A Phase 1 interventional study of Placebo and Placebo in Gastroenteritis Escherichia Coli and Immunisation, sponsored by National Institute of Allergy and Infectious Diseases (NIAID). Terminated at 2 sites in 2 countries. Open to participants aged 18 Years to 45 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-05-21.
Sponsored by National Institute of Allergy and Infectious Diseases (NIAID) · Phase 1, Interventional, and Prevention
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Among 38 studies in Escherichia coli Infections with a site in United States — 7 open to participants now, 7 under way, none of them phase 3. Escherichia coli Infections · United States.
Among the 38 studies in Escherichia coli Infections with a site in United States, this one is the 13th largest by enrollment of the 29 interventional ones that give a count, is one of 3 that started in 2019, is one of 14 in phase 1, and was the 26th registered.
100 studies on the registry are indexed under Escherichia coli Infections; 22 are open to participants now.
Browse Escherichia coli Infections studies →7 of the 38 studies in Escherichia coli Infections with a site in United States are open now. Recruiting first, the newest first:
Oregon Health and Science University · Sites in United States
Ages 18+
Barbara Trautner · Sites in United States
Ages 18+
SNIPR Biome Aps. · Sites in United States
Ages 18+
GlaxoSmithKline · Sites in United States, South Africa
Ages 18–64 · Healthy volunteers
Johns Hopkins University · Sites in United States
Ages 18+
A study can be open while its sites in United States have not opened yet or have stopped. Only those recruiting at a site in United States →
Of the 13 Escherichia coli Infections studies recruiting now, 7 (54%) set no upper age limit and 5 (38%) stop at 75 or younger; 2 take children under 18; 5 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.
38 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 16 · Phase 2 7 · Phase 3 2
First in 1997; this study’s year is marked. 3 started in 2019.
This study's enrollment of 75 is close to the median of 74 across 64 interventional studies indexed under Escherichia coli Infections.
Median enrollment 65 across the 29 interventional studies, 200 across the 9 observational. Of the 30 that completed or were terminated, 10 (33%) have results posted.
This tab as a report to print or save as PDF → With an account.
7 of 38 have an industry lead sponsor. The 10 most frequent:
National Institute of Allergy and Infectious Diseases (NIAID) is the lead sponsor of 2,446 studies on the registry; 179 are open to participants now.
Of its 406 completed or terminated interventional studies of FDA-regulated products, 302 (74%) have results posted.
National Institute of Allergy and Infectious Diseases (NIAID) has 6 studies filed under Escherichia coli Infections — fewer than ten, so there is no comparison to draw.
6 of the studies in Escherichia coli Infections with a site in United States that are under way reach primary completion within a year, 0 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT06702449GlaxoSmithKlineA Study on the Safety and Immune Response of a Urinary Tract Infection (UTI) Vaccine in Adults 18-64 Years of Age and Clinical Efficacy in Females 18-64 Years of Age | 2027-05-31 |
| NCT06080698Johns Hopkins UniversityGram-Negative Bloodstream Infection Oral Antibiotic Therapy Trial | 2027-05-31 |
| NCT05488340Locus BiosciencesA Study of LBP-EC01 in the Treatment of Acute Uncomplicated UTI Caused by Drug Resistant E. Coli (ELIMINATE Trial) | 2027-06 |
| NCT05219110University of CalgaryHyperhydration in Children With Shiga Toxin-Producing E. Coli Infection | 2027-08-31 |
| NCT06559618Barbara TrautnerBacteriophage Therapy in Spinal Cord Injury Patients With Bacteriuria | 2027-09 |
Add all 6 to your calendar (.ics) → With an account.
Among the 38 studies in Escherichia coli Infections with a site in United States, from their registry updates:
This tab as a report to print or save as PDF → With an account.
This is a trial to evaluate the safety and immunogenicity of double mutant heat-labile toxin LTR192G/L211A (dmLT) from Enterotoxigenic Escherichia coli (ETEC) by oral, sublingual, or intradermal vaccination in approximately 135 healthy adult volunteers, age 18-45 years. Study duration is approximately 2.5 years, with each participant duration for up to 9 months depending on the route of dmLT administered. There is no specific hypothesis being tested in this study. The primary objective of this study is to assess the reactogenicity, safety, and tolerability of dmLT when administered in three sequential doses, over a range of dosages by oral, sublingual, or intradermal routes.
This is a Phase 1 double-blinded, placebo-controlled, dose-escalation trial to evaluate the safety and immunogenicity of double mutant heat-labile toxin LTR192G/L211A (dmLT) from Enterotoxigenic Escherichia coli (ETEC) by oral, sublingual, or intradermal vaccination in approximately 135 healthy adult volunteers, age 18-45 years, who meet all the eligibility criteria and reside in Bangladesh. Study duration is approximately 2.5 years, with each participant duration for up to 9 months depending on the route of dmLT administered. The study population will be recruited from Mirpur, a community of Dhaka, Bangladesh, known as having a high rate of diarrheal, respiratory, and enteric disease. This clinical trial is designed to assess the safety, reactogenicity, tolerability, and immunogenicity of a range of dosages of dmLT administered by three different routes: oral, sublingual, or intradermal. The oral and sublingual routes of administration will evaluate dosages of 5, 25, and 50 micrograms of dmLT; the intradermal route of administration will evaluate dosages of 0.3, 1.0, and 2.0 micrograms of dmLT. Participants will receive a total of three sequential doses of dmLT; the oral and sublingual routes will be at days 1, 15, and 29 and the intradermal route will be at days 1, 22, and 43. There is no specific hypothesis being tested in this study. The primary objective of this study is to assess the reactogenicity, safety, and tolerability of dmLT when administered in three sequential doses, over a range of dosages by oral, sublingual, or intradermal routes. The secondary objectives of this study are: 1) to assess the long-term safety, from first vaccination through 6 months following the last dose of vaccine, 2) to evaluate the serum anti-dmLT IgG and IgA response, 3) to evaluate the IgG and IgA anti-dmLT Antibody Secreting Cell (ASC) response, 4) to evaluate the IgG and IgA anti-dmLT Antibodies in Lymphocyte Supernatant (ALS) response, 5) to evaluate the total fecal IgA and fecal anti-dmLT IgA response, and 6) to evaluate the total salivary IgA and the saliva-derived anti-dmLT IgA response.
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:
Women who are pregnant or lactating or have a positive urine pregnancy test at screening or on the day of vaccinations.
Note: all women presenting for screening will have urine pregnancy testing. "Females of must agree to use an efficacious hormonal or barrier method of from screening and through 28 days post last dose of vaccine. Abstinence is also acceptable."
Presence or history of a chronic medical condition* that would, in the opinion of the investigator, render vaccination unsafe or interfere with the evaluation of the vaccine.
*Note: this may include, but is not limited to: significant renal disease, unstable or progressive neurological disorders, diabetes, heart disease, asthma, lung disease, liver disease, organ transplant recipients and cancer.
Presence of a significant dermatologic condition*, or tattoo(s), scarring or significant skin damage at the vaccination site that would impede evaluation of local reactogenicity.
*Note: this may include severe eczema, psoriasis or history of keloid formation. Participants with history of squamous cell or basal cell skin cancer that has been surgically excised and considered cured may be enrolled in the study if the skin cancer site is healed and is not at proposed vaccine administration site.
Has major psychiatric illness* during last 12 months that in the investigator's opinion would preclude participation.
