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 Dose-ranging Study to Evaluate the Safety & Immunogenicity of a HIV Vaccine 732461 in Healthy HIV Seronegative Volunteers (NCT00434512), a randomized phase 2 study. The primary outcome is Number of Subjects With Any and Grade 3 Solicited Local Symptoms.
| Feature | Registry value |
|---|---|
| ClinicalTrials.gov identifier | NCT00434512 |
| Phase | Phase 2 |
| Condition | AIDS, HIV Infections |
| Allocation | Randomized |
| Design model | Parallel |
| Masking | Quadruple |
| Enrollment | 180 |
| Arms in the primary outcome | n/a |
| Lead sponsor | GlaxoSmithKline |
| Results posted | Yes |
2. Clinical Question
Population
Healthy HIV-seronegative adult volunteers aged 18 to 40 years. The primary endpoint population was the Total Vaccinated Cohort: vaccinated subjects with at least one documented vaccine administration, available data, and completed symptom sheets.
Intervention
HIV vaccine 732461, given intramuscularly as two doses at Day 0 and Day 30. The study included low, medium, and high antigen doses, each in an adjuvanted and a non-adjuvanted formulation.
Comparator
The six study groups allow comparison across the three antigen dose levels and between adjuvanted and non-adjuvanted formulations. The registry record does not report a single designated comparator or the allocation ratio.
Primary question
How many participants experienced solicited local symptoms, including any-grade and Grade 3 pain, redness, or swelling, during the 7-day (Days 0-6) follow-up after each vaccination and overall across doses? The numerical primary endpoint results are not reported in the registry record.
The candidate immunogen was described as containing conserved parts of HIV, including gag, pol, and nef. The study objectives also included evaluating CD4+ T-cell responses, expressed as the proportion of responders to the antigens two weeks after the second vaccination. Secondary outcomes listed frequencies of antigen-specific CD4+ T-cells expressing specified immune markers and antibody titers against p17, p24, Nef, RT, and F4co antigens.
The clinical question is therefore broader than whether local symptoms occurred. It concerns how reactogenicity and safety varied across dose levels and formulations, alongside measures of immune response. The registry record does not report numerical immune-response results, so those outcomes cannot be interpreted from the information available. Nor does the record give a single prespecified head-to-head comparison that would reduce the six-group design to one treatment contrast.
3. Trial Design
This was a randomized, quadruple-masked, parallel-group phase 2 study. The registry lists total enrollment of 180 and a completed status. The recorded study dates are start on 2007-02-20 and primary completion on 2008-06-13. The record does not explain the allocation ratio, the randomization procedure, or which roles were covered by quadruple masking.
Six groups received the candidate SB732461 vaccine. Three groups received the adjuvanted formulation at low, medium, or high antigen dose, and three received the non-adjuvanted formulation at those same dose levels. The listed antigen doses were 10 μg, 30 μg, and 90 μg, respectively. Each group description specifies two intramuscular administrations at Day 0 and Day 30. All group descriptions identify healthy adult HIV-seronegative subjects aged 18 to 40 years.
A parallel design assigns participants to a study group and follows the groups separately. Random allocation can support fair comparisons by reducing systematic differences at assignment, but the registry record does not provide enough information to assess how the randomization was implemented or whether allocation was balanced. Masking can reduce the influence of treatment knowledge on participant reports and assessment; the record does not specify the masked parties.
The registry describes objectives of assessing reactogenicity and safety and evaluating CD4+ T-cell response. It lists 15 outcome measures and three categories of secondary outcome: antigen-specific CD4+ T-cell frequencies by immune-marker expression and antibody titers. It does not report a complete statistical analysis plan, a sample-size justification, or a prespecified hierarchy among the outcome measures. The registered enrollment is a study-level figure and should not be treated as the number analyzed for every endpoint.
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.
Before assignment: A total of 229 subjects were enrolled and screened in this study, and 49 of these were excluded before vaccination.
