Clinical Trials Register

Summary
EudraCT Number:	2016-004853-34
Sponsor's Protocol Code Number:	CT1401-B
Clinical Trial Type:	Outside EU/EEA
Date on which this record was first entered in the EudraCT database:	2017-05-04
Trial 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

Expand All Collapse All

A. Protocol Information

A.2

EudraCT number

2016-004853-34

A.3

Full title of the trial

A Phase 2 Randomized, Multi-Center Double-Blind, Placebo-Controlled Study to Evaluate the Safety and Immunogenicity of the V920 (rVSVΔG-ZEBOV-GP) Ebola Virus Vaccine Candidate in HIV-Infected Adults and Adolescents

A.3.1

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

African-Canadian Study of HIV-Infected Adults and a Vaccine for Ebola – ACHIV-Ebola

A.3.2

Name or abbreviated title of the trial where available

ACHIV-Ebola

A.4.1

Sponsor's protocol code number

CT1401-B

A.5.2

US NCT (ClinicalTrials.gov registry) number

NCT03031912

A.7

Trial is part of a Paediatric Investigation Plan

Yes

A.8

EMA Decision number of Paediatric Investigation Plan

P/095/2017

B. Sponsor Information
B.Sponsor: 1
B.1.1	Name of Sponsor	Dalhousie University
B.1.3.4	Country	Canada
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	Merck Sharp & Dohme LLC
B.4.2	Country	Canada
B.5 Contact point designated by the sponsor for further information on the trial
B.5.1	Name of organisation	Dalhousie University
B.5.2	Functional name of contact point	Canadian Center for Vaccinology
B.5.3	Address:
B.5.3.1	Street Address	Box 9700, 5850/5890 University Avenue
B.5.3.2	Town/ city	Halifax
B.5.3.3	Post code	B3K 6R8
B.5.3.4	Country	Canada
B.5.4	Telephone number	1902470-8141
B.5.5	Fax number	1902470-7232
B.5.6	E-mail	ccfv@iwk.nshealth.ca

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.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	Ebola Zaire Vaccine (rVSV∆G-ZEBOV-GP, live)
D.3.9.2	Current sponsor code	V-920, BPSC 1001
D.3.9.3	Other descriptive name	Ebola Zaire Vaccine (rVSV∆G-ZEBOV-GP, live)
D.3.9.4	EV Substance Code	SUB186137
D.3.10	Strength
D.3.10.1	Concentration unit	PFU/ml plaque forming unit(s)/millilitre
D.3.10.2	Concentration type	not less then
D.3.10.3	Concentration number	72000000
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 is caused by infection with a virus of the family Filoviridae, genus Ebolavirus. There are five identified Ebola virus species, four of which are known to cause disease in humans: Ebola virus (Zaire ebolavirus); Sudan virus (Sudan ebolavirus); Taï Forest virus (Taï Forest ebolavirus, formerly Côte d’Ivoire ebolavirus); and Bundibugyo virus (Bundibugyo ebolavirus). The fifth, Reston virus (Reston ebolavirus), has caused disease in nonhuman primates, but not in humans.

E.1.1.1

Medical condition in easily understood language

Ebola, previously known as Ebola hemorrhagic fever, is a rare and deadly disease caused by infection with one of the Ebola virus species. Ebola can cause disease in humans and nonhuman primates.

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	10021881 - Infections and infestations

E.1.3

Condition being studied is a rare disease

Yes

E.2 Objective of the trial

E.2.1

Main objective of the trial

Evaluate the safety and tolerability of V920 in HIV-infected adults and adolescents.

Evaluate the immunogenicity of V920 via ZEBOV- specific antibody responses induced by V920 in HIV-infected adults and adolescents.

E.2.2

Secondary objectives of the trial

Evaluate VSV viremia and shedding after administration of V920.

Evaluate ZEBOV-specific antibody responses induced by V920 through D180 and D365.

Evaluate the impact of V920 on HIV viral load, CD4 counts, and CD4/CD8 ratio.

Evaluate the safety and tolerability of two doses of V920 in HIV-infected adults and adolescents administered 56 days apart.

Evaluate the immunogenicity of two doses of V920 administered 56 days apart via ZEBOV-specific antibody responses induced by V920 at D28 post-dose 2 in HIV-infected adults and adolescents.

E.2.3

Trial contains a sub-study

E.3

Principal inclusion criteria

•HIV-infected adult or adolescent male or non-pregnant, non-breastfeeding female, ages 13 to 65 (inclusive) at the time of screening;
•On antiretroviral therapy with an undetectable viral load (< 40 c/ml);
•CD4 T cell counts ≥ 200 cells/mm3;
•Written informed consent (subject or parent) and assent (adolescent), after reading the consent form and having adequate opportunity to discuss the study with an investigator or a qualified designee
•Free of clinically significant health problems that could affect the safety of the participant, as determined by the Investigator by pertinent medical history and clinical examination prior to entry into the study;
•Available, able, and willing to participate for all study visits and procedures;
•Males and females who are willing to practice abstinence from sexual intercourse, or are willing to use effective methods of contraception, from at least 30 days prior to vaccination until 2 months after vaccination.
1.If the female partner is NOT of childbearing potential, the couple will only be required to use condoms, without other adjunctive contraception.
2.For this study, a woman is considered of childbearing potential unless postmenopausal (≥ 1 year without menses) or surgically sterilized (tubal ligation, bilateral oophorectomy, or hysterectomy)
3.Effective contraception is defined as a contraceptive method with failure rate of less than 1% per year when used consistently and correctly and when applicable, in accordance with the product label for example:
i. Male condoms PLUS: ii. Oral contraceptives, either combined or progestogen alone iii. injectable progestogen iv. implants of etenogestrel or levonorgestrel v. oestrogenic vaginal ring vi. percutaneous contraceptive patches vii. intrauterine device or intrauterine system
•Be willing to minimize blood and body fluid exposure of others for 6 weeks after vaccination
1.Use of effective barrier prophylaxis, such as latex condoms, during penetrative sexual intercourse
2.Avoiding the sharing of needles, razors, or toothbrushes
3.Avoiding open-mouth kissing

