Clinical Trials Register

Summary
EudraCT Number:	2010-023384-18
Sponsor's Protocol Code Number:	730901
National Competent Authority:	Austria - BASG
Clinical Trial Type:	EEA CTA
Trial Status:	Completed
Date on which this record was first entered in the EudraCT database:	2010-12-14
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
N. REVIEW BY THE COMPETENT AUTHORITY OR ETHICS COMMITTEE IN THE COUNTRY CONCERNED
P. END OF TRIAL

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A. Protocol Information

A.1

Member State Concerned

Austria - BASG

A.2

EudraCT number

2010-023384-18

A.3

Full title of the trial

Randomized, double-blind, phase I/II clinical study to investigate the safety and immunogenicity of a multivalent recombinant OspA Lyme Borreliosis vaccine (mv rOspA LB Vaccine) in healthy subjects aged 18 to 70 years.

A.3.1

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

Phase I/II study to investigate the safety and immunogenicity of a Lyme Borreliosis vaccine (mv rOspA LB Vaccine) in healthy subjects aged 18 to 70 years.

A.3.2

Name or abbreviated title of the trial where available

Phase I/II Lyme Vaccine Study

A.4.1

Sponsor's protocol code number

730901

A.5.2

US NCT (ClinicalTrials.gov registry) number

NCT01504347

A.7

Trial is part of a Paediatric Investigation Plan

A.8

EMA Decision number of Paediatric Investigation Plan

B. Sponsor Information
B.Sponsor: 1
B.1.1	Name of Sponsor	Baxter Innovations GmbH
B.1.3.4	Country	Austria
B.3.1 and B.3.2	Status of the sponsor	Commercial
B.4 Source(s) of Monetary or Material Support for the clinical trial:
B.4.1	Name of organisation providing support	Baxter Innovations GmbH
B.4.2	Country	Austria
B.5 Contact point designated by the sponsor for further information on the trial
B.5.1	Name of organisation	Baxter Innovations GmbH
B.5.2	Functional name of contact point	TA Global Operations Mgr
B.5.3	Address:
B.5.3.1	Street Address	Industriestrasse 67
B.5.3.2	Town/ city	Vienna
B.5.3.3	Post code	1221
B.5.3.4	Country	Austria
B.5.4	Telephone number	+43120100-2471372
B.5.5	Fax number	+43120100717
B.5.6	E-mail	michael_krammer@baxter.com

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	No
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.3.1	Product name	Multivalent Recombinant OspA Lyme Borreliosis Vaccine (mv rOspA LB Vaccine) 30 µg adjuvanted
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.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	RECOMBINANT OSPA TYPE 1/2 ANTIGEN (CONTAINING PROTECTIVE ELEMENTS FROM SEROTYPE 1 AND 2 MOLECULES (B. BURGDORFERI S.S. AND B. AFZELII)
D.3.9.3	Other descriptive name	RECOMBINANT OSPA TYPE 1/2 ANTIGEN (CONTAINING PROTECTIVE ELEMENTS FROM SEROTYPE 1 AND 2 MOLECULES (B. BURGDORFERI S.S. AND B. AFZELII))
D.3.9.4	EV Substance Code	SUB92215
D.3.10	Strength
D.3.10.1	Concentration unit	µg microgram(s)
D.3.10.2	Concentration type	equal
D.3.10.3	Concentration number	10
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	RECOMBINANT OSPA TYPE 5/3 ANTIGEN (CONTAINING PROTECTIVE ELEMENTS FROM SEROTYPES 5 AND 3 MOLECULES (B. GARINII))
D.3.9.3	Other descriptive name	RECOMBINANT OSPA TYPE 5/3 ANTIGEN (CONTAINING PROTECTIVE ELEMENTS FROM SEROTYPES 5 AND 3 MOLECULES (B. GARINII))
D.3.9.4	EV Substance Code	SUB92216
D.3.10	Strength
D.3.10.1	Concentration unit	µg microgram(s)
D.3.10.2	Concentration type	equal
D.3.10.3	Concentration number	10
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	RECOMBINANT OSPA TYPE 6/4 ANTIGEN (CONTAINING PROTECTIVE ELEMENTS FROM SEROTYPES 6 AND 4 MOLECULES (B. GARINII AND B. BAVARIENSIS))
D.3.9.3	Other descriptive name	RECOMBINANT OSPA TYPE 6/4 ANTIGEN (CONTAINING PROTECTIVE ELEMENTS FROM SEROTYPES 6 AND 4 MOLECULES (B. GARINII AND B. BAVARIENSIS))
D.3.9.4	EV Substance Code	SUB92217
D.3.10	Strength
D.3.10.1	Concentration unit	µg microgram(s)
D.3.10.2	Concentration type	equal
D.3.10.3	Concentration number	10
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	No
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	No
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.3.1	Product name	Multivalent Recombinant OspA Lyme Borreliosis Vaccine (mv rOspA LB Vaccine) 60 µg adjuvanted
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.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	RECOMBINANT OSPA TYPE 1/2 ANTIGEN (CONTAINING PROTECTIVE ELEMENTS FROM SEROTYPE 1 AND 2 MOLECULES (B. BURGDORFERI S.S. AND B. AFZELII))
D.3.9.3	Other descriptive name	RECOMBINANT OSPA TYPE 1/2 ANTIGEN (CONTAINING PROTECTIVE ELEMENTS FROM SEROTYPE 1 AND 2 MOLECULES (B. BURGDORFERI S.S. AND B. AFZELII))
D.3.9.4	EV Substance Code	SUB92215
D.3.10	Strength
D.3.10.1	Concentration unit	µg microgram(s)
D.3.10.2	Concentration type	equal
D.3.10.3	Concentration number	20
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	RECOMBINANT OSPA TYPE 5/3 ANTIGEN (CONTAINING PROTECTIVE ELEMENTS FROM SEROTYPES 5 AND 3 MOLECULES (B. GARINII))
D.3.9.3	Other descriptive name	RECOMBINANT OSPA TYPE 5/3 ANTIGEN (CONTAINING PROTECTIVE ELEMENTS FROM SEROTYPES 5 AND 3 MOLECULES (B. GARINII))
D.3.9.4	EV Substance Code	SUB92216
D.3.10	Strength
D.3.10.1	Concentration unit	µg microgram(s)
D.3.10.2	Concentration type	equal
D.3.10.3	Concentration number	20
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	RECOMBINANT OSPA TYPE 6/4 ANTIGEN (CONTAINING PROTECTIVE ELEMENTS FROM SEROTYPES 6 AND 4 MOLECULES (B. GARINII AND B. BAVARIENSIS))
D.3.9.3	Other descriptive name	RECOMBINANT OSPA TYPE 6/4 ANTIGEN (CONTAINING PROTECTIVE ELEMENTS FROM SEROTYPES 6 AND 4 MOLECULES (B. GARINII AND B. BAVARIENSIS))
D.3.9.4	EV Substance Code	SUB92217
D.3.10	Strength
D.3.10.1	Concentration unit	µg microgram(s)
D.3.10.2	Concentration type	equal
D.3.10.3	Concentration number	20
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	No
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	No