Overall Study
| Stage | SB732461 Non-adjuvanted_LD Group | SB732461 Non-adjuvanted_MD Group | SB732461 Non-adjuvanted_HD Group | SB732461 adjuvanted_LD Group | SB732461 adjuvanted_MD Group | SB732461 adjuvanted_HD Group |
|---|---|---|---|---|---|---|
| STARTED | 10 | 10 | 10 | 50 | 50 | 50 |
| COMPLETED | 10 | 9 | 10 | 49 | 49 | 49 |
| NOT COMPLETED | 0 | 1 | 0 | 1 | 1 | 1 |
Reasons for not completing this period:
| Reason | SB732461 Non-adjuvanted_LD Group | SB732461 Non-adjuvanted_MD Group | SB732461 Non-adjuvanted_HD Group | SB732461 adjuvanted_LD Group | SB732461 adjuvanted_MD Group | SB732461 adjuvanted_HD Group |
|---|---|---|---|---|---|---|
| Migrated/moved from study area | 0 | 0 | 0 | 1 | 1 | 1 |
| Other | 0 | 1 | 0 | 0 | 0 | 0 |
Analysis population for the primary outcome, as defined in the registry: The analysis was performed on the Total Vaccinated Cohort, which included vaccinated subjects with at least one vaccine administration documented for whom data were available and who had their symptom sheets filled in.
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 7 groups are shown.
| Characteristic | Unit | SB732461 Non-adjuvanted_LD Group | SB732461 Non-adjuvanted_MD Group | SB732461 Non-adjuvanted_HD Group | SB732461 adjuvanted_LD Group | SB732461 adjuvanted_MD Group | SB732461 adjuvanted_HD Group |
|---|---|---|---|---|---|---|---|
| Participants analysed | 10 | 10 | 10 | 50 | 50 | 50 | |
| Age, Continuous | Years | 21.4 (SD 3.75) | 21.8 (SD 3.19) | 22.5 (SD 4.99) | 22.0 (SD 5.04) | 22.2 (SD 3.66) | 22.9 (SD 5.43) |
| Sex: Female, Male: Female | Participants | 7 | 7 | 7 | 33 | 28 | 32 |
| Sex: Female, Male: Male | Participants | 3 | 3 | 3 | 17 | 22 | 18 |
| Race/Ethnicity, Customized: White - Arabic/North African heritage | Participants | 1 | 0 | 0 | 0 | 1 | 0 |
| Race/Ethnicity, Customized: White - Caucasian/European heritage | Participants | 7 | 10 | 10 | 50 | 47 | 50 |
| Race/Ethnicity, Customized: Other - Unspecified | Participants | 2 | 0 | 0 | 0 | 2 | 0 |
6. Primary Endpoint
The registry lists the primary outcome as Number of Subjects With Any and Grade 3 Solicited Local Symptoms, measured over During the 7-day (Days 0-6) follow-up period after each vaccination and overall (across doses).
| Element | Registry entry |
|---|---|
| Result type | Count Of Participants |
| Measure of spread | not applicable |
| Unit | Participants |
| Endpoint classification | Binary Endpoint |
The primary endpoint counts participants with any and Grade 3 solicited local symptoms. The assessed symptoms were pain, redness, and swelling at the injection site. Any symptom means an occurrence regardless of intensity. Grade 3 pain was defined as pain that prevented normal activity; Grade 3 redness or swelling meant spread beyond 50 millimeters (mm) of the injection site.
Assessment covered the 7-day (Days 0-6) follow-up after each vaccination and an overall period across doses. The endpoint therefore concerns the number of participants experiencing symptoms, rather than a continuous measurement of symptom intensity or duration. The registry identifies the Total Vaccinated Cohort as the analysis population, requiring vaccination, available data, and a completed symptom sheet.
Solicited symptoms are collected using specified symptom categories and a defined observation window. In general, this approach makes the outcome more structured than relying only on spontaneous reports, while the grade definitions distinguish occurrence from more severe symptom criteria. These counts can describe how frequently symptoms were recorded in each group, but they do not by themselves establish why a symptom occurred.
