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HealthyPhase 3NCT02543268

A Study to Evaluate the Immunogenicity, Safety and Tolerability of Ad26.ZEBOV and MVA-BN-Filo in Healthy Adult Participants

A Phase 3 study testing Ad26.ZEBOV-Batch #1, Ad26.ZEBOV-Batch #2 and Ad26.ZEBOV-Batch #3 in people with Healthy, run by Crucell Holland BV at 6 sites 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

The purpose of this study is to compare the humoral immune response induced by 3 different batches of Ad26.ZEBOV as measured by enzyme - linked immunosorbent assay (ELISA) against the Ebola virus (EBOV) GP (Glycoprotein) at 56 days post prime. 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?
Ad26.ZEBOV-Batch #1, Ad26.ZEBOV-Batch #2 and Ad26.ZEBOV-Batch #3
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
329 participants
Where
6 sitesUnited States
Study dates
21 Sep 2015to 20 Jul 2016
Phase
Phase 3
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

  • Healthy in the Investigator's clinical judgment on the basis of medical history, physical examination, electrocardiogram (ECG) and vital signs performed at Screening
  • Healthy on the basis of clinical laboratory tests performed at Screening
  • Before randomization, a woman must be either of childbearing potential and practicing (or intending to practice) a highly effective method of birth control consistent with local regulations regarding the use of birth control methods for participants participating in clinical studies, beginning at least 28 days prior to vaccination OR not of childbearing potential: postmenopausal (greater than [>] 45 years of age with amenorrhea for at least 2 years or any age with amenorrhea for at least 6 months, and a serum follicle stimulating hormone (FSH) level >40 international unit per milliliter [IU/L]); permanently sterilized (for example, bilateral tubal occlusion [which includes tubal ligation procedures as consistent with local regulations], hysterectomy, bilateral salpingectomy, bilateral oophorectomy); or otherwise be incapable of pregnancy
  • Woman of childbearing potential must have a negative serum [beta-human chorionic gonadotropin (beta-hCG)] at Screening and a negative urine beta-hCG pregnancy test immediately prior to each study vaccine administration
  • Man who is sexually active with a woman of childbearing potential and has not had a vasectomy performed more than 1 year prior to Screening must be willing to use condoms for sexual intercourse beginning prior to enrollment, in addition to the documented birth control method used by the female partner

Who cannot join

  • Having received a candidate Ebola vaccine
  • Diagnosed with Ebola virus disease, or prior exposure to Ebola virus, including travel to West Africa less than 1 month prior to Screening. West Africa includes but is not limited to the countries of Guinea, Liberia, Mali, and Sierra Leone
  • Having received any experimental candidate adenovirus serotype 26 (vector: Ad26) or Modified Vaccinia Ankara (MVA-) based 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, egg products and aminoglycosides
  • Presence of acute illness or temperature greater than or equal to (>=) 38.0 centigrade (°C) on Day 1

Trial locations and contacts

6 sites in 1 country.

6 sites in 1 country

United States6 sites

  • Study site

    Huntsville, Alabama

  • Study site

    Melbourne, Florida

  • Study site

    Mishawaka, Indiana

  • Study site

    Peoria, Illinois

  • Study site

    Rockville, Maryland

  • Study site

    San Diego, California

Other trials in United States

About this study

Official title: A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Immunogenicity, Safety and Tolerability of a Heterologous Prime-Boost Regimen Using Three Different Batches of Ad26.ZEBOV and a Single Batch of MVA-BN®-Filo in Healthy Adult Subjects

The purpose of this study is to compare the humoral immune response induced by 3 different batches of Ad26.ZEBOV as measured by enzyme - linked immunosorbent assay (ELISA) against the Ebola virus (EBOV) GP (Glycoprotein) at 56 days post prime.

Read the detailed description

This is a randomized, double - blind, placebo - controlled, parallel - group, multicenter, Phase 3 study to evaluate the immunogenic equivalence of a heterologous prime - boost regimen using 3 different batches of Ad26.ZEBOV in healthy adult participants. The study consists of a screening period of up to 6 weeks, a vaccination period in which participants will be vaccinated at baseline (Day 1), followed by a boost vaccination on Day 57, and a post-vaccination phase until 6 months post-boost visit (Day 237). The participants will be randomized at baseline (on Day 1) in a 2:2:2:1 ratio to Groups 1, 2, 3 and 4. Safety will be monitored throughout the study.

