Trial Outcomes & Findings for Shigella CVD 30000: Study of Responses to Vaccination With Shigella Vaccine (NCT NCT04078022)

NCT ID: NCT04078022

Last Updated: 2024-05-20

Results Overview

Count of participants with primary endpoint (Moderate-Severe Shigellosis)

• Recruitment status: COMPLETED
• Study phase: PHASE2
• Target enrollment: 58 participants
• Primary outcome timeframe: 10 days after challenge
• Results posted on: 2024-05-20

Participant Flow

Cohort 4 was eliminated prior to the start of Cohort 4 enrollment. Cohorts 1-3 are pooled and reported by vaccine vs. placebo recipients.

Participant milestones

Measure	Shigella Vaccine 1:1 randomization to investigational Shigella vaccine or placebo (n=29). The majority of participants will then receive the Shigella challenge (n=22). SF2a-TT15 Shigella Vaccine: 0.5 mL of the vaccine is administered via an intramuscular injection into the deltoid muscle on Study Day 1 and Study Day 29. S. flexneri 2a strain 2457T Challenge Agent: Each participant will drink 120 mL of sodium bicarbonate buffer solution. Approximately 1 to 2 minutes later, the participant will ingest approximately 1500 cfu of S. flexneri 2a strain 2457T suspended in 30 mL of the bicarbonate buffer solution.	Placebo 1:1 randomization to investigational Shigella vaccine or placebo (n=29). The majority of participants will then receive the Shigella challenge (n=22). Placebo: 0.5 mL of normal saline is administered via an intramuscular injection into the deltoid muscle on Study Day 1 and Study Day 29. S. flexneri 2a strain 2457T Challenge Agent: Each participant will drink 120 mL of sodium bicarbonate buffer solution. Approximately 1 to 2 minutes later, the participant will ingest approximately 1500 cfu of S. flexneri 2a strain 2457T suspended in 30 mL of the bicarbonate buffer solution.
Vaccination Phase STARTED	29	29
Vaccination Phase COMPLETED	27	26
Vaccination Phase NOT COMPLETED	2	3
Challenge Phase STARTED	22	22
Challenge Phase COMPLETED	21	22
Challenge Phase NOT COMPLETED	1	0

Reasons for withdrawal

Measure	Shigella Vaccine 1:1 randomization to investigational Shigella vaccine or placebo (n=29). The majority of participants will then receive the Shigella challenge (n=22). SF2a-TT15 Shigella Vaccine: 0.5 mL of the vaccine is administered via an intramuscular injection into the deltoid muscle on Study Day 1 and Study Day 29. S. flexneri 2a strain 2457T Challenge Agent: Each participant will drink 120 mL of sodium bicarbonate buffer solution. Approximately 1 to 2 minutes later, the participant will ingest approximately 1500 cfu of S. flexneri 2a strain 2457T suspended in 30 mL of the bicarbonate buffer solution.	Placebo 1:1 randomization to investigational Shigella vaccine or placebo (n=29). The majority of participants will then receive the Shigella challenge (n=22). Placebo: 0.5 mL of normal saline is administered via an intramuscular injection into the deltoid muscle on Study Day 1 and Study Day 29. S. flexneri 2a strain 2457T Challenge Agent: Each participant will drink 120 mL of sodium bicarbonate buffer solution. Approximately 1 to 2 minutes later, the participant will ingest approximately 1500 cfu of S. flexneri 2a strain 2457T suspended in 30 mL of the bicarbonate buffer solution.
Vaccination Phase Withdrawal prior to challenge	2	3

Baseline Characteristics

Shigella CVD 30000: Study of Responses to Vaccination With Shigella Vaccine

Baseline characteristics by cohort

Measure	Vaccine n=29 Participants 1:1 randomization to investigational Shigella vaccine or placebo (n=30). The majority of participants will then receive the Shigella challenge (n=22). SF2a-TT15 Shigella Vaccine: 0.5 mL of the vaccine is administered via an intramuscular injection into the deltoid muscle on Study Day 1 and Study Day 29.	Placebo n=29 Participants 1:1 randomization to investigational Shigella vaccine or placebo (n=30). The majority of participants will then receive the Shigella challenge (n=22). Placebo: 0.5 mL of normal saline is administered via an intramuscular injection into the deltoid muscle on Study Day 1 and Study Day 29.	Total n=58 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	29 Participants n=5 Participants	29 Participants n=7 Participants	58 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Continuous	32 years n=5 Participants	32 years n=7 Participants	32 years n=5 Participants
Sex: Female, Male Female	15 Participants n=5 Participants	10 Participants n=7 Participants	25 Participants n=5 Participants
Sex: Female, Male Male	14 Participants n=5 Participants	19 Participants n=7 Participants	33 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	4 Participants n=5 Participants	2 Participants n=7 Participants	6 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	25 Participants n=5 Participants	27 Participants n=7 Participants	52 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	2 Participants n=7 Participants	2 Participants n=5 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
Race (NIH/OMB) Black or African American	5 Participants n=5 Participants	3 Participants n=7 Participants	8 Participants n=5 Participants
Race (NIH/OMB) White	20 Participants n=5 Participants	20 Participants n=7 Participants	40 Participants n=5 Participants
Race (NIH/OMB) More than one race	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	2 Participants n=5 Participants	4 Participants n=7 Participants	6 Participants n=5 Participants
Region of Enrollment United States	29 participants n=5 Participants	29 participants n=7 Participants	58 participants n=5 Participants

PRIMARY outcome

Timeframe: 10 days after challenge

Population: All participants that were randomized to vaccine or placebo and were challenged

Count of participants with primary endpoint (Moderate-Severe Shigellosis)

Outcome measures

Measure	Shigella Vaccine n=22 Participants 1:1 randomization to investigational Shigella vaccine or placebo (n=30). The majority of participants will then receive the Shigella challenge (n=22). SF2a-TT15 Shigella Vaccine: 0.5 mL of the vaccine is administered via an intramuscular injection into the deltoid muscle on Study Day 1 and Study Day 29. S. flexneri 2a strain 2457T Challenge Agent: Each participant will drink 120 mL of sodium bicarbonate buffer solution. Approximately 1 to 2 minutes later, the participant will ingest approximately 1500 cfu of S. flexneri 2a strain 2457T suspended in 30 mL of the bicarbonate buffer solution.	Placebo n=22 Participants 1:1 randomization to investigational Shigella vaccine or placebo (n=30). The majority of participants will then receive the Shigella challenge (n=22). Placebo: 0.5 mL of normal saline is administered via an intramuscular injection into the deltoid muscle on Study Day 1 and Study Day 29. S. flexneri 2a strain 2457T Challenge Agent: Each participant will drink 120 mL of sodium bicarbonate buffer solution. Approximately 1 to 2 minutes later, the participant will ingest approximately 1500 cfu of S. flexneri 2a strain 2457T suspended in 30 mL of the bicarbonate buffer solution.	Vaccine Challenged 1:1 randomization to investigational Shigella vaccine or placebo (n=30). The majority of participants will then receive the Shigella challenge (n=22). SF2a-TT15 Shigella Vaccine: 0.5 mL of the vaccine is administered via an intramuscular injection into the deltoid muscle on Study Day 1 and Study Day 29. S. flexneri 2a strain 2457T Challenge Agent: Each participant will drink 120 mL of sodium bicarbonate buffer solution. Approximately 1 to 2 minutes later, the participant will ingest approximately 1500 cfu of S. flexneri 2a strain 2457T suspended in 30 mL of the bicarbonate buffer solution.	Placebo Challenged 1:1 randomization to investigational Shigella vaccine or placebo (n=30). The majority of participants will then receive the Shigella challenge (n=22). Placebo: 0.5 mL of normal saline is administered via an intramuscular injection into the deltoid muscle on Study Day 1 and Study Day 29. S. flexneri 2a strain 2457T Challenge Agent: Each participant will drink 120 mL of sodium bicarbonate buffer solution. Approximately 1 to 2 minutes later, the participant will ingest approximately 1500 cfu of S. flexneri 2a strain 2457T suspended in 30 mL of the bicarbonate buffer solution.
Number of Participants With Moderate-Severe Shigellosis Illness, With Challenge	14 Participants	17 Participants	—	—

