NCT03869333 is a Phase 1 clinical trial of Invaplex[AR-DETOX] in Diarrhea, sponsored by PATH.

Who is sponsoring NCT03869333?

NCT03869333 is sponsored by PATH.

What drugs are being tested in NCT03869333?

Interventions in NCT03869333: Invaplex[AR-DETOX], Placebo.

Is NCT03869333 still recruiting?

NCT03869333 is currently completed. Last updated 29 July 2021.

Are results published for NCT03869333?

Yes — primary outcome results have been posted to ClinicalTrials.gov. See the outcomes section above for details.

Last reviewed 2021-07-29 · How we verify

NCT03869333

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

Dose Escalating Study of Intramuscular Invaplex[AR-DETOX]

Completed Phase 1 Results posted Last updated 29 July 2021

What this trial tests

Phase 1 trial testing Invaplex[AR-DETOX] in Diarrhea in 58 participants. Completed in 12 June 2020.

Timeline

18 March 2019

Primary endpoint
12 June 2020

12 June 2020

Quick facts

Lead sponsor	PATH
Phase	Phase 1
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	sequential
Masking	quadruple
Primary purpose	prevention
Enrollment	58
Start date	18 March 2019
Primary completion	12 June 2020
Estimated completion	12 June 2020
Sites	1 location across United States

Drugs / interventions tested

Invaplex[AR-DETOX] — full drug profile →
Placebo

Conditions studied

Diarrhea — all drugs for Diarrhea →

Sponsor

PATH — full company profile →

Who can join

Adults 18 to 50, any sex, with Diarrhea. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Percentage of Participants With Adverse Events Primary · 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 * Inpa

Any adverse event (AE)

Group	Value	95% CI
Invaplex[AR-Detox] 2.5 μg	100	76.84 – 100.00
Invaplex[AR-Detox] 10 μg	100.0	79.41 – 100.00
Invaplex[AR-Detox] 25 μg	100.0	79.41 – 100.00
Placebo	91.7	61.52 – 99.79

Any Grade 2 or greater AE

Group	Value	95% CI
Invaplex[AR-Detox] 2.5 μg	50.0	23.04 – 76.96
Invaplex[AR-Detox] 10 μg	56.3	29.88 – 80.25
Invaplex[AR-Detox] 25 μg	43.8	19.75 – 70.12
Placebo	25.0	5.49 – 57.19

Any AE related to study drug

Group	Value	95% CI
Invaplex[AR-Detox] 2.5 μg	100.0	76.84 – 100.00
Invaplex[AR-Detox] 10 μg	100.0	79.41 – 100.00
Invaplex[AR-Detox] 25 μg	100.0	79.41 – 100.00
Placebo	58.3	27.67 – 84.83

Any Grade 2 or greater AE related to study drug

Group	Value	95% CI
Invaplex[AR-Detox] 2.5 μg	14.3	1.78 – 42.81
Invaplex[AR-Detox] 10 μg	43.8	19.75 – 70.12
Invaplex[AR-Detox] 25 μg	31.3	11.02 – 58.66
Placebo	8.3	0.21 – 38.48

Any serious adverse event (SAE)

Group	Value	95% CI
Invaplex[AR-Detox] 2.5 μg	0.0	0.00 – 23.16
Invaplex[AR-Detox] 10 μg	0.0	0.00 – 20.59
Invaplex[AR-Detox] 25 μg	0.0	0.00 – 20.59
Placebo	0.0	0.00 – 26.46

Any SAE related to study drug

Group	Value	95% CI
Invaplex[AR-Detox] 2.5 μg	0.0	0.00 – 23.16
Invaplex[AR-Detox] 10 μg	0.0	0.00 – 20.59
Invaplex[AR-Detox] 25 μg	0.0	0.00 – 20.59
Placebo	0.0	0.00 – 26.46

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

Any Solicited AE

Group	Value	95% CI
Invaplex[AR-Detox] 2.5 μg	13
Invaplex[AR-Detox] 10 μg	16
Invaplex[AR-Detox] 25 μg	16
Placebo	6

Abdominal pain

Group	Value	95% CI
Invaplex[AR-Detox] 2.5 μg	0
Invaplex[AR-Detox] 10 μg	1
Invaplex[AR-Detox] 25 μg	2
Placebo	1

