A Study to Evaluate the Safety and Immunogenicity of Heterologous Prime-Boost Ebola Vaccine Regimens in Healthy Participants

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

72 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-03-31

Study Completion Date

2016-06-30

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Healthy

Keywords

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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 (MVA-BN) Filo-vector Safety Immunogenicity

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

DOUBLE

Participants Investigators

Intervention Type BIOLOGICAL

One 0.5 mL IM injection of 5\*10\^10 viral particles (vp) on Day 1, 29, 57.

Placebo

Intervention Type BIOLOGICAL

One 0.5 mL IM injection of 0.9% saline on Day 1 and 29 or on Day 1 and 57.

Interventions

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MVA-BN-Filo

One 0.5 milliliter (ml) intramuscular (IM) injection of 1\*10\^8, (50%Tissue Culture Infectious Dose \[TCID50\]) on Day 1, 29, 57.

Intervention Type BIOLOGICAL

Ad26.ZEBOV

One 0.5 mL IM injection of 5\*10\^10 viral particles (vp) on Day 1, 29, 57.

Intervention Type BIOLOGICAL

Placebo

One 0.5 mL IM injection of 0.9% saline on Day 1 and 29 or on Day 1 and 57.

Intervention Type BIOLOGICAL

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Crucell Holland BV Clinical Trial

Role: STUDY_DIRECTOR

Crucell Holland BV

Locations

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Nairobi, , Kenya

Site Status

Countries

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Ghana Kenya

References

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Mutua G, Anzala O, Luhn K, Robinson C, Bockstal V, Anumendem D, Douoguih M. Safety and Immunogenicity of a 2-Dose Heterologous Vaccine Regimen With Ad26.ZEBOV and MVA-BN-Filo Ebola Vaccines: 12-Month Data From a Phase 1 Randomized Clinical Trial in Nairobi, Kenya. J Infect Dis. 2019 Jun 5;220(1):57-67. doi: 10.1093/infdis/jiz071.

Reference Type DERIVED

PMID: 30796816 (View on PubMed)

Other Identifiers

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VAC52150EBL1003

Identifier Type: OTHER

Identifier Source: secondary_id

CR106458

Identifier Type: -

Identifier Source: org_study_id

A Study to Evaluate the Safety and Immunogenicity of Heterologous Prime-Boost Ebola Vaccine Regimens in Healthy Participants

Study Results

Basic Information

Brief Summary

Detailed Description

Conditions

Keywords

Study Design

Study Groups

Group 1

MVA-BN-Filo

Ad26.ZEBOV

Placebo

Group 2

MVA-BN-Filo

Ad26.ZEBOV

Placebo

Group 3

MVA-BN-Filo

Ad26.ZEBOV

Placebo

Group 4

MVA-BN-Filo

Ad26.ZEBOV

Placebo

Interventions

MVA-BN-Filo

Ad26.ZEBOV

Placebo

Eligibility Criteria

Inclusion Criteria

Exclusion Criteria

Sponsors

Crucell Holland BV

Responsible Party

Principal Investigators

Crucell Holland BV Clinical Trial

Locations

Countries

References

Other Identifiers

VAC52150EBL1003

CR106458