This page provides an independent statistical analysis and educational interpretation of publicly reported results. ClinicalTrials.gov provides the official trial registry record. Numerical trial results on this page are restricted to the results posted in the ClinicalTrials.gov record; calculations added by Clinical Biostats are labelled as such.
1. Trial at a Glance
This page covers the registry results for A Double-Blind Placebo-Control Dose Escalating Study to Evaluate the Safety and Immunogenicity of dmLT by Oral, Sublingual and Intradermal Vaccination in Adults Residing in an Endemic Area (NCT03548064), a randomized phase 1 study. The primary outcome is Number of Participants in the Oral Arms With Solicited Local Reactogenicity Events Post Each Dose.
| Feature | Registry value |
|---|---|
| ClinicalTrials.gov identifier | NCT03548064 |
| Phase | Phase 1 |
| Condition | Gastroenteritis Escherichia Coli, Immunisation |
| Allocation | Randomized |
| Design model | Sequential |
| Masking | Double |
| Enrollment | 75 |
| Arms in the primary outcome | n/a |
| Lead sponsor | National Institute of Allergy and Infectious Diseases (NIAID) |
| Results posted | Yes |
2. Clinical Question
Population
Adults aged 18–45 years residing in an endemic area were the intended population. The brief summary describes healthy adult volunteers, while the registry enrollment is 75. The primary endpoint’s safety analysis population includes participants who received at least one study vaccination.
Intervention
The study evaluated double mutant heat-labile toxin LTR192G/L211A (dmLT) from enterotoxigenic Escherichia coli (ETEC). The listed regimens used oral, sublingual, or intradermal administration, with different doses and schedules.
Comparator
Participants were randomized to dmLT or placebo regimens. Placebo was administered by the corresponding route in the regimen descriptions. The primary endpoint specifically concerns participants in the oral arms.
Primary question
The primary outcome counts participants in the oral arms with solicited local reactogenicity events after each dose. The registry describes collection during the post-dose windows, but does not report the endpoint results or an inferential comparison.
This is a safety and immunogenicity study, rather than a trial framed around a specific efficacy hypothesis. The brief summary explicitly states that there is no specific hypothesis being tested. Its primary objective is to assess reactogenicity, safety, and tolerability across sequential doses and routes. The registered primary outcome narrows that broad objective to solicited local events among participants receiving oral vaccination, counted after each dose.
The broader study also includes secondary immunogenicity outcomes. These concern rises in dmLT-specific serum, fecal, and ALS antibody titers, as well as antibody-secreting cell measurements. The registry lists these outcomes but provides no analysis results for them. Thus, the central question that can be addressed from the posted results is descriptive: what safety events were recorded in the adverse-event listing, and what endpoint definitions were planned? The record does not establish how the groups compared on reactogenicity or immune response.
3. Trial Design
The registry identifies this as a phase 1, randomized, double-blind, placebo-controlled, sequential dose-escalation study. It enrolled 75 participants and is marked terminated. The record lists a start date of 2019-03-10 and a primary completion date of 2020-12-31. The brief summary describes an intended study of approximately 135 healthy adult volunteers and a study duration of approximately 2.5 years, with participant duration up to 9 months depending on route. The reason for termination and the relationship between the intended enrollment and the registry enrollment are not reported in the registry record.
The planned intervention set spans three routes: oral, sublingual, and intradermal. The regimen descriptions specify repeated dosing on days 1, 15, and 29 for oral and sublingual schedules, and days 1, 22, and 43 for intradermal schedules. Placebo is described for each route. The record’s regimen descriptions include several dmLT dose levels, but the adverse-event listing does not include a corresponding group for every regimen described.
For the primary outcome, the registry specifies counts of participants in oral arms with solicited local reactogenicity after each dose. The listed windows are Day 1 through Day 8 after dose 1, Day 15 through Day 22 after dose 2, and Day 29 through Day 36 after dose 3. The safety analysis population includes anyone who received at least one study vaccination. Randomization and double masking are stated, but details of the randomization procedure, allocation concealment, masking assessment, and dose-escalation decision process are not reported in the registry record. No formal statistical analysis results are posted.
4. Participant Flow and Accounting
The registry reports how participants moved through each stage of the study. All counts below are exactly as posted; missing counts are not inferred from other stages.
