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

NCT02564575 | Completed Phase 1 DMC

• 1 other identifier: CIR 305
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Hemorrhagic Fever, Ebola

Keywords

Ebolavirus

Outcome Measures

Primary Outcomes (4)

• Frequency of vaccine-related reactogenicity events

  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.

  Measured through Day 360

• The titer of vaccine virus recovered from nasal wash specimens obtained from each recipient

  Measured through Day 360

• Number of days vaccine virus was shed, measured by plaque titration and rRT-PCR

  Measured through Day 360

Secondary Outcomes (1)

• Development of serum antibody to the EbovZ-GP

  Measured through Day 360

Study Arms (2)

Cohort 1

EXPERIMENTAL

Participants will receive two doses, separated by 4-8 weeks, of approximately 10\^6 PFU/mL of the HPIV3-EbovZ GP vaccine.

Biological: HPIV3-EbovZ GP Vaccine

Cohort 2

EXPERIMENTAL

Participants will receive two doses, separated by 4-8 weeks, of approximately 10\^7 PFU/mL of the HPIV3-EbovZ GP vaccine.

Biological: HPIV3-EbovZ GP Vaccine

Interventions

HPIV3-EbovZ GP Vaccine BIOLOGICAL

Administered intranasally by a VaxINator device

Cohort 1; Cohort 2

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 years and 50 years of age inclusive. Children will not be recruited or enrolled in this study for safety considerations and because of the need for isolation.
• General good health, without significant medical illness, physical examination findings, or significant laboratory abnormalities as determined by the investigator.
• Low pre-existing serum antibody titers to HPIV3 (HAI titer less than or equal to 1:128).
• Agree to storage of blood specimens for future research.
• Available for the duration of the trial.
• Willingness to participate in the study as evidenced by signing the informed consent document.
• Female subjects of childbearing potential must agree to use effective birth control methods for the duration of the study (for example, pharmacologic contraceptives including oral, parenteral, subcutaneous and transcutaneous delivery; condoms with spermicide; diaphragm with spermicide; intrauterine device; abstinence from heterosexual intercourse; surgical sterilization). All female subjects will be considered being of childbearing potential except those who have undergone documented hysterectomy or bilateral oophorectomy, and those in whom menopause occurred at least 1 year prior to the study, confirmed by testing.
• Willingness to refrain from blood donation during the course of the study.
• Willingness to refrain from receiving other vaccines or investigational products during the first 4 months of the study after enrollment.

You may not qualify if:

• Pregnancy as determined by a positive human choriogonadotropin (beta-HCG) test.
• Currently breastfeeding.
• Evidence of clinically significant neurologic, cardiac, pulmonary, hepatic, rheumatologic, 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 ability of the subject 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.
• History of Bell's palsy.
• Positive 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., PCR for virus) for hepatitis C virus (HCV).
• Positive hepatitis B virus surface antigen (HBsAg) by ELISA.

Sponsors & Collaborators

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

Study Sites (1)

Center for Immunization Research (CIR), Johns Hopkins Bloomberg School of Public Health (JHBSPH)

Baltimore, Maryland, 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: NON RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: NIH
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 29, 2015
• First Posted: September 30, 2015
• Study Start: August 1, 2015
• Primary Completion: November 1, 2016
• Study Completion: November 1, 2016
• Last Updated: February 1, 2017

Record last verified: 2017-01

Locations

US (1)