Trial Outcomes & Findings for Safety Study of Hepatitis E Vaccine (HEV239) (NCT NCT03827395)

NCT ID: NCT03827395

Last Updated: 2021-09-24

Results Overview

Injection site Adverse Events (AEs) solicited on an e-memory aid available to participants included: pain, tenderness, pruritis/itching, ecchymosis/bruising, induration/swelling (functional grade based on interference with daily activities). Ecchymosis/bruising (any measured value \>/= 25mm), induration/swelling (any measured value \>/= 25mm), and erythema/redness (any measured value \>/= 25mm). Participants are considered reporting the injection site AE if they reported mild or greater severity at any time during the 8 days at or following vaccination.

• Recruitment status: COMPLETED
• Study phase: PHASE1
• Target enrollment: 25 participants
• Primary outcome timeframe: Post Dose 1 (Day 1 through Day 8), Post Dose 2 (Day 29 through Day 36), Post Dose 3 (Day 180 through Day 187)
• Results posted on: 2021-09-24

Participant Flow

Participants were healthy males and non-pregnant females between 18 and 45 years old, inclusively. They were recruited from the community at large around the clinical site. Participants were enrolled between 12APR2019 and 24JUL2019.

Participant milestones

Measure	HEV-239 0.5 mL of HEV-239 administered intramuscularly into the deltoid muscle as a single injection on Days 1, 29, and 180. HEV 239: Hepatitis E vaccine against HEV genotypes 1 and 4. The HEV 239 vaccine is a 26 kDa recombinant polypeptide corresponding to amino acid residues 368-606 of the capsid protein of a genotype 1 HEV strain. The vaccine is expressed in Escherichia coli (E. coli) and vaccine doses contain 30 µg of the purified antigen in 0.5 mL buffered saline adsorbed to 0.8 mg aluminium hydroxide.	Placebo 0.5 mL of HEV-239 placebo administered intramuscularly into the deltoid muscle as a single injection on Days 1, 29, and 180. Placebo: 0.9% Sodium Chloride Injection, USP (Normal Saline) is a sterile, nonpyrogenic, isotonic solution of sodium chloride and water for injection (WFI). Each mL contains sodium chloride 9 mg and may contain HCl or NaOH for pH adjustment (pH 5.3 \[4.5 - 7.0\]).
Overall Study STARTED	20	5
Overall Study COMPLETED	17	3
Overall Study NOT COMPLETED	3	2

Reasons for withdrawal

Measure	HEV-239 0.5 mL of HEV-239 administered intramuscularly into the deltoid muscle as a single injection on Days 1, 29, and 180. HEV 239: Hepatitis E vaccine against HEV genotypes 1 and 4. The HEV 239 vaccine is a 26 kDa recombinant polypeptide corresponding to amino acid residues 368-606 of the capsid protein of a genotype 1 HEV strain. The vaccine is expressed in Escherichia coli (E. coli) and vaccine doses contain 30 µg of the purified antigen in 0.5 mL buffered saline adsorbed to 0.8 mg aluminium hydroxide.	Placebo 0.5 mL of HEV-239 placebo administered intramuscularly into the deltoid muscle as a single injection on Days 1, 29, and 180. Placebo: 0.9% Sodium Chloride Injection, USP (Normal Saline) is a sterile, nonpyrogenic, isotonic solution of sodium chloride and water for injection (WFI). Each mL contains sodium chloride 9 mg and may contain HCl or NaOH for pH adjustment (pH 5.3 \[4.5 - 7.0\]).
Overall Study Lost to Follow-up	1	0
Overall Study Protocol Violation	1	0
Overall Study Became ineligible after enrollment	1	2

Baseline Characteristics

Safety Study of Hepatitis E Vaccine (HEV239)

Baseline characteristics by cohort

Measure	HEV-239 n=20 Participants 0.5 mL of HEV-239 administered intramuscularly into the deltoid muscle as a single injection on Days 1, 29, and 180.	Placebo n=5 Participants 0.5 mL of HEV-239 placebo administered intramuscularly into the deltoid muscle as a single injection on Days 1, 29, and 180.	Total n=25 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	20 Participants n=5 Participants	5 Participants n=7 Participants	25 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	29.9 years STANDARD_DEVIATION 6.7 • n=5 Participants	32.8 years STANDARD_DEVIATION 7.9 • n=7 Participants	30.4 years STANDARD_DEVIATION 6.9 • n=5 Participants
Sex: Female, Male Female	15 Participants n=5 Participants	4 Participants n=7 Participants	19 Participants n=5 Participants
Sex: Female, Male Male	5 Participants n=5 Participants	1 Participants n=7 Participants	6 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	1 Participants n=5 Participants	1 Participants n=7 Participants	2 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	19 Participants n=5 Participants	4 Participants n=7 Participants	23 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	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Asian	2 Participants n=5 Participants	0 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	3 Participants n=5 Participants	2 Participants n=7 Participants	5 Participants n=5 Participants
Race (NIH/OMB) White	15 Participants n=5 Participants	3 Participants n=7 Participants	18 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Region of Enrollment United States	20 participants n=5 Participants	5 participants n=7 Participants	25 participants n=5 Participants

PRIMARY outcome

Timeframe: Post Dose 1 (Day 1 through Day 8), Post Dose 2 (Day 29 through Day 36), Post Dose 3 (Day 180 through Day 187)

Population: The Safety Analysis population includes all participants who received at least one study vaccination and for whom data at the corresponding time point exists.

Injection site Adverse Events (AEs) solicited on an e-memory aid available to participants included: pain, tenderness, pruritis/itching, ecchymosis/bruising, induration/swelling (functional grade based on interference with daily activities). Ecchymosis/bruising (any measured value >/= 25mm), induration/swelling (any measured value >/= 25mm), and erythema/redness (any measured value >/= 25mm). Participants are considered reporting the injection site AE if they reported mild or greater severity at any time during the 8 days at or following vaccination.

Outcome measures

Measure	HEV-239 n=20 Participants 0.5 mL of HEV-239 administered intramuscularly into the deltoid muscle as a single injection on Days 1, 29, and 180.	Placebo n=5 Participants 0.5 mL of HEV-239 placebo administered intramuscularly into the deltoid muscle as a single injection on Days 1, 29, and 180.
Number of Participants With Solicited Local Reactogenicity Events Post Dose 1	11 Participants	3 Participants
Number of Participants With Solicited Local Reactogenicity Events Post Dose 2	17 Participants	1 Participants
Number of Participants With Solicited Local Reactogenicity Events Post Dose 3	9 Participants	1 Participants
Number of Participants With Solicited Local Reactogenicity Events Post Any Dose	19 Participants	3 Participants

PRIMARY outcome

Timeframe: Post Dose 1 (Day 1 through Day 8), Post Dose 2 (Day 29 through Day 36), Post Dose 3 (Day 180 through Day 187)

Population: The Safety Analysis population includes all participants who received at least one study vaccination and for whom data at the corresponding time point exists.