Only the first 6 of 8 groups are shown.
Overall Study
| Stage | Oral 5 µg dmLT | Oral 25 µg of dmLT | Oral Placebo | Sublingual 5 µg of dmLT | Sublingual 25 µg of dmLT | Sublingual Placebo |
|---|---|---|---|---|---|---|
| STARTED | 12 | 12 | 6 | 12 | 12 | 6 |
| COMPLETED | 12 | 12 | 6 | 11 | 0 | 3 |
| NOT COMPLETED | 0 | 0 | 0 | 1 | 12 | 3 |
Reasons for not completing this period:
| Reason | Oral 5 µg dmLT | Oral 25 µg of dmLT | Oral Placebo | Sublingual 5 µg of dmLT | Sublingual 25 µg of dmLT | Sublingual Placebo |
|---|---|---|---|---|---|---|
| Withdrawal by Subject | 0 | 0 | 0 | 1 | 0 | 0 |
| Lost to Follow-up | 0 | 0 | 0 | 0 | 2 | 0 |
| Covid-19 Pandemic | 0 | 0 | 0 | 0 | 10 | 3 |
Analysis population for the primary outcome, as defined in the registry: The Safety Analysis population includes all participants who received at least one study vaccination.
5. Baseline Characteristics
The table reproduces the baseline characteristics posted in the registry, which describe the participants analysed at baseline and help show whether the randomized groups were comparable.
Only the first 6 of 9 groups are shown.
| Characteristic | Unit | Oral 5 µg dmLT | Oral 25 µg of dmLT | Oral Placebo | Sublingual 5 µg of dmLT | Sublingual 25 µg of dmLT | Sublingual Placebo |
|---|---|---|---|---|---|---|---|
| Participants analysed | 12 | 12 | 6 | 12 | 12 | 6 | |
| Age, Continuous | years | 30.8 (SD 6.6) | 28.8 (SD 7.0) | 25.5 (SD 4.9) | 27.8 (SD 7.1) | 28.8 (SD 7.4) | 32.7 (SD 5.9) |
| Sex: Female, Male: Female | Participants | 4 | 7 | 4 | 5 | 8 | 2 |
| Sex: Female, Male: Male | Participants | 8 | 5 | 2 | 7 | 4 | 4 |
| Ethnicity (NIH/OMB): Hispanic or Latino | Participants | 0 | 0 | 0 | 0 | 0 | 0 |
| Ethnicity (NIH/OMB): Not Hispanic or Latino | Participants | 12 | 12 | 6 | 12 | 12 | 6 |
| Ethnicity (NIH/OMB): Unknown or Not Reported | Participants | 0 | 0 | 0 | 0 | 0 | 0 |
| Race (NIH/OMB): American Indian or Alaska Native | Participants | 0 | 0 | 0 | 0 | 0 | 0 |
| Race (NIH/OMB): Asian | Participants | 12 | 12 | 6 | 12 | 12 | 6 |
| Race (NIH/OMB): Native Hawaiian or Other Pacific Islander | Participants | 0 | 0 | 0 | 0 | 0 | 0 |
| Race (NIH/OMB): Black or African American | Participants | 0 | 0 | 0 | 0 | 0 | 0 |
| Race (NIH/OMB): White | Participants | 0 | 0 | 0 | 0 | 0 | 0 |
| Race (NIH/OMB): More than one race | Participants | 0 | 0 | 0 | 0 | 0 | 0 |
| Race (NIH/OMB): Unknown or Not Reported | Participants | 0 | 0 | 0 | 0 | 0 | 0 |
| Region of Enrollment: Bangladesh | participants | 12 | 12 | 6 | 12 | 12 | 6 |
6. Primary Endpoint
The registry lists the primary outcome as Number of Participants in the Oral Arms With Solicited Local Reactogenicity Events Post Each Dose, measured over Day 1 through Day 8 (post dose 1), Day 15 through Day 22 (post dose 2), Day 29 through Day 36 (post dose 3).
| Element | Registry entry |
|---|---|
| Result type | Count Of Participants |
| Measure of spread | not applicable |
| Unit | Participants |
| Endpoint classification | Binary Endpoint |
The primary endpoint is a count of participants in the oral arms who experienced solicited local reactogenicity events after each dose. It is not a measure of the number of event episodes: the outcome is explicitly defined as the number of participants with events. The collection windows cover the first 7 days after each vaccination, as defined by the registry’s day ranges.
