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

• Register: ClinicalTrials.gov
• Last refreshed on: 23 October 2023
• Main ID: NCT02543268
• Date of registration: 04/09/2015
• Prospective Registration: Yes
• Primary sponsor: Crucell Holland BV
• Public title: A Study to Evaluate the Immunogenicity, Safety and Tolerability of Ad26.ZEBOV and MVA-BN-Filo in Healthy Adult Participants
• Scientific 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
• Date of first enrolment: September 21, 2015
• Target sample size: 329
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/ct2/show/NCT02543268
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Prevention. Masking: Double (Participant, Investigator).
• Phase: Phase 3

Countries of recruitment

United States

Contacts

• Name: Crucell Holland BV Clinical Trial
• Affiliation: Crucell Holland BV

Key inclusion & exclusion criteria

Inclusion Criteria:

- 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

Exclusion Criteria:

- 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



Age minimum: 18 Years
Age maximum: 50 Years
Gender: All

Health Condition(s) or Problem(s) studied

Healthy

Intervention(s)

Biological: Ad26.ZEBOV-Batch #1

Biological: Placebo

Biological: Ad26.ZEBOV-Batch #2

Biological: MVA-BN-Filo

Biological: Ad26.ZEBOV-Batch #3

Primary Outcome(s)

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]

Secondary Outcome(s)

Number of Participants with Solicited Local and Systemic Adverse Events (AEs) [Time Frame: Up to 7 days after each vaccination]

Number of Participants with Serious Adverse Events (SAEs) [Time Frame: Continuous throughout the duration of study (Up to 180 Days post boost vaccination)]

Number of Participants with Adverse Events (AEs) [Time Frame: Up to 42 days post boost vaccination]

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 Days 1, 29 post prime dose and at days 21, 42, and 180 post boost vaccination]

Secondary ID(s)

VAC52150EBL3003

CR107786

Source(s) of Monetary Support

Please refer to primary and secondary sponsors