A Safety and Immunogenicity Study of Heterologous and Homologous Prime-Boost Ebola Vaccine Regimens in Healthy Participants
A Phase 1, Randomized, Placebo-Controlled, Observer-Blind Study to Evaluate the Safety, Tolerability and Immunogenicity of Heterologous and Homologous Prime-Boost Regimens Using MVA-BN-Filo® and Ad26.ZEBOV Administered in Different Doses, Sequences and Schedules in Healthy Adult Subjects
2 other identifiers
interventional
164
1 country
1
Brief Summary
The purpose of this study is to test the safety and immunogenicity of MVA-BN-Filo and Ad26.ZEBOV as heterologous and homologous prime-boost vaccine regimens in healthy adult participants.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_1 healthy
Started Jan 2015
Longer than P75 for phase_1 healthy
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
December 19, 2014
CompletedFirst Posted
Study publicly available on registry
December 24, 2014
CompletedStudy Start
First participant enrolled
January 8, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 2, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
May 8, 2017
CompletedJune 14, 2017
June 1, 2017
6 months
December 19, 2014
June 12, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (3)
Number of participants with adverse events
Up to 21 days after the last vaccination (up to Day 381)
Number of participants with serious adverse events
Up to the end of long term follow-up (up to Day 720)
Number of participants with reactogenicity (ie, solicited local and systemic adverse events)
1 week after each study vaccine administration
Secondary Outcomes (3)
Immune responses to the study vaccine regimens as measured by a virus neutralization assay
up to Day 720 (Group 1-8); Day 360 (Group 9, 10)
Immune responses to the study vaccine regimens as measured by an enzyme-linked immunosorbent assay (ELISA)
up to Day 720 (Group 1-8); Day 360 (Group 9, 10)
Immune responses to the study vaccine regimens as measured by an enzyme-linked immunospot (ELISpot) assay
up to Day 720 (Group 1-8); Day 360 (Group 9, 10)
Study Arms (10)
Group 1
EXPERIMENTALParticipants will receive MVA-BN-Filo/ Ad26.ZEBOV (Day 1 /Day 15) or Placebo (Day 1/Day 15). Participants will receive Ad26.ZEBOV (5x10\^10 vp) on Day 360.
Group 2
EXPERIMENTALParticipants will receive MVA-BN-Filo/Ad26.ZEBOV (Day 1 /Day 29) or placebo (Day 1/Day 29). Participants will receive Ad26.ZEBOV (5x10\^10 vp) on Day 360.
Group 3
EXPERIMENTALParticipants will receive MVA-BN-Filo /Ad26.ZEBOV/ (Day 1/Day 57) or placebo (Day 1/Day 57). Participants will receive Ad26.ZEBOV (5x10\^10 vp) on Day 360.
Group 4
EXPERIMENTALParticipants will receive Ad26.ZEBOV/ MVA-BN-Filo (Day 1/Day 29) or placebo (Day 1/Day 29). Participants will receive Ad26.ZEBOV (5x10\^10 vp) on Day 360.
Group 5
EXPERIMENTALParticipants will receive MVA-BN-Filo (Day 1 and Day 15) or placebo (Day 1 and Day 15). Participants will receive Ad26.ZEBOV (5x10\^10 vp) on Day 360.
Group 6
EXPERIMENTALParticipants will receive Ad26.ZEBOV (Day 1 and Day 15) or placebo (Day 1 and Day 15). Participants will receive MVA-BN-Filo (1\*10\^8 TCID50) on Day 360.
Group 7
EXPERIMENTALParticipants will receive Ad26.ZEBOV/ MVA-BN-Filo (Day 1/Day 15) or Placebo (Day 1/Day 15). Participants will receive Ad26.ZEBOV (5x10\^10 vp) on Day 360.
Group 8
EXPERIMENTALParticipants will receive Ad26.ZEBOV/ MVA-BN-Filo (Day 1 /Day 29) or Placebo (Day 1/Day 29). Participants will receive Ad26.ZEBOV (1x10\^11 vp) on Day 360.
Group 9
EXPERIMENTALParticipants will receive MVA-BN-Filo/ Ad26.ZEBOV (Day 1 /Day 8) or Placebo (Day 1/Day 8).
Group 10
EXPERIMENTALParticipants will receive MVA-BN-Filo/ Ad26.ZEBOV (Day 1 /Day 15) or Placebo (Day 1/Day 15).
Interventions
One 0.5 milliliter (ml) intramuscular (IM) injection of 1\*10\^8, (50%Tissue Culture Infectious Dose \[TCID50\]).
One 0.5 mL IM injection of 5\*10\^10 viral particles (vp).
One 0.5 mL IM injection of 0.9% saline.
Eligibility Criteria
You may qualify if:
- Must be healthy on the basis of physical examination, medical history, and the investigator's clinical judgment
- Have a body mass index (BMI) ≥18.5 and \<35.0 kg/m2
- Women of childbearing potential must have a negative serum β-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). Agree not to donate eggs (ova, oocytes) for the purposes of assisted reproduction during participation in the study (from screening onwards until at least 3 months after the boost vaccination)
- Women of non-childbearing potential, defined as postmenopausal (\>45 years of age with amenorrhea for ≥2 years or any age with amenorrhea for ≥6 months and serum follicle-stimulating hormone \[FSH\] \>40 mIU/mL) or surgically sterile (hysterectomy, bilateral tubal ligation, or bilateral oophorectomy), are not required to use the birth control methods as specified in the study protocol
- A man who has not had a vasectomy and is sexually active with a woman of childbearing potential must agree to use a double-barrier method of birth control, such as either condom with spermicidal foam/gel/film/cream/suppository or partner with occlusive cap (diaphragm or cervical/vault caps) with spermicidal foam/gel/film/cream/suppository. In case the female partner is using an adequate method of birth control, a single-barrier method of birth control for the male subject is acceptable. Men must also agree not to donate sperm 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
You may not qualify if:
- 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 from enrollment into the study
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Unknown Facility
Rockville, Maryland, United States
Study Officials
- STUDY DIRECTOR
Janssen Vaccines & Prevention B.V. Clinical Trial
Janssen Vaccines & Prevention B.V.
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
December 19, 2014
First Posted
December 24, 2014
Study Start
January 8, 2015
Primary Completion
July 2, 2015
Study Completion
May 8, 2017
Last Updated
June 14, 2017
Record last verified: 2017-06