Appetite disorder

Group	Value	95% CI
Invaplex[AR-Detox] 2.5 μg	0
Invaplex[AR-Detox] 10 μg	1
Invaplex[AR-Detox] 25 μg	2
Placebo	0

Arthralgia

Group	Value	95% CI
Invaplex[AR-Detox] 2.5 μg	2
Invaplex[AR-Detox] 10 μg	1
Invaplex[AR-Detox] 25 μg	2
Placebo	0

Diarrhoea

Group	Value	95% CI
Invaplex[AR-Detox] 2.5 μg	2
Invaplex[AR-Detox] 10 μg	2
Invaplex[AR-Detox] 25 μg	0
Placebo	3

Fatigue

Group	Value	95% CI
Invaplex[AR-Detox] 2.5 μg	1
Invaplex[AR-Detox] 10 μg	4
Invaplex[AR-Detox] 25 μg	6
Placebo	2

Headache

Group	Value	95% CI
Invaplex[AR-Detox] 2.5 μg	3
Invaplex[AR-Detox] 10 μg	6
Invaplex[AR-Detox] 25 μg	3
Placebo	1

Malaise

Group	Value	95% CI
Invaplex[AR-Detox] 2.5 μg	2
Invaplex[AR-Detox] 10 μg	1
Invaplex[AR-Detox] 25 μg	6
Placebo	2

Number of Participants With Solicited Adverse Events Up to 7 Days After Dose 2 Primary · 7 days after the second immunization (Days 22 to 28)

Any Solicited AE

Group	Value	95% CI
Invaplex[AR-Detox] 2.5 μg	12
Invaplex[AR-Detox] 10 μg	15
Invaplex[AR-Detox] 25 μg	15
Placebo	4

Abdominal pain

Group	Value	95% CI
Invaplex[AR-Detox] 2.5 μg	1
Invaplex[AR-Detox] 10 μg	2
Invaplex[AR-Detox] 25 μg	1
Placebo	0

Appetite disorder

Group	Value	95% CI
Invaplex[AR-Detox] 2.5 μg	2
Invaplex[AR-Detox] 10 μg	2
Invaplex[AR-Detox] 25 μg	1
Placebo	0

Arthralgia

Group	Value	95% CI
Invaplex[AR-Detox] 2.5 μg	1
Invaplex[AR-Detox] 10 μg	0
Invaplex[AR-Detox] 25 μg	1
Placebo	0

Diarrhoea

Group	Value	95% CI
Invaplex[AR-Detox] 2.5 μg	0
Invaplex[AR-Detox] 10 μg	3
Invaplex[AR-Detox] 25 μg	0
Placebo	1

Fatigue

Group	Value	95% CI
Invaplex[AR-Detox] 2.5 μg	2
Invaplex[AR-Detox] 10 μg	3
Invaplex[AR-Detox] 25 μg	2
Placebo	1

Headache

Group	Value	95% CI
Invaplex[AR-Detox] 2.5 μg	2
Invaplex[AR-Detox] 10 μg	2
Invaplex[AR-Detox] 25 μg	1
Placebo	2

Malaise

Group	Value	95% CI
Invaplex[AR-Detox] 2.5 μg	1
Invaplex[AR-Detox] 10 μg	3
Invaplex[AR-Detox] 25 μg	3
Placebo	0

Number of Participants With Solicited Adverse Events After Dose 3 Primary · 7 days after the third immunization (Days 43 to 49)

Any Solicited AE

Group	Value	95% CI
Invaplex[AR-Detox] 2.5 μg	11
Invaplex[AR-Detox] 10 μg	15
Invaplex[AR-Detox] 25 μg	13
Placebo	5

Abdominal pain

Group	Value	95% CI
Invaplex[AR-Detox] 2.5 μg	0
Invaplex[AR-Detox] 10 μg	2
Invaplex[AR-Detox] 25 μg	1
Placebo	0

Appetite disorder

Group	Value	95% CI
Invaplex[AR-Detox] 2.5 μg	0
Invaplex[AR-Detox] 10 μg	1
Invaplex[AR-Detox] 25 μg	0
Placebo	0

Arthralgia

Group	Value	95% CI
Invaplex[AR-Detox] 2.5 μg	0
Invaplex[AR-Detox] 10 μg	1
Invaplex[AR-Detox] 25 μg	0
Placebo	1

