Ebolavirus DiseasePhase 1/2VSV-ZEBOVNCT02287480
VSV-ZEBOV Geneva Vaccine Trial
A Phase 1/2 study testing VSV-ZEBOV in people with Ebolavirus Disease, run by University Hospital, Geneva at 1 site in Switzerland.
Trial summary
The hemorrhagic fever resulting from Ebola infection is frequently fatal; the current Ebola outbreak, still in its ascendant phase, has a mortality rate over 50%. There is no proven therapy or prevention available at this time. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Ebolavirus Disease
- What is being tested?
- VSV-ZEBOV
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 115 participants
- Where
- 1 siteSwitzerland
- Study dates
- Nov 2014to Jan 2016
- Phase
- Phase 1/2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- Has provided written informed consent before screening
- Adult male or non-pregnant, non-lactating female, ages 18 to 65 (inclusive) at the time of screening
- Free of clinically significant health problems, as determined by pertinent medical history and clinical examination at study screening
- Females of childbearing potential who are willing to use an effective method of contraception, from at least 7 days prior to vaccination through the end of the study period, and a double method from day 0 through day 28
- Males who are willing to use effective contraception from day 0 through day 28:
- 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, be willing to refrain from blood donation during the course of the study)
Who cannot join
- Prior receipt of an Ebolavirus or Marburgvirus vaccine, a VSV-vectored vaccine, or any other investigational vaccine likely to impact on interpretation of the trial data
- Serologic evidence of prior Ebola exposure
- Has a household contact (HHC) who is immunodeficient, HIV-positive, pregnant, has an unstable medical condition in the opinion of the investigator (e.g., New York Heart Association Class ≥ II heart failure, severe debilitating asthma and/or chronic obstructive pulmonary disease)
- Works with livestock
- History of severe local or systemic reactions to any vaccination or a history of severe allergic reactions
- Known allergy to the components of the BPSC1001 vaccine product
Show all 21Show fewer
- Receipt of investigational product up to 30 days prior to enrollment or ongoing participation in another interventional clinical trial
- Receipt of licensed vaccines within 14 days of planned study immunization (30 days for live vaccines) or ongoing participation in another clinical interventional trial
- 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, 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
- Serologic evidence of hepatitis C infection, evidence of active hepatitis B infection
- Any confirmed or suspected immunosuppressive or immunodeficient condition, including human immunodeficiency virus (HIV) infection, asplenia, cytotoxic therapy in the previous 5 years, and/or diabetes
- Any chronic or active neurologic disorder, including seizures, and epilepsy, excluding febrile seizures as a child
- Has a known history of Guillain-Barré Syndrome
- Has an active malignancy or recent (< 10 years) history of metastatic or hematologic malignancy
- Suspected or known alcohol and/or illicit drug abuse within the past 5 years
- 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 30 days of enrollment or plans to donate within the study period
- Administration of chronic (> 14 days) immunosuppressants or other immune-modifying drugs within 6 months of study entry
- Any other significant finding that, in the opinion of the investigator, would increase the risk of the individual's having an adverse outcome by participating in this study
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase I/II Dose-finding Randomized, Single-center, Double-blind, Placebo-controlled Safety and Immunogenicity Trial of the Vesicular Stomatitis Virus-vectored Zaire Ebola Candidate Vaccine BPSC1001 (VSVΔG-ZEBOV) in Healthy Adults.
The hemorrhagic fever resulting from Ebola infection is frequently fatal; the current Ebola outbreak, still in its ascendant phase, has a mortality rate over 50%. There is no proven therapy or prevention available at this time.
The vaccine candidate VSV-ZEBOV (BPSC1001) has shown promising safety and efficacy in preventing Ebola Zaire infections in non-human primates (NHP). Before it can be assessed in large Phase IIb/3 trials in affected areas, safety data from phase 1 first-in-human trials are needed. To accelerate this process, the World Health Organization (WHO) has constituted a consortium of Clinical Research Centers in Switzerland, Germany, and Africa that will use similar protocols to collectively include roughly 250 volunteers, the sample size required to identify a 2-fold difference in anti-ZEBOV IgG antibody titers following immunization with 2 different doses of BPSC1001.
The joint primary objectives of this single-center, double-blind, randomized placebo-controlled phase 1 dose-finding study are to assess the safety and tolerability of the VSV-ZEBOV vaccine when administered to healthy volunteers at a lower or higher vaccine dose and to define whether seroresponses differ significantly following immunization with the lower or higher vaccine dose.
