Ebola Virus DiseasePhase 1NCT02718469
Trial to Evaluate Safety and Immunogenicity of an Ebola Zaire Vaccine in Healthy Adults
A Phase 1 study testing Ebola Vaccine - low dose, Ebola Vaccine - mid dose and Ebola Vaccine - high dose in people with Ebola Virus Disease, run by Auro Vaccines LLC at 1 site in United States.
Trial summary
The purpose of this study is to assess the safety profile of the Zaire Ebola vaccine and the strength of the immune response. Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Ebola Virus Disease
- What is being tested?
- Ebola Vaccine - low dose, Ebola Vaccine - mid dose and Ebola Vaccine - high dose
- Type of treatment
- Vaccines, Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 38 participants
- Where
- 1 siteUnited States
- Study dates
- 22 Dec 2015to 15 Sep 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 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Subjects who have provided written informed consent and an authorization for disclosure of protected health information must meet the following criteria:
- Healthy adult men or women, 18 to 60 (inclusive) years of age.
- Have provided written informed consent prior to screening procedures.
- Free of clinically significant health problems, as determined by pertinent medical history, physical examination without significant findings in the 28 days prior to enrollment, and clinical judgment of the Investigator.
- Agrees not to have, or plan to have, non-study vaccines within 60 days after receiving the initial study vaccine, unless medically indicated (i.e., tetanus, rabies vaccine).
- Agrees not to have contact with ruminant animals or other hoofed animals such as horses, pigs and cows 7 days after each vaccination.
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- Available, able, and willing to participate for all study visits and procedures through Day 182 (Week 26).
- Be willing to minimize blood and body fluid exposure of others for 7 days after vaccination by:
- using effective barrier prophylaxis, such as latex condoms, during penetrative sexual intercourse;
- avoiding the sharing of needles, razors, or toothbrushes; and
- avoiding open mouth kissing.
- Body mass index (BMI) less than 40 kg/m2.
- Laboratory criteria without clinically significant findings within 28 days prior to enrollment:
- hemoglobin ≥11.5 g/dL for women and ≥13.5 g/dL for men.
- white blood cell count ≥3500 cells/mm3.
- differential either within institutional normal range or accompanied by site physician approval;
- platelets within normal limits;
- alanine aminotransferase (ALT) or aspartate aminotransferase (AST) and alkaline phosphatase within upper limit of normal range or as approved by the Investigator; and
- serum creatinine within upper limit of normal range or as approved by the Investigator.
- Negative for Food and Drug Administration (FDA) approved HIV blood test.
- Negative hepatitis B surface antigen (HbsAg).
- Negative antibody to hepatitis C virus (antiHCV).
- Normal urinalysis defined as negative or trace glucose, protein, and blood (non-menstruating females) by dipstick.
- Negative urine pregnancy test for women of childbearing potential.
- Non-pregnant, non-lactating females must meet one of the following criteria: no reproductive potential because of menopause (one year without menses) or because of a hysterectomy, bilateral oophorectomy, or tubal ligation; or subject agrees to be heterosexually inactive at least 21 days prior to enrollment and throughout the duration of the study; or agrees to consistently practice contraception at least 21 days prior to enrollment and throughout the duration of the study by one of the following methods: abstinence, condoms (male or female with or without a spermicide), diaphragm or cervical cap with spermicide, intrauterine device, contraceptive pills or patch, Norplant, Depo-Provera or other FDA approved contraceptive method, or male partner has previously undergone a vasectomy as declared in medical history.
Who cannot join
- Any subject who meets any of the following criteria will not qualify for entry into the study:
- History of prior infection with a filovirus or prior participation in a filovirus vaccine trial.
- History of prior infection with VSV or receipt of a VSV vectored vaccine.
- Has traveled to an area where the World Health Organization (WHO) has declared as an Ebola outbreak zone.
- Healthcare worker who has direct contact with patients (nurse, physician, dentist, emergency medical technician, dental hygienist).
- Has a household contact (HHC) who is immunodeficient, on immunosuppressive medications, HIV positive, pregnant or breast-feeding, or has an unstable medical condition.
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- Breast-feeding, or is a childcare worker, or HHC, who has direct contact with children, 5 years of age or younger.
- Direct hands-on job preparing food in the food industry.
- History of employment in an industry involved in contact with ruminant animals, other hoofed animals such as pigs and horses, veterinary sciences, or other potential exposure to VSV.