*Note: Participants taking antipsychotic or antimanic drugs should not be enrolled. These include: aripiprazole, clozapine, ziprasidone, haloperidol, molindone, lamotrigine, gabapentin, topiramate, loxapine, thioridazine, thiothixene, pimozide, fluphenazine, risperidone, mesoridazine, quetiapine, trifluoperazine, chlorprothixene, chlorpromazine, perphenazine, olanzapine, carbamazepine, divalproex sodium, lithium carbonate, or lithium citrate. Participants taking a single antidepressant drug and are stable without de-compensating symptoms in the preceding 3 months can be enrolled in the study.
Use of prescription or over-the-counter (OTC) anti-inflammatory medications* 48 hours prior to receiving the product.
*Note: This includes naproxen, aspirin, ibuprofen, and other non-steroidal anti-inflammatory drugs.
Gastrointestinal symptoms* in the past 24 hours or abdominal pain lasting for more than 2 weeks in the past 6 months.
*Note: this may include, but is not limited to: abdominal pain or cramps, loss of appetite, nausea, general ill-feeling or vomiting.
Moderate or severe diarrheal illness* during the 6 weeks prior to enrollment.
*Note: Moderate or severe diarrheal illness is defined by the passage of > / = 4 unformed or loose stools (mix of liquid and solid components) in a 24 hour period
History of chronic gastrointestinal illness*.
*Note: this includes severe dyspepsia or gastroesophageal reflux disease, constipation, irritable bowel syndrome (IBS), hemorrhoids, diverticular disease, colitis, colon polyps, colon cancer, and inflammatory bowel disease. Mild or moderate heartburn or epigastric pain occurring no more than three times per week is permitted.
Isolation of specific bacteria* from screening stool cultures.
*Note: bacteria include ETEC, Vibrio cholerae, and Shigella spp. Salmonella and Campylobacter will not be evaluated as part this criterion.
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.
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
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.
The number of neutrophils, white blood cells that help fight infection, in a given amount of blood. Too few raises the risk of infection.
It is a count, not a percentage of the white cells. Limits are written in units that mean the same: ≥ 1.5 × 10⁹/L is ≥ 1,500 per mm³ (µL). Each lab has its own reference range.
The protein in red blood cells that carries oxygen. A low level is anaemia, which can cause tiredness and breathlessness. Measured in g/dL or g/L (9 g/dL is 90 g/L).
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
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.
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.
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Childbearing potential
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Autoimmune disease
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
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.
Absolute neutrophil count (ANC)
The number of neutrophils, white blood cells that help fight infection, in a given amount of blood. Too few raises the risk of infection.
It is a count, not a percentage of the white cells. Limits are written in units that mean the same: ≥ 1.5 × 10⁹/L is ≥ 1,500 per mm³ (µL). Each lab has its own reference range.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hemoglobin (Hb)
The protein in red blood cells that carries oxygen. A low level is anaemia, which can cause tiredness and breathlessness. Measured in g/dL or g/L (9 g/dL is 90 g/L).
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Platelets
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ALT and AST (liver enzymes)
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
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.
5 µg of dmLT oral on days 1, 15, 29, n=12; placebo oral on days 1, 15, 29, n=3
Other: Placebo · Biological: Recombinant Double Mutant Heat-Labile Toxin LT(R192G/L211A) (dmLT) Oral enterotoxigenic Escherichia coli (ETEC) Vaccine
25 µg of dmLT oral on days 1, 15, 29, n=12; placebo oral on days 1, 15, 29, n=3
Other: Placebo · Biological: Recombinant Double Mutant Heat-Labile Toxin LT(R192G/L211A) (dmLT) Oral enterotoxigenic Escherichia coli (ETEC) Vaccine
5 µg of dmLT sublingual on days 1, 15, 29, n=12; placebo sublingual on days 1, 15, 29, n=3
Other: Placebo · Biological: Recombinant Double Mutant Heat-Labile Toxin LT(R192G/L211A) (dmLT) Oral enterotoxigenic Escherichia coli (ETEC) Vaccine
25 µg of dmLT sublingual on days 1, 15, 29, n=12; placebo sublingual on days 1, 15, 29, n=3
Other: Placebo · Biological: Recombinant Double Mutant Heat-Labile Toxin LT(R192G/L211A) (dmLT) Oral enterotoxigenic Escherichia coli (ETEC) Vaccine
0.3 µg of dmLT intradermal on days 1, 22, 43, n=12; placebo intradermal on days 1, 22, 43, n=3
Other: Placebo · Biological: Recombinant Double Mutant Heat-Labile Toxin LT(R192G/L211A) (dmLT) Oral enterotoxigenic Escherichia coli (ETEC) Vaccine
1.0 µg of dmLT intradermal on days 1, 22, 43, n=12; placebo intradermal on days 1, 22, 43, n=3
Other: Placebo · Biological: Recombinant Double Mutant Heat-Labile Toxin LT(R192G/L211A) (dmLT) Oral enterotoxigenic Escherichia coli (ETEC) Vaccine
50 µg of dmLT oral on days 1, 15, 29, n=12; placebo oral on days 1, 15, 29, n=3
Other: Placebo · Biological: Recombinant Double Mutant Heat-Labile Toxin LT(R192G/L211A) (dmLT) Oral enterotoxigenic Escherichia coli (ETEC) Vaccine
50 µg of dmLT sublingual on days 1, 15, 29, n=12; placebo sublingual on days 1, 15, 29, n=3
Other: Placebo · Biological: Recombinant Double Mutant Heat-Labile Toxin LT(R192G/L211A) (dmLT) Oral enterotoxigenic Escherichia coli (ETEC) Vaccine
2.0 µg of dmLT intradermal on days 1, 22, 43, n=12; placebo intradermal on days 1, 22, 43, n=3
Other: Placebo · Biological: Recombinant Double Mutant Heat-Labile Toxin LT(R192G/L211A) (dmLT) Oral enterotoxigenic Escherichia coli (ETEC) Vaccine
Placebo
Placebo
Placebo
LT(R192G/L211A), or dmLT is a derivative of wild-type enterotoxigenic Escherichia coli heat-labile enterotoxin that has been genetically modified by replacing the arginine at amino acid position 192 with glycine and the leucine at amino acid position 211 with alanine. These two amino acid substitutions take place in proteolytic cleavage sites which are critical for activation of the secreted toxin molecules.
LT(R192G/L211A), or dmLT is a derivative of wild-type enterotoxigenic Escherichia coli heat-labile enterotoxin that has been genetically modified by replacing the arginine at amino acid position 192 with glycine and the leucine at amino acid position 211 with alanine. These two amino acid substitutions take place in proteolytic cleavage sites which are critical for activation of the secreted toxin molecules.
LT(R192G/L211A), or dmLT is a derivative of wild-type enterotoxigenic Escherichia coli heat-labile enterotoxin that has been genetically modified by replacing the arginine at amino acid position 192 with glycine and the leucine at amino acid position 211 with alanine. These two amino acid substitutions take place in proteolytic cleavage sites which are critical for activation of the secreted toxin molecules.
Number of Participants in the Oral Arms With Solicited Local Reactogenicity Events Post Each Dose
Solicited adverse events were collected post-vaccination and for 7 days after. Local events for the oral route include irritation of the oral cavity or tongue, diarrhea, nausea, vomiting, and abdominal discomfort.
Time frame: Day 1 through Day 8 (post dose 1), Day 15 through Day 22 (post dose 2), Day 29 through Day 36 (post dose 3)
Number of Participants in the Sublingual Arms With Solicited Local Reactogenicity Events Post Each Dose
Solicited adverse events were collected post-vaccination and for 7 days after. Local events for the sublingual route include irritation of the oral cavity or tongue, facial nerve disturbance, diarrhea, nausea, vomiting, or abdominal discomfort.
