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 Safety and Feasibility of TA-CIN Vaccine in HPV16 Associated Cervical Cancer (NCT02405221), a randomized phase 1 study. The primary outcome is Safety and Feasibility as Assessed by Number of Participants With Treatment-related Adverse Events.
| Feature | Registry value |
|---|---|
| ClinicalTrials.gov identifier | NCT02405221 |
| Phase | Phase 1 |
| Condition | HPV16 Associated Cervical Cancer |
| Allocation | Randomized |
| Design model | Single Group |
| Masking | None (open label) |
| Enrollment | 15 |
| Arms in the primary outcome | n/a |
| Lead sponsor | Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins |
| Results posted | Yes |
2. Clinical Question
Population
People with a history of HPV16-associated cervical cancer were eligible for the study. The primary outcome description specifies a history of HPV16-associated IB1-IV cervical cancer. The registry lists an enrollment of 15 participants.
Intervention
TA-CIN was administered by intramuscular injection, with one group receiving injections in the thigh and another receiving them in the arm. Each dose was fixed at 100µg. The described schedule was 3 doses at Weeks 1, 5, and 9, followed by 2 years of follow-up after the first dose.
Comparator
The registry lists both injection locations and reports adverse-event counts for the thigh and arm groups. This is a comparison of administration locations, not a comparison against a placebo or an untreated group. Details of the randomization process and allocation ratio are not reported in the registry record.
Primary question
The primary outcome concerns the number of participants with treatment-related adverse events over up to 24 months following the first vaccine dose. The outcome description also refers to treatment-emergent adverse events defined by CTCAE v4.0. The record lists safety and feasibility as the focus; it does not report a specific primary-outcome analysis comparing the two injection locations.
In statistical terms, the question is whether the registry’s safety counts differ between the arm and thigh administration groups, and how much uncertainty surrounds any such comparison. The posted adverse-event figures describe participants affected, rather than the total number of separate events. Those counts provide descriptive information, but do not by themselves establish that an event was caused by vaccination or that one location is safer. The registry also lists antibody, T-cell, and mononucleocyte responses as secondary outcomes, but their results are not reported in the registry record. The primary endpoint’s specific treatment-related participant counts are likewise not reported in the registry record as a separate analyzed result.
3. Trial Design
This is a completed Phase 1 study sponsored by Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins. The registry lists a start date of 2019-04-04, a primary completion date of 2024-12-31, and an enrollment of 15. The condition is HPV16 Associated Cervical Cancer. The study title and description identify TA-CIN vaccination as adjuvant therapy for people with a history of HPV16-associated cervical cancer.
The intervention descriptions specify a fixed 100µg dose administered intramuscularly, with 3 doses scheduled 4 weeks apart at Weeks 1, 5, and 9. One group received injections in the thigh and the other in the arm. Participants were to be followed for 2 years after the first dose. The registry reports adverse-event participant counts of 8 for the thigh group and 7 for the arm group. These are the denominators listed in the safety entries; the record does not provide further detail about enrollment flow or whether all participants completed the planned schedule and follow-up.
The registry describes allocation as randomized and masking as none, while also identifying the model as single-group. It lists two administration groups, but the record does not explain how the single-group model designation relates to the randomized allocation and the two locations. The randomization method, allocation ratio, and any procedures used to conceal allocation are not reported in the registry record. These missing details limit assessment of how comparable the groups may have been before treatment.
The study is described as a pilot assessment of safety and feasibility. The registry does not report a protocol-based sample-size justification, planned statistical analysis, or details of interim analyses. Its completion status indicates that the study is completed, but completion status alone does not establish that all planned outcomes were analyzed or entered in the registry. The record lists 8 outcome measures and no statistical analyses. It also lists secondary immune-response outcomes, but their numerical findings are not reported in the registry record.
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.
