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Ebola DiseasePhase 1NCT02891980

A Safety Trial to Test MVA-BN(R)-Filo and Ad26.ZEBOV Vaccines in Healthy Volunteers

A Phase 1 study testing Ad26 Zaire Ebola Vaccine and MVA Multi-Filo Ebola Vaccine in people with Ebola Disease and Marburg Disease, run by National Institute of Allergy and Infectious Diseases (NIAID) at 1 site in United States.

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

This is a Phase 1, double-blind, randomized trial to evaluate the safety and immunogenicity of two heterologous and two homologous prime-boost regimens using MVA-BN(R)-Filo and Ad26.ZEBOV administered in different sequences at Days 1 and 29 in healthy adult subjects aged 18 - 45 years. Read more about this study

Who is it for?
Ages 18 to 45 yearsHealthy volunteers can take part
Conditions the study is for
Ebola Disease, Marburg Disease
What is being tested?
Ad26 Zaire Ebola Vaccine and MVA Multi-Filo Ebola Vaccine
Type of treatment
Vaccines
Could I receive a placebo?
No, everyone receives an active treatment
How many people
65 participants
Where
1 siteUnited States
Study dates
24 Mar 2017to 21 Mar 2019
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 45 years
  • All sexes
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • Subject must be able to read and provide consent after completing the informed consent process.
  • Subject must be able to understand and comply with planned procedures.
  • Subject must be a man or woman aged > / = 18 to < / = 45 years.
  • Subject must have a body mass index (BMI) > / = 18.5 and < 35 kg/m^2.
  • Subject must be healthy on the basis of patient-reported medical history, physical examination, and the investigator's clinical judgment.
  • Subject must have acceptable laboratory parameters* within 28 days of enrollment:
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  • Note 1: If the following acceptable screening laboratory parameters** are out of range, repeat of screening tests is permitted once, provided there is an alternative explanation for the out of range value. The alternative explanation for the out of range value should be documented in the subject's source documents. The acceptable value for repeated screening tests must be available within the 28 days screening period.
  • Acceptable laboratory parameters include the following:
  • Hemoglobin: women: > / = 11.5 g/dL; men > / = 12.5 g/dL
  • White blood cell (WBC) count: > 3.7 Thousand/uL but < 10.9 Thousand/uL
  • Absolute neutrophil count > 1,500 cells/uL
  • Platelets: > 139 but < 550 Thousand/uL
  • Urinalysis (clean urine sample)*: protein and blood < 1+, glucose negative *Note: for women: in case of menstruation, urinalysis must be postponed, but a result should be available before Day 1.
  • Alanine aminotransferase (ALT) < / = 1 x institutional upper limit of normal
  • Serum creatinine < / = 1 x institutional upper limit of normal
  • Troponin I < / = 1 x institutional upper limit of normal
  • Fibrinogen > 140 mg/dL but < / = 500 mg/dL
  • Prothrombin time (PT) < / = 1 x institutional upper limit of normal
  • Activated partial thromboplastin time (PTT) < / = 1 x institutional upper limit of normal.
  • Negative test for HIV.
  • Negative hepatitis B surface antigen and negative antibody to hepatitis C virus.
  • Note 2: Grade 1 abnormalities for laboratory tests other than those covered in this list are considered acceptable if not clinically significant. If a Grade 2 or Grade 3 abnormality for lab tests other than those covered in this list is identified, repeating the screening tests is permitted once provided there is an alternative explanation for the out-of-range value. The alternative explanation for the out of range value should be documented in the subject's source documents.
  • 7. Women of childbearing potential must have a negative serum pregnancy test during screening and a negative urine pregnancy test immediately prior to each study vaccine administration.
  • 8. Women of childbearing potential must have an acceptable method of contraception from 28 days before the prime vaccination until at least 3 months after the last boost vaccination.
  • Acceptable methods of birth control include the following:
  • Prescription oral contraceptives, contraceptive injections, intrauterine device (IUD), implants, vaginal ring, double-barrier method, contraceptive patch, male partner sterilization b. Abstinence (defined as refraining from heterosexual intercourse) c. If not heterosexually active at screening, must agree to practice adequate birth control measures if they become heterosexually active from the start of screening onwards until at least 3 months after the last boost vaccination.
  • Women of non-childbearing potential, defined as postmenopausal (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 required birth control methods.
  • 9. Female subject agrees to not donate eggs (ova, oocytes) for the purposes of assisted reproduction from the start of screening onwards until at least 3 months after the last boost vaccination.
  • 10. Male subject who has not had a vasectomy and is sexually active with a woman of childbearing potential must agree to use an acceptable method of birth control until at least 3 months after the last boost vaccination.
  • Acceptable methods of birth control include the following:
  • A double-barrier method of birth control, such as condom and partner with occlusive cap (diaphragm, cervical/vault caps) with spermicidal foam/gel/film/cream/suppository.
  • In case the female partner is using an adequate method of birth control (see Inclusion Criterion #8), a single barrier method of birth control for the male subject is acceptable.
  • 11. Male subject must also agree not to donate sperm for the purposes of assisted reproduction from the start of screening onwards until at least 3 months after the last boost vaccination.
  • 12. Subject must be available and willing to participate for the duration of the study visits and follow-up (up to 19 months from enrollment).
  • 13. Subject must provide identification. 14. Subject must have a means to be contacted. 15. Subjects must have consistent access to the internet to perform electronic data entry.