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.3.1	Product name	Multivalent Recombinant OspA Lyme Borreliosis Vaccine (mv rOspA LB Vaccine) 90 µg adjuvanted
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.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	RECOMBINANT OSPA TYPE 1/2 ANTIGEN (CONTAINING PROTECTIVE ELEMENTS FROM SEROTYPE 1 AND 2 MOLECULES (B. BURGDORFERI S.S. AND B. AFZELII))
D.3.9.3	Other descriptive name	RECOMBINANT OSPA TYPE 1/2 ANTIGEN (CONTAINING PROTECTIVE ELEMENTS FROM SEROTYPE 1 AND 2 MOLECULES (B. BURGDORFERI S.S. AND B. AFZELII))
D.3.9.4	EV Substance Code	SUB92215
D.3.10	Strength
D.3.10.1	Concentration unit	µg microgram(s)
D.3.10.2	Concentration type	equal
D.3.10.3	Concentration number	30
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	RECOMBINANT OSPA TYPE 5/3 ANTIGEN (CONTAINING PROTECTIVE ELEMENTS FROM SEROTYPES 5 AND 3 MOLECULES (B. GARINII))
D.3.9.3	Other descriptive name	RECOMBINANT OSPA TYPE 5/3 ANTIGEN (CONTAINING PROTECTIVE ELEMENTS FROM SEROTYPES 5 AND 3 MOLECULES (B. GARINII))
D.3.9.4	EV Substance Code	SUB92216
D.3.10	Strength
D.3.10.1	Concentration unit	µg microgram(s)
D.3.10.2	Concentration type	equal
D.3.10.3	Concentration number	30
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	RECOMBINANT OSPA TYPE 6/4 ANTIGEN (CONTAINING PROTECTIVE ELEMENTS FROM SEROTYPES 6 AND 4 MOLECULES (B. GARINII AND B. BAVARIENSIS))
D.3.9.3	Other descriptive name	RECOMBINANT OSPA TYPE 6/4 ANTIGEN (CONTAINING PROTECTIVE ELEMENTS FROM SEROTYPES 6 AND 4 MOLECULES (B. GARINII AND B. BAVARIENSIS))
D.3.9.4	EV Substance Code	SUB92217
D.3.10	Strength
D.3.10.1	Concentration unit	µg microgram(s)
D.3.10.2	Concentration type	equal
D.3.10.3	Concentration number	30
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	No
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: 4
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	No
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.3.1	Product name	Multivalent Recombinant OspA Lyme Borreliosis Vaccine (mv rOspA LB Vaccine) 30 µg non-adjuvanted
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.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	RECOMBINANT OSPA TYPE 1/2 ANTIGEN (CONTAINING PROTECTIVE ELEMENTS FROM SEROTYPE 1 AND 2 MOLECULES (B. BURGDORFERI S.S. AND B. AFZELII))
D.3.9.3	Other descriptive name	RECOMBINANT OSPA TYPE 1/2 ANTIGEN (CONTAINING PROTECTIVE ELEMENTS FROM SEROTYPE 1 AND 2 MOLECULES (B. BURGDORFERI S.S. AND B. AFZELII))
D.3.9.4	EV Substance Code	SUB92215
D.3.10	Strength
D.3.10.1	Concentration unit	µg microgram(s)
D.3.10.2	Concentration type	equal
D.3.10.3	Concentration number	10
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	RECOMBINANT OSPA TYPE 5/3 ANTIGEN (CONTAINING PROTECTIVE ELEMENTS FROM SEROTYPES 5 AND 3 MOLECULES (B. GARINII))
D.3.9.3	Other descriptive name	RECOMBINANT OSPA TYPE 5/3 ANTIGEN (CONTAINING PROTECTIVE ELEMENTS FROM SEROTYPES 5 AND 3 MOLECULES (B. GARINII))
D.3.9.4	EV Substance Code	SUB92216
D.3.10	Strength
D.3.10.1	Concentration unit	µg microgram(s)
D.3.10.2	Concentration type	equal
D.3.10.3	Concentration number	10
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	RECOMBINANT OSPA TYPE 6/4 ANTIGEN (CONTAINING PROTECTIVE ELEMENTS FROM SEROTYPES 6 AND 4 MOLECULES (B. GARINII AND B. BAVARIENSIS))
D.3.9.3	Other descriptive name	RECOMBINANT OSPA TYPE 6/4 ANTIGEN (CONTAINING PROTECTIVE ELEMENTS FROM SEROTYPES 6 AND 4 MOLECULES (B. GARINII AND B. BAVARIENSIS))
D.3.9.4	EV Substance Code	SUB92217
D.3.10	Strength
D.3.10.1	Concentration unit	µg microgram(s)
D.3.10.2	Concentration type	equal
D.3.10.3	Concentration number	10
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	No
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: 5
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	No
