Dose Escalating Study of Intramuscular Invaplex[AR-DETOX]

A Phase 1 Double-blind, Placebo-controlled, Dose Escalating Study of Intramuscular Detoxified Shigella Flexneri 2a Artificial Invasin Complex (Invaplex[AR-DETOX]) Vaccine

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT03869333

Enrollment

Registered

2019-03-11

Start date

2019-03-18

Completion date

2020-06-12

Last updated

2021-07-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Diarrhea

Keywords

Shigella flexneri 2a, Enteric, Shigella

Brief summary

The main purpose of this study is to evaluate the safety of a Shigella flexneri 2a detoxified artificial invasin complex (Invaplex\[AR-Detox\]) vaccine candidate administered by intramuscular immunization.

Detailed description

This is a randomized, double-blind, placebo-controlled, Phase 1 clinical trial in which a total of 60 volunteers will receive one of three doses of Invaplex\[AR-DETOX\] or placebo (saline). The vaccine will be administered via intramuscular (IM) injection on study days 1, 22, and 43. Each participant will receive the same formulation at each vaccination dependent upon group assignment. The study will be initiated with the lowest dose level (2.5 μg) and will proceed to the next highest dose in an escalating fashion. All safety data will be summarized and reviewed by the Protocol Safety Review Team (PSRT) prior to dose-escalation. Specimens will be collected at prescribed intervals to examine systemic and mucosal immune responses. Vaccine safety will be actively monitored during vaccination and for 28 days following the third vaccine dose.

Interventions

BIOLOGICALInvaplex[AR-DETOX]

Detoxified Shigella flexneri 2a Artificial Invasin Complex (Invaplex\[AR-Detox\]) Vaccine

OTHERPlacebo

Saline

Study design

Allocation

RANDOMIZED

Intervention model

SEQUENTIAL

Primary purpose

PREVENTION

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to 50 Years

Healthy volunteers

Yes

Inclusion criteria

* Healthy, adult, male or female, age 18 to 50 years (inclusive) at the time of enrollment. * Completion and review of comprehension test (achieved ≥ 70% accuracy, two attempts allowed). * Provide written informed consent before initiation of any study procedures. * Agrees to complete all study visits and procedures and to provide a screening stool sample. * Women of childbearing capacity: Negative pregnancy test with understanding (through informed consent process) to not become pregnant during the study or within three (3) months following the last vaccine dose.

Exclusion criteria

* Health problems (for example, chronic medical conditions such as psychiatric conditions, diabetes mellitus, hypertension, or any other conditions that might place the subjects at increased risk of adverse events) - study clinicians, in consultation with the Principal Investigator (PI), will use clinical judgment on a case-by-case basis to assess safety risks under this criterion. The PI will consult with the Research Monitor as appropriate. * History of autoimmune disorders, cardiovascular and renal disease. * Use of immunosuppressive medications (systemic corticosteroids or chemotherapeutics that may influence antibody development), or immunosuppressive illness, including immunoglobulin A (IgA) deficiency (defined by serum IgA \< 7 mg/dL). * Women who are pregnant or planning to become pregnant during the study period plus 3 months beyond the last vaccine dose and currently nursing women. * Participation in research involving another investigational product (defined as receipt of an investigational product or exposure to an invasive investigational device) 30 days before planned date of first vaccination or anytime throughout the duration of the study until the last in-clinic study safety visit. * Positive blood test for hepatitis B surface antigen (HBsAG), hepatitis C virus antibody (HCV Ab), human immunodeficiency virus (HIV)-1/HIV-2 antibody. * Clinically significant abnormalities on basic laboratory screening tests. * Systemic antimicrobial treatment (i.e., topical treatments are not an exclusion) within 1 week before administration of the first vaccine dose. * Allergies that may increase the risk of adverse events (AEs). * Regular use (weekly or more often) of antidiarrheal, anti-constipation, or antacid therapy. * Abnormal stool pattern (fewer than 3 stools per week or more than 3 stools per day) on a regular basis; loose or liquid stools on other than an occasional basis. * Personal or family history of an inflammatory arthritis. * Positive blood test for human leukocyte antigen (HLA) B27 (associated with increased risk of reactive arthritis secondary to Shigella infection) * History of allergy to any vaccine. * Exclusionary skin disease history/findings that would confound assessment or prevent appropriate local monitoring of AEs, or possibly increase the risk of a local AE. * Serum immunoglobulin G (IgG) titer \> 2500 to Shigella flexneri 2a lipopolysaccharide antigen (LPS). * History of microbiologically confirmed Shigella infection. * Received previous licensed or experimental Shigella vaccine or live Shigella challenge. * Travel to countries where Shigella or other enteric infections are endemic (most of the developing world) within two years prior to dosing (clinician judgement). * Occupation involving handling of Shigella bacteria currently, or in the past 3 years.

Design outcomes

Primary

Measure	Time frame	Description
Percentage of Participants With Adverse Events	From first dose up to 28 days following the third immunization (71 days)	All adverse events (AEs) were assessed for severity by the investigator according to the following scale: Grade 1 (Mild): Does not interfere with routine activities, minimal level of discomfort; Grade 2 (Moderate): Interferes with routine activities, moderate level of discomfort; Grade 3 (Severe): Unable to perform routine activities, significant level of discomfort; Grade 4 (Potentially life-threatening): Hospitalization or ER visit for potentially life-threatening event. An AE was considered serious if it resulted in any of the following outcomes: * Death * Life-threatening AE * Inpatient hospitalization or prolongation of existing hospitalization * Persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions * Congenital anomaly/birth defect. The Investigator assessed the relationship of each adverse event to study drug.
Number of Participants With Solicited Adverse Events Up to 7 Days After Dose 1	7 days after the first immunization (Days 1 to 7)	The solicited AEs for this study included: * Site pain * Site tenderness * Swelling * Induration (determined by investigator exam) * Site redness * Pruritus * Fever * Nausea * Vomiting * Abdominal pain * Diarrhea (loose stools) * Appetite change * Fatigue * Headache * Myalgias (general pain or soreness in muscles) * Arthralgias (general pain in joints) * Malaise
Number of Participants With Solicited Adverse Events Up to 7 Days After Dose 2	7 days after the second immunization (Days 22 to 28)	The solicited AEs for this study included: * Site pain * Site tenderness * Swelling * Induration (determined by investigator exam) * Site redness * Pruritus * Fever * Nausea * Vomiting * Abdominal pain * Diarrhea (loose stools) * Appetite change * Fatigue * Headache * Myalgias (general pain or soreness in muscles) * Arthralgias (general pain in joints) * Malaise
Number of Participants With Solicited Adverse Events After Dose 3	7 days after the third immunization (Days 43 to 49)	The solicited AEs for this study included: * Site pain * Site tenderness * Swelling * Induration (determined by investigator exam) * Site redness * Pruritus * Fever * Nausea * Vomiting * Abdominal pain * Diarrhea (loose stools) * Appetite change * Fatigue * Headache * Myalgias (general pain or soreness in muscles) * Arthralgias (general pain in joints) * Malaise
Number of Participants With Unsolicited Adverse Events After Each Dose	Dose 1: Days 1 to 21; Dose 2: Days 22 to 42; Dose 3: Days 43 to 71	—

Secondary

Measure	Time frame	Description
Percentage of Participants With a ≥ 4-fold Increase in Serum IgG Antibodies From Baseline	Days 1 (Baseline), 22 43, 50, 57 and 71	Seroconversion was defined as ≥ 4-fold increase in antibody titer from Baseline.
Percentage of Participants With a ≥ 4-fold Increase in ALS IgA From Baseline	Days 1 (Baseline), 8, 29, and 50	Seroconversion was defined as ≥ 4-fold increase in antibody titer from Baseline.
Percentage of Participants With a ≥ 4-fold Increase in ALS IgG From Baseline	Days 1 (Baseline), 8, 29, and 50	Seroconversion was defined as ≥ 4-fold increase in antibody titer from Baseline.
Geometric Mean Titer (GMT) of Serum Immunoglobulin A (IgA) Antibodies to Invaplex	Days 1 (Baseline), 22, 43, 50, 57 and 71.	—
Geometric Mean Fold-rise in Serum IgG From Baseline	Days 1 (Baseline), 22, 43, 50, 57 and 71.	—
Geometric Mean Fold-rise in ALS IgA From Baseline	Days 1 (Baseline), 8, 29, and 50	—
Geometric Mean Fold-rise in ALS IgG From Baseline	Days 1 (Baseline), 8, 29, and 50	—
Geometric Mean Fold-rise (GMFR) in Serum IgA From Baseline	Days 1 (Baseline), 22, 43, 50, 57 and 71.	—
Geometric Mean Titer (GMT) of Serum Immunoglobulin G (IgG) Antibodies to Invaplex	Days 1 (Baseline), 22, 43, 50, 57 and 71.	—
Geometric Mean Titer (GMT) of Immunoglobulin A Antibodies to Invaplex in α4β7+ Antibody in Lymphocyte Supernatant (ALS)	Days 1 (Baseline), 8, 29, and 50	—
Geometric Mean Titer of Immunoglobulin G Antibodies to Invaplex in α4β7+ Antibody in Lymphocyte Supernatant	Days 1 (Baseline), 8, 29, and 50	—
Percentage of Participants With a ≥ 4-fold Increase in Serum IgA Antibodies From Baseline	Days 1 (Baseline), 22 43, 50, 57 and 71	Seroconversion was defined as ≥ 4-fold increase in antibody titer from Baseline.

Countries

United States

Participant flow

Recruitment details

This study was conducted at the Walter Reed Army Institute of Research (WRAIR) Clinical Trials Center (CTC) in Silver Spring, MD, USA. Healthy adults were recruited from the Baltimore/Washington, DC area.

Pre-assignment details

In this dose-escalation study participants were assigned to receive 3 vaccinations of 1 of 3 doses of detoxified Shigella flexneri 2a artificial invasin complex (Invaplex\[AR-Detox\]) or placebo. The study was initiated with the lowest dose level (2.5 μg) and proceeded to the next highest dose in an escalating fashion after review of safety data by the Protocol Safety Review Team. Within each dose cohort participants were randomly assigned to receive Invaplex\[AR-Detox\] or placebo in a 4: 1 ratio.

Participants by arm

Arm	Count
Invaplex[AR-Detox] 2.5 μg Participants received an intramuscular injection of 2.5 μg Invaplex\[AR-DETOX\] vaccine on Days 1, 22, and 43.	14
Invaplex[AR-Detox] 10 μg Participants received an intramuscular injection of 10 μg Invaplex\[AR-DETOX\] vaccine on Days 1, 22, and 43.	16
Invaplex[AR-Detox] 25 μg Participants received an intramuscular injection of 25 μg Invaplex\[AR-DETOX\] vaccine on Days 1, 22, and 43.	16
Placebo Participants received an intramuscular injection of placebo solution on Days 1, 22, and 43.	12
Total	58

Withdrawals & dropouts

Period	Reason	FG000	FG001
Overall Study	Lost to Follow-up	1	0
Overall Study	Physician Decision	0	1
Overall Study	Pregnancy	1	0

Baseline characteristics

Characteristic	Invaplex[AR-Detox] 2.5 μg	Invaplex[AR-Detox] 10 μg	Invaplex[AR-Detox] 25 μg	Placebo	Total
Age, Continuous	33.5 years STANDARD_DEVIATION 9.4	33.6 years STANDARD_DEVIATION 5.4	33.2 years STANDARD_DEVIATION 7.1	28.9 years STANDARD_DEVIATION 6	32.5 years STANDARD_DEVIATION 7.2
Ethnicity (NIH/OMB) Hispanic or Latino	2 Participants	1 Participants	0 Participants	2 Participants	5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	12 Participants	15 Participants	16 Participants	10 Participants	53 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Race (NIH/OMB) Asian	0 Participants	1 Participants	3 Participants	0 Participants	4 Participants
Race (NIH/OMB) Black or African American	10 Participants	6 Participants	6 Participants	1 Participants	23 Participants
Race (NIH/OMB) More than one race	0 Participants	0 Participants	1 Participants	1 Participants	2 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants	0 Participants	0 Participants	1 Participants	1 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Race (NIH/OMB) White	4 Participants	9 Participants	6 Participants	9 Participants	28 Participants
Sex: Female, Male Female	8 Participants	8 Participants	7 Participants	5 Participants	28 Participants
Sex: Female, Male Male	6 Participants	8 Participants	9 Participants	7 Participants	30 Participants

Adverse events

Event type	EG000 affected / at risk	EG001 affected / at risk	EG002 affected / at risk	EG003 affected / at risk
deaths Total, all-cause mortality	0 / 14	0 / 16	0 / 16	0 / 12
other Total, other adverse events	14 / 14	16 / 16	16 / 16	11 / 12
serious Total, serious adverse events	0 / 14	0 / 16	0 / 16	0 / 12

Outcome results

Primary

Number of Participants With Solicited Adverse Events After Dose 3

The solicited AEs for this study included: * Site pain * Site tenderness * Swelling * Induration (determined by investigator exam) * Site redness * Pruritus * Fever * Nausea * Vomiting * Abdominal pain * Diarrhea (loose stools) * Appetite change * Fatigue * Headache * Myalgias (general pain or soreness in muscles) * Arthralgias (general pain in joints) * Malaise

Time frame: 7 days after the third immunization (Days 43 to 49)

Population: All participants who received the third dose (Invaplex\[AR-Detox\] or placebo).