E.4

Principal exclusion criteria

•History of prior infection with a filovirus or prior participation in a filovirus vaccine trial;
•History of prior infection with VSV or receipt of a VSV-vectored vaccine;
•Is a healthcare worker who has direct contact with patients
•Presence of any febrile illness or any known or suspected acute illness on the day of any first immunization (subject may be rescheduled);
•Clinical manifestations of systemic diseases considered by the investigator to impact safety or immunogenicity
•Receipt of systemic glucocorticoids (a dose ≥ 20 mg/day prednisone or equivalent) within one month, or any other cytotoxic or immunosuppressive drug within six months;
•Receipt of any investigational drug within 12 months of vaccination;
•Receipt of any live virus vaccine within 42 days prior to study entry or any other (non-live virus) vaccine within 14 days prior to study entry.
•History of sensitivity to any component of study vaccines per investigator brochure or package insert;
•Any baseline laboratory screening tests which is outside of acceptable range as defined in the protocol: ALT, AST, creatinine, hemoglobin, platelet count, total white blood cell count, urine protein, urine occult blood, urine glucose (Appendix 2). To exclude transient abnormalities, the investigator may repeat a test up to twice, and if the repeat test is normal, subject may be enrolled;
•Have an active malignancy or history of metastatic or hematologic malignancy except non-melanoma skin cancers;
•Suspected or known alcohol and/or illicit drug abuse within the past 5 years;
•Moderate or severe illness and/or fever >101°F (38.3ºC) within one week prior to vaccination;
•Pregnant or breastfeeding female, or female who intends to become pregnant during the study period;
•Administration of immunoglobulins and/or any blood products within the 120 days preceding study entry or planned administration during the study period;
•Any other significant finding that in the opinion of the investigator would increase the risk of the individual having an adverse outcome from participating in this study.

E.5 End points

E.5.1

Primary end point(s)

Measure number of adverse events following V920 vaccination in HIV-infected adults and adolescents

E.5.1.1

Timepoint(s) of evaluation of this end point

The number of vaccine related SAE's from signing the consent form to day 365 will be recorded and summarized.

E.5.2

Secondary end point(s)

Measure the immunogenicity of V920 via ZEBOV- specific antibody responses induced by V920 at D28

E.5.2.1

Timepoint(s) of evaluation of this end point

ZEBOV-specific antibody responses measured by ELISA and neutralization on Day 28

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

Yes

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

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

E.8.6.3

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

Burkina Faso

Senegal

Canada

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

The subject participation portion of the overall trial ends when the last subject completes the last study related phone call or visit, discontinues from the trial or is lost to follow-up. For purposes of analysis and reporting, the overall trial ends when the Sponsor receives the last serology assay result or subject data from the last study-related phone call or visit and the database has been cleaned and locked.

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

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:

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)

F.1.1.5

Children (2-11years)

F.1.1.6

Adolescents (12-17 years)

Yes

F.1.1.6.1

Number of subjects for this age range:

F.1.2

Adults (18-64 years)

Yes

F.1.2.1

Number of subjects for this age range:

150

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

F.3.2

Patients

Yes

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

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

250

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
G.4 Investigator Network to be involved in the Trial: 1
G.4.1	Name of Organisation	Centre de recherche du Centre hospitalier de l'Universite de Montreal
G.4.3.4	Network Country	Canada
G.4 Investigator Network to be involved in the Trial: 2
G.4.1	Name of Organisation	The Ottawa Hospital - General Campus
G.4.3.4	Network Country	Canada
G.4 Investigator Network to be involved in the Trial: 3
G.4.1	Name of Organisation	Centre Muraz
G.4.3.4	Network Country	Burkina Faso
G.4 Investigator Network to be involved in the Trial: 4
G.4.1	Name of Organisation	Insitut de Recherche en Santé, de Surveillance Epidémiologique et de Formations
G.4.3.4	Network Country	Senegal
G.4 Investigator Network to be involved in the Trial: 5
G.4.1	Name of Organisation	Dalhousie University: Canadian Center for Vaccinology - Halifax
G.4.3.4	Network Country	Canada

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

Select Country:	Select Age Range:
Select Trial Status:	Select Trial Phase:
Select Gender:
Select Date Range: to
Select Rare Disease:
IMP with orphan designation in the indication
Orphan Designation Number:
Results Status:
Clear advanced search filters

Austria
Belgium
Bulgaria
Croatia
Cyprus
Czechia
Denmark
Estonia
Finland
France
Germany
Greece
Hungary
Iceland
Ireland
Italy
Latvia
Liechtenstein
Lithuania
Luxembourg
Malta
Netherlands
Norway
Poland
Portugal
Romania
Slovakia
Slovenia
Spain
Sweden
United Kingdom
Outside EU/EEA

Clinical trials