Trial · NCT03661541
Immune Response and General Immune Health in Subjects Infected With Herpes Simplex Virus Type 1 (HSV-1)
NCT03661541, Phase 1, Completed, Squarex, LLC; results first posted 2021-11-03
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Immune Response and General Immune Health in Subjects Infected With Herpes Simplex Virus Type 1 (HSV-1). Trials, record NCT03661541. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03661541
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Immune Response and General Immune Health in Subjects Infected With Herpes Simplex Virus Type 1 (HSV-1)
- NCT number
- NCT03661541
- Status
- Completed
- Phases
- Phase 1
- Enrollment
- 36 participants, actual
- Lead sponsor
- Squarex, LLC
- Conditions
- HSV, Herpes Labialis
- Interventions
- Squaric Acid Dibutyl Ester
- First posted
- 2018-09-07
- Last updated
- 2021-11-03
- Results first posted
- 2021-11-03
Source ClinicalTrials.gov
Registered outcomes3
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Ratio of Absolute Gene Expression of IFNG and IL5 in PBMCs Between 8 Weeks and Baseline | Baseline and 8 weeks after baseline (Day 1) +/- 7 days for subjects with less than 6 herpres labialis outbreaks in 12 months, relative to baseline for subjects with 6 or greater herpes labialis outbreaks | RNA gene expression of interleukin-5 (IL5) and interferon gamma (IFNG) genes in PBMCs exposed in vitro to 4 conditions: no stimulus, HSV-1 virus, HSV-1-infected cell extracts, and Candida albicans extract. Measure is qRT-PCR crossing threshold (Ct), where a lower number is higher gene expression. A lower Ct of 1 is approximately a 2-fold higher expression level of the gene. |
| Primary | Immune Monitoring - PBMC Proliferation | Baseline | PBMC proliferation in response to 3 stimuli: HSV-1 virus, HSV-1-infected cell extracts, and Candida albicans extract. |
| Primary | Immune Monitoring - PBMC Proliferation | Day 1 and 8 weeks from Day 1 (Initial visit) +/- 7 days for subjects with 6 or more herpes labalis outbreaks | PBMC proliferation in response to 3 stimuli: HSV-1 virus, HSV-1-infected cell extracts, and Candida albicans extract. |
Source ClinicalTrials.gov
Outcomes3
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Ratio of Absolute Gene Expression of IFNG and IL5 in PBMCs Between 8 Weeks and Baseline | Baseline and 8 weeks after baseline (Day 1) +/- 7 days for subjects with less than 6 herpres labialis outbreaks in 12 months, relative to baseline for subjects with 6 or greater herpes labialis outbreaks | Absolute gene expression for Group A on Day 57, Group B on day 1 and Group C on day 1 compared to Group A on Day 1. | q-RT-PCR crossing threshold cycle (Ct) | MEAN |
| PRIMARY | Immune Monitoring - PBMC Proliferation | Baseline | percent proliferation | MEAN | |
| PRIMARY | Immune Monitoring - PBMC Proliferation | Day 1 and 8 weeks from Day 1 (Initial visit) +/- 7 days for subjects with 6 or more herpes labalis outbreaks | Only subjects with 6 or more herpes labialis outbreaks were treated, therefore only subjects with 6 or more outbreaks are included in this analysis. This set of data compares them at Day 1, before treatment, and analyzed at 8 weeks from Day 1 treatment. Data were not collected at 8 weeks on the subjects with 1 or 2 outbreaks or with zero outbreaks. Data at day 1 on those groups and the subjects with 6 or more outbreaks is reported in Outcome Measure 2. | percent proliferation | MEAN |
Source ClinicalTrials.gov
Results by group52
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Ratio of Absolute Gene Expression of IFNG and IL5 in PBMCs Between 8 Weeks and Baseline | Group A: 6 or More Herpes Labialis Outbreaks, Day 1 | IL5 in negative control | 10.073 | Standard Deviation 0.544 | q-RT-PCR crossing threshold cycle (Ct) |
| Ratio of Absolute Gene Expression of IFNG and IL5 in PBMCs Between 8 Weeks and Baseline | Group B: 1 or 2 Herpes Labialis Outbreaks in Prior 12 Months, Day 1 | IL5 in negative control | 11.380 | Standard Deviation 1.233 | q-RT-PCR crossing threshold cycle (Ct) |
