Status:
SUSPENDED
Evaluating the Live-Attenuated Human Parainfluenza Virus Type 3 Vectored Vaccine Candidate Expressing Ebolavirus Zaire Glycoprotein as the Sole Envelope Glycoprotein
Lead Sponsor:
National Institute of Allergy and Infectious Diseases (NIAID)
Conditions:
Ebola Virus Disease
Eligibility:
All Genders
18-50 years
Phase:
PHASE1
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.
Detailed Description
This study will evaluate the safety, infectivity, and immunogenicity of two doses of the HPIV3/ΔHNF/EbovZ GP vaccine candidate when administered intranasally in healthy adults. Participants will be e...
Eligibility Criteria
Inclusion
- 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
- Willingness to refrain from receiving other vaccines or investigational products during the first 4 months of the study after enrollment
- Willingness to follow admission and isolation requirements for the indicated duration per protocol.
Exclusion
- 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
- Known immunodeficiency syndrome or history suggestive of impaired immune function
- Use of corticosteroids (excluding topical preparations) or immunosuppressive drugs within 30 days prior to vaccination
- Receipt of a live vaccine within 4 weeks or a killed vaccine within 2 weeks prior to study vaccination
- History of asplenia.
- Body mass index (BMI) less than 18.5 or greater than 40
- Receipt of blood or blood-derived products (including immunoglobulin) within 6 months prior to study vaccination
- Current tobacco user unwilling to refrain from smoking, snuffing, vaping, or chewing for the duration of the inpatient study (subjects may use nicotine patches if needed)
- Travel to an Ebola-endemic region at the time when cases were present or planned travel to West or Central Africa during the study period
- Receipt of another investigational vaccine or drug within 30 days prior to study vaccination
- Previous receipt of an investigational Ebola or Marburg virus vaccine, a chimpanzee adenovirus, or human parainfluenza virus (HPIV)-vectored vaccine, or any other investigational vaccine likely to affect interpretation of the trial data
- Current or past (in the last 4 weeks) user of intranasal medications (including steroids, decongestants, or hormonal medications), or planning to use them within 28 days of study vaccination
- Live or have close contact with vulnerable individuals, including infants, the elderly, or immunocompromised individuals (those with HIV/AIDS, malignancy, or transplant patients)
- History of Liver disease.
Key Trial Info
Start Date :
March 5 2018
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2025
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT03462004
Start Date
March 5 2018
End Date
December 1 2025
Last Update
April 16 2025
Active Locations (2)
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1
Center for Immunization Research, Johns Hopkins Bloomberg School of Public Health
Baltimore, Maryland, United States, 21205
2
CIR Inpatient Unit, Johns Hopkins Bayview Medical Center
Baltimore, Maryland, United States, 21224