Arm	Measure	Group	Value (COUNT_OF_PARTICIPANTS)
Invaplex[AR-Detox] 2.5 μg	Number of Participants With Solicited Adverse Events After Dose 3	Nausea	0 Participants
Invaplex[AR-Detox] 2.5 μg	Number of Participants With Solicited Adverse Events After Dose 3	Myalgia	1 Participants
Invaplex[AR-Detox] 2.5 μg	Number of Participants With Solicited Adverse Events After Dose 3	Fatigue	2 Participants
Invaplex[AR-Detox] 2.5 μg	Number of Participants With Solicited Adverse Events After Dose 3	Vaccination site swelling	2 Participants
Invaplex[AR-Detox] 2.5 μg	Number of Participants With Solicited Adverse Events After Dose 3	Malaise	0 Participants
Invaplex[AR-Detox] 2.5 μg	Number of Participants With Solicited Adverse Events After Dose 3	Headache	0 Participants
Invaplex[AR-Detox] 2.5 μg	Number of Participants With Solicited Adverse Events After Dose 3	Vaccination site pain	7 Participants
Invaplex[AR-Detox] 2.5 μg	Number of Participants With Solicited Adverse Events After Dose 3	Any Solicited AE	11 Participants
Invaplex[AR-Detox] 2.5 μg	Number of Participants With Solicited Adverse Events After Dose 3	Appetite disorder	0 Participants
Invaplex[AR-Detox] 2.5 μg	Number of Participants With Solicited Adverse Events After Dose 3	Vaccination site pruritus	0 Participants
Invaplex[AR-Detox] 2.5 μg	Number of Participants With Solicited Adverse Events After Dose 3	Vaccination site induration	1 Participants
Invaplex[AR-Detox] 2.5 μg	Number of Participants With Solicited Adverse Events After Dose 3	Vaccination site erythema	10 Participants
Invaplex[AR-Detox] 2.5 μg	Number of Participants With Solicited Adverse Events After Dose 3	Arthralgia	0 Participants
Invaplex[AR-Detox] 2.5 μg	Number of Participants With Solicited Adverse Events After Dose 3	Abdominal pain	0 Participants
Invaplex[AR-Detox] 10 μg	Number of Participants With Solicited Adverse Events After Dose 3	Vaccination site induration	0 Participants
Invaplex[AR-Detox] 10 μg	Number of Participants With Solicited Adverse Events After Dose 3	Any Solicited AE	15 Participants
Invaplex[AR-Detox] 10 μg	Number of Participants With Solicited Adverse Events After Dose 3	Abdominal pain	2 Participants
Invaplex[AR-Detox] 10 μg	Number of Participants With Solicited Adverse Events After Dose 3	Appetite disorder	1 Participants
Invaplex[AR-Detox] 10 μg	Number of Participants With Solicited Adverse Events After Dose 3	Arthralgia	1 Participants
Invaplex[AR-Detox] 10 μg	Number of Participants With Solicited Adverse Events After Dose 3	Fatigue	4 Participants
Invaplex[AR-Detox] 10 μg	Number of Participants With Solicited Adverse Events After Dose 3	Headache	5 Participants
Invaplex[AR-Detox] 10 μg	Number of Participants With Solicited Adverse Events After Dose 3	Malaise	4 Participants
Invaplex[AR-Detox] 10 μg	Number of Participants With Solicited Adverse Events After Dose 3	Myalgia	2 Participants
Invaplex[AR-Detox] 10 μg	Number of Participants With Solicited Adverse Events After Dose 3	Nausea	1 Participants
Invaplex[AR-Detox] 10 μg	Number of Participants With Solicited Adverse Events After Dose 3	Vaccination site erythema	9 Participants
Invaplex[AR-Detox] 10 μg	Number of Participants With Solicited Adverse Events After Dose 3	Vaccination site pain	11 Participants
Invaplex[AR-Detox] 10 μg	Number of Participants With Solicited Adverse Events After Dose 3	Vaccination site pruritus	2 Participants
Invaplex[AR-Detox] 10 μg	Number of Participants With Solicited Adverse Events After Dose 3	Vaccination site swelling	5 Participants
Invaplex[AR-Detox] 25 μg	Number of Participants With Solicited Adverse Events After Dose 3	Vaccination site induration	2 Participants
Invaplex[AR-Detox] 25 μg	Number of Participants With Solicited Adverse Events After Dose 3	Vaccination site pruritus	2 Participants
Invaplex[AR-Detox] 25 μg	Number of Participants With Solicited Adverse Events After Dose 3	Abdominal pain	1 Participants
Invaplex[AR-Detox] 25 μg	Number of Participants With Solicited Adverse Events After Dose 3	Arthralgia	0 Participants
Invaplex[AR-Detox] 25 μg	Number of Participants With Solicited Adverse Events After Dose 3	Vaccination site pain	12 Participants
Invaplex[AR-Detox] 25 μg	Number of Participants With Solicited Adverse Events After Dose 3	Any Solicited AE	13 Participants
Invaplex[AR-Detox] 25 μg	Number of Participants With Solicited Adverse Events After Dose 3	Vaccination site erythema	7 Participants
Invaplex[AR-Detox] 25 μg	Number of Participants With Solicited Adverse Events After Dose 3	Myalgia	1 Participants
Invaplex[AR-Detox] 25 μg	Number of Participants With Solicited Adverse Events After Dose 3	Headache	2 Participants
Invaplex[AR-Detox] 25 μg	Number of Participants With Solicited Adverse Events After Dose 3	Appetite disorder	0 Participants
Invaplex[AR-Detox] 25 μg	Number of Participants With Solicited Adverse Events After Dose 3	Fatigue	2 Participants
Invaplex[AR-Detox] 25 μg	Number of Participants With Solicited Adverse Events After Dose 3	Vaccination site swelling	1 Participants
Invaplex[AR-Detox] 25 μg	Number of Participants With Solicited Adverse Events After Dose 3	Malaise	1 Participants
Invaplex[AR-Detox] 25 μg	Number of Participants With Solicited Adverse Events After Dose 3	Nausea	0 Participants
Placebo	Number of Participants With Solicited Adverse Events After Dose 3	Malaise	0 Participants
Placebo	Number of Participants With Solicited Adverse Events After Dose 3	Myalgia	1 Participants
Placebo	Number of Participants With Solicited Adverse Events After Dose 3	Vaccination site pruritus	1 Participants
Placebo	Number of Participants With Solicited Adverse Events After Dose 3	Nausea	0 Participants
Placebo	Number of Participants With Solicited Adverse Events After Dose 3	Appetite disorder	0 Participants
Placebo	Number of Participants With Solicited Adverse Events After Dose 3	Vaccination site erythema	2 Participants
Placebo	Number of Participants With Solicited Adverse Events After Dose 3	Abdominal pain	0 Participants
Placebo	Number of Participants With Solicited Adverse Events After Dose 3	Vaccination site induration	0 Participants
Placebo	Number of Participants With Solicited Adverse Events After Dose 3	Vaccination site swelling	0 Participants
Placebo	Number of Participants With Solicited Adverse Events After Dose 3	Vaccination site pain	0 Participants
Placebo	Number of Participants With Solicited Adverse Events After Dose 3	Fatigue	0 Participants
Placebo	Number of Participants With Solicited Adverse Events After Dose 3	Any Solicited AE	5 Participants
Placebo	Number of Participants With Solicited Adverse Events After Dose 3	Headache	1 Participants
Placebo	Number of Participants With Solicited Adverse Events After Dose 3	Arthralgia	1 Participants

Primary

Number of Participants With Solicited Adverse Events Up to 7 Days After Dose 1

Time frame: 7 days after the first immunization (Days 1 to 7)

Population: All participants who received the first dose (Invaplex\[AR-Detox\] or placebo).