Systemic AEs solicited on an e-memory aid provided to participants included: feverishness, fatigue, malaise, myalgia, arthralgia, headache, nausea, vomiting, and elevated oral temperature (38.0 degrees Celsius/100.4 degrees Fahrenheit or greater). Participants are considered reporting the injection site AE if they reported mild or greater severity at any time during the 8 days at or following vaccination.

Outcome measures

Measure	HEV-239 n=20 Participants 0.5 mL of HEV-239 administered intramuscularly into the deltoid muscle as a single injection on Days 1, 29, and 180.	Placebo n=5 Participants 0.5 mL of HEV-239 placebo administered intramuscularly into the deltoid muscle as a single injection on Days 1, 29, and 180.
Number of Participants With Solicited Systemic Reactogenicity Events Post Dose 1	11 Participants	3 Participants
Number of Participants With Solicited Systemic Reactogenicity Events Post Dose 2	12 Participants	1 Participants
Number of Participants With Solicited Systemic Reactogenicity Events Post Dose 3	7 Participants	1 Participants
Number of Participants With Solicited Systemic Reactogenicity Events Post Any Dose	17 Participants	4 Participants

PRIMARY outcome

Timeframe: Post Dose 1 (Day 1 through Day 29), Post Dose 2 (Day 29 through Day 57), Post Dose 3 (Day 180 through Day 208)

Population: The Safety Analysis population includes all participants who received at least one study vaccination and for whom data at the corresponding time point exists.

Unsolicited adverse events were defined as any untoward medical occurrence in a participant administered a pharmaceutical product regardless of its causal relationship to the study treatment. Unsolicited AEs that were deemed vaccine-related were collected from participants from the time of vaccination through Day 29 after each study vaccination.

Outcome measures

Measure	HEV-239 n=20 Participants 0.5 mL of HEV-239 administered intramuscularly into the deltoid muscle as a single injection on Days 1, 29, and 180.	Placebo n=5 Participants 0.5 mL of HEV-239 placebo administered intramuscularly into the deltoid muscle as a single injection on Days 1, 29, and 180.
Number of Participants With Vaccine-related Unsolicited Adverse Events (AEs)	0 Participants	0 Participants

PRIMARY outcome

Timeframe: Baseline, Post Dose 1 (Day 8), Post Dose 2 (Day 36), Post Dose 3 (Day 187)

Population: The Safety Analysis population includes all participants who received at least one study vaccination and for whom data at the corresponding time point exists.

Chemistry parameters included: alanine aminotransferase (ALT) and creatinine. Thresholds for adverse events were considered as ALT 30 U/L or greater (female) or 47 U/L or greater (male); creatinine 1.11 mg/dL or greater (female) or 1.36 mg/dL or greater (male).

Outcome measures

Measure	HEV-239 n=20 Participants 0.5 mL of HEV-239 administered intramuscularly into the deltoid muscle as a single injection on Days 1, 29, and 180.	Placebo n=5 Participants 0.5 mL of HEV-239 placebo administered intramuscularly into the deltoid muscle as a single injection on Days 1, 29, and 180.
Number of Participants With Clinical Safety Laboratory Adverse Events (AEs) - Chemistry	0 Participants	0 Participants

PRIMARY outcome

Timeframe: Baseline, Post Dose 1 (Day 8), Post Dose 2 (Day 36), Post Dose 3 (Day 187)

Population: The Safety Analysis population includes all participants who received at least one study vaccination and for whom data at the corresponding time point exists.

Hematology parameters included: hemoglobin, platelets, absolute neutrophil count (ANC), absolute eosinophil count (AEC), and white blood cells (WBC). Thresholds for adverse events were considered as hemoglobin 11.0 g/dL or greater (female) or 12.0 g/dL or greater (male); WBC increase 10.9 thousand/uL or greater; WBC decrease 3.7 thousand/uL or less; ANC decrease 1499 cells/uL or less; AEC increase 501 cells/uL or greater; platelet decrease 139 thousand/uL or less.

Outcome measures

Measure	HEV-239 n=20 Participants 0.5 mL of HEV-239 administered intramuscularly into the deltoid muscle as a single injection on Days 1, 29, and 180.	Placebo n=5 Participants 0.5 mL of HEV-239 placebo administered intramuscularly into the deltoid muscle as a single injection on Days 1, 29, and 180.
Number of Participants With Clinical Safety Laboratory Adverse Events (AEs) - Hematology Baseline · None	20 Participants	5 Participants
Number of Participants With Clinical Safety Laboratory Adverse Events (AEs) - Hematology Baseline · Mild/Grade 1	0 Participants	0 Participants
Number of Participants With Clinical Safety Laboratory Adverse Events (AEs) - Hematology Baseline · Moderate/Grade 2	0 Participants	0 Participants
Number of Participants With Clinical Safety Laboratory Adverse Events (AEs) - Hematology Baseline · Severe/Grade 3	0 Participants	0 Participants
Number of Participants With Clinical Safety Laboratory Adverse Events (AEs) - Hematology Baseline · Missing	0 Participants	0 Participants
Number of Participants With Clinical Safety Laboratory Adverse Events (AEs) - Hematology Post Dose 1 · None	20 Participants	5 Participants
Number of Participants With Clinical Safety Laboratory Adverse Events (AEs) - Hematology Post Dose 1 · Mild/Grade 1	0 Participants	0 Participants
Number of Participants With Clinical Safety Laboratory Adverse Events (AEs) - Hematology Post Dose 1 · Moderate/Grade 2	0 Participants	0 Participants
Number of Participants With Clinical Safety Laboratory Adverse Events (AEs) - Hematology Post Dose 1 · Severe/Grade 3	0 Participants	0 Participants
Number of Participants With Clinical Safety Laboratory Adverse Events (AEs) - Hematology Post Dose 1 · Missing	0 Participants	0 Participants
Number of Participants With Clinical Safety Laboratory Adverse Events (AEs) - Hematology Post Dose 2 · None	19 Participants	3 Participants
Number of Participants With Clinical Safety Laboratory Adverse Events (AEs) - Hematology Post Dose 2 · Mild/Grade 1	0 Participants	0 Participants
Number of Participants With Clinical Safety Laboratory Adverse Events (AEs) - Hematology Post Dose 2 · Moderate/Grade 2	1 Participants	0 Participants
Number of Participants With Clinical Safety Laboratory Adverse Events (AEs) - Hematology Post Dose 2 · Severe/Grade 3	0 Participants	0 Participants
Number of Participants With Clinical Safety Laboratory Adverse Events (AEs) - Hematology Post Dose 2 · Missing	0 Participants	2 Participants
Number of Participants With Clinical Safety Laboratory Adverse Events (AEs) - Hematology Post Dose 3 · None	17 Participants	3 Participants
Number of Participants With Clinical Safety Laboratory Adverse Events (AEs) - Hematology Post Dose 3 · Mild/Grade 1	0 Participants	0 Participants
Number of Participants With Clinical Safety Laboratory Adverse Events (AEs) - Hematology Post Dose 3 · Moderate/Grade 2	1 Participants	0 Participants
Number of Participants With Clinical Safety Laboratory Adverse Events (AEs) - Hematology Post Dose 3 · Severe/Grade 3	0 Participants	0 Participants
Number of Participants With Clinical Safety Laboratory Adverse Events (AEs) - Hematology Post Dose 3 · Missing	1 Participants	0 Participants