Overall Study
| Stage | TA-CIN Administration Via Thigh | TA-CIN Administration Via Arm |
|---|---|---|
| STARTED | 8 | 7 |
| COMPLETED | 6 | 6 |
| NOT COMPLETED | 2 | 1 |
Reasons for not completing this period:
| Reason | TA-CIN Administration Via Thigh | TA-CIN Administration Via Arm |
|---|---|---|
| Adverse Event | 1 | 0 |
| Lost to Follow-up | 1 | 1 |
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.
| Characteristic | Unit | TA-CIN Administration Via Thigh | TA-CIN Administration Via Arm | Total |
|---|---|---|---|---|
| Participants analysed | 8 | 7 | 15 | |
| Age, Continuous | years | 43 (35 to 67) | 58 (37 to 83) | 44 (35 to 83) |
| Sex: Female, Male: Female | Participants | 8 | 7 | 15 |
| Sex: Female, Male: Male | Participants | 0 | 0 | 0 |
| Ethnicity (NIH/OMB): Hispanic or Latino | Participants | 1 | 0 | 1 |
| Ethnicity (NIH/OMB): Not Hispanic or Latino | Participants | 7 | 7 | 14 |
| Ethnicity (NIH/OMB): Unknown or Not Reported | Participants | 0 | 0 | 0 |
| Race/Ethnicity, Customized: Race – White | Participants | 6 | 3 | 9 |
| Race/Ethnicity, Customized: Race – Black | Participants | 1 | 3 | 4 |
| Race/Ethnicity, Customized: Race – Other | Participants | 1 | 1 | 2 |
| Region of Enrollment: United States | Participants | 8 | 7 | 15 |
| Primary Site Disease: Cervix, NOS | Participants | 4 | 3 | 7 |
| Primary Site Disease: Endocervix | Participants | 4 | 4 | 8 |
| Histology: Adenocarcinoma (ADC) | Participants | 5 | 1 | 6 |
| Histology: Squamous cell (SCC) | Participants | 3 | 5 | 8 |
| Histology: Small cell carcinoma + ADC | Participants | 0 | 1 | 1 |
| Histology Grade: Poorly differentiated | Participants | 0 | 1 | 1 |
| Histology Grade: Moderately differentiated | Participants | 3 | 2 | 5 |
| Histology Grade: Well-differentiated | Participants | 2 | 1 | 3 |
| Histology Grade: Unknown/No comment | Participants | 3 | 3 | 6 |
| Cervical Cancer Stage: IB | Participants | 4 | 6 | 10 |
| Cervical Cancer Stage: IIA/IIB | Participants | 3 | 1 | 4 |
| Cervical Cancer Stage: IIIC | Participants | 1 | 0 | 1 |
| Prior Treatment: Surgery only | Participants | 3 | 2 | 5 |
| Prior Treatment: ChemoRadiation only | Participants | 4 | 3 | 7 |
| Prior Treatment: Surgery + ChemoRadiation | Participants | 0 | 1 | 1 |
| Prior Treatment: Surgery + Radiation | Participants | 1 | 1 | 2 |
| Adjuvant Chemo Regimen: None | Participants | 5 | 3 | 8 |
| Adjuvant Chemo Regimen: Cisplatin | Participants | 3 | 3 | 6 |
| Adjuvant Chemo Regimen: Cisplatin/Etoposide | Participants | 0 | 1 | 1 |
| Adjuvant Radiation Site: No radiation | Participants | 3 | 2 | 5 |
| Adjuvant Radiation Site: Cervix | Participants | 2 | 1 | 3 |
| Adjuvant Radiation Site: Pelvis involved | Participants | 2 | 4 | 6 |
| Adjuvant Radiation Site: Syed brachytherapy | Participants | 1 | 0 | 1 |
| Months from end of prior treatment until first vaccination | months | 6.5 (4.5 to 11.6) | 8.4 (4 to 10.9) | 6.7 (4 to 11.6) |
6. Primary Endpoint
The registry lists the primary outcome as Safety and Feasibility as Assessed by Number of Participants With Treatment-related Adverse Events, measured over Up to 24 months following the first dose of study vaccine.
| Element | Registry entry |
|---|---|
| Result type | Count Of Participants |
| Measure of spread | not applicable |
| Unit | Participants |
| Endpoint classification | Binary Endpoint |
The primary endpoint is described as the number of participants with treatment-related adverse events, with assessment up to 24 months following the first dose of study vaccine. The outcome description refers to safety and feasibility of intramuscular TA-CIN via the arm or thigh among people with a history of HPV16-associated IB1-IV cervical cancer. It further describes treatment-emergent adverse events as defined by CTCAE v4.0. The endpoint title uses the term treatment-related, while the description uses treatment-emergent; the registry does not explain whether these terms were intended to represent the same analysis.
