A Phase 1 interventional study of CssBA and dmLT in Diarrhea, sponsored by PATH. Completed at 1 site in United States. Open to participants aged 18 Years to 45 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2021-01-06.
Sponsored by PATH · Phase 1, Interventional, and Prevention
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Among 10 studies in Diarrhea by PATH — none open to participants now, none under way, none of them phase 3. Diarrhea · PATH.
Among the 10 studies in Diarrhea by PATH, this one is the only one that started in 2018, is one of 4 in phase 1, and was the 9th registered.
878 studies on the registry are indexed under Diarrhea; 77 are open to participants now.
Browse Diarrhea studies →None of the 10 studies in Diarrhea by PATH is open now. The open studies under Diarrhea, anywhere →
Of the 45 Diarrhea studies recruiting now, 21 (47%) set no upper age limit and 22 (49%) stop at 75 or younger; 19 take children under 18; 15 take healthy volunteers.
This study: 18 Years to 45 Years · all sexes · healthy volunteers too.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
10 studies; the count open now beside each. This study's row is marked.
A study in two phases is counted once above. Listed by phase, each with its combined phases: Phase 1 5 · Phase 2 2 · Phase 4 1
First in 2008; this study’s year is marked. 1 started in 2018.
This study's enrollment of 50 is below the median of 138 across 739 interventional studies indexed under Diarrhea.
Median enrollment 54 across the 8 interventional studies, 271 across the 2 observational. Of the 9 that completed or were terminated, 6 (67%) have results posted.
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PATH is the lead sponsor of 113 studies on the registry; 7 are open to participants now.
Of its 10 completed or terminated interventional studies of FDA-regulated products, 10 (100%) have results posted.
None of the studies under way reaches primary completion within a year.
Among the 10 studies in Diarrhea by PATH, from their registry updates:
Nothing recorded among them since 2026-09-25.
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This study will evaluate the safety of a prototype Coli surface antigen 6 (CS6) subunit vaccine (CssBA) alone or in combination with Escherichia coli double mutant heat labile toxin (dmLT) given by intramuscular (IM) injection.
This is an open-label clinical trial in which a total of 50 participants will receive three injections of either CssBA alone, dmLT alone or CssBA + dmLT. The vaccine will be administered via IM injection to alternating deltoid regions on days 1, 22, and 43. Each participant will receive the same dose at each vaccination dependent upon group assignment. Group A is considered a pilot group in which all 3 doses will be administered and participants monitored for safety 7 days after the third vaccination, prior to the enrollment of participants in Group B.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.
Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.
Hepatitis C is a virus that infects the liver. An HCV antibody test can stay positive after an infection has cleared (and is occasionally positive without one); an HCV RNA test shows whether the virus is there now.
After treatment, hepatitis C counts as cured when HCV RNA is still undetectable 12 weeks or more after the treatment ended. Studies often accept people cured this way.
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Clinically significant
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Immunosuppression
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hepatitis B tests
Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.
Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hepatitis C tests
Hepatitis C is a virus that infects the liver. An HCV antibody test can stay positive after an infection has cleared (and is occasionally positive without one); an HCV RNA test shows whether the virus is there now.
After treatment, hepatitis C counts as cured when HCV RNA is still undetectable 12 weeks or more after the treatment ended. Studies often accept people cured this way.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
HIV
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Participants received an intramuscular injection of 5 ug CssBA on days 1, 22, and 43.
Biological: CssBA
Participants received an intramuscular injection of 100 ng DmLT on days 1, 22, and 43.
Biological: dmLT
Participants received an intramuscular injection of 5 ug CssBA + 100 ng dmLT on days 1, 22, and 43.
Biological: CssBA · Biological: dmLT
Participants received an intramuscular injection of 5 ug CssBA + 500 ng dmLT on days 1, 22, and 43.
Biological: CssBA · Biological: dmLT
Participants received an intramuscular injection of 15 ug CssBA + 500 ng dmLT on days 1, 22, and 43.
Biological: CssBA · Biological: dmLT
Participants received an intramuscular injection of 45 ug CssBA + 500 ng dmLT on days 1, 22, and 43.
Biological: CssBA · Biological: dmLT
Recombinant enterotoxigenic Escherichia coli (ETEC) surface antigen 6 containing modified structural subunits A and B
Also known as: spd_dsc16Bntd14CssBAB7A[His]₆
Escherichia coli double mutant heat-labile toxin with mutations at amino acids 192 and 211
Number of Participants With Solicited Adverse Events
Solicited adverse events included vaccine site pain, vaccine site pruritus, vaccine site rash/eruption, vaccine site swelling, vaccine site tenderness, fever, headache, diarrhea, arthralgia, myalgia, malaise, nausea, and vomiting. Adverse events were assessed for severity by the investigator according to the following: Mild (Grade 1): Does not interfere with routine activities, minimal level of discomfort Moderate (Grade 2): Interferes with routine activities, moderate level of discomfort Severe (Grade 3): Unable to perform routine activities, significant level of discomfort Potentially life-threatening (Grade 4): Hospitalization or emergency room (ER) visit for potentially life-threatening event
Time frame: From first vaccination to 28 days after the third vaccination, 71 days.
