Trial Outcomes & Findings for Safety and Immunogenicity Study of Recombinant Ricin Toxin A-Chain Vaccine (RVEc™) (NCT NCT01317667)

NCT ID: NCT01317667

Last Updated: 2020-01-03

Results Overview

Recruitment status

COMPLETED

Study phase

PHASE1

Target enrollment

30 participants

Primary outcome timeframe

Days 1, 3, 7, 14, and 28 after each vaccination and at 6 and 9 months

Results posted on

2020-01-03

Participant Flow

Participant milestones

Participant milestones
Measure	Group 1 RVEc vaccine 20 μg/dose x 3 doses	Group 2 RVEc vaccine 50 μg/dose x 3 doses	Group 3 RVEc vaccine 100 μg/dose x 1 dose
Overall Study STARTED	10	10	10
Overall Study COMPLETED	10	10	10
Overall Study NOT COMPLETED	0	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Safety and Immunogenicity Study of Recombinant Ricin Toxin A-Chain Vaccine (RVEc™)

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Group 1 n=10 Participants RVEc vaccine 20 μg/dose x 3 doses	Group 2 n=10 Participants RVEc vaccine 50 μg/dose x 3 doses	Group 3 n=10 Participants RVEc vaccine 100 μg/dose x 1 dose	Total n=30 Participants Total of all reporting groups
Age, Continuous	35.6 years STANDARD_DEVIATION 8.19 • n=5 Participants	35.0 years STANDARD_DEVIATION 7.62 • n=7 Participants	32.2 years STANDARD_DEVIATION 8.13 • n=5 Participants	34.3 years STANDARD_DEVIATION 7.85 • n=4 Participants
Sex: Female, Male Female	3 Participants n=5 Participants	4 Participants n=7 Participants	3 Participants n=5 Participants	10 Participants n=4 Participants
Sex: Female, Male Male	7 Participants n=5 Participants	6 Participants n=7 Participants	7 Participants n=5 Participants	20 Participants n=4 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	1 Participants n=5 Participants	1 Participants n=7 Participants	0 Participants n=5 Participants	2 Participants n=4 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	9 Participants n=5 Participants	9 Participants n=7 Participants	10 Participants n=5 Participants	28 Participants n=4 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants	1 Participants n=4 Participants
Race (NIH/OMB) White	10 Participants n=5 Participants	10 Participants n=7 Participants	9 Participants n=5 Participants	29 Participants n=4 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants

PRIMARY outcome

Timeframe: Days 1, 3, 7, 14, and 28 after each vaccination and at 6 and 9 months

Population: Safety population: any subject receiving a vaccination

Outcome measures

Outcome measures
Measure	Group 1 n=10 Participants RVEc vaccine 20 μg/dose x 3 doses	Group 2 n=10 Participants RVEc vaccine 50 μg/dose x 3 doses	Group 3 n=10 Participants RVEc vaccine 100 μg/dose x 1 dose
Number of Vaccinated Subjects Any Averse Events and by Location and Severity Any adverse events	10 participants	10 participants	9 participants
Number of Vaccinated Subjects Any Averse Events and by Location and Severity Local life-threatening	0 participants	0 participants	0 participants
Number of Vaccinated Subjects Any Averse Events and by Location and Severity Local severe	1 participants	0 participants	0 participants
Number of Vaccinated Subjects Any Averse Events and by Location and Severity Local moderate	1 participants	0 participants	0 participants
Number of Vaccinated Subjects Any Averse Events and by Location and Severity Local mild	7 participants	8 participants	2 participants
Number of Vaccinated Subjects Any Averse Events and by Location and Severity Systemic life-threatening	0 participants	0 participants	2 participants
Number of Vaccinated Subjects Any Averse Events and by Location and Severity Systemic severe	3 participants	2 participants	2 participants
Number of Vaccinated Subjects Any Averse Events and by Location and Severity Systemic moderate	7 participants	8 participants	5 participants
Number of Vaccinated Subjects Any Averse Events and by Location and Severity Systemic mild	10 participants	10 participants	8 participants

SECONDARY outcome

Timeframe: Day 7, 14, 28, 35, 42, 56, 63, 70, 84, month 6, 9, and 12

Population: Per-protocol population. Only observations or specimens collected according to the protocol were included in the immunogenicity analyses.

Overall response is defined as a subject having a response at any time after vaccination. A response is defined as subjects who developed total ELISA IgG titers (≥ 1:500) and TNA anti-ricin toxin-neutralizing antibody titers (≥ 1:50) at each scheduled time point for which blood samples were taken for each group and over the entire study period to study completion.

Outcome measures

Outcome measures
Measure	Group 1 n=10 Participants RVEc vaccine 20 μg/dose x 3 doses	Group 2 n=10 Participants RVEc vaccine 50 μg/dose x 3 doses	Group 3 n=10 Participants RVEc vaccine 100 μg/dose x 1 dose
Over Response Rates and Comparisons for ELISA and TNA Titers ELISA	10 participants	6 participants	6 participants
Over Response Rates and Comparisons for ELISA and TNA Titers TNA	5 participants	0 participants	1 participants

Adverse Events

Group 1

Serious events: 1 serious events

Other events: 10 other events

Deaths: 0 deaths

Group 2

Serious events: 0 serious events

Other events: 10 other events

Deaths: 0 deaths

Group 3

Serious events: 1 serious events

Other events: 9 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Group 1 n=10 participants at risk RVEc vaccine 20 μg/dose x 3 doses	Group 2 n=10 participants at risk RVEc vaccine 50 μg/dose x 3 doses	Group 3 n=10 participants at risk RVEc vaccine 100 μg/dose x 1 dose
Musculoskeletal and connective tissue disorders Arthralgia	10.0% 1/10 • Number of events 1 • 9 months Safety population: any subject receiving a vaccination	0.00% 0/10 • 9 months Safety population: any subject receiving a vaccination	0.00% 0/10 • 9 months Safety population: any subject receiving a vaccination
Musculoskeletal and connective tissue disorders Rhabdomyolysis	0.00% 0/10 • 9 months Safety population: any subject receiving a vaccination	0.00% 0/10 • 9 months Safety population: any subject receiving a vaccination	10.0% 1/10 • Number of events 1 • 9 months Safety population: any subject receiving a vaccination

Other adverse events

Additional Information

Denise P Clizbe, RN, CCRC

US Army Medical Research Institute of Infectious Diseases (USAMRIID)

Phone: 301.619.6869

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place