Time frame: Day 1 through Day 8 (post dose 1), Day 15 through Day 22 (post dose 2), Day 29 through Day 36 (post dose 3)
Number of Participants in the Intradermal Arms With Solicited Local Reactogenicity Events Post Each Dose
Solicited adverse events were collected post-vaccination and for 7 days after. Local events for the intradermal route include injection site pain, redness, swelling, bruising, itching, hypo/hyper pigmentation and induration, vesicles, or hardened mass. Study halted on Day 43 due to COVID-19 pandemic and the intradermal group did not receive the final dose.
Time frame: Day 1 through Day 8 (post dose 1), Day 22 through Day 29 (post dose 2)
Number of Participants in the Oral and Sublingual Arms With Solicited Systemic Reactogenicity Events Post Each Dose
Solicited adverse events were collected post-vaccination and for 7 days after. Systemic events for the oral and sublingual routes include fever, feverishness, fatigue, malaise, myalgia, or headache.
Time frame: Day 1 through Day 8 (post dose 1), Day 15 through Day 22 (post dose 2), Day 29 through Day 36 (post dose 3)
Number of Participants in the Intradermal Arms With Solicited Systemic Reactogenicity Events Post Each Dose
Solicited adverse events were collected post-vaccination and for 7 days after. Systemic events for the intradermal route include fever, feverishness, fatigue, malaise, myalgia, headache, diarrhea, nausea, vomiting, or abdominal discomfort. Study halted on Day 43 due to COVID-19 pandemic and the intradermal group did not receive the final dose.
Time frame: Day 1 through Day 8 (post dose 1), Day 22 through Day 29 (post dose 2)
Number of Participants Who Withdrew From the Study
Participants could voluntarily withdraw their consent for study participation for any reason at any time. Primary reason for withdrawal was recorded and early termination visits were attempted.
Time frame: Day 1 through Day 209 (Day 223 for Intradermal cohorts)
Number of Participants Who Discontinued Study Vaccination
Participants who received the first vaccination could choose to discontinue receipt of study vaccine for any reason and could choose to remain in the study (i.e., not withdraw from study). In addition, a participant could be discontinued from receipt of the second or third vaccination. Discontinuation from vaccination did not mean automatic withdrawal from the study, and participants were monitored for safety and immunogenicity if the participant consented.
Time frame: Day 1 through Day 29 (Day 43 for Intradermal cohorts)
Number of Vaccine-related Unsolicited Adverse Events From First Dose Through 28 Days After Last Dose
Adverse events were defined as any untoward medical occurrence in a participant administered a pharmaceutical product regardless of its causal relationship to the study treatment.
Time frame: Day 1 through Day 57 (Day 71 for Intradermal cohorts)
Number of Vaccine-related Serious Adverse Events From Post Dose 1 Through 6 Months After Last Dose
Serious Adverse Events (SAE) were defined as an adverse event which resulted in death, was life threatening, resulted in an inpatient hospitalization, prolongation of an existing hospitalization, led to persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions, or led to a congenital anomaly/birth defect. Important medical events that may not result in death, be life-threatening, or require hospitalizations were considered serious when, based upon appropriate medical judgment, they jeopardize the participant and may require medical or surgical intervention to prevent one of the outcomes listed in this definition.
Time frame: Day 1 through Day 209 (Day 223 for Intradermal cohorts)
Percentage of Participants With a >= 4-fold Rise in dmLT-specific Serum IgA Titers Over Baseline Measured by ELISA
Blood was collected for the IgA and IgG assay which was conducted with dmLT as the antigen. Each sample was tested per the laboratory's standard operating procedure. The percentage of participants with a \>= 4-fold rise in dmLT-specific serum IgA and IgG titers over baseline was calculated for each study arm from the available results at any time post-first study vaccination. Study halted on Day 43 due to COVID-19 pandemic and the intradermal group did not receive the final dose.
Time frame: Day 8 through Day 114
Percentage of Participants With a >= 4-fold Rise in dmLT-specific Serum IgG Titers Over Baseline Measured by ELISA
Blood was collected for the IgG and IgA assay which was conducted with dmLT as the antigen. Each sample was tested per the laboratory's standard operating procedure. The percentage of participants with a \>= 4-fold rise in dmLT-specific serum IgG and IgA titers over baseline was calculated for each study arm from the available results at any time post-first study vaccination. Study halted on Day 43 due to COVID-19 pandemic and the intradermal group did not receive the final dose.
Time frame: Day 8 through Day 114
Percentage of Participants With >= 8 dmLT-specific IgA ASC / 10^6 PBMC as Measured by ELISpot
PBMCs were collected for the IgA and IgG assay which was conducted with dmLT as the antigen. Each sample was tested per the laboratory's standard operating procedure. The percentage of participants with \>= 8 dmLT-specific IgA and IgG ASC / 10\^6 PBMC was calculated for each study arm from the available results at any time post-first study vaccination. Study halted on Day 43 due to COVID-19 pandemic and the intradermal group did not receive the final dose.
Time frame: Day 1 through Day 36
Percentage of Participants With >= 8 dmLT-specific IgG ASC / 10^6 PBMC as Measured by ELISpot
PBMCs were collected for the IgA and IgG assay which was conducted with dmLT as the antigen. Each sample was tested per the laboratory's standard operating procedure. The percentage of participants with \>= 8 dmLT-specific IgA and IgG ASC / 10\^6 PBMC was calculated for each study arm from the available results at any time post-first study vaccination. Study halted on Day 43 due to COVID-19 pandemic and the intradermal group did not receive the final dose.
Time frame: Day 1 through Day 36
Percentage of Participants With >= 2-fold Rise in ALS Anti-dmLT-specific IgA Titers Over Baseline Measured by ELISA
Blood was collected for the IgA and IgG assay which was conducted with dmLT as the antigen. Each sample was tested per the laboratory's standard operating procedure. The percentage of participants with a \>= 2-fold rise in ALS anti-dmLT-specific IgG and IgA titers over baseline was calculated for each study arm from the available results at any time post-first study vaccination. Study halted on Day 43 due to COVID-19 pandemic and the intradermal group did not receive the final dose.
Time frame: Day 1 through Day 36
Percentage of Participants With >= 2-fold Rise in ALS Anti-dmLT-specific IgG Titers Over Baseline Measured by ELISA
Blood was collected for the IgA and IgG assay which was conducted with dmLT as the antigen. Each sample was tested per the laboratory's standard operating procedure. The percentage of participants with a \>= 2-fold rise in ALS anti-dmLT-specific IgG and IgA titers over baseline was calculated for each study arm from the available results at any time post-first study vaccination. Study halted on Day 43 due to COVID-19 pandemic and the intradermal group did not receive the final dose.
Time frame: Day 1 through Day 36
Percentage of Participants With >= 4-fold Rise Over Baseline in dmLT-specific Fecal IgA Titers Measured by ELISA
Stool was collected for the IgA assay which was conducted with dmLT as the antigen. Each sample was tested per the laboratory's standard operating procedure. The percentage of participants with a \>= 4-fold rise over baseline in dmLT-specific fecal IgA titers was calculated for each study arm from the available results at any time post-first study vaccination. Study halted on Day 43 due to COVID-19 pandemic and the intradermal group did not receive the final dose.
