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Ebola VirusPhase 1NCT02269423

Vaccine Treatment for Ebola Virus in Healthy Adults (V920-001)

A Phase 1 study testing V920 in people with Ebola Virus, run by Merck Sharp & Dohme LLC.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

This is a study of the anti-Ebola vaccine vesicular stomatitis virus (VSV) ZEBOV (Zaire ebolavirus) also known as V920 and BPSC-1001. The purpose of this study is to test how safe the vaccine is in humans and how well it makes the human immune system cause an immune- or defense-response to Ebola virus. Read more about this study

Who is it for?
Ages 18 to 50 yearsHealthy volunteers can take part
Conditions the study is for
Ebola Virus
What is being tested?
V920
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
39 participants
Where
No sites listed yet
Study dates
13 Oct 2014to 25 Aug 2015
Phase
Phase 1
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 50 years
  • All sexes
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • Healthy adult male or non-pregnant, non-lactating female, ages 18 to 50 (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 willing to use effective methods of contraception, from at least 30 days prior to vaccination until study end.
  • Be willing to minimize blood and body fluid exposure of others for 7 days after vaccination
  • Score at least 80% on the Comprehension Assessment test

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, Human Immunodeficiency Virus (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
Show all 29Show fewer
  • History of employment in an industry involved in contact with ruminant animals, veterinary sciences, or other potential exposure to VSV
  • Planned or frequent contact with animals at-risk of VSV infection (e.g. cattle, horses, pigs, mules, etc.)
  • 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 BPSC1001 vaccine product
  • Receipt of investigational product up to 30 days prior to enrollment or ongoing participation in another clinical trial
  • Receipt of licensed vaccines within 30 days of planned study immunization
  • Ongoing participation in another clinical trial
  • 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, electrocardiogram, and/or laboratory screening test. This would include a known hemoglobinopathy or coagulation abnormality.
  • Any baseline laboratory screening tests which is outside of acceptable range as defined in the protocol.: alanine aminotransferase, aspartate aminotransferase, 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 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 >100.4F 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-Escalation Study to Evaluate the Safety and Immunogenicity of the BPSC-1001 (VSVΔG-ZEBOV) Ebola Virus Vaccine Candidate in Healthy Adult Subjects

This is a study of the anti-Ebola vaccine vesicular stomatitis virus (VSV) ZEBOV (Zaire ebolavirus) also known as V920 and BPSC-1001. The purpose of this study is to test how safe the vaccine is in humans and how well it makes the human immune system cause an immune- or defense-response to Ebola virus. This vaccine will be studied at different doses.

Read the detailed description

This study is being conducted to assess whether this vaccine is safe, and if it causes the body to create an infection-fighting response. Between 1994 and the present, there have been many Ebola virus outbreaks caused by 4 different strains of the virus, affecting mostly people living in central Africa and the health care providers trying to treat them. Ebola viruses are members of the filoviridae virus family, which also includes the dangerous Marburg virus. Ebola virus causes severe and often deadly infection called a viral hemorrhagic fever, characterized by organ failure, bleeding, and death.

To date, the virus is found primarily in Central and West Africa. It is not clear where these viruses come from, but it is thought that bats are the most likely source of the human outbreaks that occur. Once an outbreak occurs, the virus is spread from person to person through direct contact with infected blood or body fluids with an infected individual.

Given the recent increase in Ebola virus infections occurring in Africa, there is interest in making an effective vaccine to protect against the infection. V920/BPSC-1001 is an experimental Ebola vaccine candidate demonstrating protection against Ebola virus in animal experiments.

This is a Phase 1 study to evaluate a novel vaccine to Ebola using a live VSV replacing the gene encoding the G envelope glycoprotein with the gene encoding the envelope glycoprotein from the Zaire strain of Ebola (VSVΔG-ZEBOV also known as V920 and BPSC-1001). This phase 1 protocol provides a first-in-human study to evaluate the safety and toxicity of V920/BPSC-1001 in healthy adult participants. Participants will be randomized to receive V920/BPSC-1001 or Placebo by intramuscular injection. Three dose levels will be assessed with follow-up visits through 180 days after the injection.