Read the detailed description
This single-center, double-blind, randomized placebo-controlled phase 1 dose-finding study will have two randomization schemes. Volunteers who could later be exposed to Ebolavirus while working in epidemic areas ("deployable subjects") will be randomized to receive one of two vaccine doses. Non-deployable volunteers, with no identified risk of Ebola exposure in the near term, will be allocated to one of three groups and receive the lower or higher vaccine dose, or a placebo. A single immunization will be performed. All subjects will be observed in the clinical trials unit (CTU) for 1.5 hours after vaccine/placebo injection. Subjects will complete post-injection diaries for 7 days after injection, as well as post-injection follow-up visits (see below). On-site visits at the CTU will occur on days -90 to -1, 0, 1, 3, 7, 14, 28, 84, 168. Some subjects with a positive serologic response at 24 weeks may be requested to return for immune durability testing at 12 months.
One or more interim analyses will be undertaken to guide decisions on 1) the potential use of the vaccine in Ph2/3 trials in affected countries and 2) potential modification of the trial(s) through an amendment to evaluate a higher dose, if immunogenicity is poor, or a lower dose if the dosage levels selected are not safe and reasonably well tolerated.
- Conditions
- Ebolavirus Disease
- Being tested
- VSV-ZEBOV
- Keywords
- Ebolavirus Vaccines
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VSV-ZEBOVBiological
Also called BPSC1001
See arm/group descriptions.
| Study group | Role | What they receive |
|---|---|---|
| VSV-ZEBOV lower dose | Experimental | One intramuscular (deltoid) injection of a lower dose (10^7 plaque-forming units) of VSV-ZEBOV.
Study amendment (01.2015) : One intramuscular (deltoid) injection of a markedly lower dose (3x 10^5 plaque-forming units) of VSV-ZEBOV Receives: Biological: VSV-ZEBOV |
| VSV-ZEBOV higher dose | Experimental | One intramuscular (deltoid) injection of a higher dose (5 x 10^7 pfu) of VSV-ZEBOV.
Study amendment (01.2015) : interrupted Receives: Biological: VSV-ZEBOV |
| Placebo | Placebo comparator | One intramuscular (deltoid) injection of normal saline (0.5 ml) Receives: Biological: VSV-ZEBOV |
What is being measured
The primary outcome is the main question the study is designed to answer.
Titers of ZEBOV-specific IgG Antibodies
Primary immunogenicity outcome (required for dose selection)
Measured: Day 0 - 28
Secondary outcomes (8)
Number of Participants With Solicited Local and Systemic Reactogenicity Signs and Symptoms
Number of participants with solicited local and systemic reactogenicity signs and symptoms. Day 0 is the day of the study intervention.
Measured: Days 0 - 14
Number of Participants With Unsolicited Adverse Events
Number of participants with unsolicited adverse events in the 28 days following injection
Measured: Days 0 - 28
Number of Participants With a Serious Adverse Event (SAE)
Number of participants with a serious adverse event (SAE) in the 365 days (1 year) following injection.
Measured: Days 0 - 365
Magnitude (Copies/ml) of VSVΔG-ZEBOV Viremia
Magnitude (copies/ml) of VSVΔG-ZEBOV viremia as expressed by median VSV RNA concentrations after vaccination.
Measured: Days 1, 3 and 7
Persistence of Titers of ZEBOV-specific IgG Antibodies
The percentage of participants maintaining positive ZEBOV-specific IgG antibody titers at 168 days after vaccination.
Measured: Day 168
Titers of Neutralizing ZEBOV-specific IgG Antibodies
Geometric mean titers of neutralizing ZEBOV-specific IgG antibodies.
Measured: Days 0, 28 and 168
Duration of VSVΔG-ZEBOV Viremia
Percentage of participants with any detectable viremia on days 1, 3 and 7
Measured: Days 1, 3 and 7
Number of Participants in Whom Shedding of VSVΔG-ZEBOV Was Detected in Urine and/or Saliva.
This outcome was evaluated in a subset of vaccinees.
Measured: Days 1, 3 and 7
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Nov 2014 (estimated)
- Study startNov 2014
- Primary completionApr 2015
- Study completionJan 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Ebolavirus DiseaseStudies of the same condition, open and under way.