Number of Participants With Unsolicited Adverse Events
Adverse events were assessed for severity by the investigator according to the following: Mild (Grade 1): Does not interfere with routine activities Minimal level of discomfort Moderate (Grade 2): Interferes with routine activities Moderate level of discomfort Severe (Grade 3): Unable to perform routine activities Significant level of discomfort Potentially life-threatening (Grade 4): Hospitalization or emergency room (ER) visit for potentially life-threatening event
Time frame: From first vaccination to 28 days after the third vaccination, 71 days.
Percentage of Participants With a Serum Immunologic Response to Coli Surface Antigen 6 (CS6)
Serum samples were assayed for immunoglobulin G (IgG) and immunoglobulin A (IgA) antibody titers against CS6 using an enzyme-linked Immunosorbent assay (ELISA). Immunologic response was defined as a ≥ 4-fold increase in reciprocal endpoint titer between Baseline and any post-vaccination sample.
Time frame: Baseline (Day 1 predose), Days 22 and 43 predose, and Day 70
Percentage of Participants With a Serum Immunologic Response to Labile Toxin
Serum samples were assayed for immunoglobulin G (IgG) and immunoglobulin A (IgA) antibody titers against labile toxin using an enzyme-linked Immunosorbent assay (ELISA). Immunologic response was defined as a ≥ 4-fold increase in reciprocal endpoint titer between Baseline and any post-vaccination sample.
Time frame: Baseline (Day 1 predose), Days 22 and 43 predose, and Day 70
Percentage of Participants With a Mucosal Immunologic Response to Coli Surface Antigen 6 (CS6)
Peripheral blood mononuclear cells (PBMCs) were collected to determine antibody responses from lymphocyte supernatant against CS6 at Baseline and 7 days after each vaccination. Antibody in lymphocyte supernatant (ALS) is an indirect quantification of antibody secreting cells (ASC) activated in the mucosa that circulate in the peripheral blood about seven days post-mucosal immunization/infection. After incubation, lymphocyte supernatant was assayed for antigen-specific IgG and IgA antibodies using ELISA. A positive ALS response was defined as a four-fold rise in antibody titers between Baseline and any post vaccination sample.
Time frame: Baseline (Day 1 pre-dose), Days 8 and 29 predose, and Day 50
Percentage of Participants With a Mucosal Immunologic Response to Labile Toxin
Peripheral blood mononuclear cells (PBMCs) were collected to determine antibody responses from lymphocyte supernatant against labile toxin at Baseline and 7 days after each vaccination. Antibody in lymphocyte supernatant (ALS) is an indirect quantification of antibody secreting cells (ASC) activated in the mucosa that circulate in the peripheral blood about seven days post-mucosal immunization/infection. After incubation, lymphocyte supernatant was assayed for antigen-specific IgG and IgA antibodies using ELISA. A positive ALS response was defined as a four-fold rise in antibody titers between Baseline and any post vaccination sample.
Time frame: Baseline (Day 1 pre-dose), Days 8 and 29 predose, and Day 50
Geometric Mean Titer of Serum Anti-CS6 Immunoglobulin G Antibodies
Serum samples were assayed for IgG antibody titers against CS6 using an enzyme-linked Immunosorbent assay (ELISA).
Time frame: Days 1, 22, and 43 pre-vaccination, and Day 70
Geometric Mean Titer of Serum Anti-CS6 Immunoglobulin A Antibodies
Serum samples were assayed for IgA antibody titers against CS6 using an enzyme-linked Immunosorbent assay (ELISA).
Time frame: Days 1, 22, and 43 pre-vaccination, and Day 70
Geometric Mean Titer of Serum Anti-LT Immunoglobulin G Antibodies
Serum samples were assayed for IgG antibody titers against labile toxin using an enzyme-linked Immunosorbent assay (ELISA).
Time frame: Days 1, 22, and 43 pre-vaccination, and Day 70
Geometric Mean Titer of Serum Anti-LT Immunoglobulin A Antibodies
Serum samples were assayed for IgA antibody titers against labile toxin using an enzyme-linked Immunosorbent assay (ELISA).
