NasoShield in Healthy Adults to Study Safety and Immunogenicity (NCT04415749) | Clinical Trial Compass
CompletedPhase 1
NasoShield in Healthy Adults to Study Safety and Immunogenicity
United States43 participantsStarted 2020-06-15
Plain-language summary
The purpose of this study is to evaluate the safety for up to two doses of NasoShield, to determine if antibodies that protect against anthrax are formed after treatment with NasoShield, and to determine whether the formation of these antibodies are affected by different positions of administration.
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
. Men and women 18 to 49 years of age, inclusive
. Good general health status
. Adequate venous access for repeated phlebotomies
. Screening laboratory results within institutional normal range or Grade 1 abnormality if the Investigator documents clinical insignificance. Creatine kinase or bilirubin may be Grade 2 if associated with normal alanine aminotransferase (ALT) and aspartate aminotransferase (AST) and the Investigator considers the result not to be clinically significant due to vigorous exercise or Gilbert's syndrome
. Negative drug and alcohol screen at Screening and predose on Day 1
. For women who have not been surgically sterilized or who do not have laboratory confirmation of postmenopausal status, negative pregnancy test
. Willingness to practice a highly effective method of contraception that may include, but is not limited to, abstinence, sex only with persons of the same sex, monogamous relationship with a postmenopausal partner, monogamous relationship with vasectomized partner, vasectomy, surgical sterilization (hysterectomy, bilateral tubal ligation, salpingectomy, or oophorectomy), licensed hormonal methods, intrauterine device (IUD), or consistent use of a barrier method (eg, condom, diaphragm) with spermicide for 28 days after the last IP dose
. Willingness to participate and comply with all aspects of the study through the entire study period, including nasopharyngeal swabs and blood and urine samples
Exclusion criteria
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
Reactogenicity to evaluate the safety of NasoShield
Timeframe: For 7 days after vaccination
2
Adverse Events (AEs) to evaluate the safety of NasoShield
. Positive result for HIV, hepatitis B virus, or hepatitis C virus at Screening
. Asthma or other chronic lung disease that is greater than mild in severity. Specifically excluded are participants with any of the following events in the past year:
. History of diabetes mellitus (gestational diabetes is allowed if treatment was not required postpartum and serum glucose is currently in the normal range)
. History of coronary artery disease, arrhythmia, or congestive heart failure
. Clinically significant ECG abnormality
. Poorly controlled hypertension (systolic blood pressure \> 150 mmHg or diastolic blood pressure \> 95 mmHg) at Screening or predose on Day 1