Trial Outcomes & Findings for Phase I/II Trial of a Malaria Vaccine in Adults Living in the United States of America (NCT NCT00312702)

NCT ID: NCT00312702

Last Updated: 2018-11-26

Results Overview

An AE was defined as any reaction, side effect, or untoward event that occurred during the course of the trial whether or not the event was considered related to study drug or clinically significant. Grade 1: Mild Grade 2: Moderate Grade 3: Severe

• Recruitment status: COMPLETED
• Study phase: PHASE1/PHASE2
• Target enrollment: 18 participants
• Primary outcome timeframe: 30 days post vaccination
• Results posted on: 2018-11-26

Participant Flow

18 immunized, 12 IC's from high dose group and 6 control subject

18 subjects were randomly assigned to the immunization phase for each of the 2 vaccine formulations. 12 IC's from high does group and 1 non immunized infectivity control subject out of the 6 came from this phase 1 study, the other 5 came from the phase 2 study (WRAIR 1250, NCT00312663). Both studies were included in one final clinical study report.

Participant milestones

Measure	10µg Dose FMP011 Falciparum Malaria Protein 11 with AS02A adjuvant Falciparum Malaria Protein 11 with AS02A adjuvant: vaccine	50µg Dose FMP011 Falciparum Malaria Protein 11 with AS02A adjuvant Falciparum Malaria Protein 11 with AS02A adjuvant: vaccine	Infectivity Controls (IC) 12 Subjects from the high dose group and 1 non immunized subject enrolled prior to challenge to serve as IC's for malaria sporozoite challenge. 1 infectivity control subject out of the 6 came from this phase 1 study, the other 5 came from the phase 2 study (WRAIR 1250, NCT00312663). Both studies were included in one final clinical study report.
Immunization Phase STARTED	5	13	0
Immunization Phase COMPLETED	5	12	0
Immunization Phase NOT COMPLETED	0	1	0
Challenge Phase STARTED	0	12	1
Challenge Phase COMPLETED	0	12	1
Challenge Phase NOT COMPLETED	0	0	0

Reasons for withdrawal

Measure	10µg Dose FMP011 Falciparum Malaria Protein 11 with AS02A adjuvant Falciparum Malaria Protein 11 with AS02A adjuvant: vaccine	50µg Dose FMP011 Falciparum Malaria Protein 11 with AS02A adjuvant Falciparum Malaria Protein 11 with AS02A adjuvant: vaccine	Infectivity Controls (IC) 12 Subjects from the high dose group and 1 non immunized subject enrolled prior to challenge to serve as IC's for malaria sporozoite challenge. 1 infectivity control subject out of the 6 came from this phase 1 study, the other 5 came from the phase 2 study (WRAIR 1250, NCT00312663). Both studies were included in one final clinical study report.
Immunization Phase Lost to Follow-up	0	1	0

Baseline Characteristics

Phase I/II Trial of a Malaria Vaccine in Adults Living in the United States of America