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.3.1	Product name	Multivalent Recombinant OspA Lyme Borreliosis Vaccine (mv rOspA LB Vaccine) 60 µg non-adjuvanted
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.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	RECOMBINANT OSPA TYPE 1/2 ANTIGEN (CONTAINING PROTECTIVE ELEMENTS FROM SEROTYPE 1 AND 2 MOLECULES (B. BURGDORFERI S.S. AND B. AFZELII))
D.3.9.3	Other descriptive name	RECOMBINANT OSPA TYPE 1/2 ANTIGEN (CONTAINING PROTECTIVE ELEMENTS FROM SEROTYPE 1 AND 2 MOLECULES (B. BURGDORFERI S.S. AND B. AFZELII))
D.3.9.4	EV Substance Code	SUB92215
D.3.10	Strength
D.3.10.1	Concentration unit	µg microgram(s)
D.3.10.2	Concentration type	equal
D.3.10.3	Concentration number	20
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	RECOMBINANT OSPA TYPE 5/3 ANTIGEN (CONTAINING PROTECTIVE ELEMENTS FROM SEROTYPES 5 AND 3 MOLECULES (B. GARINII))
D.3.9.3	Other descriptive name	RECOMBINANT OSPA TYPE 5/3 ANTIGEN (CONTAINING PROTECTIVE ELEMENTS FROM SEROTYPES 5 AND 3 MOLECULES (B. GARINII))
D.3.9.4	EV Substance Code	SUB92216
D.3.10	Strength
D.3.10.1	Concentration unit	µg microgram(s)
D.3.10.2	Concentration type	equal
D.3.10.3	Concentration number	20
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	RECOMBINANT OSPA TYPE 6/4 ANTIGEN (CONTAINING PROTECTIVE ELEMENTS FROM SEROTYPES 6 AND 4 MOLECULES (B. GARINII AND B. BAVARIENSIS))
D.3.9.3	Other descriptive name	RECOMBINANT OSPA TYPE 6/4 ANTIGEN (CONTAINING PROTECTIVE ELEMENTS FROM SEROTYPES 6 AND 4 MOLECULES (B. GARINII AND B. BAVARIENSIS))
D.3.9.4	EV Substance Code	SUB92217
D.3.10	Strength
D.3.10.1	Concentration unit	µg microgram(s)
D.3.10.2	Concentration type	equal
D.3.10.3	Concentration number	20
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	No
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: 6
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	No
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.3.1	Product name	Multivalent Recombinant OspA Lyme Borreliosis Vaccine (mv rOspA LB Vaccine) 90 µg non-adjuvanted
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.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	RECOMBINANT OSPA TYPE 1/2 ANTIGEN (CONTAINING PROTECTIVE ELEMENTS FROM SEROTYPE 1 AND 2 MOLECULES (B. BURGDORFERI S.S. AND B. AFZELII))
D.3.9.3	Other descriptive name	RECOMBINANT OSPA TYPE 1/2 ANTIGEN (CONTAINING PROTECTIVE ELEMENTS FROM SEROTYPE 1 AND 2 MOLECULES (B. BURGDORFERI S.S. AND B. AFZELII))
D.3.9.4	EV Substance Code	SUB92215
D.3.10	Strength
D.3.10.1	Concentration unit	µg microgram(s)
D.3.10.2	Concentration type	equal
D.3.10.3	Concentration number	30
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	RECOMBINANT OSPA TYPE 5/3 ANTIGEN (CONTAINING PROTECTIVE ELEMENTS FROM SEROTYPES 5 AND 3 MOLECULES (B. GARINII))
D.3.9.3	Other descriptive name	RECOMBINANT OSPA TYPE 5/3 ANTIGEN (CONTAINING PROTECTIVE ELEMENTS FROM SEROTYPES 5 AND 3 MOLECULES (B. GARINII))
D.3.9.4	EV Substance Code	SUB92216
D.3.10	Strength
D.3.10.1	Concentration unit	µg microgram(s)
D.3.10.2	Concentration type	equal
D.3.10.3	Concentration number	30
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	RECOMBINANT OSPA TYPE 6/4 ANTIGEN (CONTAINING PROTECTIVE ELEMENTS FROM SEROTYPES 6 AND 4 MOLECULES (B. GARINII AND B. BAVARIENSIS))
D.3.9.3	Other descriptive name	RECOMBINANT OSPA TYPE 6/4 ANTIGEN (CONTAINING PROTECTIVE ELEMENTS FROM SEROTYPES 6 AND 4 MOLECULES (B. GARINII AND B. BAVARIENSIS))
D.3.9.4	EV Substance Code	SUB92217
D.3.10	Strength
D.3.10.1	Concentration unit	µg microgram(s)
D.3.10.2	Concentration type	equal
D.3.10.3	Concentration number	30
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	No
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