Fatigue

Group	Value	95% CI
Invaplex[AR-Detox] 2.5 μg	2
Invaplex[AR-Detox] 10 μg	4
Invaplex[AR-Detox] 25 μg	2
Placebo	0

Headache

Group	Value	95% CI
Invaplex[AR-Detox] 2.5 μg	0
Invaplex[AR-Detox] 10 μg	5
Invaplex[AR-Detox] 25 μg	2
Placebo	1

Malaise

Group	Value	95% CI
Invaplex[AR-Detox] 2.5 μg	0
Invaplex[AR-Detox] 10 μg	4
Invaplex[AR-Detox] 25 μg	1
Placebo	0

Myalgia

Group	Value	95% CI
Invaplex[AR-Detox] 2.5 μg	1
Invaplex[AR-Detox] 10 μg	2
Invaplex[AR-Detox] 25 μg	1
Placebo	1

Number of Participants With Unsolicited Adverse Events After Each Dose Primary · Dose 1: Days 1 to 21; Dose 2: Days 22 to 42; Dose 3: Days 43 to 71

Unsolicited adverse events after first dose

Group	Value	95% CI
Invaplex[AR-Detox] 2.5 μg	5
Invaplex[AR-Detox] 10 μg	5
Invaplex[AR-Detox] 25 μg	5
Placebo	6

Unsolicited adverse events after second dose

Group	Value	95% CI
Invaplex[AR-Detox] 2.5 μg	7
Invaplex[AR-Detox] 10 μg	6
Invaplex[AR-Detox] 25 μg	4
Placebo	5

Unsolicited adverse events after third dose

Group	Value	95% CI
Invaplex[AR-Detox] 2.5 μg	4
Invaplex[AR-Detox] 10 μg	5
Invaplex[AR-Detox] 25 μg	6
Placebo	2

Geometric Mean Titer (GMT) of Serum Immunoglobulin A (IgA) Antibodies to Invaplex Secondary · Days 1 (Baseline), 22, 43, 50, 57 and 71.

Baseline

Group	Value	95% CI
Invaplex[AR-Detox] 2.5 μg	189.6	101.3 – 355.1
Invaplex[AR-Detox] 10 μg	126.0	NA – 206.8
Invaplex[AR-Detox] 25 μg	141.4	NA – 246.6
Placebo	200.0	117.6 – 340.2

Day 22 (pre-dose 2)

Group	Value	95% CI
Invaplex[AR-Detox] 2.5 μg	3560.1	1077.5 – 11762.5
Invaplex[AR-Detox] 10 μg	2917.5	1607.8 – 5294.0
Invaplex[AR-Detox] 25 μg	14576.5	7212.2 – 29460.2
Placebo	188.8	127.0 – 280.6

Day 43 (pre-dose 3)

Group	Value	95% CI
Invaplex[AR-Detox] 2.5 μg	3375.3	955.5 – 11922.4
Invaplex[AR-Detox] 10 μg	2425.1	1443.2 – 4075.3
Invaplex[AR-Detox] 25 μg	9451.7	4631.8 – 19287.4
Placebo	165.6	NA – 276.8

Day 50 (7 days after dose 3)

Group	Value	95% CI
Invaplex[AR-Detox] 2.5 μg	3200.0	975.8 – 10494.3
Invaplex[AR-Detox] 10 μg	2785.8	1612.5 – 4812.6
Invaplex[AR-Detox] 25 μg	11033.3	5649.8 – 21546.2
Placebo	149.8	NA – 241.5

Day 57 (14 days after dose 3)

Group	Value	95% CI
Invaplex[AR-Detox] 2.5 μg	4271.5	1293.7 – 14103.6
Invaplex[AR-Detox] 10 μg	3200.0	1729.1 – 5922.1
Invaplex[AR-Detox] 25 μg	10307.1	5419.5 – 19602.9
Placebo	178.2	109.1 – 291.1

Day 71 (28 days after dose 3)

Group	Value	95% CI
Invaplex[AR-Detox] 2.5 μg	4031.7	1063.9 – 15279.1
Invaplex[AR-Detox] 10 μg	2211.1	1158.1 – 4221.3
Invaplex[AR-Detox] 25 μg	9451.7	4883.7 – 18292.3
Placebo	211.9	126.9 – 353.9

Geometric Mean Titer (GMT) of Serum Immunoglobulin G (IgG) Antibodies to Invaplex Secondary · Days 1 (Baseline), 22, 43, 50, 57 and 71.