Conditions
Ebola Virus
Being tested
V920, Placebo

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • V920Biological

    Also called BPSC-1001

    Vesicular Stomatitis Virus (VSV)-based vaccine 1-mL injection containing 3x10^6, 2x10^7, or 1x10^8 pfu.

  • PlaceboOther

    Normal saline placebo.

Study groups in NCT02269423
Study groupRoleWhat they receive
3x10^6 plaque-forming units (pfu) Vaccine CohortExperimentalParticipants will receive a 1-mL intramuscular injection of V920 3x10^6 pfu in one deltoid and a 1-mL intramuscular injection of placebo in the contralateral deltoid on Day 0.
Receives: Biological: V920; Other: Placebo
2x10^7 pfu Vaccine CohortExperimentalParticipants will receive a 1-mL intramuscular injection of V920 2x10^7 pfu in one deltoid and a 1-mL intramuscular injection of placebo in the contralateral deltoid on Day 0.
Receives: Biological: V920; Other: Placebo
1x10^8 pfu Vaccine CohortExperimentalParticipants will receive a 1-mL intramuscular injection of V920 1x10^8 pfu in one deltoid and a 1-mL intramuscular injection of placebo in the contralateral deltoid on Day 0.
Receives: Biological: V920; Other: Placebo
Placebo CohortPlacebo comparatorParticipants will receive a 1-mL intramuscular injection of placebo in each deltoid on Day 0.
Receives: Other: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Number of Participants With One or More Solicited Local Treatment-Emergent Adverse Events (TEAE)

    An adverse event (AE) is defined as any untoward medical occurrence in a participant which does not necessarily have a causal relationship with study vaccine. A treatment-emergent adverse event (TEAE) is defined as an AE that starts or worsens on or after the date and time of the study vaccination. Local reactogenicity signs and symptoms include pain, erythema (redness), and induration (swelling). The number of participants that experienced at least one solicited local TEAE was assessed. Solicited TEAEs occurred from the time of each injection through 14 days following the procedure, facilitated with the use of a memory aid to record participant observations.

    Measured: Up to 14 days postvaccination

  2. Number of Participants With One or More Solicited Local Treatment-Emergent Adverse Events (TEAE) by Severity

    An AE is defined as any untoward medical occurrence in a participant which does not necessarily have a causal relationship with study vaccine. A TEAE is defined as an AE that starts or worsens on or after the date and time of the study vaccination. Local reactogenicity signs and symptoms include pain, erythema (redness), and induration (swelling). AEs were assessed for severity by the investigator according to a toxicity grading scale based on the FDA's Guidance for Industry "Toxicity Grading Scale for Healthy Adult and Adolescent Volunteers Enrolled in Preventive Vaccine Clinical Trials": Grade 1=Mild; Grade 2=Moderate; Grade 3=Severe; Grade 4=Potentially life-threatening. The number of participants that experienced at least one solicited local TEAE was summarized by grade. Solicited TEAEs occurred from the time of each injection through 14 days following the procedure, facilitated with the use of a memory aid to record participant observations.

    Measured: Up to 14 days postvaccination

  3. Number of Participants With One or More Solicited Systemic Treatment-Emergent Adverse Events (TEAE)

    An adverse event (AE) is defined as any untoward medical occurrence in a participant which does not necessarily have a causal relationship with study vaccine. A treatment-emergent adverse event is defined as an AE that starts or worsens on or after the date and time of the study vaccination. Systemic reactogenicity signs and symptoms include pyrexia (subjective and objective fever), chills, hyperhidrosis (sweats), myalgia, arthralgia, fatigue, headache, and gastrointestinal symptoms including nausea, vomiting, abdominal pain, and/or diarrhea. The number of participants that experienced at least one solicited systemic TEAE was assessed. Solicited TEAEs occurred from the time of each injection through 14 days following the procedure, facilitated with the use of a memory aid to record participant observations.