Time frame: Day 1 through Day 57
Percentage of Participants With >= 4-fold Rise Over Baseline in dmLT-specific Salivary IgA Titers Measured by ELISA
Saliva was collected for the IgA assay which was conducted with dmLT as the antigen. Each sample was tested per the laboratory's standard operating procedure. The percentage of participants with a \>= 4-fold rise over baseline in dmLT-specific salivary IgA titers was calculated for each study arm from the available results at any time post-first study vaccination. Study halted on Day 43 due to COVID-19 pandemic and the intradermal group did not receive the final dose.
Time frame: Day 1 through Day 57
Participants were healthy males and non-pregnant females between 18 and 45 years old, inclusively. They were recruited from the community at large around the clinic site. The enrollment period occurred between 10MAR2019 and 11FEB2020.
| Milestone | Oral 5 µg dmLT | Oral 25 µg of dmLT | Oral Placebo | Sublingual 5 µg of dmLT | Sublingual 25 µg of dmLT | Sublingual Placebo | Intradermal 0.3 µg of dmLT | Intradermal Placebo |
|---|---|---|---|---|---|---|---|---|
| Started | 12 | 12 | 6 | 12 | 12 | 6 | 12 | 3 |
| Completed | 12 | 12 | 6 | 11 | 0 | 3 | 12 | 3 |
| Not completed | 0 | 0 | 0 | 1 | 12 | 3 | 0 | 0 |
| Withdrew: Withdrawal by subject | 0 | 0 | 0 | 1 | 0 | 0 | 0 | 0 |
| Withdrew: Lost to follow-up | 0 | 0 | 0 | 0 | 2 | 0 | 0 | 0 |
| Withdrew: Covid-19 pandemic | 0 | 0 | 0 | 0 | 10 | 3 | 0 | 0 |
Solicited adverse events were collected post-vaccination and for 7 days after. Local events for the oral route include irritation of the oral cavity or tongue, diarrhea, nausea, vomiting, and abdominal discomfort.
| Participants | Oral 5 µg dmLT | Oral 25 µg dmLT | Oral Placebo |
|---|---|---|---|
| Post Dose 1 — Irritation of oral cavity or tongue | 0 | 0 | 0 |
| Post Dose 1 — Diarrhea | 0 | 0 | 0 |
| Post Dose 1 — Nausea | 0 | 0 | 0 |
| Post Dose 1 — Vomiting | 0 | 0 | 0 |
| Post Dose 1 — Abdominal discomfort | 0 | 0 | 0 |
| Post Dose 1 — None | 12 | 12 | 6 |
| Post Dose 2 — Irritation of oral cavity or tongue | 0 | 0 | 0 |
| Post Dose 2 — Diarrhea | 0 | 0 | 0 |
| Post Dose 2 — Nausea | 0 | 0 | 0 |
| Post Dose 2 — Vomiting | 0 | 3 | 0 |
| Post Dose 2 — Abdominal discomfort | 0 | 0 | 0 |
| Post Dose 2 — None | 12 | 9 | 6 |
| Post Dose 3 — Irritation of oral cavity or tongue | 0 | 0 | 0 |
| Post Dose 3 — Diarrhea | 0 | 0 | 0 |
| Post Dose 3 — Nausea | 0 | 0 | 0 |
| Post Dose 3 — Vomiting | 0 | 0 | 0 |
| Post Dose 3 — Abdominal discomfort | 0 | 0 | 0 |
| Post Dose 3 — None | 11 | 12 | 6 |
Solicited adverse events were collected post-vaccination and for 7 days after. Local events for the sublingual route include irritation of the oral cavity or tongue, facial nerve disturbance, diarrhea, nausea, vomiting, or abdominal discomfort.
| Participants | Sublingual 5 µg of dmLT | Sublingual 25 µg of dmLT | Sublingual Placebo |
|---|---|---|---|
| Post Dose 1 — Irritation of oral cavity or tongue | 0 | 0 | 0 |
| Post Dose 1 — Facial nerve disturbance | 0 | 0 | 0 |
| Post Dose 1 — Diarrhea | 0 | 0 | 0 |
| Post Dose 1 — Nausea | 0 | 0 | 0 |
| Post Dose 1 — Vomiting | 0 | 0 | 0 |
| Post Dose 1 — Abdominal discomfort | 0 | 0 | 0 |
| Post Dose 1 — None | 12 | 12 | 6 |
| Post Dose 2 — Irritation of oral cavity or tongue | 0 | 0 | 0 |
| Post Dose 2 — Facial nerve disturbance | 0 | 0 | 0 |
| Post Dose 2 — Diarrhea | 0 | 0 | 0 |
| Post Dose 2 — Nausea | 0 | 0 | 0 |
| Post Dose 2 — Vomiting | 0 | 0 | 0 |
| Post Dose 2 — Abdominal discomfort | 0 | 0 | 0 |
| Post Dose 2 — None | 12 | 10 | 6 |
| Post Dose 3 — Irritation of oral cavity or tongue | 0 | 0 | 0 |
| Post Dose 3 — Facial nerve disturbance | 0 | 0 | 0 |
| Post Dose 3 — Diarrhea | 0 | 0 | 0 |
| Post Dose 3 — Nausea | 0 | 0 | 0 |
| Post Dose 3 — Vomiting | 0 | 0 | 0 |
| Post Dose 3 — Abdominal discomfort | 0 | 0 | 0 |
| Post Dose 3 — None | 12 | 10 | 6 |
Solicited adverse events were collected post-vaccination and for 7 days after. Local events for the intradermal route include injection site pain, redness, swelling, bruising, itching, hypo/hyper pigmentation and induration, vesicles, or hardened mass. Study halted on Day 43 due to COVID-19 pandemic and the intradermal group did not receive the final dose.
| Participants | Intradermal 0.3 µg dmLT | Intradermal Placebo |
|---|---|---|
| Post Dose 1 — Injection site pain | 0 | 0 |
| Post Dose 1 — Injection site redness | 2 | 0 |
| Post Dose 1 — Injection site swelling | 0 | 0 |
| Post Dose 1 — Injection site bruising | 0 | 0 |
| Post Dose 1 — Injection site pruritus | 0 | 0 |
| Post Dose 1 — Injection site hypopigmentation | 0 | 0 |
| Post Dose 1 — Injection site hyperpigmentation | 0 | 0 |
| Post Dose 1 — Injection site induration | 1 | 0 |
| Post Dose 1 — Injection site vesicles | 0 | 0 |
| Post Dose 1 — Injection site mass | 0 | 0 |
| Post Dose 1 — None | 9 | 3 |
| Post Dose 2 — Injection site pain | 0 | 0 |
| Post Dose 2 — Injection site redness | 0 | 0 |
| Post Dose 2 — Injection site swelling | 0 | 0 |
| Post Dose 2 — Injection site bruising | 0 | 0 |
| Post Dose 2 — Injection site pruritus | 0 | 0 |
| Post Dose 2 — Injection site hypopigmentation | 0 | 0 |
| Post Dose 2 — Injection site hyperpigmentation | 0 | 0 |
| Post Dose 2 — Injection site induration | 0 | 0 |
| Post Dose 2 — Injection site vesicles | 0 | 0 |
| Post Dose 2 — Injection site mass | 0 | 0 |
| Post Dose 2 — None | 12 | 3 |
Solicited adverse events were collected post-vaccination and for 7 days after. Systemic events for the oral and sublingual routes include fever, feverishness, fatigue, malaise, myalgia, or headache.