Baseline characteristics by cohort

Measure	10µg Dose FMP011 n=5 Participants Falciparum Malaria Protein 11 with AS02A adjuvant Falciparum Malaria Protein 11 with AS02A adjuvant: vaccine	50µg Dose FMP011 n=13 Participants Falciparum Malaria Protein 11 with AS02A adjuvant Falciparum Malaria Protein 11 with AS02A adjuvant: vaccine	Infectivity Control (IC) n=1 Participants 12 Subjects from the high dose group and 1 non immunized subject enrolled prior to challenge to serve as IC's for malaria sporozoite challenge. 1 infectivity control subject out of the 6 came from this phase 1 study, the other 5 came from the phase 2 study (WRAIR 1250, NCT00312663). Both studies were included in one final clinical study report.	Total n=19 Participants Total of all reporting groups
Age, Continuous	25.4 years STANDARD_DEVIATION 6.2 • n=5 Participants	32.8 years STANDARD_DEVIATION 8.2 • n=7 Participants	34.5 years STANDARD_DEVIATION 0.0 • n=5 Participants	30.7 years STANDARD_DEVIATION 8.2 • n=4 Participants
Sex: Female, Male Female	2 Participants n=5 Participants	7 Participants n=7 Participants	1 Participants n=5 Participants	10 Participants n=4 Participants
Sex: Female, Male Male	3 Participants n=5 Participants	6 Participants n=7 Participants	0 Participants n=5 Participants	9 Participants n=4 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	5 Participants n=5 Participants	13 Participants n=7 Participants	1 Participants n=5 Participants	19 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	1 Participants n=7 Participants	0 Participants n=5 Participants	1 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	0 Participants n=5 Participants	0 Participants n=4 Participants
Race (NIH/OMB) White	5 Participants n=5 Participants	11 Participants n=7 Participants	1 Participants n=5 Participants	17 Participants n=4 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	1 Participants n=7 Participants	0 Participants n=5 Participants	1 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
Region of Enrollment United States	5 participants n=5 Participants	13 participants n=7 Participants	1 participants n=5 Participants	18 participants n=4 Participants

PRIMARY outcome

Timeframe: 30 days post vaccination

Population: The AE's were tabulated and summarized by subject and treatment groups. No additional analyses were performed. Grade 1 = mild, Grade 2 = moderate, Grade 3 = severe Infectivity Controls were not included in this analysis.

An AE was defined as any reaction, side effect, or untoward event that occurred during the course of the trial whether or not the event was considered related to study drug or clinically significant.

Grade 1: Mild Grade 2: Moderate Grade 3: Severe

Outcome measures

Measure	10µg Dose FMP011 n=5 Participants Falciparum Malaria Protein 11 with AS02A adjuvant Falciparum Malaria Protein 11 with AS02A adjuvant: vaccine	50µg Dose FMP011 n=13 Participants Falciparum Malaria Protein 11 with AS02A adjuvant Falciparum Malaria Protein 11 with AS02A adjuvant: vaccine	Infectivity Control n=1 Participants 12 Subjects from the high dose group and 1 non immunized subject enrolled prior to challenge to serve as IC's for malaria sporozoite challenge. 1 infectivity control subject out of the 6 came from this phase 1 study, the other 5 came from the phase 2 study (WRAIR 1250, NCT00312663). Both studies were included in one final clinical study report.
Safety - Most Frequently Reported Adverse Events and Grade Pain - Grade 1	3 Number of adverse events	10 Number of adverse events	0 Number of adverse events
Safety - Most Frequently Reported Adverse Events and Grade Pain - Grade 2	2 Number of adverse events	3 Number of adverse events	0 Number of adverse events
Safety - Most Frequently Reported Adverse Events and Grade Pain - Grade 3	0 Number of adverse events	0 Number of adverse events	0 Number of adverse events
Safety - Most Frequently Reported Adverse Events and Grade Redness - Grade 1	3 Number of adverse events	1 Number of adverse events	0 Number of adverse events
Safety - Most Frequently Reported Adverse Events and Grade Redness - Grade 2	0 Number of adverse events	0 Number of adverse events	0 Number of adverse events
Safety - Most Frequently Reported Adverse Events and Grade Redness - Grade 3	0 Number of adverse events	1 Number of adverse events	0 Number of adverse events
Safety - Most Frequently Reported Adverse Events and Grade Swelling - Grade 1	1 Number of adverse events	1 Number of adverse events	0 Number of adverse events
Safety - Most Frequently Reported Adverse Events and Grade Swelling - Grade 2	0 Number of adverse events	1 Number of adverse events	0 Number of adverse events
Safety - Most Frequently Reported Adverse Events and Grade Swelling - Grade 3	0 Number of adverse events	0 Number of adverse events	0 Number of adverse events