SECONDARY outcome

Timeframe: 10 days after challenge

Population: Participants randomized to vaccine or placebo and were challenged

Outcome measures

Measure	Shigella Vaccine n=22 Participants 1:1 randomization to investigational Shigella vaccine or placebo (n=30). The majority of participants will then receive the Shigella challenge (n=22). SF2a-TT15 Shigella Vaccine: 0.5 mL of the vaccine is administered via an intramuscular injection into the deltoid muscle on Study Day 1 and Study Day 29. S. flexneri 2a strain 2457T Challenge Agent: Each participant will drink 120 mL of sodium bicarbonate buffer solution. Approximately 1 to 2 minutes later, the participant will ingest approximately 1500 cfu of S. flexneri 2a strain 2457T suspended in 30 mL of the bicarbonate buffer solution.	Placebo n=22 Participants 1:1 randomization to investigational Shigella vaccine or placebo (n=30). The majority of participants will then receive the Shigella challenge (n=22). Placebo: 0.5 mL of normal saline is administered via an intramuscular injection into the deltoid muscle on Study Day 1 and Study Day 29. S. flexneri 2a strain 2457T Challenge Agent: Each participant will drink 120 mL of sodium bicarbonate buffer solution. Approximately 1 to 2 minutes later, the participant will ingest approximately 1500 cfu of S. flexneri 2a strain 2457T suspended in 30 mL of the bicarbonate buffer solution.	Vaccine Challenged 1:1 randomization to investigational Shigella vaccine or placebo (n=30). The majority of participants will then receive the Shigella challenge (n=22). SF2a-TT15 Shigella Vaccine: 0.5 mL of the vaccine is administered via an intramuscular injection into the deltoid muscle on Study Day 1 and Study Day 29. S. flexneri 2a strain 2457T Challenge Agent: Each participant will drink 120 mL of sodium bicarbonate buffer solution. Approximately 1 to 2 minutes later, the participant will ingest approximately 1500 cfu of S. flexneri 2a strain 2457T suspended in 30 mL of the bicarbonate buffer solution.	Placebo Challenged 1:1 randomization to investigational Shigella vaccine or placebo (n=30). The majority of participants will then receive the Shigella challenge (n=22). Placebo: 0.5 mL of normal saline is administered via an intramuscular injection into the deltoid muscle on Study Day 1 and Study Day 29. S. flexneri 2a strain 2457T Challenge Agent: Each participant will drink 120 mL of sodium bicarbonate buffer solution. Approximately 1 to 2 minutes later, the participant will ingest approximately 1500 cfu of S. flexneri 2a strain 2457T suspended in 30 mL of the bicarbonate buffer solution.
Number of Participants Meeting Other Case Definitions and Endpoint Definitions Count of participants with any diarrhea endpoint	15 Participants	18 Participants	—	—
Number of Participants Meeting Other Case Definitions and Endpoint Definitions Count of participants with any dysentery endpoint	4 Participants	12 Participants	—	—
Number of Participants Meeting Other Case Definitions and Endpoint Definitions Count of participants with any fever endpoint	12 Participants	15 Participants	—	—
Number of Participants Meeting Other Case Definitions and Endpoint Definitions Count of participants with any combination of diarrhea, dysentery, and/or fever	16 Participants	19 Participants	—	—

SECONDARY outcome

Timeframe: Days 29, 57 and 85

Population: Enrolled participants

Anti-LPS serum IgG ELISA response, by response rates (proportion of 4-fold increases from baseline, Day 1)

Outcome measures

Measure	Shigella Vaccine n=29 Participants 1:1 randomization to investigational Shigella vaccine or placebo (n=30). The majority of participants will then receive the Shigella challenge (n=22). SF2a-TT15 Shigella Vaccine: 0.5 mL of the vaccine is administered via an intramuscular injection into the deltoid muscle on Study Day 1 and Study Day 29. S. flexneri 2a strain 2457T Challenge Agent: Each participant will drink 120 mL of sodium bicarbonate buffer solution. Approximately 1 to 2 minutes later, the participant will ingest approximately 1500 cfu of S. flexneri 2a strain 2457T suspended in 30 mL of the bicarbonate buffer solution.	Placebo n=29 Participants 1:1 randomization to investigational Shigella vaccine or placebo (n=30). The majority of participants will then receive the Shigella challenge (n=22). Placebo: 0.5 mL of normal saline is administered via an intramuscular injection into the deltoid muscle on Study Day 1 and Study Day 29. S. flexneri 2a strain 2457T Challenge Agent: Each participant will drink 120 mL of sodium bicarbonate buffer solution. Approximately 1 to 2 minutes later, the participant will ingest approximately 1500 cfu of S. flexneri 2a strain 2457T suspended in 30 mL of the bicarbonate buffer solution.	Vaccine Challenged n=22 Participants 1:1 randomization to investigational Shigella vaccine or placebo (n=30). The majority of participants will then receive the Shigella challenge (n=22). SF2a-TT15 Shigella Vaccine: 0.5 mL of the vaccine is administered via an intramuscular injection into the deltoid muscle on Study Day 1 and Study Day 29. S. flexneri 2a strain 2457T Challenge Agent: Each participant will drink 120 mL of sodium bicarbonate buffer solution. Approximately 1 to 2 minutes later, the participant will ingest approximately 1500 cfu of S. flexneri 2a strain 2457T suspended in 30 mL of the bicarbonate buffer solution.	Placebo Challenged n=22 Participants 1:1 randomization to investigational Shigella vaccine or placebo (n=30). The majority of participants will then receive the Shigella challenge (n=22). Placebo: 0.5 mL of normal saline is administered via an intramuscular injection into the deltoid muscle on Study Day 1 and Study Day 29. S. flexneri 2a strain 2457T Challenge Agent: Each participant will drink 120 mL of sodium bicarbonate buffer solution. Approximately 1 to 2 minutes later, the participant will ingest approximately 1500 cfu of S. flexneri 2a strain 2457T suspended in 30 mL of the bicarbonate buffer solution.
Number of Participants With Anti-LPS Serum IgG ELISA Response Count of participants with serum IgG ELISA response rates, post-dose 1 (Day 29)	27 Participants	1 Participants	20 Participants	1 Participants
Number of Participants With Anti-LPS Serum IgG ELISA Response Count of participants with serum IgG ELISA response rates, post-dose 2 (Day 57)	26 Participants	1 Participants	21 Participants	1 Participants
Number of Participants With Anti-LPS Serum IgG ELISA Response Count of participants with serum IgG ELISA response rates, post-challenge (Day 85)	26 Participants	17 Participants	22 Participants	17 Participants

SECONDARY outcome

Timeframe: Days 1, 29, 57 and 85

Outcome measures

Measure	Shigella Vaccine n=29 Participants 1:1 randomization to investigational Shigella vaccine or placebo (n=30). The majority of participants will then receive the Shigella challenge (n=22). SF2a-TT15 Shigella Vaccine: 0.5 mL of the vaccine is administered via an intramuscular injection into the deltoid muscle on Study Day 1 and Study Day 29. S. flexneri 2a strain 2457T Challenge Agent: Each participant will drink 120 mL of sodium bicarbonate buffer solution. Approximately 1 to 2 minutes later, the participant will ingest approximately 1500 cfu of S. flexneri 2a strain 2457T suspended in 30 mL of the bicarbonate buffer solution.	Placebo n=29 Participants 1:1 randomization to investigational Shigella vaccine or placebo (n=30). The majority of participants will then receive the Shigella challenge (n=22). Placebo: 0.5 mL of normal saline is administered via an intramuscular injection into the deltoid muscle on Study Day 1 and Study Day 29. S. flexneri 2a strain 2457T Challenge Agent: Each participant will drink 120 mL of sodium bicarbonate buffer solution. Approximately 1 to 2 minutes later, the participant will ingest approximately 1500 cfu of S. flexneri 2a strain 2457T suspended in 30 mL of the bicarbonate buffer solution.	Vaccine Challenged n=22 Participants 1:1 randomization to investigational Shigella vaccine or placebo (n=30). The majority of participants will then receive the Shigella challenge (n=22). SF2a-TT15 Shigella Vaccine: 0.5 mL of the vaccine is administered via an intramuscular injection into the deltoid muscle on Study Day 1 and Study Day 29. S. flexneri 2a strain 2457T Challenge Agent: Each participant will drink 120 mL of sodium bicarbonate buffer solution. Approximately 1 to 2 minutes later, the participant will ingest approximately 1500 cfu of S. flexneri 2a strain 2457T suspended in 30 mL of the bicarbonate buffer solution.	Placebo Challenged n=22 Participants 1:1 randomization to investigational Shigella vaccine or placebo (n=30). The majority of participants will then receive the Shigella challenge (n=22). Placebo: 0.5 mL of normal saline is administered via an intramuscular injection into the deltoid muscle on Study Day 1 and Study Day 29. S. flexneri 2a strain 2457T Challenge Agent: Each participant will drink 120 mL of sodium bicarbonate buffer solution. Approximately 1 to 2 minutes later, the participant will ingest approximately 1500 cfu of S. flexneri 2a strain 2457T suspended in 30 mL of the bicarbonate buffer solution.
Anti-LPS Serum IgG ELISA Response, by Titer Mean ±SD pre-vaccination (Day 1)	1020.69 titer Standard Deviation 1143.11	662.07 titer Standard Deviation 638.87	800 titer Standard Deviation 489.9	772.73 titer Standard Deviation 696.37
Anti-LPS Serum IgG ELISA Response, by Titer Mean ±SD post-dose 1 (Day 29)	17441.38 titer Standard Deviation 21018.59	965.52 titer Standard Deviation 1549.03	18190.91 titer Standard Deviation 22253.3	1172.73 titer Standard Deviation 1734.02
Anti-LPS Serum IgG ELISA Response, by Titer Mean ±SD post-dose 2 (Day 57)	15318.52 titer Standard Deviation 13574.1	965.38 titer Standard Deviation 1285.91	16327.27 titer Standard Deviation 14392.93	1081.82 titer Standard Deviation 1368.57
Anti-LPS Serum IgG ELISA Response, by Titer Mean ±SD post-challenge (Day 85)	18755.56 titer Standard Deviation 14338.9	5850 titer Standard Deviation 6204.14	21345.45 titer Standard Deviation 14537.76	6940 titer Standard Deviation 6251.27