PRIMARY outcome

Timeframe: Day 1 through Day 360

Population: The Safety Analysis population includes all participants who received at least one study vaccination and for whom data at the corresponding time point exists.

SAEs included any untoward medical occurrence that resulted in death; was life threatening; was a persistent/significant disability/incapacity; required inpatient hospitalization or prolongation of existing hospitalization; persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions; a congenital anomaly/birth defect; or any important medical event that may not result in death, be life-threatening, or require hospitalizations, that may be considered serious when, based on appropriate medical judgment, they may jeopardize the participant and may require medical or surgical intervention to prevent one of the outcomes listed in this definition.

Outcome measures

Measure	HEV-239 n=20 Participants 0.5 mL of HEV-239 administered intramuscularly into the deltoid muscle as a single injection on Days 1, 29, and 180.	Placebo n=5 Participants 0.5 mL of HEV-239 placebo administered intramuscularly into the deltoid muscle as a single injection on Days 1, 29, and 180.
Number of Participants With Vaccine-related Serious Adverse Events (SAEs)	0 Participants	0 Participants

PRIMARY outcome

Timeframe: Day 8, Day 15, Day 29 (Dose 2), Day 36, Day 43, Day 57, Day 180 (Dose 3), Day 187, Day 194, Day 208, Day 360

Population: The modified intent-to-treat (mITT) population includes all participants who received at least one study vaccination and contributed both pre- and at least one post-study vaccination blood sample for immunogenicity testing for which valid results were reported at the corresponding time point.

Blood was collected for IgG assay which was conducted with HEV as the antigen. Each sample was tested at least twice per the laboratory's standard operating procedure, and the geometric mean of the replicate results was calculated as that sample's result. The geometric mean fold rise was calculated for each study arm from the available results at Day 8 and Day 15 post first study vaccination, Day 29 prior to second study vaccination, Day 36, Day 43, Day 57, Day 180 prior to third study vaccination, Day 187, Day 194, Day 208 and Day 360. A 4-fold rise was defined as a HEV IgG >/=0.154 Wu/mL in a participant that was HEV seronegative at Day 1.

Outcome measures

Measure	HEV-239 n=20 Participants 0.5 mL of HEV-239 administered intramuscularly into the deltoid muscle as a single injection on Days 1, 29, and 180.	Placebo n=5 Participants 0.5 mL of HEV-239 placebo administered intramuscularly into the deltoid muscle as a single injection on Days 1, 29, and 180.
Percentage of Participants Showing >/=4-fold Rise in Serum Hepatitis E Virus Immunoglobulin G (IgG) Concentration Day 8	0 percentage of participants Interval 0.0 to 17.0	0 percentage of participants Interval 0.0 to 52.0
Percentage of Participants Showing >/=4-fold Rise in Serum Hepatitis E Virus Immunoglobulin G (IgG) Concentration Day 15	65 percentage of participants Interval 41.0 to 85.0	0 percentage of participants Interval 0.0 to 52.0
Percentage of Participants Showing >/=4-fold Rise in Serum Hepatitis E Virus Immunoglobulin G (IgG) Concentration Day 29 (Dose 2)	100 percentage of participants Interval 83.0 to 100.0	0 percentage of participants Interval 0.0 to 52.0
Percentage of Participants Showing >/=4-fold Rise in Serum Hepatitis E Virus Immunoglobulin G (IgG) Concentration Day 36	100 percentage of participants Interval 83.0 to 100.0	0 percentage of participants Interval 0.0 to 71.0
Percentage of Participants Showing >/=4-fold Rise in Serum Hepatitis E Virus Immunoglobulin G (IgG) Concentration Day 43	100 percentage of participants Interval 82.0 to 100.0	0 percentage of participants Interval 0.0 to 71.0
Percentage of Participants Showing >/=4-fold Rise in Serum Hepatitis E Virus Immunoglobulin G (IgG) Concentration Day 57	100 percentage of participants Interval 83.0 to 100.0	0 percentage of participants Interval 0.0 to 52.0
Percentage of Participants Showing >/=4-fold Rise in Serum Hepatitis E Virus Immunoglobulin G (IgG) Concentration Day 180 (Dose 3)	100 percentage of participants Interval 82.0 to 100.0	0 percentage of participants Interval 0.0 to 52.0
Percentage of Participants Showing >/=4-fold Rise in Serum Hepatitis E Virus Immunoglobulin G (IgG) Concentration Day 187	100 percentage of participants Interval 81.0 to 100.0	0 percentage of participants Interval 0.0 to 71.0
Percentage of Participants Showing >/=4-fold Rise in Serum Hepatitis E Virus Immunoglobulin G (IgG) Concentration Day 194	100 percentage of participants Interval 81.0 to 100.0	0 percentage of participants Interval 0.0 to 71.0
Percentage of Participants Showing >/=4-fold Rise in Serum Hepatitis E Virus Immunoglobulin G (IgG) Concentration Day 208	100 percentage of participants Interval 82.0 to 100.0	0 percentage of participants Interval 0.0 to 71.0
Percentage of Participants Showing >/=4-fold Rise in Serum Hepatitis E Virus Immunoglobulin G (IgG) Concentration Day 360	100 percentage of participants Interval 80.0 to 100.0	0 percentage of participants Interval 0.0 to 71.0

SECONDARY outcome

Timeframe: Day 8, Day 15, Day 29 (Dose 2), Day 36, Day 43, Day 57, Day 180 (Dose 3), Day 187, Day 194, Day 208, Day 360

Population: The modified intent-to-treat (mITT) population includes all participants who received at least one study vaccination and contributed both pre- and at least one post-study vaccination blood sample for immunogenicity testing for which valid results were reported at the corresponding time point.