- More trials run by University Hospital, GenevaThe 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 1/2
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 115 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Geneva
- Sponsor type
- University, hospital or other
- Collaborators
- World Health Organization, Wellcome Trust, Universitätsklinikum Hamburg-Eppendorf, Philipps University Marburg, Albert Schweitzer Hospital, Institute of Tropical Medicine, University of Tuebingen, KEMRI-Wellcome Trust Collaborative Research Program
- Responsible party
- Principal investigator, Siegrist Claire-Anne, University Hospital, Geneva
- Investigators
- Claire-Anne Siegrist, MD, Principal investigator, University Hospita, Geneva
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02287480
- Sponsor's protocol ID
- CCER 14-221
- Acronym
- VSV-ZEBOV
- Status last verified
- May 2023
- First submitted
- 2 Nov 2014
- Last updated
- 10 May 2023
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Publications
Agnandji ST, Huttner A, Zinser ME, Njuguna P, Dahlke C, Fernandes JF, Yerly S, Dayer JA, Kraehling V, Kasonta R, Adegnika AA, Altfeld M, Auderset F, Bache EB, Biedenkopf N, Borregaard S, Brosnahan JS, Burrow R, Combescure C, Desmeules J, Eickmann M, Fehling SK, Finckh A, Goncalves AR, Grobusch MP, Hooper J, Jambrecina A, Kabwende AL, Kaya G, Kimani D, Lell B, Lemaitre B, Lohse AW, Massinga-Loembe M, Matthey A, Mordmuller B, Nolting A, Ogwang C, Ramharter M, Schmidt-Chanasit J, Schmiedel S, Silvera P, Stahl FR, Staines HM, Strecker T, Stubbe HC, Tsofa B, Zaki S, Fast P, Moorthy V, Kaiser L, Krishna S, Becker S, Kieny MP, Bejon P, Kremsner PG, Addo MM, Siegrist CA. Phase 1 Trials of rVSV Ebola Vaccine in Africa and Europe. N Engl J Med. 2016 Apr 28;374(17):1647-60. doi: 10.1056/NEJMoa1502924. Epub 2015 Apr 1.
PubMed 25830326Huttner A, Dayer JA, Yerly S, Combescure C, Auderset F, Desmeules J, Eickmann M, Finckh A, Goncalves AR, Hooper JW, Kaya G, Krahling V, Kwilas S, Lemaitre B, Matthey A, Silvera P, Becker S, Fast PE, Moorthy V, Kieny MP, Kaiser L, Siegrist CA; VSV-Ebola Consortium. The effect of dose on the safety and immunogenicity of the VSV Ebola candidate vaccine: a randomised double-blind, placebo-controlled phase 1/2 trial. Lancet Infect Dis. 2015 Oct;15(10):1156-1166. doi: 10.1016/S1473-3099(15)00154-1. Epub 2015 Aug 4.
PubMed 26248510Huttner A, Agnandji ST, Combescure C, Fernandes JF, Bache EB, Kabwende L, Ndungu FM, Brosnahan J, Monath TP, Lemaitre B, Grillet S, Botto M, Engler O, Portmann J, Siegrist D, Bejon P, Silvera P, Kremsner P, Siegrist CA; VEBCON; VSV-EBOVAC; VSV-EBOPLUS Consortia. Determinants of antibody persistence across doses and continents after single-dose rVSV-ZEBOV vaccination for Ebola virus disease: an observational cohort study. Lancet Infect Dis. 2018 Jul;18(7):738-748. doi: 10.1016/S1473-3099(18)30165-8. Epub 2018 Apr 5.
PubMed 29627147Coller 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 28647166Medaglini D, Harandi AM, Ottenhoff TH, Siegrist CA; VSV-Ebovac Consortium. Ebola vaccine R&D: Filling the knowledge gaps. Sci Transl Med. 2015 Dec 9;7(317):317ps24. doi: 10.1126/scitranslmed.aad3106.
PubMed 26659569
Study at a glance
From the registry record, last updated by the sponsor on 10 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I/II Dose-finding Randomized, Single-center, Double-blind, Placebo-controlled Safety and Immunogenicity Trial of the Vesicular Stomatitis Virus-vectored Zaire Ebola Candidate Vaccine BPSC1001 (VSVΔG-ZEBOV) in Healthy Adults.
- ClinicalTrials.gov ID
- NCT02287480
- Acronym / sponsor ID
- VSV-ZEBOV / CCER 14-221
- Conditions
- Ebolavirus Disease
- Keywords
- Ebolavirus Vaccines
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 115 participants (actual)
- Lead sponsor
- University Hospital, GenevaUniversity, hospital or other
- Collaborators
- World Health Organization, Wellcome Trust, Universitätsklinikum Hamburg-Eppendorf, Philipps University Marburg, Albert Schweitzer Hospital, Institute of Tropical Medicine, University of Tuebingen, KEMRI-Wellcome Trust Collaborative Research Program
- Study start
- Nov 2014
- Primary completion
- Apr 2015 (actual)
- Study completion
- Jan 2016 (actual)
- First posted
- 10 Nov 2014 (estimated)
- Results
- Posted 10 May 2023
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The hemorrhagic fever resulting from Ebola infection is frequently fatal; the current Ebola outbreak, still in its ascendant phase, has a mortality rate over 50%. There is no proven therapy or prevention available at this time.
