Ebola Virus DiseasePhase 1NCT03462004
Evaluating the Live-Attenuated Human Parainfluenza Virus Type 3 Vectored Vaccine Candidate Expressing Ebolavirus Zaire Glycoprotein as the Sole Envelope Glycoprotein
A Phase 1 study testing HPIV3/ΔHNF/EbovZ GP vaccine in people with Ebola Virus Disease, run by National Institute of Allergy and Infectious Diseases (NIAID) at 2 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Ebola Virus Disease
- What is being tested?
- HPIV3/ΔHNF/EbovZ GP vaccine
- Type of treatment
- Vaccines
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 15 participants
- Where
- 2 sitesUnited States
- Study dates
- 5 Mar 2018to 15 Mar 2019
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
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- 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.
Who cannot join
- 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
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- 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.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Center for Immunization Research, Johns Hopkins Bloomberg School of Public Health
Baltimore, Maryland, 21205
CIR Inpatient Unit, Johns Hopkins Bayview Medical Center
Baltimore, Maryland, 21224
About this study
Official title: Phase 1 Evaluation of a Live-Attenuated Human Parainfluenza Virus Type 3 Vectored Vaccine Candidate Expressing Ebolavirus Zaire Glycoprotein as the Sole Envelope Glycoprotein
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.
Read the 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 enrolled sequentially in two cohorts. Participants in Cohort 1 will be randomly assigned to receive two doses of either 10^6.0 PFU/mL of HPIV3/ΔHNF/EbovZ-GP vaccine or placebo. The first dose will be given on Day 0 and the second dose will be given 4-8 weeks later. Participants in Cohort 2 will be randomly assigned to receive two doses of either 10^7.0 PFU/mL of HPIV3/ΔHNF/EbovZ-GP vaccine or placebo on Days 0 and 28.
Participants will be admitted to the inpatient unit 2 days prior to receiving their first dose of the vaccine or placebo. While in the inpatient unit, study procedures will include physical examinations, nasal washes, and blood collection. Participants will be discharged from the inpatient unit on Day 8 or thereafter once two consecutive rRT-PCR assay results are below the pre-determined threshold. An additional study visit will occur on Day 14.
On Day 26 (+28), participants will be readmitted to the inpatient unit, and will receive their second dose of the vaccine or placebo on Day 28 (+28). Participants will undergo the same study procedures that occurred during the first inpatient stay, and will be discharged 7 days after the second dose, or once the subject is without respiratory symptoms and rRT-PCR assay is below the pre-determined threshold (around Day 35). Additional study visits will occur on Days 42 ± 3, 56 ± 5, 84 ± 5, 112 ± 7, 180 ± 14, 270 ± 14, and 360 ± 30.
- Conditions
- Ebola Virus Disease
- Being tested
- HPIV3/ΔHNF/EbovZ GP vaccine, Placebo
- Keywords
- Healthy Volunteer
- Medical subject headings
- Hemorrhagic Fever, Ebola
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HPIV3/ΔHNF/EbovZ GP vaccineBiological
Administered intranasally
PlaceboBiological
Administered intranasally
| Study group | Role | What they receive |
|---|---|---|
| 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). Receives: Biological: HPIV3/ΔHNF/EbovZ GP vaccine |
| Cohort 1: Placebo | Placebo comparator | Participants will receive two doses of placebo on Days 0 and 28 (+28). Receives: 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). Receives: Biological: HPIV3/ΔHNF/EbovZ GP vaccine |
| Cohort 2: Placebo | Placebo comparator | Participants will receive two doses of placebo on Days 0 and 28 (+28). Receives: Biological: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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: 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: Measured through Day 35
Development of serum antibody to the EbovZ GP
As measured by enzyme-linked immunosorbent assay (ELISA)
Measured: Measured through Day 360
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Mar 2018
- Study start5 Mar 2018
- Primary completion15 Mar 2019
- Study completion15 Mar 2019
Why it stopped: Cancel Enrollment due to Covid-19 Pandemic, Not restarted
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ebola Virus DiseaseStudies of the same condition, open and under way.
