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A Study to Assess Safety Tolerability and Immunogenicity of Three Prime-boost Regimens of the Candidate Prophylactic Vaccines for Ebola in Healthy Adults

This study is currently recruiting participants. (see Contacts and Locations)
Verified May 2017 by Janssen Vaccines & Prevention B.V.
Sponsor:
Information provided by (Responsible Party):
Janssen Vaccines & Prevention B.V.
ClinicalTrials.gov Identifier:
NCT02416453
First received: April 10, 2015
Last updated: May 19, 2017
Last verified: May 2017
  Purpose
The purpose of this study is to evaluate the safety and tolerability of 3 vaccination schedules of Ad26.ZEBOV and MVA-BN-Filo administered intramuscularly (IM) as heterologous prime-boost regimens.

Condition Intervention Phase
Healthy
Biological: MVA-BN-Filo
Biological: Ad26.ZEBOV
Biological: Placebo
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Participant, Investigator, Outcomes Assessor
Primary Purpose: Treatment
Official Title: A Randomized, Observer-Blind, Placebo-Controlled, Phase 2 Study to Evaluate the Safety, Tolerability and Immunogenicity of Three Prime-Boost Regimens of the Candidate Prophylactic Vaccines for Ebola Ad26.ZEBOV and MVA-BN-Filo in Healthy Adults in Europe

Resource links provided by NLM:


Further study details as provided by Janssen Vaccines & Prevention B.V.:

Primary Outcome Measures:
  • Number of Participants With Adverse Events [ Time Frame: Up to 42-day post-boost visit (Day 71 for Group 1; Day 99 for Group 2; or Day 127 for Group 3) ]
  • Number of Participants With Serious Adverse Events [ Time Frame: Up to the end of study (day 365) ]
  • Number of Participants with Reactogenicity (that is, Solicited Local and Systemic Adverse Events) [ Time Frame: Up to 1 week after each study vaccine administration ]

Secondary Outcome Measures:
  • Immune Responses to the Study Vaccine Regimens Measured by an Enzyme-linked Immunosorbent Assay (ELISA) [ Time Frame: At 21-days post boost (Day 50 for Group 1; Day 78 for Group 2; or Day 106 for Group 3) ]

Estimated Enrollment: 408
Actual Study Start Date: June 15, 2015
Estimated Study Completion Date: September 4, 2017
Estimated Primary Completion Date: September 4, 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Group 1
Participants will receive intramuscular (IM) injection of Ad26.ZEBOV/Placebo on Day 1 followed by IM injection of MVA-BN-Filo/Placebo on Day 29.
Biological: MVA-BN-Filo
One 0.5 mL intramuscular (IM) injection of 1E8 Infectious Unit [Inf. U.] on Day 29, 57, or 85.
Biological: Ad26.ZEBOV
One 0.5 mL IM injection of 5E10 viral particles (vp) on Day 1.
Biological: Placebo
One 0.5 mL IM injection of 0.9% saline on Day 1 and Day 29, 57, or 85.
Experimental: Group 2
Participants will receive IM injection of Ad26.ZEBOV/Placebo on Day 1 followed by IM injection of MVA-BN-Filo/Placebo on Day 57.
Biological: MVA-BN-Filo
One 0.5 mL intramuscular (IM) injection of 1E8 Infectious Unit [Inf. U.] on Day 29, 57, or 85.
Biological: Ad26.ZEBOV
One 0.5 mL IM injection of 5E10 viral particles (vp) on Day 1.
Biological: Placebo
One 0.5 mL IM injection of 0.9% saline on Day 1 and Day 29, 57, or 85.
Experimental: Group 3
Participants will receive IM injection of Ad26.ZEBOV/Placebo on Day 1 followed by IM injection of MVA-BN-Filo/Placebo on Day 85.
Biological: MVA-BN-Filo
One 0.5 mL intramuscular (IM) injection of 1E8 Infectious Unit [Inf. U.] on Day 29, 57, or 85.
Biological: Ad26.ZEBOV
One 0.5 mL IM injection of 5E10 viral particles (vp) on Day 1.
Biological: Placebo
One 0.5 mL IM injection of 0.9% saline on Day 1 and Day 29, 57, or 85.