Baseline

Group	Value	95% CI
Invaplex[AR-Detox] 2.5 μg	1516.9	850.2 – 2706.4
Invaplex[AR-Detox] 10 μg	1269.9	592.0 – 2723.9
Invaplex[AR-Detox] 25 μg	2166.8	1308.9 – 3587.0
Placebo	1695.1	830.0 – 3461.9

Day 22 (pre-dose 2)

Group	Value	95% CI
Invaplex[AR-Detox] 2.5 μg	15020.3	4474.5 – 50421.6
Invaplex[AR-Detox] 10 μg	22286.1	11426.7 – 43465.7
Invaplex[AR-Detox] 25 μg	75613.5	41386.6 – 138146.2
Placebo	1795.9	916.5 – 3519.3

Day 43 (pre-dose 3)

Group	Value	95% CI
Invaplex[AR-Detox] 2.5 μg	25600.0	8027.0 – 81644.6
Invaplex[AR-Detox] 10 μg	29406.7	15572.4 – 55531.0
Invaplex[AR-Detox] 25 μg	106933.6	65186.0 – 175418.1
Placebo	1704.1	696.6 – 4168.8

Day 50 (7 days after dose 3)

Group	Value	95% CI
Invaplex[AR-Detox] 2.5 μg	27122.3	8727.4 – 84288.0
Invaplex[AR-Detox] 10 μg	37050.1	20418.3 – 67229.4
Invaplex[AR-Detox] 25 μg	113058.8	70861.9 – 180383.0
Placebo	1795.9	996.7 – 3236.2

Day 57 (14 days after dose 3)

Group	Value	95% CI
Invaplex[AR-Detox] 2.5 μg	34171.9	11722.7 – 99611.8
Invaplex[AR-Detox] 10 μg	44572.2	22853.4 – 86931.5
Invaplex[AR-Detox] 25 μg	116612.0	79218.2 – 171656.8
Placebo	2015.9	1135.8 – 3577.8

Day 71 (28 days after dose 3)

Group	Value	95% CI
Invaplex[AR-Detox] 2.5 μg	36203.9	13769.6 – 95189.5
Invaplex[AR-Detox] 10 μg	42559.4	23621.8 – 76679.4
Invaplex[AR-Detox] 25 μg	106933.6	65186.0 – 175418.1
Placebo	1425.4	747.1 – 2719.6

Geometric Mean Titer (GMT) of Immunoglobulin A Antibodies to Invaplex in α4β7+ Antibody in Lymphocyte Supernatant (ALS) Secondary · Days 1 (Baseline), 8, 29, and 50

Baseline

Group	Value	95% CI
Invaplex[AR-Detox] 2.5 μg	1.1	0.9 – 1.2
Invaplex[AR-Detox] 10 μg	1.3	1.0 – 1.7
Invaplex[AR-Detox] 25 μg	1.1	1.0 – 1.3
Placebo	1.0	NA – NA

Day 8 (7 days after dose 1)

Group	Value	95% CI
Invaplex[AR-Detox] 2.5 μg	139.6	36.1 – 539.9
Invaplex[AR-Detox] 10 μg	115.2	21.6 – 614.4
Invaplex[AR-Detox] 25 μg	275.5	62.1 – 1222.3
Placebo	1.2	0.9 – 1.6

Day 29 (7 days after dose 2)

Group	Value	95% CI
Invaplex[AR-Detox] 2.5 μg	19.4	5.8 – 64.7
Invaplex[AR-Detox] 10 μg	11.0	4.0 – 30.7
Invaplex[AR-Detox] 25 μg	8.8	3.8 – 20.6
Placebo	1.1	0.9 – 1.2

Day 50 (7 days after dose 3)

Group	Value	95% CI
Invaplex[AR-Detox] 2.5 μg	4.8	1.8 – 13.2
Invaplex[AR-Detox] 10 μg	4.0	1.8 – 8.7
Invaplex[AR-Detox] 25 μg	4.4	2.2 – 9.0
Placebo	0.0	NA – NA

Geometric Mean Titer of Immunoglobulin G Antibodies to Invaplex in α4β7+ Antibody in Lymphocyte Supernatant Secondary · Days 1 (Baseline), 8, 29, and 50

