NCT02564575

Evaluating the Safety of and Immune Response to a Human Parainfluenza Virus Type 3 Ebola Virus Vaccine (HPIV3-EbovZ GP) in Healthy Adults

Phase 1 Evaluation of a Live Attenuated Human Parainfluenza Virus Type 3 Vectored Vaccine Candidate Expressing Ebolavirus Zaire Glycoprotein

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 30 (estimated)
• Sponsor: National Institute of Allergy and Infectious Diseases (NIAID) · NIH
• Sex: All
• Age: 18 Years – 50 Years
• Healthy volunteers: Accepted

Summary

The purpose of this study is to evaluate the safety, infectivity, and immunogenicity of the HPIV3-EbovZ GP Ebola vaccine candidate in healthy adults.

Detailed description

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.

Conditions

• Hemorrhagic Fever, Ebola

Interventions

Type	Name	Description
BIOLOGICAL	HPIV3-EbovZ GP Vaccine	Administered intranasally by a VaxINator device

Timeline

• Start date: 2015-08-01
• Primary completion: 2016-11-01
• Completion: 2016-11-01
• First posted: 2015-09-30
• Last updated: 2017-02-01

Locations

1 site across 1 country: United States