SECONDARY outcome

Timeframe: Days 29, 57 and 85

Population: Enrolled participants

Outcome measures

Measure	Shigella Vaccine n=29 Participants 1:1 randomization to investigational Shigella vaccine or placebo (n=30). The majority of participants will then receive the Shigella challenge (n=22). SF2a-TT15 Shigella Vaccine: 0.5 mL of the vaccine is administered via an intramuscular injection into the deltoid muscle on Study Day 1 and Study Day 29. S. flexneri 2a strain 2457T Challenge Agent: Each participant will drink 120 mL of sodium bicarbonate buffer solution. Approximately 1 to 2 minutes later, the participant will ingest approximately 1500 cfu of S. flexneri 2a strain 2457T suspended in 30 mL of the bicarbonate buffer solution.	Placebo n=29 Participants 1:1 randomization to investigational Shigella vaccine or placebo (n=30). The majority of participants will then receive the Shigella challenge (n=22). Placebo: 0.5 mL of normal saline is administered via an intramuscular injection into the deltoid muscle on Study Day 1 and Study Day 29. S. flexneri 2a strain 2457T Challenge Agent: Each participant will drink 120 mL of sodium bicarbonate buffer solution. Approximately 1 to 2 minutes later, the participant will ingest approximately 1500 cfu of S. flexneri 2a strain 2457T suspended in 30 mL of the bicarbonate buffer solution.	Vaccine Challenged n=22 Participants 1:1 randomization to investigational Shigella vaccine or placebo (n=30). The majority of participants will then receive the Shigella challenge (n=22). SF2a-TT15 Shigella Vaccine: 0.5 mL of the vaccine is administered via an intramuscular injection into the deltoid muscle on Study Day 1 and Study Day 29. S. flexneri 2a strain 2457T Challenge Agent: Each participant will drink 120 mL of sodium bicarbonate buffer solution. Approximately 1 to 2 minutes later, the participant will ingest approximately 1500 cfu of S. flexneri 2a strain 2457T suspended in 30 mL of the bicarbonate buffer solution.	Placebo Challenged n=22 Participants 1:1 randomization to investigational Shigella vaccine or placebo (n=30). The majority of participants will then receive the Shigella challenge (n=22). Placebo: 0.5 mL of normal saline is administered via an intramuscular injection into the deltoid muscle on Study Day 1 and Study Day 29. S. flexneri 2a strain 2457T Challenge Agent: Each participant will drink 120 mL of sodium bicarbonate buffer solution. Approximately 1 to 2 minutes later, the participant will ingest approximately 1500 cfu of S. flexneri 2a strain 2457T suspended in 30 mL of the bicarbonate buffer solution.
Serum Bactericidal Activity Response, by Response Rates (Proportion of 4-fold Increases From Baseline, Day 1) Count post-dose 1 (Day 29)	21 Participants	2 Participants	17 Participants	2 Participants
Serum Bactericidal Activity Response, by Response Rates (Proportion of 4-fold Increases From Baseline, Day 1) Count post-dose 2 (Day 57)	22 Participants	1 Participants	17 Participants	1 Participants
Serum Bactericidal Activity Response, by Response Rates (Proportion of 4-fold Increases From Baseline, Day 1) Count post-challenge (Day 85)	23 Participants	12 Participants	19 Participants	12 Participants

SECONDARY outcome

Timeframe: Days 1, 29, 57 and 85

Population: Enrolled participants

Outcome measures

Measure	Shigella Vaccine n=29 Participants 1:1 randomization to investigational Shigella vaccine or placebo (n=30). The majority of participants will then receive the Shigella challenge (n=22). SF2a-TT15 Shigella Vaccine: 0.5 mL of the vaccine is administered via an intramuscular injection into the deltoid muscle on Study Day 1 and Study Day 29. S. flexneri 2a strain 2457T Challenge Agent: Each participant will drink 120 mL of sodium bicarbonate buffer solution. Approximately 1 to 2 minutes later, the participant will ingest approximately 1500 cfu of S. flexneri 2a strain 2457T suspended in 30 mL of the bicarbonate buffer solution.	Placebo n=29 Participants 1:1 randomization to investigational Shigella vaccine or placebo (n=30). The majority of participants will then receive the Shigella challenge (n=22). Placebo: 0.5 mL of normal saline is administered via an intramuscular injection into the deltoid muscle on Study Day 1 and Study Day 29. S. flexneri 2a strain 2457T Challenge Agent: Each participant will drink 120 mL of sodium bicarbonate buffer solution. Approximately 1 to 2 minutes later, the participant will ingest approximately 1500 cfu of S. flexneri 2a strain 2457T suspended in 30 mL of the bicarbonate buffer solution.	Vaccine Challenged n=22 Participants 1:1 randomization to investigational Shigella vaccine or placebo (n=30). The majority of participants will then receive the Shigella challenge (n=22). SF2a-TT15 Shigella Vaccine: 0.5 mL of the vaccine is administered via an intramuscular injection into the deltoid muscle on Study Day 1 and Study Day 29. S. flexneri 2a strain 2457T Challenge Agent: Each participant will drink 120 mL of sodium bicarbonate buffer solution. Approximately 1 to 2 minutes later, the participant will ingest approximately 1500 cfu of S. flexneri 2a strain 2457T suspended in 30 mL of the bicarbonate buffer solution.	Placebo Challenged n=22 Participants 1:1 randomization to investigational Shigella vaccine or placebo (n=30). The majority of participants will then receive the Shigella challenge (n=22). Placebo: 0.5 mL of normal saline is administered via an intramuscular injection into the deltoid muscle on Study Day 1 and Study Day 29. S. flexneri 2a strain 2457T Challenge Agent: Each participant will drink 120 mL of sodium bicarbonate buffer solution. Approximately 1 to 2 minutes later, the participant will ingest approximately 1500 cfu of S. flexneri 2a strain 2457T suspended in 30 mL of the bicarbonate buffer solution.
Serum Bactericidal Activity Response, by Titer Mean ±SD pre-vaccination (Day 1)	1131.48 titer Standard Deviation 2542.76	399.04 titer Standard Deviation 723.1	1229.55 titer Standard Deviation 2752.74	279.55 titer Standard Deviation 466.6
Serum Bactericidal Activity Response, by Titer Mean ±SD post-dose 1 (Day 29)	11973.15 titer Standard Deviation 38813.69	1856.73 titer Standard Deviation 5465.05	13729.55 titer Standard Deviation 42920.28	2006.82 titer Standard Deviation 5923.36
Serum Bactericidal Activity Response, by Titer Mean ±SD post-dose 2 (Day 57)	8553.7 titer Standard Deviation 19417.73	745.19 titer Standard Deviation 1723.18	9147.73 titer Standard Deviation 21379.99	547.73 titer Standard Deviation 1388.06
Serum Bactericidal Activity Response, by Titer Mean ±SD post-challenge (Day 85)	8479.63 titer Standard Deviation 19301.06	2345.83 titer Standard Deviation 3228.33	9420.45 titer Standard Deviation 21232.07	2448.75 titer Standard Deviation 3326.45