A count of participants with an event records how many people experienced an event, rather than how many events occurred in total. A participant may experience more than one event, so participant counts and event counts answer different questions. For safety monitoring, the participant-based measure can show how many people were affected during the stated observation period. It does not, without further detail, describe event severity, duration, recurrence, or causal attribution.
The endpoint is relevant to the stated safety and feasibility aim because it tracks adverse events following vaccination. However, the registry record does not provide a separate primary-outcome analysis or a count specifically identified as treatment-related. The adverse-event module provides serious and other adverse-event participant counts, but those figures should not automatically be treated as the primary endpoint result. The record’s precise primary outcome findings, and any comparison between injection locations for that endpoint, are not reported in the registry record.
7. Why No Re-analysis Is Shown
8. Statistical Interpretation
The registry reports serious adverse events affecting 1 of 8 participants in the thigh group and 0 of 7 participants in the arm group. It reports other adverse events affecting 8 of 8 participants in the thigh group and 7 of 7 participants in the arm group. Deaths are listed as 0 in both groups. These are descriptive counts. They indicate how many participants in each listed group were recorded as affected, but they do not establish whether the events were caused by TA-CIN, whether the groups differed in underlying risk, or whether the counts would be similar in a larger study.
The reported serious-event count is sparse, and the group sizes are small. With few participants, a single participant’s outcome can have a substantial influence on the apparent pattern. No confidence intervals, hypothesis tests, or adjusted comparisons are reported in the registry record. Therefore, the observed difference in serious adverse-event counts should not be interpreted as evidence of a reliable difference between injection locations. The absence of a serious-event entry in the arm group is not proof that serious events cannot occur in that group.
The record identifies bowel obstruction (adhesion-related) at 12.5% among the top serious terms. It does not give enough context in that entry to determine the denominator or to connect the term specifically with a particular injection group or causal assessment. The percentage should therefore be read as a registry-reported serious-event term, not as a group-specific rate or an estimate of treatment risk.
There is also a distinction between the primary endpoint and the adverse-event counts. The primary outcome is framed as participants with treatment-related adverse events, while the description refers to treatment-emergent events. The safety entries separately report serious and other adverse events. The record does not establish that these categories reproduce the primary endpoint definition, nor does it provide a dedicated primary endpoint result. It is therefore not possible to infer the primary endpoint comparison from the safety entries alone.
The registry lists randomized allocation but also labels the study model single-group. It does not explain this combination or report details of randomization. That uncertainty matters when interpreting between-group contrasts: random allocation can support a fair comparison when properly implemented, but the registry record does not supply enough information to assess its implementation. The record also does not report confidence intervals or a prespecified statistical analysis. The posted data are best treated as a descriptive safety account from a pilot study, rather than as a precise comparative estimate.
Nothing in these counts establishes vaccine efficacy, a protective immune response, or a clinical benefit. The registry lists antibody, T-cell, and mononucleocyte outcomes, but their results are not reported in the registry record. The data support only a limited description of the adverse-event counts recorded for the two administration locations.
9. Statistical Methods Explained
Statistical interpretation begins with identifying what was counted. The primary endpoint is expressed as a count of participants with treatment-related adverse events, not a count of all event episodes. A participant who experiences several events may still contribute as one affected participant to a participant-count endpoint. Event counts, participant counts, and counts classified by severity are distinct summaries. The registry’s adverse-event entries distinguish serious from other adverse events, while the primary outcome description uses treatment-related and treatment-emergent wording. The record does not specify how those definitions were aligned in the analysis.
What do participant counts tell us?
Participant counts are direct summaries of how many people were recorded as affected within each group. They are useful for describing the observed safety experience, especially in a pilot study. They do not, on their own, quantify uncertainty or establish a causal relationship. A count also does not show when an event occurred, how long it lasted, whether it recurred, or whether a participant had multiple events. Those details are not reported in the registry record for the endpoint results.
For the adverse-event entries, the record gives the numbers at risk and the numbers affected. The serious-event counts are 1 in the thigh group and 0 in the arm group; the other-event counts are 8 and 7, respectively. Deaths are listed as 0 in both groups. These raw summaries should be kept distinct from estimates of comparative risk. No comparative effect estimate or uncertainty interval is reported in the registry record, and no new estimate should be inferred from the counts when interpreting the posted results.