Arm	Measure	Group	Value (COUNT_OF_PARTICIPANTS)
Invaplex[AR-Detox] 2.5 μg	Number of Participants With Solicited Adverse Events Up to 7 Days After Dose 1	Diarrhoea	2 Participants
Invaplex[AR-Detox] 2.5 μg	Number of Participants With Solicited Adverse Events Up to 7 Days After Dose 1	Abdominal pain	0 Participants
Invaplex[AR-Detox] 2.5 μg	Number of Participants With Solicited Adverse Events Up to 7 Days After Dose 1	Appetite disorder	0 Participants
Invaplex[AR-Detox] 2.5 μg	Number of Participants With Solicited Adverse Events Up to 7 Days After Dose 1	Arthralgia	2 Participants
Invaplex[AR-Detox] 2.5 μg	Number of Participants With Solicited Adverse Events Up to 7 Days After Dose 1	Any Solicited AE	13 Participants
Invaplex[AR-Detox] 2.5 μg	Number of Participants With Solicited Adverse Events Up to 7 Days After Dose 1	Fatigue	1 Participants
Invaplex[AR-Detox] 2.5 μg	Number of Participants With Solicited Adverse Events Up to 7 Days After Dose 1	Headache	3 Participants
Invaplex[AR-Detox] 2.5 μg	Number of Participants With Solicited Adverse Events Up to 7 Days After Dose 1	Malaise	2 Participants
Invaplex[AR-Detox] 2.5 μg	Number of Participants With Solicited Adverse Events Up to 7 Days After Dose 1	Myalgia	0 Participants
Invaplex[AR-Detox] 2.5 μg	Number of Participants With Solicited Adverse Events Up to 7 Days After Dose 1	Nausea	1 Participants
Invaplex[AR-Detox] 2.5 μg	Number of Participants With Solicited Adverse Events Up to 7 Days After Dose 1	Pyrexia	0 Participants
Invaplex[AR-Detox] 2.5 μg	Number of Participants With Solicited Adverse Events Up to 7 Days After Dose 1	Vaccination site erythema	8 Participants
Invaplex[AR-Detox] 2.5 μg	Number of Participants With Solicited Adverse Events Up to 7 Days After Dose 1	Vaccination site induration	3 Participants
Invaplex[AR-Detox] 2.5 μg	Number of Participants With Solicited Adverse Events Up to 7 Days After Dose 1	Vaccination site pain	12 Participants
Invaplex[AR-Detox] 2.5 μg	Number of Participants With Solicited Adverse Events Up to 7 Days After Dose 1	Vaccination site pruritus	0 Participants
Invaplex[AR-Detox] 2.5 μg	Number of Participants With Solicited Adverse Events Up to 7 Days After Dose 1	Vaccination site swelling	1 Participants
Invaplex[AR-Detox] 10 μg	Number of Participants With Solicited Adverse Events Up to 7 Days After Dose 1	Fatigue	4 Participants
Invaplex[AR-Detox] 10 μg	Number of Participants With Solicited Adverse Events Up to 7 Days After Dose 1	Myalgia	1 Participants
Invaplex[AR-Detox] 10 μg	Number of Participants With Solicited Adverse Events Up to 7 Days After Dose 1	Vaccination site swelling	2 Participants
Invaplex[AR-Detox] 10 μg	Number of Participants With Solicited Adverse Events Up to 7 Days After Dose 1	Vaccination site erythema	9 Participants
Invaplex[AR-Detox] 10 μg	Number of Participants With Solicited Adverse Events Up to 7 Days After Dose 1	Vaccination site pruritus	3 Participants
Invaplex[AR-Detox] 10 μg	Number of Participants With Solicited Adverse Events Up to 7 Days After Dose 1	Nausea	1 Participants
Invaplex[AR-Detox] 10 μg	Number of Participants With Solicited Adverse Events Up to 7 Days After Dose 1	Appetite disorder	1 Participants
Invaplex[AR-Detox] 10 μg	Number of Participants With Solicited Adverse Events Up to 7 Days After Dose 1	Pyrexia	1 Participants
Invaplex[AR-Detox] 10 μg	Number of Participants With Solicited Adverse Events Up to 7 Days After Dose 1	Diarrhoea	2 Participants
Invaplex[AR-Detox] 10 μg	Number of Participants With Solicited Adverse Events Up to 7 Days After Dose 1	Headache	6 Participants
Invaplex[AR-Detox] 10 μg	Number of Participants With Solicited Adverse Events Up to 7 Days After Dose 1	Arthralgia	1 Participants
Invaplex[AR-Detox] 10 μg	Number of Participants With Solicited Adverse Events Up to 7 Days After Dose 1	Abdominal pain	1 Participants
Invaplex[AR-Detox] 10 μg	Number of Participants With Solicited Adverse Events Up to 7 Days After Dose 1	Vaccination site induration	3 Participants
Invaplex[AR-Detox] 10 μg	Number of Participants With Solicited Adverse Events Up to 7 Days After Dose 1	Malaise	1 Participants
Invaplex[AR-Detox] 10 μg	Number of Participants With Solicited Adverse Events Up to 7 Days After Dose 1	Vaccination site pain	16 Participants
Invaplex[AR-Detox] 10 μg	Number of Participants With Solicited Adverse Events Up to 7 Days After Dose 1	Any Solicited AE	16 Participants
Invaplex[AR-Detox] 25 μg	Number of Participants With Solicited Adverse Events Up to 7 Days After Dose 1	Fatigue	6 Participants
Invaplex[AR-Detox] 25 μg	Number of Participants With Solicited Adverse Events Up to 7 Days After Dose 1	Diarrhoea	0 Participants
Invaplex[AR-Detox] 25 μg	Number of Participants With Solicited Adverse Events Up to 7 Days After Dose 1	Vaccination site pain	16 Participants
Invaplex[AR-Detox] 25 μg	Number of Participants With Solicited Adverse Events Up to 7 Days After Dose 1	Headache	3 Participants
Invaplex[AR-Detox] 25 μg	Number of Participants With Solicited Adverse Events Up to 7 Days After Dose 1	Malaise	6 Participants
Invaplex[AR-Detox] 25 μg	Number of Participants With Solicited Adverse Events Up to 7 Days After Dose 1	Vaccination site swelling	2 Participants
Invaplex[AR-Detox] 25 μg	Number of Participants With Solicited Adverse Events Up to 7 Days After Dose 1	Myalgia	1 Participants
Invaplex[AR-Detox] 25 μg	Number of Participants With Solicited Adverse Events Up to 7 Days After Dose 1	Nausea	1 Participants
Invaplex[AR-Detox] 25 μg	Number of Participants With Solicited Adverse Events Up to 7 Days After Dose 1	Vaccination site pruritus	2 Participants
Invaplex[AR-Detox] 25 μg	Number of Participants With Solicited Adverse Events Up to 7 Days After Dose 1	Pyrexia	3 Participants
Invaplex[AR-Detox] 25 μg	Number of Participants With Solicited Adverse Events Up to 7 Days After Dose 1	Vaccination site erythema	7 Participants
Invaplex[AR-Detox] 25 μg	Number of Participants With Solicited Adverse Events Up to 7 Days After Dose 1	Any Solicited AE	16 Participants
Invaplex[AR-Detox] 25 μg	Number of Participants With Solicited Adverse Events Up to 7 Days After Dose 1	Abdominal pain	2 Participants
Invaplex[AR-Detox] 25 μg	Number of Participants With Solicited Adverse Events Up to 7 Days After Dose 1	Vaccination site induration	2 Participants
Invaplex[AR-Detox] 25 μg	Number of Participants With Solicited Adverse Events Up to 7 Days After Dose 1	Appetite disorder	2 Participants
Invaplex[AR-Detox] 25 μg	Number of Participants With Solicited Adverse Events Up to 7 Days After Dose 1	Arthralgia	2 Participants
Placebo	Number of Participants With Solicited Adverse Events Up to 7 Days After Dose 1	Vaccination site swelling	1 Participants
Placebo	Number of Participants With Solicited Adverse Events Up to 7 Days After Dose 1	Malaise	2 Participants
Placebo	Number of Participants With Solicited Adverse Events Up to 7 Days After Dose 1	Appetite disorder	0 Participants
Placebo	Number of Participants With Solicited Adverse Events Up to 7 Days After Dose 1	Any Solicited AE	6 Participants
Placebo	Number of Participants With Solicited Adverse Events Up to 7 Days After Dose 1	Vaccination site pain	1 Participants
Placebo	Number of Participants With Solicited Adverse Events Up to 7 Days After Dose 1	Headache	1 Participants
Placebo	Number of Participants With Solicited Adverse Events Up to 7 Days After Dose 1	Vaccination site induration	1 Participants
Placebo	Number of Participants With Solicited Adverse Events Up to 7 Days After Dose 1	Abdominal pain	1 Participants
Placebo	Number of Participants With Solicited Adverse Events Up to 7 Days After Dose 1	Diarrhoea	3 Participants
Placebo	Number of Participants With Solicited Adverse Events Up to 7 Days After Dose 1	Nausea	0 Participants
Placebo	Number of Participants With Solicited Adverse Events Up to 7 Days After Dose 1	Fatigue	2 Participants
Placebo	Number of Participants With Solicited Adverse Events Up to 7 Days After Dose 1	Pyrexia	0 Participants
Placebo	Number of Participants With Solicited Adverse Events Up to 7 Days After Dose 1	Vaccination site pruritus	1 Participants
Placebo	Number of Participants With Solicited Adverse Events Up to 7 Days After Dose 1	Myalgia	1 Participants
Placebo	Number of Participants With Solicited Adverse Events Up to 7 Days After Dose 1	Arthralgia	0 Participants
Placebo	Number of Participants With Solicited Adverse Events Up to 7 Days After Dose 1	Vaccination site erythema	1 Participants

Primary

Number of Participants With Solicited Adverse Events Up to 7 Days After Dose 2

Time frame: 7 days after the second immunization (Days 22 to 28)

Population: All participants who received the second dose (Invaplex\[AR-Detox\] or placebo).

Arm	Measure	Group	Value (COUNT_OF_PARTICIPANTS)
Invaplex[AR-Detox] 2.5 μg	Number of Participants With Solicited Adverse Events Up to 7 Days After Dose 2	Any Solicited AE	12 Participants
Invaplex[AR-Detox] 2.5 μg	Number of Participants With Solicited Adverse Events Up to 7 Days After Dose 2	Vaccination site induration	3 Participants
Invaplex[AR-Detox] 2.5 μg	Number of Participants With Solicited Adverse Events Up to 7 Days After Dose 2	Myalgia	1 Participants
Invaplex[AR-Detox] 2.5 μg	Number of Participants With Solicited Adverse Events Up to 7 Days After Dose 2	Appetite disorder	2 Participants
Invaplex[AR-Detox] 2.5 μg	Number of Participants With Solicited Adverse Events Up to 7 Days After Dose 2	Nausea	2 Participants
Invaplex[AR-Detox] 2.5 μg	Number of Participants With Solicited Adverse Events Up to 7 Days After Dose 2	Vaccination site erythema	9 Participants
Invaplex[AR-Detox] 2.5 μg	Number of Participants With Solicited Adverse Events Up to 7 Days After Dose 2	Arthralgia	1 Participants
Invaplex[AR-Detox] 2.5 μg	Number of Participants With Solicited Adverse Events Up to 7 Days After Dose 2	Abdominal pain	1 Participants
Invaplex[AR-Detox] 2.5 μg	Number of Participants With Solicited Adverse Events Up to 7 Days After Dose 2	Vaccination site pruritus	1 Participants
Invaplex[AR-Detox] 2.5 μg	Number of Participants With Solicited Adverse Events Up to 7 Days After Dose 2	Diarrhoea	0 Participants
Invaplex[AR-Detox] 2.5 μg	Number of Participants With Solicited Adverse Events Up to 7 Days After Dose 2	Fatigue	2 Participants
Invaplex[AR-Detox] 2.5 μg	Number of Participants With Solicited Adverse Events Up to 7 Days After Dose 2	Vaccination site pain	7 Participants
Invaplex[AR-Detox] 2.5 μg	Number of Participants With Solicited Adverse Events Up to 7 Days After Dose 2	Headache	2 Participants
Invaplex[AR-Detox] 2.5 μg	Number of Participants With Solicited Adverse Events Up to 7 Days After Dose 2	Vaccination site swelling	0 Participants
Invaplex[AR-Detox] 2.5 μg	Number of Participants With Solicited Adverse Events Up to 7 Days After Dose 2	Malaise	1 Participants
Invaplex[AR-Detox] 10 μg	Number of Participants With Solicited Adverse Events Up to 7 Days After Dose 2	Malaise	3 Participants
Invaplex[AR-Detox] 10 μg	Number of Participants With Solicited Adverse Events Up to 7 Days After Dose 2	Vaccination site induration	3 Participants
Invaplex[AR-Detox] 10 μg	Number of Participants With Solicited Adverse Events Up to 7 Days After Dose 2	Diarrhoea	3 Participants
Invaplex[AR-Detox] 10 μg	Number of Participants With Solicited Adverse Events Up to 7 Days After Dose 2	Myalgia	0 Participants
Invaplex[AR-Detox] 10 μg	Number of Participants With Solicited Adverse Events Up to 7 Days After Dose 2	Abdominal pain	2 Participants
Invaplex[AR-Detox] 10 μg	Number of Participants With Solicited Adverse Events Up to 7 Days After Dose 2	Vaccination site erythema	9 Participants
Invaplex[AR-Detox] 10 μg	Number of Participants With Solicited Adverse Events Up to 7 Days After Dose 2	Vaccination site pain	15 Participants
Invaplex[AR-Detox] 10 μg	Number of Participants With Solicited Adverse Events Up to 7 Days After Dose 2	Nausea	0 Participants
Invaplex[AR-Detox] 10 μg	Number of Participants With Solicited Adverse Events Up to 7 Days After Dose 2	Appetite disorder	2 Participants
Invaplex[AR-Detox] 10 μg	Number of Participants With Solicited Adverse Events Up to 7 Days After Dose 2	Headache	2 Participants
Invaplex[AR-Detox] 10 μg	Number of Participants With Solicited Adverse Events Up to 7 Days After Dose 2	Vaccination site swelling	4 Participants
Invaplex[AR-Detox] 10 μg	Number of Participants With Solicited Adverse Events Up to 7 Days After Dose 2	Vaccination site pruritus	3 Participants
Invaplex[AR-Detox] 10 μg	Number of Participants With Solicited Adverse Events Up to 7 Days After Dose 2	Fatigue	3 Participants
Invaplex[AR-Detox] 10 μg	Number of Participants With Solicited Adverse Events Up to 7 Days After Dose 2	Arthralgia	0 Participants
Invaplex[AR-Detox] 10 μg	Number of Participants With Solicited Adverse Events Up to 7 Days After Dose 2	Any Solicited AE	15 Participants
Invaplex[AR-Detox] 25 μg	Number of Participants With Solicited Adverse Events Up to 7 Days After Dose 2	Malaise	3 Participants
Invaplex[AR-Detox] 25 μg	Number of Participants With Solicited Adverse Events Up to 7 Days After Dose 2	Any Solicited AE	15 Participants
Invaplex[AR-Detox] 25 μg	Number of Participants With Solicited Adverse Events Up to 7 Days After Dose 2	Abdominal pain	1 Participants
Invaplex[AR-Detox] 25 μg	Number of Participants With Solicited Adverse Events Up to 7 Days After Dose 2	Appetite disorder	1 Participants
Invaplex[AR-Detox] 25 μg	Number of Participants With Solicited Adverse Events Up to 7 Days After Dose 2	Arthralgia	1 Participants
Invaplex[AR-Detox] 25 μg	Number of Participants With Solicited Adverse Events Up to 7 Days After Dose 2	Diarrhoea	0 Participants
Invaplex[AR-Detox] 25 μg	Number of Participants With Solicited Adverse Events Up to 7 Days After Dose 2	Fatigue	2 Participants
Invaplex[AR-Detox] 25 μg	Number of Participants With Solicited Adverse Events Up to 7 Days After Dose 2	Headache	1 Participants
Invaplex[AR-Detox] 25 μg	Number of Participants With Solicited Adverse Events Up to 7 Days After Dose 2	Myalgia	1 Participants
Invaplex[AR-Detox] 25 μg	Number of Participants With Solicited Adverse Events Up to 7 Days After Dose 2	Nausea	1 Participants
Invaplex[AR-Detox] 25 μg	Number of Participants With Solicited Adverse Events Up to 7 Days After Dose 2	Vaccination site erythema	7 Participants
Invaplex[AR-Detox] 25 μg	Number of Participants With Solicited Adverse Events Up to 7 Days After Dose 2	Vaccination site induration	2 Participants
Invaplex[AR-Detox] 25 μg	Number of Participants With Solicited Adverse Events Up to 7 Days After Dose 2	Vaccination site pain	15 Participants
Invaplex[AR-Detox] 25 μg	Number of Participants With Solicited Adverse Events Up to 7 Days After Dose 2	Vaccination site pruritus	0 Participants
Invaplex[AR-Detox] 25 μg	Number of Participants With Solicited Adverse Events Up to 7 Days After Dose 2	Vaccination site swelling	2 Participants
Placebo	Number of Participants With Solicited Adverse Events Up to 7 Days After Dose 2	Headache	2 Participants
Placebo	Number of Participants With Solicited Adverse Events Up to 7 Days After Dose 2	Abdominal pain	0 Participants
Placebo	Number of Participants With Solicited Adverse Events Up to 7 Days After Dose 2	Vaccination site induration	0 Participants
Placebo	Number of Participants With Solicited Adverse Events Up to 7 Days After Dose 2	Fatigue	1 Participants
Placebo	Number of Participants With Solicited Adverse Events Up to 7 Days After Dose 2	Diarrhoea	1 Participants
Placebo	Number of Participants With Solicited Adverse Events Up to 7 Days After Dose 2	Any Solicited AE	4 Participants
Placebo	Number of Participants With Solicited Adverse Events Up to 7 Days After Dose 2	Vaccination site pain	1 Participants
Placebo	Number of Participants With Solicited Adverse Events Up to 7 Days After Dose 2	Arthralgia	0 Participants
Placebo	Number of Participants With Solicited Adverse Events Up to 7 Days After Dose 2	Appetite disorder	0 Participants
Placebo	Number of Participants With Solicited Adverse Events Up to 7 Days After Dose 2	Vaccination site swelling	0 Participants
Placebo	Number of Participants With Solicited Adverse Events Up to 7 Days After Dose 2	Nausea	0 Participants
Placebo	Number of Participants With Solicited Adverse Events Up to 7 Days After Dose 2	Myalgia	1 Participants
Placebo	Number of Participants With Solicited Adverse Events Up to 7 Days After Dose 2	Vaccination site pruritus	0 Participants
Placebo	Number of Participants With Solicited Adverse Events Up to 7 Days After Dose 2	Vaccination site erythema	0 Participants
Placebo	Number of Participants With Solicited Adverse Events Up to 7 Days After Dose 2	Malaise	0 Participants

