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A Study to Evaluate the Immunogenicity, Safety and Tolerability of Ad26.ZEBOV and MVA‐BN‐Filo in Healthy Adult Participants

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: NCT02543268
Recruitment Status : Completed
First Posted : September 7, 2015
Last Update Posted : November 17, 2016
Sponsor:
Information provided by (Responsible Party):
Crucell Holland BV

Tracking Information
First Submitted Date  ICMJE September 4, 2015
First Posted Date  ICMJE September 7, 2015
Last Update Posted Date November 17, 2016
Study Start Date  ICMJE September 2015
Actual Primary Completion Date January 2016   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: December 23, 2015)
Immune Responses to the Study Vaccine Regimens against Ebola virus (EBOV) Glycoprotein (GP) using EBOV GP protein enzyme‐linked immunosorbent assay (ELISA) [ Time Frame: At 56 days post prime vaccination ]
The humoral immune response will be assessed by enzyme‐linked immunosorbent assay (ELISA) binding antibody
Original Primary Outcome Measures  ICMJE
 (submitted: September 4, 2015)
Immune Responses to the Study Vaccine Regimens against Ebola virus (EBOV) Glycoprotein (GP) using EBOV GP protein enzyme‐linked immunosorbent assay (ELISA) [ Time Frame: At 21 days post boost vaccination ]
The humoral immune response will be assessed by enzyme‐linked immunosorbent assay (ELISA) binding antibody
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: December 23, 2015)
  • Immune Responses to the Study Vaccine Regimens against Ebola virus (EBOV) Glycoprotein (GP) using EBOV GP protein enzyme‐linked immunosorbent assay (ELISA) [ Time Frame: At Days 1, 29 post prime dose and at days 21, 42, and 180 post boost vaccination ]
    The humoral immune response will be assessed by enzyme‐linked immunosorbent assay (ELISA) binding antibody
  • Number of Participants with Solicited Local and Systemic Adverse Events (AEs) [ Time Frame: Up to 7 days after each vaccination ]
  • Number of Participants with Adverse Events (AEs) [ Time Frame: Up to 42 days post boost vaccination ]
  • Number of Participants with Serious Adverse Events (SAEs) [ Time Frame: Continuous throughout the duration of study (Up to 180 Days post boost vaccination) ]
Original Secondary Outcome Measures  ICMJE
 (submitted: September 4, 2015)
  • Immune Responses to the Study Vaccine Regimens against Ebola virus (EBOV) Glycoprotein (GP) using EBOV GP protein enzyme‐linked immunosorbent assay (ELISA) [ Time Frame: At Days 1, 29, 57 post prime dose and at days 21, 42, and 180 post boost vaccination ]
    The humoral immune response will be assessed by enzyme‐linked immunosorbent assay (ELISA) binding antibody
  • Number of Participants with Solicited Local and Systemic Adverse Events (AEs) [ Time Frame: Up to 7 days after each vaccination ]
  • Number of Participants with Adverse Events (AEs) [ Time Frame: Up to 42 days post boost vaccination ]
  • Number of Participants with Serious Adverse Events (SAEs) [ Time Frame: Continuous throughout the duration of study (Up to 180 Days post boost vaccination) ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Study to Evaluate the Immunogenicity, Safety and Tolerability of Ad26.ZEBOV and MVA‐BN‐Filo in Healthy Adult Participants
Official Title  ICMJE A Phase 3, Randomized, Double‐Blind, Placebo‐Controlled Study to Evaluate the Immunogenicity, Safety and Tolerability of a Heterologous Prime‐Boost Regimen Using Three Different Batches of Ad26.ZEBOV and a Single Batch of MVA‐BN®‐Filo in Healthy Adult Subjects
Brief Summary The purpose of this study is to compare the humoral immune response induced by 3 different batches of Ad26.ZEBOV as measured by enzyme - linked immunosorbent assay (ELISA) against the Ebola virus (EBOV) GP (Glycoprotein) at 56 days post prime.
Detailed Description This is a randomized, double - blind, placebo - controlled, parallel - group, multicenter, Phase 3 study to evaluate the immunogenic equivalence of a heterologous prime - boost regimen using 3 different batches of Ad26.ZEBOV in healthy adult participants. The study consists of a screening period of up to 6 weeks, a vaccination period in which participants will be vaccinated at baseline (Day 1), followed by a boost vaccination on Day 57, and a post-vaccination phase until 6 months post‐boost visit (Day 237). The participants will be randomized at baseline (on Day 1) in a 2:2:2:1 ratio to Groups 1, 2, 3 and 4. Safety will be monitored throughout the study.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Prevention
Condition  ICMJE Healthy
Intervention  ICMJE
  • Biological: Ad26.ZEBOV‐Batch #1
    Ad26.ZEBOV ‐ Batch #1, live, replication incompetent vaccine, sterile suspension of 0.5 milliliter (mL) intramuscular (IM) injection of 5*10^10 viral particles on Day 1