Blood was collected for the IgM assay conducted with HEV as the antigen. Each sample was tested in duplicate per the laboratory's standard operating procedure and retested in duplicate if a result was borderline (A / C.O. = 0.9-1.1). If any replicate was seropositive [A/C.O. >1.1 as defined by the Wantai HEV-IgM enzyme-linked immunosorbent assay (ELISA) package insert] the sample's result was positive. If no replicates were positive the sample's result was negative. Seroconversion was defined as a change from a seronegative result to a seropositive result.

Outcome measures

Measure	HEV-239 n=20 Participants 0.5 mL of HEV-239 administered intramuscularly into the deltoid muscle as a single injection on Days 1, 29, and 180.	Placebo n=5 Participants 0.5 mL of HEV-239 placebo administered intramuscularly into the deltoid muscle as a single injection on Days 1, 29, and 180.
Percentage of Participants With Hepatitis E Virus Immunoglobulin M (IgM) Seroconversion Day 8	0 percentage of participants Interval 0.0 to 17.0	0 percentage of participants Interval 0.0 to 52.0
Percentage of Participants With Hepatitis E Virus Immunoglobulin M (IgM) Seroconversion Day 15	0 percentage of participants Interval 0.0 to 17.0	0 percentage of participants Interval 0.0 to 52.0
Percentage of Participants With Hepatitis E Virus Immunoglobulin M (IgM) Seroconversion Day 29 (Dose 2)	15 percentage of participants Interval 3.0 to 38.0	0 percentage of participants Interval 0.0 to 52.0
Percentage of Participants With Hepatitis E Virus Immunoglobulin M (IgM) Seroconversion Day 36	15 percentage of participants Interval 3.0 to 38.0	0 percentage of participants Interval 0.0 to 71.0
Percentage of Participants With Hepatitis E Virus Immunoglobulin M (IgM) Seroconversion Day 43	16 percentage of participants Interval 3.0 to 40.0	0 percentage of participants Interval 0.0 to 71.0
Percentage of Participants With Hepatitis E Virus Immunoglobulin M (IgM) Seroconversion Day 57	10 percentage of participants Interval 1.0 to 32.0	0 percentage of participants Interval 0.0 to 52.0
Percentage of Participants With Hepatitis E Virus Immunoglobulin M (IgM) Seroconversion Day 180 (Dose 3)	0 percentage of participants Interval 0.0 to 18.0	0 percentage of participants Interval 0.0 to 52.0
Percentage of Participants With Hepatitis E Virus Immunoglobulin M (IgM) Seroconversion Day 187	0 percentage of participants Interval 0.0 to 19.0	0 percentage of participants Interval 0.0 to 71.0
Percentage of Participants With Hepatitis E Virus Immunoglobulin M (IgM) Seroconversion Day 194	0 percentage of participants Interval 0.0 to 19.0	0 percentage of participants Interval 0.0 to 71.0
Percentage of Participants With Hepatitis E Virus Immunoglobulin M (IgM) Seroconversion Day 208	0 percentage of participants Interval 0.0 to 18.0	0 percentage of participants Interval 0.0 to 71.0
Percentage of Participants With Hepatitis E Virus Immunoglobulin M (IgM) Seroconversion Day 360	0 percentage of participants Interval 0.0 to 20.0	0 percentage of participants Interval 0.0 to 71.0

SECONDARY outcome

Timeframe: Day 8, Day 15, Day 29 (Dose 2), Day 36, Day 43, Day 57, Day 180 (Dose 3), Day 187, Day 194, Day 208, Day 360

Population: The modified intent-to-treat (mITT) population includes all participants who received at least one study vaccination and contributed both pre- and at least one post-study vaccination blood sample for immunogenicity testing for which valid results were reported at the corresponding time point.

Blood was collected for the IgG assay conducted with HEV as the antigen. Each sample was tested in duplicate per the laboratory's standard operating procedure and retested in duplicate if a result was borderline (A / C.O. = 0.9-1.1). If any replicate was seropositive (A/C.O. >1.1 as defined by the Wantai HEV-IgG ELISA package insert) the sample's result was positive. If no replicates were positive the sample's result was negative. Seroconversion was defined as a change from a seronegative result to a seropositive result.

Outcome measures

Measure	HEV-239 n=20 Participants 0.5 mL of HEV-239 administered intramuscularly into the deltoid muscle as a single injection on Days 1, 29, and 180.	Placebo n=5 Participants 0.5 mL of HEV-239 placebo administered intramuscularly into the deltoid muscle as a single injection on Days 1, 29, and 180.
Percentage of Participants With Hepatitis E Virus IgG Seroconversion Day 8	0 percentage of participants Interval 0.0 to 17.0	0 percentage of participants Interval 0.0 to 52.0
Percentage of Participants With Hepatitis E Virus IgG Seroconversion Day 15	60 percentage of participants Interval 36.0 to 81.0	0 percentage of participants Interval 0.0 to 52.0
Percentage of Participants With Hepatitis E Virus IgG Seroconversion Day 29 (Dose 2)	100 percentage of participants Interval 83.0 to 100.0	0 percentage of participants Interval 0.0 to 52.0
Percentage of Participants With Hepatitis E Virus IgG Seroconversion Day 36	100 percentage of participants Interval 83.0 to 100.0	0 percentage of participants Interval 0.0 to 71.0
Percentage of Participants With Hepatitis E Virus IgG Seroconversion Day 43	100 percentage of participants Interval 82.0 to 100.0	0 percentage of participants Interval 0.0 to 71.0
Percentage of Participants With Hepatitis E Virus IgG Seroconversion Day 57	100 percentage of participants Interval 83.0 to 100.0	0 percentage of participants Interval 0.0 to 52.0
Percentage of Participants With Hepatitis E Virus IgG Seroconversion Day 180 (Dose 3)	100 percentage of participants Interval 82.0 to 100.0	0 percentage of participants Interval 0.0 to 52.0
Percentage of Participants With Hepatitis E Virus IgG Seroconversion Day 187	100 percentage of participants Interval 81.0 to 100.0	0 percentage of participants Interval 0.0 to 71.0
Percentage of Participants With Hepatitis E Virus IgG Seroconversion Day 194	100 percentage of participants Interval 81.0 to 100.0	0 percentage of participants Interval 0.0 to 71.0
Percentage of Participants With Hepatitis E Virus IgG Seroconversion Day 208	100 percentage of participants Interval 82.0 to 100.0	0 percentage of participants Interval 0.0 to 71.0
Percentage of Participants With Hepatitis E Virus IgG Seroconversion Day 360	100 percentage of participants Interval 80.0 to 100.0	0 percentage of participants Interval 0.0 to 71.0

SECONDARY outcome

Timeframe: Day 1 (Dose 1), Day 8, Day 15, Day 29 (Dose 2), Day 36, Day 43, Day 57, Day 180 (Dose 3), Day 187, Day 194, Day 208, Day 360

Population: The modified intent-to-treat (mITT) population includes all participants who received at least one study vaccination and contributed both pre- and at least one post-study vaccination blood sample for immunogenicity testing for which valid results were reported at the corresponding time point.

