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.
The proposed study is a single center, open label study to be conducted at the Johns Hopkins Bloomberg School of Public Health, Center for Immunization Research (CIR) in Baltimore, MD. Participants will be followed for 12 months after the first immunization, so the duration of study participation will be 12 months after receipt of initial vaccination. Approximately 30 subjects will be enrolled in a rolling fashion to receive 2 doses of the B/HPIV3/S-6P vaccine intranasally 56 days apart. Participants who are enrolled and receive the first vaccine dose will not be replaced, even in the event they are ineligible or unable to take the second dose. Up to 60 subjects will be consented to ensure that 30 subjects are eligible for enrollment and vaccination. Volunteers will be enrolled in a staggered fashion: Group 1: Up to 5 volunteers will be enrolled and vaccinated. Group 2: Up to 10 volunteers will be enrolled and vaccinated. Group 3: The remaining volunteers (up to 15) will be enrolled and vaccinated.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
PREVENTION
Masking
NONE
Enrollment
27
Intranasal vaccine.
Johns Hopkins Bloomberg School of Public Health
Baltimore, Maryland, United States
To determine the frequency of vaccine-related solicited adverse events (AEs)
Summary and line listing of individual clinical solicited of the frequency of solicited AEs
Time frame: During study days 0 to 28 and 56 to 84 (28 days after each dose)
To determine the frequency of vaccine-related unsolicited AEs
Summary and line listing of individual clinical solicited of the frequency of unsolicited AEs
Time frame: During study days 0 to 28 and 56 to 84 (28 days after each dose)
To determine the frequency of vaccine-related lower respiratory illness
Summary and line listing of individual clinical solicited of the frequency of vaccine-related lower respiratory illness
Time frame: During study days 0 to 28 and 56 to 84 (28 days after each dose)
Vaccine virus shedding on 1 or more days
As assessed by culture, or rRT-PCR
Time frame: On Days 4, 7, and 10, and 60, 63, and 66
Evidence of a >4-fold rise in HPIV3 antibody titers
Using PRNT60 or ELISA
Time frame: When comparing pre-vaccination titers day 29, 56 or 90
Rise in serum neutralizing antibody titer to SARS-CoV-2 S protein
Will be measured by ELISA and neutralization assay
Time frame: On days 63, 70, 84, 180, 360
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