Why does uncertainty matter?
A confidence interval is a range of values that, under the statistical method used, expresses uncertainty around an estimated quantity. It is not a guarantee that the true value lies within the interval, and its interpretation depends on the method and assumptions. For small groups and uncommon outcomes, estimates can be especially imprecise. The registry record does not report confidence intervals for the primary endpoint or the adverse-event comparisons, so the precision of any group contrast cannot be assessed from the record.
A hypothesis test asks whether the observed data are inconsistent with a specified null hypothesis under a model. A p-value, if reported, would not measure the probability that the null hypothesis is true, nor would it measure the size or clinical importance of an effect. No p-values or hypothesis tests for the relevant safety comparison are reported in the registry record. The lack of a reported test is not evidence that the groups are identical; it means the registry does not provide that inferential result.
How should planning illustrations be read?
Sample-size calculations are planning tools, not outcomes of the trial. The listed planning assumptions describe an illustration based on the observed effect, with a two-sided significance level of 0.05, equal allocation between groups, and a normal approximation. The effect to detect is described as a stated fraction of the observed effect. Such calculations depend on their assumptions and are not a retrospective measure of whether a trial had adequate power. In particular, an illustration based on an observed effect should not be called observed power or treated as the study’s original design justification.
The record does not report a protocol-based sample-size justification, and the planning assumptions are explicitly illustrative rather than the trial’s own design. Any participant counts shown for planning should be understood as hypothetical requirements under those assumptions, not as observed enrollment or evidence that a particular effect was established. The assumptions do not resolve uncertainty about the primary outcome definition, the analysis population, or the relationship between the randomized allocation and single-group model designation.
Why can over-dispersion matter?
General statistical explanation: over-dispersion occurs when observed variability is greater than a statistical model expects. For count outcomes, a model that assumes less variability than the data contain can produce uncertainty estimates that are too narrow and tests that appear more decisive than warranted. Model choice should therefore reflect the outcome scale and the way observations vary. The registry identifies a participant-count outcome, but it does not report a model, variance assessment, or analysis plan for that endpoint. There is no basis in the registry record for claiming that over-dispersion was assessed or that a particular count model was used.
In a small pilot, descriptive counts can be informative for documenting the observed experience, while formal estimates may remain highly uncertain. The appropriate interpretation depends on the prespecified endpoint, the event definitions, follow-up completeness, and the analysis method. Those details are not fully reported in the registry record. As a result, the most supportable statistical reading is to describe the posted counts and their limitations, without assigning a causal or comparative conclusion.
10. Multiplicity, Missing Data and Analysis Populations
The registry lists 8 outcome measures, including the primary safety and feasibility outcome and secondary immune-response outcomes. When a study examines several outcomes or makes several comparisons, the chance of obtaining an apparently unusual result can increase if each is tested separately. Statistical methods can address multiplicity by specifying a primary comparison, adjusting tests, or treating secondary analyses as exploratory. The registry record does not report a multiplicity plan or indicate whether any adjustment was used. It also lists no statistical analyses, so there are no posted test results from which to assess how multiple outcomes were handled.
Missing-data procedures are not reported in the registry record. The record does not describe how incomplete follow-up, missed vaccine doses, unavailable laboratory measurements, or missing adverse-event assessments were handled. It also does not report a primary analysis population, such as whether the endpoint was analyzed among all randomized participants or only those with available assessments. The listed adverse-event denominators are 8 for the thigh group and 7 for the arm group, but they do not by themselves establish the completeness of follow-up over the stated period of up to 24 months.
These omissions limit assessment of potential bias. If participants with missing observations differ from those with complete data, the available counts may not represent all enrolled participants’ experience. This is a general concern, not a claim that missingness occurred in this study. The registry does not report whether it occurred or how it was addressed. Likewise, without an analysis population and prespecified handling rules, readers cannot determine whether the posted counts follow an intention-to-treat, per-protocol, or other approach. These details are not reported in the registry record.
