Hemorrhagic Fever, EbolaPhase 1NCT02564575
Evaluating the Safety of and Immune Response to a Human Parainfluenza Virus Type 3 Ebola Virus Vaccine (HPIV3-EbovZ GP) in Healthy Adults
A Phase 1 study testing HPIV3-EbovZ GP Vaccine in people with Hemorrhagic Fever, Ebola, run by National Institute of Allergy and Infectious Diseases (NIAID) at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Hemorrhagic Fever, Ebola
- What is being tested?
- HPIV3-EbovZ GP Vaccine
- Type of treatment
- Vaccines
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2015to Nov 2016
- 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 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.
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- 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.
Who cannot join
- 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.
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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.
- 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.
- 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 smoker unwilling to stop smoking for the duration of the inpatient study.
- A current smoker includes anyone stating they currently smoke any amount of a tobacco product.
- The decision to exclude a potential subject is determined by medical history and a clinician's clinical judgment based on the physical examination.
- After admission to the unit, nicotine patches will be provided to current smokers who request them for the inpatient portion of the study.
- Travel to Liberia, Sierra Leone or Guinea in the last 12 months or are intending to travel to an Ebola endemic region 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 HPIV vectored vaccine or any other investigational vaccine likely to impact on interpretation of the trial data.
- Individuals with current or past (in the last 4 weeks) use of intranasal medications (including steroids, decongestants, or hormonal medications) or who have plans to use them within 28 days of study vaccination.
Trial locations and contacts
1 site in 1 country.
United States1 site
Center for Immunization Research (CIR), Johns Hopkins Bloomberg School of Public Health (JHBSPH)
Baltimore, Maryland
About this study
Official title: Phase 1 Evaluation of a Live Attenuated Human Parainfluenza Virus Type 3 Vectored Vaccine Candidate Expressing Ebolavirus Zaire Glycoprotein
The purpose of this study is to evaluate the safety, infectivity, and immunogenicity of the HPIV3-EbovZ GP Ebola vaccine candidate in healthy adults.
Read the detailed description
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.
- Conditions
- Hemorrhagic Fever, Ebola
- Being tested
- HPIV3-EbovZ GP Vaccine
- Keywords
- Ebolavirus
- 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-EbovZ GP VaccineBiological
Administered intranasally by a VaxINator device
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Biological: HPIV3-EbovZ GP Vaccine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Frequency of vaccine-related reactogenicity events
Measured: 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: Measured through Day 360
The titer of vaccine virus recovered from nasal wash specimens obtained from each recipient
Measured: Measured through Day 360
Number of days vaccine virus was shed, measured by plaque titration and rRT-PCR
Measured: Measured through Day 360
Secondary outcomes (1)
Development of serum antibody to the EbovZ-GP
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 posted30 Sep 2015 (estimated)
- Study startAug 2015
- Primary completionNov 2016
- Study completionNov 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hemorrhagic Fever, EbolaStudies 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
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
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
- NCT02564575
- Sponsor's protocol ID
- CIR 305
- Status last verified
- Jan 2017
- First submitted
- 29 Sep 2015
- Last updated
- 1 Feb 2017
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 1 Feb 2017. 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
- ClinicalTrials.gov ID
- NCT02564575
- Acronym / sponsor ID
- CIR 305
- Conditions
- Hemorrhagic Fever, Ebola
- Keywords
- Ebolavirus
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)US National Institutes of Health
- Study start
- Aug 2015
- Primary completion
- Nov 2016 (actual)
- Study completion
- Nov 2016 (actual)
- First posted
- 30 Sep 2015 (estimated)
- 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 the HPIV3-EbovZ GP Ebola vaccine candidate in healthy adults.
Detailed description
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cohort 1 | Experimental | Biological: HPIV3-EbovZ GP VaccineParticipants will receive two doses, separated by 4-8 weeks, of approximately 10^6 PFU/mL of the HPIV3-EbovZ GP vaccine. |
| Cohort 2 | Experimental | Biological: HPIV3-EbovZ GP VaccineParticipants will receive two doses, separated by 4-8 weeks, of approximately 10^7 PFU/mL of the HPIV3-EbovZ GP vaccine. |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (9 listed)
- 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.
Key exclusion criteria (29 listed)
- 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.
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-EbovZ GP VaccineAdministered intranasally by a VaxINator device | Biological | Cohort 1, Cohort 2 |
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
1 secondary outcome
Development of serum antibody to the EbovZ-GP
Time frame: Measured through Day 360
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Feb 2017.
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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
1 site 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-EbovZ GP Vaccine in people with Hemorrhagic Fever, Ebola, run by National Institute of Allergy and Infectious Diseases (NIAID) at 1 site 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 9 inclusion and 29 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: finished, as of the sponsor's last update on 1 Feb 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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 reactogenicity events (time frame: Measured through Day 56). The study lists 4 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 1 Feb 2017.