| Participants | Oral 5 µg dmLT | Oral 25 µg of dmLT | Oral Placebo | Sublingual 5 µg of dmLT | Sublingual 25 µg of dmLT | Sublingual Placebo |
|---|---|---|---|---|---|---|
| Post Dose 1 | 3 | 1 | 0 | 0 | 0 | 1 |
| Post Dose 2 | 1 | 0 | 0 | 1 | 0 | 0 |
| Post Dose 3 | 1 | 0 | 0 | 1 | 0 | 0 |
Solicited adverse events were collected post-vaccination and for 7 days after. Systemic events for the intradermal route include fever, feverishness, fatigue, malaise, myalgia, headache, diarrhea, nausea, vomiting, or abdominal discomfort. Study halted on Day 43 due to COVID-19 pandemic and the intradermal group did not receive the final dose.
| Participants | Intradermal 0.3 µg dmLT | Intradermal Placebo |
|---|---|---|
| Post Dose 1 | 0 | 0 |
| Post Dose 2 | 0 | 0 |
Participants could voluntarily withdraw their consent for study participation for any reason at any time. Primary reason for withdrawal was recorded and early termination visits were attempted.
| Participants | Oral 5 µg dmLT | Oral 25 µg of dmLT | Oral Placebo | Sublingual 5 µg of dmLT | Sublingual 25 µg of dmLT | Sublingual Placebo | Intradermal 0.3 µg of dmLT | Intradermal Placebo |
|---|---|---|---|---|---|---|---|---|
| Number of Participants Who Withdrew From the Study | 0 | 0 | 0 | 1 | 12 | 3 | 0 | 0 |
Participants who received the first vaccination could choose to discontinue receipt of study vaccine for any reason and could choose to remain in the study (i.e., not withdraw from study). In addition, a participant could be discontinued from receipt of the second or third vaccination. Discontinuation from vaccination did not mean automatic withdrawal from the study, and participants were monitored for safety and immunogenicity if the participant consented.
| Participants | Oral 5 µg dmLT | Oral 25 µg of dmLT | Oral Placebo | Sublingual 5 µg of dmLT | Sublingual 25 µg of dmLT | Sublingual Placebo | Intradermal 0.3 µg of dmLT | Intradermal Placebo |
|---|---|---|---|---|---|---|---|---|
| Number of Participants Who Discontinued Study Vaccination | 1 | 0 | 0 | 0 | 2 | 0 | 12 | 3 |
Adverse events were defined as any untoward medical occurrence in a participant administered a pharmaceutical product regardless of its causal relationship to the study treatment.
| Participants | Oral 5 µg dmLT | Oral 25 µg of dmLT | Oral Placebo | Sublingual 5 µg of dmLT | Sublingual 25 µg of dmLT | Sublingual Placebo | Intradermal 0.3 µg of dmLT | Intradermal Placebo |
|---|---|---|---|---|---|---|---|---|
| Mild (Grade 1) | 0 | 0 | 0 | 0 | 2 | 0 | 0 | 0 |
| Moderate (Grade 2) | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Severe (Grade 3) | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
Serious Adverse Events (SAE) were defined as an adverse event which resulted in death, was life threatening, resulted in an inpatient hospitalization, prolongation of an existing hospitalization, led to persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions, or led to a congenital anomaly/birth defect. Important medical events that may not result in death, be life-threatening, or require hospitalizations were considered serious when, based upon appropriate medical judgment, they jeopardize the participant and may require medical or surgical intervention to prevent one of the outcomes listed in this definition.
| Participants | Oral 5 µg dmLT | Oral 25 µg of dmLT | Oral Placebo | Sublingual 5 µg of dmLT | Sublingual 25 µg of dmLT | Sublingual Placebo | Intradermal 0.3 µg of dmLT | Intradermal Placebo |
|---|---|---|---|---|---|---|---|---|
| Number of Vaccine-related Serious Adverse Events From Post Dose 1 Through 6 Months After Last Dose | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
Blood was collected for the IgA and IgG assay which was conducted with dmLT as the antigen. Each sample was tested per the laboratory's standard operating procedure. The percentage of participants with a \>= 4-fold rise in dmLT-specific serum IgA and IgG titers over baseline was calculated for each study arm from the available results at any time post-first study vaccination. Study halted on Day 43 due to COVID-19 pandemic and the intradermal group did not receive the final dose.
| percentage of participants | Oral 5 µg dmLT | Oral 25 µg of dmLT | Oral Placebo | Sublingual 5 µg of dmLT | Sublingual 25 µg of dmLT | Sublingual Placebo | Intradermal 0.3 µg of dmLT | Intradermal Placebo |
|---|---|---|---|---|---|---|---|---|
| Post-Dose 1 Day 7 (Day 8) | 0 (0 to 26.5) | 42 (15.2 to 72.3) | 0 (0 to 45.9) | 0 (0 to 26.5) | 0 (0 to 30.8) | 0 (0 to 45.9) | 0 (0 to 26.5) | 0 (0 to 70.8) |
| Pre-Dose 2 (Day 15 oral/sublingual, Day 22 intradermal) | 8 (0.2 to 38.5) | 67 (34.9 to 90.1) | 0 (0 to 45.9) | 0 (0 to 26.5) | 0 (0 to 30.8) | 0 (0 to 45.9) | 75 (42.8 to 94.5) | 0 (0 to 70.8) |
| Post-Dose 2 Day 7 (Day 22 oral/sublingual, Day 29 intradermal) | 0 (0 to 26.5) | 83 (51.6 to 97.9) | 0 (0 to 45.9) | 0 (0 to 26.5) | 10 (0.3 to 44.5) | 0 (0 to 45.9) | 83 (51.6 to 97.9) | 0 (0 to 70.8) |
| Pre-Dose 3 (Day 29 oral/sublingual) | 17 (2.1 to 48.4) | 75 (42.8 to 94.5) | 0 (0 to 45.9) | 0 (0 to 26.5) | 10 (0.3 to 44.5) | 0 (0 to 45.9) | — | — |
| Post-Dose 3 Day 7 (Day 36 oral/sublingual) | 0 (0 to 26.5) | 67 (34.9 to 90.1) | 0 (0 to 45.9) | 0 (0 to 26.5) | 10 (0.3 to 44.5) | 0 (0 to 45.9) | — | — |
| Post-Dose 3 Day 28 (Day 57 oral/sublingual) | 0 (0 to 26.5) | 33 (9.9 to 65.1) | 0 (0 to 45.9) | 0 (0 to 28.5) | 10 (0.3 to 44.5) | 0 (0 to 45.9) | — | — |
| Post-Dose 3 Day 85 (Day 114 oral/sublingual) | 0 (0 to 26.5) | 0 (0 to 26.5) | 0 (0 to 45.9) | 0 (0 to 28.5) | — | 0 (0 to 70.8) | — | — |
Blood was collected for the IgG and IgA assay which was conducted with dmLT as the antigen. Each sample was tested per the laboratory's standard operating procedure. The percentage of participants with a \>= 4-fold rise in dmLT-specific serum IgG and IgA titers over baseline was calculated for each study arm from the available results at any time post-first study vaccination. Study halted on Day 43 due to COVID-19 pandemic and the intradermal group did not receive the final dose.
