HealthyPhase 1NCT02313077

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

A Phase 1 study testing MVA-BN-filo and Ad26. ZEBOV in people with Healthy, run by Crucell Holland BV at 1 site in United Kingdom.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

The purpose of this study is to test the safety and immunogenicity of MVA-BN-Filo and Ad26.ZEBOV as heterologous prime-boost vaccine regimens in healthy adult participants. Read more about this study

Who is it for?: Ages 18 to 50 yearsHealthy volunteers can take part
Conditions the study is for: Healthy
What is being tested?: MVA-BN-filo and Ad26. ZEBOV
Type of treatment: Injection or infusion
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 87 participants
Where: 1 siteUnited Kingdom
Study dates: 17 Dec 2014to 15 Mar 2016
Phase: Phase 1
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 50 years
All sexes
Healthy volunteers accepted
Adult

Who may be able to join

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 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 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 is sexually active with a woman of childbearing potential and who has not had a vasectomy 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 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

Who cannot join

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
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

Trial locations and contacts

1 site in 1 country.

United Kingdom1 site

Study site
Oxford

Other trials in United Kingdom

About this study

Official title: A Phase 1, First-in-Human 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 as heterologous prime-boost vaccine regimens in healthy adult participants.

Read the detailed description

This first-in-human study consists of 2 parts: 1) The main study, which is randomized, placebo-controlled, observer-blind; 2) A sub-study, which is open-label, uncontrolled, non-randomized 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 (up to 28 days in the main study and up to 56 days in the sub-study), a vaccination period in which participants will be vaccinated at baseline (Day 1) followed by a boost on Day 15, 29 or 57, and a post-boost follow-up until all participants have had their 21-day post-boost visit (Day 36, 50 or Day 78). 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. Safety will be monitored during the study.

Conditions: Healthy
Being tested: MVA-BN-filo, Ad26. ZEBOV, Placebo
Keywords: 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

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

MVA-BN-filoBiological
One 0.5 mL intramuscular (IM) injection of 1E8 (50%Tissue Culture Infectious Dose [TCID50]) on Day 1 (Groups 1 and 2), or on Day 29 (Group 3), or on Day 57 (Group 4), or on Day 15 (Group 5).
Ad26. ZEBOVBiological
One 0.5 mL IM injection of 5E10 viral particles (vp) on Day 1 (Groups 3, 4 and 5), or on Day 29 (Group 1), or on Day 57 (Group 2).
PlaceboOther
One 0.5 mL IM injection of 0.9% saline on Day 1 and 29 (Groups 1 and 3), or on Day 1 and 57 (Groups 2 and 4).

Study groups in NCT02313077
Study group	Role	What they receive
Group 1	Experimental	Participants will receive MVA-BN-filo/ Ad26.ZEBOV (Day 1 /Day 29) or Placebo (Day 1/Day 29). Receives: Biological: MVA-BN-filo; Biological: Ad26. ZEBOV; Other: Placebo
Group 2	Experimental	Participants will receive MVA-BN-filo/Ad26.ZEBOV (Day 1 /Day 57) or placebo ( Day 1/Day 57). Receives: Biological: MVA-BN-filo; Biological: Ad26. ZEBOV; Other: Placebo
Group 3	Experimental	Participants will receive Ad26.ZEBOV/ MVA-BN-filo (Day 1/Day 29) or placebo (Day 1/Day 29). Receives: Biological: MVA-BN-filo; Biological: Ad26. ZEBOV; Other: Placebo
Group 4	Experimental	Participants will receive Ad26.ZEBOV/ MVA-BN-filo (Day 1/Day 57) or placebo (Day 1/Day 57). Receives: Biological: MVA-BN-filo; Biological: Ad26. ZEBOV; Other: Placebo
Group 5	Experimental	Participants will receive Ad26.ZEBOV/ MVA-BN-filo (Day 1/Day 15). Receives: Biological: MVA-BN-filo; Biological: Ad26. ZEBOV

What is being measured

The primary outcome is the main question the study is designed to answer.

Number of participants with adverse events
Measured: Up to 21 days after the 2nd vaccination (Day 36 for Group 5 or Day 50 for Groups 1 and 3 or Day 78 for Groups 2 and 4)
Number of participants with serious adverse events
Measured: Up to the end of long-term follow-up (Day 360)
Number of participants with reactogenicity (ie, solicited local and systemic adverse events)
Measured: Up to 1 week after each study vaccine administration

Secondary outcomes (3)

