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 range18 Years – 49 Years
SexALL
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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
✕. Pregnant, possibly pregnant, or lactating women
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