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

Sponsor

Crucell Holland BV (Industry)

Overall Status

Completed

CT.gov ID

NCT02543268

Collaborator

(none)

329

Enrollment

Locations

Arms

Duration (Months)

54.8

Patients Per Site

5.5

Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Healthy	Biological: Ad26.ZEBOV-Batch #1 Biological: Ad26.ZEBOV-Batch #2 Biological: Ad26.ZEBOV-Batch #3 Biological: MVA-BN-Filo Biological: Placebo	Phase 3

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.

Study Design

Study Type:

Interventional

Actual Enrollment :

329 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Double (Participant, Investigator)

Primary Purpose:

Prevention

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

Study Start Date :

Sep 1, 2015

Actual Primary Completion Date :

Jan 1, 2016

Actual Study Completion Date :

Jul 1, 2016

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Group 1 Ad26.ZEBOV -Batch #1, single dose intramuscular (IM) injection on Day 1; MVA-BN-Filo, single dose IM injection on Day 57	Biological: Ad26.ZEBOV-Batch #1 Ad26.ZEBOV - Batch #1, live, replication incompetent vaccine, sterile suspension of 0.5 milliliter (mL) intramuscular (IM) injection of 510^10 viral particles on Day 1 Biological: MVA-BN-Filo* MVA-BN-Filo- live replication incompetent vaccine, 0.5 mL IM injection of 1*10^8 Infectious Unit [Inf. U.] once on Day 57.
Experimental: Group 2 Ad26.ZEBOV -Batch #2, single dose intramuscular (IM) injection on Day 1; MVA-BN-Filo, single dose IM injection on Day 57	Biological: Ad26.ZEBOV-Batch #2 Ad26.ZEBOV - Batch #2, live, replication incompetent vaccine, sterile suspension of 0.5 milliliter (mL) intramuscular (IM) injection of 510^10 viral particles on Day 1 Biological: MVA-BN-Filo* MVA-BN-Filo- live replication incompetent vaccine, 0.5 mL IM injection of 1*10^8 Infectious Unit [Inf. U.] once on Day 57.
Experimental: Group 3 Ad26.ZEBOV -Batch #3, single dose intramuscular (IM) injection on Day 1; MVA-BN-Filo, single dose IM injection on Day 57	Biological: Ad26.ZEBOV-Batch #3 Ad26.ZEBOV - Batch #3, live, replication incompetent vaccine, sterile suspension of 0.5 milliliter (mL) intramuscular (IM) injection of 510^10 viral particles on Day 1 Biological: MVA-BN-Filo* MVA-BN-Filo- live replication incompetent vaccine, 0.5 mL IM injection of 1*10^8 Infectious Unit [Inf. U.] once on Day 57.
Experimental: Group 4 Placebo (0.9% saline)- single dose IM injection on Day 1 and Day 57	Biological: Placebo One 0.5 ml IM injection of 0.9% saline once on Day 1 and Day 57.

Outcome Measures

Primary Outcome Measures

Immune Responses to the Study Vaccine Regimens against Ebola virus (EBOV) Glycoprotein (GP) using EBOV GP protein enzyme-linked immunosorbent assay (ELISA) [At 56 days post prime vaccination]
The humoral immune response will be assessed by enzyme-linked immunosorbent assay (ELISA) binding antibody

Secondary Outcome Measures

Immune Responses to the Study Vaccine Regimens against Ebola virus (EBOV) Glycoprotein (GP) using EBOV GP protein enzyme-linked immunosorbent assay (ELISA) [At Days 1, 29 post prime dose and at days 21, 42, and 180 post boost vaccination]
The humoral immune response will be assessed by enzyme-linked immunosorbent assay (ELISA) binding antibody
Number of Participants with Solicited Local and Systemic Adverse Events (AEs) [Up to 7 days after each vaccination]
Number of Participants with Adverse Events (AEs) [Up to 42 days post boost vaccination]
Number of Participants with Serious Adverse Events (SAEs) [Continuous throughout the duration of study (Up to 180 Days post boost vaccination)]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 50 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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

Contacts and Locations

Locations

	City	State	Country
1	Huntsville	Alabama	United States
2	San Diego	California	United States
3	Melbourne	Florida	United States
4	Peoria	Illinois	United States
5	Mishawaka	Indiana	United States
6	Rockville	Maryland	United States