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

NCT02269423 | Completed Phase 1 Results DMC

• 2 other identifiers: V920-001NLG0307 (WRAIR #2163)
• Study Type: interventional
• Target: 39
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Ebola Virus

Outcome Measures

Primary Outcomes (9)

• 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.

  Up to 14 days postvaccination

• 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.

  Up to 14 days postvaccination

• 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.

  Up to 14 days postvaccination

• 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.

  Up to 14 days postvaccination

• 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.

  Up to 28 days postvaccination

• 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.

  Up to 28 days postvaccination

• 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.

  Up to 28 days postvaccination

• 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.

  Up to 28 days postvaccination

• 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.

  Up to 180 days postvaccination

Secondary Outcomes (5)

• Geometric Mean Titers of ZEBOV Envelope Glycoprotein-specific Binding Antibodies

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

• Geometric Mean Titers of ZEBOV-specific Neutralizing Antibodies

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

• Number of Participants With Vaccine Viremia

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

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

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

• Mean Copy Number of Vector RNA (Vector Viremia)

  Up to 14 days postvaccination

Study Arms (4)

3x10^6 plaque-forming units (pfu) Vaccine Cohort

EXPERIMENTAL

Participants 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.

Biological: V920; Other: Placebo

2x10^7 pfu Vaccine Cohort

EXPERIMENTAL

Participants 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.

Biological: V920; Other: Placebo

1x10^8 pfu Vaccine Cohort

EXPERIMENTAL

Participants 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.

Biological: V920; Other: Placebo

Placebo Cohort

PLACEBO COMPARATOR

Participants will receive a 1-mL intramuscular injection of placebo in each deltoid on Day 0.

Other: Placebo

Interventions

V920 BIOLOGICAL

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

Also known as: BPSC-1001

1x10^8 pfu Vaccine Cohort; 2x10^7 pfu Vaccine Cohort; 3x10^6 plaque-forming units (pfu) Vaccine Cohort

Placebo OTHER

Normal saline placebo.

1x10^8 pfu Vaccine Cohort; 2x10^7 pfu Vaccine Cohort; 3x10^6 plaque-forming units (pfu) Vaccine Cohort; Placebo Cohort

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Merck Sharp & Dohme LLC: lead
• BioProtection Systems Corporation: collaborator
• United States Department of Defense: collaborator

Related Publications (2)

• 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.

  PMID: 28647166 DERIVED

• 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.

  PMID: 25830322 DERIVED

Results Point of Contact

• Title: Senior Vice President, Global Clinical Development
• Organization: Merck Sharp & Dohme Corp.

ClinicalTrialsDisclosure@merck.com

1-800-672-6372

Study Officials

• Medical Director

  Merck Sharp & Dohme LLC

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 10, 2014
• First Posted: October 21, 2014
• Study Start: October 13, 2014
• Primary Completion: August 25, 2015
• Study Completion: August 25, 2015
• Last Updated: October 23, 2019
• Results First Posted: October 23, 2019

Record last verified: 2019-10

Data Sharing

• IPD Sharing: Will share