    Measured: Up to 14 days postvaccination

  4. Number of Participants With One or More Solicited Systemic Treatment-Emergent Adverse Events (TEAE) by Severity

    An AE is defined as any untoward medical occurrence in a participant which does not necessarily have a causal relationship with study vaccine. A TEAE is defined as an AE that starts or worsens on or after the date and time of the study vaccination. Systemic reactogenicity signs and symptoms include pyrexia (subjective and objective fever), chills, hyperhidrosis (sweats), myalgia, arthralgia, fatigue, headache, and gastrointestinal symptoms including nausea, vomiting, abdominal pain, and/or diarrhea. AEs were assessed for severity by the investigator as follows: Grade 1=Mild; Grade 2=Moderate; Grade 3=Severe; Grade 4=Potentially life-threatening. The number of participants that experienced at least 1 solicited systemic TEAE was summarized by grade. Solicited TEAEs occurred from the time of each injection through 14 days following the procedure, facilitated with the use of a memory aid to record participant observations.

    Measured: Up to 14 days postvaccination

  5. Number of Participants With One or More Unsolicited Treatment-Emergent Adverse Events (TEAE)

    An adverse event (AE) is defined as any untoward medical occurrence in a participant which does not necessarily have a causal relationship with study vaccine. A treatment-emergent adverse event is defined as an AE that starts or worsens on or after the date and time of the study vaccination. The number of participants that experienced at least one unsolicited TEAE was assessed. Unsolicited AEs occurred from the time of injection through 28 days following injection.

    Measured: Up to 28 days postvaccination

  6. Number of Participants With One or More Vaccination-Related Unsolicited Treatment-Emergent Adverse Events (TEAE)

    An adverse event (AE) is defined as any untoward medical occurrence in a participant which does not necessarily have a causal relationship with study vaccine. A treatment-emergent adverse event is defined as an AE that starts or worsens on or after the date and time of the study vaccination. A related TEAE is defined as a TEAE that was possibly, probably, or definitely related to the vaccination as assessed by the investigator. The number of participants that experienced at least one unsolicited TEAE related to study vaccination was assessed.

    Measured: Up to 28 days postvaccination

  7. Number of Participants With One or More Vaccination-Related Unsolicited Treatment-Emergent Adverse Events (TEAE) by Severity

    An adverse event (AE) is defined as any untoward medical occurrence in a participant which does not necessarily have a causal relationship with study vaccine. A treatment-emergent adverse event is defined as an AE that starts or worsens on or after the date and time of the study vaccination. A related TEAE is defined as a TEAE that was possibly, probably, or definitely related to the vaccination as assessed by the investigator. AEs were assessed for severity by the investigator according to a toxicity grading scale based on the FDA's Guidance for Industry "Toxicity Grading Scale for Healthy Adult and Adolescent Volunteers Enrolled in Preventive Vaccine Clinical Trials": Grade 1=Mild; Grade 2=Moderate; Grade 3=Severe; Grade 4=Potentially life-threatening. The number of participants that experienced at least one unsolicited TEAE related to study vaccination was summarized by grade.

    Measured: Up to 28 days postvaccination

  8. Number of Participants With Early Study Discontinuation Due to an Adverse Event

    An adverse event (AE) is defined as any untoward medical occurrence in a participant which does not necessarily have a causal relationship with study vaccine. The number of participants prematurely withdrawing from the study due to an AE was assessed.

    Measured: Up to 28 days postvaccination

  9. Number of Participants With One or More Serious Adverse Event

    An adverse event is defined as any untoward medical occurrence in a participant which does not necessarily have a causal relationship with study vaccine. A serious adverse event (SAE) is an AE that results in death, is life-threatening, results in a persistent or significant disability or incapacity, results in or prolongs an existing hospitalization, is a congenital anomaly or birth defect, or is another important medical event. The number of participants that experienced one or more SAE was summarized.

    Measured: Up to 180 days postvaccination

Secondary outcomes (5)

  1. Geometric Mean Titers of ZEBOV Envelope Glycoprotein-specific Binding Antibodies

    The Geometric Mean Titers (GMT) of ZEBOV-specific Immunoglobulin G antibodies were measured by unqualified ZEBOV immunoglobulin (IgG) enzyme-linked immunosorbent assay (ELISA). For titers expressed in ELISA Units/mL, the lower level of quantitation (LLOQ) was 58.84. ZEBOV IgG titers at baseline (Day 0) and analysis Days 7, 14, 28, 56, 84, and 180 were summarized by V920 vaccine dose level and placebo as the mean of log10 titers, transformed into GMT. The geometric standard deviation (GSD) for the GMT at each visit was obtained by exponentiating the standard deviation for the mean of log (base 10) transformed titers.

