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 range18 Years – 49 Years
SexALL
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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.
✓. 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.
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
8
Number of Participants Experiencing Severe Solicited Systemic Reactogenicity AEs
Trial details
NCT IDNCT03541499
SponsorNational Institute of Allergy and Infectious Diseases (NIAID)
. 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.