- History of employment or activity that involves potential contact with filoviruses.
- History of severe local or systemic reactions to any vaccination or a history of severe allergic reactions.
- Known allergy to any rVSVN4CT1 vectored vaccine component.
- Receipt of investigational product (IP) up to 30 days prior to randomization or ongoing participation in another clinical trial except observational studies.
- Receipt of licensed non-live or live vaccines within 30 days prior to planned study immunization.
- Ability to observe possible local reactions at the eligible injection sites (deltoid region) is, in the opinion of the Investigator, unacceptably obscured due to a physical condition or permanent body art.
- Acute or chronic, clinically significant dermatologic, psychiatric, hematologic, pulmonary, cardiovascular, or hepatic or renal functional abnormality as determined by the Investigator based on medical history, physical examination, and/or laboratory screening test. This would include a known autoimmune arthritis, hemoglobinopathy or coagulation abnormality as judged by the Investigator.
- Leukopenia due to a clinical or pathological process, unless leukopenia is directly attributable to a transient process (e.g., acute viral infection) and resolution has been documented at time of enrollment.
- Any screening or baseline laboratory test which in the opinion of the Investigator, is considered clinically significant.
- Any cytotoxic therapy in the previous 5 years.
- Diabetes mellitus (type I or II), with the exception of previous gestational diabetes.
- Any chronic or active neurologic disorder, such as migraines (including silent), seizures or epilepsy (excluding a single febrile seizure as a child as judged by the Investigator).
- Have a known history of Guillain Barré Syndrome (GBS).
- Have an active malignancy or history of metastatic or hematologic malignancy.
- Suspected or known alcohol and/or illicit drug abuse within the past 5 years per the judgment of the Investigator.
- Moderate or severe illness and/or fever >100.4 °F within 1 week prior to vaccination (subjects can be rescheduled).
- Administration of immunoglobulin G (IgGs) and/or any blood products within the 120 days preceding study entry or planned administration during the study period.
- History of blood donation within 60 days of enrollment or plans to donate within the study period.
- Administration of chronic (defined as more than 14 days) immunosuppressants or other immune modifying drugs within 6 months of study entry: for corticosteroids, this includes chronic oral >14 days or intraarticular steroids in the past 6 months (intranasal and topical are allowed).
- Major surgery or hospitalization planned during the period of study participation.
- Research staff or the immediate family of research staff directly involved with the clinical study.
- Any other significant finding that in the opinion of the Investigator that would increase the risk of the individual having an adverse outcome from participating in this study.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase 1 Clinical Trial to Evaluate the Safety and Immunogenicity of a Monovalent Ebola Zaire Vaccine (rVSVN4CT1-EBOVGP1) Delivered by Intramuscular Injection in Healthy Adult Subjects
The purpose of this study is to assess the safety profile of the Zaire Ebola vaccine and the strength of the immune response.
Read the detailed description
Ebola Zaire is a filovirus that has caused devastating epidemics of hemorrhagic fever in South Africa. Research is underway to create a safe and effective vaccine to protect against Ebola disease, especially for the military and health care workers. Promising animal studies with this vaccine indicate safety and immunogenicity, and the vaccine platform used to deliver the Ebola protein antigen has been successful in creating a safe and protective immune response in people. Note that only one Ebola protein is used in this vaccine; since the entire intact Ebola virus is required for infection, it is impossible to get Ebola disease from this vaccine.
The study targets enrollment of 39 healthy adults. These participants are divided into 3 groups that will be administered one of three dose levels of the vaccine (low, medium, high). The study participants will receive two doses of vaccine: one on day 1 and the second on day 28 (1 month). Three participants at each dose level will act as controls and receive a placebo instead of the active vaccine. A total of 13 visits to the clinic are required over a period of 26 weeks. The total study is expected to take 9 months.
- Conditions
- Ebola Virus Disease
- Being tested
- Ebola Vaccine - low dose, Ebola Vaccine - mid dose, Ebola Vaccine - high dose, Placebo
- Keywords
- Ebola, VSV, Vesicular Stomatitis Virus, Vaccine, Zaire
- 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.
