Clinical Trials Register

Summary
EudraCT Number:	2017-001798-18
Sponsor's Protocol Code Number:	C15-33
Clinical Trial Type:	Outside EU/EEA
Date on which this record was first entered in the EudraCT database:	2017-05-10
Trial results	View results

Index
A. PROTOCOL INFORMATION
B. SPONSOR INFORMATION
C. APPLICANT IDENTIFICATION
D. IMP IDENTIFICATION
D.8 INFORMATION ON PLACEBO
E. GENERAL INFORMATION ON THE TRIAL
F. POPULATION OF TRIAL SUBJECTS
G. INVESTIGATOR NETWORKS TO BE INVOLVED IN THE TRIAL
H.4 THIRD COUNTRY IN WHICH THE TRIAL WAS FIRST AUTHORISED

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A. Protocol Information

A.2

EudraCT number

2017-001798-18

A.3

Full title of the trial

Partnership for Research on Ebola VACcinations
P/0307/2021
P/0334/2021

Partenariat de recherche sur les vaccins contre Ebola

A.3.1

Title of the trial for lay people, in easily understood, i.e. non-technical, language

Partnership for Research on Ebola VACcinations

A.3.2

Name or abbreviated title of the trial where available

PREVAC

A.4.1

Sponsor's protocol code number

C15-33

A.5.2

US NCT (ClinicalTrials.gov registry) number

NCT02876328

A.5.4

Other Identifiers

Name:	PACTR	Number:	PACTR201712002760250
Name:	London School of Hygiene & Tropical Medicine	Number:	PREVACEBL3005
Name:	Merck Sharp & Dohme, Corp.	Number:	V920-016
Name:	Janssen Vaccines & Prevention B.V.	Number:	VAC52150EBL2004

A.7

Trial is part of a Paediatric Investigation Plan

Yes

A.8

EMA Decision number of Paediatric Investigation Plan

P/429/2021

B. Sponsor Information
B.Sponsor: 1
B.1.1	Name of Sponsor	Inserm
B.1.3.4	Country	France
B.3.1 and B.3.2	Status of the sponsor	Non-Commercial
B.4 Source(s) of Monetary or Material Support for the clinical trial:
B.4.1	Name of organisation providing support	European and Developing Countries Clinical Trials Partnership Association implementing EDCTP2
B.4.2	Country	Netherlands
B.4.1	Name of organisation providing support	National Institute of Allergy and Infectious Diseases
B.4.2	Country	United States
B.4.1	Name of organisation providing support	London School of Hygiene & Tropical Medicine
B.4.2	Country	United Kingdom
B.5 Contact point designated by the sponsor for further information on the trial
B.5.1	Name of organisation	Inserm
B.5.2	Functional name of contact point	Hélène Espérou
B.5.3	Address:
B.5.3.1	Street Address	101 rue de Tolbiac
B.5.3.2	Town/ city	Paris
B.5.3.3	Post code	75654 Cedex 13
B.5.3.4	Country	France
B.5.6	E-mail	rqrc.siege@inserm.fr