Time frame: Days 1, 22, and 43 pre-vaccination, and Day 70
Geometric Mean Titer of Antibody Lymphocyte Supernatant Anti-CS6 Immunoglobulin G Antibodies
Lymphocyte supernatant was assayed for IgG antibody titers against CS6 using ELISA.
Time frame: Days 1, 8, 29 and 50
Geometric Mean Titer of Antibody Lymphocyte Supernatant Anti-CS6 Immunoglobulin A Antibodies
Lymphocyte supernatant was assayed for IgA antibody titers against CS6 using ELISA.
Time frame: Days 1, 8, 29, and 50
Geometric Mean Titer of Antibody Lymphocyte Supernatant Anti-LT Immunoglobulin G Antibodies
Lymphocyte supernatant was assayed for IgG antibody titers against labile toxin using ELISA.
Time frame: Days 1, 8, 29, and 50
Geometric Mean Titer of Antibody Lymphocyte Supernatant Anti-LT Immunoglobulin A Antibodies
Lymphocyte supernatant was assayed for IgA antibody titers against labile toxin using ELISA.
Time frame: Days 1, 8, 29, and 50
Healthy adult men and women, civilian and active-duty military, were recruited from the Baltimore/Washington, DC area through the Walter Reed Army Institute of Research (WRAIR) Clinical Trials Center (CTC) by the use of advertisement in multiple media formats.
| Milestone | Group A1: CssBA 5 µg | Group A2: DmLT 100 ng | Group B: CssBA 5 µg + DmLT 100 ng | Group C: CssBA 5 µg + DmLT 500 ng | Group D: CssBA 15 µg + DmLT 500 ng | Group E: CssBA 45 µg + DmLT 500 ng |
|---|---|---|---|---|---|---|
| Started | 5 | 5 | 10 | 10 | 10 | 10 |
| Received dose 2 | 5 | 4 | 10 | 9 | 10 | 10 |
| Received dose 3 | 5 | 4 | 9 | 9 | 10 | 9 |
| Completed | 5 | 4 | 8 | 9 | 10 | 9 |
| Not completed | 0 | 1 | 2 | 1 | 0 | 1 |
| Withdrew: Inability to attend future visits | 0 | 1 | 1 | 0 | 0 | 0 |
| Withdrew: Behavioral problems | 0 | 0 | 1 | 0 | 0 | 0 |
| Withdrew: Started a medication that precluded eligibility | 0 | 0 | 0 | 1 | 0 | 1 |
Solicited adverse events included vaccine site pain, vaccine site pruritus, vaccine site rash/eruption, vaccine site swelling, vaccine site tenderness, fever, headache, diarrhea, arthralgia, myalgia, malaise, nausea, and vomiting. Adverse events were assessed for severity by the investigator according to the following: Mild (Grade 1): Does not interfere with routine activities, minimal level of discomfort Moderate (Grade 2): Interferes with routine activities, moderate level of discomfort Severe (Grade 3): Unable to perform routine activities, significant level of discomfort Potentially life-threatening (Grade 4): Hospitalization or emergency room (ER) visit for potentially life-threatening event
| Participants | Group A1: CssBA 5 µg | Group A2: DmLT 100 ng | Group B: CssBA 5 µg + DmLT 100 ng | Group C: CssBA 5 µg + DmLT 500 ng | Group D: CssBA 15 µg + DmLT 500 ng | Group E: CssBA 45 µg + DmLT 500 ng |
|---|---|---|---|---|---|---|
| Mild | 2 | 5 | 9 | 9 | 10 | 10 |
| Moderate | 0 | 0 | 2 | 1 | 2 | 2 |
| Severe | 0 | 0 | 0 | 0 | 1 | 0 |
| Life-threatening | 0 | 0 | 0 | 0 | 0 | 0 |
Serum samples were assayed for immunoglobulin G (IgG) and immunoglobulin A (IgA) antibody titers against CS6 using an enzyme-linked Immunosorbent assay (ELISA). Immunologic response was defined as a ≥ 4-fold increase in reciprocal endpoint titer between Baseline and any post-vaccination sample.
| percentage of participants | Group A1: CssBA 5 µg | Group A2: DmLT 100 ng | Group B: CssBA 5 µg + DmLT 100 ng | Group C: CssBA 5 µg + DmLT 500 ng | Group D: CssBA 15 µg + DmLT 500 ng | Group E: CssBA 45 µg + DmLT 500 ng |
|---|---|---|---|---|---|---|
| IgA response | 0.0 | 0.0 | 0.0 | 44.4 | 30.0 | 50.0 |
| IgG response | 20.0 | 0.0 | 77.8 | 100.0 | 100.0 | 90.0 |
Serum samples were assayed for immunoglobulin G (IgG) and immunoglobulin A (IgA) antibody titers against labile toxin using an enzyme-linked Immunosorbent assay (ELISA). Immunologic response was defined as a ≥ 4-fold increase in reciprocal endpoint titer between Baseline and any post-vaccination sample.
