CompletedNCT02287480VSV-ZEBOVUpdated May 10, 2023Results posted

VSV-ZEBOV Geneva Vaccine Trial

A Phase 1/2 interventional study of VSV-ZEBOV in Ebolavirus Disease, sponsored by University Hospital, Geneva. Completed at 1 site in Switzerland. Open to participants aged 18 Years to 65 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2023-05-10.

Sponsored by University Hospital, Geneva · Phase 1/2, Interventional, and Prevention

Phase: Phase 1/2
Study type: Interventional
Enrollment: 115
Allocation: Randomized
Ages: 18 Years to 65 Years
Sex: All

Study 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.

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 studied

Ebolavirus Disease

Keywords

Ebolavirus Vaccines

In context

Lead sponsor

University Hospital, Geneva is the lead sponsor of 372 studies on the registry; 68 are open to participants now.

Counted across the registry records on this site, refreshed daily.

Who can participate

Ages eligible: 18 Years to 65 Years
Sexes eligible: All
Accepts healthy volunteers: Yes

Inclusion criteria

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)

Exclusion criteria

Exclusion Criteria:

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
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

Study design

Phase: Phase 1 / Phase 2
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel assignment
Masking: Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment: 115 participants (actual)

Study arms

Experimental
VSV-ZEBOV lower dose
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
Biological: VSV-ZEBOV
Experimental
VSV-ZEBOV higher dose
One intramuscular (deltoid) injection of a higher dose (5 x 10\^7 pfu) of VSV-ZEBOV. Study amendment (01.2015) : interrupted
Biological: VSV-ZEBOV
Placebo comparator
Placebo
One intramuscular (deltoid) injection of normal saline (0.5 ml)
Biological: VSV-ZEBOV

Interventions

BiologicalVSV-ZEBOV
See arm/group descriptions.
Also known as: BPSC1001

What researchers measure

Primary outcomes

Titers of ZEBOV-specific IgG Antibodies
Primary immunogenicity outcome (required for dose selection)
Time frame: Day 0 - 28

Secondary outcomes

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.
Time frame: Days 0 - 14
Number of Participants With Unsolicited Adverse Events
Number of participants with unsolicited adverse events in the 28 days following injection
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: Day 168
Titers of Neutralizing ZEBOV-specific IgG Antibodies
Geometric mean titers of neutralizing ZEBOV-specific IgG antibodies.
Time frame: Days 0, 28 and 168
Duration of VSVΔG-ZEBOV Viremia
Percentage of participants with any detectable viremia on days 1, 3 and 7
Time frame: 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.
Time frame: Days 1, 3 and 7

Results

Posted May 10, 2023

Participant flow

Participant flow — Overall Study
Milestone	VSV-ZEBOV High Dose	VSV-ZEBOV Highest Dose	Placebo	VSV-ZEBOV Lowest Dose
Started	35	16	13	51
Completed	35	16	13	51
Not completed	0	0	0	0

Outcome measures

PrimaryTiters of ZEBOV-specific IgG Antibodies

Primary immunogenicity outcome (required for dose selection)

Time frame:: Day 0 - 28
Reported as:: Geometric mean · ELISA units per ml

Titers of ZEBOV-specific IgG Antibodies
ELISA units per ml	VSV-ZEBOV 5x 10^7 OR 10^7 Pfu/ml Dose	Placebo	VSV-ZEBOV 3x 10^5 Pfu/ml Dose
Titers of ZEBOV-specific IgG Antibodies	1227 (917.3 to 1641.2)	25 (25.0 to 25.0)	344.5 (229.7 to 516.4)

SecondaryNumber 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.

