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

Study Description

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Brief Summary:

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 or disease	Intervention/treatment	Phase
Healthy	Biological: MVA-BN-Filo; Biological: Ad26.ZEBOV; Biological: Placebo	Phase 2

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.

Study Design

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Study Type :	Interventional (Clinical Trial)
Actual Enrollment :	423 participants
Allocation:	Randomized
Intervention Model:	Parallel Assignment
Masking:	Triple (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
Actual Study Start Date :	June 15, 2015
Actual Primary Completion Date :	January 19, 2018
Actual Study Completion Date :	January 19, 2018

Arms and Interventions

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Arm	Intervention/treatment
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.

Outcome Measures

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Primary Outcome Measures :

1. 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) ]
2. Number of Participants With Serious Adverse Events [ Time Frame: Up to the end of study (day 365) ]
3. 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 :

1. 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) ]

Eligibility Criteria

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Ages Eligible for Study:	18 Years to 65 Years (Adult, Older 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

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Locations

France
Creteil, France
Marseille, France
Paris, France
Pierre Benite, France
Rennes, France
Saint Etienne, France
Strasbourg, France
Tours, France
United Kingdom
London, United Kingdom
Oxford, United Kingdom
Southampton, United Kingdom

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

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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 )
First Posted:	April 15, 2015
Last Update Posted:	March 9, 2018
Last Verified:	March 2018

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