| percentage of participants | Group A1: CssBA 5 µg | Group A2: DmLT 100 ng | Group B: CssBA 5 µg + DmLT 100 ng | Group C: CssBA 5 µg + DmLT 500 ng | Group D: CssBA 15 µg + DmLT 500 ng | Group E: CssBA 45 µg + DmLT 500 ng |
|---|---|---|---|---|---|---|
| IgA response | 0.0 | 50.0 | 22.2 | 77.8 | 50.0 | 70.0 |
| IgG response | 0.0 | 100.0 | 66.7 | 100.0 | 90.0 | 100.0 |
Peripheral blood mononuclear cells (PBMCs) were collected to determine antibody responses from lymphocyte supernatant against CS6 at Baseline and 7 days after each vaccination. Antibody in lymphocyte supernatant (ALS) is an indirect quantification of antibody secreting cells (ASC) activated in the mucosa that circulate in the peripheral blood about seven days post-mucosal immunization/infection. After incubation, lymphocyte supernatant was assayed for antigen-specific IgG and IgA antibodies using ELISA. A positive ALS response was defined as a four-fold rise in antibody titers between Baseline and any post vaccination sample.
| percentage of participants | Group A1: CssBA 5 µg | Group A2: DmLT 100 ng | Group B: CssBA 5 µg + DmLT 100 ng | Group C: CssBA 5 µg + DmLT 500 ng | Group D: CssBA 15 µg + DmLT 500 ng | Group E: CssBA 45 µg + DmLT 500 ng |
|---|---|---|---|---|---|---|
| IgA response | 0.0 | 0.0 | 33.3 | 88.9 | 80.0 | 100.0 |
| IgG response | 60.0 | 0.0 | 100.0 | 88.9 | 100.0 | 80.0 |
Peripheral blood mononuclear cells (PBMCs) were collected to determine antibody responses from lymphocyte supernatant against labile toxin at Baseline and 7 days after each vaccination. Antibody in lymphocyte supernatant (ALS) is an indirect quantification of antibody secreting cells (ASC) activated in the mucosa that circulate in the peripheral blood about seven days post-mucosal immunization/infection. After incubation, lymphocyte supernatant was assayed for antigen-specific IgG and IgA antibodies using ELISA. A positive ALS response was defined as a four-fold rise in antibody titers between Baseline and any post vaccination sample.
| percentage of participants | Group A1: CssBA 5 µg | Group A2: DmLT 100 ng | Group B: CssBA 5 µg + DmLT 100 ng | Group C: CssBA 5 µg + DmLT 500 ng | Group D: CssBA 15 µg + DmLT 500 ng | Group E: CssBA 45 µg + DmLT 500 ng |
|---|---|---|---|---|---|---|
| IgA response | 0.0 | 100.0 | 22.2 | 77.8 | 90.0 | 100.0 |
| IgG response | 0.0 | 100.0 | 100.0 | 100.0 | 100.0 | 100.0 |
Serum samples were assayed for IgG antibody titers against CS6 using an enzyme-linked Immunosorbent assay (ELISA).
| titer | Group A1: CssBA 5 µg | Group A2: DmLT 100 ng | Group B: CssBA 5 µg + DmLT 100 ng | Group C: CssBA 5 µg + DmLT 500 ng | Group D: CssBA 15 µg + DmLT 500 ng | Group E: CssBA 45 µg + DmLT 500 ng |
|---|---|---|---|---|---|---|
| Day 1 (pre-vaccination) | 39.0 (18.2 to 83.6) | 29.6 (17.5 to 50.1) | 39.1 (22.2 to 69.1) | 36.9 (20.5 to 66.6) | 40.5 (24.6 to 66.7) | 51.5 (26.1 to 101.4) |
| Day 22 (pre-vaccination) | 40.2 (17.8 to 90.8) | 34.1 (12.9 to 90.7) | 28.2 (21.6 to 36.8) | 81.2 (16.6 to 396.6) | 80.1 (39.4 to 162.9) | 107.1 (28.3 to 405.7) |
| Day 43 (pre-vacination) | 57.4 (16.9 to 195) | 46.6 (14.5 to 149.8) | 108.9 (54.3 to 218.4) | 513.5 (77.2 to 3415.4) | 288.2 (100.2 to 829.2) | 958.3 (235.9 to 3893.4) |
| Day 70 (28 days after last vaccination) | 81.3 (19.0 to 346.7) | 29.4 (17.8 to 48.5) | 695.3 (182.1 to 2655.3) | 4631.2 (1462.3 to 14667.6) | 2520.4 (1199.2 to 5297.2) | 5167.1 (1298.8 to 20556.8) |
Serum samples were assayed for IgA antibody titers against CS6 using an enzyme-linked Immunosorbent assay (ELISA).