Blood was collected for IgG assay which was conducted with HEV as the antigen. Each sample was tested at least twice per the laboratory's standard operating procedure, and the geometric mean of the replicate results was calculated as that sample's result. The geometric mean concentration (Wu/mL) was calculated for each study arm from the available results at each timepoint.

Outcome measures

Measure	HEV-239 n=20 Participants 0.5 mL of HEV-239 administered intramuscularly into the deltoid muscle as a single injection on Days 1, 29, and 180.	Placebo n=5 Participants 0.5 mL of HEV-239 placebo administered intramuscularly into the deltoid muscle as a single injection on Days 1, 29, and 180.
Geometric Mean Concentrations (GMC) of Hepatitis E Virus IgG Day 360	2.92278 Wu/mL Interval 0.6188 to 11.0412	0.05396 Wu/mL Interval 0.0385 to 0.106
Geometric Mean Concentrations (GMC) of Hepatitis E Virus IgG Day 1 (Dose 1)	0.0385 Wu/mL Interval 0.0385 to 0.0385	0.0385 Wu/mL Interval 0.0385 to 0.0385
Geometric Mean Concentrations (GMC) of Hepatitis E Virus IgG Day 8	0.0385 Wu/mL Interval 0.0385 to 0.0385	0.0385 Wu/mL Interval 0.0385 to 0.0385
Geometric Mean Concentrations (GMC) of Hepatitis E Virus IgG Day 15	0.24999 Wu/mL Interval 0.0385 to 1.4405	0.0385 Wu/mL Interval 0.0385 to 0.0385
Geometric Mean Concentrations (GMC) of Hepatitis E Virus IgG Day 29 (Dose 2)	1.44483 Wu/mL Interval 0.2175 to 8.9019	0.0385 Wu/mL Interval 0.0385 to 0.0385
Geometric Mean Concentrations (GMC) of Hepatitis E Virus IgG Day 36	3.3466 Wu/mL Interval 0.9397 to 13.1263	0.0385 Wu/mL Interval 0.0385 to 0.0385
Geometric Mean Concentrations (GMC) of Hepatitis E Virus IgG Day 43	5.8947 Wu/mL Interval 1.2107 to 20.2568	0.0385 Wu/mL Interval 0.0385 to 0.0385
Geometric Mean Concentrations (GMC) of Hepatitis E Virus IgG Day 57	6.15722 Wu/mL Interval 1.6774 to 18.7678	0.0385 Wu/mL Interval 0.0385 to 0.0385
Geometric Mean Concentrations (GMC) of Hepatitis E Virus IgG Day 180 (Dose 3)	3.79298 Wu/mL Interval 1.0944 to 13.2313	0.0385 Wu/mL Interval 0.0385 to 0.0385
Geometric Mean Concentrations (GMC) of Hepatitis E Virus IgG Day 187	5.52867 Wu/mL Interval 1.8484 to 23.2002	0.0385 Wu/mL Interval 0.0385 to 0.0385
Geometric Mean Concentrations (GMC) of Hepatitis E Virus IgG Day 194	9.62189 Wu/mL Interval 2.7346 to 47.4511	0.0385 Wu/mL Interval 0.0385 to 0.0385
Geometric Mean Concentrations (GMC) of Hepatitis E Virus IgG Day 208	11.50262 Wu/mL Interval 2.7182 to 33.0241	0.0385 Wu/mL Interval 0.0385 to 0.0385

Adverse Events

HEV-239

Serious events: 0 serious events

Other events: 19 other events

Deaths: 0 deaths

Placebo

Serious events: 1 serious events

Other events: 5 other events

Deaths: 0 deaths

Serious adverse events

Measure	HEV-239 n=20 participants at risk 0.5 mL of HEV-239 administered intramuscularly into the deltoid muscle as a single injection on Days 1, 29, and 180.	Placebo n=5 participants at risk 0.5 mL of HEV-239 placebo administered intramuscularly into the deltoid muscle as a single injection on Days 1, 29, and 180.
Reproductive system and breast disorders Dysmenorrhoea	0.00% 0/20 • Solicited injection site and systemic reactogenicity events were reported from the time of each study vaccination through Day 8 after each study vaccination. Unsolicited non-serious AEs were documented and reported at all visits from signing of the ICF until Day 57, then from Day 180 through Day 208. Serious Adverse Events (SAEs) were collected from the time of the first study vaccination through the last study visit on Day 360.	20.0% 1/5 • Number of events 1 • Solicited injection site and systemic reactogenicity events were reported from the time of each study vaccination through Day 8 after each study vaccination. Unsolicited non-serious AEs were documented and reported at all visits from signing of the ICF until Day 57, then from Day 180 through Day 208. Serious Adverse Events (SAEs) were collected from the time of the first study vaccination through the last study visit on Day 360.