For oral vaccination, the registry defines local events to include irritation of the oral cavity or tongue, diarrhea, nausea, vomiting, and abdominal discomfort. The outcome is intended to describe short-term tolerability following vaccination. Counting participants with at least one event can make the frequency of affected participants easier to interpret than a total event count when an individual might report multiple events. That is a general feature of participant-level event counts, not a result from this trial.
The outcome is specified separately after each dose, so the dose-specific windows matter: an overall count across all windows would not answer exactly the same question. The registry record does not report the observed primary endpoint counts, the number assessed in each window, or a comparison between dmLT and placebo. It also does not state a formal hypothesis test or an effect estimate for this endpoint. Consequently, its definition can be described, but its observed frequency and precision cannot be evaluated from the posted results.
7. Why No Re-analysis Is Shown
8. Statistical Interpretation
The registry record gives a clear description of the trial’s primary safety question, but no primary endpoint analysis. It lists 17 outcome measures and 0 analyses. In particular, it does not report the number of participants with solicited local reactogenicity in the oral arms after any dose. No effect estimate, confidence interval, or p-value for that endpoint is reported in the registry record. The absence of an analysis is not evidence that the event frequency was zero or that the groups were alike.
The adverse-event listing provides a separate descriptive view of safety. Across the listed groups, the serious adverse event count is 0 in each group, and the death count is 0 in each group. For other adverse events, the listing reports 1 participant for Oral 5 µg dmLT, 0 for Oral 25 µg of dmLT, 1 for Oral Placebo, 0 for Sublingual 5 µg of dmLT, 4 for Sublingual 25 µg of dmLT, 0 for Sublingual Placebo, 0 for Intradermal 0.3 µg of dmLT, and 0 for Intradermal Placebo. These are descriptive counts in the listed safety groups; they are not the primary endpoint counts and do not, by themselves, establish a treatment-related difference.
The adverse-event groups have different numbers at risk, and the record does not provide a comparative analysis accounting for those group sizes or other features of the design. It also does not provide event details for the other adverse-event counts in this listing. The top serious-event terms list is empty. These details should not be expanded into claims about types of events or causality that the record does not establish.
The study’s immunogenicity outcomes are listed as secondary outcomes, including antibody titer rises and antibody-secreting cell thresholds. The outcome definitions alone do not show whether an immune response occurred. Their results, as well as any uncertainty estimates, are not reported in the registry record. The posted information therefore supports a description of trial structure and the listed adverse-event counts, but not a conclusion about comparative safety, immunogenicity, or efficacy.
Precision is also not assessable for the primary outcome because no observed counts or confidence intervals are reported. Even a zero count in a particular adverse-event category would not by itself prove that the underlying risk is zero; it would describe only the observed participants and the recorded category. General statistical interpretation requires the denominator, follow-up, outcome ascertainment, and uncertainty estimates, and the registry’s primary endpoint results do not include these elements.
9. Statistical Methods Explained
What does a participant count measure?
The primary outcome is a participant count: how many people experienced a solicited local event in a specified post-dose window. This differs from counting all event episodes. A person with more than one event still contributes as a participant with an event under a participant-level outcome. That is a general distinction between participant counts and event counts; the registry does not give further rules for combining different symptoms or handling repeated reports.
Because the primary outcome is recorded after each dose, each window represents a distinct period of observation. Reading the count for one dose window answers a dose-specific question. Combining windows would require a defined rule, such as whether a participant is counted once across all doses or once in every window in which an event occurs. Such a combined rule is not reported in the registry record.
Why use descriptive counts in a phase 1 safety study?
General: descriptive counts can show how many participants in each group experienced recorded events, which is useful when the objective is to characterize safety and tolerability. They do not automatically quantify a causal effect. A comparative interpretation depends on the study design, group sizes, outcome definitions, follow-up, and a specified analysis. Here, randomization and double masking are recorded, but the primary endpoint results and inferential analysis are not reported.
Counts also need context. The safety listing gives numbers at risk alongside counts of participants affected, but it does not report confidence intervals for those counts or a model-based comparison. A confidence interval is a range of values that reflects statistical uncertainty under a specified method and assumptions. General: when event counts are small, estimates can be imprecise, and uncertainty can remain even when no events are observed. No precision interval for the listed adverse-event counts is reported in the registry record.
