CompletedPhase 1

NasoShield Study of Safety and Immunogenicity

United States145 participantsStarted 2018-01-18

Plain-language summary

This study is a Phase 1, randomized, double-blind, placebo-controlled, dose-escalation clinical trial to evaluate the safety and immunogenicity of NasoShield in healthy adults 18 to 49 years of age.

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 as determined by the Investigator
✓. 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 and do not have laboratory confirmation of postmenopausal status, negative pregnancy test
✓. Willingness to practice a highly effective method of contraception: 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
✕. Household contacts of pregnant women, children \< 5 years of age, or immunocompromised individuals for the period up through 2 weeks postvaccination
✕. Persons who care for pregnant women, children \< 5 years of age, or immunocompromised individuals for the period up through 2 weeks postvaccination
✕. Body mass index \> 35.0 kg/m2
✕. 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

What they're measuring

Reactogenicity

Timeframe: For 14 days after vaccination

Adverse events (AEs)

Timeframe: From Day 1 to Day 361

Trial details

NCT IDNCT03352466

SponsorAltimmune, Inc.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2019-05-13

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