- More trials run by National Institute of Allergy and Infectious Diseases (NIAID)The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Sponsor type
- US National Institutes of Health
- Responsible party
- Sponsor
- Investigators
- Kawsar Talaat, MD, Principal investigator, Johns Hopkins Bloomberg School of Public Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03462004
- Sponsor's protocol ID
- CIR 324
- Status last verified
- Apr 2025
- First submitted
- 6 Mar 2018
- Last updated
- 18 Mar 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase 1 Evaluation of a Live-Attenuated Human Parainfluenza Virus Type 3 Vectored Vaccine Candidate Expressing Ebolavirus Zaire Glycoprotein as the Sole Envelope Glycoprotein
- ClinicalTrials.gov ID
- NCT03462004
- Acronym / sponsor ID
- CIR 324
- Conditions
- Ebola Virus Disease
- Keywords
- Healthy Volunteer
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Cancel Enrollment due to Covid-19 Pandemic, Not restarted
- Enrolment
- 15 participants (actual)
- Lead sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)US National Institutes of Health
- Study start
- 5 Mar 2018 (actual)
- Primary completion
- 15 Mar 2019 (actual)
- Study completion
- 15 Mar 2019 (actual)
- First posted
- 12 Mar 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 enrolled sequentially in two cohorts. Participants in Cohort 1 will be randomly assigned to receive two doses of either 10^6.0 PFU/mL of HPIV3/ΔHNF/EbovZ-GP vaccine or placebo. The first dose will be given on Day 0 and the second dose will be given 4-8 weeks later. Participants in Cohort 2 will be randomly assigned to receive two doses of either 10^7.0 PFU/mL of HPIV3/ΔHNF/EbovZ-GP vaccine or placebo on Days 0 and 28.
Participants will be admitted to the inpatient unit 2 days prior to receiving their first dose of the vaccine or placebo. While in the inpatient unit, study procedures will include physical examinations, nasal washes, and blood collection. Participants will be discharged from the inpatient unit on Day 8 or thereafter once two consecutive rRT-PCR assay results are below the pre-determined threshold. An additional study visit will occur on Day 14.
On Day 26 (+28), participants will be readmitted to the inpatient unit, and will receive their second dose of the vaccine or placebo on Day 28 (+28). Participants will undergo the same study procedures that occurred during the first inpatient stay, and will be discharged 7 days after the second dose, or once the subject is without respiratory symptoms and rRT-PCR assay is below the pre-determined threshold (around Day 35). Additional study visits will occur on Days 42 ± 3, 56 ± 5, 84 ± 5, 112 ± 7, 180 ± 14, 270 ± 14, and 360 ± 30.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Cohort 1: HPIV3/ΔHNF/EbovZ GP vaccine | Experimental | Biological: HPIV3/ΔHNF/EbovZ GP vaccineParticipants will receive two doses of 10^6.0 PFU/mL of HPIV3/ΔHNF/EbovZ GP vaccine on Days 0 and 28 (+28). |
| Cohort 1: Placebo | Placebo comparator | Biological: PlaceboParticipants will receive two doses of placebo on Days 0 and 28 (+28). |
| Cohort 2: HPIV3/ΔHNF/EbovZ GP vaccine | Experimental | Biological: HPIV3/ΔHNF/EbovZ GP vaccineParticipants will receive two doses of 10^7.0 PFU/mL of HPIV3/ΔHNF/EbovZ GP vaccine on Days 0 and 28 (+28). |
| Cohort 2: Placebo | Placebo comparator | Biological: PlaceboParticipants will receive two doses of placebo on Days 0 and 28 (+28). |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (17 listed)
- 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.
Key exclusion criteria (28 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| HPIV3/ΔHNF/EbovZ GP vaccineAdministered intranasally | Biological | Cohort 1: HPIV3/ΔHNF/EbovZ GP vaccine, Cohort 2: HPIV3/ΔHNF/EbovZ GP vaccine |
| PlaceboAdministered intranasally | Biological | Cohort 1: Placebo, Cohort 2: Placebo |
Primary outcome
Frequency of vaccine-related solicited adverse events
Time frame: Measured through Day 35
Graded according to Division of AIDS (DAIDS) Table for Grading the Severity of Adult and Pediatric Adverse Events, Version 2.1, March 2017
Area under the curve of nasal virus shedding after each dose of vaccine
Time frame: Measured through Day 35
Assessed by liquid titration of nasal secretions on LLC-MK2 monkey kidney cells
Development of serum antibody to the EbovZ GP
Time frame: Measured through Day 360
As measured by enzyme-linked immunosorbent assay (ELISA)
Results and safety
The study was stopped early (reason given: Cancel Enrollment due to Covid-19 Pandemic, Not restarted). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Mar 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kawsar Talaat, MD principal investigator
Johns Hopkins Bloomberg School of Public Health
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing HPIV3/ΔHNF/EbovZ GP vaccine in people with Ebola Virus Disease, run by National Institute of Allergy and Infectious Diseases (NIAID) at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 17 inclusion and 28 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 18 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: Cancel Enrollment due to Covid-19 Pandemic, Not restarted). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Frequency of vaccine-related solicited adverse events (time frame: Measured through Day 35). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Mar 2026.