Time frame:: Days 0 - 14
Reported as:: Number · participants

Number of Participants With Solicited Local and Systemic Reactogenicity Signs and Symptoms
participants	VSV-ZEBOV 5x 10^7 Pfu/ml OR 10^7 Pfu/ml	Placebo	Lower Dose (3x10^5 Pfu)
Erythema	1	0	0
Swelling/induration	2	0	1
Pain at injection site	23	3	9
Objective fever	10	0	1
Subjective fever	20	2	7
Chills	19	2	14
Myalgia	22	3	14
Headache	19	4	12
Fatigue	20	4	24
Arthralgia	6	1	5

SecondaryNumber of Participants With Unsolicited Adverse Events

Number of participants with unsolicited adverse events in the 28 days following injection

Time frame:: Days 0 - 28
Reported as:: Count of participants · Participants

Number of Participants With Unsolicited Adverse Events
Participants	VSV-ZEBOV 5x 10^7 Pfu/ml OR 10^7 Pfu/ml	Placebo	Lower Dose (3x10^5 Pfu)
Number of Participants With Unsolicited Adverse Events	11	0	13

SecondaryNumber 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.

Time frame:: Days 0 - 365
Reported as:: Number · number of participants

Number of Participants With a Serious Adverse Event (SAE)
number of participants	VSV-ZEBOV 5x 10^7 Pfu/ml OR 10^7 Pfu/ml	Placebo	Lower Dose (3x10^5 Pfu)
Number of Participants With a Serious Adverse Event (SAE)	1	0	1

SecondaryMagnitude (Copies/ml) of VSVΔG-ZEBOV Viremia

Magnitude (copies/ml) of VSVΔG-ZEBOV viremia as expressed by median VSV RNA concentrations after vaccination.

Time frame:: Days 1, 3 and 7
Reported as:: Median · VSV RNA copies/ml

Magnitude (Copies/ml) of VSVΔG-ZEBOV Viremia
VSV RNA copies/ml	VSV-ZEBOV 5x 10^7 Pfu/ml OR 10^7 Pfu/ml	Lower Dose (3x10^5 Pfu)
VSV viremia, day 1	323 (65 to 912)	15 (15 to 15)
VSV viremia, day 3 (±1)	178 (65 to 676)	15 (15 to 15)
VSV viremia, day 7 (±1)	15 (15 to 15)	15 (15 to 15)

SecondaryPersistence of Titers of ZEBOV-specific IgG Antibodies

The percentage of participants maintaining positive ZEBOV-specific IgG antibody titers at 168 days after vaccination.

Time frame:: Day 168
Reported as:: Count of participants · Participants

Persistence of Titers of ZEBOV-specific IgG Antibodies
Participants	VSV-ZEBOV 5x 10^7 Pfu/ml OR 10^7 Pfu/ml	Placebo	Lower Dose (3x10^5 Pfu)
Persistence of Titers of ZEBOV-specific IgG Antibodies	51	0	49

SecondaryTiters of Neutralizing ZEBOV-specific IgG Antibodies

Geometric mean titers of neutralizing ZEBOV-specific IgG antibodies.

Time frame:: Days 0, 28 and 168
Reported as:: Geometric mean · Geometric mean titer

Titers of Neutralizing ZEBOV-specific IgG Antibodies
Geometric mean titer	VSV-ZEBOV 10^7 Pfu Dose	VSV-ZEBOV 5x10'^7 Dose	Placebo	VSV-ZEBOV 3x10^5 Pfu Dose
GMT, day 0	4.24 (3.91 to 4.57)	4.00 (4.00 to 4.00)	4.00 (4.00 to 4.00)	4.22 (4.03 to 4.41)
GMT, day 28	13.24 (8.84 to 17.64)	16.02 (10.23 to 21.81)	4.11 (3.95 to 4.26)	14.79 (11.55 to 18.02)
GMT, day 168	7.23 (5.72 to 8.74)	5.86 (4.49 to 7.23)	4.54 (4.08 to 4.99)	6.12 (5.39 to 6.85)

SecondaryDuration of VSVΔG-ZEBOV Viremia

Percentage of participants with any detectable viremia on days 1, 3 and 7

Time frame:: Days 1, 3 and 7
Reported as:: Count of participants · Participants

Duration of VSVΔG-ZEBOV Viremia
Participants	VSV-ZEBOV 5x 10^7 Pfu/ml OR 10^7 Pfu/ml	Lower Dose (3x10^5 Pfu)
day 1	42	6
day 3	39	8
day 7	1	1

SecondaryNumber of Participants in Whom Shedding of VSVΔG-ZEBOV Was Detected in Urine and/or Saliva.