  • Biological: Ad26.ZEBOV‐Batch #2
    Ad26.ZEBOV ‐ Batch #2, live, replication incompetent vaccine, sterile suspension of 0.5 milliliter (mL) intramuscular (IM) injection of 5*10^10 viral particles on Day 1
  • Biological: Ad26.ZEBOV‐Batch #3
    Ad26.ZEBOV ‐ Batch #3, live, replication incompetent vaccine, sterile suspension of 0.5 milliliter (mL) intramuscular (IM) injection of 5*10^10 viral particles on Day 1
  • Biological: MVA‐BN‐Filo
    MVA‐BN‐Filo‐ live replication incompetent vaccine, 0.5 mL IM injection of 1*10^8 Infectious Unit [Inf. U.] once on Day 57.
  • Biological: Placebo
    One 0.5 ml IM injection of 0.9% saline once on Day 1 and Day 57.
Study Arms  ICMJE
  • Experimental: Group 1
    Ad26.ZEBOV -Batch #1, single dose intramuscular (IM) injection on Day 1; MVA-BN‐Filo, single dose IM injection on Day 57
    Interventions:
    • Biological: Ad26.ZEBOV‐Batch #1
    • Biological: MVA‐BN‐Filo
  • Experimental: Group 2
    Ad26.ZEBOV -Batch #2, single dose intramuscular (IM) injection on Day 1; MVA-BN‐Filo, single dose IM injection on Day 57
    Interventions:
    • Biological: Ad26.ZEBOV‐Batch #2
    • Biological: MVA‐BN‐Filo
  • Experimental: Group 3
    Ad26.ZEBOV -Batch #3, single dose intramuscular (IM) injection on Day 1; MVA-BN‐Filo, single dose IM injection on Day 57
    Interventions:
    • Biological: Ad26.ZEBOV‐Batch #3
    • Biological: MVA‐BN‐Filo
  • Experimental: Group 4
    Placebo (0.9% saline)‐ single dose IM injection on Day 1 and Day 57
    Intervention: Biological: Placebo
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: September 4, 2015)
329
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE July 2016
Actual Primary Completion Date January 2016   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Healthy in the Investigator's clinical judgment on the basis of medical history, physical examination, electrocardiogram (ECG) and vital signs performed at Screening
  • Healthy on the basis of clinical laboratory tests performed at Screening
  • Before randomization, a woman must be either of childbearing potential and practicing (or intending to practice) a highly effective method of birth control consistent with local regulations regarding the use of birth control methods for participants participating in clinical studies, beginning at least 28 days prior to vaccination OR not of childbearing potential: postmenopausal (greater than [>] 45 years of age with amenorrhea for at least 2 years or any age with amenorrhea for at least 6 months, and a serum follicle stimulating hormone (FSH) level >40 international unit per milliliter [IU/L]); permanently sterilized (for example, bilateral tubal occlusion [which includes tubal ligation procedures as consistent with local regulations], hysterectomy, bilateral salpingectomy, bilateral oophorectomy); or otherwise be incapable of pregnancy
  • Woman of childbearing potential must have a negative serum [beta‐human chorionic gonadotropin (beta‐hCG)] at Screening and a negative urine beta‐hCG pregnancy test immediately prior to each study vaccine administration
  • Man who is sexually active with a woman of childbearing potential and has not had a vasectomy performed more than 1 year prior to Screening must be willing to use condoms for sexual intercourse beginning prior to enrollment, in addition to the documented birth control method used by the female partner

Exclusion Criteria:

  • Having received a candidate Ebola vaccine
  • Diagnosed with Ebola virus disease, or prior exposure to Ebola virus, including travel to West Africa less than 1 month prior to Screening. West Africa includes but is not limited to the countries of Guinea, Liberia, Mali, and Sierra Leone
  • Having received any experimental candidate adenovirus serotype 26 (vector: Ad26) or Modified Vaccinia Ankara (MVA-) based vaccine in the past
  • Known allergy or history of anaphylaxis or other serious adverse reactions to vaccines or vaccine products (including any of the constituents of the study vaccines) including known allergy to egg, egg products and aminoglycosides
  • Presence of acute illness or temperature greater than or equal to (>=) 38.0 centigrade (°C) on Day 1
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 50 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02543268
Other Study ID Numbers  ICMJE CR107786
VAC52150EBL3003 ( Other Identifier: Crucell Holland BV )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Crucell Holland BV
Study Sponsor  ICMJE Crucell Holland BV
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Crucell Holland BV Clinical Trial Crucell Holland BV
PRS Account Crucell Holland BV
Verification Date November 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP