- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02376426
A Study to Evaluate the Safety and Immunogenicity of Heterologous Prime-Boost Ebola Vaccine Regimens in Healthy Participants
December 7, 2016 updated by: Crucell Holland BV
A Phase 1 Study to Evaluate the Safety, Tolerability and Immunogenicity of Heterologous Prime-Boost Regimens Using MVA-BN®-Filo and Ad26.ZEBOV Administered in Different Sequences and Schedules in Healthy Adults
The purpose of this study is to test the safety and immunogenicity of MVA-BN-Filo and Ad26.ZEBOV administered as heterologous prime-boost vaccine regimens in healthy adult participants.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
This is a randomized placebo-controlled, double-blind study evaluating the safety, tolerability and immunogenicity of MVA-BN-Filo and Ad26.ZEBOV administered in different sequences and schedules to healthy adult participants.
The study consists of a screening period of up to 28 days, a vaccination period in which participants will be vaccinated at Baseline [Day 1] followed by a boost on Day 29 or 57 and a post-boost follow-up, until all participants have had their 21-day post-boost visit (Day 50 or Day 78).
The participants who received active vaccine will enter a long-term follow-up.
The total duration of the study will be about 1 year for participants who received vaccine and about 3 months for participants who received placebo.
Immunogenicity and safety will be monitored during the study.
Study Type
Interventional
Enrollment (Actual)
72
Phase
- Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Nairobi, Kenya
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 50 years (Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Must be healthy on the basis of physical examination, medical history, and the investigator's clinical judgment
- Women of childbearing potential must have a negative serum beta-human chorionic gonadotropin pregnancy test at screening, a negative urine pregnancy test immediately prior to each study vaccine administration, and practice adequate birth control measures from 28 days before the prime vaccination until at least 3 months after the boost vaccination as specified in the study protocol. If not heterosexually active at screening, must agree to practice adequate birth control measures if they become heterosexually active during their participation in the study (from screening onwards until at least 3 months after the boost vaccination).
- Must be available and willing to participate for the duration of the study visits and follow-up, provide verifiable identification, and have a means to be contacted
Exclusion Criteria:
- Has been vaccinated with a candidate Ebola vaccine
- Has been diagnosed with Ebola disease or exposed to Ebola including travel to West Africa in the last 12 months. West Africa includes but is not limited to the countries of Guinea, Liberia, Mali, and Sierra Leone. Participants who anticipate traveling to epidemic Ebola areas before the start of the long-term follow-up period will also be excluded. During the long-term follow-up period, travel to epidemic Ebola areas is allowed but during this period sampling can only take place if participant has returned at least 1 month from the epidemic Ebola area to ensure the samples are not carrying the Ebola-virus
- Has received any Ad26- or MVA-based candidate 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 or aminoglycosides
- A woman who is pregnant or breast-feeding, or planning to become pregnant while enrolled in the study or within 3 months after the boost vaccination
- History of diabetes mellitus type 1 or type 2, including cases controlled with diet alone; thyroidectomy, or thyroid disease requiring medication during the last 12 months; uncontrolled hypertension as defined in the study protocol; or, major psychiatric illness and/or substance abuse problems during the past 12 months that in the opinion of the investigator would preclude participation
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Group 1
Participants will receive MVA-BN-filo/ Ad26.ZEBOV (Day 1 /Day 29) or Placebo (Day 1/Day 29).
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One 0.5 milliliter (ml) intramuscular (IM) injection of 1*10^8, (50%Tissue Culture Infectious Dose [TCID50]) on Day 1, 29, 57.
One 0.5 mL IM injection of 5*10^10 viral particles (vp) on Day 1, 29, 57.
One 0.5 mL IM injection of 0.9% saline on Day 1 and 29 or on Day 1 and 57.
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Experimental: Group 2
Participants will receive MVA-BN-filo/Ad26.ZEBOV (Day 1 /Day 57) or placebo ( Day 1/Day 57).
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One 0.5 milliliter (ml) intramuscular (IM) injection of 1*10^8, (50%Tissue Culture Infectious Dose [TCID50]) on Day 1, 29, 57.
One 0.5 mL IM injection of 5*10^10 viral particles (vp) on Day 1, 29, 57.
One 0.5 mL IM injection of 0.9% saline on Day 1 and 29 or on Day 1 and 57.