Primary

Number of Participants With Unsolicited Adverse Events After Each Dose

Time frame: Dose 1: Days 1 to 21; Dose 2: Days 22 to 42; Dose 3: Days 43 to 71

Population: Participants who received each dose (Invaplex\[AR-Detox\] or placebo).

Arm	Measure	Group	Value (COUNT_OF_PARTICIPANTS)
Invaplex[AR-Detox] 2.5 μg	Number of Participants With Unsolicited Adverse Events After Each Dose	Unsolicited adverse events after first dose	5 Participants
Invaplex[AR-Detox] 2.5 μg	Number of Participants With Unsolicited Adverse Events After Each Dose	Unsolicited adverse events after third dose	4 Participants
Invaplex[AR-Detox] 2.5 μg	Number of Participants With Unsolicited Adverse Events After Each Dose	Unsolicited adverse events after second dose	7 Participants
Invaplex[AR-Detox] 10 μg	Number of Participants With Unsolicited Adverse Events After Each Dose	Unsolicited adverse events after first dose	5 Participants
Invaplex[AR-Detox] 10 μg	Number of Participants With Unsolicited Adverse Events After Each Dose	Unsolicited adverse events after third dose	5 Participants
Invaplex[AR-Detox] 10 μg	Number of Participants With Unsolicited Adverse Events After Each Dose	Unsolicited adverse events after second dose	6 Participants
Invaplex[AR-Detox] 25 μg	Number of Participants With Unsolicited Adverse Events After Each Dose	Unsolicited adverse events after second dose	4 Participants
Invaplex[AR-Detox] 25 μg	Number of Participants With Unsolicited Adverse Events After Each Dose	Unsolicited adverse events after first dose	5 Participants
Invaplex[AR-Detox] 25 μg	Number of Participants With Unsolicited Adverse Events After Each Dose	Unsolicited adverse events after third dose	6 Participants
Placebo	Number of Participants With Unsolicited Adverse Events After Each Dose	Unsolicited adverse events after first dose	6 Participants
Placebo	Number of Participants With Unsolicited Adverse Events After Each Dose	Unsolicited adverse events after third dose	2 Participants
Placebo	Number of Participants With Unsolicited Adverse Events After Each Dose	Unsolicited adverse events after second dose	5 Participants

Primary

Percentage of Participants With Adverse Events

All adverse events (AEs) were assessed for severity by the investigator according to the following scale: Grade 1 (Mild): Does not interfere with routine activities, minimal level of discomfort; Grade 2 (Moderate): Interferes with routine activities, moderate level of discomfort; Grade 3 (Severe): Unable to perform routine activities, significant level of discomfort; Grade 4 (Potentially life-threatening): Hospitalization or ER visit for potentially life-threatening event. An AE was considered serious if it resulted in any of the following outcomes: * Death * Life-threatening AE * Inpatient hospitalization or prolongation of existing hospitalization * Persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions * Congenital anomaly/birth defect. The Investigator assessed the relationship of each adverse event to study drug.

Time frame: From first dose up to 28 days following the third immunization (71 days)

Population: The safety population included all participants who received at least one immunization (Invaplex\[AR-Detox\] or placebo).

Arm	Measure	Group	Value (NUMBER)
Invaplex[AR-Detox] 2.5 μg	Percentage of Participants With Adverse Events	Any adverse event (AE)	100 percentage of participants
Invaplex[AR-Detox] 2.5 μg	Percentage of Participants With Adverse Events	Any Grade 2 or greater AE	50.0 percentage of participants
Invaplex[AR-Detox] 2.5 μg	Percentage of Participants With Adverse Events	Any AE related to study drug	100.0 percentage of participants
Invaplex[AR-Detox] 2.5 μg	Percentage of Participants With Adverse Events	Any Grade 2 or greater AE related to study drug	14.3 percentage of participants
Invaplex[AR-Detox] 2.5 μg	Percentage of Participants With Adverse Events	Any serious adverse event (SAE)	0.0 percentage of participants
Invaplex[AR-Detox] 2.5 μg	Percentage of Participants With Adverse Events	Any SAE related to study drug	0.0 percentage of participants
Invaplex[AR-Detox] 10 μg	Percentage of Participants With Adverse Events	Any SAE related to study drug	0.0 percentage of participants
Invaplex[AR-Detox] 10 μg	Percentage of Participants With Adverse Events	Any Grade 2 or greater AE related to study drug	43.8 percentage of participants
Invaplex[AR-Detox] 10 μg	Percentage of Participants With Adverse Events	Any adverse event (AE)	100.0 percentage of participants
Invaplex[AR-Detox] 10 μg	Percentage of Participants With Adverse Events	Any AE related to study drug	100.0 percentage of participants
Invaplex[AR-Detox] 10 μg	Percentage of Participants With Adverse Events	Any Grade 2 or greater AE	56.3 percentage of participants
Invaplex[AR-Detox] 10 μg	Percentage of Participants With Adverse Events	Any serious adverse event (SAE)	0.0 percentage of participants
Invaplex[AR-Detox] 25 μg	Percentage of Participants With Adverse Events	Any Grade 2 or greater AE	43.8 percentage of participants
Invaplex[AR-Detox] 25 μg	Percentage of Participants With Adverse Events	Any AE related to study drug	100.0 percentage of participants
Invaplex[AR-Detox] 25 μg	Percentage of Participants With Adverse Events	Any Grade 2 or greater AE related to study drug	31.3 percentage of participants
Invaplex[AR-Detox] 25 μg	Percentage of Participants With Adverse Events	Any SAE related to study drug	0.0 percentage of participants
Invaplex[AR-Detox] 25 μg	Percentage of Participants With Adverse Events	Any serious adverse event (SAE)	0.0 percentage of participants
Invaplex[AR-Detox] 25 μg	Percentage of Participants With Adverse Events	Any adverse event (AE)	100.0 percentage of participants
Placebo	Percentage of Participants With Adverse Events	Any serious adverse event (SAE)	0.0 percentage of participants
Placebo	Percentage of Participants With Adverse Events	Any SAE related to study drug	0.0 percentage of participants
Placebo	Percentage of Participants With Adverse Events	Any Grade 2 or greater AE	25.0 percentage of participants
Placebo	Percentage of Participants With Adverse Events	Any Grade 2 or greater AE related to study drug	8.3 percentage of participants
Placebo	Percentage of Participants With Adverse Events	Any adverse event (AE)	91.7 percentage of participants
Placebo	Percentage of Participants With Adverse Events	Any AE related to study drug	58.3 percentage of participants

Secondary

Geometric Mean Fold-rise (GMFR) in Serum IgA From Baseline

Time frame: Days 1 (Baseline), 22, 43, 50, 57 and 71.

Population: The immunogenicity population includes all participants who received at least two vaccinations, who had baseline and post-vaccination data for the immunogenicity variable of interest

Arm	Measure	Group	Value (GEOMETRIC_MEAN)
Invaplex[AR-Detox] 2.5 μg	Geometric Mean Fold-rise (GMFR) in Serum IgA From Baseline	Day 57 (14 days after dose 3)	21.4 fold-rise
Invaplex[AR-Detox] 2.5 μg	Geometric Mean Fold-rise (GMFR) in Serum IgA From Baseline	Day 43 (pre-dose 3)	17.8 fold-rise
Invaplex[AR-Detox] 2.5 μg	Geometric Mean Fold-rise (GMFR) in Serum IgA From Baseline	Day 71 (28 days after dose 3)	20.2 fold-rise
Invaplex[AR-Detox] 2.5 μg	Geometric Mean Fold-rise (GMFR) in Serum IgA From Baseline	Day 50 (7 days after dose 3)	16.0 fold-rise
Invaplex[AR-Detox] 2.5 μg	Geometric Mean Fold-rise (GMFR) in Serum IgA From Baseline	Day 22 (pre-dose 2)	18.8 fold-rise
Invaplex[AR-Detox] 10 μg	Geometric Mean Fold-rise (GMFR) in Serum IgA From Baseline	Day 50 (7 days after dose 3)	22.1 fold-rise
Invaplex[AR-Detox] 10 μg	Geometric Mean Fold-rise (GMFR) in Serum IgA From Baseline	Day 57 (14 days after dose 3)	25.4 fold-rise
Invaplex[AR-Detox] 10 μg	Geometric Mean Fold-rise (GMFR) in Serum IgA From Baseline	Day 71 (28 days after dose 3)	17.5 fold-rise
Invaplex[AR-Detox] 10 μg	Geometric Mean Fold-rise (GMFR) in Serum IgA From Baseline	Day 43 (pre-dose 3)	19.2 fold-rise
Invaplex[AR-Detox] 10 μg	Geometric Mean Fold-rise (GMFR) in Serum IgA From Baseline	Day 22 (pre-dose 2)	23.2 fold-rise
Invaplex[AR-Detox] 25 μg	Geometric Mean Fold-rise (GMFR) in Serum IgA From Baseline	Day 50 (7 days after dose 3)	74.2 fold-rise
Invaplex[AR-Detox] 25 μg	Geometric Mean Fold-rise (GMFR) in Serum IgA From Baseline	Day 22 (pre-dose 2)	103.1 fold-rise
Invaplex[AR-Detox] 25 μg	Geometric Mean Fold-rise (GMFR) in Serum IgA From Baseline	Day 43 (pre-dose 3)	66.8 fold-rise
Invaplex[AR-Detox] 25 μg	Geometric Mean Fold-rise (GMFR) in Serum IgA From Baseline	Day 57 (14 days after dose 3)	72.9 fold-rise
Invaplex[AR-Detox] 25 μg	Geometric Mean Fold-rise (GMFR) in Serum IgA From Baseline	Day 71 (28 days after dose 3)	66.8 fold-rise
Placebo	Geometric Mean Fold-rise (GMFR) in Serum IgA From Baseline	Day 57 (14 days after dose 3)	0.9 fold-rise
Placebo	Geometric Mean Fold-rise (GMFR) in Serum IgA From Baseline	Day 43 (pre-dose 3)	0.8 fold-rise
Placebo	Geometric Mean Fold-rise (GMFR) in Serum IgA From Baseline	Day 22 (pre-dose 2)	0.9 fold-rise
Placebo	Geometric Mean Fold-rise (GMFR) in Serum IgA From Baseline	Day 50 (7 days after dose 3)	0.7 fold-rise
Placebo	Geometric Mean Fold-rise (GMFR) in Serum IgA From Baseline	Day 71 (28 days after dose 3)	1.1 fold-rise

Comparison: Kruskal-Wallis test of any difference between the 3 active dose groups in GMFR at Day 22p-value: 0.009Kruskal-Wallis

Comparison: Kruskal-Wallis test of any difference between the 3 active dose groups in GMFR at Day 43p-value: 0.037Kruskal-Wallis

Comparison: Kruskal-Wallis test of any difference between the 3 active dose groups in GMFR at Day 50p-value: 0.009Kruskal-Wallis