Adverse Events

Vaccine Enrolled

Serious events: 0 serious events

Other events: 18 other events

Deaths: 0 deaths

Placebo Enrolled

Serious events: 0 serious events

Other events: 21 other events

Deaths: 0 deaths

Vaccine Challenged

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Placebo Challenged

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	Vaccine Enrolled n=29 participants at risk 1:1 randomization to investigational Shigella vaccine or placebo (n=29). The majority of participants will then receive the Shigella challenge (n=22). SF2a-TT15 Shigella Vaccine: 0.5 mL of the vaccine is administered via an intramuscular injection into the deltoid muscle on Study Day 1 and Study Day 29. S. flexneri 2a strain 2457T Challenge Agent: Each participant will drink 120 mL of sodium bicarbonate buffer solution. Approximately 1 to 2 minutes later, the participant will ingest approximately 1500 cfu of S. flexneri 2a strain 2457T suspended in 30 mL of the bicarbonate buffer solution.	Placebo Enrolled n=29 participants at risk 1:1 randomization to investigational Shigella vaccine or placebo (n=29). The majority of participants will then receive the Shigella challenge (n=22). Placebo: 0.5 mL of normal saline is administered via an intramuscular injection into the deltoid muscle on Study Day 1 and Study Day 29. S. flexneri 2a strain 2457T Challenge Agent: Each participant will drink 120 mL of sodium bicarbonate buffer solution. Approximately 1 to 2 minutes later, the participant will ingest approximately 1500 cfu of S. flexneri 2a strain 2457T suspended in 30 mL of the bicarbonate buffer solution.	Vaccine Challenged n=22 participants at risk 1:1 randomization to investigational Shigella vaccine or placebo (n=29). The majority of participants will then receive the Shigella challenge (n=22). Placebo: 0.5 mL of normal saline is administered via an intramuscular injection into the deltoid muscle on Study Day 1 and Study Day 29. S. flexneri 2a strain 2457T Challenge Agent: Each participant will drink 120 mL of sodium bicarbonate buffer solution. Approximately 1 to 2 minutes later, the participant will ingest approximately 1500 cfu of S. flexneri 2a strain 2457T suspended in 30 mL of the bicarbonate buffer solution.	Placebo Challenged n=22 participants at risk 1:1 randomization to investigational Shigella vaccine or placebo (n=29). The majority of participants will then receive the Shigella challenge (n=22). Placebo: 0.5 mL of normal saline is administered via an intramuscular injection into the deltoid muscle on Study Day 1 and Study Day 29. S. flexneri 2a strain 2457T Challenge Agent: Each participant will drink 120 mL of sodium bicarbonate buffer solution. Approximately 1 to 2 minutes later, the participant will ingest approximately 1500 cfu of S. flexneri 2a strain 2457T suspended in 30 mL of the bicarbonate buffer solution.
Cardiac disorders Syncope	3.4% 1/29 • The assessment of the safety of the vaccine was through the detection and documentation of adverse effects, both solicited AEs and unsolicited AEs, and/or clinically significant laboratory abnormalities, from enrollment through 28 days post-vaccination. Only the occurrence of SAEs were reported between Day 57 (or 28 days post-last dose of vaccine) through the end of the study (Day 237).	3.4% 1/29 • The assessment of the safety of the vaccine was through the detection and documentation of adverse effects, both solicited AEs and unsolicited AEs, and/or clinically significant laboratory abnormalities, from enrollment through 28 days post-vaccination. Only the occurrence of SAEs were reported between Day 57 (or 28 days post-last dose of vaccine) through the end of the study (Day 237).	0.00% 0/22 • The assessment of the safety of the vaccine was through the detection and documentation of adverse effects, both solicited AEs and unsolicited AEs, and/or clinically significant laboratory abnormalities, from enrollment through 28 days post-vaccination. Only the occurrence of SAEs were reported between Day 57 (or 28 days post-last dose of vaccine) through the end of the study (Day 237).	0.00% 0/22 • The assessment of the safety of the vaccine was through the detection and documentation of adverse effects, both solicited AEs and unsolicited AEs, and/or clinically significant laboratory abnormalities, from enrollment through 28 days post-vaccination. Only the occurrence of SAEs were reported between Day 57 (or 28 days post-last dose of vaccine) through the end of the study (Day 237).
Gastrointestinal disorders Abdominal Discomfort	0.00% 0/29 • The assessment of the safety of the vaccine was through the detection and documentation of adverse effects, both solicited AEs and unsolicited AEs, and/or clinically significant laboratory abnormalities, from enrollment through 28 days post-vaccination. Only the occurrence of SAEs were reported between Day 57 (or 28 days post-last dose of vaccine) through the end of the study (Day 237).	3.4% 1/29 • The assessment of the safety of the vaccine was through the detection and documentation of adverse effects, both solicited AEs and unsolicited AEs, and/or clinically significant laboratory abnormalities, from enrollment through 28 days post-vaccination. Only the occurrence of SAEs were reported between Day 57 (or 28 days post-last dose of vaccine) through the end of the study (Day 237).	0.00% 0/22 • The assessment of the safety of the vaccine was through the detection and documentation of adverse effects, both solicited AEs and unsolicited AEs, and/or clinically significant laboratory abnormalities, from enrollment through 28 days post-vaccination. Only the occurrence of SAEs were reported between Day 57 (or 28 days post-last dose of vaccine) through the end of the study (Day 237).	0.00% 0/22 • The assessment of the safety of the vaccine was through the detection and documentation of adverse effects, both solicited AEs and unsolicited AEs, and/or clinically significant laboratory abnormalities, from enrollment through 28 days post-vaccination. Only the occurrence of SAEs were reported between Day 57 (or 28 days post-last dose of vaccine) through the end of the study (Day 237).
Gastrointestinal disorders Anorexia	3.4% 1/29 • The assessment of the safety of the vaccine was through the detection and documentation of adverse effects, both solicited AEs and unsolicited AEs, and/or clinically significant laboratory abnormalities, from enrollment through 28 days post-vaccination. Only the occurrence of SAEs were reported between Day 57 (or 28 days post-last dose of vaccine) through the end of the study (Day 237).	0.00% 0/29 • The assessment of the safety of the vaccine was through the detection and documentation of adverse effects, both solicited AEs and unsolicited AEs, and/or clinically significant laboratory abnormalities, from enrollment through 28 days post-vaccination. Only the occurrence of SAEs were reported between Day 57 (or 28 days post-last dose of vaccine) through the end of the study (Day 237).	0.00% 0/22 • The assessment of the safety of the vaccine was through the detection and documentation of adverse effects, both solicited AEs and unsolicited AEs, and/or clinically significant laboratory abnormalities, from enrollment through 28 days post-vaccination. Only the occurrence of SAEs were reported between Day 57 (or 28 days post-last dose of vaccine) through the end of the study (Day 237).	0.00% 0/22 • The assessment of the safety of the vaccine was through the detection and documentation of adverse effects, both solicited AEs and unsolicited AEs, and/or clinically significant laboratory abnormalities, from enrollment through 28 days post-vaccination. Only the occurrence of SAEs were reported between Day 57 (or 28 days post-last dose of vaccine) through the end of the study (Day 237).
Gastrointestinal disorders Gastroenteritis	3.4% 1/29 • The assessment of the safety of the vaccine was through the detection and documentation of adverse effects, both solicited AEs and unsolicited AEs, and/or clinically significant laboratory abnormalities, from enrollment through 28 days post-vaccination. Only the occurrence of SAEs were reported between Day 57 (or 28 days post-last dose of vaccine) through the end of the study (Day 237).	0.00% 0/29 • The assessment of the safety of the vaccine was through the detection and documentation of adverse effects, both solicited AEs and unsolicited AEs, and/or clinically significant laboratory abnormalities, from enrollment through 28 days post-vaccination. Only the occurrence of SAEs were reported between Day 57 (or 28 days post-last dose of vaccine) through the end of the study (Day 237).	0.00% 0/22 • The assessment of the safety of the vaccine was through the detection and documentation of adverse effects, both solicited AEs and unsolicited AEs, and/or clinically significant laboratory abnormalities, from enrollment through 28 days post-vaccination. Only the occurrence of SAEs were reported between Day 57 (or 28 days post-last dose of vaccine) through the end of the study (Day 237).	0.00% 0/22 • The assessment of the safety of the vaccine was through the detection and documentation of adverse effects, both solicited AEs and unsolicited AEs, and/or clinically significant laboratory abnormalities, from enrollment through 28 days post-vaccination. Only the occurrence of SAEs were reported between Day 57 (or 28 days post-last dose of vaccine) through the end of the study (Day 237).