| Ratio of Absolute Gene Expression of IFNG and IL5 in PBMCs Between 8 Weeks and Baseline | Group C: Zero Herpes Labialis Outbreaks in Prior 12 Months, Day 1 | IL5 in negative control | 10.711 | Standard Deviation 1.274 | q-RT-PCR crossing threshold cycle (Ct) |
| Ratio of Absolute Gene Expression of IFNG and IL5 in PBMCs Between 8 Weeks and Baseline | Group A, Day 57. Subjects With 6 or More Outbreaks, 8 Weeks After Single Dose of SADBE. | IL5 in negative control | 11.431 | Standard Deviation 1.143 | q-RT-PCR crossing threshold cycle (Ct) |
| Ratio of Absolute Gene Expression of IFNG and IL5 in PBMCs Between 8 Weeks and Baseline | Group A: 6 or More Herpes Labialis Outbreaks, Day 1 | IL5 with HSV-1-infected cell extract stimulus | 9.624 | Standard Deviation 0.666 | q-RT-PCR crossing threshold cycle (Ct) |
| Ratio of Absolute Gene Expression of IFNG and IL5 in PBMCs Between 8 Weeks and Baseline | Group B: 1 or 2 Herpes Labialis Outbreaks in Prior 12 Months, Day 1 | IL5 with HSV-1-infected cell extract stimulus | 10.983 | Standard Deviation 0.971 | q-RT-PCR crossing threshold cycle (Ct) |
| Ratio of Absolute Gene Expression of IFNG and IL5 in PBMCs Between 8 Weeks and Baseline | Group C: Zero Herpes Labialis Outbreaks in Prior 12 Months, Day 1 | IL5 with HSV-1-infected cell extract stimulus | 10.986 | Standard Deviation 1.268 | q-RT-PCR crossing threshold cycle (Ct) |
| Ratio of Absolute Gene Expression of IFNG and IL5 in PBMCs Between 8 Weeks and Baseline | Group A, Day 57. Subjects With 6 or More Outbreaks, 8 Weeks After Single Dose of SADBE. | IL5 with HSV-1-infected cell extract stimulus | 10.627 | Standard Deviation 0.810 | q-RT-PCR crossing threshold cycle (Ct) |
| Ratio of Absolute Gene Expression of IFNG and IL5 in PBMCs Between 8 Weeks and Baseline | Group A: 6 or More Herpes Labialis Outbreaks, Day 1 | IL5 with HSV-1 virus stimulus | 9.747 | Standard Deviation 0.697 | q-RT-PCR crossing threshold cycle (Ct) |
| Ratio of Absolute Gene Expression of IFNG and IL5 in PBMCs Between 8 Weeks and Baseline | Group B: 1 or 2 Herpes Labialis Outbreaks in Prior 12 Months, Day 1 | IL5 with HSV-1 virus stimulus | 10.736 | Standard Deviation 0.880 | q-RT-PCR crossing threshold cycle (Ct) |
1 to 10 of 52Source ClinicalTrials.gov
See all 52 results by groupParticipant flow9
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | 6 or More Herpes Labialis Outbreaks | 12 | |
| Overall Study | STARTED | 1 to 2 Herpes Labialis Outbreaks | 12 | |
| Overall Study | STARTED | Zero Herpes Labialis Outbreaks | 12 | |
| Overall Study | COMPLETED | 6 or More Herpes Labialis Outbreaks | 10 | |
| Overall Study | COMPLETED | 1 to 2 Herpes Labialis Outbreaks | 10 | |
| Overall Study | COMPLETED | Zero Herpes Labialis Outbreaks | 10 | |
| Overall Study | NOT COMPLETED | 6 or More Herpes Labialis Outbreaks | 2 | |
| Overall Study | NOT COMPLETED | 1 to 2 Herpes Labialis Outbreaks | 2 | |
| Overall Study | NOT COMPLETED | Zero Herpes Labialis Outbreaks | 2 |
Source ClinicalTrials.gov
Adverse events2
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Local reaction | Skin and subcutaneous tissue disorders | 6 or More Herpes Labialis Outbreaks | 2 | 12 | 2 |
| other | Nausea | Gastrointestinal disorders | 6 or More Herpes Labialis Outbreaks | 1 | 12 | 1 |
Source ClinicalTrials.gov
Adverse event totals3
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | 6 or More Herpes Labialis Outbreaks | 0 | 12 |
| Total, other adverse events | 6 or More Herpes Labialis Outbreaks | 3 | 12 |
| Total, serious adverse events | 6 or More Herpes Labialis Outbreaks | 0 | 12 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 30756512 | RESULT |
Source PubMed
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT03661541
GET https://conductscience.org/api/trials/v1/NCT03661541/results?page=2