Ebola VirusesPhase 1VSVΔG-ZEBOVNCT02374385
Phase I Trial to Assess the Safety, Tolerability and Immunogenicity of a Ebola Virus Vaccine
A Phase 1 study testing BPSC-1001 (VSVΔG-ZEBOV) in people with Ebola Viruses, run by Dalhousie University.
Trial summary
Background: Ebola virus has infected and killed people, mostly in Africa. In 2014, the Ebola virus has affected several thousand people. There is no approved effective way to treat or prevent Ebola. Researchers are trying to develop a vaccine for it. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Ebola Viruses
- What is being tested?
- BPSC-1001 (VSVΔG-ZEBOV)
- Type of treatment
- Vaccines
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- No sites listed yet
- Study dates
- Nov 2014to Jun 2015
- 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 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Healthy adult male or non-pregnant, non-lactating female, ages 18 to 65 (inclusive) at the time of screening
- Have provided written informed consent before screening
- Free of clinically significant health problems, as determined by pertinent medical history and clinical examination prior to entry into the study
- Available, able, and willing to participate for all study visits and procedures
- Males and females who are willing to practice abstinence from sexual intercourse, or are willing to use effective methods of contraception, from at least 30 days prior to vaccination until study end.
- If the female partner is NOT of childbearing potential, the couple will only be required to use condoms, without other adjunctive contraception.
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- For this study, a woman is considered of childbearing potential unless postmenopausal (≥ 1 year without menses) or surgically sterilized (tubal ligation, bilateral oophorectomy, or hysterectomy)
- Effective contraception is defined as a contraceptive method with failure rate of less than 1% per year when used consistently and correctly and when applicable, in accordance with the product label, for example:
- Male condoms PLUS: Oral contraceptives, either combined or progestogen alone, injectable progestogen,implants of etonogestrel or levonorgestrel, oestrogenic vaginal ring, percutaneous contraceptive patches, intrauterine device or intrauterine system
- Be willing to minimize blood and body fluid exposure of others for 7 days after vaccination
- Use of effective barrier prophylaxis, such as latex condoms, during penetrative sexual intercourse
- Avoiding the sharing of needles, razors, or toothbrushes
- Avoiding open-mouth kissing
Who cannot join
- 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
- Is a healthcare worker who has direct contact with patients
- Has a house-hold contact (HHC) who is immunodeficient, HIV-positive, pregnant, has an unstable medical condition, or is under the age of 5 years
- Is a childcare worker who has direct contact with children 5 years of age or younger
- Directly prepares food in the food industry
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- History of employment in an industry involved in contact with ruminant animals, veterinary sciences, or other potential exposure to VSV
- History of employment or activity which 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 the components of the BPSC-1001 vaccine product
- Receipt of investigational product up to 30 days prior to enrollment or ongoing participation in another clinical trial involving an investigational product
- Receipt of licensed vaccines within 30 days of planned study immunization
- Ability to observe possible local reactions at the eligible injections 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 psychiatric, hematologic, pulmonary, cardiovascular, or hepatic or renal functional abnormality as determined by the investigator based on medical history, physical exam, ECG, and/or laboratory screening test
- Any baseline laboratory screening tests which is outside of acceptable range as defined in the protocol ALT, AST, creatinine, hemoglobin, platelet count, total white blood cell count, urine protein, urine occult blood, urine glucose
- Any serologic evidence of hepatitis B or C infection
- Any confirmed or suspected immunosuppressive or immunodeficient condition, including human immunodeficiency virus (HIV) infection, cytotoxic therapy in the previous 5 years, and/or diabetes
- Any chronic or active neurologic disorder, including migraines, seizures, and epilepsy, excluding a single febrile seizure as a child
- 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
- Moderate or severe illness and/or fever greater than 100.4 F within one week prior to vaccination
- Pregnant or lactating female, or female who intends to become pregnant during the study period
- Administration of immunoglobulins 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 will mean prednisone, or equivalent, greater than or equal to 0.5 mg/kg/day
- Intranasal and topical steroids are allowed
- Unwilling to allow storage and use of blood for future vaccine research
- Any other significant finding that in the opinion of the investigator would increase the risk of the individual having an adverse outcome from participating in this study
About this study
Official title: A Phase 1 Randomized, Single-Center, Double-Blind, Placebo Controlled, Dose-Ranging Study to Evaluate the Safety and Immunogenicity of the BPSC-1001 (VSVΔG-ZEBOV) Ebola Virus Vaccine Candidate in Healthy Adult Subjects
Background:
Ebola virus has infected and killed people, mostly in Africa. In 2014, the Ebola virus has affected several thousand people. There is no approved effective way to treat or prevent Ebola. Researchers are trying to develop a vaccine for it.