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 |
|---|---|---|---|
| TA-CIN Administration Via Thigh | 1 | 8 | 12.5% |
| TA-CIN Administration Via Arm | 0 | 7 | 0.0% |
Deaths
| Arm | Deaths (participants affected of at risk) |
|---|---|
| TA-CIN Administration Via Thigh | 0 of 8 |
| TA-CIN Administration Via Arm | 0 of 7 |
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 |
|---|---|
| TA-CIN Administration Via Thigh | 8 of 8 |
| TA-CIN Administration Via Arm | 7 of 7 |
Most frequent serious adverse event terms
| Event term | Organ system | TA-CIN Administration Via Thigh | TA-CIN Administration Via Arm |
|---|---|---|---|
| Bowel obstruction (adhesion-related) | Gastrointestinal disorders | 1 of 8 | 0 of 7 |
Most frequent non-serious adverse event terms
| Event term | Organ system | TA-CIN Administration Via Thigh | TA-CIN Administration Via Arm |
|---|---|---|---|
| Injection site reaction | General disorders | 5 of 8 | 3 of 7 |
| Nausea | Gastrointestinal disorders | 2 of 8 | 1 of 7 |
| Hypertension | Vascular disorders | 1 of 8 | 1 of 7 |
| Peripheral sensory neuropathy | Nervous system disorders | 1 of 8 | 1 of 7 |
| Abdominal distension | Gastrointestinal disorders | 1 of 8 | 0 of 7 |
| Abdominal pain | Gastrointestinal disorders | 1 of 8 | 0 of 7 |
| Arthralgia | Musculoskeletal and connective tissue disorders | 0 of 8 | 1 of 7 |
| Back pain | Musculoskeletal and connective tissue disorders | 1 of 8 | 0 of 7 |
| Bloating | Gastrointestinal disorders | 1 of 8 | 0 of 7 |
| Depression | Psychiatric disorders | 0 of 8 | 1 of 7 |
Serious events with the highest arm-level rate: bowel obstruction (adhesion-related) (12.5%).
The serious adverse-event entries list 8 participants at risk in the thigh group, with 1 affected, and 7 at risk in the arm group, with 0 affected. The record lists 0 deaths in each group. The other adverse-event entries list 8 participants at risk and 8 affected in the thigh group, and 7 at risk and 7 affected in the arm group. These are participant counts, not counts of all individual event episodes.
The registry identifies bowel obstruction (adhesion-related) at 12.5% among the top serious terms. The entry does not provide context sufficient to interpret that percentage as a group-specific risk, nor does it establish that the event was caused by vaccination. Seriousness, severity, and causal attribution are separate properties: an event may meet a seriousness criterion without being judged related to treatment.
The counts are descriptive and come from small groups. They should not be read as a definitive comparison of injection locations. The record does not provide a statistical analysis, uncertainty intervals, or a separate primary endpoint result linked to these categories. The primary outcome wording and the adverse-event summaries are not shown to be identical definitions. The safest reading is limited to what the registry records: the number of participants listed as affected in each adverse-event category.
12. What the Result Does, and Does Not, Mean
The posted safety data describe the number of participants recorded with serious and other adverse events in the arm and thigh groups. They also list no deaths in either group. The result is a small descriptive account of events among participants enrolled in a Phase 1 pilot study. It does not supply a precise estimate of comparative safety, and it does not show whether any observed difference is larger than would be expected from random variation.
The counts do not establish causation. An adverse event occurring after vaccination is not automatically caused by vaccination, and the record does not report causal assessments for each event in a way that supports a treatment-related comparison. The bowel obstruction (adhesion-related) entry is a serious-event term reported at 12.5%, but the record does not provide enough context to assign that figure to a particular group or interpret it as an attributable risk.
The primary endpoint is intended to capture participants with treatment-related adverse events over up to 24 months following the first dose. However, a separately analyzed primary endpoint result is not reported in the registry record. The available serious and other event counts should not be substituted for that result without evidence that the event definitions and analysis match. The registry’s treatment-related and treatment-emergent wording also leaves a definitional question unresolved.
The study does not provide evidence about clinical efficacy. Although antibody, T-cell, and mononucleocyte responses are listed as secondary outcomes, their results are not reported in the registry record. Safety counts alone cannot answer whether vaccination changes immune responses or clinical outcomes. Nor can a small pilot establish that a pattern will generalize to a broader population.