D. IMP Identification
D.IMP: 1
D.1.2 and D.1.3	IMP Role	Test
D.2	Status of the IMP to be used in the clinical trial
D.2.1	IMP to be used in the trial has a marketing authorisation	Yes
D.2.1.1.1	Trade name	Ervebo
D.2.1.1.2	Name of the Marketing Authorisation holder	Merck Sharp & Dohme B.V.
D.2.1.2	Country which granted the Marketing Authorisation	European Union
D.2.5	The IMP has been designated in this indication as an orphan drug in the Community	No
D.2.5.1	Orphan drug designation number
D.3 Description of the IMP
D.3.4	Pharmaceutical form	Solution for injection
D.3.4.1	Specific paediatric formulation	No
D.3.7	Routes of administration for this IMP	Intramuscular use
D.3.11 The IMP contains an:
D.3.11.1	Active substance of chemical origin	No
D.3.11.2	Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP)	Yes
	The IMP is a:
D.3.11.3	Advanced Therapy IMP (ATIMP)	No
D.3.11.3.1	Somatic cell therapy medicinal product	No
D.3.11.3.2	Gene therapy medical product	No
D.3.11.3.3	Tissue Engineered Product	No
D.3.11.3.4	Combination ATIMP (i.e. one involving a medical device)	No
D.3.11.3.5	Committee on Advanced therapies (CAT) has issued a classification for this product	No
D.3.11.4	Combination product that includes a device, but does not involve an Advanced Therapy	No
D.3.11.5	Radiopharmaceutical medicinal product	No
D.3.11.6	Immunological medicinal product (such as vaccine, allergen, immune serum)	Yes
D.3.11.7	Plasma derived medicinal product	No
D.3.11.8	Extractive medicinal product	No
D.3.11.9	Recombinant medicinal product	Yes
D.3.11.10	Medicinal product containing genetically modified organisms	Yes
D.3.11.11	Herbal medicinal product	No
D.3.11.12	Homeopathic medicinal product	No
D.3.11.13	Another type of medicinal product	No
D.IMP: 2
D.1.2 and D.1.3	IMP Role	Test
D.2	Status of the IMP to be used in the clinical trial
D.2.1	IMP to be used in the trial has a marketing authorisation	Yes
D.2.1.1.1	Trade name	Zabdeno
D.2.1.1.2	Name of the Marketing Authorisation holder	Janssen-Cilag International NV
D.2.1.2	Country which granted the Marketing Authorisation	European Union
D.2.5	The IMP has been designated in this indication as an orphan drug in the Community	No
D.2.5.1	Orphan drug designation number
D.3 Description of the IMP
D.3.4	Pharmaceutical form	Suspension for injection
D.3.4.1	Specific paediatric formulation	No
D.3.7	Routes of administration for this IMP	Intramuscular use
D.3.11 The IMP contains an:
D.3.11.1	Active substance of chemical origin	No
D.3.11.2	Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP)	Yes
	The IMP is a:
D.3.11.3	Advanced Therapy IMP (ATIMP)	No
D.3.11.3.1	Somatic cell therapy medicinal product	No
D.3.11.3.2	Gene therapy medical product	No
D.3.11.3.3	Tissue Engineered Product	No
D.3.11.3.4	Combination ATIMP (i.e. one involving a medical device)	No
D.3.11.3.5	Committee on Advanced therapies (CAT) has issued a classification for this product	No
D.3.11.4	Combination product that includes a device, but does not involve an Advanced Therapy	No
D.3.11.5	Radiopharmaceutical medicinal product	No
D.3.11.6	Immunological medicinal product (such as vaccine, allergen, immune serum)	Yes
D.3.11.7	Plasma derived medicinal product	No
D.3.11.8	Extractive medicinal product	No
D.3.11.9	Recombinant medicinal product	Yes
D.3.11.10	Medicinal product containing genetically modified organisms	Yes
D.3.11.11	Herbal medicinal product	No
D.3.11.12	Homeopathic medicinal product	No
D.3.11.13	Another type of medicinal product	No
D.IMP: 3
D.1.2 and D.1.3	IMP Role	Test
D.2	Status of the IMP to be used in the clinical trial
D.2.1	IMP to be used in the trial has a marketing authorisation	Yes
D.2.1.1.1	Trade name	Mvabea
D.2.1.1.2	Name of the Marketing Authorisation holder	Janssen-Cilag International NV
D.2.1.2	Country which granted the Marketing Authorisation	European Union
D.2.5	The IMP has been designated in this indication as an orphan drug in the Community	No
D.2.5.1	Orphan drug designation number
D.3 Description of the IMP
D.3.4	Pharmaceutical form	Suspension for injection
D.3.4.1	Specific paediatric formulation	No
D.3.7	Routes of administration for this IMP	Intramuscular use
D.3.11 The IMP contains an:
D.3.11.1	Active substance of chemical origin	No
D.3.11.2	Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP)	Yes
	The IMP is a:
D.3.11.3	Advanced Therapy IMP (ATIMP)	No
D.3.11.3.1	Somatic cell therapy medicinal product	No
D.3.11.3.2	Gene therapy medical product	No
D.3.11.3.3	Tissue Engineered Product	No
D.3.11.3.4	Combination ATIMP (i.e. one involving a medical device)	No
D.3.11.3.5	Committee on Advanced therapies (CAT) has issued a classification for this product	No
D.3.11.4	Combination product that includes a device, but does not involve an Advanced Therapy	No
D.3.11.5	Radiopharmaceutical medicinal product	No
D.3.11.6	Immunological medicinal product (such as vaccine, allergen, immune serum)	Yes
D.3.11.7	Plasma derived medicinal product	No
D.3.11.8	Extractive medicinal product	No
D.3.11.9	Recombinant medicinal product	Yes
D.3.11.10	Medicinal product containing genetically modified organisms	Yes
D.3.11.11	Herbal medicinal product	No
D.3.11.12	Homeopathic medicinal product	No
D.3.11.13	Another type of medicinal product	No

