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Safety and Immunogenicity of Intranasal BPZE1 Vaccination in Healthy Adults | Clinical Trials | Clareo Health

COMPLETEDPHASE2

Safety and Immunogenicity of Intranasal BPZE1 Vaccination in Healthy Adults

A Phase 2A Partially-Blind Placebo Controlled Trial to Evaluate the Safety and Immunogenicity of Live Attenuated, Intranasal B. Pertussis Vaccine (BPZE1) in Healthy Adults

NCT03541499•National Institute of Allergy and Infectious Diseases (NIAID)

View on ClinicalTrials.gov

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.

Detailed Description

This is a phase 2a, single center, randomized, partially blind, placebo controlled, clinical trial evaluating a single intranasal dose of either 10\^7 colony forming units (CFU) or 10\^9 CFU 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 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. The secondary objectives of this study are: 1) to assess the humoral immunogenicity of lyophilized BPZE1 vaccine at Day 15, Day 29 and Day 181 following receipt of one intranasal dose of 10\^7 or 10\^9 CFU of BPZE1; 2) to assess mucosal immunogenicity of lyophilized BPZE1 vaccine at Day 29 and Day 181 following receipt of one intranasal dose of 10\^7 or 10\^9 CFU of BPZE1; 3) to evaluate nasal clearance of BPZE1 by culture at Day 29 (and if still positive, at Day 46) following receipt of one intranasal dose of lyophilized BPZE1 vaccine of 10\^7 or 10\^9 CFU of BPZE1.

Eligibility

Age

18 - 49 years

Sex

ALL

Healthy Volunteers

Yes

Inclusion Criteria

•1. Provide written informed consent prior to initiation of any study procedures.
•2. Able to understand and comply with planned study procedures and be available for all study visits.
•3. Males or non-pregnant females, 18-49 years of age, inclusive.
•4. In good health\*.
•\*As determined by medical history and physical examination to evaluate acute or currently ongoing chronic medical diagnoses or conditions, defined as those that have been present for at least 90 days that would affect the assessment of the safety of subjects or the immunogenicity of study vaccinations. Chronic medical diagnoses or conditions should be stable for the last 60 days. This includes no change in chronic prescription medication, dose, or frequency because of deterioration of the chronic medical diagnosis or condition in the 60 days prior to enrollment. Any prescription change that is due to change of health care provider, insurance company, etc., or that is done for financial reasons, if it is in the same class of medication, will not be considered a deviation of this inclusion criterion. Any change in prescription medication due to improvement of a disease outcome, as determined by the site principal investigator or appropriate sub-investigator, will not be considered a deviation of this inclusion criterion. Subjects may be on chronic or as needed (prn) medications if, in the opinion of the site principal investigator or appropriate sub-investigator, they pose no additional risk to subject safety or assessment of reactogenicity and immunogenicity and do not indicate a worsening of medical diagnosis or condition. Similarly, medication changes after enrollment and study vaccination are acceptable provided there was no deterioration in the subject's chronic medical condition that necessitated a medication change, and there is no additional risk to the subject or interference with the evaluation of responses to study vaccination. Note: Topical and inhaled medications (with the exception of inhaled or nasal corticosteroids within 30 days prior to enrollment), herbals, vitamins, and supplements are permitted.
•5. Oral temperature is \< / = 100 degrees Fahrenheit.
•6. Pulse is 45 to 100 bpm, inclusive\*. \*Pulse can be 45 to 50 bpm, inclusive, if no other symptoms are present. Otherwise, pulse should be 50-100 bpm.
•7. Systolic blood pressure is 85 to 150 mm Hg, inclusive.
•8. Diastolic blood pressure is 55 to 95 mm Hg, inclusive.
•9. White blood cell count is 3,900 cells/microliter or greater\*.
+13 more criteria

Exclusion Criteria

•1. Have immunosuppression as a result of an underlying illness or treatment, or use of anticancer chemotherapy or radiation therapy (cytotoxic) within 3 years prior to study vaccination.
•2. Have known or suspected active chronic autoinflammatory condition.
•3. Have known active neoplastic disease (excluding non-melanoma skin cancer) or a history of any hematologic malignancy.
•4. Have a history of persistent asthma, major anatomic nasopharyngeal abnormality, or sinus polyp disease due to chronic sinusitis\*.
•\*If a patient has a history of nasopharyngeal surgery such as, but not limited to rhinoplasty, tonsillectomy or sinus surgery, adequate healing time per the judgement of the investigator must occur prior to enrollment.
•5. Have known hepatitis B or hepatitis C infection.
•6. Have a history of alcohol or drug abuse within 5 years prior to study vaccination.
•7. Currently untreated or clinically unstable (in the opinion of the investigator) schizophrenia, bipolar disease, or other psychiatric diagnosis that may interfere with subject compliance or safety evaluations.
•8. Have been hospitalized for psychiatric illness, history of suicide attempt, or confinement for danger to self or others within 5 years prior to study vaccination.
•9. Have received corticosteroids (including oral, parenteral, inhaled, nasal, or intra-articular) of any dose within 30 days prior to study vaccination.
+17 more criteria

Locations (1)

Vanderbilt University - Pediatric - Vanderbilt Vaccine Research Center

Nashville, Tennessee, United States

Key Dates

Start Date

October 23, 2018

Primary Completion Date

May 15, 2020

Completion Date

May 15, 2020

Last Updated

September 19, 2024

Enrollment

ACTUAL participants

Conditions

PertussisPertussis Immunisation

Interventions

BPZE1

BIOLOGICAL

Placebo

OTHER

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: September 19, 2024Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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Safety and Immunogenicity of Intranasal BPZE1 Vaccination in Healthy Adults

Inclusion Criteria

Exclusion Criteria

Clinical Trial of the Adsorbed Acellular Pertussis (Tricomponent) DTaP-Haemophilus Influenzae Type b (Conjugate)-ACYW135 Group Meningococcal (Conjugate) Combined Vaccine

A Phase II/III Study to Evaluate the Immunogenicity, Safety and Lot-to-lot Consistency of LBVD, a Fully Liquid Hexavalent Diphtheria-tetanus-whole Cell Pertussis-hepatitis B-poliovirus-Haemophilus Influenzae Type b Conjugate (DTwP-HepB-IPV-Hib) Vaccine, in Healthy Infants as Primary Series

10-year Follow-up After a Single Dose Acellular Pertussis Vaccination

Safety of Tetanus, Diphtheria, Acellular Pertussis With 5 Acellular Pertussis Components (Tdap5) Vaccination During Pregnancy

A Clinical Trials of Adsorbed Cell-free DPT Vaccine (Five-component)

Study of BPZE1 (High Dose) Nasal Live Attenuated B. Pertussis Vaccine