Conditions
Healthy
Being tested
Ad26.ZEBOV-Batch #1, Ad26.ZEBOV-Batch #2, Ad26.ZEBOV-Batch #3, MVA-BN-Filo, Placebo
Keywords
Ebola viruses, Ebola virus disease (EVD), Filoviruses, Monovalent vaccine, Safety, Immunogenicity, Human adenovirus serotype 26 (Ad26) expressing the Ebola virus Mayinga variant glycoprotein (Ad26.ZEBOV), Modified Vaccinia Virus Ankara - Bavarian Nordic Filo-vector (MVA-BN Filo), Healthy participants
Medical subject headings
Hemorrhagic Fever, Ebola

What participants receive

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

  • Ad26.ZEBOV-Batch #1Biological

    Ad26.ZEBOV - Batch #1, live, replication incompetent vaccine, sterile suspension of 0.5 milliliter (mL) intramuscular (IM) injection of 5*10^10 viral particles on Day 1

  • Ad26.ZEBOV-Batch #2Biological

    Ad26.ZEBOV - Batch #2, live, replication incompetent vaccine, sterile suspension of 0.5 milliliter (mL) intramuscular (IM) injection of 5*10^10 viral particles on Day 1

  • Ad26.ZEBOV-Batch #3Biological

    Ad26.ZEBOV - Batch #3, live, replication incompetent vaccine, sterile suspension of 0.5 milliliter (mL) intramuscular (IM) injection of 5*10^10 viral particles on Day 1

  • MVA-BN-FiloBiological

    MVA-BN-Filo- live replication incompetent vaccine, 0.5 mL IM injection of 1*10^8 Infectious Unit [Inf. U.] once on Day 57.

  • PlaceboBiological

    One 0.5 ml IM injection of 0.9% saline once on Day 1 and Day 57.

Study groups in NCT02543268
Study groupRoleWhat they receive
Group 1ExperimentalAd26.ZEBOV -Batch #1, single dose intramuscular (IM) injection on Day 1; MVA-BN-Filo, single dose IM injection on Day 57
Receives: Biological: Ad26.ZEBOV-Batch #1; Biological: MVA-BN-Filo
Group 2ExperimentalAd26.ZEBOV -Batch #2, single dose intramuscular (IM) injection on Day 1; MVA-BN-Filo, single dose IM injection on Day 57
Receives: Biological: Ad26.ZEBOV-Batch #2; Biological: MVA-BN-Filo
Group 3ExperimentalAd26.ZEBOV -Batch #3, single dose intramuscular (IM) injection on Day 1; MVA-BN-Filo, single dose IM injection on Day 57
Receives: Biological: Ad26.ZEBOV-Batch #3; Biological: MVA-BN-Filo
Group 4ExperimentalPlacebo (0.9% saline)- single dose IM injection on Day 1 and Day 57
Receives: Biological: Placebo

What is being measured

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

  1. Immune Responses to the Study Vaccine Regimens against Ebola virus (EBOV) Glycoprotein (GP) using EBOV GP protein enzyme-linked immunosorbent assay (ELISA)

    The humoral immune response will be assessed by enzyme-linked immunosorbent assay (ELISA) binding antibody

    Measured: At 56 days post prime vaccination

Secondary outcomes (4)

  1. Immune Responses to the Study Vaccine Regimens against Ebola virus (EBOV) Glycoprotein (GP) using EBOV GP protein enzyme-linked immunosorbent assay (ELISA)

    The humoral immune response will be assessed by enzyme-linked immunosorbent assay (ELISA) binding antibody

    Measured: At Days 1, 29 post prime dose and at days 21, 42, and 180 post boost vaccination

  2. Number of Participants with Solicited Local and Systemic Adverse Events (AEs)

    Measured: Up to 7 days after each vaccination

  3. Number of Participants with Adverse Events (AEs)

    Measured: Up to 42 days post boost vaccination

  4. Number of Participants with Serious Adverse Events (SAEs)

    Measured: Continuous throughout the duration of study (Up to 180 Days post boost vaccination)

Timeline

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

  1. First posted7 Sep 2015 (estimated)
  2. Study start21 Sep 2015
  3. Primary completion22 Jan 2016
  4. Study completion20 Jul 2016

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 3
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
329 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02543268
Sponsor's protocol ID
CR107786
Other IDs
VAC52150EBL3003
Status last verified
Jun 2025
First submitted
4 Sep 2015
Last updated
22 Jun 2025
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes

Publications

  • Bockstal V, Gaddah A, Goldstein N, Shukarev G, Bart S, Luhn K, Robinson C, Anumendem D, Leyssen M, Douoguih M. Assessments of different batches and dose levels of a two-dose Ad26.ZEBOV and MVA-BN-Filo vaccine regimen. NPJ Vaccines. 2021 Dec 20;6(1):157. doi: 10.1038/s41541-021-00402-8.

    PubMed 34930928

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Ad26.ZEBOV-Batch #1, Ad26.ZEBOV-Batch #2 and Ad26.ZEBOV-Batch #3 in people with Healthy, run by Crucell Holland BV at 6 sites 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 5 inclusion and 5 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 22 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 6 sites 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

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?

Immune Responses to the Study Vaccine Regimens against Ebola virus (EBOV) Glycoprotein (GP) using EBOV GP protein enzyme-linked immunosorbent assay (ELISA) (time frame: At 56 days post prime vaccination). 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 NCT02543268, 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 22 Jun 2025.

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Clinical Trial NCT02543268 | AzTrials