Safety and Immunogenicity of Intranasal BPZE1 Vaccination in Healthy Adults (NCT03541499) | Clinical Trial Compass
CompletedPhase 2
Safety and Immunogenicity of Intranasal BPZE1 Vaccination in Healthy Adults
United States50 participantsStarted 2018-10-23
Plain-language 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.
Who can participate
Age range
18 Years – 49 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. Provide written informed consent prior to initiation of any study procedures.
. Able to understand and comply with planned study procedures and be available for all study visits.
. Males or non-pregnant females, 18-49 years of age, inclusive.
. In good health\*.
. Oral temperature is \< / = 100 degrees Fahrenheit.
. 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.
. Systolic blood pressure is 85 to 150 mm Hg, inclusive.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Number of Participants Experiencing Adverse Events of Special Interest (AESIs)
Timeframe: Day 1 through Day 29
2
Number of Participants Experiencing New Onset Chronic Medical Conditions (NOCMCs)
Timeframe: Day 1 through Day 181
3
Number of Participants Experiencing Serious Adverse Events (SAEs)
Timeframe: Day 1 through Day 181
4
Number of Participants Experiencing Solicited Local Reactogenicity Adverse Events (AEs)
Timeframe: Day 1 through Day 15
5
Number of Participants Experiencing Solicited Systemic Reactogenicity AEs
Timeframe: Day 1 through Day 15
6
Number of Participants Experiencing Unsolicited Non-Serious AEs
Timeframe: Day 1 through Day 29
7
Number of Participants Experiencing Severe Solicited Local Reactogenicity Adverse Events
Timeframe: Day 1 through Day 15
Trial details
NCT IDNCT03541499
SponsorNational Institute of Allergy and Infectious Diseases (NIAID)
. Diastolic blood pressure is 55 to 95 mm Hg, inclusive.
Exclusion criteria
. 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.
. Have known or suspected active chronic autoinflammatory condition.
. Have known active neoplastic disease (excluding non-melanoma skin cancer) or a history of any hematologic malignancy.
. Have a history of persistent asthma, major anatomic nasopharyngeal abnormality, or sinus polyp disease due to chronic sinusitis\*.
. Have known hepatitis B or hepatitis C infection.
. Have a history of alcohol or drug abuse within 5 years prior to study vaccination.
. 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.
. 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.
8
Number of Participants Experiencing Severe Solicited Systemic Reactogenicity AEs