| titer | Group A1: CssBA 5 µg | Group A2: DmLT 100 ng | Group B: CssBA 5 µg + DmLT 100 ng | Group C: CssBA 5 µg + DmLT 500 ng | Group D: CssBA 15 µg + DmLT 500 ng | Group E: CssBA 45 µg + DmLT 500 ng |
|---|---|---|---|---|---|---|
| Day 1 (pre-vaccination) | 269.9 (133.6 to 545.1) | 213.4 (73.0 to 623.6) | 308.5 (181.4 to 524.4) | 330.0 (176.1 to 618.6) | 368.2 (192.3 to 705.0) | 370.8 (180.9 to 760.0) |
| Day 22 (pre-vaccination) | 294.3 (128.7 to 672.9) | 215 (64.9 to 712.4) | 285.1 (172.9 to 469.9) | 846.9 (189.1 to 3792.6) | 408.0 (223.1 to 746.1) | 523.5 (262.0 to 1045.9) |
| Day 43 (pre-vacination) | 260.9 (122.0 to 557.8) | 164.7 (47.5 to 571.3) | 328.7 (200.5 to 538.8) | 1571.0 (341.7 to 7222.1) | 505.2 (275.8 to 925.4) | 1188.9 (515.4 to 2742.6) |
| Day 70 (28 days after last vaccination) | 339.1 (143.6 to 800.6) | 218.0 (48.4 to 982.4) | 521.6 (236.5 to 1150.3) | 2483.1 (595.3 to 10357.2) | 970.3 (553.4 to 1701.4) | 2170.4 (1053.0 to 4473.7) |
Adverse events were assessed for severity by the investigator according to the following: Mild (Grade 1): Does not interfere with routine activities Minimal level of discomfort Moderate (Grade 2): Interferes with routine activities Moderate level of discomfort Severe (Grade 3): Unable to perform routine activities Significant level of discomfort Potentially life-threatening (Grade 4): Hospitalization or emergency room (ER) visit for potentially life-threatening event
| Participants | Group A1: CssBA 5 µg | Group A2: DmLT 100 ng | Group B: CssBA 5 µg + DmLT 100 ng | Group C: CssBA 5 µg + DmLT 500 ng | Group D: CssBA 15 µg + DmLT 500 ng | Group E: CssBA 45 µg + DmLT 500 ng |
|---|---|---|---|---|---|---|
| Mild | 4 | 3 | 5 | 6 | 10 | 9 |
| Moderate | 2 | 0 | 2 | 0 | 1 | 3 |
| Severe | 1 | 0 | 1 | 0 | 1 | 2 |
| Life-threatening | 0 | 0 | 0 | 0 | 0 | 0 |
Serum samples were assayed for IgG antibody titers against labile toxin using an enzyme-linked Immunosorbent assay (ELISA).
| titer | Group A1: CssBA 5 µg | Group A2: DmLT 100 ng | Group B: CssBA 5 µg + DmLT 100 ng | Group C: CssBA 5 µg + DmLT 500 ng | Group D: CssBA 15 µg + DmLT 500 ng | Group E: CssBA 45 µg + DmLT 500 ng |
|---|---|---|---|---|---|---|
| Day 1 (pre-vaccination) | 46.1 (16.4 to 129.7) | 25.1 (NA to NA) | 84.5 (31.8 to 224.0) | 88.9 (54.0 to 146.5) | 75.0 (37.4 to 150.4) | 48.8 (25.0 to 95.2) |
| Day 22 (pre-vaccination) | 48.3 (15.3 to 152.1) | 52.8 (11.4 to 243.9) | 172.9 (42.4 to 705.5) | 1010.3 (182.9 to 5579.8) | 235.0 (64.1 to 860.7) | 193.2 (80.0 to 466.6) |
| Day 43 (pre-vacination) | 46.3 (15.8 to 136.0) | 303.7 (39.8 to 2316.2) | 235.6 (67.5 to 822.0) | 2671.0 (754.2 to 9459.1) | 679.2 (256.7 to 1797.0) | 666.8 (339.7 to 1308.9) |
| Day 70 (28 days after last vaccination) | 55.0 (17.8 to 170.1) | 398.1 (91.9 to 1724.3) | 424.1 (159.7 to 1126.6) | 3114.1 (965.3 to 10046.6) | 1116.9 (467.8 to 2666.7) | 1086.4 (473.8 to 2491.2) |
Serum samples were assayed for IgA antibody titers against labile toxin using an enzyme-linked Immunosorbent assay (ELISA).