The vaccine candidate VSV-ZEBOV (BPSC1001) has shown promising safety and efficacy in preventing Ebola Zaire infections in non-human primates (NHP). Before it can be assessed in large Phase IIb/3 trials in affected areas, safety data from phase 1 first-in-human trials are needed. To accelerate this process, the World Health Organization (WHO) has constituted a consortium of Clinical Research Centers in Switzerland, Germany, and Africa that will use similar protocols to collectively include roughly 250 volunteers, the sample size required to identify a 2-fold difference in anti-ZEBOV IgG antibody titers following immunization with 2 different doses of BPSC1001.
The joint primary objectives of this single-center, double-blind, randomized placebo-controlled phase 1 dose-finding study are to assess the safety and tolerability of the VSV-ZEBOV vaccine when administered to healthy volunteers at a lower or higher vaccine dose and to define whether seroresponses differ significantly following immunization with the lower or higher vaccine dose.
Detailed description
This single-center, double-blind, randomized placebo-controlled phase 1 dose-finding study will have two randomization schemes. Volunteers who could later be exposed to Ebolavirus while working in epidemic areas ("deployable subjects") will be randomized to receive one of two vaccine doses. Non-deployable volunteers, with no identified risk of Ebola exposure in the near term, will be allocated to one of three groups and receive the lower or higher vaccine dose, or a placebo. A single immunization will be performed. All subjects will be observed in the clinical trials unit (CTU) for 1.5 hours after vaccine/placebo injection. Subjects will complete post-injection diaries for 7 days after injection, as well as post-injection follow-up visits (see below). On-site visits at the CTU will occur on days -90 to -1, 0, 1, 3, 7, 14, 28, 84, 168. Some subjects with a positive serologic response at 24 weeks may be requested to return for immune durability testing at 12 months.
One or more interim analyses will be undertaken to guide decisions on 1) the potential use of the vaccine in Ph2/3 trials in affected countries and 2) potential modification of the trial(s) through an amendment to evaluate a higher dose, if immunogenicity is poor, or a lower dose if the dosage levels selected are not safe and reasonably well tolerated.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| VSV-ZEBOV lower dose | Experimental | Biological: VSV-ZEBOVOne intramuscular (deltoid) injection of a lower dose (10^7 plaque-forming units) of VSV-ZEBOV. Study amendment (01.2015) : One intramuscular (deltoid) injection of a markedly lower dose (3x 10^5 plaque-forming units) of VSV-ZEBOV |
| VSV-ZEBOV higher dose | Experimental | Biological: VSV-ZEBOVOne intramuscular (deltoid) injection of a higher dose (5 x 10^7 pfu) of VSV-ZEBOV. Study amendment (01.2015) : interrupted |
| Placebo | Placebo comparator | Biological: VSV-ZEBOVOne intramuscular (deltoid) injection of normal saline (0.5 ml) |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Has provided written informed consent before screening
- Adult male or non-pregnant, non-lactating female, ages 18 to 65 (inclusive) at the time of screening
- Free of clinically significant health problems, as determined by pertinent medical history and clinical examination at study screening
- Females of childbearing potential who are willing to use an effective method of contraception, from at least 7 days prior to vaccination through the end of the study period, and a double method from day 0 through day 28
- Males who are willing to use effective contraception from day 0 through day 28:
Key exclusion criteria (21 listed)
- Prior receipt of an Ebolavirus or Marburgvirus vaccine, a VSV-vectored vaccine, or any other investigational vaccine likely to impact on interpretation of the trial data
- Serologic evidence of prior Ebola exposure
- Has a household contact (HHC) who is immunodeficient, HIV-positive, pregnant, has an unstable medical condition in the opinion of the investigator (e.g., New York Heart Association Class ≥ II heart failure, severe debilitating asthma and/or chronic obstructive pulmonary disease)
- Works with livestock
- History of severe local or systemic reactions to any vaccination or a history of severe allergic reactions
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 |
|---|---|---|
| VSV-ZEBOVAlso: BPSC1001See arm/group descriptions. | Biological | Placebo, VSV-ZEBOV higher dose, VSV-ZEBOV lower dose |
Primary outcome
Titers of ZEBOV-specific IgG Antibodies
Time frame: Day 0 - 28
Primary immunogenicity outcome (required for dose selection)
8 secondary outcomes
Number of Participants With Solicited Local and Systemic Reactogenicity Signs and Symptoms
Time frame: Days 0 - 14
Number of Participants With Unsolicited Adverse Events
Time frame: Days 0 - 28
Number of Participants With a Serious Adverse Event (SAE)
Time frame: Days 0 - 365
Magnitude (Copies/ml) of VSVΔG-ZEBOV Viremia
Time frame: Days 1, 3 and 7
Persistence of Titers of ZEBOV-specific IgG Antibodies
Time frame: Day 168
Titers of Neutralizing ZEBOV-specific IgG Antibodies
Time frame: Days 0, 28 and 168
Duration of VSVΔG-ZEBOV Viremia
Time frame: Days 1, 3 and 7
Number of Participants in Whom Shedding of VSVΔG-ZEBOV Was Detected in Urine and/or Saliva.
