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NCT03541499 · ClinicalTrials.gov registry record · Phase 2
Safety and Immunogenicity of Intranasal BPZE1 Vaccination in Healthy Adults
A Phase 2 study of Pertussis and Pertussis Immunisation, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
- Completed
- Registry status
- Phase 2
- Development phase
- 50
- Enrollment target
- 1
- Study location
NCT03541499: Completed Phase 2 study of Pertussis and Pertussis Immunisation, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
NCT03541499 is a Phase 2 study of Pertussis and Pertussis Immunisation that has completed, run by National Institute of Allergy and Infectious Diseases (NIAID). The registered enrollment target is 50 participants, below the 38,926-participant average among 14 other Pertussis trials with a reported enrollment target (100% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03541499, a Phase 2 study of Pertussis and Pertussis Immunisation, has completed, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 50 participants
- Enrollment target
- 1
- Study location
Study Summary
This is a randomized, partially blind, placebo controlled, clinical trial evaluating a single intranasal dose of BPZE1 in healthy adults. The study will evaluate a lyophilized formulation of the product, with the goal of testing for the optimal dose for subsequent clinical trials. Fifty healthy adults, 18-49 years of age will be randomized to one of the four following treatment groups in a 3:3:3:1 ratio: 10\^7 colony forming units (CFU) of BPZE1 administered by VaxINator device, 10\^9 CFU of BPZE1 administered by VaxINator device, placebo administered by VaxINator device, 10\^9 CFU of BPZE1 administered by needleless tuberculin syringe. Study duration will be approximately 12 months with a subject participation duration of approximately 6 months. The primary objective of this study is to assess the safety and tolerability of a single intranasal dose of either 10\^7 or 10\^9 CFU of lyophilized BPZE1 vaccine.
Primary Outcome
AESIs included medically attended wheezing events given the route of study product administration and the nature of the study product.
Conditions Studied
Interventions
- OTHER Placebo
- BIOLOGICAL BPZE1
Study Locations (1)
Tennessee
- Vanderbilt University - Pediatric - Vanderbilt Vaccine Research Center - Nashville
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 50 participants |
| Start Date | 2018-10-23 |
| Est. Completion | 2020-05-15 |
| Phase | Phase 2 |
What the finished NCT03541499 record still lists
NCT03541499 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 50 participants, a relatively small participant target, below the 38,926-participant average among 14 other Pertussis trials with a reported enrollment target (100% lower).
The record links to 2 conditions, with Pertussis appearing as the primary indexed condition, and to 2 interventions - of which Placebo is the first listed.
NCT03541499 reports a single indexed study location in Tennessee.
Frequently Asked Questions
What is clinical trial NCT03541499 about?
NCT03541499 is a clinical study titled "Safety and Immunogenicity of Intranasal BPZE1 Vaccination in Healthy Adults". This is a randomized, partially blind, placebo controlled, clinical trial evaluating a single intranasal dose of BPZE1 in healthy adults. The study will evaluate a lyophilized formulation of the product, with the goal of testing for the optimal dose for subsequent clinical trials. Fifty healthy adul...
What is the current status of trial NCT03541499?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 50 participants. The study started on 2018-10-23. Estimated completion is 2020-05-15.
What conditions does trial NCT03541499 study?
This clinical trial studies the following conditions: Pertussis, Pertussis Immunisation.
What interventions are being tested in trial NCT03541499?
The interventions under investigation include: Placebo (OTHER), BPZE1 (BIOLOGICAL).
Who is sponsoring clinical trial NCT03541499?
This trial is sponsored by National Institute of Allergy and Infectious Diseases (NIAID), which has 2,006 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03541499 being conducted?
This trial has 1 study location across Tennessee. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT03541499's enrollment target sits among peer trials
50 14th of 14 higher than 1 of 14 other Pertussis trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Pertussis 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.
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