General disorders Fatigue	6.9% 2/29 • The assessment of the safety of the vaccine was through the detection and documentation of adverse effects, both solicited AEs and unsolicited AEs, and/or clinically significant laboratory abnormalities, from enrollment through 28 days post-vaccination. Only the occurrence of SAEs were reported between Day 57 (or 28 days post-last dose of vaccine) through the end of the study (Day 237).	3.4% 1/29 • The assessment of the safety of the vaccine was through the detection and documentation of adverse effects, both solicited AEs and unsolicited AEs, and/or clinically significant laboratory abnormalities, from enrollment through 28 days post-vaccination. Only the occurrence of SAEs were reported between Day 57 (or 28 days post-last dose of vaccine) through the end of the study (Day 237).	0.00% 0/22 • The assessment of the safety of the vaccine was through the detection and documentation of adverse effects, both solicited AEs and unsolicited AEs, and/or clinically significant laboratory abnormalities, from enrollment through 28 days post-vaccination. Only the occurrence of SAEs were reported between Day 57 (or 28 days post-last dose of vaccine) through the end of the study (Day 237).	0.00% 0/22 • The assessment of the safety of the vaccine was through the detection and documentation of adverse effects, both solicited AEs and unsolicited AEs, and/or clinically significant laboratory abnormalities, from enrollment through 28 days post-vaccination. Only the occurrence of SAEs were reported between Day 57 (or 28 days post-last dose of vaccine) through the end of the study (Day 237).
General disorders Injection Site Pain	3.4% 1/29 • The assessment of the safety of the vaccine was through the detection and documentation of adverse effects, both solicited AEs and unsolicited AEs, and/or clinically significant laboratory abnormalities, from enrollment through 28 days post-vaccination. Only the occurrence of SAEs were reported between Day 57 (or 28 days post-last dose of vaccine) through the end of the study (Day 237).	0.00% 0/29 • The assessment of the safety of the vaccine was through the detection and documentation of adverse effects, both solicited AEs and unsolicited AEs, and/or clinically significant laboratory abnormalities, from enrollment through 28 days post-vaccination. Only the occurrence of SAEs were reported between Day 57 (or 28 days post-last dose of vaccine) through the end of the study (Day 237).	0.00% 0/22 • The assessment of the safety of the vaccine was through the detection and documentation of adverse effects, both solicited AEs and unsolicited AEs, and/or clinically significant laboratory abnormalities, from enrollment through 28 days post-vaccination. Only the occurrence of SAEs were reported between Day 57 (or 28 days post-last dose of vaccine) through the end of the study (Day 237).	0.00% 0/22 • The assessment of the safety of the vaccine was through the detection and documentation of adverse effects, both solicited AEs and unsolicited AEs, and/or clinically significant laboratory abnormalities, from enrollment through 28 days post-vaccination. Only the occurrence of SAEs were reported between Day 57 (or 28 days post-last dose of vaccine) through the end of the study (Day 237).
Infections and infestations COVID-19	6.9% 2/29 • The assessment of the safety of the vaccine was through the detection and documentation of adverse effects, both solicited AEs and unsolicited AEs, and/or clinically significant laboratory abnormalities, from enrollment through 28 days post-vaccination. Only the occurrence of SAEs were reported between Day 57 (or 28 days post-last dose of vaccine) through the end of the study (Day 237).	3.4% 1/29 • The assessment of the safety of the vaccine was through the detection and documentation of adverse effects, both solicited AEs and unsolicited AEs, and/or clinically significant laboratory abnormalities, from enrollment through 28 days post-vaccination. Only the occurrence of SAEs were reported between Day 57 (or 28 days post-last dose of vaccine) through the end of the study (Day 237).	0.00% 0/22 • The assessment of the safety of the vaccine was through the detection and documentation of adverse effects, both solicited AEs and unsolicited AEs, and/or clinically significant laboratory abnormalities, from enrollment through 28 days post-vaccination. Only the occurrence of SAEs were reported between Day 57 (or 28 days post-last dose of vaccine) through the end of the study (Day 237).	0.00% 0/22 • The assessment of the safety of the vaccine was through the detection and documentation of adverse effects, both solicited AEs and unsolicited AEs, and/or clinically significant laboratory abnormalities, from enrollment through 28 days post-vaccination. Only the occurrence of SAEs were reported between Day 57 (or 28 days post-last dose of vaccine) through the end of the study (Day 237).
Infections and infestations Pharyngitis	0.00% 0/29 • The assessment of the safety of the vaccine was through the detection and documentation of adverse effects, both solicited AEs and unsolicited AEs, and/or clinically significant laboratory abnormalities, from enrollment through 28 days post-vaccination. Only the occurrence of SAEs were reported between Day 57 (or 28 days post-last dose of vaccine) through the end of the study (Day 237).	3.4% 1/29 • The assessment of the safety of the vaccine was through the detection and documentation of adverse effects, both solicited AEs and unsolicited AEs, and/or clinically significant laboratory abnormalities, from enrollment through 28 days post-vaccination. Only the occurrence of SAEs were reported between Day 57 (or 28 days post-last dose of vaccine) through the end of the study (Day 237).	0.00% 0/22 • The assessment of the safety of the vaccine was through the detection and documentation of adverse effects, both solicited AEs and unsolicited AEs, and/or clinically significant laboratory abnormalities, from enrollment through 28 days post-vaccination. Only the occurrence of SAEs were reported between Day 57 (or 28 days post-last dose of vaccine) through the end of the study (Day 237).	0.00% 0/22 • The assessment of the safety of the vaccine was through the detection and documentation of adverse effects, both solicited AEs and unsolicited AEs, and/or clinically significant laboratory abnormalities, from enrollment through 28 days post-vaccination. Only the occurrence of SAEs were reported between Day 57 (or 28 days post-last dose of vaccine) through the end of the study (Day 237).
Injury, poisoning and procedural complications Facial Injury	0.00% 0/29 • The assessment of the safety of the vaccine was through the detection and documentation of adverse effects, both solicited AEs and unsolicited AEs, and/or clinically significant laboratory abnormalities, from enrollment through 28 days post-vaccination. Only the occurrence of SAEs were reported between Day 57 (or 28 days post-last dose of vaccine) through the end of the study (Day 237).	3.4% 1/29 • The assessment of the safety of the vaccine was through the detection and documentation of adverse effects, both solicited AEs and unsolicited AEs, and/or clinically significant laboratory abnormalities, from enrollment through 28 days post-vaccination. Only the occurrence of SAEs were reported between Day 57 (or 28 days post-last dose of vaccine) through the end of the study (Day 237).	0.00% 0/22 • The assessment of the safety of the vaccine was through the detection and documentation of adverse effects, both solicited AEs and unsolicited AEs, and/or clinically significant laboratory abnormalities, from enrollment through 28 days post-vaccination. Only the occurrence of SAEs were reported between Day 57 (or 28 days post-last dose of vaccine) through the end of the study (Day 237).	0.00% 0/22 • The assessment of the safety of the vaccine was through the detection and documentation of adverse effects, both solicited AEs and unsolicited AEs, and/or clinically significant laboratory abnormalities, from enrollment through 28 days post-vaccination. Only the occurrence of SAEs were reported between Day 57 (or 28 days post-last dose of vaccine) through the end of the study (Day 237).
Investigations Alanine Aminotransferase Increased	0.00% 0/29 • The assessment of the safety of the vaccine was through the detection and documentation of adverse effects, both solicited AEs and unsolicited AEs, and/or clinically significant laboratory abnormalities, from enrollment through 28 days post-vaccination. Only the occurrence of SAEs were reported between Day 57 (or 28 days post-last dose of vaccine) through the end of the study (Day 237).	3.4% 1/29 • The assessment of the safety of the vaccine was through the detection and documentation of adverse effects, both solicited AEs and unsolicited AEs, and/or clinically significant laboratory abnormalities, from enrollment through 28 days post-vaccination. Only the occurrence of SAEs were reported between Day 57 (or 28 days post-last dose of vaccine) through the end of the study (Day 237).	0.00% 0/22 • The assessment of the safety of the vaccine was through the detection and documentation of adverse effects, both solicited AEs and unsolicited AEs, and/or clinically significant laboratory abnormalities, from enrollment through 28 days post-vaccination. Only the occurrence of SAEs were reported between Day 57 (or 28 days post-last dose of vaccine) through the end of the study (Day 237).	0.00% 0/22 • The assessment of the safety of the vaccine was through the detection and documentation of adverse effects, both solicited AEs and unsolicited AEs, and/or clinically significant laboratory abnormalities, from enrollment through 28 days post-vaccination. Only the occurrence of SAEs were reported between Day 57 (or 28 days post-last dose of vaccine) through the end of the study (Day 237).