Other adverse events

Measure	HEV-239 n=20 participants at risk 0.5 mL of HEV-239 administered intramuscularly into the deltoid muscle as a single injection on Days 1, 29, and 180.	Placebo n=5 participants at risk 0.5 mL of HEV-239 placebo administered intramuscularly into the deltoid muscle as a single injection on Days 1, 29, and 180.
Gastrointestinal disorders Gastrooesophageal Reflux Disease	5.0% 1/20 • Number of events 1 • Solicited injection site and systemic reactogenicity events were reported from the time of each study vaccination through Day 8 after each study vaccination. Unsolicited non-serious AEs were documented and reported at all visits from signing of the ICF until Day 57, then from Day 180 through Day 208. Serious Adverse Events (SAEs) were collected from the time of the first study vaccination through the last study visit on Day 360.	0.00% 0/5 • Solicited injection site and systemic reactogenicity events were reported from the time of each study vaccination through Day 8 after each study vaccination. Unsolicited non-serious AEs were documented and reported at all visits from signing of the ICF until Day 57, then from Day 180 through Day 208. Serious Adverse Events (SAEs) were collected from the time of the first study vaccination through the last study visit on Day 360.
Gastrointestinal disorders Nausea	25.0% 5/20 • Number of events 8 • Solicited injection site and systemic reactogenicity events were reported from the time of each study vaccination through Day 8 after each study vaccination. Unsolicited non-serious AEs were documented and reported at all visits from signing of the ICF until Day 57, then from Day 180 through Day 208. Serious Adverse Events (SAEs) were collected from the time of the first study vaccination through the last study visit on Day 360.	0.00% 0/5 • Solicited injection site and systemic reactogenicity events were reported from the time of each study vaccination through Day 8 after each study vaccination. Unsolicited non-serious AEs were documented and reported at all visits from signing of the ICF until Day 57, then from Day 180 through Day 208. Serious Adverse Events (SAEs) were collected from the time of the first study vaccination through the last study visit on Day 360.
Gastrointestinal disorders Vomiting	5.0% 1/20 • Number of events 1 • Solicited injection site and systemic reactogenicity events were reported from the time of each study vaccination through Day 8 after each study vaccination. Unsolicited non-serious AEs were documented and reported at all visits from signing of the ICF until Day 57, then from Day 180 through Day 208. Serious Adverse Events (SAEs) were collected from the time of the first study vaccination through the last study visit on Day 360.	20.0% 1/5 • Number of events 1 • Solicited injection site and systemic reactogenicity events were reported from the time of each study vaccination through Day 8 after each study vaccination. Unsolicited non-serious AEs were documented and reported at all visits from signing of the ICF until Day 57, then from Day 180 through Day 208. Serious Adverse Events (SAEs) were collected from the time of the first study vaccination through the last study visit on Day 360.
General disorders Fatigue	35.0% 7/20 • Number of events 12 • Solicited injection site and systemic reactogenicity events were reported from the time of each study vaccination through Day 8 after each study vaccination. Unsolicited non-serious AEs were documented and reported at all visits from signing of the ICF until Day 57, then from Day 180 through Day 208. Serious Adverse Events (SAEs) were collected from the time of the first study vaccination through the last study visit on Day 360.	20.0% 1/5 • Number of events 2 • Solicited injection site and systemic reactogenicity events were reported from the time of each study vaccination through Day 8 after each study vaccination. Unsolicited non-serious AEs were documented and reported at all visits from signing of the ICF until Day 57, then from Day 180 through Day 208. Serious Adverse Events (SAEs) were collected from the time of the first study vaccination through the last study visit on Day 360.
General disorders Injection Site Haemorrhage	10.0% 2/20 • Number of events 3 • Solicited injection site and systemic reactogenicity events were reported from the time of each study vaccination through Day 8 after each study vaccination. Unsolicited non-serious AEs were documented and reported at all visits from signing of the ICF until Day 57, then from Day 180 through Day 208. Serious Adverse Events (SAEs) were collected from the time of the first study vaccination through the last study visit on Day 360.	20.0% 1/5 • Number of events 1 • Solicited injection site and systemic reactogenicity events were reported from the time of each study vaccination through Day 8 after each study vaccination. Unsolicited non-serious AEs were documented and reported at all visits from signing of the ICF until Day 57, then from Day 180 through Day 208. Serious Adverse Events (SAEs) were collected from the time of the first study vaccination through the last study visit on Day 360.
General disorders Injection Site Induration	50.0% 10/20 • Number of events 15 • Solicited injection site and systemic reactogenicity events were reported from the time of each study vaccination through Day 8 after each study vaccination. Unsolicited non-serious AEs were documented and reported at all visits from signing of the ICF until Day 57, then from Day 180 through Day 208. Serious Adverse Events (SAEs) were collected from the time of the first study vaccination through the last study visit on Day 360.	20.0% 1/5 • Number of events 1 • Solicited injection site and systemic reactogenicity events were reported from the time of each study vaccination through Day 8 after each study vaccination. Unsolicited non-serious AEs were documented and reported at all visits from signing of the ICF until Day 57, then from Day 180 through Day 208. Serious Adverse Events (SAEs) were collected from the time of the first study vaccination through the last study visit on Day 360.
General disorders Injection Site Pain	85.0% 17/20 • Number of events 40 • Solicited injection site and systemic reactogenicity events were reported from the time of each study vaccination through Day 8 after each study vaccination. Unsolicited non-serious AEs were documented and reported at all visits from signing of the ICF until Day 57, then from Day 180 through Day 208. Serious Adverse Events (SAEs) were collected from the time of the first study vaccination through the last study visit on Day 360.	60.0% 3/5 • Number of events 4 • Solicited injection site and systemic reactogenicity events were reported from the time of each study vaccination through Day 8 after each study vaccination. Unsolicited non-serious AEs were documented and reported at all visits from signing of the ICF until Day 57, then from Day 180 through Day 208. Serious Adverse Events (SAEs) were collected from the time of the first study vaccination through the last study visit on Day 360.
General disorders Injection Site Pruritus	5.0% 1/20 • Number of events 1 • Solicited injection site and systemic reactogenicity events were reported from the time of each study vaccination through Day 8 after each study vaccination. Unsolicited non-serious AEs were documented and reported at all visits from signing of the ICF until Day 57, then from Day 180 through Day 208. Serious Adverse Events (SAEs) were collected from the time of the first study vaccination through the last study visit on Day 360.	0.00% 0/5 • Solicited injection site and systemic reactogenicity events were reported from the time of each study vaccination through Day 8 after each study vaccination. Unsolicited non-serious AEs were documented and reported at all visits from signing of the ICF until Day 57, then from Day 180 through Day 208. Serious Adverse Events (SAEs) were collected from the time of the first study vaccination through the last study visit on Day 360.