Comparison: Kruskal-Wallis test of any difference between the 3 active dose groups in GMFR at Day 57p-value: 0.036Kruskal-Wallis

Comparison: Kruskal-Wallis test of any difference between the 3 active dose groups in GMFR at Day 71p-value: 0.042Kruskal-Wallis

Secondary

Geometric Mean Fold-rise in ALS IgA From Baseline

Time frame: Days 1 (Baseline), 8, 29, and 50

Population: The immunogenicity population includes all participants who received at least two vaccinations, who had baseline and post-vaccination data for the immunogenicity variable of interest

Arm	Measure	Group	Value (GEOMETRIC_MEAN)
Invaplex[AR-Detox] 2.5 μg	Geometric Mean Fold-rise in ALS IgA From Baseline	Day 50 (7 days after dose 3)	4.6 fold-rise
Invaplex[AR-Detox] 2.5 μg	Geometric Mean Fold-rise in ALS IgA From Baseline	Day 8 (7 days after dose 1)	132.3 fold-rise
Invaplex[AR-Detox] 2.5 μg	Geometric Mean Fold-rise in ALS IgA From Baseline	Day 29 (7 days after dose 2)	18.4 fold-rise
Invaplex[AR-Detox] 10 μg	Geometric Mean Fold-rise in ALS IgA From Baseline	Day 29 (7 days after dose 2)	8.4 fold-rise
Invaplex[AR-Detox] 10 μg	Geometric Mean Fold-rise in ALS IgA From Baseline	Day 8 (7 days after dose 1)	87.3 fold-rise
Invaplex[AR-Detox] 10 μg	Geometric Mean Fold-rise in ALS IgA From Baseline	Day 50 (7 days after dose 3)	3.0 fold-rise
Invaplex[AR-Detox] 25 μg	Geometric Mean Fold-rise in ALS IgA From Baseline	Day 50 (7 days after dose 3)	3.8 fold-rise
Invaplex[AR-Detox] 25 μg	Geometric Mean Fold-rise in ALS IgA From Baseline	Day 8 (7 days after dose 1)	241.9 fold-rise
Invaplex[AR-Detox] 25 μg	Geometric Mean Fold-rise in ALS IgA From Baseline	Day 29 (7 days after dose 2)	7.7 fold-rise
Placebo	Geometric Mean Fold-rise in ALS IgA From Baseline	Day 29 (7 days after dose 2)	1.1 fold-rise
Placebo	Geometric Mean Fold-rise in ALS IgA From Baseline	Day 8 (7 days after dose 1)	1.2 fold-rise
Placebo	Geometric Mean Fold-rise in ALS IgA From Baseline	Day 50 (7 days after dose 3)	1.0 fold-rise

Secondary

Geometric Mean Fold-rise in ALS IgG From Baseline

Time frame: Days 1 (Baseline), 8, 29, and 50

Population: The immunogenicity population includes all participants who received at least two vaccinations, who had baseline and post-vaccination data for the immunogenicity variable of interest.

Arm	Measure	Group	Value (GEOMETRIC_MEAN)
Invaplex[AR-Detox] 2.5 μg	Geometric Mean Fold-rise in ALS IgG From Baseline	Day 8 (7 days after dose 1)	250.9 fold-rise
Invaplex[AR-Detox] 2.5 μg	Geometric Mean Fold-rise in ALS IgG From Baseline	Day 50 (7 days after dose 3)	12.4 fold-rise
Invaplex[AR-Detox] 2.5 μg	Geometric Mean Fold-rise in ALS IgG From Baseline	Day 29 (7 days after dose 2)	19.0 fold-rise
Invaplex[AR-Detox] 10 μg	Geometric Mean Fold-rise in ALS IgG From Baseline	Day 8 (7 days after dose 1)	200.7 fold-rise
Invaplex[AR-Detox] 10 μg	Geometric Mean Fold-rise in ALS IgG From Baseline	Day 50 (7 days after dose 3)	64.9 fold-rise
Invaplex[AR-Detox] 10 μg	Geometric Mean Fold-rise in ALS IgG From Baseline	Day 29 (7 days after dose 2)	51.2 fold-rise
Invaplex[AR-Detox] 25 μg	Geometric Mean Fold-rise in ALS IgG From Baseline	Day 29 (7 days after dose 2)	70.3 fold-rise
Invaplex[AR-Detox] 25 μg	Geometric Mean Fold-rise in ALS IgG From Baseline	Day 8 (7 days after dose 1)	708.3 fold-rise
Invaplex[AR-Detox] 25 μg	Geometric Mean Fold-rise in ALS IgG From Baseline	Day 50 (7 days after dose 3)	59.2 fold-rise
Placebo	Geometric Mean Fold-rise in ALS IgG From Baseline	Day 8 (7 days after dose 1)	1.1 fold-rise
Placebo	Geometric Mean Fold-rise in ALS IgG From Baseline	Day 50 (7 days after dose 3)	0.8 fold-rise
Placebo	Geometric Mean Fold-rise in ALS IgG From Baseline	Day 29 (7 days after dose 2)	0.8 fold-rise

Comparison: Kruskal-Wallis test of any difference between the 3 active dose groups in GMFR at Day 8p-value: 0.348Kruskal-Wallis

Comparison: Kruskal-Wallis test of any difference between the 3 active dose groups in GMFR at Day 29p-value: 0.179Kruskal-Wallis

Comparison: Kruskal-Wallis test of any difference between the 3 active dose groups in GMFR at Day 50p-value: 0.089Kruskal-Wallis

Secondary

Geometric Mean Fold-rise in Serum IgG From Baseline

Time frame: Days 1 (Baseline), 22, 43, 50, 57 and 71.

Population: The immunogenicity population includes all participants who received at least two vaccinations, who had baseline and post-vaccination data for the immunogenicity variable of interest

Arm	Measure	Group	Value (GEOMETRIC_MEAN)
Invaplex[AR-Detox] 2.5 μg	Geometric Mean Fold-rise in Serum IgG From Baseline	Day 57 (14 days after dose 3)	21.4 fold-rise
Invaplex[AR-Detox] 2.5 μg	Geometric Mean Fold-rise in Serum IgG From Baseline	Day 43 (pre-dose 3)	16.9 fold-rise
Invaplex[AR-Detox] 2.5 μg	Geometric Mean Fold-rise in Serum IgG From Baseline	Day 71 (28 days after dose 3)	22.6 fold-rise
Invaplex[AR-Detox] 2.5 μg	Geometric Mean Fold-rise in Serum IgG From Baseline	Day 50 (7 days after dose 3)	17.0 fold-rise
Invaplex[AR-Detox] 2.5 μg	Geometric Mean Fold-rise in Serum IgG From Baseline	Day 22 (pre-dose 2)	9.9 fold-rise
Invaplex[AR-Detox] 10 μg	Geometric Mean Fold-rise in Serum IgG From Baseline	Day 50 (7 days after dose 3)	29.2 fold-rise
Invaplex[AR-Detox] 10 μg	Geometric Mean Fold-rise in Serum IgG From Baseline	Day 57 (14 days after dose 3)	35.1 fold-rise
Invaplex[AR-Detox] 10 μg	Geometric Mean Fold-rise in Serum IgG From Baseline	Day 71 (28 days after dose 3)	33.5 fold-rise
Invaplex[AR-Detox] 10 μg	Geometric Mean Fold-rise in Serum IgG From Baseline	Day 43 (pre-dose 3)	23.2 fold-rise
Invaplex[AR-Detox] 10 μg	Geometric Mean Fold-rise in Serum IgG From Baseline	Day 22 (pre-dose 2)	17.5 fold-rise
Invaplex[AR-Detox] 25 μg	Geometric Mean Fold-rise in Serum IgG From Baseline	Day 50 (7 days after dose 3)	45.3 fold-rise
Invaplex[AR-Detox] 25 μg	Geometric Mean Fold-rise in Serum IgG From Baseline	Day 22 (pre-dose 2)	34.9 fold-rise
Invaplex[AR-Detox] 25 μg	Geometric Mean Fold-rise in Serum IgG From Baseline	Day 43 (pre-dose 3)	49.4 fold-rise
Invaplex[AR-Detox] 25 μg	Geometric Mean Fold-rise in Serum IgG From Baseline	Day 57 (14 days after dose 3)	53.8 fold-rise
Invaplex[AR-Detox] 25 μg	Geometric Mean Fold-rise in Serum IgG From Baseline	Day 71 (28 days after dose 3)	49.4 fold-rise
Placebo	Geometric Mean Fold-rise in Serum IgG From Baseline	Day 57 (14 days after dose 3)	1.2 fold-rise
Placebo	Geometric Mean Fold-rise in Serum IgG From Baseline	Day 43 (pre-dose 3)	1.0 fold-rise
Placebo	Geometric Mean Fold-rise in Serum IgG From Baseline	Day 22 (pre-dose 2)	1.1 fold-rise
Placebo	Geometric Mean Fold-rise in Serum IgG From Baseline	Day 50 (7 days after dose 3)	1.1 fold-rise
Placebo	Geometric Mean Fold-rise in Serum IgG From Baseline	Day 71 (28 days after dose 3)	0.8 fold-rise

Comparison: Kruskal-Wallis test of any difference between the 3 active dose groups in GMFR at Day 22p-value: 0.028Kruskal-Wallis

Comparison: Kruskal-Wallis test of any difference between the 3 active dose groups in GMFR at Day 43p-value: 0.088Kruskal-Wallis

Comparison: Kruskal-Wallis test of any difference between the 3 active dose groups in GMFR at Day 50p-value: 0.146Kruskal-Wallis

Comparison: Kruskal-Wallis test of any difference between the 3 active dose groups in GMFR at Day 57p-value: 0.126Kruskal-Wallis

Comparison: Kruskal-Wallis test of any difference between the 3 active dose groups in GMFR at Day 71p-value: 0.273Kruskal-Wallis

Secondary

Geometric Mean Titer (GMT) of Immunoglobulin A Antibodies to Invaplex in α4β7+ Antibody in Lymphocyte Supernatant (ALS)

Time frame: Days 1 (Baseline), 8, 29, and 50

Population: The immunogenicity population includes all participants who received at least two vaccinations, who had baseline and post-vaccination data for the immunogenicity variable of interest

Arm	Measure	Group	Value (GEOMETRIC_MEAN)
Invaplex[AR-Detox] 2.5 μg	Geometric Mean Titer (GMT) of Immunoglobulin A Antibodies to Invaplex in α4β7+ Antibody in Lymphocyte Supernatant (ALS)	Baseline	1.1 titer
Invaplex[AR-Detox] 2.5 μg	Geometric Mean Titer (GMT) of Immunoglobulin A Antibodies to Invaplex in α4β7+ Antibody in Lymphocyte Supernatant (ALS)	Day 8 (7 days after dose 1)	139.6 titer
Invaplex[AR-Detox] 2.5 μg	Geometric Mean Titer (GMT) of Immunoglobulin A Antibodies to Invaplex in α4β7+ Antibody in Lymphocyte Supernatant (ALS)	Day 29 (7 days after dose 2)	19.4 titer
Invaplex[AR-Detox] 2.5 μg	Geometric Mean Titer (GMT) of Immunoglobulin A Antibodies to Invaplex in α4β7+ Antibody in Lymphocyte Supernatant (ALS)	Day 50 (7 days after dose 3)	4.8 titer
Invaplex[AR-Detox] 10 μg	Geometric Mean Titer (GMT) of Immunoglobulin A Antibodies to Invaplex in α4β7+ Antibody in Lymphocyte Supernatant (ALS)	Day 8 (7 days after dose 1)	115.2 titer
Invaplex[AR-Detox] 10 μg	Geometric Mean Titer (GMT) of Immunoglobulin A Antibodies to Invaplex in α4β7+ Antibody in Lymphocyte Supernatant (ALS)	Day 29 (7 days after dose 2)	11.0 titer
Invaplex[AR-Detox] 10 μg	Geometric Mean Titer (GMT) of Immunoglobulin A Antibodies to Invaplex in α4β7+ Antibody in Lymphocyte Supernatant (ALS)	Day 50 (7 days after dose 3)	4.0 titer
Invaplex[AR-Detox] 10 μg	Geometric Mean Titer (GMT) of Immunoglobulin A Antibodies to Invaplex in α4β7+ Antibody in Lymphocyte Supernatant (ALS)	Baseline	1.3 titer
Invaplex[AR-Detox] 25 μg	Geometric Mean Titer (GMT) of Immunoglobulin A Antibodies to Invaplex in α4β7+ Antibody in Lymphocyte Supernatant (ALS)	Day 29 (7 days after dose 2)	8.8 titer
Invaplex[AR-Detox] 25 μg	Geometric Mean Titer (GMT) of Immunoglobulin A Antibodies to Invaplex in α4β7+ Antibody in Lymphocyte Supernatant (ALS)	Day 8 (7 days after dose 1)	275.5 titer
Invaplex[AR-Detox] 25 μg	Geometric Mean Titer (GMT) of Immunoglobulin A Antibodies to Invaplex in α4β7+ Antibody in Lymphocyte Supernatant (ALS)	Day 50 (7 days after dose 3)	4.4 titer
Invaplex[AR-Detox] 25 μg	Geometric Mean Titer (GMT) of Immunoglobulin A Antibodies to Invaplex in α4β7+ Antibody in Lymphocyte Supernatant (ALS)	Baseline	1.1 titer
Placebo	Geometric Mean Titer (GMT) of Immunoglobulin A Antibodies to Invaplex in α4β7+ Antibody in Lymphocyte Supernatant (ALS)	Day 50 (7 days after dose 3)	0.0 titer
Placebo	Geometric Mean Titer (GMT) of Immunoglobulin A Antibodies to Invaplex in α4β7+ Antibody in Lymphocyte Supernatant (ALS)	Day 8 (7 days after dose 1)	1.2 titer
Placebo	Geometric Mean Titer (GMT) of Immunoglobulin A Antibodies to Invaplex in α4β7+ Antibody in Lymphocyte Supernatant (ALS)	Baseline	1.0 titer
Placebo	Geometric Mean Titer (GMT) of Immunoglobulin A Antibodies to Invaplex in α4β7+ Antibody in Lymphocyte Supernatant (ALS)	Day 29 (7 days after dose 2)	1.1 titer

