Evaluating the Live-Attenuated Human Parainfluenza Virus Type 3 Vectored Vaccine Candidate Expressing Ebolavirus Zaire Glycoprotein as the Sole Envelope Glycoprotein

NCT03462004 | Terminated Phase 1 DMC FDA Drug

• 1 other identifier: CIR 324
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 2

Brief Summary

The purpose of this study is to evaluate the safety, infectivity, and immunogenicity of two doses of the HPIV3/ΔHNF/EbovZ GP vaccine candidate when administered intranasally in healthy adults.

Conditions

Ebola Virus Disease

Keywords

Healthy Volunteer

Outcome Measures

Primary Outcomes (3)

• Frequency of vaccine-related solicited adverse events

  Graded according to Division of AIDS (DAIDS) Table for Grading the Severity of Adult and Pediatric Adverse Events, Version 2.1, March 2017

  Measured through Day 35

• Area under the curve of nasal virus shedding after each dose of vaccine

  Assessed by liquid titration of nasal secretions on LLC-MK2 monkey kidney cells

  Measured through Day 35

• Development of serum antibody to the EbovZ GP

  As measured by enzyme-linked immunosorbent assay (ELISA)

  Measured through Day 360

Study Arms (4)

Cohort 1: HPIV3/ΔHNF/EbovZ GP vaccine

EXPERIMENTAL

Participants will receive two doses of 10\^6.0 PFU/mL of HPIV3/ΔHNF/EbovZ GP vaccine on Days 0 and 28 (+28).

Biological: HPIV3/ΔHNF/EbovZ GP vaccine

Cohort 1: Placebo

PLACEBO COMPARATOR

Participants will receive two doses of placebo on Days 0 and 28 (+28).

Biological: Placebo

Cohort 2: HPIV3/ΔHNF/EbovZ GP vaccine

EXPERIMENTAL

Participants will receive two doses of 10\^7.0 PFU/mL of HPIV3/ΔHNF/EbovZ GP vaccine on Days 0 and 28 (+28).

Biological: HPIV3/ΔHNF/EbovZ GP vaccine

Cohort 2: Placebo

PLACEBO COMPARATOR

Participants will receive two doses of placebo on Days 0 and 28 (+28).

Biological: Placebo

Interventions

Placebo BIOLOGICAL

Administered intranasally

Cohort 1: Placebo; Cohort 2: Placebo

HPIV3/ΔHNF/EbovZ GP vaccine BIOLOGICAL

Administered intranasally

Cohort 1: HPIV3/ΔHNF/EbovZ GP vaccine; Cohort 2: HPIV3/ΔHNF/EbovZ GP vaccine

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Adult males and non-pregnant females between 18 and 50 years of age inclusive
• General good health, without significant medical illness, physical examination findings, or significant laboratory abnormalities as determined by the investigator
• Agree to storage of blood specimens for future research
• Available for the duration of the trial
• Able to demonstrate understanding of key study concepts, study rationale, and study participation requirements by scoring greater than or equal to 70% on a written comprehension assessment in less than or equal to 3 attempts.
• Willingness to participate in the study as evidenced by signing the informed consent document
• Female subjects of childbearing potential must agree to have used effective birth control methods beginning at least one month prior to vaccination, and continuing with 'per label/fully effective use' for the chosen method for the duration of the study, from amongst these:
• pharmacologic/hormonal contraceptives, including oral, parenteral, subcutaneous, and transcutaneous delivery;
• condoms with spermicide;
• diaphragm with spermicide;
• intrauterine device;
• absolute abstinence from heterosexual intercourse as a matter of normal preferred lifestyle;
• or must be surgically sterile, or must be age 50 AND have had no menses at all for at least one full year.
• All females must provide samples for urine and serum pregnancy testing prior to enrollment (immediately prior to each vaccination), as well as a statement of menstrual history and a summary of all potentially reproductive sexual activity for the month prior to each vaccination, and at each study contact throughout the study, and report if they may be pregnant immediately.
• Willingness to refrain from blood donation during the course of the study

You may not qualify if:

• Pregnancy as determined by a positive human choriogonadotropin (ß-HCG) test or history of recent unprotected intercourse in a woman of reproductive capacity
• Currently breastfeeding
• Evidence of clinically significant neurological, cardiac, pulmonary, hepatic, rheumatological, autoimmune, or renal disease by history, physical examination, and/or laboratory studies
• History of intranasal pathology or evidence of structural abnormalities of the sinuses or nasal cavity upon examination
• Behavioral or cognitive impairment or psychiatric disease that, in the opinion of the investigator, affects the subject's ability to understand and cooperate with the study protocol
• Positive urine drug toxicology test indicating narcotic use or history of dependency
• Have medical, occupational, or family problems as a result of alcohol or illicit drug use during the past 12 months
• Other condition that, in the opinion of the investigator, would jeopardize the safety or rights of a subject participating in the trial, or would render the subject unable to comply with the protocol.
• History of anaphylaxis
• Current diagnosis of asthma or reactive airway disease (within the past 2 years)
• Current history of allergic rhinitis requiring the use of medication in the 2 weeks before enrollment or the first 56 days of the study
• History of Bell's palsy
• Positive enzyme-linked immunosorbent assay (ELISA) and confirmatory test (e.g., Western blot or HIV-1/HIV-2 differentiation assay) for human immunodeficiency virus-1 (HIV-1)
• Positive ELISA and confirmatory test (e.g., polymerase chain reaction (PCR) for virus) for hepatitis C virus (HCV)
• Positive hepatitis B virus surface antigen (HBsAg) by ELISA test

Sponsors & Collaborators

• National Institute of Allergy and Infectious Diseases (NIAID): lead

Study Sites (2)

Center for Immunization Research, Johns Hopkins Bloomberg School of Public Health

Baltimore, Maryland, 21205, United States

Location

CIR Inpatient Unit, Johns Hopkins Bayview Medical Center

Baltimore, Maryland, 21224, United States

Location

MeSH Terms

Conditions

Hemorrhagic Fever, Ebola

Condition Hierarchy (Ancestors)

Hemorrhagic Fevers, Viral; RNA Virus Infections; Virus Diseases; Infections; Filoviridae Infections; Mononegavirales Infections

Study Officials

• Kawsar Talaat, MD

  Johns Hopkins Bloomberg School of Public Health

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: NIH
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 6, 2018
• First Posted: March 12, 2018
• Study Start: March 5, 2018
• Primary Completion: March 15, 2019
• Study Completion: March 15, 2019
• Last Updated: March 18, 2026

Record last verified: 2025-04

Locations

US (2)