Phase I Safety Study of B/HPIV3/S-6P Vaccine Via Nasal Spray in Adults (NCT06026514) | Clinical Trial Compass
CompletedPhase 1
Phase I Safety Study of B/HPIV3/S-6P Vaccine Via Nasal Spray in Adults
United States27 participantsStarted 2023-09-18
Plain-language summary
This Phase 1 clinical trial will evaluate the safety and immunogenicity of an intranasal vaccine candidate, a recombinant, live-attenuated, bovine/human parainfluenza virus vector vaccine expressing the 6-P prefusion-stabilized version of the SARS-CoV-2 spike protein.
Who can participate
Age range18 Years – 50 Years
SexALL
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Inclusion criteria
✓. Nonpregnant adults between 18 years and 50 years of age, inclusive.
✓. General good health, without significant medical illness, physical examination findings, or significant laboratory abnormalities as determined by the investigator.
✓. Demonstrates comprehension of the protocol procedures and knowledge of the trial by passing a written comprehension examination (passing grade \> 70%).
✓. Available for the duration of the trial.
✓. Willingness to participate in the study and cooperate with the study procedures as evidenced by signing the informed consent document.
✓. Persons of childbearing potential must have used effective birth control methods for at least one month prior to vaccination, and agree to continue with 'per label/fully effective use' for the chosen method for the duration of the study (30 days prior to first vaccination until 12 months after first vaccination), from amongst these:
✓. Willingness to refrain from blood donation during participation in the study and for at least 1 year after receiving the second dose of vaccine.
✓. Willingness to refrain from receiving vaccines or other investigational products during the first 90 days of the study after enrollment.
Exclusion criteria
✕. Pregnancy as determined by a positive human choriogonadotropin (ßHCG) test in a person of reproductive capacity.
✕. Currently breastfeeding.
What they're measuring
1
To determine the frequency of vaccine-related solicited adverse events (AEs)
Timeframe: During study days 0 to 28 and 56 to 84 (28 days after each dose)
2
To determine the frequency of vaccine-related unsolicited AEs
Timeframe: During study days 0 to 28 and 56 to 84 (28 days after each dose)
3
To determine the frequency of vaccine-related lower respiratory illness
Timeframe: During study days 0 to 28 and 56 to 84 (28 days after each dose)
4
Vaccine virus shedding on 1 or more days
Timeframe: On Days 4, 7, and 10, and 60, 63, and 66
5
Evidence of a >4-fold rise in HPIV3 antibody titers
Timeframe: When comparing pre-vaccination titers day 29, 56 or 90
Trial details
NCT IDNCT06026514
SponsorNational Institute of Allergy and Infectious Diseases (NIAID)
✕. Evidence of clinically significant neurologic, cardiac, pulmonary, hepatic, rheumatologic, autoimmune, or renal disease by history, physical examination, electrocardiogram (EKG), and/or laboratory studies.
✕. Behavioral or cognitive impairment or psychiatric disease that in the opinion of the investigator affects the ability of the subject to understand and cooperate with the study protocol.
✕. A history of asthma within the past 5 years, or a current diagnosis of asthma or reactive airway disease associated with exercise, seasonal hay fever or allergic rhinitis.
✕. Presence of any febrile illness or symptoms suggestive of a respiratory infection within 2 weeks prior to inoculation.
✕. Use of systemic or nasal steroid preparations or immunosuppressive drugs within 30 days prior to vaccination. Topical steroid preparations are permitted.
✕. Inhaled bronchodilator or inhaled steroid use within the last year or use after upper respiratory tract infections within the last 5 years.