Who cannot join

  • Has been vaccinated with an Ebola vaccine.
  • Has been diagnosed with Ebola disease, or exposed to Ebola including travel to West Africa* in 2014-2016.
  • Note: West Africa includes but is not limited to the countries of Guinea, Liberia, Mali, and Sierra Leone. Subjects who anticipate traveling to epidemic Ebola areas before the end of the study will also be excluded from enrollment into the study.
  • Known or suspected receipt of an adenovirus serotype 26 (Ad26)-based vaccine.
  • Known or suspected receipt of any licensed or investigational small pox (vaccinia)-based vaccine* *Note: Includes any MVA-based candidate vaccine (Imvamune or Imvanex), Dryvax, or Acam2000. Military history should be reviewed with potential subjects for receipt of vaccinia-based vaccine. The presence of a typical vaccinia scar should be considered exclusionary.
  • Positive serology for human immunodeficiency virus (HIV)
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  • Positive Hepatitis B surface antigen
  • Positive antibody to Hepatitis C virus (HCV)
  • Known allergy or history of anaphylaxis or other serious adverse reactions to vaccines or vaccine products*.
  • Note: This includes a known allergy to egg, egg products and aminoglycosides or any of the constituents of the study vaccines [e.g., polysorbate 80, ethylenediaminetetraacetic acid (EDTA), L-histidine, tris (hydroxymethyl)-amino methane (THAM)).
  • Has an acute illness or temperature > / = 38.0 degrees Celsius within the 3 days prior to Day 1.* *Note: Potential subjects can be rescheduled due to acute illness within the 28 day window between screening and enrollment. If acute illness prevents administration of vaccine within the 28 day screening window, the potential subject can be enrolled once the acute illness resolves after repeating safety laboratories and if the subject is otherwise eligible. The ECG does not need to be repeated as it is not a safety laboratory and unlikely to change without clinical event in this age group of volunteers.
  • Female subject is pregnant or breast-feeding, or planning to become pregnant while enrolled in the study or within 3 months after the last boost vaccination.
  • A history of bleeding or clotting disorders.
  • Any clinically significant acute or chronic medical condition* that, in the opinion of the investigator, would preclude participation.
  • E.g., history of seizure disorders, autoimmune disease, immunodeficiency, any spleen disease, active malignancy, active tuberculosis, asthma, or other systemic infections.
  • History of malignancy other than squamous cell or basal cell skin cancer*, unless there has been surgical excision that is considered to have achieved cure.
  • Note: Subjects with a history of skin cancer must not be vaccinated at the previous tumor site.
  • Prior organ and/or stem cell transplant.
  • Major surgery (per the investigator's judgment) within the 4 weeks prior to study entry or planned major surgery through the course of the study.
  • History of myocarditis, pericarditis, cardiomyopathy, transient ischemic attack or stroke, myocardial infarction, angina, coronary artery disease, congestive heart failure, or arrhythmia*.
  • Note: This includes any clinically significant arrhythmia requiring medication, treatment, or clinical follow-up.
  • Electrocardiogram (ECG) with clinically significant findings,* or features that would interfere with the assessment of myocarditis/pericarditis.
  • Clinical significant findings include the following:
  • Conduction disturbance (complete left or complete right bundle branch block or nonspecific intraventricular conduction disturbance with QRS > / = 120 ms, PR interval > / = 210 ms, any second- or third-degree atrioventricular block, or prolongation of the QT interval corrected according to Bazett's formula [QTcB] [> 450 ms]) b. Significant repolarization (ST-segment or T-wave) abnormality. c. Significant atrial or ventricular arrhythmia; frequent atrial or ventricular ectopy (e.g., frequent premature atrial contractions, 2 premature ventricular contractions in a row).