Immune responses to the study vaccine regimens as measured by a virus neutralization assay
Measured: Groups 1 and 3:Day 1(pre-vaccination), 8, 29(pre-vaccination), 36, 50, 180, 240, 360; Groups 2 and 4:Day 1(pre-vaccination), 8, 29, 57(pre-vaccination), 64, 78, 180, 240, 360; Group 5:Day 1(pre-vaccination), 8, 15(pre-vaccination), 22, 36, 180, 240, 360
Immune responses to the study vaccine regimens measured by an enzyme-linked immunosorbent assay (ELISA)
Measured: Groups 1 and 3:Day 1(pre-vaccination), 8, 29(pre-vaccination), 36, 50, 180, 240, 360; Groups 2 and 4:Day 1(pre-vaccination), 8, 29, 57(pre-vaccination), 64, 78, 180, 240, 360; Group 5:Day 1(pre-vaccination), 8, 15(pre-vaccination), 22, 36, 180, 240, 360
Immune responses to the study vaccine regimens as measured by an enzyme-linked immunospot (ELISpot) assay
Measured: Groups 1 and 3:Day 1(pre-vaccination), 8, 29(pre-vaccination), 36, 50, 180, 240, 360; Groups 2 and 4:Day 1(pre-vaccination), 8, 29, 57(pre-vaccination), 64, 78, 180, 240, 360; Group 5:Day 1(pre-vaccination), 8, 15(pre-vaccination), 22, 36, 180, 240, 360

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

17 Dec 201415 Mar 2016

First posted9 Dec 2014 (estimated)
Study start17 Dec 2014
Primary completion17 Apr 2015
Study completion15 Mar 2016

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (2)Papers the sponsor has linked to this study.
Other trials for HealthyStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 1
Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: Triple blind
Who is masked: Participant, Investigator, Outcomes assessor
Enrolment: 87 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02313077
Sponsor's protocol ID: CR106478
Other IDs: VAC52150EBL1001, 2014-004883-39, 2014
Status last verified: Apr 2017
First submitted: 5 Dec 2014
Last updated: 14 Apr 2017
Results posted: No
Data monitoring committee: Yes
FDA-regulated drug: No

Publications

Wagstaffe HR, Clutterbuck EA, Bockstal V, Stoop JN, Luhn K, Douoguih M, Shukarev G, Snape MD, Pollard AJ, Riley EM, Goodier MR. Ebola virus glycoprotein stimulates IL-18-dependent natural killer cell responses. J Clin Invest. 2020 Jul 1;130(7):3936-3946. doi: 10.1172/JCI132438.
PubMed 32315287
Milligan ID, Gibani MM, Sewell R, Clutterbuck EA, Campbell D, Plested E, Nuthall E, Voysey M, Silva-Reyes L, McElrath MJ, De Rosa SC, Frahm N, Cohen KW, Shukarev G, Orzabal N, van Duijnhoven W, Truyers C, Bachmayer N, Splinter D, Samy N, Pau MG, Schuitemaker H, Luhn K, Callendret B, Van Hoof J, Douoguih M, Ewer K, Angus B, Pollard AJ, Snape MD. Safety and Immunogenicity of Novel Adenovirus Type 26- and Modified Vaccinia Ankara-Vectored Ebola Vaccines: A Randomized Clinical Trial. JAMA. 2016 Apr 19;315(15):1610-23. doi: 10.1001/jama.2016.4218.
PubMed 27092831

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 14 Apr 2017. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Phase 1, First-in-Human 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
ClinicalTrials.gov ID: NCT02313077
Acronym / sponsor ID: CR106478
Conditions: Healthy
Keywords: 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
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 87 participants (actual)
Lead sponsor: Crucell Holland BVIndustry (pharma, biotech, devices)
Study start: 17 Dec 2014 (actual)
Primary completion: 17 Apr 2015 (actual)
Study completion: 15 Mar 2016 (actual)
First posted: 9 Dec 2014 (estimated)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

The purpose of this study is to test the safety and immunogenicity of MVA-BN-Filo and Ad26.ZEBOV as heterologous prime-boost vaccine regimens in healthy adult participants.

Detailed description

Study design

Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: Triple blind (participant, investigator, outcomes assessor)
Number of arms: 5

Arm	Type	Receives
Group 1	Experimental	Biological: MVA-BN-filo, Biological: Ad26. ZEBOV, Other: PlaceboParticipants will receive MVA-BN-filo/ Ad26.ZEBOV (Day 1 /Day 29) or Placebo (Day 1/Day 29).
Group 2	Experimental	Biological: MVA-BN-filo, Biological: Ad26. ZEBOV, Other: PlaceboParticipants will receive MVA-BN-filo/Ad26.ZEBOV (Day 1 /Day 57) or placebo ( Day 1/Day 57).
Group 3	Experimental	Biological: MVA-BN-filo, Biological: Ad26. ZEBOV, Other: PlaceboParticipants will receive Ad26.ZEBOV/ MVA-BN-filo (Day 1/Day 29) or placebo (Day 1/Day 29).
Group 4	Experimental	Biological: MVA-BN-filo, Biological: Ad26. ZEBOV, Other: PlaceboParticipants will receive Ad26.ZEBOV/ MVA-BN-filo (Day 1/Day 57) or placebo (Day 1/Day 57).
Group 5	Experimental	Biological: MVA-BN-filo, Biological: Ad26. ZEBOVParticipants will receive Ad26.ZEBOV/ MVA-BN-filo (Day 1/Day 15).