Baseline

Group	Value	95% CI
Invaplex[AR-Detox] 2.5 μg	1.2	1.0 – 1.6
Invaplex[AR-Detox] 10 μg	1.1	1.0 – 1.3
Invaplex[AR-Detox] 25 μg	1.1	1.0 – 1.3
Placebo	1.3	0.7 – 2.5

Day 8 (7 days after dose 1)

Group	Value	95% CI
Invaplex[AR-Detox] 2.5 μg	310.6	76.6 – 1259.2
Invaplex[AR-Detox] 10 μg	220.1	38.3 – 1266.3
Invaplex[AR-Detox] 25 μg	806.7	192.9 – 3373.5
Placebo	1.5	0.9 – 2.6

Day 29 (7 days after dose 2)

Group	Value	95% CI
Invaplex[AR-Detox] 2.5 μg	23.6	7.1 – 78.3
Invaplex[AR-Detox] 10 μg	56.1	14.5 – 217.0
Invaplex[AR-Detox] 25 μg	80.8	31.8 – 205.0
Placebo	1.1	0.9 – 1.2

Day 50 (7 days after dose 3)

Group	Value	95% CI
Invaplex[AR-Detox] 2.5 μg	13.9	5.0 – 38.2
Invaplex[AR-Detox] 10 μg	71.2	20.5 – 246.5
Invaplex[AR-Detox] 25 μg	65.4	17.8 – 240.2
Placebo	1.1	0.9 – 1.2

Percentage of Participants With a ≥ 4-fold Increase in Serum IgA Antibodies From Baseline Secondary · Days 1 (Baseline), 22 43, 50, 57 and 71

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

Day 22 (pre-dose 2)

Group	Value	95% CI
Invaplex[AR-Detox] 2.5 μg	92.3	63.97 – 99.81
Invaplex[AR-Detox] 10 μg	86.7	59.54 – 98.34
Invaplex[AR-Detox] 25 μg	93.8	69.77 – 99.84
Placebo	0.0	0.00 – 26.46

Day 43 (pre-dose 3)

Group	Value	95% CI
Invaplex[AR-Detox] 2.5 μg	100.0	75.29 – 100.00
Invaplex[AR-Detox] 10 μg	86.7	59.54 – 98.34
Invaplex[AR-Detox] 25 μg	93.8	69.77 – 99.84
Placebo	0.0	0.00 – 28.49

Day 50 (7 days after dose 3)

Group	Value	95% CI
Invaplex[AR-Detox] 2.5 μg	100.0	73.54 – 100.00
Invaplex[AR-Detox] 10 μg	93.3	68.05 – 99.83
Invaplex[AR-Detox] 25 μg	92.9	66.13 – 99.82
Placebo	0.0	0.00 – 26.46

Day 57 (14 days after dose 3)

Group	Value	95% CI
Invaplex[AR-Detox] 2.5 μg	100.0	73.54 – 100.00
Invaplex[AR-Detox] 10 μg	93.3	68.05 – 99.83
Invaplex[AR-Detox] 25 μg	93.8	69.77 – 99.84
Placebo	0.0	0.00 – 26.46

Day 71 (28 days after dose 3)

Group	Value	95% CI
Invaplex[AR-Detox] 2.5 μg	91.7	61.52 – 99.79
Invaplex[AR-Detox] 10 μg	86.7	59.54 – 98.34
Invaplex[AR-Detox] 25 μg	93.8	69.77 – 99.84
Placebo	0.0	0.00 – 26.46

Percentage of Participants With a ≥ 4-fold Increase in Serum IgG Antibodies From Baseline Secondary · Days 1 (Baseline), 22 43, 50, 57 and 71

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

Day 22 (pre-dose 2)

Group	Value	95% CI
Invaplex[AR-Detox] 2.5 μg	69.2	38.57 – 90.91
Invaplex[AR-Detox] 10 μg	100.0	78.20 – 100.00
Invaplex[AR-Detox] 25 μg	100.0	79.41 – 100.00
Placebo	0.0	0.00 – 26.46

Day 43 (pre-dose 3)