  • ST-elevation consistent with ischemia or evidence of past or evolving myocardial infarction.
  • 18. History of diabetes mellitus type 1 or type 2, including cases controlled with diet alone.
  • Note: A history of isolated gestational diabetes is not an exclusion criterion. 19. Thyroidectomy or thyroid disease requiring medication during the last 12 months.
  • 20. Uncontrolled hypertension, defined as systolic blood pressure > / = 140 mmHg or diastolic blood pressure > / = 90 mmHg.
  • Note: Vital signs must be normal by protocol toxicity grading scale or determined to be normal-variant by investigator. In the event of an abnormal heart rate or blood pressure due to physiological variation or activity, the subject may rest for 10 minutes in a quiet room, and then blood pressure and/or heart rate may be re-measured. Repeated vital signs may be used to determine eligibility.
  • 21. Received a licensed live vaccine within 30 days prior to enrollment in this study, or plans to receive a licensed live vaccine within 30 days before or after each study vaccine.
  • 22. Received a licensed inactivated vaccine within 14 days prior to enrollment in this study, or plans to receive a licensed inactivated vaccine within 14 days before or after each study vaccine.
  • 23. Use of experimental therapeutic agents within 3 months from the start of screening.
  • 24. Current or planned participation in another clinical study during the study period.
  • Note: Participation in an observational clinical study is allowed. 25. Receipt of blood products or immunoglobulin in the past 3 months. 26. Donation of a unit of blood within 8 weeks before Day 1 or plans to donate blood during participation in the study (from the start of screening onwards).
  • 27. Major psychiatric illness during the past 12 months that in the opinion of the investigator would preclude participation.
  • 28. Current or past abuse of recreational or narcotic drugs.
  • Note: Urine will be tested only at screening to check for use of amphetamines, benzodiazepines, cocaine, and opioids.
  • 29. Current or past alcohol use judged by the investigator to potentially interfere with subject study adherence.
  • 30. History of chronic urticaria (recurrent hives). 31. Chronic or recurrent use of medications which modify host immune response (e.g., cancer chemotherapeutic agents, parenteral corticosteroids).
  • Note: This is defined as greater than 2 weeks duration within three months prior to vaccination or current use of immunosuppressive medication:
  • Permissible use during study include: corticosteroid nasal sprays for allergic rhinitis and low dose inhaled corticosteroids defined as < 800 mcg/day of beclomethasone dipropionate CFC or equivalent.
  • Topical steroid for mild uncomplicated dermatitis such as poison ivy or contact dermatitis should be completed before study.
  • Oral/parenteral corticosteroids given for non-chronic conditions not expected to recur are permissible if the length of therapy was < / = 14 days with completion at least 30 days prior to enrollment.
  • 32. Subject who cannot communicate reliably with the investigator. 33. Subject who, in the opinion of the investigator, is unlikely to adhere to the requirements of the study.
  • 34. Any condition that, in the opinion of the investigator, might interfere with assessing the study objectives.
  • 35. Personnel involved in the study.
  • Note: This includes the Principal Investigator (PI), sub-Investigators listed in Form FDA 1572 or Investigator of Record Form, all staff who are paid entirely or partially by/through the OCRR contract for the trial, and staff who are supervised by the PI or sub-Investigators.