Comparison: Kruskal-Wallis test of any difference between the 3 active dose groups in GMT at Baselinep-value: 0.226Kruskal-Wallis

Comparison: Kruskal-Wallis test of any difference between the 3 active dose groups in GMT at Day 8p-value: 0.601Kruskal-Wallis

Comparison: Kruskal-Wallis test of any difference between the 3 active dose groups in GMT at Day 29p-value: 0.628Kruskal-Wallis

Comparison: Kruskal-Wallis test of any difference between the 3 active dose groups in GMT at Day 50p-value: 0.878Kruskal-Wallis

Secondary

Geometric Mean Titer (GMT) of Serum Immunoglobulin A (IgA) Antibodies to Invaplex

Time frame: Days 1 (Baseline), 22, 43, 50, 57 and 71.

Population: The immunogenicity population includes all participants who received at least two vaccinations, who had baseline and post-vaccination data for the immunogenicity variable of interest

Arm	Measure	Group	Value (GEOMETRIC_MEAN)
Invaplex[AR-Detox] 2.5 μg	Geometric Mean Titer (GMT) of Serum Immunoglobulin A (IgA) Antibodies to Invaplex	Baseline	189.6 titer
Invaplex[AR-Detox] 2.5 μg	Geometric Mean Titer (GMT) of Serum Immunoglobulin A (IgA) Antibodies to Invaplex	Day 22 (pre-dose 2)	3560.1 titer
Invaplex[AR-Detox] 2.5 μg	Geometric Mean Titer (GMT) of Serum Immunoglobulin A (IgA) Antibodies to Invaplex	Day 43 (pre-dose 3)	3375.3 titer
Invaplex[AR-Detox] 2.5 μg	Geometric Mean Titer (GMT) of Serum Immunoglobulin A (IgA) Antibodies to Invaplex	Day 50 (7 days after dose 3)	3200.0 titer
Invaplex[AR-Detox] 2.5 μg	Geometric Mean Titer (GMT) of Serum Immunoglobulin A (IgA) Antibodies to Invaplex	Day 57 (14 days after dose 3)	4271.5 titer
Invaplex[AR-Detox] 2.5 μg	Geometric Mean Titer (GMT) of Serum Immunoglobulin A (IgA) Antibodies to Invaplex	Day 71 (28 days after dose 3)	4031.7 titer
Invaplex[AR-Detox] 10 μg	Geometric Mean Titer (GMT) of Serum Immunoglobulin A (IgA) Antibodies to Invaplex	Day 71 (28 days after dose 3)	2211.1 titer
Invaplex[AR-Detox] 10 μg	Geometric Mean Titer (GMT) of Serum Immunoglobulin A (IgA) Antibodies to Invaplex	Day 50 (7 days after dose 3)	2785.8 titer
Invaplex[AR-Detox] 10 μg	Geometric Mean Titer (GMT) of Serum Immunoglobulin A (IgA) Antibodies to Invaplex	Baseline	126.0 titer
Invaplex[AR-Detox] 10 μg	Geometric Mean Titer (GMT) of Serum Immunoglobulin A (IgA) Antibodies to Invaplex	Day 43 (pre-dose 3)	2425.1 titer
Invaplex[AR-Detox] 10 μg	Geometric Mean Titer (GMT) of Serum Immunoglobulin A (IgA) Antibodies to Invaplex	Day 22 (pre-dose 2)	2917.5 titer
Invaplex[AR-Detox] 10 μg	Geometric Mean Titer (GMT) of Serum Immunoglobulin A (IgA) Antibodies to Invaplex	Day 57 (14 days after dose 3)	3200.0 titer
Invaplex[AR-Detox] 25 μg	Geometric Mean Titer (GMT) of Serum Immunoglobulin A (IgA) Antibodies to Invaplex	Day 22 (pre-dose 2)	14576.5 titer
Invaplex[AR-Detox] 25 μg	Geometric Mean Titer (GMT) of Serum Immunoglobulin A (IgA) Antibodies to Invaplex	Day 43 (pre-dose 3)	9451.7 titer
Invaplex[AR-Detox] 25 μg	Geometric Mean Titer (GMT) of Serum Immunoglobulin A (IgA) Antibodies to Invaplex	Day 50 (7 days after dose 3)	11033.3 titer
Invaplex[AR-Detox] 25 μg	Geometric Mean Titer (GMT) of Serum Immunoglobulin A (IgA) Antibodies to Invaplex	Day 71 (28 days after dose 3)	9451.7 titer
Invaplex[AR-Detox] 25 μg	Geometric Mean Titer (GMT) of Serum Immunoglobulin A (IgA) Antibodies to Invaplex	Day 57 (14 days after dose 3)	10307.1 titer
Invaplex[AR-Detox] 25 μg	Geometric Mean Titer (GMT) of Serum Immunoglobulin A (IgA) Antibodies to Invaplex	Baseline	141.4 titer
Placebo	Geometric Mean Titer (GMT) of Serum Immunoglobulin A (IgA) Antibodies to Invaplex	Day 57 (14 days after dose 3)	178.2 titer
Placebo	Geometric Mean Titer (GMT) of Serum Immunoglobulin A (IgA) Antibodies to Invaplex	Day 71 (28 days after dose 3)	211.9 titer
Placebo	Geometric Mean Titer (GMT) of Serum Immunoglobulin A (IgA) Antibodies to Invaplex	Day 22 (pre-dose 2)	188.8 titer
Placebo	Geometric Mean Titer (GMT) of Serum Immunoglobulin A (IgA) Antibodies to Invaplex	Day 50 (7 days after dose 3)	149.8 titer
Placebo	Geometric Mean Titer (GMT) of Serum Immunoglobulin A (IgA) Antibodies to Invaplex	Baseline	200.0 titer
Placebo	Geometric Mean Titer (GMT) of Serum Immunoglobulin A (IgA) Antibodies to Invaplex	Day 43 (pre-dose 3)	165.6 titer

Comparison: Kruskal-Wallis test of any difference between the 3 active dose groups in GMT at Baselinep-value: 0.504Kruskal-Wallis

Comparison: Kruskal-Wallis test of any difference between the 3 active dose groups in GMT at Day 22p-value: 0.01Kruskal-Wallis

Comparison: Kruskal-Wallis test of any difference between the 3 active dose groups in GMT at Day 43p-value: 0.038Kruskal-Wallis

Comparison: Kruskal-Wallis test of any difference between the 3 active dose groups in GMT at Day 50p-value: 0.016Kruskal-Wallis

Comparison: Kruskal-Wallis test of any difference between the 3 active dose groups in GMT at Day 57p-value: 0.058Kruskal-Wallis

Comparison: Kruskal-Wallis test of any difference between the 3 active dose groups in GMT at Day 71p-value: 0.038Kruskal-Wallis

Secondary

Geometric Mean Titer (GMT) of Serum Immunoglobulin G (IgG) Antibodies to Invaplex

Time frame: Days 1 (Baseline), 22, 43, 50, 57 and 71.

Population: The immunogenicity population includes all participants who received at least two vaccinations, who had baseline and post-vaccination data for the immunogenicity variable of interest

Arm	Measure	Group	Value (GEOMETRIC_MEAN)
Invaplex[AR-Detox] 2.5 μg	Geometric Mean Titer (GMT) of Serum Immunoglobulin G (IgG) Antibodies to Invaplex	Baseline	1516.9 titer
Invaplex[AR-Detox] 2.5 μg	Geometric Mean Titer (GMT) of Serum Immunoglobulin G (IgG) Antibodies to Invaplex	Day 22 (pre-dose 2)	15020.3 titer
Invaplex[AR-Detox] 2.5 μg	Geometric Mean Titer (GMT) of Serum Immunoglobulin G (IgG) Antibodies to Invaplex	Day 43 (pre-dose 3)	25600.0 titer
Invaplex[AR-Detox] 2.5 μg	Geometric Mean Titer (GMT) of Serum Immunoglobulin G (IgG) Antibodies to Invaplex	Day 50 (7 days after dose 3)	27122.3 titer
Invaplex[AR-Detox] 2.5 μg	Geometric Mean Titer (GMT) of Serum Immunoglobulin G (IgG) Antibodies to Invaplex	Day 57 (14 days after dose 3)	34171.9 titer
Invaplex[AR-Detox] 2.5 μg	Geometric Mean Titer (GMT) of Serum Immunoglobulin G (IgG) Antibodies to Invaplex	Day 71 (28 days after dose 3)	36203.9 titer
Invaplex[AR-Detox] 10 μg	Geometric Mean Titer (GMT) of Serum Immunoglobulin G (IgG) Antibodies to Invaplex	Day 71 (28 days after dose 3)	42559.4 titer
Invaplex[AR-Detox] 10 μg	Geometric Mean Titer (GMT) of Serum Immunoglobulin G (IgG) Antibodies to Invaplex	Day 50 (7 days after dose 3)	37050.1 titer
Invaplex[AR-Detox] 10 μg	Geometric Mean Titer (GMT) of Serum Immunoglobulin G (IgG) Antibodies to Invaplex	Baseline	1269.9 titer
Invaplex[AR-Detox] 10 μg	Geometric Mean Titer (GMT) of Serum Immunoglobulin G (IgG) Antibodies to Invaplex	Day 43 (pre-dose 3)	29406.7 titer
Invaplex[AR-Detox] 10 μg	Geometric Mean Titer (GMT) of Serum Immunoglobulin G (IgG) Antibodies to Invaplex	Day 22 (pre-dose 2)	22286.1 titer
Invaplex[AR-Detox] 10 μg	Geometric Mean Titer (GMT) of Serum Immunoglobulin G (IgG) Antibodies to Invaplex	Day 57 (14 days after dose 3)	44572.2 titer
Invaplex[AR-Detox] 25 μg	Geometric Mean Titer (GMT) of Serum Immunoglobulin G (IgG) Antibodies to Invaplex	Day 22 (pre-dose 2)	75613.5 titer
Invaplex[AR-Detox] 25 μg	Geometric Mean Titer (GMT) of Serum Immunoglobulin G (IgG) Antibodies to Invaplex	Day 43 (pre-dose 3)	106933.6 titer
Invaplex[AR-Detox] 25 μg	Geometric Mean Titer (GMT) of Serum Immunoglobulin G (IgG) Antibodies to Invaplex	Day 50 (7 days after dose 3)	113058.8 titer
Invaplex[AR-Detox] 25 μg	Geometric Mean Titer (GMT) of Serum Immunoglobulin G (IgG) Antibodies to Invaplex	Day 71 (28 days after dose 3)	106933.6 titer
Invaplex[AR-Detox] 25 μg	Geometric Mean Titer (GMT) of Serum Immunoglobulin G (IgG) Antibodies to Invaplex	Day 57 (14 days after dose 3)	116612.0 titer
Invaplex[AR-Detox] 25 μg	Geometric Mean Titer (GMT) of Serum Immunoglobulin G (IgG) Antibodies to Invaplex	Baseline	2166.8 titer
Placebo	Geometric Mean Titer (GMT) of Serum Immunoglobulin G (IgG) Antibodies to Invaplex	Day 57 (14 days after dose 3)	2015.9 titer
Placebo	Geometric Mean Titer (GMT) of Serum Immunoglobulin G (IgG) Antibodies to Invaplex	Day 71 (28 days after dose 3)	1425.4 titer
Placebo	Geometric Mean Titer (GMT) of Serum Immunoglobulin G (IgG) Antibodies to Invaplex	Day 22 (pre-dose 2)	1795.9 titer
Placebo	Geometric Mean Titer (GMT) of Serum Immunoglobulin G (IgG) Antibodies to Invaplex	Day 50 (7 days after dose 3)	1795.9 titer
Placebo	Geometric Mean Titer (GMT) of Serum Immunoglobulin G (IgG) Antibodies to Invaplex	Baseline	1695.1 titer
Placebo	Geometric Mean Titer (GMT) of Serum Immunoglobulin G (IgG) Antibodies to Invaplex	Day 43 (pre-dose 3)	1704.1 titer