General disorders Malaise	25.0% 5/20 • Number of events 7 • Solicited injection site and systemic reactogenicity events were reported from the time of each study vaccination through Day 8 after each study vaccination. Unsolicited non-serious AEs were documented and reported at all visits from signing of the ICF until Day 57, then from Day 180 through Day 208. Serious Adverse Events (SAEs) were collected from the time of the first study vaccination through the last study visit on Day 360.	0.00% 0/5 • Solicited injection site and systemic reactogenicity events were reported from the time of each study vaccination through Day 8 after each study vaccination. Unsolicited non-serious AEs were documented and reported at all visits from signing of the ICF until Day 57, then from Day 180 through Day 208. Serious Adverse Events (SAEs) were collected from the time of the first study vaccination through the last study visit on Day 360.
General disorders Pyrexia	10.0% 2/20 • Number of events 2 • Solicited injection site and systemic reactogenicity events were reported from the time of each study vaccination through Day 8 after each study vaccination. Unsolicited non-serious AEs were documented and reported at all visits from signing of the ICF until Day 57, then from Day 180 through Day 208. Serious Adverse Events (SAEs) were collected from the time of the first study vaccination through the last study visit on Day 360.	0.00% 0/5 • Solicited injection site and systemic reactogenicity events were reported from the time of each study vaccination through Day 8 after each study vaccination. Unsolicited non-serious AEs were documented and reported at all visits from signing of the ICF until Day 57, then from Day 180 through Day 208. Serious Adverse Events (SAEs) were collected from the time of the first study vaccination through the last study visit on Day 360.
Infections and infestations Nasopharyngitis	20.0% 4/20 • Number of events 4 • Solicited injection site and systemic reactogenicity events were reported from the time of each study vaccination through Day 8 after each study vaccination. Unsolicited non-serious AEs were documented and reported at all visits from signing of the ICF until Day 57, then from Day 180 through Day 208. Serious Adverse Events (SAEs) were collected from the time of the first study vaccination through the last study visit on Day 360.	0.00% 0/5 • Solicited injection site and systemic reactogenicity events were reported from the time of each study vaccination through Day 8 after each study vaccination. Unsolicited non-serious AEs were documented and reported at all visits from signing of the ICF until Day 57, then from Day 180 through Day 208. Serious Adverse Events (SAEs) were collected from the time of the first study vaccination through the last study visit on Day 360.
Injury, poisoning and procedural complications Skin Abrasion	5.0% 1/20 • Number of events 1 • Solicited injection site and systemic reactogenicity events were reported from the time of each study vaccination through Day 8 after each study vaccination. Unsolicited non-serious AEs were documented and reported at all visits from signing of the ICF until Day 57, then from Day 180 through Day 208. Serious Adverse Events (SAEs) were collected from the time of the first study vaccination through the last study visit on Day 360.	0.00% 0/5 • Solicited injection site and systemic reactogenicity events were reported from the time of each study vaccination through Day 8 after each study vaccination. Unsolicited non-serious AEs were documented and reported at all visits from signing of the ICF until Day 57, then from Day 180 through Day 208. Serious Adverse Events (SAEs) were collected from the time of the first study vaccination through the last study visit on Day 360.
Injury, poisoning and procedural complications Sunburn	5.0% 1/20 • Number of events 1 • Solicited injection site and systemic reactogenicity events were reported from the time of each study vaccination through Day 8 after each study vaccination. Unsolicited non-serious AEs were documented and reported at all visits from signing of the ICF until Day 57, then from Day 180 through Day 208. Serious Adverse Events (SAEs) were collected from the time of the first study vaccination through the last study visit on Day 360.	0.00% 0/5 • Solicited injection site and systemic reactogenicity events were reported from the time of each study vaccination through Day 8 after each study vaccination. Unsolicited non-serious AEs were documented and reported at all visits from signing of the ICF until Day 57, then from Day 180 through Day 208. Serious Adverse Events (SAEs) were collected from the time of the first study vaccination through the last study visit on Day 360.
Injury, poisoning and procedural complications Thermal Burn	5.0% 1/20 • Number of events 1 • Solicited injection site and systemic reactogenicity events were reported from the time of each study vaccination through Day 8 after each study vaccination. Unsolicited non-serious AEs were documented and reported at all visits from signing of the ICF until Day 57, then from Day 180 through Day 208. Serious Adverse Events (SAEs) were collected from the time of the first study vaccination through the last study visit on Day 360.	0.00% 0/5 • Solicited injection site and systemic reactogenicity events were reported from the time of each study vaccination through Day 8 after each study vaccination. Unsolicited non-serious AEs were documented and reported at all visits from signing of the ICF until Day 57, then from Day 180 through Day 208. Serious Adverse Events (SAEs) were collected from the time of the first study vaccination through the last study visit on Day 360.
Investigations Blood Creatinine Increased	5.0% 1/20 • Number of events 1 • Solicited injection site and systemic reactogenicity events were reported from the time of each study vaccination through Day 8 after each study vaccination. Unsolicited non-serious AEs were documented and reported at all visits from signing of the ICF until Day 57, then from Day 180 through Day 208. Serious Adverse Events (SAEs) were collected from the time of the first study vaccination through the last study visit on Day 360.	0.00% 0/5 • Solicited injection site and systemic reactogenicity events were reported from the time of each study vaccination through Day 8 after each study vaccination. Unsolicited non-serious AEs were documented and reported at all visits from signing of the ICF until Day 57, then from Day 180 through Day 208. Serious Adverse Events (SAEs) were collected from the time of the first study vaccination through the last study visit on Day 360.
Investigations Haemoglobin Decreased	10.0% 2/20 • Number of events 6 • Solicited injection site and systemic reactogenicity events were reported from the time of each study vaccination through Day 8 after each study vaccination. Unsolicited non-serious AEs were documented and reported at all visits from signing of the ICF until Day 57, then from Day 180 through Day 208. Serious Adverse Events (SAEs) were collected from the time of the first study vaccination through the last study visit on Day 360.	0.00% 0/5 • Solicited injection site and systemic reactogenicity events were reported from the time of each study vaccination through Day 8 after each study vaccination. Unsolicited non-serious AEs were documented and reported at all visits from signing of the ICF until Day 57, then from Day 180 through Day 208. Serious Adverse Events (SAEs) were collected from the time of the first study vaccination through the last study visit on Day 360.
Investigations Heart Rate Increased	5.0% 1/20 • Number of events 1 • Solicited injection site and systemic reactogenicity events were reported from the time of each study vaccination through Day 8 after each study vaccination. Unsolicited non-serious AEs were documented and reported at all visits from signing of the ICF until Day 57, then from Day 180 through Day 208. Serious Adverse Events (SAEs) were collected from the time of the first study vaccination through the last study visit on Day 360.	0.00% 0/5 • Solicited injection site and systemic reactogenicity events were reported from the time of each study vaccination through Day 8 after each study vaccination. Unsolicited non-serious AEs were documented and reported at all visits from signing of the ICF until Day 57, then from Day 180 through Day 208. Serious Adverse Events (SAEs) were collected from the time of the first study vaccination through the last study visit on Day 360.