The registry record does not report the primary endpoint counts by group or time point. Consequently, the listed definitions clarify what was intended to be measured, but do not establish the observed frequency or severity of local symptoms in this study.
7. Why No Re-analysis Is Shown
8. Statistical Interpretation
The primary outcome is defined in detail, but the registry record does not report its numerical results. In particular, it gives no group-specific counts for participants with any local symptom or Grade 3 local symptom, and no results separated by vaccination follow-up or overall across doses. The endpoint therefore cannot be compared across antigen doses or between adjuvanted and non-adjuvanted groups from this record.
The available adverse-event summary reports serious adverse events and other adverse events by group. For the three non-adjuvanted groups, the record lists 0 serious events among 10 participants at risk in each group, and other adverse events affecting 8, 7, and 9 participants among 10, respectively. For each of the three adjuvanted groups, it lists 2 serious events among 50 participants at risk and other adverse events affecting 50 of 50 participants. No deaths are listed in any group. These are recorded counts; the registry does not provide uncertainty intervals or a statistical comparison for these figures.
The summary also lists six serious-event terms, each with a recorded value of 2.0%: Appendicitis perforated, Tonsillitis, Brain contusion, Ligament rupture, Henoch-schonlein purpura, and Urticaria. The record does not provide enough detail to determine from these terms alone how events were distributed across individuals, whether any person had more than one event, or whether each term was considered related to vaccination. These figures should not be treated as evidence of causation.
Counts from groups of different sizes are not directly comparable as raw totals. Even when a count is accompanied by a denominator, a registry summary without confidence intervals or an explicit comparison does not show the precision of a difference between groups. The group-level figures are descriptive, not a reported hypothesis test.
The posted sample-size assumptions describe planning illustrations based on a fraction of an observed effect, with a two-sided significance level of 0.05, equal allocation between two arms, and a normal approximation. Such illustrations are not observed power and do not supply missing endpoint results. The numerical effect inputs and resulting planning values are not reported in the registry record.
Overall, the registry supports a description of the study structure and selected adverse-event counts. It does not support a statistical conclusion about the primary local-symptom outcome or immune-response outcomes, because their numerical results and inferential analyses are not reported.
9. Statistical Methods Explained
Statistical interpretation starts by distinguishing the outcome definition from the outcome result. The registry defines solicited local symptoms, severity criteria, follow-up windows, and an analysis population. Those details describe how an outcome was intended to be measured. Without group-specific outcome counts, they do not tell how often the outcome occurred or whether the groups differed.
What does a participant count represent?
The primary outcome is a participant count. Each participant is classified according to whether a specified symptom occurred in the relevant period and whether it met the Grade 3 definition. A participant count is not the same as a count of all symptom episodes: the primary outcome title specifies the number of subjects, and the registry does not report episode-level totals. The record also specifies both follow-up after each vaccination and an overall summary across doses. These are distinct summaries; an overall participant count should not be assumed to equal the sum of counts from separate follow-up periods, because the same participant may contribute to more than one period.
In general, binary outcomes are often described using counts and proportions. A proportion places the count in the context of the number assessed, while uncertainty intervals communicate how imprecise that estimate may be. A comparison between groups may use an effect measure and an interval, with the analysis method chosen to match the design and data. The registry record does not report the primary endpoint counts, proportions, effect estimates, confidence intervals, or test results, so none can be interpreted for this outcome.
How should the six-group design be understood?
The study includes three antigen dose levels for each of two formulations. That creates several possible comparisons: dose levels within a formulation, formulations at a given dose, or broader comparisons across groups. Each answers a different question. A single result cannot automatically stand in for all of them, and a result from one group does not establish a trend across dose levels. The registry record does not identify a single primary contrast or report a statistical analysis plan that specifies how these comparisons were to be handled.