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Emory University School of Medicine

    Atlanta, Georgia, 30322-1014

Other trials in United States

About this study

Official title: A Phase I Trial to Utilize Systems Biology Approaches to Examine the Safety, Immunogenicity, and 'Omics Response to MVA-BN(R)-Filo and Ad26.ZEBOV Vaccines in Healthy Volunteers

This is a Phase 1, double-blind, randomized trial to evaluate the safety and immunogenicity of two heterologous and two homologous prime-boost regimens using MVA-BN(R)-Filo and Ad26.ZEBOV administered in different sequences at Days 1 and 29 in healthy adult subjects aged 18 - 45 years. The study will evaluate the 'omics (transcriptomics, proteomics, lipidomics, metabolomics), antibodies for immunogenicity, CMI, ADCC, and plasmablast responses to MVA-BN(R)-Filo and Ad26.ZEBOV vaccines. The primary objectives of this study are: 1) To assess the safety and reactogenicity of each study group. 2) To assess responses to the study vaccination by study group after the first, second and third dose by transcriptomics. 3) To assess the peak antibody response to the study vaccination by study group to filovirus antigens.

Read the detailed description

This is a Phase 1, double-blind, randomized trial to evaluate the safety and immunogenicity of two heterologous and two homologous prime-boost regimens using MVA-BN(R)-Filo and Ad26.ZEBOV administered in different sequences at Days 1 and 29 in healthy adult subjects aged 18 - 45 years. The two heterologous prime-boost groups will also receive MVA-BN(R)-Filo at day 366. Sixty subjects will be randomized 1:1:1:1 to one of four study groups (15 per group). Subjects and study staff will be blinded to a subject's study vaccine assignment within study vaccination schedule (e.g., enrollment into Group 1 or 4 versus 2 or 3 will be known). The study will evaluate the 'omics (transcriptomics, proteomics, lipidomics, metabolomics), antibodies for immunogenicity, CMI, ADCC, and plasmablast responses to MVA-BN(R)-Filo and Ad26.ZEBOV vaccines. The primary objectives of this study are: 1) To assess the safety and reactogenicity of each study group. 2) To assess responses to the study vaccination by study group after the first, second and third dose by transcriptomics. 3) To assess the peak antibody response to the study vaccination by study group to filovirus antigens. Secondary objectives are: 1) To assess antigen-specific cell-mediated immune (CMI) responses to the study vaccination by study group. 2) To assess antibody-dependent cell-mediated cytotoxicity (ADCC) responses to the study vaccination by study group.

Being tested
Ad26 Zaire Ebola Vaccine, MVA Multi-Filo Ebola Vaccine
Keywords
Ad26.ZEBOV, Ebola, Immunogenicity, Marburg, MVA-BN-Filo, Omics, Zaire
Medical subject headings
Hemorrhagic Fever, Ebola, Marburg Virus Disease

What participants receive

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

  • Ad26 Zaire Ebola VaccineBiological

    A recombinant adenovirus vector comprising a polynucleotide encoding a filovirus antigenic protein, wherein the recombinant adenovirus vector comprises an adenovirus 26 capsid protein.

  • MVA Multi-Filo Ebola VaccineBiological

    A multivalent MVA-BN Filovirus vaccine, designed to protect against Ebola Zaire, Ebola Sudan and Marburg virus.

Study groups in NCT02891980
Study groupRoleWhat they receive
Group 2ExperimentalMVA-BN®-Filo Day 1, Ad26.ZEBOV Day 29 and MVA-BN®-Filo Day 366
Receives: Biological: Ad26 Zaire Ebola Vaccine; Biological: MVA Multi-Filo Ebola Vaccine
Group 3ExperimentalAd26.ZEBOV Day 1, MVA-BN®-Filo Day 29 and MVA-BN®-Filo Day 366
Receives: Biological: Ad26 Zaire Ebola Vaccine; Biological: MVA Multi-Filo Ebola Vaccine
Group 4ExperimentalAd26.ZEBOV Day 1, Ad26.ZEBOV Day 29
Receives: Biological: Ad26 Zaire Ebola Vaccine
Group1ExperimentalMVA-BN®-Filo Day 1 and MVA-BN®-Filo Day 29
Receives: Biological: MVA Multi-Filo Ebola Vaccine