Read more
Objectives:
To study the anti-Ebola vaccine VSV ZEBOV (BPSC1001) to see if it is safe. Also, to see how it affects people's immune system.
Eligibility:
- Healthy men and women ages 18-65. They must not have a chronic medical condition that requires medicine. They must not be a healthcare worker, an animal care worker, or a childcare worker, and they must not have a household contact that has a compromised immune system, is pregnant, or is under the age of 5 years.
Design:
- Participants will be screened with medical history, physical exam, and blood tests.
- Participants will be randomly assigned to get the vaccine or the placebo.
- At visit 1 (vaccination), vital signs will be taken and blood will be drawn. The vaccine or placebo will be injected into the upper arm muscle.
- Participants will return to the clinic 11 times over the next 6 months. Participants will have blood drawn at every study visit. Their mouth will be swabbed and urine tested at least four times after vaccination.
- For 14 days after vaccination, participants will write down their temperature, any symptoms, and any redness at the injection site. They will bring the booklet to each study visit.
All visits take place at the Canadian Center for Vaccinology, Dalhousie University/IWK Health Centre, Halifax, NS.
- Conditions
- Ebola Viruses
- Being tested
- BPSC-1001 (VSVΔG-ZEBOV), Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BPSC-1001 (VSVΔG-ZEBOV)Biological
Also called BPSC-1001
Ebola vaccine candidate
PlaceboOther
Normal saline
| Study group | Role | What they receive |
|---|---|---|
| Group 1 | Experimental | 1x10(5) pfu VSV G-ZEBOV vaccine (BPSC1001) each dose, total volume 1 mL Receives: Biological: BPSC-1001 (VSVΔG-ZEBOV) |
| Group 2 | Experimental | 5x10(5) pfu VSV G-ZEBOV vaccine (BPSC1001) each dose, total volume 1 mL Receives: Biological: BPSC-1001 (VSVΔG-ZEBOV) |
| Group 3 | Experimental | 3x10(6) pfu VSV G-ZEBOV vaccine (BPSC1001) each dose, total volume 1 mL. Receives: Biological: BPSC-1001 (VSVΔG-ZEBOV) |
| Group 4 | Placebo comparator | Group 4 will receive placebo (normal saline). Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Frequency and severity of local injection site reactogenicity signs and symptoms: pain, erythema, and induration
Measured: 2 months
Frequency of adverse events (AEs), severity and assessed relationship to study products
Measured: 2 months
Distribution of values of safety laboratory measures at baseline and at follow-up visits post-vaccination
Measured: 3 months
Number of participants with early discontinuation of vaccinations and reason for discontinuation
Measured: 3 months
Secondary outcomes (2)
Measurement of ZEBOV envelope glycoprotein-specific binding antibody by ELISA
Measured: 6 months
rVSV in blood, urine, or saliva as detected by real-time polymerase chain reaction [RT-PCR]
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Feb 2015 (estimated)
- Study startNov 2014
- Primary completionMar 2015
- Study completionJun 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Ebola VirusesStudies 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
- Single group
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Dalhousie University
- Sponsor type
- University, hospital or other
- Collaborators
- Canadian Institutes of Health Research (CIHR), NewLink Genetics Corporation
- Responsible party
- Principal investigator, Scott Halperin, Dalhousie University
- Investigators
- Scott A. Halperin, MD, Principal investigator, Dalhousie University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02374385
- Sponsor's protocol ID
- CI1401
- Acronym
- VSVΔG-ZEBOV
- Status last verified
- Feb 2016
- First submitted
- 6 Jan 2015
- Last updated
- 9 Feb 2016
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Coller BG, Blue J, Das R, Dubey S, Finelli L, Gupta S, Helmond F, Grant-Klein RJ, Liu K, Simon J, Troth S, VanRheenen S, Waterbury J, Wivel A, Wolf J, Heppner DG, Kemp T, Nichols R, Monath TP. Clinical development of a recombinant Ebola vaccine in the midst of an unprecedented epidemic. Vaccine. 2017 Aug 16;35(35 Pt A):4465-4469. doi: 10.1016/j.vaccine.2017.05.097. Epub 2017 Jun 21.
