
n=4 Participants
Subjects will be receive one 50-μg dose of RVEc
50-μg booster dose RVEc: Subjects will be recruited from the 10 subjects who received three 50-μg doses of RVEc during the Phase 1 trial. Subjects will receive a single booster dose only and will be followed for 6 months after vaccination.
|
|---|---|
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Number of Vaccinated Participants Who Experienced Adverse Events by Nature and Severity.
Vaccinated without symptoms
|
0 participants
|
|
Number of Vaccinated Participants Who Experienced Adverse Events by Nature and Severity.
Vaccinated with any severity of local reaction
|
3 participants
|
|
Number of Vaccinated Participants Who Experienced Adverse Events by Nature and Severity.
Vaccinated with mild systemic reactions
|
3 participants
|
|
Number of Vaccinated Participants Who Experienced Adverse Events by Nature and Severity.
Vaccinated with moderate systemic reactions
|
2 participants
|
|
Number of Vaccinated Participants Who Experienced Adverse Events by Nature and Severity.
Vaccinated with severe systemic reactions
|
1 participants
|
|
Number of Vaccinated Participants Who Experienced Adverse Events by Nature and Severity.
Vaccinated with life-threating systemic reaction
|
0 participants
|
|
Number of Vaccinated Participants Who Experienced Adverse Events by Nature and Severity.
Vaccinated that developed hypernatraemia
|
3 participants
|
|
Number of Vaccinated Participants Who Experienced Adverse Events by Nature and Severity.
Vaccinated that developed injection site pain
|
3 participants
|
SECONDARY outcome
Timeframe: Six monthsPopulation: All statistical analysis of immunogenicity data was conducted using 4 subjects at every time point except Day 84 and 180 (for which there were 3 subjects).
Outcome measures
| Measure |
50-μg Booster Dose RVEc
n=4 Participants
Subjects will be receive one 50-μg dose of RVEc
50-μg booster dose RVEc: Subjects will be recruited from the 10 subjects who received three 50-μg doses of RVEc during the Phase 1 trial. Subjects will receive a single booster dose only and will be followed for 6 months after vaccination.
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|---|---|
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Number of Subjects Who Developed Total ELISA IgG Titers (≥ 1:500)
Day 0
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0 Subjects with Total ELISA IgG (≥ 1:500)
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|
Number of Subjects Who Developed Total ELISA IgG Titers (≥ 1:500)
Day 1
|
1 Subjects with Total ELISA IgG (≥ 1:500)
|
|
Number of Subjects Who Developed Total ELISA IgG Titers (≥ 1:500)
Day 3
|
1 Subjects with Total ELISA IgG (≥ 1:500)
|
|
Number of Subjects Who Developed Total ELISA IgG Titers (≥ 1:500)
Day 7
|
3 Subjects with Total ELISA IgG (≥ 1:500)
|
|
Number of Subjects Who Developed Total ELISA IgG Titers (≥ 1:500)
Day 14
|
4 Subjects with Total ELISA IgG (≥ 1:500)
|
|
Number of Subjects Who Developed Total ELISA IgG Titers (≥ 1:500)
Day 28
|
4 Subjects with Total ELISA IgG (≥ 1:500)
|
|
Number of Subjects Who Developed Total ELISA IgG Titers (≥ 1:500)
Day 42
|
4 Subjects with Total ELISA IgG (≥ 1:500)
|
|
Number of Subjects Who Developed Total ELISA IgG Titers (≥ 1:500)
Day 56
|
4 Subjects with Total ELISA IgG (≥ 1:500)
|
|
Number of Subjects Who Developed Total ELISA IgG Titers (≥ 1:500)
Day 84
|
3 Subjects with Total ELISA IgG (≥ 1:500)
|
|
Number of Subjects Who Developed Total ELISA IgG Titers (≥ 1:500)
Day 180
|
3 Subjects with Total ELISA IgG (≥ 1:500)
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SECONDARY outcome
Timeframe: Six monthsPopulation: All statistical analysis of immunogenicity data was conducted using 4 subjects at every time point except Day 84 and 180 (for which there were 3 subjects).
Outcome measures
| Measure |
50-μg Booster Dose RVEc
n=4 Participants
Subjects will be receive one 50-μg dose of RVEc
50-μg booster dose RVEc: Subjects will be recruited from the 10 subjects who received three 50-μg doses of RVEc during the Phase 1 trial. Subjects will receive a single booster dose only and will be followed for 6 months after vaccination.
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|---|---|
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Number of Subjects Who Developed TNA Anti-ricin Toxin-neutralizing Antibody Titers (≥ 1:50)
Day 0
|
0 participants
|
|
Number of Subjects Who Developed TNA Anti-ricin Toxin-neutralizing Antibody Titers (≥ 1:50)
Day 1
|
0 participants
|
|
Number of Subjects Who Developed TNA Anti-ricin Toxin-neutralizing Antibody Titers (≥ 1:50)
Day 3
|
0 participants
|
|
Number of Subjects Who Developed TNA Anti-ricin Toxin-neutralizing Antibody Titers (≥ 1:50)
Day 7
|
3 participants
|
|
Number of Subjects Who Developed TNA Anti-ricin Toxin-neutralizing Antibody Titers (≥ 1:50)
Day 14
|
4 participants
|
|
Number of Subjects Who Developed TNA Anti-ricin Toxin-neutralizing Antibody Titers (≥ 1:50)
Day 28
|
4 participants
|
|
Number of Subjects Who Developed TNA Anti-ricin Toxin-neutralizing Antibody Titers (≥ 1:50)
Day 42
|
4 participants
|
|
Number of Subjects Who Developed TNA Anti-ricin Toxin-neutralizing Antibody Titers (≥ 1:50)
Day 56
|
4 participants
|
|
Number of Subjects Who Developed TNA Anti-ricin Toxin-neutralizing Antibody Titers (≥ 1:50)
Day 84
|
3 participants
|
|
Number of Subjects Who Developed TNA Anti-ricin Toxin-neutralizing Antibody Titers (≥ 1:50)
Day 180
|
3 participants
|
Adverse Events
50-μg Booster Dose RVEc
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
50-μg Booster Dose RVEc
n=4 participants at risk
Subjects will be receive one 50-μg dose of RVEc
50-μg booster dose RVEc: Subjects will be recruited from the 10 subjects who received three 50-μg doses of RVEc during the Phase 1 trial. Subjects will receive a single booster dose only and will be followed for 6 months after vaccination.
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|---|---|
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General disorders
Injection site pain
|
75.0%
3/4 • Number of events 3 • 9 months
|
|
Nervous system disorders
Migrain
|
25.0%
1/4 • Number of events 1 • 9 months
|
|
Musculoskeletal and connective tissue disorders
Temporo-mandibular joint syndrome
|
25.0%
1/4 • Number of events 1 • 9 months
|
|
Renal and urinary disorders
Haematuria
|
25.0%
1/4 • Number of events 1 • 9 months
|
|
Metabolism and nutrition disorders
Hyper-natraemia
|
75.0%
3/4 • Number of events 3 • 9 months
|
|
Investigations
Blood creatine phosphor-kinase increased
|
25.0%
1/4 • Number of events 1 • 9 months
|
|
General disorders
Vessel puncture site haematoma
|
25.0%
1/4 • Number of events 1 • 9 months
|
|
Metabolism and nutrition disorders
Blood urea increased
|
25.0%
1/4 • Number of events 1 • 9 months
|
Additional Information
Matthew Chambers, MD
Department of Clinical Research Division of Medicine USAMRIID
Phone: 301-619-6731
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place