| percentage of participants | Oral 5 µg dmLT | Oral 25 µg of dmLT | Oral Placebo | Sublingual 5 µg of dmLT | Sublingual 25 µg of dmLT | Sublingual Placebo | Intradermal 0.3 µg of dmLT | Intradermal Placebo |
|---|---|---|---|---|---|---|---|---|
| Post-Dose 1 Day 7 (Day 8) | 8 (0.2 to 38.5) | 17 (2.1 to 48.4) | 0 (0 to 45.9) | 0 (0 to 26.5) | 0 (0 to 30.8) | 0 (0 to 45.9) | 0 (0 to 26.5) | 0 (0 to 70.8) |
| Pre-Dose 2 (Day 15 oral/sublingual, Day 22 intradermal) | 17 (2.1 to 48.4) | 67 (34.9 to 90.1) | 0 (0 to 45.9) | 0 (0 to 26.5) | 0 (0 to 30.8) | 0 (0 to 45.9) | 67 (34.9 to 90.1) | 0 (0 to 70.8) |
| Post-Dose 2 Day 7 (Day 22 oral/sublingual, Day 29 intradermal) | 25 (5.5 to 57.2) | 83 (51.6 to 97.9) | 0 (0 to 45.9) | 0 (0 to 26.5) | 20 (2.5 to 55.6) | 0 (0 to 45.9) | 75 (42.8 to 94.5) | 0 (0 to 70.8) |
| Pre-Dose 3 (Day 29 oral/sublingual) | 25 (5.5 to 57.2) | 83 (51.6 to 97.9) | 0 (0 to 45.9) | 0 (0 to 26.5) | 20 (2.5 to 55.6) | 0 (0 to 45.9) | — | — |
| Post-Dose 3 Day 7 (Day 36 oral/sublingual) | 25 (5.5 to 57.2) | 83 (51.6 to 97.9) | 0 (0 to 45.9) | 0 (0 to 26.5) | 20 (2.5 to 55.6) | 0 (0 to 45.9) | — | — |
| Post-Dose 3 Day 28 (Day 57 oral/sublingual) | 33 (9.9 to 65.1) | 92 (61.5 to 99.8) | 0 (0 to 45.9) | 0 (0 to 28.5) | 20 (2.5 to 55.6) | 0 (0 to 45.9) | — | — |
| Post-Dose 3 Day 85 (Day 114 oral/sublingual) | 25 (5.5 to 57.2) | 50 (21.1 to 78.9) | 0 (0 to 45.9) | 0 (0 to 28.5) | — | 0 (0 to 70.8) | — | — |
PBMCs were collected for the IgA and IgG assay which was conducted with dmLT as the antigen. Each sample was tested per the laboratory's standard operating procedure. The percentage of participants with \>= 8 dmLT-specific IgA and IgG ASC / 10\^6 PBMC was calculated for each study arm from the available results at any time post-first study vaccination. Study halted on Day 43 due to COVID-19 pandemic and the intradermal group did not receive the final dose.
| percentage of participants | Oral 5 µg dmLT | Oral 25 µg of dmLT | Oral Placebo | Sublingual 5 µg of dmLT | Sublingual 25 µg of dmLT | Sublingual Placebo | Intradermal 0.3 µg of dmLT | Intradermal Placebo |
|---|---|---|---|---|---|---|---|---|
| Pre-Dose 1 (Day 1) | 0 (0 to 26.5) | 8 (0.2 to 38.5) | 0 (0 to 45.9) | 0 (0 to 26.5) | 0 (0 to 30.8) | 0 (0 to 45.9) | 0 (0 to 33.6) | 0 (0 to 84.2) |
| Post-Dose 1 Day 7 (Day 8) | 0 (0 to 26.5) | 25 (5.5 to 57.2) | 0 (0 to 45.9) | 8 (0.2 to 38.5) | 0 (0 to 30.8) | 0 (0 to 45.9) | 17 (2.1 to 48.4) | 0 (0 to 70.8) |
| Pre-Dose 2 (Day 15 oral/sublingual, Day 22 intradermal) | 0 (0 to 26.5) | 0 (0 to 26.5) | 0 (0 to 45.9) | 0 (0 to 26.5) | 0 (0 to 30.8) | 0 (0 to 45.9) | 0 (0 to 26.5) | 0 (0 to 70.8) |
| Post-Dose 2 Day 7 (Day 22 oral/sublingual, Day 29 intradermal) | 0 (0 to 26.5) | 8 (0.2 to 38.5) | 0 (0 to 45.9) | 0 (0 to 26.5) | 0 (0 to 30.8) | 0 (0 to 45.9) | 42 (15.2 to 72.3) | 0 (0 to 70.8) |
| Pre-Dose 3 (Day 29 oral/sublingual) | 0 (0 to 26.5) | 0 (0 to 26.5) | 0 (0 to 45.9) | 0 (0 to 26.5) | 0 (0 to 30.8) | 0 (0 to 45.9) | — | — |
| Post-Dose 3 Day 7 (Day 36 oral/sublingual) | 0 (0 to 26.5) | 0 (0 to 26.5) | 0 (0 to 45.9) | 0 (0 to 26.5) | 0 (0 to 30.8) | 0 (0 to 45.9) | — | — |
PBMCs were collected for the IgA and IgG assay which was conducted with dmLT as the antigen. Each sample was tested per the laboratory's standard operating procedure. The percentage of participants with \>= 8 dmLT-specific IgA and IgG ASC / 10\^6 PBMC was calculated for each study arm from the available results at any time post-first study vaccination. Study halted on Day 43 due to COVID-19 pandemic and the intradermal group did not receive the final dose.
| percentage of participants | Oral 5 µg dmLT | Oral 25 µg of dmLT | Oral Placebo | Sublingual 5 µg of dmLT | Sublingual 25 µg of dmLT | Sublingual Placebo | Intradermal 0.3 µg of dmLT | Intradermal Placebo |
|---|---|---|---|---|---|---|---|---|
| Pre-Dose 1 (Day 1) | 0 (0 to 26.5) | 0 (0 to 26.5) | 0 (0 to 45.9) | 0 (0 to 26.5) | 10 (0.3 to 44.5) | 0 (0 to 45.9) | 0 (0 to 33.6) | 0 (0 to 84.2) |
| Post-Dose 1 Day 7 (Day 8) | 25 (5.5 to 57.2) | 58 (27.7 to 84.8) | 0 (0 to 45.9) | 0 (0 to 26.5) | 20 (2.5 to 55.6) | 17 (0.4 to 64.1) | 58 (27.7 to 84.8) | 0 (0 to 70.8) |
| Pre-Dose 2 (Day 15 oral/sublingual, Day 22 intradermal) | 0 (0 to 26.5) | 0 (0 to 26.5) | 0 (0 to 45.9) | 0 (0 to 26.5) | 10 (0.3 to 44.5) | 0 (0 to 45.9) | 17 (2.1 to 48.4) | 0 (0 to 70.8) |
| Post-Dose 2 Day 7 (Day 22 oral/sublingual, Day 29 intradermal) | 17 (2.1 to 48.4) | 17 (2.1 to 48.4) | 0 (0 to 45.9) | 8 (0.2 to 38.5) | 20 (2.5 to 55.6) | 0 (0 to 45.9) | 83 (51.6 to 97.9) | 0 (0 to 70.8) |
| Pre-Dose 3 (Day 29 oral/sublingual) | 0 (0 to 26.5) | 0 (0 to 26.5) | 0 (0 to 45.9) | 8 (0.2 to 38.5) | 10 (0.3 to 44.5) | 0 (0 to 45.9) | — | — |
| Post-Dose 3 Day 7 (Day 36 oral/sublingual) | 8 (0.2 to 38.5) | 17 (2.1 to 48.4) | 0 (0 to 45.9) | 0 (0 to 26.5) | 10 (0.3 to 44.5) | 0 (0 to 45.9) | — | — |
Blood was collected for the IgA and IgG assay which was conducted with dmLT as the antigen. Each sample was tested per the laboratory's standard operating procedure. The percentage of participants with a \>= 2-fold rise in ALS anti-dmLT-specific IgG and IgA titers over baseline was calculated for each study arm from the available results at any time post-first study vaccination. Study halted on Day 43 due to COVID-19 pandemic and the intradermal group did not receive the final dose.