| titer | Group A1: CssBA 5 µg | Group A2: DmLT 100 ng | Group B: CssBA 5 µg + DmLT 100 ng | Group C: CssBA 5 µg + DmLT 500 ng | Group D: CssBA 15 µg + DmLT 500 ng | Group E: CssBA 45 µg + DmLT 500 ng |
|---|---|---|---|---|---|---|
| Day 1 (pre-vaccination) | 25.1 (NA to NA) | 25.1 (NA to NA) | 28.4 (21.4 to 37.7) | 25.8 (24.2 to 27.6) | 28.6 (21.3 to 38.5) | 25.1 (NA to NA) |
| Day 22 (pre-vaccination) | 25.1 (NA to NA) | 30.4 (16.6 to 55.6) | 55.8 (24.6 to 126.5) | 258.4 (49.3 to 1352.9) | 77.8 (35.3 to 171.3) | 134.6 (57.0 to 317.6) |
| Day 43 (pre-vacination) | 25.1 (NA to NA) | 46.2 (9.0 to 238.30) | 48.5 (22.0 to 107.0) | 317.9 (72.8 to 1388.5) | 75.9 (33.6 to 171.4) | 159.6 (62.8 to 405.3) |
| Day 70 (28 days after last vaccination) | 25.1 (NA to NA) | 66.1 (10.6 to 410.1) | 51.4 (20.9 to 126.4) | 202.1 (43.8 to 932.2) | 68.2 (29.9 to 155.6) | 121.1 (57.2 to 256.1) |
Lymphocyte supernatant was assayed for IgG antibody titers against CS6 using ELISA.
| titer | Group A1: CssBA 5 µg | Group A2: DmLT 100 ng | Group B: CssBA 5 µg + DmLT 100 ng | Group C: CssBA 5 µg + DmLT 500 ng | Group D: CssBA 15 µg + DmLT 500 ng | Group E: CssBA 45 µg + DmLT 500 ng |
|---|---|---|---|---|---|---|
| Day 1 (pre-vaccination) | 4.0 (NA to NA) | 4.0 (NA to NA) | 4.0 (NA to NA) | 5.7 (2.5 to 12.8) | 4. (NA to NA) | 4.0 (NA to NA) |
| Day 8 (7 days after 1st vaccination) | 4.0 (NA to NA) | 4.0 (NA to NA) | 5.0 (2.9 to 8.6) | 14.9 (3.2 to 70.3) | 8.5 (2.7 to 26.6) | 7.1 (3.0 to 17.0) |
| Day 29 (7 days after 2nd vacination) | 6.0 (2.0 to 18.4) | 4.0 (NA to NA) | 4.0 (NA to NA) | 42.9 (10.7 to 172.0) | 29.8 (8.2 to 108.6) | 47.4 (12.7 to 176.5) |
| Day 50 (7 days after 3rd vaccination) | 18.1 (3.1 to 106.4) | 4.0 (NA to NA) | 86.7 (43.1 to 174.4) | 356.9 (208.5 to 610.7) | 238.3 (115.3 to 492.3) | 142.8 (32.2 to 633.2) |
Lymphocyte supernatant was assayed for IgA antibody titers against CS6 using ELISA.
| titer | Group A1: CssBA 5 µg | Group A2: DmLT 100 ng | Group B: CssBA 5 µg + DmLT 100 ng | Group C: CssBA 5 µg + DmLT 500 ng | Group D: CssBA 15 µg + DmLT 500 ng | Group E: CssBA 45 µg + DmLT 500 ng |
|---|---|---|---|---|---|---|
| Day 1 (pre-vaccination) | 2.5 (NA to NA) | 2.5 (NA to NA) | 2.5 (NA to NA) | 2.5 (NA to NA) | 2.5 (NA to NA) | 2.5 (2.5 to 2.5) |
| Day 8 (7 days after 1st vaccination) | 2.5 (NA to NA) | 2.5 (NA to NA) | 2.5 (NA to NA) | 7.3 (1.3 to 42.2) | 2.5 (NA to NA) | 4.5 (1.9 to 10.8) |
| Day 29 (7 days after 2nd vacination) | 2.5 (NA to NA) | 2.5 (NA to NA) | 2.5 (NA to NA) | 17.5 (4.0 to 76.0) | 3.3 (1.8 to 6.0) | 33.1 (14.7 to 74.3) |
| Day 50 (7 days after 3rd vaccination) | 2.5 (NA to NA) | 2.5 (NA to NA) | 6.4 (2.1 to 19.6) | 46.6 (13.8 to 157.2) | 24.1 (8.5 to 68.7) | 35.2 (17.4 to 71.0) |
Lymphocyte supernatant was assayed for IgG antibody titers against labile toxin using ELISA.