In general, multiple comparisons raise a multiplicity issue: when many hypotheses are tested, the chance of at least one apparently unusual result can increase unless the analysis plan accounts for the testing structure. That general concern is relevant to a multi-group study with multiple outcomes, but the registry record does not report whether any adjustment, hierarchy, or other multiplicity strategy was planned or used. It would be inappropriate to infer one.
What do the adverse-event counts tell us?
The adverse-event entries are descriptive counts for participants at risk and participants affected. The listed serious-event counts are 0 in each non-adjuvanted group and 2 in each adjuvanted group; other adverse-event counts are 8, 7, and 9 in the non-adjuvanted groups and 50 in each adjuvanted group. The denominators also differ across these groups. A raw count alone does not quantify the precision of a group comparison, and these data do not include an inferential analysis.
In general, confidence intervals indicate a range of values compatible with the data and the specified statistical method. They help distinguish a precise estimate from one with substantial uncertainty. The registry record gives no such interval for the primary endpoint or the adverse-event comparisons. Also, statistical uncertainty is not the only interpretive issue: attribution, event definitions, follow-up, and completeness of recording matter. The record does not report enough detail to resolve those questions for the serious-event terms.
How should the planning illustrations be read?
The stated assumptions describe planning illustrations, not a reconstruction of the trial’s design justification. They use a two-sided significance level of 0.05, equal allocation between two arms, a normal approximation, and an effect to detect expressed as a fraction of the observed effect. In general, a sample-size calculation estimates how many participants per arm would be needed under chosen assumptions to target a specified power for a defined comparison. It depends on the outcome, effect size, variability or event frequency, analysis method, and design assumptions.
These illustrations must not be read as observed power. Observed power is not a substitute for an effect estimate and its uncertainty; the relevant interpretation comes from the results and their precision. The registry record does not state the trial’s own sample-size justification, the effect used in the illustration, or the resulting numeric planning values. It also does not report whether interim analyses were planned or conducted. Those details are not reported in the registry record.
Finally, the registry identifies the Total Vaccinated Cohort for the primary outcome but does not give endpoint-specific analyzed counts or describe how missing symptom sheets and other missing data were handled. In general, analysis populations and missing-data procedures can influence which participants contribute to an estimate. Those choices cannot be reconstructed from the population definition alone.
10. Multiplicity, Missing Data and Analysis Populations
The registry lists a primary endpoint with several symptom categories and time summaries: any and Grade 3 local symptoms, assessed after each vaccination and overall across doses. It also lists 15 outcome measures and secondary immunogenicity outcomes involving CD4+ T-cell markers and antibody titers. This creates multiple possible results and comparisons to interpret. The registry record does not report a multiplicity strategy, such as a testing hierarchy or adjustment procedure, nor does it specify which secondary outcomes were intended to be confirmatory.
The analysis population for the primary outcome is described as the Total Vaccinated Cohort. It includes vaccinated subjects with at least one documented administration, available data, and completed symptom sheets. That definition is useful, but it does not give the number included in each endpoint analysis or explain how incomplete symptom records were treated. The registry record does not report a missing-data method, imputation strategy, or sensitivity analysis.
The record does not describe whether analyses were based on randomized assignment, vaccination received, or another analysis population for outcomes other than the stated primary population. Nor does it report an interim-analysis plan. These details are not reported in the registry record and should not be inferred from the randomized design or the completed status.
In general, multiplicity affects how strongly a collection of statistical tests can support claims, while missing-data handling affects which observations inform estimates and how robust those estimates may be. Those are methodological considerations, not evidence that any particular procedure was used in this study. Without reported methods and numerical results, the primary endpoint and secondary outcomes cannot be evaluated for multiplicity-adjusted inference or sensitivity to missing data.