Comparison: Kruskal-Wallis test of any difference between the 3 active dose groups in GMT at Baselinep-value: 0.129Kruskal-Wallis

Comparison: Kruskal-Wallis test of any difference between the 3 active dose groups in GMT at Day 22p-value: 0.017Kruskal-Wallis

Comparison: Kruskal-Wallis test of any difference between the 3 active dose groups in GMT at Day 43p-value: 0.008Kruskal-Wallis

Comparison: Kruskal-Wallis test of any difference between the 3 active dose groups in GMT at Day 50p-value: 0.011Kruskal-Wallis

Comparison: Kruskal-Wallis test of any difference between the 3 active dose groups in GMT at Day 57p-value: 0.029Kruskal-Wallis

Comparison: Kruskal-Wallis test of any difference between the 3 active dose groups in GMT at Day 71p-value: 0.042Kruskal-Wallis

Secondary

Geometric Mean Titer of Immunoglobulin G Antibodies to Invaplex in α4β7+ Antibody in Lymphocyte Supernatant

Time frame: Days 1 (Baseline), 8, 29, and 50

Population: The immunogenicity population includes all participants who received at least two vaccinations, who had baseline and post-vaccination data for the immunogenicity variable of interest

Arm	Measure	Group	Value (GEOMETRIC_MEAN)
Invaplex[AR-Detox] 2.5 μg	Geometric Mean Titer of Immunoglobulin G Antibodies to Invaplex in α4β7+ Antibody in Lymphocyte Supernatant	Baseline	1.2 titer
Invaplex[AR-Detox] 2.5 μg	Geometric Mean Titer of Immunoglobulin G Antibodies to Invaplex in α4β7+ Antibody in Lymphocyte Supernatant	Day 8 (7 days after dose 1)	310.6 titer
Invaplex[AR-Detox] 2.5 μg	Geometric Mean Titer of Immunoglobulin G Antibodies to Invaplex in α4β7+ Antibody in Lymphocyte Supernatant	Day 29 (7 days after dose 2)	23.6 titer
Invaplex[AR-Detox] 2.5 μg	Geometric Mean Titer of Immunoglobulin G Antibodies to Invaplex in α4β7+ Antibody in Lymphocyte Supernatant	Day 50 (7 days after dose 3)	13.9 titer
Invaplex[AR-Detox] 10 μg	Geometric Mean Titer of Immunoglobulin G Antibodies to Invaplex in α4β7+ Antibody in Lymphocyte Supernatant	Day 8 (7 days after dose 1)	220.1 titer
Invaplex[AR-Detox] 10 μg	Geometric Mean Titer of Immunoglobulin G Antibodies to Invaplex in α4β7+ Antibody in Lymphocyte Supernatant	Day 29 (7 days after dose 2)	56.1 titer
Invaplex[AR-Detox] 10 μg	Geometric Mean Titer of Immunoglobulin G Antibodies to Invaplex in α4β7+ Antibody in Lymphocyte Supernatant	Day 50 (7 days after dose 3)	71.2 titer
Invaplex[AR-Detox] 10 μg	Geometric Mean Titer of Immunoglobulin G Antibodies to Invaplex in α4β7+ Antibody in Lymphocyte Supernatant	Baseline	1.1 titer
Invaplex[AR-Detox] 25 μg	Geometric Mean Titer of Immunoglobulin G Antibodies to Invaplex in α4β7+ Antibody in Lymphocyte Supernatant	Day 29 (7 days after dose 2)	80.8 titer
Invaplex[AR-Detox] 25 μg	Geometric Mean Titer of Immunoglobulin G Antibodies to Invaplex in α4β7+ Antibody in Lymphocyte Supernatant	Day 8 (7 days after dose 1)	806.7 titer
Invaplex[AR-Detox] 25 μg	Geometric Mean Titer of Immunoglobulin G Antibodies to Invaplex in α4β7+ Antibody in Lymphocyte Supernatant	Day 50 (7 days after dose 3)	65.4 titer
Invaplex[AR-Detox] 25 μg	Geometric Mean Titer of Immunoglobulin G Antibodies to Invaplex in α4β7+ Antibody in Lymphocyte Supernatant	Baseline	1.1 titer
Placebo	Geometric Mean Titer of Immunoglobulin G Antibodies to Invaplex in α4β7+ Antibody in Lymphocyte Supernatant	Day 50 (7 days after dose 3)	1.1 titer
Placebo	Geometric Mean Titer of Immunoglobulin G Antibodies to Invaplex in α4β7+ Antibody in Lymphocyte Supernatant	Day 8 (7 days after dose 1)	1.5 titer
Placebo	Geometric Mean Titer of Immunoglobulin G Antibodies to Invaplex in α4β7+ Antibody in Lymphocyte Supernatant	Baseline	1.3 titer
Placebo	Geometric Mean Titer of Immunoglobulin G Antibodies to Invaplex in α4β7+ Antibody in Lymphocyte Supernatant	Day 29 (7 days after dose 2)	1.1 titer

Comparison: Kruskal-Wallis test of any difference between the 3 active dose groups in GMT at Baselinep-value: 0.762Kruskal-Wallis

Comparison: Kruskal-Wallis test of any difference between the 3 active dose groups in GMT at Day 8p-value: 0.335Kruskal-Wallis

Comparison: Kruskal-Wallis test of any difference between the 3 active dose groups in GMT at Day 29p-value: 0.229Kruskal-Wallis

Comparison: Kruskal-Wallis test of any difference between the 3 active dose groups in GMT at Day 50p-value: 0.102Kruskal-Wallis

Secondary

Percentage of Participants With a ≥ 4-fold Increase in ALS IgA From Baseline

Seroconversion was defined as ≥ 4-fold increase in antibody titer from Baseline.

Time frame: Days 1 (Baseline), 8, 29, and 50

Population: The immunogenicity population includes all participants who received at least two vaccinations, who had baseline and post-vaccination data for the immunogenicity variable of interest.

Arm	Measure	Group	Value (NUMBER)
Invaplex[AR-Detox] 2.5 μg	Percentage of Participants With a ≥ 4-fold Increase in ALS IgA From Baseline	Day 8 (7 days after dose 1)	92.3 percentage of participants
Invaplex[AR-Detox] 2.5 μg	Percentage of Participants With a ≥ 4-fold Increase in ALS IgA From Baseline	Day 50 (7 days after dose 3)	50.0 percentage of participants
Invaplex[AR-Detox] 2.5 μg	Percentage of Participants With a ≥ 4-fold Increase in ALS IgA From Baseline	Day 29 (7 days after dose 2)	76.9 percentage of participants
Invaplex[AR-Detox] 10 μg	Percentage of Participants With a ≥ 4-fold Increase in ALS IgA From Baseline	Day 8 (7 days after dose 1)	86.7 percentage of participants
Invaplex[AR-Detox] 10 μg	Percentage of Participants With a ≥ 4-fold Increase in ALS IgA From Baseline	Day 50 (7 days after dose 3)	40.0 percentage of participants
Invaplex[AR-Detox] 10 μg	Percentage of Participants With a ≥ 4-fold Increase in ALS IgA From Baseline	Day 29 (7 days after dose 2)	73.3 percentage of participants
Invaplex[AR-Detox] 25 μg	Percentage of Participants With a ≥ 4-fold Increase in ALS IgA From Baseline	Day 29 (7 days after dose 2)	66.7 percentage of participants
Invaplex[AR-Detox] 25 μg	Percentage of Participants With a ≥ 4-fold Increase in ALS IgA From Baseline	Day 8 (7 days after dose 1)	93.8 percentage of participants
Invaplex[AR-Detox] 25 μg	Percentage of Participants With a ≥ 4-fold Increase in ALS IgA From Baseline	Day 50 (7 days after dose 3)	42.9 percentage of participants
Placebo	Percentage of Participants With a ≥ 4-fold Increase in ALS IgA From Baseline	Day 8 (7 days after dose 1)	8.3 percentage of participants
Placebo	Percentage of Participants With a ≥ 4-fold Increase in ALS IgA From Baseline	Day 50 (7 days after dose 3)	0.0 percentage of participants
Placebo	Percentage of Participants With a ≥ 4-fold Increase in ALS IgA From Baseline	Day 29 (7 days after dose 2)	0.0 percentage of participants

Comparison: Fisher's exact 2-tail tests of differences between the 3 Invaplex\[AR-Detox\] dose groups in seroconversion rates at Day 8p-value: 0.828Fisher Exact

Comparison: Fisher's exact 2-tail tests of differences between the 3 Invaplex\[AR-Detox\] dose groups in seroconversion rates at Day 29p-value: 0.913Fisher Exact

Comparison: Fisher's exact 2-tail tests of differences between the 3 Invaplex\[AR-Detox\] dose groups in seroconversion rates at Day 50p-value: 0.924Fisher Exact

Secondary

Percentage of Participants With a ≥ 4-fold Increase in ALS IgG From Baseline

Seroconversion was defined as ≥ 4-fold increase in antibody titer from Baseline.

Time frame: Days 1 (Baseline), 8, 29, and 50

Population: The immunogenicity population includes all participants who received at least two vaccinations, who had baseline and post-vaccination data for the immunogenicity variable of interest

Arm	Measure	Group	Value (NUMBER)
Invaplex[AR-Detox] 2.5 μg	Percentage of Participants With a ≥ 4-fold Increase in ALS IgG From Baseline	Day 8 (7 days after dose 1)	100.0 percentage of participants
Invaplex[AR-Detox] 2.5 μg	Percentage of Participants With a ≥ 4-fold Increase in ALS IgG From Baseline	Day 50 (7 days after dose 3)	83.3 percentage of participants
Invaplex[AR-Detox] 2.5 μg	Percentage of Participants With a ≥ 4-fold Increase in ALS IgG From Baseline	Day 29 (7 days after dose 2)	76.9 percentage of participants
Invaplex[AR-Detox] 10 μg	Percentage of Participants With a ≥ 4-fold Increase in ALS IgG From Baseline	Day 8 (7 days after dose 1)	93.3 percentage of participants
Invaplex[AR-Detox] 10 μg	Percentage of Participants With a ≥ 4-fold Increase in ALS IgG From Baseline	Day 50 (7 days after dose 3)	86.7 percentage of participants
Invaplex[AR-Detox] 10 μg	Percentage of Participants With a ≥ 4-fold Increase in ALS IgG From Baseline	Day 29 (7 days after dose 2)	93.3 percentage of participants
Invaplex[AR-Detox] 25 μg	Percentage of Participants With a ≥ 4-fold Increase in ALS IgG From Baseline	Day 29 (7 days after dose 2)	93.3 percentage of participants
Invaplex[AR-Detox] 25 μg	Percentage of Participants With a ≥ 4-fold Increase in ALS IgG From Baseline	Day 8 (7 days after dose 1)	93.8 percentage of participants
Invaplex[AR-Detox] 25 μg	Percentage of Participants With a ≥ 4-fold Increase in ALS IgG From Baseline	Day 50 (7 days after dose 3)	92.9 percentage of participants
Placebo	Percentage of Participants With a ≥ 4-fold Increase in ALS IgG From Baseline	Day 8 (7 days after dose 1)	8.3 percentage of participants
Placebo	Percentage of Participants With a ≥ 4-fold Increase in ALS IgG From Baseline	Day 50 (7 days after dose 3)	0.0 percentage of participants
Placebo	Percentage of Participants With a ≥ 4-fold Increase in ALS IgG From Baseline	Day 29 (7 days after dose 2)	0.0 percentage of participants

Comparison: Fisher's exact 2-tail tests of differences between the 3 Invaplex\[AR-Detox\] dose groups in seroconversion rates at Day 8p-value: >0.999Fisher Exact

Comparison: Fisher's exact 2-tail tests of differences between the 3 Invaplex\[AR-Detox\] dose groups in seroconversion rates at Day 29p-value: 0.412Fisher Exact

Comparison: Fisher's exact 2-tail tests of differences between the 3 Invaplex\[AR-Detox\] dose groups in seroconversion rates at Day 50p-value: 0.847Fisher Exact

Secondary

Percentage of Participants With a ≥ 4-fold Increase in Serum IgA Antibodies From Baseline

Seroconversion was defined as ≥ 4-fold increase in antibody titer from Baseline.

