ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT02269423
Recruitment Status : Completed
First Posted : October 21, 2014
Last Update Posted : January 18, 2017
Sponsor:
Collaborators:
BioProtection Systems Corporation
United States Department of Defense
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Ebola Virus Biological: BPSC-1001 Vaccine Other: Placebo Phase 1

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 and 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.. BPSC-1001 is an experimental Ebola vaccine candidate demonstrating protection against Ebola virus in animal experiments.

This phase 1 protocol provides a first-in-human study to evaluate the safety and toxicity of BPSC-1001 in healthy adult participants. Participants will be randomized to receive BPSC-1001 or Placebo by intramuscular injection. Three dose levels will be assessed with follow-up visits through 180 days after the injection.


Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 39 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Prevention
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
Study Start Date : October 2014
Actual Primary Completion Date : August 2015
Actual Study Completion Date : August 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Ebola

Arm Intervention/treatment
Experimental: 3x10^6 pfu Vaccine Cohort
Participants will receive a 1-mL intramuscular injection of BPSC-1001 3x10^6 pfu in one deltoid and a 1-mL intramuscular injection of placebo in the contralateral deltoid on Day 0.
Biological: BPSC-1001 Vaccine
Vesicular Stomatitis Virus (VSV)-based vaccine 1-mL injection containing 3x10^6, 2x10^7, or 1x10^8 pfu.

Other: Placebo
Normal saline placebo.

Experimental: 2x10^7 pfu Vaccine Cohort
Participants will receive a 1-mL intramuscular injection of BPSC-1001 2x10^7 pfu in one deltoid and a 1-mL intramuscular injection of placebo in the contralateral deltoid on Day 0.
Biological: BPSC-1001 Vaccine
Vesicular Stomatitis Virus (VSV)-based vaccine 1-mL injection containing 3x10^6, 2x10^7, or 1x10^8 pfu.

Other: Placebo
Normal saline placebo.

Experimental: 1x10^8 pfu Vaccine Cohort
Participants will receive a 1-mL intramuscular injection of BPSC-1001 1x10^8 pfu in one deltoid and a 1-mL intramuscular injection of placebo in the contralateral deltoid on Day 0.
Biological: BPSC-1001 Vaccine
Vesicular Stomatitis Virus (VSV)-based vaccine 1-mL injection containing 3x10^6, 2x10^7, or 1x10^8 pfu.

Other: Placebo
Normal saline placebo.

Placebo Comparator: Placebo Cohort
Participants will receive a 1-mL intramuscular injection of placebo in each deltoid on Day 0.
Other: Placebo
Normal saline placebo.




Primary Outcome Measures :
  1. Percentage of Participants with One or More Injection-site Adverse Event: Pain, Erythema, and Induration [ Time Frame: Up to 14 days postvaccination ]
  2. Percentage of Participants with One or More Injection-site Adverse Event: Pain, Erythema, and Induration by Severity [ Time Frame: Up to 14 days postvaccination ]
  3. Percentage of Participants with One or More Systemic Adverse Event [ Time Frame: Up to 28 days postvaccination ]
  4. Percentage of Participants with One or More Systemic Adverse Event by Severity [ Time Frame: Up to 28 days postvaccination ]
  5. Percentage of Participants with One or More Adverse Event [ Time Frame: Up to 180 days postvaccination ]
  6. Percentage of Participants with One or More Adverse Event by Severity [ Time Frame: Up to 180 days postvaccination ]
  7. Percentage of Participants with One or More Adverse Event by Relationship to Study Vaccination [ Time Frame: Up to 180 days postvaccination ]
  8. Percentage of Participants with Early Study Discontinuation [ Time Frame: Up to 180 days postvaccination ]

Secondary Outcome Measures :
  1. Geometric Mean Titers of ZEBOV Envelope Glycoprotein-Specific Binding Antibodies [ Time Frame: Up to 180 days postvaccination ]
  2. Geometric Mean Titers of ZEBOV-specific Neutralizing Antibodies [ Time Frame: Up to 180 days postvaccination ]
  3. Mean Copy Number of Vector RNA (Vector Viremia) [ Time Frame: Up to 14 days postvaccination ]

Other Outcome Measures:
  1. Geometric Mean Titers of Antibodies Specific to Hemorrhagic Fever Viruses Related to Ebola [ Time Frame: Up to 180 days postvaccination ]
  2. Geometric Mean Titers of ZEBOV Envelope Glycoprotein-Specific Binding Antibodies by Human Leukocyte Antigen Allele Expression Profile [ Time Frame: Up to 180 days postvaccination ]
  3. Cellular Immune Response: B-cell repertoire [ Time Frame: Up to 180 days postvaccination ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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
  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02269423


Sponsors and Collaborators
Merck Sharp & Dohme Corp.
BioProtection Systems Corporation
United States Department of Defense
Investigators
Study Director: Medical Director Merck Sharp & Dohme Corp.

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT02269423     History of Changes
Other Study ID Numbers: V920-001
NLG0307 (WRAIR #2163) ( Other Identifier: NewLink Genetics Corp. )
First Posted: October 21, 2014    Key Record Dates
Last Update Posted: January 18, 2017
Last Verified: January 2017

Additional relevant MeSH terms:
Vaccines
Immunologic Factors
Physiological Effects of Drugs