Investigations Bilirubin Increased	0.00% 0/29 • The assessment of the safety of the vaccine was through the detection and documentation of adverse effects, both solicited AEs and unsolicited AEs, and/or clinically significant laboratory abnormalities, from enrollment through 28 days post-vaccination. Only the occurrence of SAEs were reported between Day 57 (or 28 days post-last dose of vaccine) through the end of the study (Day 237).	10.3% 3/29 • The assessment of the safety of the vaccine was through the detection and documentation of adverse effects, both solicited AEs and unsolicited AEs, and/or clinically significant laboratory abnormalities, from enrollment through 28 days post-vaccination. Only the occurrence of SAEs were reported between Day 57 (or 28 days post-last dose of vaccine) through the end of the study (Day 237).	0.00% 0/22 • The assessment of the safety of the vaccine was through the detection and documentation of adverse effects, both solicited AEs and unsolicited AEs, and/or clinically significant laboratory abnormalities, from enrollment through 28 days post-vaccination. Only the occurrence of SAEs were reported between Day 57 (or 28 days post-last dose of vaccine) through the end of the study (Day 237).	0.00% 0/22 • The assessment of the safety of the vaccine was through the detection and documentation of adverse effects, both solicited AEs and unsolicited AEs, and/or clinically significant laboratory abnormalities, from enrollment through 28 days post-vaccination. Only the occurrence of SAEs were reported between Day 57 (or 28 days post-last dose of vaccine) through the end of the study (Day 237).
Investigations Blood Pressure Decreased	0.00% 0/29 • The assessment of the safety of the vaccine was through the detection and documentation of adverse effects, both solicited AEs and unsolicited AEs, and/or clinically significant laboratory abnormalities, from enrollment through 28 days post-vaccination. Only the occurrence of SAEs were reported between Day 57 (or 28 days post-last dose of vaccine) through the end of the study (Day 237).	3.4% 1/29 • The assessment of the safety of the vaccine was through the detection and documentation of adverse effects, both solicited AEs and unsolicited AEs, and/or clinically significant laboratory abnormalities, from enrollment through 28 days post-vaccination. Only the occurrence of SAEs were reported between Day 57 (or 28 days post-last dose of vaccine) through the end of the study (Day 237).	0.00% 0/22 • The assessment of the safety of the vaccine was through the detection and documentation of adverse effects, both solicited AEs and unsolicited AEs, and/or clinically significant laboratory abnormalities, from enrollment through 28 days post-vaccination. Only the occurrence of SAEs were reported between Day 57 (or 28 days post-last dose of vaccine) through the end of the study (Day 237).	0.00% 0/22 • The assessment of the safety of the vaccine was through the detection and documentation of adverse effects, both solicited AEs and unsolicited AEs, and/or clinically significant laboratory abnormalities, from enrollment through 28 days post-vaccination. Only the occurrence of SAEs were reported between Day 57 (or 28 days post-last dose of vaccine) through the end of the study (Day 237).
Investigations Blood Pressure Diastolic Increased	3.4% 1/29 • The assessment of the safety of the vaccine was through the detection and documentation of adverse effects, both solicited AEs and unsolicited AEs, and/or clinically significant laboratory abnormalities, from enrollment through 28 days post-vaccination. Only the occurrence of SAEs were reported between Day 57 (or 28 days post-last dose of vaccine) through the end of the study (Day 237).	0.00% 0/29 • The assessment of the safety of the vaccine was through the detection and documentation of adverse effects, both solicited AEs and unsolicited AEs, and/or clinically significant laboratory abnormalities, from enrollment through 28 days post-vaccination. Only the occurrence of SAEs were reported between Day 57 (or 28 days post-last dose of vaccine) through the end of the study (Day 237).	0.00% 0/22 • The assessment of the safety of the vaccine was through the detection and documentation of adverse effects, both solicited AEs and unsolicited AEs, and/or clinically significant laboratory abnormalities, from enrollment through 28 days post-vaccination. Only the occurrence of SAEs were reported between Day 57 (or 28 days post-last dose of vaccine) through the end of the study (Day 237).	0.00% 0/22 • The assessment of the safety of the vaccine was through the detection and documentation of adverse effects, both solicited AEs and unsolicited AEs, and/or clinically significant laboratory abnormalities, from enrollment through 28 days post-vaccination. Only the occurrence of SAEs were reported between Day 57 (or 28 days post-last dose of vaccine) through the end of the study (Day 237).
Investigations Blood Pressure Systolic Increased	3.4% 1/29 • The assessment of the safety of the vaccine was through the detection and documentation of adverse effects, both solicited AEs and unsolicited AEs, and/or clinically significant laboratory abnormalities, from enrollment through 28 days post-vaccination. Only the occurrence of SAEs were reported between Day 57 (or 28 days post-last dose of vaccine) through the end of the study (Day 237).	0.00% 0/29 • The assessment of the safety of the vaccine was through the detection and documentation of adverse effects, both solicited AEs and unsolicited AEs, and/or clinically significant laboratory abnormalities, from enrollment through 28 days post-vaccination. Only the occurrence of SAEs were reported between Day 57 (or 28 days post-last dose of vaccine) through the end of the study (Day 237).	0.00% 0/22 • The assessment of the safety of the vaccine was through the detection and documentation of adverse effects, both solicited AEs and unsolicited AEs, and/or clinically significant laboratory abnormalities, from enrollment through 28 days post-vaccination. Only the occurrence of SAEs were reported between Day 57 (or 28 days post-last dose of vaccine) through the end of the study (Day 237).	0.00% 0/22 • The assessment of the safety of the vaccine was through the detection and documentation of adverse effects, both solicited AEs and unsolicited AEs, and/or clinically significant laboratory abnormalities, from enrollment through 28 days post-vaccination. Only the occurrence of SAEs were reported between Day 57 (or 28 days post-last dose of vaccine) through the end of the study (Day 237).
Investigations Heart Rate Increased	3.4% 1/29 • The assessment of the safety of the vaccine was through the detection and documentation of adverse effects, both solicited AEs and unsolicited AEs, and/or clinically significant laboratory abnormalities, from enrollment through 28 days post-vaccination. Only the occurrence of SAEs were reported between Day 57 (or 28 days post-last dose of vaccine) through the end of the study (Day 237).	10.3% 3/29 • The assessment of the safety of the vaccine was through the detection and documentation of adverse effects, both solicited AEs and unsolicited AEs, and/or clinically significant laboratory abnormalities, from enrollment through 28 days post-vaccination. Only the occurrence of SAEs were reported between Day 57 (or 28 days post-last dose of vaccine) through the end of the study (Day 237).	0.00% 0/22 • The assessment of the safety of the vaccine was through the detection and documentation of adverse effects, both solicited AEs and unsolicited AEs, and/or clinically significant laboratory abnormalities, from enrollment through 28 days post-vaccination. Only the occurrence of SAEs were reported between Day 57 (or 28 days post-last dose of vaccine) through the end of the study (Day 237).	0.00% 0/22 • The assessment of the safety of the vaccine was through the detection and documentation of adverse effects, both solicited AEs and unsolicited AEs, and/or clinically significant laboratory abnormalities, from enrollment through 28 days post-vaccination. Only the occurrence of SAEs were reported between Day 57 (or 28 days post-last dose of vaccine) through the end of the study (Day 237).
Investigations Hemoglobin Decreased	3.4% 1/29 • The assessment of the safety of the vaccine was through the detection and documentation of adverse effects, both solicited AEs and unsolicited AEs, and/or clinically significant laboratory abnormalities, from enrollment through 28 days post-vaccination. Only the occurrence of SAEs were reported between Day 57 (or 28 days post-last dose of vaccine) through the end of the study (Day 237).	0.00% 0/29 • The assessment of the safety of the vaccine was through the detection and documentation of adverse effects, both solicited AEs and unsolicited AEs, and/or clinically significant laboratory abnormalities, from enrollment through 28 days post-vaccination. Only the occurrence of SAEs were reported between Day 57 (or 28 days post-last dose of vaccine) through the end of the study (Day 237).	0.00% 0/22 • The assessment of the safety of the vaccine was through the detection and documentation of adverse effects, both solicited AEs and unsolicited AEs, and/or clinically significant laboratory abnormalities, from enrollment through 28 days post-vaccination. Only the occurrence of SAEs were reported between Day 57 (or 28 days post-last dose of vaccine) through the end of the study (Day 237).	0.00% 0/22 • The assessment of the safety of the vaccine was through the detection and documentation of adverse effects, both solicited AEs and unsolicited AEs, and/or clinically significant laboratory abnormalities, from enrollment through 28 days post-vaccination. Only the occurrence of SAEs were reported between Day 57 (or 28 days post-last dose of vaccine) through the end of the study (Day 237).