Time frame: Days 1 (Baseline), 22 43, 50, 57 and 71

Population: The immunogenicity population includes all participants who received at least two vaccinations, who had baseline and post-vaccination data for the immunogenicity variable of interest.

Arm	Measure	Group	Value (NUMBER)
Invaplex[AR-Detox] 2.5 μg	Percentage of Participants With a ≥ 4-fold Increase in Serum IgA Antibodies From Baseline	Day 57 (14 days after dose 3)	100.0 percentage of participants
Invaplex[AR-Detox] 2.5 μg	Percentage of Participants With a ≥ 4-fold Increase in Serum IgA Antibodies From Baseline	Day 43 (pre-dose 3)	100.0 percentage of participants
Invaplex[AR-Detox] 2.5 μg	Percentage of Participants With a ≥ 4-fold Increase in Serum IgA Antibodies From Baseline	Day 71 (28 days after dose 3)	91.7 percentage of participants
Invaplex[AR-Detox] 2.5 μg	Percentage of Participants With a ≥ 4-fold Increase in Serum IgA Antibodies From Baseline	Day 50 (7 days after dose 3)	100.0 percentage of participants
Invaplex[AR-Detox] 2.5 μg	Percentage of Participants With a ≥ 4-fold Increase in Serum IgA Antibodies From Baseline	Day 22 (pre-dose 2)	92.3 percentage of participants
Invaplex[AR-Detox] 10 μg	Percentage of Participants With a ≥ 4-fold Increase in Serum IgA Antibodies From Baseline	Day 50 (7 days after dose 3)	93.3 percentage of participants
Invaplex[AR-Detox] 10 μg	Percentage of Participants With a ≥ 4-fold Increase in Serum IgA Antibodies From Baseline	Day 57 (14 days after dose 3)	93.3 percentage of participants
Invaplex[AR-Detox] 10 μg	Percentage of Participants With a ≥ 4-fold Increase in Serum IgA Antibodies From Baseline	Day 71 (28 days after dose 3)	86.7 percentage of participants
Invaplex[AR-Detox] 10 μg	Percentage of Participants With a ≥ 4-fold Increase in Serum IgA Antibodies From Baseline	Day 43 (pre-dose 3)	86.7 percentage of participants
Invaplex[AR-Detox] 10 μg	Percentage of Participants With a ≥ 4-fold Increase in Serum IgA Antibodies From Baseline	Day 22 (pre-dose 2)	86.7 percentage of participants
Invaplex[AR-Detox] 25 μg	Percentage of Participants With a ≥ 4-fold Increase in Serum IgA Antibodies From Baseline	Day 50 (7 days after dose 3)	92.9 percentage of participants
Invaplex[AR-Detox] 25 μg	Percentage of Participants With a ≥ 4-fold Increase in Serum IgA Antibodies From Baseline	Day 22 (pre-dose 2)	93.8 percentage of participants
Invaplex[AR-Detox] 25 μg	Percentage of Participants With a ≥ 4-fold Increase in Serum IgA Antibodies From Baseline	Day 43 (pre-dose 3)	93.8 percentage of participants
Invaplex[AR-Detox] 25 μg	Percentage of Participants With a ≥ 4-fold Increase in Serum IgA Antibodies From Baseline	Day 57 (14 days after dose 3)	93.8 percentage of participants
Invaplex[AR-Detox] 25 μg	Percentage of Participants With a ≥ 4-fold Increase in Serum IgA Antibodies From Baseline	Day 71 (28 days after dose 3)	93.8 percentage of participants
Placebo	Percentage of Participants With a ≥ 4-fold Increase in Serum IgA Antibodies From Baseline	Day 57 (14 days after dose 3)	0.0 percentage of participants
Placebo	Percentage of Participants With a ≥ 4-fold Increase in Serum IgA Antibodies From Baseline	Day 43 (pre-dose 3)	0.0 percentage of participants
Placebo	Percentage of Participants With a ≥ 4-fold Increase in Serum IgA Antibodies From Baseline	Day 22 (pre-dose 2)	0.0 percentage of participants
Placebo	Percentage of Participants With a ≥ 4-fold Increase in Serum IgA Antibodies From Baseline	Day 50 (7 days after dose 3)	0.0 percentage of participants
Placebo	Percentage of Participants With a ≥ 4-fold Increase in Serum IgA Antibodies From Baseline	Day 71 (28 days after dose 3)	0.0 percentage of participants

Comparison: Fisher's exact 2-tail test of the difference between the 3 Invaplex\[AR-Detox\] dose groups in seroconversion rates at Day 22.p-value: 0.828Fisher Exact

Comparison: Fisher's exact 2-tail test of the difference between the 3 Invaplex\[AR-Detox\] dose groups in seroconversion rates at Day 43p-value: 0.629Fisher Exact

Comparison: Fisher's exact 2-tail test of the difference between the 3 Invaplex\[AR-Detox\] dose groups in seroconversion rates at Day 50p-value: >0.999Fisher Exact

Comparison: Fisher's exact 2-tail test of the difference between the 3 Invaplex\[AR-Detox\] dose groups in seroconversion rates at Day 57p-value: >0.999Fisher Exact

Comparison: Fisher's exact 2-tail test of the difference between the 3 Invaplex\[AR-Detox\] dose groups in seroconversion rates at Day 71p-value: 0.825Fisher Exact

Secondary

Percentage of Participants With a ≥ 4-fold Increase in Serum IgG Antibodies From Baseline

Seroconversion was defined as ≥ 4-fold increase in antibody titer from Baseline.

Time frame: Days 1 (Baseline), 22 43, 50, 57 and 71

Population: The immunogenicity population includes all participants who received at least two vaccinations, who had baseline and post-vaccination data for the immunogenicity variable of interest

Arm	Measure	Group	Value (NUMBER)
Invaplex[AR-Detox] 2.5 μg	Percentage of Participants With a ≥ 4-fold Increase in Serum IgG Antibodies From Baseline	Day 57 (14 days after dose 3)	100.0 percentage of participants
Invaplex[AR-Detox] 2.5 μg	Percentage of Participants With a ≥ 4-fold Increase in Serum IgG Antibodies From Baseline	Day 43 (pre-dose 3)	84.6 percentage of participants
Invaplex[AR-Detox] 2.5 μg	Percentage of Participants With a ≥ 4-fold Increase in Serum IgG Antibodies From Baseline	Day 71 (28 days after dose 3)	100.0 percentage of participants
Invaplex[AR-Detox] 2.5 μg	Percentage of Participants With a ≥ 4-fold Increase in Serum IgG Antibodies From Baseline	Day 50 (7 days after dose 3)	91.7 percentage of participants
Invaplex[AR-Detox] 2.5 μg	Percentage of Participants With a ≥ 4-fold Increase in Serum IgG Antibodies From Baseline	Day 22 (pre-dose 2)	69.2 percentage of participants
Invaplex[AR-Detox] 10 μg	Percentage of Participants With a ≥ 4-fold Increase in Serum IgG Antibodies From Baseline	Day 50 (7 days after dose 3)	100.0 percentage of participants
Invaplex[AR-Detox] 10 μg	Percentage of Participants With a ≥ 4-fold Increase in Serum IgG Antibodies From Baseline	Day 57 (14 days after dose 3)	100.0 percentage of participants
Invaplex[AR-Detox] 10 μg	Percentage of Participants With a ≥ 4-fold Increase in Serum IgG Antibodies From Baseline	Day 71 (28 days after dose 3)	100.0 percentage of participants
Invaplex[AR-Detox] 10 μg	Percentage of Participants With a ≥ 4-fold Increase in Serum IgG Antibodies From Baseline	Day 43 (pre-dose 3)	100.0 percentage of participants
Invaplex[AR-Detox] 10 μg	Percentage of Participants With a ≥ 4-fold Increase in Serum IgG Antibodies From Baseline	Day 22 (pre-dose 2)	100.0 percentage of participants
Invaplex[AR-Detox] 25 μg	Percentage of Participants With a ≥ 4-fold Increase in Serum IgG Antibodies From Baseline	Day 50 (7 days after dose 3)	100. percentage of participants
Invaplex[AR-Detox] 25 μg	Percentage of Participants With a ≥ 4-fold Increase in Serum IgG Antibodies From Baseline	Day 22 (pre-dose 2)	100.0 percentage of participants
Invaplex[AR-Detox] 25 μg	Percentage of Participants With a ≥ 4-fold Increase in Serum IgG Antibodies From Baseline	Day 43 (pre-dose 3)	100.0 percentage of participants
Invaplex[AR-Detox] 25 μg	Percentage of Participants With a ≥ 4-fold Increase in Serum IgG Antibodies From Baseline	Day 57 (14 days after dose 3)	100.0 percentage of participants
Invaplex[AR-Detox] 25 μg	Percentage of Participants With a ≥ 4-fold Increase in Serum IgG Antibodies From Baseline	Day 71 (28 days after dose 3)	100.0 percentage of participants
Placebo	Percentage of Participants With a ≥ 4-fold Increase in Serum IgG Antibodies From Baseline	Day 57 (14 days after dose 3)	.0 percentage of participants
Placebo	Percentage of Participants With a ≥ 4-fold Increase in Serum IgG Antibodies From Baseline	Day 43 (pre-dose 3)	0.0 percentage of participants
Placebo	Percentage of Participants With a ≥ 4-fold Increase in Serum IgG Antibodies From Baseline	Day 22 (pre-dose 2)	0.0 percentage of participants
Placebo	Percentage of Participants With a ≥ 4-fold Increase in Serum IgG Antibodies From Baseline	Day 50 (7 days after dose 3)	0.0 percentage of participants
Placebo	Percentage of Participants With a ≥ 4-fold Increase in Serum IgG Antibodies From Baseline	Day 71 (28 days after dose 3)	0.0 percentage of participants

Comparison: Fisher's exact 2-tail test of the difference between the 3 Invaplex\[AR-Detox\] dose groups in seroconversion rates at Day 22.p-value: 0.005Fisher Exact

Comparison: Fisher's exact 2-tail test of the difference between the 3 Invaplex\[AR-Detox\] dose groups in seroconversion rates at Day 43p-value: 0.082Fisher Exact

Comparison: Fisher's exact 2-tail test of the difference between the 3 Invaplex\[AR-Detox\] dose groups in seroconversion rates at Day 50p-value: 0.293Fisher Exact

Comparison: Fisher's exact 2-tail test of the difference between the 3 Invaplex\[AR-Detox\] dose groups in seroconversion rates at Day 57p-value: >0.999Fisher Exact

Comparison: Fisher's exact 2-tail test of the difference between the 3 Invaplex\[AR-Detox\] dose groups in seroconversion rates at Day 71p-value: >0.999Fisher Exact

Source: ClinicalTrials.gov · Data processed: Feb 6, 2026

Dose Escalating Study of Intramuscular Invaplex[AR-DETOX]

Conditions

Keywords

Brief summary

Detailed description

Related papers

Interventions

Sponsors

Study design

Eligibility

Inclusion criteria

Exclusion criteria

Design outcomes

Primary

Secondary

Countries

Participant flow

Recruitment details

Pre-assignment details

Participants by arm

Withdrawals & dropouts

Baseline characteristics

Adverse events

Outcome results

Number of Participants With Solicited Adverse Events After Dose 3

Number of Participants With Solicited Adverse Events Up to 7 Days After Dose 1

Number of Participants With Solicited Adverse Events Up to 7 Days After Dose 2

Number of Participants With Unsolicited Adverse Events After Each Dose

Percentage of Participants With Adverse Events

Geometric Mean Fold-rise (GMFR) in Serum IgA From Baseline

Geometric Mean Fold-rise in ALS IgA From Baseline

Geometric Mean Fold-rise in ALS IgG From Baseline

Geometric Mean Fold-rise in Serum IgG From Baseline

Geometric Mean Titer (GMT) of Immunoglobulin A Antibodies to Invaplex in α4β7+ Antibody in Lymphocyte Supernatant (ALS)

Geometric Mean Titer (GMT) of Serum Immunoglobulin A (IgA) Antibodies to Invaplex

Geometric Mean Titer (GMT) of Serum Immunoglobulin G (IgG) Antibodies to Invaplex

Geometric Mean Titer of Immunoglobulin G Antibodies to Invaplex in α4β7+ Antibody in Lymphocyte Supernatant

Percentage of Participants With a ≥ 4-fold Increase in ALS IgA From Baseline

Percentage of Participants With a ≥ 4-fold Increase in ALS IgG From Baseline

Percentage of Participants With a ≥ 4-fold Increase in Serum IgA Antibodies From Baseline

Percentage of Participants With a ≥ 4-fold Increase in Serum IgG Antibodies From Baseline