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

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

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

Brief 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 Summary:

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.


Sponsor: National Institute of Allergy and Infectious Diseases (NIAID)

Current Primary Outcome:

  • 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 [ Time Frame: Measured through Day 360 ]
    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.
  • 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 ]


Original Primary Outcome: Same as current

Current Secondary Outcome: Development of serum antibody to the EbovZ-GP [ Time Frame: Measured through Day 360 ]

Original Secondary Outcome: Same as current

Information By: National Institute of Allergy and Infectious Diseases (NIAID)

Dates:
Date Received: September 29, 2015
Date Started: August 2015
Date Completion:
Last Updated: January 31, 2017
Last Verified: January 2017