PubMed 28647166ElSherif MS, Brown C, MacKinnon-Cameron D, Li L, Racine T, Alimonti J, Rudge TL, Sabourin C, Silvera P, Hooper JW, Kwilas SA, Kilgore N, Badorrek C, Ramsey WJ, Heppner DG, Kemp T, Monath TP, Nowak T, McNeil SA, Langley JM, Halperin SA; Canadian Immunization Research Network. Assessing the safety and immunogenicity of recombinant vesicular stomatitis virus Ebola vaccine in healthy adults: a randomized clinical trial. CMAJ. 2017 Jun 19;189(24):E819-E827. doi: 10.1503/cmaj.170074.
PubMed 28630358
Study at a glance
From the registry record, last updated by the sponsor on 9 Feb 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1 Randomized, Single-Center, Double-Blind, Placebo Controlled, Dose-Ranging Study to Evaluate the Safety and Immunogenicity of the BPSC-1001 (VSVΔG-ZEBOV) Ebola Virus Vaccine Candidate in Healthy Adult Subjects
- ClinicalTrials.gov ID
- NCT02374385
- Acronym / sponsor ID
- VSVΔG-ZEBOV / CI1401
- Conditions
- Ebola Viruses
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Dalhousie UniversityUniversity, hospital or other
- Collaborators
- Canadian Institutes of Health Research (CIHR), NewLink Genetics Corporation
- Study start
- Nov 2014
- Primary completion
- Mar 2015 (actual)
- Study completion
- Jun 2015 (actual)
- First posted
- 27 Feb 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.
Background:
Ebola virus has infected and killed people, mostly in Africa. In 2014, the Ebola virus has affected several thousand people. There is no approved effective way to treat or prevent Ebola. Researchers are trying to develop a vaccine for it.
Objectives:
To study the anti-Ebola vaccine VSV ZEBOV (BPSC1001) to see if it is safe. Also, to see how it affects people's immune system.
Eligibility:
- Healthy men and women ages 18-65. They must not have a chronic medical condition that requires medicine. They must not be a healthcare worker, an animal care worker, or a childcare worker, and they must not have a household contact that has a compromised immune system, is pregnant, or is under the age of 5 years.
Design:
- Participants will be screened with medical history, physical exam, and blood tests.
- Participants will be randomly assigned to get the vaccine or the placebo.
- At visit 1 (vaccination), vital signs will be taken and blood will be drawn. The vaccine or placebo will be injected into the upper arm muscle.
- Participants will return to the clinic 11 times over the next 6 months. Participants will have blood drawn at every study visit. Their mouth will be swabbed and urine tested at least four times after vaccination.
- For 14 days after vaccination, participants will write down their temperature, any symptoms, and any redness at the injection site. They will bring the booklet to each study visit.