SECONDARY outcome

Timeframe: days 0, 28, 42 (challenge day) and 84

Population: Low dose group didn't participate in challenge (day 42) and day 84

Anti-LSA-1 Antibody Response in Titer Units on days 0, 28, 42 and 84

Outcome measures

Measure	10µg Dose FMP011 n=5 Participants Falciparum Malaria Protein 11 with AS02A adjuvant Falciparum Malaria Protein 11 with AS02A adjuvant: vaccine	50µg Dose FMP011 n=13 Participants Falciparum Malaria Protein 11 with AS02A adjuvant Falciparum Malaria Protein 11 with AS02A adjuvant: vaccine	Infectivity Control 12 Subjects from the high dose group and 1 non immunized subject enrolled prior to challenge to serve as IC's for malaria sporozoite challenge. 1 infectivity control subject out of the 6 came from this phase 1 study, the other 5 came from the phase 2 study (WRAIR 1250, NCT00312663). Both studies were included in one final clinical study report.
Anti-LSA-1 Antibody Response in Titer Units Day 28	1629.9 Titer units Interval 82.3 to 2855.6	834.8 Titer units Interval 51.4 to 2207.3	—
Anti-LSA-1 Antibody Response in Titer Units Day 42 (challenge day)	NA Titer units Low dose group didn't participate in challenge (day 42)	29851.5 Titer units Interval 10590.0 to 64250.0	—
Anti-LSA-1 Antibody Response in Titer Units Day 0	24.8 Titer units Interval 21.4 to 171.2	47.1 Titer units Interval 18.5 to 220.2	—
Anti-LSA-1 Antibody Response in Titer Units Day 84	NA Titer units Low dose group didn't participate in day 84	10378.5 Titer units Interval 3397.0 to 49800.0	—

Adverse Events

10µg Dose FMP011

Serious events: 0 serious events

Other events: 5 other events

Deaths: 0 deaths

50µg Dose FMP011

Serious events: 0 serious events

Other events: 13 other events

Deaths: 0 deaths

Infecticvity Control (IC)