| percentage of participants | Oral 5 µg dmLT | Oral 25 µg of dmLT | Oral Placebo | Sublingual 5 µg of dmLT | Sublingual 25 µg of dmLT | Sublingual Placebo | Intradermal 0.3 µg of dmLT | Intradermal Placebo |
|---|---|---|---|---|---|---|---|---|
| Post-Dose 1 Day 7 (Day 8) | 75 (42.8 to 94.5) | 100 (73.5 to 100) | 0 (0 to 45.9) | 0 (0 to 26.5) | 10 (0.3 to 44.5) | 0 (0 to 45.9) | 83 (51.6 to 97.9) | 0 (0 to 70.8) |
| Pre-Dose 2 (Day 15 oral/sublingual, Day 22 intradermal) | 0 (0 to 26.5) | 17 (2.1 to 48.4) | 17 (0.4 to 64.1) | 0 (0 to 26.5) | 10 (0.3 to 44.5) | 0 (0 to 45.9) | 58 (27.7 to 84.8) | 0 (0 to 70.8) |
| Post-Dose 2 Day 7 (Day 22 oral/sublingual, Day 29 intradermal) | 42 (15.2 to 72.3) | 42 (15.2 to 72.3) | 0 (0 to 45.9) | 8 (0.2 to 38.5) | 40 (12.2 to 73.8) | 17 (0.4 to 64.1) | 92 (61.5 to 99.8) | 0 (0 to 70.8) |
| Pre-Dose 3 (Day 29 oral/sublingual) | 0 (0 to 26.5) | 0 (0 to 26.5) | 0 (0 to 45.9) | 0 (0 to 26.5) | 20 (2.5 to 55.6) | 0 (0 to 45.9) | — | — |
| Post-Dose 3 Day 7 (Day 36 oral/sublingual) | 25 (5.5 to 57.2) | 42 (15.2 to 72.3) | 0 (0 to 45.9) | 8 (0.2 to 38.5) | 30 (6.7 to 65.2) | 17 (0.4 to 64.1) | — | — |
Blood was collected for the IgA and IgG assay which was conducted with dmLT as the antigen. Each sample was tested per the laboratory's standard operating procedure. The percentage of participants with a \>= 2-fold rise in ALS anti-dmLT-specific IgG and IgA titers over baseline was calculated for each study arm from the available results at any time post-first study vaccination. Study halted on Day 43 due to COVID-19 pandemic and the intradermal group did not receive the final dose.
| percentage of participants | Oral 5 µg dmLT | Oral 25 µg of dmLT | Oral Placebo | Sublingual 5 µg of dmLT | Sublingual 25 µg of dmLT | Sublingual Placebo | Intradermal 0.3 µg of dmLT | Intradermal Placebo |
|---|---|---|---|---|---|---|---|---|
| Post-Dose 1 Day 7 (Day 8) | 67 (34.9 to 90.1) | 100 (73.5 to 100) | 17 (0.4 to 64.1) | 8 (0.2 to 38.5) | 40 (12.2 to 73.8) | 0 (0 to 45.9) | 100 (73.5 to 100) | 0 (0 to 70.8) |
| Pre-Dose 2 (Day 15 oral/sublingual, Day 22 intradermal) | 8 (0.2 to 38.5) | 75 (42.8 to 94.5) | 17 (0.4 to 64.1) | 8 (0.2 to 38.5) | 20 (2.5 to 55.6) | 0 (0 to 45.9) | 100 (73.5 to 100) | 33 (0.8 to 90.6) |
| Post-Dose 2 Day 7 (Day 22 oral/sublingual, Day 29 intradermal) | 50 (21.1 to 78.9) | 83 (51.6 to 97.9) | 0 (0 to 45.9) | 25 (5.5 to 57.2) | 60 (26.2 to 87.8) | 0 (0 to 45.9) | 100 (73.5 to 100) | 0 (0 to 70.8) |
| Pre-Dose 3 (Day 29 oral/sublingual) | 17 (2.1 to 48.4) | 42 (15.2 to 72.3) | 0 (0 to 45.9) | 17 (2.1 to 48.4) | 10 (0.3 to 44.5) | 0 (0 to 45.9) | — | — |
| Post-Dose 3 Day 7 (Day 36 oral/sublingual) | 42 (15.2 to 72.3) | 58 (27.7 to 84.8) | 0 (0 to 45.9) | 17 (2.1 to 48.4) | 30 (6.7 to 65.2) | 17 (0.4 to 64.1) | — | — |
Stool was collected for the IgA assay which was conducted with dmLT as the antigen. Each sample was tested per the laboratory's standard operating procedure. The percentage of participants with a \>= 4-fold rise over baseline in dmLT-specific fecal IgA titers was calculated for each study arm from the available results at any time post-first study vaccination. Study halted on Day 43 due to COVID-19 pandemic and the intradermal group did not receive the final dose.
| percentage of participants | Oral 5 µg dmLT | Oral 25 µg of dmLT | Oral Placebo | Sublingual 5 µg of dmLT | Sublingual 25 µg of dmLT | Sublingual Placebo | Intradermal 0.3 µg of dmLT | Intradermal Placebo |
|---|---|---|---|---|---|---|---|---|
| Post-Dose 1 Day 7 (Day 8) | 0 (0 to 26.5) | 25 (5.5 to 57.2) | 0 (0 to 45.9) | 17 (2.1 to 48.4) | 40 (12.2 to 73.8) | 17 (0.4 to 64.1) | 8 (0.2 to 38.5) | 67 (9.4 to 99.2) |
| Pre-Dose 2 (Day 15 oral/sublingual, Day 22 intradermal) | 25 (5.5 to 57.2) | 33 (9.9 to 65.1) | 17 (0.4 to 64.1) | 17 (2.1 to 48.4) | 30 (6.7 to 65.2) | 33 (4.3 to 77.7) | 0 (0 to 26.5) | 33 (0.8 to 90.6) |
| Post-Dose 2 Day 7 (Day 22 oral/sublingual, Day 29 intradermal) | 8 (0.2 to 38.5) | 58 (27.7 to 84.8) | 17 (0.4 to 64.1) | 8 (0.2 to 38.5) | 20 (2.5 to 55.6) | 33 (4.3 to 77.7) | 0 (0 to 26.5) | 33 (0.8 to 90.6) |
| Pre-Dose 3 (Day 29 oral/sublingual) | 25 (5.5 to 57.2) | 33 (9.9 to 65.1) | 0 (0 to 45.9) | 8 (0.2 to 38.5) | 30 (6.7 to 65.2) | 50 (11.8 to 88.2) | — | — |
| Post-Dose 3 Day 7 (Day 36 oral/sublingual) | 25 (5.5 to 57.2) | 33 (9.9 to 65.1) | 17 (0.4 to 64.1) | 8 (0.2 to 38.5) | 30 (6.7 to 65.2) | 17 (0.4 to 64.1) | — | — |
| Post-Dose 3 Day 28 (Day 57 oral/sublingual) | 25 (5.5 to 57.2) | 42 (15.2 to 72.3) | 17 (0.4 to 64.1) | 27 (6.0 to 61.0) | 20 (2.5 to 55.6) | 33 (4.3 to 77.7) | — | — |
Saliva was collected for the IgA assay which was conducted with dmLT as the antigen. Each sample was tested per the laboratory's standard operating procedure. The percentage of participants with a \>= 4-fold rise over baseline in dmLT-specific salivary IgA titers was calculated for each study arm from the available results at any time post-first study vaccination. Study halted on Day 43 due to COVID-19 pandemic and the intradermal group did not receive the final dose.
