Hemorrhagic Fever, Ebola Clinical Trial
Official title:
Phase 1 Evaluation of a Live Attenuated Human Parainfluenza Virus Type 3 Vectored Vaccine Candidate Expressing Ebolavirus Zaire Glycoprotein
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.
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