Ebola Vaccine - low doseBiological
Also called Ebola Zaire Vaccine (2.5 x 10^4 pfu)
2 x 0.5ml vaccine will be given as intramuscular injections on each of day 1 and day 28
Ebola Vaccine - mid doseBiological
Also called Ebola Zaire Vaccine (2.5 x 10^5 pfu)
2 x 0.5ml vaccine will be given as intramuscular injections on each of day 1 and day 28
Ebola Vaccine - high doseBiological
Also called High Dose Ebola Zaire Vaccine (2.0 x 10^6 pfu)
2 x 1.0ml vaccine will be given as intramuscular injections on each of day 1 and day 28
PlaceboBiological
2 x 0.5ml or 2 x 1.0ml placebo will be given as intramuscular injections on each of day 1 and day 28 depending on cohort
| Study group | Role | What they receive |
|---|---|---|
| Ebola Vaccine - low dose | Experimental | Low Dose Zaire Ebola Vaccine Receives: Biological: Ebola Vaccine - low dose |
| Ebola Vaccine - mid dose | Experimental | Mid Dose Zaire Ebola Vaccine Receives: Biological: Ebola Vaccine - mid dose |
| Ebola Vaccine - high dose | Experimental | High Dose Zaire Ebola Vaccine Receives: Biological: Ebola Vaccine - high dose |
| Placebo | Placebo comparator | Placebo Receives: Biological: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of Treatment Emergent Adverse Events (Safety and Tolerability)
To establish the maximum safe and tolerated dose of a monovalent Ebola Zaire vaccine, as determined by local and systemic reactogenicity signs and symptoms, laboratory measures of safety, and adverse and serious adverse experiences.
Measured: 9 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Mar 2016 (estimated)
- Study start22 Dec 2015
- Primary completion15 Sep 2016
- Study completion15 Sep 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Ebola Virus DiseaseStudies of the same condition, open and under way.
- 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
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 38 participants (actual)
Sponsor and investigators
- Lead sponsor
- Auro Vaccines LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Accelovance, United States Department of Defense
- Responsible party
- Sponsor
- Investigators
- Murray A Kimmel, DO, Principal investigator, Optimal Research, LLC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02718469
- Sponsor's protocol ID
- rVSV-EBOV-01
- Status last verified
- Apr 2017
- First submitted
- 9 Mar 2016
- Last updated
- 4 Apr 2017
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Publications
Clarke DK, Xu R, Matassov D, Latham TE, Ota-Setlik A, Gerardi CS, Luckay A, Witko SE, Hermida L, Higgins T, Tremblay M, Sciotto-Brown S, Chen T, Egan MA, Rusnak JM, Ward LA, Eldridge JH. Safety and immunogenicity of a highly attenuated rVSVN4CT1-EBOVGP1 Ebola virus vaccine: a randomised, double-blind, placebo-controlled, phase 1 clinical trial. Lancet Infect Dis. 2020 Apr;20(4):455-466. doi: 10.1016/S1473-3099(19)30614-0. Epub 2020 Jan 14.
PubMed 31952923
Study at a glance
From the registry record, last updated by the sponsor on 4 Apr 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1 Clinical Trial to Evaluate the Safety and Immunogenicity of a Monovalent Ebola Zaire Vaccine (rVSVN4CT1-EBOVGP1) Delivered by Intramuscular Injection in Healthy Adult Subjects
- ClinicalTrials.gov ID
- NCT02718469
- Acronym / sponsor ID
- rVSV-EBOV-01
- Conditions
- Ebola Virus Disease
- Keywords
- Ebola, VSV, Vesicular Stomatitis Virus, Vaccine, Zaire
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 38 participants (actual)
- Lead sponsor
- Auro Vaccines LLCIndustry (pharma, biotech, devices)
- Collaborators
- Accelovance, United States Department of Defense
- Study start
- 22 Dec 2015 (actual)
- Primary completion
- 15 Sep 2016 (actual)
- Study completion
- 15 Sep 2016 (actual)
- First posted
- 24 Mar 2016 (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 assess the safety profile of the Zaire Ebola vaccine and the strength of the immune response.
Detailed description
Ebola Zaire is a filovirus that has caused devastating epidemics of hemorrhagic fever in South Africa. Research is underway to create a safe and effective vaccine to protect against Ebola disease, especially for the military and health care workers. Promising animal studies with this vaccine indicate safety and immunogenicity, and the vaccine platform used to deliver the Ebola protein antigen has been successful in creating a safe and protective immune response in people. Note that only one Ebola protein is used in this vaccine; since the entire intact Ebola virus is required for infection, it is impossible to get Ebola disease from this vaccine.
