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NCT03063736 · ClinicalTrials.gov registry record · Early Phase 1
Entolimod, an Adjuvant for Vaccine Augmentation
A Early Phase 1 study, sponsored by Baylor College of Medicine.
- Completed
- Registry status
- Early Phase 1
- Development phase
- 40
- Enrollment target
NCT03063736: Completed Early Phase 1 study, sponsored by Baylor College of Medicine.
NCT03063736 is a Early Phase 1 study that has completed, run by Baylor College of Medicine. The registered enrollment target is 40 participants, below the 53-participant average among 2,764 other Early Phase 1 trials with a reported enrollment target (25% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03063736, a Early Phase 1 study, has completed, sponsored by Baylor College of Medicine.
- COMPLETED
- Registry status
- Early Phase 1
- Development phase
- 40 participants
- Enrollment target
Study Summary
The primary objective of this pilot study to evaluate the safety of low dose Entolimod in normal, healthy, non-patient normals. This clinical trial in 40 normal humans compares a single dose of 4 ug Td (2 ug of TT and 2 ug of diphtheria toxoid + 3000 ug of alum with or without entolimod. Subjects will be randomized to: Td alone (n=15) and Td+ entolimod (n=25). The investigators expect that Td + entolimod will double the anti-TT and anti-diphtheria AB levels over Td alone.
Primary Outcome
The proposed dose of entolimod used in our study is 30-40 times lesser than that previously given safely to humans. Although our pre-clinical data suggest that these very low levels of entolimod efficiently enhances the antibody levels to TT vaccine in rodents, the safety and success rate at these low doses of entolimod to enhance anti-TT AB in humans requires examination.
Interventions
- DRUG Entolimod
- BIOLOGICAL Td Vaccine
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 40 participants |
| Start Date | 2017-12-08 |
| Est. Completion | 2019-12-31 |
| Phase | Early Phase 1 |
What the finished NCT03063736 record still lists
NCT03063736 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 40 participants, a relatively small participant target, below the 53-participant average among 2,764 other Early Phase 1 trials with a reported enrollment target (25% lower).
The record links to 0 conditions, and to 2 interventions - of which Entolimod is the first listed.
NCT03063736 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03063736 about?
NCT03063736 is a clinical study titled "Entolimod, an Adjuvant for Vaccine Augmentation". The primary objective of this pilot study to evaluate the safety of low dose Entolimod in normal, healthy, non-patient normals. This clinical trial in 40 normal humans compares a single dose of 4 ug Td (2 ug of TT and 2 ug of diphtheria toxoid + 3000 ug of alum with or without entolimod. Subjects wi...
What is the current status of trial NCT03063736?
This trial is currently completed. It is a Early Phase 1 study. The enrollment target is 40 participants. The study started on 2017-12-08. Estimated completion is 2019-12-31.
What interventions are being tested in trial NCT03063736?
The interventions under investigation include: Entolimod (DRUG), Td Vaccine (BIOLOGICAL).
Who is sponsoring clinical trial NCT03063736?
This trial is sponsored by Baylor College of Medicine, which has 616 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03063736's enrollment target sits among peer trials
40 629th of 2000 higher than 1,313 of 2,000 other Early Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Early Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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