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	10µg Dose FMP011 n=5 participants at risk Falciparum Malaria Protein 11 with AS02A adjuvant Falciparum Malaria Protein 11 with AS02A adjuvant: vaccine	50µg Dose FMP011 n=13 participants at risk Falciparum Malaria Protein 11 with AS02A adjuvant Falciparum Malaria Protein 11 with AS02A adjuvant: vaccine	Infecticvity Control (IC) n=1 participants at risk 12 Subjects from the high dose group and 1 non immunized subject enrolled prior to challenge to serve as IC's for malaria sporozoite challenge. 1 infectivity control subject out of the 6 came from this phase 1 study, the other 5 came from the phase 2 study (WRAIR 1250, NCT00312663). Both studies were included in one final clinical study report.
General disorders Local	100.0% 5/5 • Number of events 5 • Up to 6 months Evaluate the safety by 1) the occurrence of solicited AEs over a 7 day follow-up period (day of immunization and 6 days post-immunization); 2) the occurrence of unsolicited AEs over a 30 day follow-up period (day of immunization and 29 day follow-up period ); and 3) the occurrence of SAE's during the study period. Subjects in the Infectivity Control group were not included in this analysis and are not presented in the final clinical study report.	76.9% 10/13 • Number of events 10 • Up to 6 months Evaluate the safety by 1) the occurrence of solicited AEs over a 7 day follow-up period (day of immunization and 6 days post-immunization); 2) the occurrence of unsolicited AEs over a 30 day follow-up period (day of immunization and 29 day follow-up period ); and 3) the occurrence of SAE's during the study period. Subjects in the Infectivity Control group were not included in this analysis and are not presented in the final clinical study report.	0.00% 0/1 • Up to 6 months Evaluate the safety by 1) the occurrence of solicited AEs over a 7 day follow-up period (day of immunization and 6 days post-immunization); 2) the occurrence of unsolicited AEs over a 30 day follow-up period (day of immunization and 29 day follow-up period ); and 3) the occurrence of SAE's during the study period. Subjects in the Infectivity Control group were not included in this analysis and are not presented in the final clinical study report.
General disorders Pain	100.0% 5/5 • Number of events 5 • Up to 6 months Evaluate the safety by 1) the occurrence of solicited AEs over a 7 day follow-up period (day of immunization and 6 days post-immunization); 2) the occurrence of unsolicited AEs over a 30 day follow-up period (day of immunization and 29 day follow-up period ); and 3) the occurrence of SAE's during the study period. Subjects in the Infectivity Control group were not included in this analysis and are not presented in the final clinical study report.	69.2% 9/13 • Number of events 9 • Up to 6 months Evaluate the safety by 1) the occurrence of solicited AEs over a 7 day follow-up period (day of immunization and 6 days post-immunization); 2) the occurrence of unsolicited AEs over a 30 day follow-up period (day of immunization and 29 day follow-up period ); and 3) the occurrence of SAE's during the study period. Subjects in the Infectivity Control group were not included in this analysis and are not presented in the final clinical study report.	0.00% 0/1 • Up to 6 months Evaluate the safety by 1) the occurrence of solicited AEs over a 7 day follow-up period (day of immunization and 6 days post-immunization); 2) the occurrence of unsolicited AEs over a 30 day follow-up period (day of immunization and 29 day follow-up period ); and 3) the occurrence of SAE's during the study period. Subjects in the Infectivity Control group were not included in this analysis and are not presented in the final clinical study report.
General disorders Swelling	0.00% 0/5 • Up to 6 months Evaluate the safety by 1) the occurrence of solicited AEs over a 7 day follow-up period (day of immunization and 6 days post-immunization); 2) the occurrence of unsolicited AEs over a 30 day follow-up period (day of immunization and 29 day follow-up period ); and 3) the occurrence of SAE's during the study period. Subjects in the Infectivity Control group were not included in this analysis and are not presented in the final clinical study report.	7.7% 1/13 • Number of events 1 • Up to 6 months Evaluate the safety by 1) the occurrence of solicited AEs over a 7 day follow-up period (day of immunization and 6 days post-immunization); 2) the occurrence of unsolicited AEs over a 30 day follow-up period (day of immunization and 29 day follow-up period ); and 3) the occurrence of SAE's during the study period. Subjects in the Infectivity Control group were not included in this analysis and are not presented in the final clinical study report.	0.00% 0/1 • Up to 6 months Evaluate the safety by 1) the occurrence of solicited AEs over a 7 day follow-up period (day of immunization and 6 days post-immunization); 2) the occurrence of unsolicited AEs over a 30 day follow-up period (day of immunization and 29 day follow-up period ); and 3) the occurrence of SAE's during the study period. Subjects in the Infectivity Control group were not included in this analysis and are not presented in the final clinical study report.
Skin and subcutaneous tissue disorders Redness	0.00% 0/5 • Up to 6 months Evaluate the safety by 1) the occurrence of solicited AEs over a 7 day follow-up period (day of immunization and 6 days post-immunization); 2) the occurrence of unsolicited AEs over a 30 day follow-up period (day of immunization and 29 day follow-up period ); and 3) the occurrence of SAE's during the study period. Subjects in the Infectivity Control group were not included in this analysis and are not presented in the final clinical study report.	7.7% 1/13 • Number of events 1 • Up to 6 months Evaluate the safety by 1) the occurrence of solicited AEs over a 7 day follow-up period (day of immunization and 6 days post-immunization); 2) the occurrence of unsolicited AEs over a 30 day follow-up period (day of immunization and 29 day follow-up period ); and 3) the occurrence of SAE's during the study period. Subjects in the Infectivity Control group were not included in this analysis and are not presented in the final clinical study report.	0.00% 0/1 • Up to 6 months Evaluate the safety by 1) the occurrence of solicited AEs over a 7 day follow-up period (day of immunization and 6 days post-immunization); 2) the occurrence of unsolicited AEs over a 30 day follow-up period (day of immunization and 29 day follow-up period ); and 3) the occurrence of SAE's during the study period. Subjects in the Infectivity Control group were not included in this analysis and are not presented in the final clinical study report.
General disorders Fever	20.0% 1/5 • Number of events 1 • Up to 6 months Evaluate the safety by 1) the occurrence of solicited AEs over a 7 day follow-up period (day of immunization and 6 days post-immunization); 2) the occurrence of unsolicited AEs over a 30 day follow-up period (day of immunization and 29 day follow-up period ); and 3) the occurrence of SAE's during the study period. Subjects in the Infectivity Control group were not included in this analysis and are not presented in the final clinical study report.	7.7% 1/13 • Number of events 1 • Up to 6 months Evaluate the safety by 1) the occurrence of solicited AEs over a 7 day follow-up period (day of immunization and 6 days post-immunization); 2) the occurrence of unsolicited AEs over a 30 day follow-up period (day of immunization and 29 day follow-up period ); and 3) the occurrence of SAE's during the study period. Subjects in the Infectivity Control group were not included in this analysis and are not presented in the final clinical study report.	0.00% 0/1 • Up to 6 months Evaluate the safety by 1) the occurrence of solicited AEs over a 7 day follow-up period (day of immunization and 6 days post-immunization); 2) the occurrence of unsolicited AEs over a 30 day follow-up period (day of immunization and 29 day follow-up period ); and 3) the occurrence of SAE's during the study period. Subjects in the Infectivity Control group were not included in this analysis and are not presented in the final clinical study report.
Gastrointestinal disorders Nausea	0.00% 0/5 • Up to 6 months Evaluate the safety by 1) the occurrence of solicited AEs over a 7 day follow-up period (day of immunization and 6 days post-immunization); 2) the occurrence of unsolicited AEs over a 30 day follow-up period (day of immunization and 29 day follow-up period ); and 3) the occurrence of SAE's during the study period. Subjects in the Infectivity Control group were not included in this analysis and are not presented in the final clinical study report.	30.8% 4/13 • Number of events 4 • Up to 6 months Evaluate the safety by 1) the occurrence of solicited AEs over a 7 day follow-up period (day of immunization and 6 days post-immunization); 2) the occurrence of unsolicited AEs over a 30 day follow-up period (day of immunization and 29 day follow-up period ); and 3) the occurrence of SAE's during the study period. Subjects in the Infectivity Control group were not included in this analysis and are not presented in the final clinical study report.	0.00% 0/1 • Up to 6 months Evaluate the safety by 1) the occurrence of solicited AEs over a 7 day follow-up period (day of immunization and 6 days post-immunization); 2) the occurrence of unsolicited AEs over a 30 day follow-up period (day of immunization and 29 day follow-up period ); and 3) the occurrence of SAE's during the study period. Subjects in the Infectivity Control group were not included in this analysis and are not presented in the final clinical study report.