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 |
|---|---|---|---|
| SB732461 Non-adjuvanted_LD Group | 0 | 10 | 0.0% |
| SB732461 Non-adjuvanted_MD Group | 0 | 10 | 0.0% |
| SB732461 Non-adjuvanted_HD Group | 0 | 10 | 0.0% |
| SB732461 adjuvanted_LD Group | 2 | 50 | 4.0% |
| SB732461 adjuvanted_MD Group | 2 | 50 | 4.0% |
| SB732461 adjuvanted_HD Group | 2 | 50 | 4.0% |
Deaths
| Arm | Deaths (participants affected of at risk) |
|---|---|
| SB732461 Non-adjuvanted_LD Group | 0 of 10 |
| SB732461 Non-adjuvanted_MD Group | 0 of 10 |
| SB732461 Non-adjuvanted_HD Group | 0 of 10 |
| SB732461 adjuvanted_LD Group | 0 of 50 |
| SB732461 adjuvanted_MD Group | 0 of 50 |
| SB732461 adjuvanted_HD Group | 0 of 50 |
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 |
|---|---|
| SB732461 Non-adjuvanted_LD Group | 8 of 10 |
| SB732461 Non-adjuvanted_MD Group | 7 of 10 |
| SB732461 Non-adjuvanted_HD Group | 9 of 10 |
| SB732461 adjuvanted_LD Group | 50 of 50 |
| SB732461 adjuvanted_MD Group | 50 of 50 |
| SB732461 adjuvanted_HD Group | 50 of 50 |
Most frequent serious adverse event terms
| Event term | Organ system | SB732461 Non-adjuvanted_LD Group | SB732461 Non-adjuvanted_MD Group | SB732461 Non-adjuvanted_HD Group | SB732461 adjuvanted_LD Group | SB732461 adjuvanted_MD Group | SB732461 adjuvanted_HD Group |
|---|---|---|---|---|---|---|---|
| Appendicitis perforated | Infections and infestations | 0 of 10 | 0 of 10 | 0 of 10 | 0 of 50 | 0 of 50 | 1 of 50 |
| Tonsillitis | Infections and infestations | 0 of 10 | 0 of 10 | 0 of 10 | 1 of 50 | 0 of 50 | 0 of 50 |
| Brain contusion | Injury, poisoning and procedural complications | 0 of 10 | 0 of 10 | 0 of 10 | 0 of 50 | 1 of 50 | 0 of 50 |
| Ligament rupture | Injury, poisoning and procedural complications | 0 of 10 | 0 of 10 | 0 of 10 | 1 of 50 | 0 of 50 | 0 of 50 |
| Henoch-schonlein purpura | Skin and subcutaneous tissue disorders | 0 of 10 | 0 of 10 | 0 of 10 | 0 of 50 | 0 of 50 | 1 of 50 |
| Urticaria | Skin and subcutaneous tissue disorders | 0 of 10 | 0 of 10 | 0 of 10 | 0 of 50 | 1 of 50 | 0 of 50 |
Most frequent non-serious adverse event terms
| Event term | Organ system | SB732461 Non-adjuvanted_LD Group | SB732461 Non-adjuvanted_MD Group | SB732461 Non-adjuvanted_HD Group | SB732461 adjuvanted_LD Group | SB732461 adjuvanted_MD Group | SB732461 adjuvanted_HD Group |
|---|---|---|---|---|---|---|---|
| Pain | General disorders | 3 of 10 | 2 of 10 | 5 of 10 | 49 of 50 | 50 of 50 | 50 of 50 |
| Fatigue | General disorders | 5 of 10 | 5 of 10 | 6 of 10 | 41 of 50 | 47 of 50 | 46 of 50 |
| Headache | Nervous system disorders | 5 of 10 | 4 of 10 | 5 of 10 | 43 of 50 | 42 of 50 | 41 of 50 |
| Myalgia | Musculoskeletal and connective tissue disorders | 2 of 10 | 1 of 10 | 2 of 10 | 31 of 50 | 35 of 50 | 36 of 50 |
| Hyperhidrosis | Skin and subcutaneous tissue disorders | 1 of 10 | 1 of 10 | 3 of 10 | 28 of 50 | 28 of 50 | 26 of 50 |
| Pyrexia | General disorders | 0 of 10 | 0 of 10 | 0 of 10 | 30 of 50 | 29 of 50 | 26 of 50 |
| Gastrointestinal disorder | Gastrointestinal disorders | 2 of 10 | 2 of 10 | 2 of 10 | 23 of 50 | 21 of 50 | 17 of 50 |
| Erythema | Skin and subcutaneous tissue disorders | 0 of 10 | 0 of 10 | 0 of 10 | 14 of 50 | 23 of 50 | 25 of 50 |
| Swelling | General disorders | 0 of 10 | 0 of 10 | 0 of 10 | 13 of 50 | 18 of 50 | 19 of 50 |
| Musculoskeletal stiffness | Musculoskeletal and connective tissue disorders | 0 of 10 | 0 of 10 | 0 of 10 | 3 of 50 | 5 of 50 | 6 of 50 |
Serious events with the highest arm-level rate: appendicitis perforated (2.0%), tonsillitis (2.0%), brain contusion (2.0%), ligament rupture (2.0%), henoch-schonlein purpura (2.0%).