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Experimental: Group 3
Participants will receive Ad26.ZEBOV/ MVA-BN-filo (Day 1/Day 29) or placebo (Day 1/Day 29).
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One 0.5 milliliter (ml) intramuscular (IM) injection of 1*10^8, (50%Tissue Culture Infectious Dose [TCID50]) on Day 1, 29, 57.
One 0.5 mL IM injection of 5*10^10 viral particles (vp) on Day 1, 29, 57.
One 0.5 mL IM injection of 0.9% saline on Day 1 and 29 or on Day 1 and 57.
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Experimental: Group 4
Participants will receive Ad26.ZEBOV/ MVA-BN-filo (Day 1/Day 57) or placebo (Day 1/Day 57).
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One 0.5 milliliter (ml) intramuscular (IM) injection of 1*10^8, (50%Tissue Culture Infectious Dose [TCID50]) on Day 1, 29, 57.
One 0.5 mL IM injection of 5*10^10 viral particles (vp) on Day 1, 29, 57.
One 0.5 mL IM injection of 0.9% saline on Day 1 and 29 or on Day 1 and 57.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Number of Participants With Adverse Events
Time Frame: Up to 21 days post-boost (Day 50 for Groups 1 and 3 or Day 78 for Groups 2 and 4)
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Up to 21 days post-boost (Day 50 for Groups 1 and 3 or Day 78 for Groups 2 and 4)
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Number of Participants With Serious Adverse Events
Time Frame: Up to the end of long-term follow-up (day 360)
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Up to the end of long-term follow-up (day 360)
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Number of participants with reactogenicity (ie, solicited local and systemic adverse events)
Time Frame: 1 week after each study vaccine administration
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1 week after each study vaccine administration
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Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Immune responses to the study vaccine regimens as measured by a virus neutralization assay
Time Frame: Groups 1 and 3: Days 1 (pre-vaccination), 8, 29 (pre-vaccination), 36, 50, 113, 180, 240, and 360; Groups 2 and 4: Days 1 (pre-vaccination), 8, 29, 57 (pre-vaccination), 64, 78, 141, 180, 240, and 360)
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Groups 1 and 3: Days 1 (pre-vaccination), 8, 29 (pre-vaccination), 36, 50, 113, 180, 240, and 360; Groups 2 and 4: Days 1 (pre-vaccination), 8, 29, 57 (pre-vaccination), 64, 78, 141, 180, 240, and 360)
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Immune responses to the study vaccine regimens measured by an enzyme-linked immunosorbent assay (ELISA)
Time Frame: Groups 1 and 3: Days 1 (pre-vaccination), 8, 29 (pre-vaccination), 36, 50, 113, 180, 240, and 360; Groups 2 and 4: Days 1 (pre-vaccination), 8, 29, 57 (pre-vaccination), 64, 78, 141, 180, 240, and 360)
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Groups 1 and 3: Days 1 (pre-vaccination), 8, 29 (pre-vaccination), 36, 50, 113, 180, 240, and 360; Groups 2 and 4: Days 1 (pre-vaccination), 8, 29, 57 (pre-vaccination), 64, 78, 141, 180, 240, and 360)
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Immune responses to the study vaccine regimens as measured by an Enzyme-linked Immunospot Assay (ELISpot)
Time Frame: Groups 1 and 3: Days 1 (pre-vaccination), 8, 29 (pre-vaccination), 36, 50, 113, 180, 240, and 360; Groups 2 and 4: Days 1 (pre-vaccination), 8, 29, 57 (pre-vaccination), 64, 78, 141, 180, 240, and 360)
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Groups 1 and 3: Days 1 (pre-vaccination), 8, 29 (pre-vaccination), 36, 50, 113, 180, 240, and 360; Groups 2 and 4: Days 1 (pre-vaccination), 8, 29, 57 (pre-vaccination), 64, 78, 141, 180, 240, and 360)
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
March 1, 2015
Primary Completion (Actual)
September 1, 2015
Study Completion (Actual)
June 1, 2016
Study Registration Dates
First Submitted
January 26, 2015
First Submitted That Met QC Criteria
February 25, 2015
First Posted (Estimate)
March 3, 2015
Study Record Updates
Last Update Posted (Estimate)
December 8, 2016
Last Update Submitted That Met QC Criteria
December 7, 2016
Last Verified
December 1, 2016
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- CR106458
- VAC52150EBL1003 (Other Identifier: Crucell Holland BV)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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