| percentage of participants | Oral 5 µg dmLT | Oral 25 µg of dmLT | Oral Placebo | Sublingual 5 µg of dmLT | Sublingual 25 µg of dmLT | Sublingual Placebo | Intradermal 0.3 µg of dmLT | Intradermal Placebo |
|---|---|---|---|---|---|---|---|---|
| Post-Dose 1 Day 7 (Day 8) | 0 (0 to 26.5) | 8 (0.2 to 38.5) | 0 (0 to 45.9) | 0 (0 to 26.5) | 0 (0 to 30.8) | 0 (0 to 45.9) | 8 (0.2 to 38.5) | 33 (0.8 to 90.6) |
| Pre-Dose 2 (Day 15 oral/sublingual, Day 22 intradermal) | 8 (0.2 to 38.5) | 17 (2.1 to 48.4) | 0 (0 to 45.9) | 0 (0 to 26.5) | 0 (0 to 30.8) | 0 (0 to 45.9) | 0 (0 to 26.5) | 0 (0 to 70.8) |
| Post-Dose 2 Day 7 (Day 22 oral/sublingual, Day 29 intradermal) | 0 (0 to 26.5) | 8 (0.2 to 38.5) | 0 (0 to 45.9) | 0 (0 to 26.5) | 10 (0.3 to 44.5) | 0 (0 to 45.9) | 8 (0.2 to 38.5) | 33 (0.8 to 90.6) |
| Pre-Dose 3 (Day 29 oral/sublingual) | 8 (0.2 to 38.5) | 17 (2.1 to 48.4) | 0 (0 to 45.9) | 8 (0.2 to 38.5) | 0 (0 to 30.8) | 0 (0 to 45.9) | — | — |
| Post-Dose 3 Day 7 (Day 36 oral/sublingual) | 0 (0 to 26.5) | 8 (0.2 to 38.5) | 0 (0 to 45.9) | 17 (2.1 to 48.4) | 0 (0 to 30.8) | 0 (0 to 45.9) | — | — |
| Post-Dose 3 Day 28 (Day 57 oral/sublingual) | 8 (0.2 to 38.5) | 17 (2.1 to 48.4) | 0 (0 to 45.9) | 9 (0.2 to 41.3) | 0 (0 to 30.8) | 0 (0 to 45.9) | — | — |
Collected over Solicited AEs were collected for 7 days after each vaccine administration. Unsolicited AEs were collected from the time of each study vaccination through 28 days after the last vaccination. Serious adverse events (SAEs) were collected from the time of the first study vaccination through 6 months after the last study vaccination.. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Oral 5 µg dmLT | 0/12 (0%) | 0/12 (0%) | 1/12 (8.3%) |
| Oral 25 µg of dmLT | 0/12 (0%) | 0/12 (0%) | 0/12 (0%) |
| Oral Placebo | 0/6 (0%) | 0/6 (0%) | 1/6 (16.7%) |
| Sublingual 5 µg of dmLT | 0/12 (0%) | 0/12 (0%) | 0/12 (0%) |
| Sublingual 25 µg of dmLT | 0/12 (0%) | 0/12 (0%) | 4/12 (33.3%) |
| Sublingual Placebo | 0/6 (0%) | 0/6 (0%) | 0/6 (0%) |
| Intradermal 0.3 µg of dmLT | 0/12 (0%) | 0/12 (0%) | 0/12 (0%) |
| Intradermal Placebo | 0/3 (0%) | 0/3 (0%) | 0/3 (0%) |
| Event | Oral 5 µg dmLT | Oral 25 µg of dmLT | Oral Placebo | Sublingual 5 µg of dmLT | Sublingual 25 µg of dmLT | Sublingual Placebo | Intradermal 0.3 µg of dmLT | Intradermal Placebo |
|---|---|---|---|---|---|---|---|---|
| Alanine aminotransferase increasedInvestigations | 0/12 | 0/12 | 0/6 | 0/12 | 2/12 | 0/6 | 0/12 | 0/3 |
| Neutropihl count increasedInvestigations | 0/12 | 0/12 | 1/6 | 0/12 | 2/12 | 0/6 | 0/12 | 0/3 |
| White blood cell count increasedInvestigations | 1/12 | 0/12 | 1/6 | 0/12 | 0/12 | 0/6 | 0/12 | 0/3 |
| Age, Continuous(years) | Oral 5 µg dmLT | Oral 25 µg of dmLT | Oral Placebo | Sublingual 5 µg of dmLT | Sublingual 25 µg of dmLT | Sublingual Placebo | Intradermal 0.3 µg of dmLT | Intradermal Placebo | Total |
|---|---|---|---|---|---|---|---|---|---|
| Mean | 30.8 ± 6.6 | 28.8 ± 7.0 | 25.5 ± 4.9 | 27.8 ± 7.1 | 28.8 ± 7.4 | 32.7 ± 5.9 | 31.0 ± 7.4 | 35.0 ± 3.6 | 29.6 ± 6.8 |
| Sex: Female, Male(Participants) | Oral 5 µg dmLT | Oral 25 µg of dmLT | Oral Placebo | Sublingual 5 µg of dmLT | Sublingual 25 µg of dmLT | Sublingual Placebo | Intradermal 0.3 µg of dmLT | Intradermal Placebo | Total |
|---|---|---|---|---|---|---|---|---|---|
| Female | 4 | 7 | 4 | 5 | 8 | 2 | 6 | 2 | 38 |
| Male | 8 | 5 | 2 | 7 | 4 | 4 | 6 | 1 | 37 |
| Ethnicity (NIH/OMB)(Participants) | Oral 5 µg dmLT | Oral 25 µg of dmLT | Oral Placebo | Sublingual 5 µg of dmLT | Sublingual 25 µg of dmLT | Sublingual Placebo | Intradermal 0.3 µg of dmLT | Intradermal Placebo | Total |
|---|---|---|---|---|---|---|---|---|---|
| Hispanic or Latino | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Not Hispanic or Latino | 12 | 12 | 6 | 12 | 12 | 6 | 12 | 3 | 75 |
| Unknown or Not Reported | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Race (NIH/OMB)(Participants) | Oral 5 µg dmLT | Oral 25 µg of dmLT | Oral Placebo | Sublingual 5 µg of dmLT | Sublingual 25 µg of dmLT | Sublingual Placebo | Intradermal 0.3 µg of dmLT | Intradermal Placebo | Total |
|---|---|---|---|---|---|---|---|---|---|
| American Indian or Alaska Native | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Asian | 12 | 12 | 6 | 12 | 12 | 6 | 12 | 3 | 75 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Black or African American | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| White | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| More than one race | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Unknown or Not Reported | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Region of Enrollment(participants) | Oral 5 µg dmLT | Oral 25 µg of dmLT | Oral Placebo | Sublingual 5 µg of dmLT | Sublingual 25 µg of dmLT | Sublingual Placebo | Intradermal 0.3 µg of dmLT | Intradermal Placebo | Total |
|---|---|---|---|---|---|---|---|---|---|
| Bangladesh | 12 | 12 | 6 | 12 | 12 | 6 | 12 | 3 | 75 |
PDFs hosted by the registry, ClinicalTrials.gov.
Ran from Mar 2019 to primary completion in Dec 2020, 21 months.
Results were first posted in Jan 2022, 1 year after primary completion.
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