| titer | Group A1: CssBA 5 µg | Group A2: DmLT 100 ng | Group B: CssBA 5 µg + DmLT 100 ng | Group C: CssBA 5 µg + DmLT 500 ng | Group D: CssBA 15 µg + DmLT 500 ng | Group E: CssBA 45 µg + DmLT 500 ng |
|---|---|---|---|---|---|---|
| Day 1 (pre-vaccination) | 2.5 (NA to NA) | 2.5 (NA to NA) | 3.5 (1.6 to 7.8) | 2.5 (NA to NA) | 3.1 (2.0 to 4.8) | 2.5 (NA to NA) |
| Day 8 (7 days after 1st vaccination) | 2.5 (NA to NA) | 2.5 (NA to NA) | 6.6 (1.5 to 29.2) | 24.0 (6.0 to 97.0) | 47.4 (8.7 to 258.8) | 17.6 (5.0 to 61.4) |
| Day 29 (7 days after 2nd vacination) | 2.5 (NA to NA) | 13.4 (0.6 to 305.9) | 10.0 (2.0 to 49.9) | 105.8 (60.7 to 184.3) | 80.7 (50.2 to 129.9) | 253.5 (116.5 to 551.8) |
| Day 50 (7 days after 3rd vaccination) | 2.5 (NA to NA) | 88.1 (48.2 to 161.0) | 70.0 (41.5 to 117.9) | 138.4 (102.0 to 187.7) | 123.3 (100.0 to 152.0) | 187.5 (101.9 to 345.0) |
Lymphocyte supernatant was assayed for IgA antibody titers against labile toxin using ELISA.
| titer | Group A1: CssBA 5 µg | Group A2: DmLT 100 ng | Group B: CssBA 5 µg + DmLT 100 ng | Group C: CssBA 5 µg + DmLT 500 ng | Group D: CssBA 15 µg + DmLT 500 ng | Group E: CssBA 45 µg + DmLT 500 ng |
|---|---|---|---|---|---|---|
| Day 1 (pre-vaccination) | 2.0 (NA to NA) | 2.0 (NA to NA) | 2.0 (NA to NA) | 2.8 (1.3 to 5.9) | 2.0 (NA to NA) | 2.0 (NA to NA) |
| Day 8 (7 days after 1st vaccination) | 2.0 (NA to NA) | 2.0 (NA to NA) | 3.0 (1.1 to 8.1) | 11.7 (2.9 to 46.9) | 12.7 (3.8 to 42.8) | 9.0 (2.8 to 28.2) |
| Day 29 (7 days after 2nd vacination) | 2.0 (NA to NA) | 9.9 (0.5 to 198.1) | 4.1 (1.4 to 12.4) | 28.7 (8.8 to 93.9) | 19.3 (7.9 to 47.3) | 60.5 (44.9 to 81.6) |
| Day 50 (7 days after 3rd vaccination) | 2.0 (NA to NA) | 13.3 (1.6 to 107.6) | 3.6 (1.4 to 9.5) | 24.7 (7.6 to 80.0) | 23.6 (8.5 to 65.4) | 18.7 (5.8 to 60.5) |
Collected over From the day of the first vaccination up to 28 days after the third vaccination, 71 days.. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Group A1: CssBA 5 µg | 0/5 (0%) | 0/5 (0%) | 4/5 (80%) |
| Group A2: DmLT 100 ng | 0/5 (0%) | 0/5 (0%) | 5/5 (100%) |
| Group B: CssBA 5 µg + DmLT 100 ng | 0/10 (0%) | 0/10 (0%) | 10/10 (100%) |
| Group C: CssBA 5 µg + DmLT 500 ng | 0/10 (0%) | 0/10 (0%) | 10/10 (100%) |
| Group D: CssBA 15 µg + DmLT 500 ng | 0/10 (0%) | 0/10 (0%) | 10/10 (100%) |
| Group E: CssBA 45 µg + DmLT 500 ng | 0/10 (0%) | 0/10 (0%) | 10/10 (100%) |
| Event | Group A1: CssBA 5 µg | Group A2: DmLT 100 ng | Group B: CssBA 5 µg + DmLT 100 ng | Group C: CssBA 5 µg + DmLT 500 ng | Group D: CssBA 15 µg + DmLT 500 ng | Group E: CssBA 45 µg + DmLT 500 ng |
|---|---|---|---|---|---|---|
| Vaccination Site PainGeneral disorders | 0/5 | 1/5 | 2/10 | 5/10 | 9/10 | 9/10 |
| Vaccination Site ErythemaGeneral disorders | 1/5 | 4/5 | 7/10 | 7/10 | 8/10 | 8/10 |
| Vaccination Site PruritusGeneral disorders | 0/5 | 0/5 | 1/10 | 1/10 | 7/10 | 0/10 |
| AnemiaBlood and lymphatic system disorders | 3/5 | 1/5 | 0/10 | 0/10 | 2/10 | 0/10 |
| Upper Respiratory Tract InfectionInfections and infestations | 2/5 | 0/5 | 1/10 | 1/10 | 2/10 | 6/10 |