Nervous system disorders Headache	20.0% 1/5 • Number of events 1 • Up to 6 months Evaluate the safety by 1) the occurrence of solicited AEs over a 7 day follow-up period (day of immunization and 6 days post-immunization); 2) the occurrence of unsolicited AEs over a 30 day follow-up period (day of immunization and 29 day follow-up period ); and 3) the occurrence of SAE's during the study period. Subjects in the Infectivity Control group were not included in this analysis and are not presented in the final clinical study report.	38.5% 5/13 • Number of events 5 • Up to 6 months Evaluate the safety by 1) the occurrence of solicited AEs over a 7 day follow-up period (day of immunization and 6 days post-immunization); 2) the occurrence of unsolicited AEs over a 30 day follow-up period (day of immunization and 29 day follow-up period ); and 3) the occurrence of SAE's during the study period. Subjects in the Infectivity Control group were not included in this analysis and are not presented in the final clinical study report.	0.00% 0/1 • Up to 6 months Evaluate the safety by 1) the occurrence of solicited AEs over a 7 day follow-up period (day of immunization and 6 days post-immunization); 2) the occurrence of unsolicited AEs over a 30 day follow-up period (day of immunization and 29 day follow-up period ); and 3) the occurrence of SAE's during the study period. Subjects in the Infectivity Control group were not included in this analysis and are not presented in the final clinical study report.
General disorders Malaise	40.0% 2/5 • Number of events 2 • Up to 6 months Evaluate the safety by 1) the occurrence of solicited AEs over a 7 day follow-up period (day of immunization and 6 days post-immunization); 2) the occurrence of unsolicited AEs over a 30 day follow-up period (day of immunization and 29 day follow-up period ); and 3) the occurrence of SAE's during the study period. Subjects in the Infectivity Control group were not included in this analysis and are not presented in the final clinical study report.	46.2% 6/13 • Number of events 6 • Up to 6 months Evaluate the safety by 1) the occurrence of solicited AEs over a 7 day follow-up period (day of immunization and 6 days post-immunization); 2) the occurrence of unsolicited AEs over a 30 day follow-up period (day of immunization and 29 day follow-up period ); and 3) the occurrence of SAE's during the study period. Subjects in the Infectivity Control group were not included in this analysis and are not presented in the final clinical study report.	0.00% 0/1 • Up to 6 months Evaluate the safety by 1) the occurrence of solicited AEs over a 7 day follow-up period (day of immunization and 6 days post-immunization); 2) the occurrence of unsolicited AEs over a 30 day follow-up period (day of immunization and 29 day follow-up period ); and 3) the occurrence of SAE's during the study period. Subjects in the Infectivity Control group were not included in this analysis and are not presented in the final clinical study report.
Musculoskeletal and connective tissue disorders Myalgia	40.0% 2/5 • Number of events 2 • Up to 6 months Evaluate the safety by 1) the occurrence of solicited AEs over a 7 day follow-up period (day of immunization and 6 days post-immunization); 2) the occurrence of unsolicited AEs over a 30 day follow-up period (day of immunization and 29 day follow-up period ); and 3) the occurrence of SAE's during the study period. Subjects in the Infectivity Control group were not included in this analysis and are not presented in the final clinical study report.	30.8% 4/13 • Number of events 4 • Up to 6 months Evaluate the safety by 1) the occurrence of solicited AEs over a 7 day follow-up period (day of immunization and 6 days post-immunization); 2) the occurrence of unsolicited AEs over a 30 day follow-up period (day of immunization and 29 day follow-up period ); and 3) the occurrence of SAE's during the study period. Subjects in the Infectivity Control group were not included in this analysis and are not presented in the final clinical study report.	0.00% 0/1 • Up to 6 months Evaluate the safety by 1) the occurrence of solicited AEs over a 7 day follow-up period (day of immunization and 6 days post-immunization); 2) the occurrence of unsolicited AEs over a 30 day follow-up period (day of immunization and 29 day follow-up period ); and 3) the occurrence of SAE's during the study period. Subjects in the Infectivity Control group were not included in this analysis and are not presented in the final clinical study report.