What does randomization contribute?
General: random allocation is intended to make comparison groups similar on average with respect to factors that could influence outcomes. It does not guarantee identical groups in a particular trial, especially when group sizes are limited. Double masking can reduce some differences in care, reporting, and outcome assessment, but its success depends on how masking was implemented and maintained. The registry records randomized allocation and double masking; the specific procedures and any assessment of masking are not reported in the registry record.
The design is described as sequential and dose-escalating. General: sequential dose escalation can organize the evaluation of different doses over successive groups or stages, but the details matter for interpreting comparisons, including how decisions to proceed were made. The dose-escalation rules, stopping criteria, and any interim review procedures are not reported in the registry record. They should not be inferred from the label alone.
What can and cannot be inferred from the analysis listing?
The registry lists 17 outcome measures and 0 analyses. General: an outcome definition explains what investigators intended to measure; an analysis gives observed results and may include estimates of differences, uncertainty, and statistical tests. Without the latter, there is no basis for estimating the magnitude or precision of a contrast between dmLT and placebo for the primary endpoint. The record also states no specific hypothesis was being tested, so a conventional confirmatory hypothesis-testing framework should not be assumed.
The secondary outcomes use threshold-based definitions, such as rises in antibody titers or counts of antibody-secreting cells. General: converting a continuous laboratory measurement into a threshold outcome can simplify reporting, but it loses information about values below and above the threshold. The registry provides outcome definitions but no results or analysis methods for these measures. The handling of baseline values, missing measurements, and values at assay limits is not reported in the registry record.
The brief summary’s stated intended enrollment and the registry’s enrollment are not the same figure. The record does not explain the difference. General: planned sample size and actual enrollment answer different questions. Neither figure on its own gives observed power or indicates whether a study was adequately powered for an endpoint. No sample-size justification, target power, or minimum clinically important difference is reported in the registry record.
Over-dispersion is relevant in some count-data analyses when variability exceeds what a chosen probability model expects. General: a model that ignores over-dispersion can give uncertainty estimates that are too narrow. The primary outcome is a participant count in dose-specific windows, and no count model or dispersion estimate is reported. It would therefore be inappropriate to attribute a particular model or over-dispersion adjustment to this study.
10. Multiplicity, Missing Data and Analysis Populations
The registry lists multiple outcomes: the primary endpoint concerns oral local reactogenicity after each dose, and secondary outcomes cover serious adverse events and several measures of dmLT-specific immune response. The primary outcome also has multiple dose-specific time windows. Considering multiple outcomes or time points can create multiplicity: general statistical explanations note that, when many tests are performed, the chance of at least one apparently unusual result can rise unless the analysis plan addresses this. The registry record does not report a multiplicity strategy, a prespecified hierarchy among secondary outcomes, or an adjustment method. It also reports 0 analyses, so no multiplicity-adjusted or unadjusted inferential results are available.
Missing-data handling is not reported in the registry record. The record does not state how incomplete post-dose symptom diaries, missed visits, unavailable laboratory specimens, or participants who discontinued were handled. The primary safety analysis population is defined as participants who received at least one study vaccination, but the record does not provide the number included in each endpoint window or explain whether all such participants contributed data at each time point.
The registry does not report analysis populations for the secondary immune outcomes, the denominators used for those outcomes, or methods for handling missing baseline or follow-up measurements. No intention-to-treat, per-protocol, or other named analysis population is specified in the posted information. These omissions limit interpretation of both safety and immunogenicity findings, particularly if completeness of follow-up differed across routes, doses, or groups.
11. Safety Results
The registry reports serious adverse events as affected participants divided by participants at risk.