| Vaccination Site IndurationGeneral disorders | 0/5 | 0/5 | 0/10 | 6/10 | 5/10 | 6/10 |
| HeadacheNervous system disorders | 1/5 | 0/5 | 6/10 | 2/10 | 3/10 | 2/10 |
| HyperkalemiaMetabolism and nutrition disorders | 0/5 | 0/5 | 1/10 | 0/10 | 3/10 | 4/10 |
| Systolic HypertensionVascular disorders | 2/5 | 0/5 | 0/10 | 0/10 | 0/10 | 2/10 |
| MyalgiaMusculoskeletal and connective tissue disorders | 1/5 | 0/5 | 0/10 | 1/10 | 2/10 | 4/10 |
All enrolled participants
| Age, Continuous(years) | Group A1: CssBA 5 µg | Group A2: DmLT 100 ng | Group B: CssBA 5 µg + DmLT 100 ng | Group C: CssBA 5 µg + DmLT 500 ng | Group D: CssBA 15 µg + DmLT 500 ng | Group E: CssBA 45 µg + DmLT 500 ng | Total |
|---|---|---|---|---|---|---|---|
| Median | 32 (30 to 41) | 29 (27 to 37) | 29.5 (26 to 32) | 31.5 (27 to 37) | 28 (22 to 38) | 29.5 (25 to 33) | 30 (26 to 37) |
| Sex: Female, Male(Participants) | Group A1: CssBA 5 µg | Group A2: DmLT 100 ng | Group B: CssBA 5 µg + DmLT 100 ng | Group C: CssBA 5 µg + DmLT 500 ng | Group D: CssBA 15 µg + DmLT 500 ng | Group E: CssBA 45 µg + DmLT 500 ng | Total |
|---|---|---|---|---|---|---|---|
| Female | 4 | 2 | 5 | 7 | 5 | 7 | 30 |
| Male | 1 | 3 | 5 | 3 | 5 | 3 | 20 |
| Ethnicity (NIH/OMB)(Participants) | Group A1: CssBA 5 µg | Group A2: DmLT 100 ng | Group B: CssBA 5 µg + DmLT 100 ng | Group C: CssBA 5 µg + DmLT 500 ng | Group D: CssBA 15 µg + DmLT 500 ng | Group E: CssBA 45 µg + DmLT 500 ng | Total |
|---|---|---|---|---|---|---|---|
| Hispanic or Latino | 0 | 2 | 1 | 0 | 2 | 1 | 6 |
| Not Hispanic or Latino | 5 | 3 | 9 | 10 | 8 | 9 | 44 |
| Unknown or Not Reported | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Race/Ethnicity, Customized(Participants) | Group A1: CssBA 5 µg | Group A2: DmLT 100 ng | Group B: CssBA 5 µg + DmLT 100 ng | Group C: CssBA 5 µg + DmLT 500 ng | Group D: CssBA 15 µg + DmLT 500 ng | Group E: CssBA 45 µg + DmLT 500 ng | Total |
|---|---|---|---|---|---|---|---|
| Asian | 0 | 0 | 0 | 2 | 0 | 0 | 2 |
| Black | 4 | 4 | 3 | 5 | 3 | 4 | 23 |
| White | 1 | 1 | 7 | 3 | 7 | 5 | 24 |
| Multi-race | 0 | 0 | 0 | 0 | 0 | 1 | 1 |
| Region of Enrollment(participants) | Group A1: CssBA 5 µg | Group A2: DmLT 100 ng | Group B: CssBA 5 µg + DmLT 100 ng | Group C: CssBA 5 µg + DmLT 500 ng | Group D: CssBA 15 µg + DmLT 500 ng | Group E: CssBA 45 µg + DmLT 500 ng | Total |
|---|---|---|---|---|---|---|---|
| United States | 5 | 5 | 10 | 10 | 10 | 10 | 10 |
PDFs hosted by the registry, ClinicalTrials.gov.
Ran from Jan 2018 to primary completion in Mar 2019, 14 months.
Results were first posted in Jan 2021, 1 year 9 months after primary completion.
Of 22 phase 1 interventional studies under Diarrhea, half reached primary completion within 14 months of starting (the median), counting those still running; a quarter within 6 and three quarters within 23. This study's 14 months is close to that.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Nov 2020. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Heat-labile enterotoxin, E coli