What is being measured

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

  1. Determine the differential expression from baseline in mRNA after each study vaccination by study group

    Measured: Screening and Days 1, 2, 4, 8, 15, 29, 30, 32, 36, 43, and 57 for Groups 1 and 4; additionally Days 366, 367, 369, 373, 380, 394, and 546 for Groups 2 and 3.

  2. Determine the number of subjects with a vaccine-related serious adverse event (SAE) from the time of first study vaccination by study group through the duration of the study

    Measured: Day 1 through Day 366 in Groups 1 and 4; Day 1 through Day 546 in Groups 2 and 3

  3. Determine the number of subjects with a vaccine-related unsolicited adverse event (AE) from the time of each study vaccination by study group

    Measured: Day 1 through Day 29

  4. Determine the number of subjects with solicited local and systemic reactogenicity events from the time of study vaccination by study group.

    Measured: Day 1 through Day 8

  5. Determine the peak antibody response against filovirus glycoproteins (GPs) for each study group

    Measured: Days 1, 15, 29, 36, 43, 57, 209, and 366 for Groups 1 and 4; additionally Days 369, 373, 380, 394, 546 for Groups 2 and 3.

Secondary outcomes (2)

  1. Determine the change in CMI response from baseline against filovirus antigen using peptide pools and measurement by intracellular cytokine staining (ICS) in each of the study groups

    Measured: Days 1, 15, 29, 36, 43, 57, 209, and 366 in Groups 1 and 4; additionally Days 369, 373, 380, 394, and 546 in Groups 2 and 3.

  2. Determine the change in the ADCC from baseline in each of the study groups

    Measured: Days 1, 15, 29, 36, 43, 57, 209, and 366 for Groups 1 and 4; additionally Days 373, 380, 394, and 546 for Groups 2 and 3.

Timeline

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

  1. First posted8 Sep 2016 (estimated)
  2. Study start24 Mar 2017
  3. Primary completion21 Mar 2019
  4. Study completion21 Mar 2019

Resources

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
Double blind
Who is masked
Participant, Investigator
Enrolment
65 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02891980
Sponsor's protocol ID
14-0094
Status last verified
19 Jul 2017
First submitted
1 Sep 2016
Last updated
29 Jul 2025
Results posted
No
FDA-regulated drug
Yes
FDA-regulated device
No

Publications

  • Rostad CA, Yildirim I, Kao C, Yi J, Kamidani S, Peters E, Stephens K, Gibson T, Hsiao HM, Singh K, Spearman P, McCracken C, Agbakoba V, Tomashek KM, Goll JB, Gelber CE, Johnson RA, Lee S, Maner-Smith K, Bosinger S, Ortlund EA, Chen X, Anderson LJ, Wrammert J, Suthar M, Rouphael N, Anderson EJ. A Phase 1 randomized trial of homologous and heterologous filovirus vaccines with a late booster dose. NPJ Vaccines. 2024 Dec 23;9(1):255. doi: 10.1038/s41541-024-01042-4.

    PubMed 39715748

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Ad26 Zaire Ebola Vaccine and MVA Multi-Filo Ebola Vaccine in people with Ebola Disease and Marburg Disease, run by National Institute of Allergy and Infectious Diseases (NIAID) at 1 site in United States.

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 35 inclusion and 47 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 29 Jul 2025. 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 States. 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?

Determine the differential expression from baseline in mRNA after each study vaccination by study group (time frame: Screening and Days 1, 2, 4, 8, 15, 29, 30, 32, 36, 43, and 57 for Groups 1 and 4; additionally Days 366, 367, 369, 373, 380, 394, and 546 for Groups 2 and 3.). The study lists 5 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 NCT02891980, which also lists 1 linked publication.

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 29 Jul 2025.

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