| Arm | Participants with serious adverse events | Participants at risk | Percentage |
|---|---|---|---|
| Oral 5 µg dmLT | 0 | 12 | 0.0% |
| Oral 25 µg of dmLT | 0 | 12 | 0.0% |
| Oral Placebo | 0 | 6 | 0.0% |
| Sublingual 5 µg of dmLT | 0 | 12 | 0.0% |
| Sublingual 25 µg of dmLT | 0 | 12 | 0.0% |
| Sublingual Placebo | 0 | 6 | 0.0% |
| Intradermal 0.3 µg of dmLT | 0 | 12 | 0.0% |
| Intradermal Placebo | 0 | 3 | 0.0% |
Deaths
| Arm | Deaths (participants affected of at risk) |
|---|---|
| Oral 5 µg dmLT | 0 of 12 |
| Oral 25 µg of dmLT | 0 of 12 |
| Oral Placebo | 0 of 6 |
| Sublingual 5 µg of dmLT | 0 of 12 |
| Sublingual 25 µg of dmLT | 0 of 12 |
| Sublingual Placebo | 0 of 6 |
Other (non-serious) adverse events
Participants with at least one non-serious event at or above the registry's 5% reporting threshold.
| Arm | Participants affected of at risk |
|---|---|
| Oral 5 µg dmLT | 1 of 12 |
| Oral 25 µg of dmLT | 0 of 12 |
| Oral Placebo | 1 of 6 |
| Sublingual 5 µg of dmLT | 0 of 12 |
| Sublingual 25 µg of dmLT | 4 of 12 |
| Sublingual Placebo | 0 of 6 |
Most frequent non-serious adverse event terms
| Event term | Organ system | Oral 5 µg dmLT | Oral 25 µg of dmLT | Oral Placebo | Sublingual 5 µg of dmLT | Sublingual 25 µg of dmLT | Sublingual Placebo |
|---|---|---|---|---|---|---|---|
| Neutropihl count increased | Investigations | 0 of 12 | 0 of 12 | 1 of 6 | 0 of 12 | 2 of 12 | 0 of 6 |
| Alanine aminotransferase increased | Investigations | 0 of 12 | 0 of 12 | 0 of 6 | 0 of 12 | 2 of 12 | 0 of 6 |
| White blood cell count increased | Investigations | 1 of 12 | 0 of 12 | 1 of 6 | 0 of 12 | 0 of 12 | 0 of 6 |
The adverse-event listing reports zero serious adverse events and zero deaths in every listed group. The number at risk varies by group: it is 12 for the listed active groups, 6 for the oral and sublingual placebo groups, and 3 for the intradermal placebo group. These are group-level counts from the registry listing, not estimates of comparative risk.
For other adverse events, the listing records 1 participant in Oral 5 µg dmLT, 0 in Oral 25 µg of dmLT, 1 in Oral Placebo, 0 in Sublingual 5 µg of dmLT, 4 in Sublingual 25 µg of dmLT, 0 in Sublingual Placebo, 0 in Intradermal 0.3 µg of dmLT, and 0 in Intradermal Placebo. The record does not provide event terms for these counts in the listing, so they should not be interpreted as particular symptoms or as necessarily caused by vaccination. The top serious-event terms list is empty.
These adverse-event counts are distinct from the primary endpoint, which concerns solicited local reactogenicity in oral arms during specified post-dose windows. The registry does not report those primary outcome counts. The safety listing also lacks comparative tests and uncertainty estimates, so differences in the raw counts should not be treated as evidence of a group effect. The listed groups do not cover every regimen described in the trial record.
12. What the Result Does, and Does Not, Mean
The registry record documents a randomized, double-blind, phase 1 study intended to assess safety, tolerability, and immunogenicity of dmLT by three routes. It defines a participant-level primary safety outcome for solicited local reactogenicity in the oral arms and gives the observation windows after each dose. It also lists adverse-event counts for several groups. These details clarify what was intended to be assessed and what safety counts appear in the posting.
The record does not report the observed primary endpoint results, any statistical analysis, or results for the listed immunogenicity outcomes. Consequently, it cannot establish the frequency of the primary events, quantify a difference between dmLT and placebo, or characterize the precision of such a difference. It also cannot support conclusions about whether dmLT produces an immune response, because secondary outcome definitions are not results.
Zero serious adverse events in the listed groups is a descriptive observation, not proof that serious events cannot occur or that risks are equivalent. General: a lack of observed events in a study does not eliminate uncertainty about uncommon outcomes, and comparative safety conclusions require suitable estimates and follow-up. The registry’s adverse-event counts do not include a causal assessment or comparative analysis.
The record’s terminated status is an administrative trial status; the reason for termination and its implications for data collection are not reported in the registry record. The difference between the brief summary’s intended enrollment of approximately 135 and the registry enrollment of 75 is also unexplained. The posted information therefore permits a careful account of the planned questions and available descriptive safety listing, but not a determination of treatment benefit or harm.
