A Study of 2-dose Vaccine Regimen Using 3 Consecutive Lots of Ad26.ZEBOV and MVA-BN-Filo in Adult Participants

Janssen (J&J Innovative Medicine)

Status and phase: Completed; Phase 3

Conditions: Ebola

Treatments: Biological: Placebo; Biological: MVA-BN-Filo; Biological: Ad26.ZEBOV

Study type: Interventional

Funder types: Industry

Identifiers

NCT04228783

VAC52150EBL3004 (Other Identifier)

CR108694

Details and patient eligibility

About

The purpose of this study is to demonstrate that the paired 2-dose vaccine regimens from 3 consecutively manufactured lots of Adenovirus serotype 26 encoding the Ebola virus Mayinga glycoprotein (Ad26.ZEBOV) as Dose 1 and 3 consecutively manufactured lots of Modified Vaccinia Ankara Bavarian Nordic vector encoding multiple filovirus proteins (MVA-BN-Filo) including the ebola virus mayinga glycoprotein as Dose 2, administered at a 56-day interval, induce an equivalent humoral immune response.

Enrollment: 974 patients

Sex: All

Ages: 18 to 50 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Signed an informed consent form (ICF)
• Medically stable in the investigator's clinical judgment on the basis of physical examination, medical history, and vital signs performed at screening
• Before randomization, a woman must be either: a. Not of childbearing potential; b. Of childbearing potential and practicing an acceptable effective method of birth control and agrees to remain on such a method of birth control from signing the informed consent form (ICF) until at least 3 months post Dose 1 vaccination or 28 days post Dose 2 vaccination or 3 months post booster vaccination (Groups 5-6 only), whichever comes later. Use of hormonal contraception should start at least 28 days before the first administration of study vaccine. Acceptable effective methods for this study include: 1) hormonal contraception; 2) intrauterine device (IUD); 3) intrauterine hormone-releasing system (IUS); 4) male or female condom with or without spermicide; 5) cap, diaphragm, or sponge with a vaginal spermicide; 6) vasectomized partner (the vasectomized partner should be the sole partner for that participant); 7) sexual abstinence
• Women of childbearing potential must have a negative urine Beta-human chorionic gonadotropin (Beta-hCG) pregnancy test at screening and immediately prior to each study vaccine administration
• Available and willing to participate for the duration of the study and follow-up visit
• Willing to provide verifiable identification

Exclusion criteria

• Having received any candidate Ebola vaccine
• Diagnosed with Ebola virus disease (EVD), or prior exposure to Ebola virus, including travel to an area with Ebola outbreak less than 1 month prior to screening (if applicable)
• 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 (this does not include minor illnesses such as diarrhea or mild upper respiratory tract infection) or temperature greater than or equal to (>=) 38.0ºCelcius on Day 1. Participants with such symptoms will be excluded from enrollment at that time but may be rescheduled for enrollment at a later date
• Human immunodeficiency virus (HIV) type 1 or type 2 infection, based on the medical history reported by the participant
• Pregnant, breast-feeding
• History of an underlying clinically significant acute or chronic medical condition

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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974 participants in 6 patient groups, including a placebo group

Active Vaccine: Group 1 (Ad26.ZEBOV-Lot A, MVA-BN-Filo-Lot 1)

Experimental group

Description:

Participants will receive Intramuscular injection (0.5 milliliter \[mL\]) of Adenovirus serotype 26 encoding the Ebola virus Mayinga glycoprotein (Ad26.ZEBOV) as Dose 1 (5\*10\^10 viral particle(s) \[vp\], Lot A) on Day 1, followed by Modified Vaccinia Ankara Bavarian Nordic vector encoding multiple filovirus proteins (MVA-BN-Filo) as Dose 2 (1\*10\^8 infectious unit(s) \[Inf U\], Lot 1) on Day 57.

Treatment:

Biological: Ad26.ZEBOV

Biological: MVA-BN-Filo

Active Vaccine: Group 2 (Ad26.ZEBOV-Lot B, MVA-BN-Filo-Lot 2)

Experimental group

Description:

Participants will receive Intramuscular injection (0.5 mL) of Ad26.ZEBOV as Dose 1 (5\*10\^10 vp, Lot B) on Day 1, followed by MVA-BN-Filo as Dose 2 (1\*10\^8 Inf U, Lot 2) on Day 57.

Treatment:

Biological: Ad26.ZEBOV

Biological: MVA-BN-Filo

Active Vaccine: Group 3 (Ad26.ZEBOV-Lot C, MVA-BN-Filo-Lot 3)

Experimental group

Description:

Participants will receive Intramuscular injection (0.5 mL) of Ad26.ZEBOV as Dose 1 (5\*10\^10 vp, Lot C) on Day 1, followed by MVA-BN-Filo as Dose 2 (1\*10\^8 Inf U, Lot 3) on Day 57.

Treatment:

Biological: Ad26.ZEBOV

Biological: MVA-BN-Filo

Control Vaccine: Group 4 (Placebo)

Placebo Comparator group

Description:

Participants will receive Intramuscular injection (0.5 mL) of placebo (0.9 percent \[%\] saline) matching to Ad26.ZEBOV as Dose 1 on Day 1, followed by placebo matching to MVA-BN-Filo as Dose 2 on Day 57.

Treatment:

Biological: Placebo

Booster Cohort: Group 5 (Ad26.ZEBOV, MVA-BN-Filo, Ad26.ZEBOV)

Experimental group

Description:

Participants will receive Intramuscular injection (0.5 mL) of Ad26.ZEBOV as Dose 1 (5\*10\^10 vp, a single Lot) on Day 1, followed by MVA-BN-Filo as Dose 2 (1\*10\^8 Inf U, a single Lot) on Day 57 and a booster dose of Ad26.ZEBOV (at a dose of 5\*10\^10 vp, a single Lot) 4 months after Dose 2 (on Day 177).

Treatment:

Biological: Ad26.ZEBOV

Biological: MVA-BN-Filo

Booster Cohort: Group 6 (Placebo)

Placebo Comparator group

Description:

Participants will receive Intramuscular injection (0.5 mL) of placebo (0.9% saline) matching to Ad26.ZEBOV as Dose 1 on Day 1, followed by placebo matching to MVA-BN-Filo as Dose 2 on Day 57 and a booster dose of matching placebo on Day 177.

Treatment:

Biological: Placebo