    Measured: Baseline, Days 7, 14, 28, 56, 84 and 180 post-vaccination

  2. Geometric Mean Titers of ZEBOV-specific Neutralizing Antibodies

    The Geometric Mean Titers (GMT) of ZEBOV-specific neutralizing antibodies were measured by pseudovirion neutralization assays (PsVNA). Titers were reported for PsVNA50 values which were derived from the reciprocal of the dilution that resulted in a 50% decrease in luciferase activity. The LLOQ for the PsVNA was 20. If the PsVNA was reported ≤20, the numeric portion of the titer was divided by 2 for statistical purposes, which could result in a reported GMT <20.0. PsVNA50 titers at baseline (Day 0) and analysis Days 7, 14, 28, 56, and 180 were summarized by V920 vaccine dose level and placebo as the mean of log10 titers, transformed into GMT. The geometric standard deviation (GSD) for the GMT at each visit was obtained by exponentiating the standard deviation for the mean of log (base 10) transformed titers.

    Measured: Baseline, Days 7, 14, 28, 56, and 180 post-vaccination

  3. Number of Participants With Vaccine Viremia

    The number of participants with viremia detected by recombinant vesicular stomatitis virus (rVSV) reverse transcription polymerase chain reaction (PCR) of blood specimens was assessed.

    Measured: Days 1, 3, 7, and 14 post-vaccination

  4. Number of Participants With Vaccine Shedding/Excretion in Saliva or Urine

    The number of participants with viremia detected by rVSV reverse transcription PCR of saliva or urine specimens was assessed.

    Measured: Days 1, 3, 7, and 14 post-vaccination

  5. Mean Copy Number of Vector RNA (Vector Viremia)

    Although the protocol specified a secondary endpoint that included the mean copy number of vector RNA (vector viremia), the Polymerase Chain Reaction (PCR) test used for the study reported a qualitative rather than a quantitative outcome, so the proportion of participants with viremia is reported instead of the mean copy number of vector RNA. Qualitative results are therefore reported in Outcome Measures 12 and 13.

    Measured: Up to 14 days postvaccination

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted21 Oct 2014 (estimated)
  2. Study start13 Oct 2014
  3. Primary completion25 Aug 2015
  4. Study completion25 Aug 2015

Resources

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
39 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02269423
Sponsor's protocol ID
V920-001
Other IDs
NLG0307 (WRAIR #2163), V920-001
Status last verified
Oct 2019
First submitted
10 Oct 2014
Last updated
23 Oct 2019
Data monitoring committee
Yes
Individual data sharing
Yes: http://engagezone.msd.com/doc/ProcedureAccessClinicalTrialData.pdf

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 28647166

  • Regules JA, Beigel JH, Paolino KM, Voell J, Castellano AR, Hu Z, Munoz P, Moon JE, Ruck RC, Bennett JW, Twomey PS, Gutierrez RL, Remich SA, Hack HR, Wisniewski ML, Josleyn MD, Kwilas SA, Van Deusen N, Mbaya OT, Zhou Y, Stanley DA, Jing W, Smith KS, Shi M, Ledgerwood JE, Graham BS, Sullivan NJ, Jagodzinski LL, Peel SA, Alimonti JB, Hooper JW, Silvera PM, Martin BK, Monath TP, Ramsey WJ, Link CJ, Lane HC, Michael NL, Davey RT Jr, Thomas SJ; rVSVDeltaG-ZEBOV-GP Study Group. A Recombinant Vesicular Stomatitis Virus Ebola Vaccine. N Engl J Med. 2017 Jan 26;376(4):330-341. doi: 10.1056/NEJMoa1414216. Epub 2015 Apr 1.

    PubMed 25830322

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing V920 in people with Ebola Virus, run by Merck Sharp & Dohme LLC.

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 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 23 Oct 2019. 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?

Yes. Results are posted in the registry (first posted 23 Oct 2019). 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?

Number of Participants With One or More Solicited Local Treatment-Emergent Adverse Events (TEAE) (time frame: Up to 14 days postvaccination). The study lists 9 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 NCT02269423, 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 23 Oct 2019.

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