13. Why This Trial Matters Statistically
This trial illustrates an important distinction in clinical statistics: an outcome can be carefully defined without its results being available. The registry specifies a participant-level oral reactogenicity outcome, its symptom scope, and post-dose observation windows. Those definitions are necessary for interpretation, but they do not reveal event frequencies or group differences. The record lists 0 analyses, making the distinction especially relevant.
The study also spans multiple routes, doses, outcomes, and observation periods. General: such a design raises practical questions about how comparisons are organized, how dose escalation proceeds, how multiplicity is handled, and how missing observations are treated. The registry record describes the broad design but does not report those analysis details. Statistical interpretation depends on these methods as well as on outcome counts.
The adverse-event listing shows why raw counts must be read alongside their denominators and context. The listed groups differ in numbers at risk, and not every regimen in the regimen descriptions has a corresponding adverse-event group in the listing. Without endpoint-specific results, uncertainty estimates, and a comparative analysis, the counts do not answer the trial’s primary question.
Finally, the contrast between the intended enrollment in the brief summary and the registry enrollment highlights the need to distinguish planned participation from the recorded enrollment. The record does not explain this difference or the termination. These limitations do not erase the value of transparent outcome definitions and safety reporting, but they set clear boundaries on what can be learned from the posted results.
14. Limitations
- The posted summary statistics are the only data these results rest on; patient-level data, full protocols and statistical analysis plans are not available.
- Recalculated results are simple, unadjusted calculations from posted summaries. They do not replace the sponsor's prespecified analysis.
The most important limitation for interpretation is that the registry reports no analyses. The primary outcome is defined, but its counts are not posted. No effect estimates, confidence intervals, or p-values are reported for the primary or secondary outcomes. The adverse-event listing is descriptive and does not include comparative inference.
The registry marks the trial terminated but does not report why it was terminated or whether termination affected the planned enrollment, follow-up, or outcome collection. The brief summary describes approximately 135 intended volunteers, whereas registry enrollment is 75; the reason for that difference is not reported in the registry record. No sample-size justification or statistical plan is reported.
The adverse-event listing includes only some of the regimens described in the record. The listed serious-event counts are zero, but the posting does not provide serious-event terms, and the top serious terms list is empty. The other-adverse-event counts are not accompanied by event descriptions in this listing. The record does not explain how these counts relate to the primary solicited reactogenicity endpoint.
Other trial details needed for fuller appraisal are not reported in the registry record, including dose-escalation rules, randomization procedures, missing-data methods, multiplicity handling, and the specific populations used for secondary analyses. The registry’s safety population is defined as participants who received at least one vaccination, but endpoint-specific denominators are not given. These gaps prevent assessment of completeness, precision, and comparability across groups.
15. Related Tutorials
16. Related Statistical Calculators
17. Sources
- ClinicalTrials.gov: A Double-Blind Placebo-Control Dose Escalating Study to Evaluate the Safety and Immunogenicity of dmLT by Oral, Sublingual and Intradermal Vaccination in Adults Residing in an Endemic Area — NCT03548064.
- Registry record last updated 2025-05-21; status last verified 2017-12-14.
- Results first posted 2022-01-18.
- Data retrieved from ClinicalTrials.gov on 2026-11-09.
- Group sizes, means, event counts and sponsor-reported p-values are reproduced as posted. Effect estimates, confidence intervals and p-values not attributed to the sponsor are independently calculated from the posted summary statistics.
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18. Record Summary
NCT03548064 is a randomized, double-blind, phase 1, sequential dose-escalation study of dmLT administered orally, sublingually, or intradermally in adults residing in an endemic area. The registry reports enrollment of 75, status terminated, a start date of 2019-03-10, and a primary completion date of 2020-12-31. Its primary outcome counts participants in oral arms with solicited local reactogenicity after each dose.
The record lists 17 outcome measures and 0 analyses. It includes adverse-event counts for several groups, with zero serious adverse events and zero deaths in each listed group. Primary endpoint results, immunogenicity results, comparative analyses, and uncertainty estimates are not reported in the registry record. The reason for termination, sample-size justification, and explanation for the difference between the intended enrollment in the brief summary and registry enrollment are also not reported.