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 June 2016 by Crucell Holland BV
Sponsor:
Information provided by (Responsible Party):
Crucell Holland BV
ClinicalTrials.gov Identifier:
NCT02416453
First received: April 10, 2015
Last updated: June 23, 2016
Last verified: June 2016
  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 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
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, 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 Crucell Holland BV:

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) ] [ Designated as safety issue: Yes ]
  • Number of Participants With Serious Adverse Events [ Time Frame: Up to the end of study (day 365) ] [ Designated as safety issue: Yes ]
  • Number of Participants with Reactogenicity (that is, Solicited Local and Systemic Adverse Events) [ Time Frame: Up to 1 week after each study vaccine administration ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Immune Responses to the Study Vaccine Regimens as Measured by a Virus Neutralization Assay [ Time Frame: Group 1: Days 1(pre-vaccination), 29 (pre-vaccination), 36, 50, 180 and 365; Group 2: Days 1(pre-vaccination), 57(pre-vaccination), 64, 78, 180 and 365; Group 3: Days 1(pre-vaccination), 15, 85(pre-vaccination), 92, 106, 180, 365 ] [ Designated as safety issue: No ]
  • Immune Responses to the Study Vaccine Regimens Measured by an Enzyme-linked Immunosorbent Assay (ELISA) [ Time Frame: Group 1: Days 1(pre-vaccination), 29 (pre-vaccination), 36, 50, 180 and 365; Group 2: Days 1(pre-vaccination), 57(pre-vaccination), 64, 78, 180 and 365; Group 3: Days 1(pre-vaccination), 15, 85(pre-vaccination), 92, 106, 180, 365 ] [ Designated as safety issue: No ]
  • Immune Responses to the Study Vaccine Regimens as Measured by an Enzyme-linked Immunospot (ELIspot) Assay [ Time Frame: Group 1: Days 1(pre-vaccination), 29 (pre-vaccination), 36, 50, 180 and 365; Group 2: Days 1(pre-vaccination), 57(pre-vaccination), 64, 78, 180 and 365; Group 3: Days 1(pre-vaccination), 15, 85(pre-vaccination), 92, 106, 180, 365 ] [ Designated as safety issue: No ]

Estimated Enrollment: 612
Study Start Date: June 2015
Estimated Study Completion Date: June 2017
Estimated Primary Completion Date: September 2016 (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 the 42 day post-boost visit (Days 71, 99 or 127). The participants who received active vaccine will enter a long-term follow-up phase, with visits on Days 180 and 365 after the prime vaccination to assess long-term safety and immunogenicity. Participants will enroll into 3 cohorts: that is, Cohort 1, Cohort 2 and Cohort 3. 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, plasmablast response kinetics will be evaluated. Safety will be monitored during the study.
  Eligibility

Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Genders Eligible for Study:   Both
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 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

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
Withdrawn
Clermont-Ferrand, France
Recruiting
Creteil, France
Withdrawn
Dijon, France
Withdrawn
Limoges, France
Recruiting
Marseille, France
Recruiting
Paris, France
Recruiting
Pierre Benite, France
Recruiting
Rennes, France
Recruiting
Saint Etienne, France
Recruiting
Strasbourg, France
Recruiting
Tours, France
United Kingdom
Recruiting
London, United Kingdom
Recruiting
Oxford, United Kingdom
Recruiting
Southampton, United Kingdom
Sponsors and Collaborators
Crucell Holland BV
Investigators
Study Director: Crucell Holland BV Clinical Trial Crucell Holland BV
Study Director: Inserm Clinical Trials Institut National de la Santé Et de la Recherche Médicale, France
  More Information

Additional Information:
Responsible Party: Crucell Holland BV
ClinicalTrials.gov Identifier: NCT02416453     History of Changes
Other Study ID Numbers: CR107227  VAC52150EBL2001  2015-000596-27 
Study First Received: April 10, 2015
Last Updated: June 23, 2016
Health Authority: Great Britain: Medicines and Healthcare Products Regulatory Agency
France: Agence Nationale de Sécurité du Médicament et des produits de santé

Keywords provided by Crucell Holland BV:
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 August 23, 2016