Group	Value	95% CI
Invaplex[AR-Detox] 2.5 μg	84.6	54.55 – 98.08
Invaplex[AR-Detox] 10 μg	100.0	78.20 – 100.00
Invaplex[AR-Detox] 25 μg	100.0	79.41 – 100.00
Placebo	0.0	0.00 – 28.49

Day 50 (7 days after dose 3)

Group	Value	95% CI
Invaplex[AR-Detox] 2.5 μg	91.7	61.52 – 99.79
Invaplex[AR-Detox] 10 μg	100.0	78.20 – 100.00
Invaplex[AR-Detox] 25 μg	100.	76.84 – 100.00
Placebo	0.0	0.00 – 26.46

Day 57 (14 days after dose 3)

Group	Value	95% CI
Invaplex[AR-Detox] 2.5 μg	100.0	73.54 – 100.00
Invaplex[AR-Detox] 10 μg	100.0	78.20 – 100.0
Invaplex[AR-Detox] 25 μg	100.0	79.41 – 100.00
Placebo	.0	0.00 – 26.46

Day 71 (28 days after dose 3)

Group	Value	95% CI
Invaplex[AR-Detox] 2.5 μg	100.0	73.54 – 100.00
Invaplex[AR-Detox] 10 μg	100.0	78.20 – 100.00
Invaplex[AR-Detox] 25 μg	100.0	79.41 – 100.00
Placebo	0.0	0.00 – 26.46

Percentage of Participants With a ≥ 4-fold Increase in ALS IgA From Baseline Secondary · Days 1 (Baseline), 8, 29, and 50

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

Day 8 (7 days after dose 1)

Group	Value	95% CI
Invaplex[AR-Detox] 2.5 μg	92.3	63.97 – 99.81
Invaplex[AR-Detox] 10 μg	86.7	59.54 – 98.34
Invaplex[AR-Detox] 25 μg	93.8	69.77 – 99.84
Placebo	8.3	0.21 – 38.48

Day 29 (7 days after dose 2)

Group	Value	95% CI
Invaplex[AR-Detox] 2.5 μg	76.9	46.19 – 94.96
Invaplex[AR-Detox] 10 μg	73.3	44.90 – 92.21
Invaplex[AR-Detox] 25 μg	66.7	38.38 – 88.18
Placebo	0.0	0.00 – 26.46

Day 50 (7 days after dose 3)

Group	Value	95% CI
Invaplex[AR-Detox] 2.5 μg	50.0	21.09 – 78.91
Invaplex[AR-Detox] 10 μg	40.0	16.34 – 67.71
Invaplex[AR-Detox] 25 μg	42.9	17.66 – 71.14
Placebo	0.0	0.00 – 26.46

Adverse events — posted to ClinicalTrials.gov

Time frame: From first dose up to 28 days following the third immunization (71 days). Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Invaplex[AR-Detox] 2.5 μg

Serious: 0/14 (0%)

Deaths: 0/14

Invaplex[AR-Detox] 10 μg

Serious: 0/16 (0%)

Deaths: 0/16

Invaplex[AR-Detox] 25 μg

Serious: 0/16 (0%)

Deaths: 0/16

Placebo

Serious: 0/12 (0%)

Deaths: 0/12

Other adverse events (47 terms — click to expand)