D.8 Information on Placebo
D.8 Placebo: 1
D.8.1	Is a Placebo used in this Trial?	Yes
D.8.3	Pharmaceutical form of the placebo	Solution for injection
D.8.4	Route of administration of the placebo	Intramuscular use

E. General Information on the Trial

E.1 Medical condition or disease under investigation

E.1.1

Medical condition(s) being investigated

Ebola virus disease (EVD)

E.1.1.1

Medical condition in easily understood language

Ebola virus disease (EVD), formerly known as Ebola hemorrhagic fever, is a severe, very often fatal illness in humans

E.1.1.2

Therapeutic area

Diseases [C] - Virus Diseases [C02]

MedDRA Classification

E.1.2 Medical condition or disease under investigation

E.1.2	Version	21.1
E.1.2	Level	LLT
E.1.2	Classification code	10014074
E.1.2	Term	Ebola virus infection
E.1.2	System Organ Class	100000004862

E.1.3

Condition being studied is a rare disease

E.2 Objective of the trial

E.2.1

Main objective of the trial

Antibody response 12 months after randomization

E.2.2

Secondary objectives of the trial

- antibody response at 7, 14, 28, 56, 63 days and at 3, 6, 24, 36, 48, 60 months after randomization
- serious adverse events up to 60 months after randomization
- injection site reactions and adverse events at the prime- and booster-vaccination visits, during the first week following randomization and through 7, 14, and 28 days and through 3 months
- changes in biochemical markers and complete blood count measurements at 7 and 63 days after randomization (children only)
- operational research including ethnographic, participatory and/or qualitative
- analyze the early vaccine signature, identify early correlates of durable antibody responses and propose in silico methods to optimally allocate vaccine strategies at the individual level

E.2.3

Trial contains a sub-study

Yes

E.2.3.1

Full title, date and version of each sub-study and their related objectives

- PREVAC Immunological Substudy Protocol, version 7.0, 13 August 2021: to analyze T cell responses induced by the vaccines
- PREVAC Saliva Sample Substudy, version 7.0, 13 August 2021: to estimate the proportion of children who shed vaccine virus and to quantify the rVSVΔG-ZEBOV-GP vaccine shed in children (participants aged < 18 years) after the prime and boost vaccinations
- Malaria and helminth infections susbstudy, version 7.0, 13 August 2021: to determine whether the rate of decline in antibody titre to the Ebola virus glycoprotein induced by immunisation with the vaccines is influenced by exposure to malaria or helminth infections
- Empirical research on barriers and facilitators to study retention in the PREVAC trial, version 7.0, 13 August 2021: 1. Identify multilevel facilitators and barriers to participant retention in PREVAC through retrospective qualitative research with participants after the conclusion of the blinded trial period, 2. Identify factors that predict participant retention, loss-to-follow-up, and timeliness of appointment attendance during the unblinded PREVAC long-term follow-up period (from 12 months up to 5 years) through prospective research

E.3

Principal inclusion criteria

- Informed consent/assent
- Age greater than or equal to 1 year
- Planned residency in the area of the study site for the next 12 months
- Willingness to comply with the protocol requirements

E.4

Principal exclusion criteria

- Fever greater than 38º Celsius
- History of EVD (self-report)
- Pregnancy (a negative urine pregnancy test is required for females of child-bearing potential, i.e., females who have experienced menarche or who are aged 14 years and older)
- Positive HIV test for participants less than 18 years of age
- Reported current breast-feeding
- Prior vaccination against Ebola (self-report)
- Any vaccination in the past 28 days or planned within the 28 days after randomization (initial vaccination)
- In the judgement of the clinician, any clinically significant acute/chronic condition that would limit the ability of the participant to meet the requirements of the study protocol

E.5 End points

E.5.1

Primary end point(s)

GP-EBOV antibody response

E.5.1.1

Timepoint(s) of evaluation of this end point

12 months after randomization

E.5.2

Secondary end point(s)

There are a number of secondary endpoints. Antibody levels will be determined at multiple time points to assess the immediacy and long-term durability of the response. SAEs through 60 months will be collected. AEs of lesser severity, including injection site reactions and targeted symptoms, will be collected following the initial vaccination and following the booster. In addition, substudies will examine a) T cell and memory B cell changes, b) viral shedding and c) the relationship between the levels of exposure to malaria and helminth infections and the rate of decline in antibody titre to Ebola.