General disorders Fatigue	40.0% 2/5 • Number of events 2 • Up to 6 months Evaluate the safety by 1) the occurrence of solicited AEs over a 7 day follow-up period (day of immunization and 6 days post-immunization); 2) the occurrence of unsolicited AEs over a 30 day follow-up period (day of immunization and 29 day follow-up period ); and 3) the occurrence of SAE's during the study period. Subjects in the Infectivity Control group were not included in this analysis and are not presented in the final clinical study report.	46.2% 6/13 • Number of events 6 • Up to 6 months Evaluate the safety by 1) the occurrence of solicited AEs over a 7 day follow-up period (day of immunization and 6 days post-immunization); 2) the occurrence of unsolicited AEs over a 30 day follow-up period (day of immunization and 29 day follow-up period ); and 3) the occurrence of SAE's during the study period. Subjects in the Infectivity Control group were not included in this analysis and are not presented in the final clinical study report.	0.00% 0/1 • Up to 6 months Evaluate the safety by 1) the occurrence of solicited AEs over a 7 day follow-up period (day of immunization and 6 days post-immunization); 2) the occurrence of unsolicited AEs over a 30 day follow-up period (day of immunization and 29 day follow-up period ); and 3) the occurrence of SAE's during the study period. Subjects in the Infectivity Control group were not included in this analysis and are not presented in the final clinical study report.
Musculoskeletal and connective tissue disorders Chills	0.00% 0/5 • Up to 6 months Evaluate the safety by 1) the occurrence of solicited AEs over a 7 day follow-up period (day of immunization and 6 days post-immunization); 2) the occurrence of unsolicited AEs over a 30 day follow-up period (day of immunization and 29 day follow-up period ); and 3) the occurrence of SAE's during the study period. Subjects in the Infectivity Control group were not included in this analysis and are not presented in the final clinical study report.	15.4% 2/13 • Number of events 2 • Up to 6 months Evaluate the safety by 1) the occurrence of solicited AEs over a 7 day follow-up period (day of immunization and 6 days post-immunization); 2) the occurrence of unsolicited AEs over a 30 day follow-up period (day of immunization and 29 day follow-up period ); and 3) the occurrence of SAE's during the study period. Subjects in the Infectivity Control group were not included in this analysis and are not presented in the final clinical study report.	0.00% 0/1 • Up to 6 months Evaluate the safety by 1) the occurrence of solicited AEs over a 7 day follow-up period (day of immunization and 6 days post-immunization); 2) the occurrence of unsolicited AEs over a 30 day follow-up period (day of immunization and 29 day follow-up period ); and 3) the occurrence of SAE's during the study period. Subjects in the Infectivity Control group were not included in this analysis and are not presented in the final clinical study report.
Injury, poisoning and procedural complications Bruise at injection site	0.00% 0/5 • Up to 6 months Evaluate the safety by 1) the occurrence of solicited AEs over a 7 day follow-up period (day of immunization and 6 days post-immunization); 2) the occurrence of unsolicited AEs over a 30 day follow-up period (day of immunization and 29 day follow-up period ); and 3) the occurrence of SAE's during the study period. Subjects in the Infectivity Control group were not included in this analysis and are not presented in the final clinical study report.	7.7% 1/13 • Number of events 1 • Up to 6 months Evaluate the safety by 1) the occurrence of solicited AEs over a 7 day follow-up period (day of immunization and 6 days post-immunization); 2) the occurrence of unsolicited AEs over a 30 day follow-up period (day of immunization and 29 day follow-up period ); and 3) the occurrence of SAE's during the study period. Subjects in the Infectivity Control group were not included in this analysis and are not presented in the final clinical study report.	0.00% 0/1 • Up to 6 months Evaluate the safety by 1) the occurrence of solicited AEs over a 7 day follow-up period (day of immunization and 6 days post-immunization); 2) the occurrence of unsolicited AEs over a 30 day follow-up period (day of immunization and 29 day follow-up period ); and 3) the occurrence of SAE's during the study period. Subjects in the Infectivity Control group were not included in this analysis and are not presented in the final clinical study report.
