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Phase 1 N=39 Randomized Triple-blind Prevention

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

Ebola Virus

Enrolled (actual)
39
Serious AEs
0.0%
Results posted
Oct 2019
Primary outcome: Primary: Number of Participants With One or More Solicited Local Treatment-Emergent Adverse Events (TEAE) — 8; 8; 10; 3 Participants

Study Design & Population

Study type
Interventional
Phase
Phase 1
Interventions
V920 (Biological); Placebo (Other)
Age
Adult · 18+ yrs
Sex
All
Sponsor
Merck Sharp & Dohme LLC
Primary completion
Aug 2015

Outcome Measures

OutcomeResultp-value
PRIMARY
Number of Participants With One or More Solicited Local Treatment-Emergent Adverse Events (TEAE)
8; 8; 10; 3
PRIMARY
Number of Participants With One or More Solicited Local Treatment-Emergent Adverse Events (TEAE) by Severity
6; 7; 9; 3; 2; 1
PRIMARY
Number of Participants With One or More Solicited Systemic Treatment-Emergent Adverse Events (TEAE)
9; 7; 9; 6
PRIMARY
Number of Participants With One or More Solicited Systemic Treatment-Emergent Adverse Events (TEAE) by Severity
3; 2; 2; 5; 3; 3
PRIMARY
Number of Participants With One or More Unsolicited Treatment-Emergent Adverse Events (TEAE)
10; 9; 9; 8
PRIMARY
Number of Participants With One or More Vaccination-Related Unsolicited Treatment-Emergent Adverse Events (TEAE)
8; 8; 7; 6
PRIMARY
Number of Participants With One or More Vaccination-Related Unsolicited Treatment-Emergent Adverse Events (TEAE) by Severity
1; 2; 2; 5; 3; 3
PRIMARY
Number of Participants With Early Study Discontinuation Due to an Adverse Event
0; 0; 0; 0
PRIMARY
Number of Participants With One or More Serious Adverse Event
0; 0; 0; 0
SECONDARY
Geometric Mean Titers of ZEBOV Envelope Glycoprotein-specific Binding Antibodies
29.42; 29.42; 33.85; 35.09; 29.42; 29.42 <0.001 sig
SECONDARY
Geometric Mean Titers of ZEBOV-specific Neutralizing Antibodies
10.0; 10.0; 10.0; 10.0; 10.0; 10.0 <0.001 sig
SECONDARY
Number of Participants With Vaccine Viremia
10; 10; 10; 0; 10; 10
SECONDARY
Number of Participants With Vaccine Shedding/Excretion in Saliva or Urine
0; 0; 1; 0; 1; 0
SECONDARY
Mean Copy Number of Vector RNA (Vector Viremia)

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. This vaccine will be studied at different doses.

Eligibility 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 s
View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT02269423). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.

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