E.5.2.1

Timepoint(s) of evaluation of this end point

Up to 60 months after randomization

E.6 and E.7 Scope of the trial

E.6

Scope of the trial

E.6.1

Diagnosis

E.6.2

Prophylaxis

Yes

E.6.3

Therapy

E.6.4

Safety

Yes

E.6.5

Efficacy

E.6.6

Pharmacokinetic

E.6.7

Pharmacodynamic

E.6.8

Bioequivalence

E.6.9

Dose response

E.6.10

Pharmacogenetic

E.6.11

Pharmacogenomic

E.6.12

Pharmacoeconomic

E.6.13

Others

Yes

E.6.13.1

Other scope of the trial description

- Immunogenicity
- Ethnographic, participatory and/or qualitative research

E.7

Trial type and phase

E.7.1

Human pharmacology (Phase I)

E.7.1.1

First administration to humans

E.7.1.2

Bioequivalence study

E.7.1.3

Other

E.7.1.3.1

Other trial type description

E.7.2

Therapeutic exploratory (Phase II)

Yes

E.7.3

Therapeutic confirmatory (Phase III)

E.7.4

Therapeutic use (Phase IV)

E.8 Design of the trial

E.8.1

Controlled

Yes

E.8.1.1

Randomised

Yes

E.8.1.2

Open

E.8.1.3

Single blind

E.8.1.4

Double blind

Yes

E.8.1.5

Parallel group

Yes

E.8.1.6

Cross over

E.8.1.7

Other

E.8.2

Comparator of controlled trial

E.8.2.1

Other medicinal product(s)

E.8.2.2

Placebo

Yes

E.8.2.3

Other

E.8.2.4

Number of treatment arms in the trial

E.8.3

Will this trial be conducted at a single site globally?

E.8.4

Will this trial be conducted at multiple sites globally?

Yes

E.8.6 Trial involving sites outside the EEA

E.8.6.2

Trial being conducted completely outside of the EEA

Yes

E.8.6.3

Specify the countries outside of the EEA in which trial sites are planned

Guinea

Liberia

Mali

Sierra Leone

E.8.7

Trial has a data monitoring committee

Yes

E.8.8

Definition of the end of the trial and justification where it is not the last visit of the last subject undergoing the trial

For regulatory purpose, the study completion for PREVAC is defined as the time when database locks are achieved for both the M12 non-validated and validated FANG GP-ELISA assay results.
The study completion for the long term follow-up of PREVAC is defined as the time when database locks are achieved for both the M60 non-validated and validated FANG GP-ELISA assay results.

E.8.9 Initial estimate of the duration of the trial

E.8.9.2

In all countries concerned by the trial years

E.8.9.2

In all countries concerned by the trial months

E.8.9.2

In all countries concerned by the trial days

F. Population of Trial Subjects

F.1 Age Range

F.1.1

Trial has subjects under 18

Yes

F.1.1

Number of subjects for this age range:

1400

F.1.1.1

In Utero

F.1.1.2

Preterm newborn infants (up to gestational age < 37 weeks)

F.1.1.3

Newborns (0-27 days)

F.1.1.4

Infants and toddlers (28 days-23 months)

Yes

F.1.1.4.1

Number of subjects for this age range:

233

F.1.1.5

Children (2-11years)

Yes

F.1.1.5.1

Number of subjects for this age range:

700

F.1.1.6

Adolescents (12-17 years)

Yes

F.1.1.6.1

Number of subjects for this age range:

467

F.1.2

Adults (18-64 years)

Yes

F.1.2.1

Number of subjects for this age range:

3450

F.1.3

Elderly (>=65 years)

Yes

F.1.3.1

Number of subjects for this age range:

F.2 Gender

F.2.1

Female

Yes

F.2.2

Male

Yes

F.3 Group of trial subjects

F.3.1

Healthy volunteers

Yes

F.3.2

Patients

F.3.3

Specific vulnerable populations

Yes

F.3.3.1

Women of childbearing potential not using contraception

F.3.3.2

Women of child-bearing potential using contraception

Yes

F.3.3.3

Pregnant women

F.3.3.4

Nursing women

F.3.3.5

Emergency situation

F.3.3.6

Subjects incapable of giving consent personally

Yes

F.3.3.6.1

Details of subjects incapable of giving consent

Children

F.3.3.7

Others

F.4 Planned number of subjects to be included

F.4.2

For a multinational trial

F.4.2.2

In the whole clinical trial

4900

F.5

Plans for treatment or care after the subject has ended the participation in the trial (if it is different from the expected normal treatment of that condition)

None

G. Investigator Networks to be involved in the Trial

H.4 Third Country in which the Trial was first authorised
H.4.1	Third Country in which the trial was first authorised:	Guinea

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