The study targets enrollment of 39 healthy adults. These participants are divided into 3 groups that will be administered one of three dose levels of the vaccine (low, medium, high). The study participants will receive two doses of vaccine: one on day 1 and the second on day 28 (1 month). Three participants at each dose level will act as controls and receive a placebo instead of the active vaccine. A total of 13 visits to the clinic are required over a period of 26 weeks. The total study is expected to take 9 months.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Ebola Vaccine - low dose | Experimental | Biological: Ebola Vaccine - low doseLow Dose Zaire Ebola Vaccine |
| Ebola Vaccine - mid dose | Experimental | Biological: Ebola Vaccine - mid doseMid Dose Zaire Ebola Vaccine |
| Ebola Vaccine - high dose | Experimental | Biological: Ebola Vaccine - high doseHigh Dose Zaire Ebola Vaccine |
| Placebo | Placebo comparator | Biological: PlaceboPlacebo |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (25 listed)
- Subjects who have provided written informed consent and an authorization for disclosure of protected health information must meet the following criteria:
- Healthy adult men or women, 18 to 60 (inclusive) years of age.
- Have provided written informed consent prior to screening procedures.
- Free of clinically significant health problems, as determined by pertinent medical history, physical examination without significant findings in the 28 days prior to enrollment, and clinical judgment of the Investigator.
- Agrees not to have, or plan to have, non-study vaccines within 60 days after receiving the initial study vaccine, unless medically indicated (i.e., tetanus, rabies vaccine).
Key exclusion criteria (31 listed)
- Any subject who meets any of the following criteria will not qualify for entry into the study:
- History of prior infection with a filovirus or prior participation in a filovirus vaccine trial.
- History of prior infection with VSV or receipt of a VSV vectored vaccine.
- Has traveled to an area where the World Health Organization (WHO) has declared as an Ebola outbreak zone.
- Healthcare worker who has direct contact with patients (nurse, physician, dentist, emergency medical technician, dental hygienist).
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 |
|---|---|---|
| Ebola Vaccine - low doseAlso: Ebola Zaire Vaccine (2.5 x 10^4 pfu)2 x 0.5ml vaccine will be given as intramuscular injections on each of day 1 and day 28 | Biological | Ebola Vaccine - low dose |
| Ebola Vaccine - mid doseAlso: Ebola Zaire Vaccine (2.5 x 10^5 pfu)2 x 0.5ml vaccine will be given as intramuscular injections on each of day 1 and day 28 | Biological | Ebola Vaccine - mid dose |
| Ebola Vaccine - high doseAlso: High Dose Ebola Zaire Vaccine (2.0 x 10^6 pfu)2 x 1.0ml vaccine will be given as intramuscular injections on each of day 1 and day 28 | Biological | Ebola Vaccine - high dose |
| Placebo2 x 0.5ml or 2 x 1.0ml placebo will be given as intramuscular injections on each of day 1 and day 28 depending on cohort | Biological | Placebo |
Primary outcome
Incidence of Treatment Emergent Adverse Events (Safety and Tolerability)
Time frame: 9 months
To establish the maximum safe and tolerated dose of a monovalent Ebola Zaire vaccine, as determined by local and systemic reactogenicity signs and symptoms, laboratory measures of safety, and adverse and serious adverse experiences.
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 4 Apr 2017.
- Derived from this study: PubMed 31952923Clarke DK, Xu R, Matassov D, Latham TE, Ota-Setlik A, Gerardi CS, Luckay A, Witko SE, Hermida L, Higgins T, Tremblay M, Sciotto-Brown S, Chen T, Egan MA, Rusnak JM, Ward LA, Eldridge JH. Safety and immunogenicity of a highly attenuated rVSVN4CT1-EBOVGP1 Ebola virus vaccine: a randomised, double-blind, placebo-controlled, phase 1 clinical trial. Lancet Infect Dis. 2020 Apr;20(4):455-466. doi: 10.1016/S1473-3099(19)30614-0. Epub 2020 Jan 14.
- Individual participant dataSharing planned: No
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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.
Murray A Kimmel, DO principal investigator
Optimal Research, LLC
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 Ebola Vaccine - low dose, Ebola Vaccine - mid dose and Ebola Vaccine - high dose in people with Ebola Virus Disease, run by Auro Vaccines LLC 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 25 inclusion and 31 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 4 Apr 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. 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 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?
Incidence of Treatment Emergent Adverse Events (Safety and Tolerability) (time frame: 9 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02718469, which also lists 1 linked publication.
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 4 Apr 2017.