For interpretation, the key distinction is between a record of what happened in the enrolled groups and a reliable estimate of what would happen in future participants. The registry supports the former at a descriptive level. It does not report the analysis details and precision measures needed for a strong comparative conclusion. The findings should therefore be understood as limited observations from the groups listed, not as proof that either administration location has a particular safety profile.
13. Why This Trial Matters Statistically
This trial illustrates why a safety result needs more than an event count to support a comparison. The registry provides counts for serious and other adverse events by injection location, but the groups are small and the record does not report uncertainty intervals or a statistical analysis. Without those elements, the counts describe the observed participants but do not establish the precision or reliability of a difference between locations.
It also highlights the importance of clear endpoint definitions. The primary outcome title refers to treatment-related adverse events, while its description refers to treatment-emergent adverse events defined by CTCAE v4.0. The posted safety entries are divided into serious and other events. Readers need to know how these definitions map to each other to understand whether the safety summaries correspond to the primary endpoint. That mapping is not reported in the registry record.
The registry’s design labels also require careful reading. It lists randomized allocation and two administration locations, but identifies the model as single-group. Without explanation of this combination or details of the allocation process, the basis for interpreting between-group comparisons is uncertain. Reporting the randomization method, allocation ratio, analysis population, and prespecified comparison would help readers judge how the groups were formed and analyzed.
Finally, planning illustrations should be kept separate from evidence generated by the enrolled participants. Sample-size calculations can help plan future studies, but assumptions based on an observed effect do not substitute for an original design justification or an adequately precise result. The distinction matters especially in a pilot study, where descriptive learning and feasibility may be central, while comparative inference remains limited. Clear reporting of methods, missing data, and endpoint results would make the evidence easier to interpret.
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 main limitation is the small enrollment: 15 participants are listed, with adverse-event denominators of 8 in the thigh group and 7 in the arm group. Such counts provide limited precision for uncommon outcomes. The registry does not report confidence intervals or an inferential analysis, so the uncertainty around comparative safety cannot be quantified from the record.
The design description is internally difficult to interpret. Allocation is listed as randomized, masking as none, and the model as single-group, while the registry also reports separate arm and thigh administration groups. The record does not explain this combination or provide details of randomization, allocation ratio, or allocation concealment. This restricts assessment of the comparability of the groups.
The primary endpoint has a terminology difference between its title and description: treatment-related adverse events versus treatment-emergent adverse events. The adverse-event module reports serious and other categories, but the record does not establish that these are the same as the primary endpoint definition. A dedicated primary outcome result is not reported in the registry record. Details of event attribution, event timing, recurrence, and completeness of follow-up are also not reported in the registry record.
The registry lists 8 outcome measures but no statistical analyses. Multiplicity procedures, missing-data methods, and analysis populations are not reported in the registry record. The secondary immune-response outcomes are listed without numerical results. These gaps mean that interpretation must remain descriptive and cannot determine whether outcomes were fully observed, how multiple outcomes were handled, or how findings relate to the planned analysis.
15. Related Tutorials
16. Related Statistical Calculators
17. Sources
- ClinicalTrials.gov: Safety and Feasibility of TA-CIN Vaccine in HPV16 Associated Cervical Cancer — NCT02405221.
- Registry record last updated 2026-01-29; status last verified 2026-01.
- Results first posted 2026-01-22.
- 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
The registry record describes a completed Phase 1 pilot study of intramuscular TA-CIN for people with a history of HPV16-associated cervical cancer. It lists randomized allocation, no masking, a single-group model, and two administration locations: thigh and arm. The stated regimen was a fixed 100µg per dose, given for 3 doses at Weeks 1, 5, and 9, with follow-up for 2 years after the first dose. Enrollment was 15.
The primary outcome concerns participants with treatment-related adverse events over up to 24 months; its description refers to treatment-emergent events defined by CTCAE v4.0. The registry lists serious adverse events affecting 1 of 8 thigh participants and 0 of 7 arm participants, other adverse events affecting 8 of 8 and 7 of 7, and 0 deaths in each group. It lists bowel obstruction (adhesion-related) at 12.5% among the top serious terms.
A separate primary-outcome analysis, statistical analyses, and results for the listed immune-response outcomes are not reported in the registry record. The posted counts are descriptive and do not establish causation or a reliable comparative conclusion.