Reaction	System	Invaplex[AR-Detox] 2.5 μg	Invaplex[AR-Detox] 10 μg	Invaplex[AR-Detox] 25 μg	Placebo
Vaccination site pain	General disorders	—	—	—	—
Vaccination site erythema	General disorders	—	—	—	—
Fatigue	General disorders	—	—	—	—
Malaise	General disorders	—	—	—	—
Headache	Nervous system disorders	—	—	—	—
Vaccination site induration	General disorders	—	—	—	—
Vaccination site swelling	General disorders	—	—	—	—
Haemoglobin decreased	Investigations	—	—	—	—
Diarrhea	Gastrointestinal disorders	—	—	—	—
Vaccination site pruritus	General disorders	—	—	—	—
Abdominal pain	Gastrointestinal disorders	—	—	—	—
Upper respiratory tract infection	Infections and infestations	—	—	—	—
Nausea	Gastrointestinal disorders	—	—	—	—
Pyrexia	General disorders	—	—	—	—
Appetite disorder	Metabolism and nutrition disorders	—	—	—	—
Hyperkalaemia	Metabolism and nutrition disorders	—	—	—	—
Arthralgia	Musculoskeletal and connective tissue disorders	—	—	—	—
Myalgia	Musculoskeletal and connective tissue disorders	—	—	—	—
Leukopenia	Blood and lymphatic system disorders	—	—	—	—
Lymph node pain	Blood and lymphatic system disorders	—	—	—	—
Lymphadenopathy	Blood and lymphatic system disorders	—	—	—	—
Aspartate aminotransferase increased	Investigations	—	—	—	—
Neutropenia	Blood and lymphatic system disorders	—	—	—	—
Ear pain	Ear and labyrinth disorders	—	—	—	—
Gingival pain	Gastrointestinal disorders	—	—	—	—
Gingival swelling	Gastrointestinal disorders	—	—	—	—
Hordeolum	Infections and infestations	—	—	—	—
Nasopharyngitis	Infections and infestations	—	—	—	—
Oral herpes	Infections and infestations	—	—	—	—
Procedural pain	Injury, poisoning and procedural complications	—	—	—	—
Skin abrasion	Injury, poisoning and procedural complications	—	—	—	—
Stress fracture	Injury, poisoning and procedural complications	—	—	—	—
Hypernatraemia	Metabolism and nutrition disorders	—	—	—	—
Back pain	Musculoskeletal and connective tissue disorders	—	—	—	—
Neck pain	Musculoskeletal and connective tissue disorders	—	—	—	—
Pain in extremity	Musculoskeletal and connective tissue disorders	—	—	—	—
Dizziness	Nervous system disorders	—	—	—	—
Sciatica	Nervous system disorders	—	—	—	—
Cough	Respiratory, thoracic and mediastinal disorders	—	—	—	—
Nasal congestion	Respiratory, thoracic and mediastinal disorders	—	—	—	—

Data from ClinicalTrials.gov NCT03869333 adverse events section.

Sponsor's own description

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.

Publications & conference data

6 peer-reviewed publications reference this trial (live from Europe PMC):

Vaccines for Protecting Infants from Bacterial Causes of Diarrheal Disease.
Walker R, Kaminski RW, Porter C, Choy RKM, et al · · 2021 · cited 34× · PMID 34202102 · DOI 10.3390/microorganisms9071382
From Concept to Clinical Product: A Brief History of the Novel Shigella Invaplex Vaccine's Refinement and Evolution.
Turbyfill KR, Clarkson KA, Oaks EV, Kaminski RW. · · 2022 · cited 26× · PMID 35455297 · DOI 10.3390/vaccines10040548
Functional antibodies as immunological endpoints to evaluate protective immunity against Shigella.
Ndungo E, Pasetti MF. · · 2020 · cited 26× · PMID 31287754 · DOI 10.1080/21645515.2019.1640427
Glycoconjugate vaccines against Salmonella enterica serovars and Shigella species: existing and emerging methods for their analysis.
Bazhenova A, Gao F, Bolgiano B, Harding SE. · · 2021 · cited 11× · PMID 33868505 · DOI 10.1007/s12551-021-00791-z
Safety, Tolerability, and Immunogenicity of the InvaplexAR-DetoxShigella Vaccine Co-Administered with the dmLT Adjuvant in Dutch and Zambian Adults: Study Protocol for a Multi-Center, Randomized, Double-Blind, Placebo-Controlled, Dose-Escalation Phase Ia/b Clini
Roozen GVT, Sukwa N, Chirwa M, White JA, et al · · 2025 · cited 2× · PMID 39852827 · DOI 10.3390/vaccines13010048
Evaluation of a Quadrivalent Shigella flexneri Serotype 2a, 3a, 6, and Shigella sonnei O-Specific Polysaccharide and IpaB MAPS Vaccine.
Boerth EM, Gong J, Roffler B, Hancock Z, et al · · 2024 · cited 2× · PMID 39460258 · DOI 10.3390/vaccines12101091

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Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT03869333 (US National Library of Medicine, public domain)
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by PATH
Last refreshed: 29 July 2021

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03869333.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing

NCT03869333

Quick facts

Drugs / interventions tested

Conditions studied

Sponsor

Who can join

Results — posted to ClinicalTrials.gov

Adverse events — posted to ClinicalTrials.gov

Sponsor's own description

Publications & conference data

Related trials

Other recruiting trials for Diarrhea

Other PATH trials

Verify against primary sources