Musculoskeletal and connective tissue disorders Arthralgia	10.0% 2/20 • Number of events 2 • Solicited injection site and systemic reactogenicity events were reported from the time of each study vaccination through Day 8 after each study vaccination. Unsolicited non-serious AEs were documented and reported at all visits from signing of the ICF until Day 57, then from Day 180 through Day 208. Serious Adverse Events (SAEs) were collected from the time of the first study vaccination through the last study visit on Day 360.	20.0% 1/5 • Number of events 1 • Solicited injection site and systemic reactogenicity events were reported from the time of each study vaccination through Day 8 after each study vaccination. Unsolicited non-serious AEs were documented and reported at all visits from signing of the ICF until Day 57, then from Day 180 through Day 208. Serious Adverse Events (SAEs) were collected from the time of the first study vaccination through the last study visit on Day 360.
Musculoskeletal and connective tissue disorders Myalgia	30.0% 6/20 • Number of events 10 • Solicited injection site and systemic reactogenicity events were reported from the time of each study vaccination through Day 8 after each study vaccination. Unsolicited non-serious AEs were documented and reported at all visits from signing of the ICF until Day 57, then from Day 180 through Day 208. Serious Adverse Events (SAEs) were collected from the time of the first study vaccination through the last study visit on Day 360.	40.0% 2/5 • Number of events 2 • Solicited injection site and systemic reactogenicity events were reported from the time of each study vaccination through Day 8 after each study vaccination. Unsolicited non-serious AEs were documented and reported at all visits from signing of the ICF until Day 57, then from Day 180 through Day 208. Serious Adverse Events (SAEs) were collected from the time of the first study vaccination through the last study visit on Day 360.
Nervous system disorders Dizziness	10.0% 2/20 • Number of events 2 • Solicited injection site and systemic reactogenicity events were reported from the time of each study vaccination through Day 8 after each study vaccination. Unsolicited non-serious AEs were documented and reported at all visits from signing of the ICF until Day 57, then from Day 180 through Day 208. Serious Adverse Events (SAEs) were collected from the time of the first study vaccination through the last study visit on Day 360.	0.00% 0/5 • Solicited injection site and systemic reactogenicity events were reported from the time of each study vaccination through Day 8 after each study vaccination. Unsolicited non-serious AEs were documented and reported at all visits from signing of the ICF until Day 57, then from Day 180 through Day 208. Serious Adverse Events (SAEs) were collected from the time of the first study vaccination through the last study visit on Day 360.
Nervous system disorders Headache	55.0% 11/20 • Number of events 18 • Solicited injection site and systemic reactogenicity events were reported from the time of each study vaccination through Day 8 after each study vaccination. Unsolicited non-serious AEs were documented and reported at all visits from signing of the ICF until Day 57, then from Day 180 through Day 208. Serious Adverse Events (SAEs) were collected from the time of the first study vaccination through the last study visit on Day 360.	60.0% 3/5 • Number of events 3 • Solicited injection site and systemic reactogenicity events were reported from the time of each study vaccination through Day 8 after each study vaccination. Unsolicited non-serious AEs were documented and reported at all visits from signing of the ICF until Day 57, then from Day 180 through Day 208. Serious Adverse Events (SAEs) were collected from the time of the first study vaccination through the last study visit on Day 360.
Psychiatric disorders Anxiety	5.0% 1/20 • Number of events 1 • Solicited injection site and systemic reactogenicity events were reported from the time of each study vaccination through Day 8 after each study vaccination. Unsolicited non-serious AEs were documented and reported at all visits from signing of the ICF until Day 57, then from Day 180 through Day 208. Serious Adverse Events (SAEs) were collected from the time of the first study vaccination through the last study visit on Day 360.	0.00% 0/5 • Solicited injection site and systemic reactogenicity events were reported from the time of each study vaccination through Day 8 after each study vaccination. Unsolicited non-serious AEs were documented and reported at all visits from signing of the ICF until Day 57, then from Day 180 through Day 208. Serious Adverse Events (SAEs) were collected from the time of the first study vaccination through the last study visit on Day 360.
Psychiatric disorders Initial Insomnia	5.0% 1/20 • Number of events 1 • Solicited injection site and systemic reactogenicity events were reported from the time of each study vaccination through Day 8 after each study vaccination. Unsolicited non-serious AEs were documented and reported at all visits from signing of the ICF until Day 57, then from Day 180 through Day 208. Serious Adverse Events (SAEs) were collected from the time of the first study vaccination through the last study visit on Day 360.	0.00% 0/5 • Solicited injection site and systemic reactogenicity events were reported from the time of each study vaccination through Day 8 after each study vaccination. Unsolicited non-serious AEs were documented and reported at all visits from signing of the ICF until Day 57, then from Day 180 through Day 208. Serious Adverse Events (SAEs) were collected from the time of the first study vaccination through the last study visit on Day 360.
Respiratory, thoracic and mediastinal disorders Oropharyngeal Pain	5.0% 1/20 • Number of events 1 • Solicited injection site and systemic reactogenicity events were reported from the time of each study vaccination through Day 8 after each study vaccination. Unsolicited non-serious AEs were documented and reported at all visits from signing of the ICF until Day 57, then from Day 180 through Day 208. Serious Adverse Events (SAEs) were collected from the time of the first study vaccination through the last study visit on Day 360.	0.00% 0/5 • Solicited injection site and systemic reactogenicity events were reported from the time of each study vaccination through Day 8 after each study vaccination. Unsolicited non-serious AEs were documented and reported at all visits from signing of the ICF until Day 57, then from Day 180 through Day 208. Serious Adverse Events (SAEs) were collected from the time of the first study vaccination through the last study visit on Day 360.
Respiratory, thoracic and mediastinal disorders Rhinorrhoea	5.0% 1/20 • Number of events 1 • Solicited injection site and systemic reactogenicity events were reported from the time of each study vaccination through Day 8 after each study vaccination. Unsolicited non-serious AEs were documented and reported at all visits from signing of the ICF until Day 57, then from Day 180 through Day 208. Serious Adverse Events (SAEs) were collected from the time of the first study vaccination through the last study visit on Day 360.	0.00% 0/5 • Solicited injection site and systemic reactogenicity events were reported from the time of each study vaccination through Day 8 after each study vaccination. Unsolicited non-serious AEs were documented and reported at all visits from signing of the ICF until Day 57, then from Day 180 through Day 208. Serious Adverse Events (SAEs) were collected from the time of the first study vaccination through the last study visit on Day 360.
Skin and subcutaneous tissue disorders Rosacea	5.0% 1/20 • Number of events 1 • Solicited injection site and systemic reactogenicity events were reported from the time of each study vaccination through Day 8 after each study vaccination. Unsolicited non-serious AEs were documented and reported at all visits from signing of the ICF until Day 57, then from Day 180 through Day 208. Serious Adverse Events (SAEs) were collected from the time of the first study vaccination through the last study visit on Day 360.	0.00% 0/5 • Solicited injection site and systemic reactogenicity events were reported from the time of each study vaccination through Day 8 after each study vaccination. Unsolicited non-serious AEs were documented and reported at all visits from signing of the ICF until Day 57, then from Day 180 through Day 208. Serious Adverse Events (SAEs) were collected from the time of the first study vaccination through the last study visit on Day 360.

Additional Information

Evan J. Anderson, MD

Emory University

Phone: 404-727-1746

Email: evanderson@emory.edu

Results disclosure agreements

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

Restriction type: LTE60