The purpose of this study is to evaluate the safety, infectivity, and immunogenicity of the HPIV3-EbovZ GP Ebola vaccine candidate in healthy adults.
The ongoing Ebola virus outbreak in West Africa highlights the need for prevention and treatment strategies, as supportive therapy is currently the only treatment for Ebola virus disease. The purpose of this study is to evaluate the safety, infectivity, and immunogenicity of two doses of the HPIV3-EbovZ GP vaccine candidate administered intranasally in healthy adults. This study will enroll healthy adults who have low pre-existing serum antibody titers to human parainfluenza virus type 3 (HPIV3). Participants will be enrolled sequentially in two cohorts. Cohort 1 will receive two doses of 10\^6.0 PFU/mL of HPIV3-EbovZ GP, approximately 4-8 weeks apart. Cohort 2 will receive two doses of 10\^7.0 PFU/mL of HPIV3-EbovZ GP, approximately 4-8 weeks apart. Participants will be admitted to the inpatient unit 1 or 2 days before receiving their first dose of the vaccine. While in the inpatient unit, all participants will undergo a medical history review, physical examination, nasal wash, blood collection, pregnancy testing (for female participants), and pregnancy prevention counseling. Participants will be discharged from the inpatient unit on Day 7 or possibly later, depending on the results of participant's lab tests. An additional study visit will occur at Day 14. On Day 26, participants will be readmitted to the inpatient unit, and they will receive their second dose of the vaccine on Day 28. Participants will undergo the same study procedures that occurred during the first inpatient stay, and they will be discharged on Day 35. Additional study visits will occur on Days 42, 56, 84, 112, 180, 270, and 360.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Enrollment
30
Administered intranasally by a VaxINator device
Center for Immunization Research (CIR), Johns Hopkins Bloomberg School of Public Health (JHBSPH)
Baltimore, Maryland, United States
Frequency of vaccine-related reactogenicity events
Time frame: Measured through Day 56
Number of vaccinees infected with HPIV3-EbovZ GP vaccine virus when given at 10^6.0 or 10^7.0 PFU
Infection is defined as the recovery of vaccine virus from nasal wash, and/or the detection of virus in nasal wash by rRT-PCR, and/or a ≥4-fold rise in serum antibody titer to ebolavirus GP or HPIV3.
Time frame: Measured through Day 360
The titer of vaccine virus recovered from nasal wash specimens obtained from each recipient
Time frame: Measured through Day 360
Number of days vaccine virus was shed, measured by plaque titration and rRT-PCR
Time frame: Measured through Day 360
Development of serum antibody to the EbovZ-GP
Time frame: Measured through Day 360
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