Detailed Description:
This is a randomized, observer-blind, placebo-controlled, parallel-group, multicenter, Phase 2 study evaluating the safety, tolerability and immunogenicity of 3 heterologous prime-boost regimens using Ad26.ZEBOV and MVA-BN-Filo administered to healthy adults participants in Europe. The study consists of a screening period of up to 12 weeks, a vaccination period in which participants will be vaccinated at baseline (Day 1), followed by a boost vaccination on Days 29, 57 or 85, and a post-vaccination phase until 6 month post-boost visit (Days 209, 237 or 265). After unblinding, only participants who received Ad26.ZEBOV and/or MVA-BN-Filo will continue the study until the Day 365 (or until the start of the roll-over study or for an additional 12 months [whichever comes first] for participants in France who agree to continue the long-term follow-up after Day 365) visit to assess long-term safety and immunogenicity. Participants will enroll into 3 cohorts: that is, Cohort 1(Participants will receive Ad26.ZEBOV and MVA-BN-Filo in an open-label fashion), Cohort 2 (Participants will be randomized to receive the prime-boost vaccination with either Ad26.ZEBOV followed by MVA-BN-Filo, or placebo in a 14:1 ratio) and Cohort 3 (Participants will be randomized to receive the prime-boost vaccination with either Ad26.ZEBOV followed by MVA-BN-Filo, or placebo in a 10:3 ratio). In Cohorts 2 and 3, core immunogenicity assessments (humoral and cellular assays) will be performed. In Cohort 2, additional immunogenicity assessments will be done. In Cohort 1, plasma blast response kinetics will be evaluated. Safety will be monitored during the study.
  Eligibility

Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Must be healthy in the Investigator's clinical judgment on the basis of medical history, physical examination, electrocardiogram (ECG) and vital signs performed at Screening
  • Must be healthy on the basis of clinical laboratory tests performed at Screening. If the results of the laboratory screening tests are outside the normal reference ranges, the participant may be included only if the Investigator judges the abnormalities or deviations from normal to be not clinically significant or to be appropriate and reasonable for the population under study
  • 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 lesser than or equal to [<=] 45 years of 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

Exclusion Criteria:

  • Having received any 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 C on Day 1
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02416453

Contacts
Contact: Use link at the bottom of the page to see if you qualify for an enrolling site (see list). If you still have questions: JNJ.CT@sylogent.com

Locations
France
CHU de Clermont-Ferrand Withdrawn
Clermont-Ferrand, France, 63000
APHP - Hôpital Henri Mondor Active, not recruiting
Creteil, France, 94000
Hopital Du Bocage Withdrawn
Dijon, France, 21000
CHRU Lille Withdrawn
Lille, France, 59037
CHU de Limoges, Hôpital Dupuytren Withdrawn
Limoges, France, 87042 cedex
Hôpital de la Timone Recruiting
Marseille, France, 13385
CHU de Montpellier, Hôpital Saint-Eloi Withdrawn
Montpellier, France, 34295 cedex 05
Hopital Cochin Recruiting
Paris, France, 75014
APHP - Hôpital Bichat - Claude Bernard Withdrawn
Paris, France, 75018
CHU Lyon Sud Active, not recruiting
Pierre Benite, France, 69495
Chu Rennes - Hôpital Pontchaillou Active, not recruiting
Rennes, France, 35000
Centre hospitalier universitaire de St Etienne Active, not recruiting
Saint Etienne, France, 42100
Hopitaux universitaires de Strasbourg Active, not recruiting
Strasbourg, France, 67091
Centre Hospitalier Universitaire de Tours Active, not recruiting
Tours, France, 37000
United Kingdom
Hammersmith Medicines Research Ltd Active, not recruiting
London, United Kingdom, NW10 7EW
Oxford Vaccine Group Active, not recruiting
Oxford, United Kingdom, OX3 7LE
University Hospital Southampton NHS Foundation Trust Completed
Southampton, United Kingdom, SO166YD
Sponsors and Collaborators
Janssen Vaccines & Prevention B.V.
Investigators
Study Director: Janssen Vaccines & Prevention B.V. Clinical Trial Janssen Vaccines & Prevention B.V.
Study Director: Inserm Clinical Trials Institut National de la Santé Et de la Recherche Médicale, France
  More Information

Additional Information:
Responsible Party: Janssen Vaccines & Prevention B.V.
ClinicalTrials.gov Identifier: NCT02416453     History of Changes
Other Study ID Numbers: CR107227
VAC52150EBL2001 ( Other Identifier: Janssen Vaccines & Prevention B.V. )
2015-000596-27 ( EudraCT Number )
Study First Received: April 10, 2015
Last Updated: May 19, 2017

Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Janssen Vaccines & Prevention B.V.:
Healthy
Ebola viruses
Ebola Viral Disease (EVD)
Filoviruses
Monovalent vaccine
Human adenovirus serotype 26 (Ad26) expressing the Ebola virus Mayinga variant glycoprotein (Ad26.ZEBOV)
Modified Vaccinia Virus Ankara - Bavarian Nordic Filo-vector (MVA-BN Filo)
Safety
Immunogenicity

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

ClinicalTrials.gov processed this record on May 25, 2017