Investigations White Blood Cell Count Decreased	0.00% 0/29 • The assessment of the safety of the vaccine was through the detection and documentation of adverse effects, both solicited AEs and unsolicited AEs, and/or clinically significant laboratory abnormalities, from enrollment through 28 days post-vaccination. Only the occurrence of SAEs were reported between Day 57 (or 28 days post-last dose of vaccine) through the end of the study (Day 237).	3.4% 1/29 • The assessment of the safety of the vaccine was through the detection and documentation of adverse effects, both solicited AEs and unsolicited AEs, and/or clinically significant laboratory abnormalities, from enrollment through 28 days post-vaccination. Only the occurrence of SAEs were reported between Day 57 (or 28 days post-last dose of vaccine) through the end of the study (Day 237).	0.00% 0/22 • The assessment of the safety of the vaccine was through the detection and documentation of adverse effects, both solicited AEs and unsolicited AEs, and/or clinically significant laboratory abnormalities, from enrollment through 28 days post-vaccination. Only the occurrence of SAEs were reported between Day 57 (or 28 days post-last dose of vaccine) through the end of the study (Day 237).	0.00% 0/22 • The assessment of the safety of the vaccine was through the detection and documentation of adverse effects, both solicited AEs and unsolicited AEs, and/or clinically significant laboratory abnormalities, from enrollment through 28 days post-vaccination. Only the occurrence of SAEs were reported between Day 57 (or 28 days post-last dose of vaccine) through the end of the study (Day 237).
Investigations White Blood Cell Count Increaed	0.00% 0/29 • The assessment of the safety of the vaccine was through the detection and documentation of adverse effects, both solicited AEs and unsolicited AEs, and/or clinically significant laboratory abnormalities, from enrollment through 28 days post-vaccination. Only the occurrence of SAEs were reported between Day 57 (or 28 days post-last dose of vaccine) through the end of the study (Day 237).	3.4% 1/29 • The assessment of the safety of the vaccine was through the detection and documentation of adverse effects, both solicited AEs and unsolicited AEs, and/or clinically significant laboratory abnormalities, from enrollment through 28 days post-vaccination. Only the occurrence of SAEs were reported between Day 57 (or 28 days post-last dose of vaccine) through the end of the study (Day 237).	0.00% 0/22 • The assessment of the safety of the vaccine was through the detection and documentation of adverse effects, both solicited AEs and unsolicited AEs, and/or clinically significant laboratory abnormalities, from enrollment through 28 days post-vaccination. Only the occurrence of SAEs were reported between Day 57 (or 28 days post-last dose of vaccine) through the end of the study (Day 237).	0.00% 0/22 • The assessment of the safety of the vaccine was through the detection and documentation of adverse effects, both solicited AEs and unsolicited AEs, and/or clinically significant laboratory abnormalities, from enrollment through 28 days post-vaccination. Only the occurrence of SAEs were reported between Day 57 (or 28 days post-last dose of vaccine) through the end of the study (Day 237).
Musculoskeletal and connective tissue disorders Arthralgia	6.9% 2/29 • The assessment of the safety of the vaccine was through the detection and documentation of adverse effects, both solicited AEs and unsolicited AEs, and/or clinically significant laboratory abnormalities, from enrollment through 28 days post-vaccination. Only the occurrence of SAEs were reported between Day 57 (or 28 days post-last dose of vaccine) through the end of the study (Day 237).	3.4% 1/29 • The assessment of the safety of the vaccine was through the detection and documentation of adverse effects, both solicited AEs and unsolicited AEs, and/or clinically significant laboratory abnormalities, from enrollment through 28 days post-vaccination. Only the occurrence of SAEs were reported between Day 57 (or 28 days post-last dose of vaccine) through the end of the study (Day 237).	0.00% 0/22 • The assessment of the safety of the vaccine was through the detection and documentation of adverse effects, both solicited AEs and unsolicited AEs, and/or clinically significant laboratory abnormalities, from enrollment through 28 days post-vaccination. Only the occurrence of SAEs were reported between Day 57 (or 28 days post-last dose of vaccine) through the end of the study (Day 237).	0.00% 0/22 • The assessment of the safety of the vaccine was through the detection and documentation of adverse effects, both solicited AEs and unsolicited AEs, and/or clinically significant laboratory abnormalities, from enrollment through 28 days post-vaccination. Only the occurrence of SAEs were reported between Day 57 (or 28 days post-last dose of vaccine) through the end of the study (Day 237).
Musculoskeletal and connective tissue disorders Foot Fracture	0.00% 0/29 • The assessment of the safety of the vaccine was through the detection and documentation of adverse effects, both solicited AEs and unsolicited AEs, and/or clinically significant laboratory abnormalities, from enrollment through 28 days post-vaccination. Only the occurrence of SAEs were reported between Day 57 (or 28 days post-last dose of vaccine) through the end of the study (Day 237).	3.4% 1/29 • The assessment of the safety of the vaccine was through the detection and documentation of adverse effects, both solicited AEs and unsolicited AEs, and/or clinically significant laboratory abnormalities, from enrollment through 28 days post-vaccination. Only the occurrence of SAEs were reported between Day 57 (or 28 days post-last dose of vaccine) through the end of the study (Day 237).	0.00% 0/22 • The assessment of the safety of the vaccine was through the detection and documentation of adverse effects, both solicited AEs and unsolicited AEs, and/or clinically significant laboratory abnormalities, from enrollment through 28 days post-vaccination. Only the occurrence of SAEs were reported between Day 57 (or 28 days post-last dose of vaccine) through the end of the study (Day 237).	0.00% 0/22 • The assessment of the safety of the vaccine was through the detection and documentation of adverse effects, both solicited AEs and unsolicited AEs, and/or clinically significant laboratory abnormalities, from enrollment through 28 days post-vaccination. Only the occurrence of SAEs were reported between Day 57 (or 28 days post-last dose of vaccine) through the end of the study (Day 237).
Musculoskeletal and connective tissue disorders Myalgia	3.4% 1/29 • The assessment of the safety of the vaccine was through the detection and documentation of adverse effects, both solicited AEs and unsolicited AEs, and/or clinically significant laboratory abnormalities, from enrollment through 28 days post-vaccination. Only the occurrence of SAEs were reported between Day 57 (or 28 days post-last dose of vaccine) through the end of the study (Day 237).	0.00% 0/29 • The assessment of the safety of the vaccine was through the detection and documentation of adverse effects, both solicited AEs and unsolicited AEs, and/or clinically significant laboratory abnormalities, from enrollment through 28 days post-vaccination. Only the occurrence of SAEs were reported between Day 57 (or 28 days post-last dose of vaccine) through the end of the study (Day 237).	0.00% 0/22 • The assessment of the safety of the vaccine was through the detection and documentation of adverse effects, both solicited AEs and unsolicited AEs, and/or clinically significant laboratory abnormalities, from enrollment through 28 days post-vaccination. Only the occurrence of SAEs were reported between Day 57 (or 28 days post-last dose of vaccine) through the end of the study (Day 237).	0.00% 0/22 • The assessment of the safety of the vaccine was through the detection and documentation of adverse effects, both solicited AEs and unsolicited AEs, and/or clinically significant laboratory abnormalities, from enrollment through 28 days post-vaccination. Only the occurrence of SAEs were reported between Day 57 (or 28 days post-last dose of vaccine) through the end of the study (Day 237).
Musculoskeletal and connective tissue disorders Wrist Pain	0.00% 0/29 • The assessment of the safety of the vaccine was through the detection and documentation of adverse effects, both solicited AEs and unsolicited AEs, and/or clinically significant laboratory abnormalities, from enrollment through 28 days post-vaccination. Only the occurrence of SAEs were reported between Day 57 (or 28 days post-last dose of vaccine) through the end of the study (Day 237).	3.4% 1/29 • The assessment of the safety of the vaccine was through the detection and documentation of adverse effects, both solicited AEs and unsolicited AEs, and/or clinically significant laboratory abnormalities, from enrollment through 28 days post-vaccination. Only the occurrence of SAEs were reported between Day 57 (or 28 days post-last dose of vaccine) through the end of the study (Day 237).	0.00% 0/22 • The assessment of the safety of the vaccine was through the detection and documentation of adverse effects, both solicited AEs and unsolicited AEs, and/or clinically significant laboratory abnormalities, from enrollment through 28 days post-vaccination. Only the occurrence of SAEs were reported between Day 57 (or 28 days post-last dose of vaccine) through the end of the study (Day 237).	0.00% 0/22 • The assessment of the safety of the vaccine was through the detection and documentation of adverse effects, both solicited AEs and unsolicited AEs, and/or clinically significant laboratory abnormalities, from enrollment through 28 days post-vaccination. Only the occurrence of SAEs were reported between Day 57 (or 28 days post-last dose of vaccine) through the end of the study (Day 237).
Respiratory, thoracic and mediastinal disorders Asthma	0.00% 0/29 • The assessment of the safety of the vaccine was through the detection and documentation of adverse effects, both solicited AEs and unsolicited AEs, and/or clinically significant laboratory abnormalities, from enrollment through 28 days post-vaccination. Only the occurrence of SAEs were reported between Day 57 (or 28 days post-last dose of vaccine) through the end of the study (Day 237).	3.4% 1/29 • The assessment of the safety of the vaccine was through the detection and documentation of adverse effects, both solicited AEs and unsolicited AEs, and/or clinically significant laboratory abnormalities, from enrollment through 28 days post-vaccination. Only the occurrence of SAEs were reported between Day 57 (or 28 days post-last dose of vaccine) through the end of the study (Day 237).	0.00% 0/22 • The assessment of the safety of the vaccine was through the detection and documentation of adverse effects, both solicited AEs and unsolicited AEs, and/or clinically significant laboratory abnormalities, from enrollment through 28 days post-vaccination. Only the occurrence of SAEs were reported between Day 57 (or 28 days post-last dose of vaccine) through the end of the study (Day 237).	0.00% 0/22 • The assessment of the safety of the vaccine was through the detection and documentation of adverse effects, both solicited AEs and unsolicited AEs, and/or clinically significant laboratory abnormalities, from enrollment through 28 days post-vaccination. Only the occurrence of SAEs were reported between Day 57 (or 28 days post-last dose of vaccine) through the end of the study (Day 237).
Skin and subcutaneous tissue disorders Burn	3.4% 1/29 • The assessment of the safety of the vaccine was through the detection and documentation of adverse effects, both solicited AEs and unsolicited AEs, and/or clinically significant laboratory abnormalities, from enrollment through 28 days post-vaccination. Only the occurrence of SAEs were reported between Day 57 (or 28 days post-last dose of vaccine) through the end of the study (Day 237).	0.00% 0/29 • The assessment of the safety of the vaccine was through the detection and documentation of adverse effects, both solicited AEs and unsolicited AEs, and/or clinically significant laboratory abnormalities, from enrollment through 28 days post-vaccination. Only the occurrence of SAEs were reported between Day 57 (or 28 days post-last dose of vaccine) through the end of the study (Day 237).	0.00% 0/22 • The assessment of the safety of the vaccine was through the detection and documentation of adverse effects, both solicited AEs and unsolicited AEs, and/or clinically significant laboratory abnormalities, from enrollment through 28 days post-vaccination. Only the occurrence of SAEs were reported between Day 57 (or 28 days post-last dose of vaccine) through the end of the study (Day 237).	0.00% 0/22 • The assessment of the safety of the vaccine was through the detection and documentation of adverse effects, both solicited AEs and unsolicited AEs, and/or clinically significant laboratory abnormalities, from enrollment through 28 days post-vaccination. Only the occurrence of SAEs were reported between Day 57 (or 28 days post-last dose of vaccine) through the end of the study (Day 237).
Skin and subcutaneous tissue disorders Rash	3.4% 1/29 • The assessment of the safety of the vaccine was through the detection and documentation of adverse effects, both solicited AEs and unsolicited AEs, and/or clinically significant laboratory abnormalities, from enrollment through 28 days post-vaccination. Only the occurrence of SAEs were reported between Day 57 (or 28 days post-last dose of vaccine) through the end of the study (Day 237).	0.00% 0/29 • The assessment of the safety of the vaccine was through the detection and documentation of adverse effects, both solicited AEs and unsolicited AEs, and/or clinically significant laboratory abnormalities, from enrollment through 28 days post-vaccination. Only the occurrence of SAEs were reported between Day 57 (or 28 days post-last dose of vaccine) through the end of the study (Day 237).	0.00% 0/22 • The assessment of the safety of the vaccine was through the detection and documentation of adverse effects, both solicited AEs and unsolicited AEs, and/or clinically significant laboratory abnormalities, from enrollment through 28 days post-vaccination. Only the occurrence of SAEs were reported between Day 57 (or 28 days post-last dose of vaccine) through the end of the study (Day 237).	0.00% 0/22 • The assessment of the safety of the vaccine was through the detection and documentation of adverse effects, both solicited AEs and unsolicited AEs, and/or clinically significant laboratory abnormalities, from enrollment through 28 days post-vaccination. Only the occurrence of SAEs were reported between Day 57 (or 28 days post-last dose of vaccine) through the end of the study (Day 237).
Skin and subcutaneous tissue disorders Ecchymosis	0.00% 0/29 • The assessment of the safety of the vaccine was through the detection and documentation of adverse effects, both solicited AEs and unsolicited AEs, and/or clinically significant laboratory abnormalities, from enrollment through 28 days post-vaccination. Only the occurrence of SAEs were reported between Day 57 (or 28 days post-last dose of vaccine) through the end of the study (Day 237).	3.4% 1/29 • The assessment of the safety of the vaccine was through the detection and documentation of adverse effects, both solicited AEs and unsolicited AEs, and/or clinically significant laboratory abnormalities, from enrollment through 28 days post-vaccination. Only the occurrence of SAEs were reported between Day 57 (or 28 days post-last dose of vaccine) through the end of the study (Day 237).	0.00% 0/22 • The assessment of the safety of the vaccine was through the detection and documentation of adverse effects, both solicited AEs and unsolicited AEs, and/or clinically significant laboratory abnormalities, from enrollment through 28 days post-vaccination. Only the occurrence of SAEs were reported between Day 57 (or 28 days post-last dose of vaccine) through the end of the study (Day 237).	0.00% 0/22 • The assessment of the safety of the vaccine was through the detection and documentation of adverse effects, both solicited AEs and unsolicited AEs, and/or clinically significant laboratory abnormalities, from enrollment through 28 days post-vaccination. Only the occurrence of SAEs were reported between Day 57 (or 28 days post-last dose of vaccine) through the end of the study (Day 237).
Skin and subcutaneous tissue disorders Pruritus	3.4% 1/29 • The assessment of the safety of the vaccine was through the detection and documentation of adverse effects, both solicited AEs and unsolicited AEs, and/or clinically significant laboratory abnormalities, from enrollment through 28 days post-vaccination. Only the occurrence of SAEs were reported between Day 57 (or 28 days post-last dose of vaccine) through the end of the study (Day 237).	0.00% 0/29 • The assessment of the safety of the vaccine was through the detection and documentation of adverse effects, both solicited AEs and unsolicited AEs, and/or clinically significant laboratory abnormalities, from enrollment through 28 days post-vaccination. Only the occurrence of SAEs were reported between Day 57 (or 28 days post-last dose of vaccine) through the end of the study (Day 237).	0.00% 0/22 • The assessment of the safety of the vaccine was through the detection and documentation of adverse effects, both solicited AEs and unsolicited AEs, and/or clinically significant laboratory abnormalities, from enrollment through 28 days post-vaccination. Only the occurrence of SAEs were reported between Day 57 (or 28 days post-last dose of vaccine) through the end of the study (Day 237).	0.00% 0/22 • The assessment of the safety of the vaccine was through the detection and documentation of adverse effects, both solicited AEs and unsolicited AEs, and/or clinically significant laboratory abnormalities, from enrollment through 28 days post-vaccination. Only the occurrence of SAEs were reported between Day 57 (or 28 days post-last dose of vaccine) through the end of the study (Day 237).

Additional Information

Dr. Wilbur Chen

University of Maryland, Baltimore Center for Vaccine Development and Global Health (CVD)

Phone: 410-706-5328

Email: wchen@som.umaryland.edu

Results disclosure agreements

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