Time frame: Days 1, 3 and 7
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 May 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 25830326Agnandji ST, Huttner A, Zinser ME, Njuguna P, Dahlke C, Fernandes JF, Yerly S, Dayer JA, Kraehling V, Kasonta R, Adegnika AA, Altfeld M, Auderset F, Bache EB, Biedenkopf N, Borregaard S, Brosnahan JS, Burrow R, Combescure C, Desmeules J, Eickmann M, Fehling SK, Finckh A, Goncalves AR, Grobusch MP, Hooper J, Jambrecina A, Kabwende AL, Kaya G, Kimani D, Lell B, Lemaitre B, Lohse AW, Massinga-Loembe M, Matthey A, Mordmuller B, Nolting A, Ogwang C, Ramharter M, Schmidt-Chanasit J, Schmiedel S, Silvera P, Stahl FR, Staines HM, Strecker T, Stubbe HC, Tsofa B, Zaki S, Fast P, Moorthy V, Kaiser L, Krishna S, Becker S, Kieny MP, Bejon P, Kremsner PG, Addo MM, Siegrist CA. Phase 1 Trials of rVSV Ebola Vaccine in Africa and Europe. N Engl J Med. 2016 Apr 28;374(17):1647-60. doi: 10.1056/NEJMoa1502924. Epub 2015 Apr 1.
- Results publication: PubMed 26248510Huttner A, Dayer JA, Yerly S, Combescure C, Auderset F, Desmeules J, Eickmann M, Finckh A, Goncalves AR, Hooper JW, Kaya G, Krahling V, Kwilas S, Lemaitre B, Matthey A, Silvera P, Becker S, Fast PE, Moorthy V, Kieny MP, Kaiser L, Siegrist CA; VSV-Ebola Consortium. The effect of dose on the safety and immunogenicity of the VSV Ebola candidate vaccine: a randomised double-blind, placebo-controlled phase 1/2 trial. Lancet Infect Dis. 2015 Oct;15(10):1156-1166. doi: 10.1016/S1473-3099(15)00154-1. Epub 2015 Aug 4.
- Derived from this study: PubMed 29627147Huttner A, Agnandji ST, Combescure C, Fernandes JF, Bache EB, Kabwende L, Ndungu FM, Brosnahan J, Monath TP, Lemaitre B, Grillet S, Botto M, Engler O, Portmann J, Siegrist D, Bejon P, Silvera P, Kremsner P, Siegrist CA; VEBCON; VSV-EBOVAC; VSV-EBOPLUS Consortia. Determinants of antibody persistence across doses and continents after single-dose rVSV-ZEBOV vaccination for Ebola virus disease: an observational cohort study. Lancet Infect Dis. 2018 Jul;18(7):738-748. doi: 10.1016/S1473-3099(18)30165-8. Epub 2018 Apr 5.
- 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 26659569Medaglini D, Harandi AM, Ottenhoff TH, Siegrist CA; VSV-Ebovac Consortium. Ebola vaccine R&D: Filling the knowledge gaps. Sci Transl Med. 2015 Dec 9;7(317):317ps24. doi: 10.1126/scitranslmed.aad3106.
- Study websiteLink provided by the sponsor.
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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.
Claire-Anne Siegrist, MD principal investigator
University Hospita, Geneva
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing VSV-ZEBOV in people with Ebolavirus Disease, run by University Hospital, Geneva at 1 site in Switzerland.
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 7 inclusion and 21 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 10 May 2023. 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 Switzerland. 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 combined 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.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 10 May 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Titers of ZEBOV-specific IgG Antibodies (time frame: Day 0 - 28). 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 NCT02287480, which also lists 5 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 10 May 2023.