The registry lists serious adverse events, other adverse events, and deaths by study group. Serious-event counts were 0 among 10 participants in each non-adjuvanted group and 2 among 50 participants in each adjuvanted group. Other adverse events affected 8, 7, and 9 of 10 participants in the non-adjuvanted low-, medium-, and high-dose groups, respectively; the corresponding listed count was 50 of 50 in each adjuvanted group. No deaths were listed.
These entries describe recorded counts within the groups. They are not, by themselves, estimates of a causal effect, and the registry does not report a statistical comparison or uncertainty interval for them. The listed group sizes differ, so raw counts should not be compared without considering the denominators. The record does not explain the event-attribution criteria or provide additional context for the reported adverse-event summaries.
Six serious-event terms are listed, each at 2.0%: Appendicitis perforated, Tonsillitis, Brain contusion, Ligament rupture, Henoch-schonlein purpura, and Urticaria. The record does not provide participant-level detail or enough information to infer whether each event was considered related to vaccination. These terms and counts are best read as registry safety listings, not as proof of a relationship or absence of a relationship.
12. What the Result Does, and Does Not, Mean
The registry establishes that this was a randomized, quadruple-masked, parallel-group phase 2 study of an HIV vaccine candidate, with three antigen doses and adjuvanted and non-adjuvanted formulations. It defines the solicited local symptoms of interest, the grading criteria, the follow-up windows, and the primary analysis population. It also reports selected serious and other adverse-event counts and lists secondary immune-response outcomes.
It does not report numerical results for the primary endpoint. As a result, no conclusion about the frequency of any-grade or Grade 3 local symptoms across groups can be drawn from the registry record. The numerical results for the listed CD4+ T-cell and antibody outcomes are also not reported. The record therefore does not establish the magnitude, precision, or statistical significance of any difference in immune response.
The safety counts provide descriptive information, but do not establish whether an event was caused by vaccination or whether groups differed beyond what could be due to sampling variation. No confidence intervals or statistical comparisons are reported. The absence of listed deaths is a statement about the registry entries, not a complete characterization of all safety outcomes or their ascertainment.
In general, a randomized comparison can help estimate differences between assigned groups when outcomes are measured and analyzed as planned. Its interpretation still depends on the specific contrast, the completeness of follow-up, the analysis population, the handling of missing observations, and the precision of the estimates. The registry record does not report enough information to assess all of those elements.
The sample-size material is described as planning illustration under stated assumptions, not observed power and not the study’s own documented design justification. It cannot replace missing outcome results. These limits mean the registry record supports description of the trial’s framework and selected event counts, but not a full assessment of efficacy, immune response, or comparative safety.