Blood and lymphatic system disorders Axilla lymphadenopathy	20.0% 1/5 • Number of events 1 • Up to 6 months Evaluate the safety by 1) the occurrence of solicited AEs over a 7 day follow-up period (day of immunization and 6 days post-immunization); 2) the occurrence of unsolicited AEs over a 30 day follow-up period (day of immunization and 29 day follow-up period ); and 3) the occurrence of SAE's during the study period. Subjects in the Infectivity Control group were not included in this analysis and are not presented in the final clinical study report.	0.00% 0/13 • Up to 6 months Evaluate the safety by 1) the occurrence of solicited AEs over a 7 day follow-up period (day of immunization and 6 days post-immunization); 2) the occurrence of unsolicited AEs over a 30 day follow-up period (day of immunization and 29 day follow-up period ); and 3) the occurrence of SAE's during the study period. Subjects in the Infectivity Control group were not included in this analysis and are not presented in the final clinical study report.	0.00% 0/1 • Up to 6 months Evaluate the safety by 1) the occurrence of solicited AEs over a 7 day follow-up period (day of immunization and 6 days post-immunization); 2) the occurrence of unsolicited AEs over a 30 day follow-up period (day of immunization and 29 day follow-up period ); and 3) the occurrence of SAE's during the study period. Subjects in the Infectivity Control group were not included in this analysis and are not presented in the final clinical study report.
Ear and labyrinth disorders Ringing in ears - bilateral	0.00% 0/5 • Up to 6 months Evaluate the safety by 1) the occurrence of solicited AEs over a 7 day follow-up period (day of immunization and 6 days post-immunization); 2) the occurrence of unsolicited AEs over a 30 day follow-up period (day of immunization and 29 day follow-up period ); and 3) the occurrence of SAE's during the study period. Subjects in the Infectivity Control group were not included in this analysis and are not presented in the final clinical study report.	7.7% 1/13 • Number of events 1 • Up to 6 months Evaluate the safety by 1) the occurrence of solicited AEs over a 7 day follow-up period (day of immunization and 6 days post-immunization); 2) the occurrence of unsolicited AEs over a 30 day follow-up period (day of immunization and 29 day follow-up period ); and 3) the occurrence of SAE's during the study period. Subjects in the Infectivity Control group were not included in this analysis and are not presented in the final clinical study report.	0.00% 0/1 • Up to 6 months Evaluate the safety by 1) the occurrence of solicited AEs over a 7 day follow-up period (day of immunization and 6 days post-immunization); 2) the occurrence of unsolicited AEs over a 30 day follow-up period (day of immunization and 29 day follow-up period ); and 3) the occurrence of SAE's during the study period. Subjects in the Infectivity Control group were not included in this analysis and are not presented in the final clinical study report.
Nervous system disorders Vasovagal event	0.00% 0/5 • Up to 6 months Evaluate the safety by 1) the occurrence of solicited AEs over a 7 day follow-up period (day of immunization and 6 days post-immunization); 2) the occurrence of unsolicited AEs over a 30 day follow-up period (day of immunization and 29 day follow-up period ); and 3) the occurrence of SAE's during the study period. Subjects in the Infectivity Control group were not included in this analysis and are not presented in the final clinical study report.	7.7% 1/13 • Number of events 1 • Up to 6 months Evaluate the safety by 1) the occurrence of solicited AEs over a 7 day follow-up period (day of immunization and 6 days post-immunization); 2) the occurrence of unsolicited AEs over a 30 day follow-up period (day of immunization and 29 day follow-up period ); and 3) the occurrence of SAE's during the study period. Subjects in the Infectivity Control group were not included in this analysis and are not presented in the final clinical study report.	0.00% 0/1 • Up to 6 months Evaluate the safety by 1) the occurrence of solicited AEs over a 7 day follow-up period (day of immunization and 6 days post-immunization); 2) the occurrence of unsolicited AEs over a 30 day follow-up period (day of immunization and 29 day follow-up period ); and 3) the occurrence of SAE's during the study period. Subjects in the Infectivity Control group were not included in this analysis and are not presented in the final clinical study report.

Additional Information

James F. Cummings, MD

Walter Reed Army Institute of Research

Phone: 301-319-9312

Email: james.cummings@us.army.mil

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place