All visits take place at the Canadian Center for Vaccinology, Dalhousie University/IWK Health Centre, Halifax, NS.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Group 1 | Experimental | Biological: BPSC-1001 (VSVΔG-ZEBOV)1x10(5) pfu VSV G-ZEBOV vaccine (BPSC1001) each dose, total volume 1 mL |
| Group 2 | Experimental | Biological: BPSC-1001 (VSVΔG-ZEBOV)5x10(5) pfu VSV G-ZEBOV vaccine (BPSC1001) each dose, total volume 1 mL |
| Group 3 | Experimental | Biological: BPSC-1001 (VSVΔG-ZEBOV)3x10(6) pfu VSV G-ZEBOV vaccine (BPSC1001) each dose, total volume 1 mL. |
| Group 4 | Placebo comparator | Other: PlaceboGroup 4 will receive placebo (normal saline). |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- Healthy adult male or non-pregnant, non-lactating female, ages 18 to 65 (inclusive) at the time of screening
- Have provided written informed consent before screening
- Free of clinically significant health problems, as determined by pertinent medical history and clinical examination prior to entry into the study
- Available, able, and willing to participate for all study visits and procedures
- Males and females who are willing to practice abstinence from sexual intercourse, or are willing to use effective methods of contraception, from at least 30 days prior to vaccination until study end.
Key exclusion criteria (29 listed)
- 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
- Is a healthcare worker who has direct contact with patients
- Has a house-hold contact (HHC) who is immunodeficient, HIV-positive, pregnant, has an unstable medical condition, or is under the age of 5 years
- Is a childcare worker who has direct contact with children 5 years of age or younger
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 |
|---|---|---|
| BPSC-1001 (VSVΔG-ZEBOV)Also: BPSC-1001Ebola vaccine candidate | Biological | Group 1, Group 2, Group 3 |
| PlaceboNormal saline | Other | Group 4 |
Primary outcome
Frequency and severity of local injection site reactogenicity signs and symptoms: pain, erythema, and induration
Time frame: 2 months
Frequency of adverse events (AEs), severity and assessed relationship to study products
Time frame: 2 months
Distribution of values of safety laboratory measures at baseline and at follow-up visits post-vaccination
Time frame: 3 months
Number of participants with early discontinuation of vaccinations and reason for discontinuation
Time frame: 3 months
2 secondary outcomes
Measurement of ZEBOV envelope glycoprotein-specific binding antibody by ELISA
Time frame: 6 months
rVSV in blood, urine, or saliva as detected by real-time polymerase chain reaction [RT-PCR]
Time frame: 6 months
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 9 Feb 2016.
- Derived from this study: PubMed 28647166Coller BG, Blue J, Das R, Dubey S, Finelli L, Gupta S, Helmond F, Grant-Klein RJ, Liu K, Simon J, Troth S, VanRheenen S, Waterbury J, Wivel A, Wolf J, Heppner DG, Kemp T, Nichols R, Monath TP. Clinical development of a recombinant Ebola vaccine in the midst of an unprecedented epidemic. Vaccine. 2017 Aug 16;35(35 Pt A):4465-4469. doi: 10.1016/j.vaccine.2017.05.097. Epub 2017 Jun 21.
- Derived from this study: PubMed 28630358ElSherif MS, Brown C, MacKinnon-Cameron D, Li L, Racine T, Alimonti J, Rudge TL, Sabourin C, Silvera P, Hooper JW, Kwilas SA, Kilgore N, Badorrek C, Ramsey WJ, Heppner DG, Kemp T, Monath TP, Nowak T, McNeil SA, Langley JM, Halperin SA; Canadian Immunization Research Network. Assessing the safety and immunogenicity of recombinant vesicular stomatitis virus Ebola vaccine in healthy adults: a randomized clinical trial. CMAJ. 2017 Jun 19;189(24):E819-E827. doi: 10.1503/cmaj.170074.
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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.
Scott A. Halperin, MD principal investigator
Dalhousie University
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing BPSC-1001 (VSVΔG-ZEBOV) in people with Ebola Viruses, run by Dalhousie University.
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 13 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 9 Feb 2016. Status can change between updates, so confirm with the study contact before making plans.
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?
Frequency and severity of local injection site reactogenicity signs and symptoms: pain, erythema, and induration (time frame: 2 months). 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?
On the ClinicalTrials.gov record for NCT02374385, which also lists 2 linked publications.
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 9 Feb 2016.