13. Why This Trial Matters Statistically
This trial is statistically notable for its structured comparison across formulation and dose. The six groups combine three antigen dose levels with the presence or absence of an adjuvant. That arrangement can address more than one scientific question, but it also makes clear why the intended comparisons and analysis plan matter. A contrast between formulations at one dose is not the same question as a dose pattern within a formulation.
The primary endpoint also illustrates the importance of defining an outcome before interpreting counts. The registry specifies symptoms, severity criteria, observation windows, and the Total Vaccinated Cohort. Those definitions make the target of measurement more concrete. Yet definitions alone are not results: with no reported group counts, uncertainty estimates, or inferential analysis for the primary endpoint, the clinical question remains unanswered by the registry record.
The study further illustrates the difference between descriptive safety listings and a comparative analysis. Serious and other adverse events are reported by group, but the record does not provide intervals or tests for those comparisons, nor enough detail to establish attribution. In general, event counts need their denominators and an account of uncertainty before they can support a careful comparison. Even then, association in a trial report does not automatically prove causation for an individual event.
Finally, the listed range of immunogenicity outcomes alongside local symptoms and safety outcomes highlights the need for transparent multiplicity and missing-data methods. The registry record does not report those methods. This is a useful reminder that a trial’s design, endpoint definitions, and statistical plan are all needed to interpret results; when numerical results or methods are absent, a precise statistical conclusion is not possible.
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.
A central limitation of interpretation is that numerical results for the primary endpoint are not reported in the registry record. Although the symptom definitions and assessment periods are specified, there are no group-specific counts for any or Grade 3 local symptoms, and no reported comparison or uncertainty interval. The listed secondary immunogenicity outcomes also lack numerical results in the record.
The adverse-event summary is limited to group counts and selected serious-event terms. It does not report confidence intervals, hypothesis tests, or additional detail about event attribution. The record does not provide participant-level information, so it is not possible to determine whether multiple listed terms occurred in the same participant or how events related to the vaccination schedule.
The registry does not report the randomization ratio, details of the allocation procedure, or the identities of the roles covered by quadruple masking. It also does not report the trial’s sample-size justification, a full statistical analysis plan, a multiplicity procedure, or interim-analysis details. The stated planning assumptions are illustrative and do not fill those gaps.
The primary population definition does not state the endpoint-specific number analyzed or how missing symptom sheets were handled. The record does not report sensitivity analyses or the approach to missing data for the other outcomes. Although total enrollment is recorded as 180, the endpoint-specific denominators and analyzed populations are not reported in the registry record.
These limitations restrict interpretation to the design and the adverse-event counts that are listed. They prevent assessment of the precision of the primary outcome, the robustness of comparisons, and the full pattern of immune-response results.
15. Related Tutorials
16. Related Statistical Calculators
17. Sources
- ClinicalTrials.gov: Dose-ranging Study to Evaluate the Safety & Immunogenicity of a HIV Vaccine 732461 in Healthy HIV Seronegative Volunteers — NCT00434512.
- Registry record last updated 2019-10-01; status last verified 2019-09.
- Results first posted 2019-10-01.
- 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.
Continue through the Clinical Biostats statistical pathway
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18. Record Summary
NCT00434512 is a completed randomized, quadruple-masked, parallel-group phase 2 study with recorded enrollment of 180. It evaluated HIV vaccine 732461 in healthy HIV-seronegative adults aged 18 to 40 years. The six groups covered three antigen doses, 10 μg, 30 μg, and 90 μg, with and without adjuvant; each group description specifies intramuscular vaccination at Day 0 and Day 30.
The primary endpoint counted participants with any and Grade 3 solicited local symptoms during the 7-day (Days 0-6) follow-up after each vaccination and overall across doses. Numerical primary endpoint results are not reported in the registry record. The record lists serious and other adverse-event counts by group and no deaths, but provides no inferential comparisons for these counts. It also lists secondary CD4+ T-cell and antibody outcomes without numerical results. Details on the sample-size justification, multiplicity, missing-data handling, and interim analyses are not reported in the registry record.