E. General Information on the Trial

E.1 Medical condition or disease under investigation

E.1.1

Medical condition(s) being investigated

-) To obtain safety and immunogenicity data of different dose levels of a mv rOspA LB Vaccine with and without adjuvant in seronegative healthy volunteers aged 18 to 70 years. The outcome shall provide the basis for dose/formulation selection for Section 2 of the study.
-) To evaluate the safety and immunogenicity of the optimal dose(s)/formulation of the mv rOspA LB vaccine in a larger population of seronegative and seropositive healthy subjects aged 18 to 70 years.

E.1.1.1

Medical condition in easily understood language

To obtain safety and immunogenicity data with different doses of an mv rOspA Lyme Borreliosis Vaccine with and without adjuvant, and to evaluate the optimal dose for further investigation.

E.1.1.2

Therapeutic area

Diseases [C] - Bacterial Infections and Mycoses [C01]

MedDRA Classification

E.1.2 Medical condition or disease under investigation

E.1.2	Version	16.0
E.1.2	Level	LLT
E.1.2	Classification code	10067559
E.1.2	Term	Lyme borreliosis
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

-) To evaluate the safety characteristics and immunogenicity of the mv rOspA LB Vaccine using 6 different formulations (3 dose levels with and without adjuvant) and to identify the optimal dose level(s) and/or formulation of the mv rOspA LB Vaccine in seronegative healthy subjects aged 18 to 70 years.
-) To evaluate the safety and immunogenicity of the optimal dose(s)/formulation of the mv rOspA LB vaccine in a larger population of healthy seronegative and seropositive subjects aged 18 to 70 years.

E.2.2

Secondary objectives of the trial

To assess antibody persistence and responses to booster vaccinations with the mv rOspA LB Vaccine.

Note: The currently applied for Protocol Amendment 6 pertains to Section 3 of the study: In Section 3, approximately 87 subjects who had been randomized to the 9-12 month booster group to receive the 60 µg adjuvanted formulation of the mv rOspA LB Vaccine will be administered a second booster vaccination at 27 months. Based on recent data from Section 2, the 60 µg adjuvanted dose (instead of the 30 µg adjuvanted dose previously applied for with Protocol Amendment 5) has now been selected for this additional booster vaccination in the extension of the study in Section 3.

E.2.3

Trial contains a sub-study

E.3

Principal inclusion criteria

* Subject is 18 to 70 years old at the time of screening.
* Subject has an understanding of the study, agrees to its provisions, and gives written informed consent prior to study entry;
* Subject is generally healthy , as determined by the investigator’s clinical judgment through collection of medical history and the performance of a physical examination;
* Subject is physically and mentally capable of participating in the study and willing to adhere to study procedures;
* Subject agrees to keep a daily record of symptoms for the duration of the study;
* If female of childbearing potential, subject presents with a negative urine pregnancy test and agrees to employ adequate birth control measures for the duration of the study.
Additional inclusion criterion for subjects in Cohort 5 only:
* Subject is seropositive for Borrelia burgdorferi sensu lato (s.l.) antibodies at study entry

E.4

Principal exclusion criteria

* Subject has a physician-diagnosed chronic illness related to LB or active LB;
* Subject has been treated for LB with antibiotics within 3 months of study entry.
* Subject had a tick bite within 3 weeks prior to screening or first vaccination;
* Subject has a history of or active infection with Babesia microtii or Anaplasma phagocytosum (ehrlichiosis);
* Subject currently has or has a history of significant cardiovascular, respiratory (including asthma), metabolic, neurological, hepatic, rheumatic, autoimmune, hematological, gastrointestinal or renal disorder ;
* Subject has clinically significant abnormal laboratory values at screening; NOTE: a 1.5 fold or greater increase over the upper limit of normal (ULN) for ALT and AST and a value of > 1.5 mg/dl for creatinine is considered clinically significant (see Section 12.4.4.2).
Furthermore, any laboratory parameters included in the FDA toxicity grading scale and graded as moderate or higher are to be considered clinically significant. Clinical significance of all other laboratory parameters will be evaluated by the investigator using his/her clinical expertise and judgment.
* Subject currently has or has a history of immunodeficiency;
*Subject tests positive for human immunodeficiency virus (HIV), hepatitis B surface antigen (HBsAg) or hepatitis C virus (HCV); for subjects in Cohort 1 for whom the original exclusion criterion “Subject has a history of testing positive for human immunodeficiency virus (HIV), hepatitis B surface antigen (HBsAg) or hepatitis C virus (HCV). No confirmatory testing for previous infection with these viruses will be conducted as part of this study” is applicable, testing will be performed at a later time point upon implementation of Amendment 2
* Subject has a disease or is currently undergoing a form of treatment or was undergoing a form of treatment within 30 days prior to study entry that could be expected to influence immune response. Such treatment includes, but is not limited to: systemic or high dose inhaled (>800 µg/day of beclomethasone dipropionate or equivalent) corticosteroids, radiation treatment, or other immunosuppressive or cytotoxic drugs;
* Subject has a history of anaphylaxis or severe allergic reactions;
*Subject has a rash, dermatologic condition or tattoos which might interfere with injection site reaction rating;
* Subject has a body mass index > 35.0;
* Subject has received any blood products or immunoglobulins within 90 days prior to vaccination in this study;
* Subject has donated blood or plasma within 30 days prior to vaccination in this study;
* Subject has received any live vaccine within 4 weeks or inactivated vaccine within 2 weeks prior to vaccination in this study;
* Subject has functional or surgical asplenia;
* Subject has a known or suspected problem with alcohol or drug abuse;
* Subject has participated in another clinical study involving an investigational product (IP), biological product or device within 30 days prior to study enrollment or is scheduled to participate in another clinical study involving an IP, biological product or device during the course of this study;
* Subject is pregnant or lactating at the time of study enrollment;
* Subject is a member of the team conducting the study or in a dependent relationship with one of the study team members. Dependent relationships include close relatives (i.e., children, partner/spouse, siblings, parents) as well as employees of the investigator or site personnel conducting the study
Additional exclusion criteria for subjects in Cohorts 1, 2, 3 and 4:
* Subject is seropositive for Borrelia burgdorferi sensu lato (s.l.) antibodies at study entry. For subjects with a borderline result the test shall be repeated. If the second test confirm a borderline result, the subject shall be excluded.