This outcome was evaluated in a subset of vaccinees.

Time frame:: Days 1, 3 and 7
Reported as:: Count of participants · Participants

Number of Participants in Whom Shedding of VSVΔG-ZEBOV Was Detected in Urine and/or Saliva.
Participants	VSV-ZEBOV 5x 10^7 Pfu/ml OR 10^7 Pfu/ml	Placebo	Lower Dose (3x10^5 Pfu)
Number of Participants in Whom Shedding of VSVΔG-ZEBOV Was Detected in Urine and/or Saliva.	0	0	0

Adverse events

Collected over Non-serious adverse events were collected in the first 28 days. (Serious adverse events were collected throughout the entire study period, an average of 1 year.). Non-serious events are listed at a 0% frequency threshold.

Adverse event summary by group
Group	Deaths	Serious	Other
VSV-ZEBOV 10^7 Pfu Dose	—	1/35 (2.9%)	8/35 (22.9%)
VSV-ZEBOV 5x10'^7 Dose	—	0/16 (0%)	3/16 (18.8%)
Placebo	—	0/13 (0%)	0/13 (0%)
VSV-ZEBOV 3x10^5 Pfu Dose	—	1/51 (2%)	13/51 (25.5%)

Most frequent serious events

Most frequent serious events
Event	VSV-ZEBOV 10^7 Pfu Dose	VSV-ZEBOV 5x10'^7 Dose	Placebo	VSV-ZEBOV 3x10^5 Pfu Dose
Hospitalization for left ulnar fracture after a fallMusculoskeletal and connective tissue disorders	1/35	0/16	0/13	0/51
Hospitalization for rupture of the right quadriceps tendon after a fallMusculoskeletal and connective tissue disorders	0/35	0/16	0/13	1/51

Most frequent other events

Most frequent other events
Event	VSV-ZEBOV 10^7 Pfu Dose	VSV-ZEBOV 5x10'^7 Dose	Placebo	VSV-ZEBOV 3x10^5 Pfu Dose
arthritisMusculoskeletal and connective tissue disorders	8/35	3/16	0/13	13/51

Baseline characteristics

Age, Continuous
Age, Continuous(years)	VSV-ZEBOV High Dose	VSV-ZEBOV Highest Dose	Placebo	VSV-ZEBOV Lowest Dose	Total
Median	44 (34 to 51)	39 (30 to 54)	39 (30 to 51)	40 (29 to 49)	41 (31 to 51)

Sex: Female, Male
Sex: Female, Male(Participants)	VSV-ZEBOV High Dose	VSV-ZEBOV Highest Dose	Placebo	VSV-ZEBOV Lowest Dose	Total
Female	15	4	7	27	53
Male	20	12	6	24	62

Region of Enrollment
Region of Enrollment(participants)	VSV-ZEBOV High Dose	VSV-ZEBOV Highest Dose	Placebo	VSV-ZEBOV Lowest Dose	Total
Switzerland	35	16	13	51	115

Study locations

1 site

University Hospitals of Geneva
Geneva, 1211, Switzerland

References and documents

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 25830326 ↗
Huttner 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 26248510 ↗
Huttner 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 29627147 ↗
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 28647166 ↗
Medaglini 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 ↗

Updates

Tracking since Sep 25, 2026

No changes since tracking began. The registry record was last updated on May 10, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT02287480
Lead sponsor: University Hospital, Geneva
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: Siegrist Claire-Anne (Director of Center for Vaccinology, University Hospital, Geneva) — Principal investigator
First posted: Nov 10, 2014
Start date: Nov 2014
Primary completion: Apr 2015
Completion: Jan 2016
Results posted: May 10, 2023
Last update: May 10, 2023

Study contacts

Claire-Anne Siegrist, MD

principal investigator · University Hospita, Geneva

Oversight

Data monitoring committee: Yes

View the source record on ClinicalTrials.gov ↗

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