Who may qualify

Ages: 18 to 50 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult

Key inclusion criteria (5 listed)

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 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 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 is sexually active with a woman of childbearing potential and who has not had a vasectomy 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 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

Key exclusion criteria (6 listed)

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
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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
MVA-BN-filoOne 0.5 mL intramuscular (IM) injection of 1E8 (50%Tissue Culture Infectious Dose [TCID50]) on Day 1 (Groups 1 and 2), or on Day 29 (Group 3), or on Day 57 (Group 4), or on Day 15 (Group 5).	Biological	Group 1, Group 2, Group 3, Group 4, Group 5
Ad26. ZEBOVOne 0.5 mL IM injection of 5E10 viral particles (vp) on Day 1 (Groups 3, 4 and 5), or on Day 29 (Group 1), or on Day 57 (Group 2).	Biological	Group 1, Group 2, Group 3, Group 4, Group 5
PlaceboOne 0.5 mL IM injection of 0.9% saline on Day 1 and 29 (Groups 1 and 3), or on Day 1 and 57 (Groups 2 and 4).	Other	Group 1, Group 2, Group 3, Group 4

Primary outcome

Number of participants with adverse events
Time frame: Up to 21 days after the 2nd vaccination (Day 36 for Group 5 or Day 50 for Groups 1 and 3 or Day 78 for Groups 2 and 4)
Number of participants with serious adverse events
Time frame: Up to the end of long-term follow-up (Day 360)
Number of participants with reactogenicity (ie, solicited local and systemic adverse events)
Time frame: Up to 1 week after each study vaccine administration

3 secondary outcomes

Immune responses to the study vaccine regimens as measured by a virus neutralization assay
Time frame: Groups 1 and 3:Day 1(pre-vaccination), 8, 29(pre-vaccination), 36, 50, 180, 240, 360; Groups 2 and 4:Day 1(pre-vaccination), 8, 29, 57(pre-vaccination), 64, 78, 180, 240, 360; Group 5:Day 1(pre-vaccination), 8, 15(pre-vaccination), 22, 36, 180, 240, 360
Immune responses to the study vaccine regimens measured by an enzyme-linked immunosorbent assay (ELISA)
Time frame: Groups 1 and 3:Day 1(pre-vaccination), 8, 29(pre-vaccination), 36, 50, 180, 240, 360; Groups 2 and 4:Day 1(pre-vaccination), 8, 29, 57(pre-vaccination), 64, 78, 180, 240, 360; Group 5:Day 1(pre-vaccination), 8, 15(pre-vaccination), 22, 36, 180, 240, 360
Immune responses to the study vaccine regimens as measured by an enzyme-linked immunospot (ELISpot) assay
Time frame: Groups 1 and 3:Day 1(pre-vaccination), 8, 29(pre-vaccination), 36, 50, 180, 240, 360; Groups 2 and 4:Day 1(pre-vaccination), 8, 29, 57(pre-vaccination), 64, 78, 180, 240, 360; Group 5:Day 1(pre-vaccination), 8, 15(pre-vaccination), 22, 36, 180, 240, 360

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 14 Apr 2017.
Derived from this study: PubMed 32315287Wagstaffe HR, Clutterbuck EA, Bockstal V, Stoop JN, Luhn K, Douoguih M, Shukarev G, Snape MD, Pollard AJ, Riley EM, Goodier MR. Ebola virus glycoprotein stimulates IL-18-dependent natural killer cell responses. J Clin Invest. 2020 Jul 1;130(7):3936-3946. doi: 10.1172/JCI132438.
Derived from this study: PubMed 27092831Milligan ID, Gibani MM, Sewell R, Clutterbuck EA, Campbell D, Plested E, Nuthall E, Voysey M, Silva-Reyes L, McElrath MJ, De Rosa SC, Frahm N, Cohen KW, Shukarev G, Orzabal N, van Duijnhoven W, Truyers C, Bachmayer N, Splinter D, Samy N, Pau MG, Schuitemaker H, Luhn K, Callendret B, Van Hoof J, Douoguih M, Ewer K, Angus B, Pollard AJ, Snape MD. Safety and Immunogenicity of Novel Adenovirus Type 26- and Modified Vaccinia Ankara-Vectored Ebola Vaccines: A Randomized Clinical Trial. JAMA. 2016 Apr 19;315(15):1610-23. doi: 10.1001/jama.2016.4218.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Crucell Holland BV Clinical Trial study director

Crucell Holland BV

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing MVA-BN-filo and Ad26. ZEBOV in people with Healthy, run by Crucell Holland BV at 1 site in United Kingdom.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 14 Apr 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of participants with adverse events (time frame: Up to 21 days after the 2nd vaccination (Day 36 for Group 5 or Day 50 for Groups 1 and 3 or Day 78 for Groups 2 and 4)). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02313077, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Apr 2017; AzTrials last refreshed its copy on 8 Nov 2026.