Eligibility criteria for the booster vaccination

E.5 End points

E.5.1

Primary end point(s)

-) The primary safety endpoint is the frequency and severity of injection site and systemic reactions within 7 days after each vaccination.
-) The primary immunogenicity endpoint is the antibody response determined 28 days after the third vaccination to each of the 6 rOspA serotypes contained in the vaccine.

E.5.1.1

Timepoint(s) of evaluation of this end point

E.5.2

Secondary end point(s)

Immunogenicity:
The following endpoints will be determined for each of the 6 rOspA serotypes contained in the vaccine:
• Antibody response at baseline, 28 days after the first, second and each booster vaccination, 180 and 270 days after the first vaccination,180 days after the first booster vaccination and 180 and 270 days after the second booster vaccination.
• Fold increase in antibody titer compared to baseline determined 28 days after each vaccination, 180 and 270 days after the first vaccination,180 days after the first booster vaccination and 180 and 270 days after the second booster vaccination.
• Seroconversion rate (at least 4-fold increase of each rOspA type-specific IgG titer) as compared to baseline determined 28 days after each vaccination, 180 and 270 days after the first vaccination,180 days after the first booster vaccination and 180 and 270 days after the second booster vaccination.
Safety:
• Frequency and severity of adverse events (AEs) observed within 28 days after each vaccination and during the entire study period.

E.5.2.1

Timepoint(s) of evaluation of this end point

• Ab response at baseline, 28 d after 1st, 2nd & each booster vaccination, 180 & 270 d after 1st vaccination,180 d after 1st booster vaccination & 180 and 270d after the 2nd booster vaccination;
• Fold increase in Ab titer compared to baseline 28 d after each vaccination, 180 and 270 d after 1st vaccination,180 d after 1st booster vaccination & 180 and 270 d after 2nd booster vaccination;
• Seroconversion rate (at least 4-fold increase of each rOspA type-specific IgG titer) as compared to baseline determined 28 d after each vaccination, 180 & 270 d after the 1st vaccination, 180 d after the 1st booster vaccination & 180 and 270 d after the 2nd booster vaccination.

• Frequency and severity of AEs within 28 d after each vaccination ´& during entire study period.

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

Yes

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
Antibody persistance

E.7

Trial type and phase

E.7.1

Human pharmacology (Phase I)

Yes

E.7.1.1

First administration to humans

Yes

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

Yes

E.8.1.7.1

Other trial design description

In section 3 trial becomes open label

E.8.2

Comparator of controlled trial

E.8.2.1

Other medicinal product(s)

E.8.2.2

Placebo

E.8.2.3

Other

Yes

E.8.2.3.1

Comparator description

same IMP in different dosage with or without adjuvant; in section 3 only 60ug adj will be used

E.8.2.4

Number of treatment arms in the trial

E.8.3

The trial involves single site in the Member State concerned

E.8.4

The trial involves multiple sites in the Member State concerned

Yes

E.8.4.1

Number of sites anticipated in Member State concerned

E.8.5

The trial involves multiple Member States

Yes

E.8.5.1

Number of sites anticipated in the EEA

E.8.6 Trial involving sites outside the EEA

E.8.6.1

Trial being conducted both within and outside the EEA

E.8.6.2

Trial being conducted completely outside of the EEA

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

LVLS

E.8.9 Initial estimate of the duration of the trial

E.8.9.1

In the Member State concerned years

E.8.9.1

In the Member State concerned months

E.8.9.1

In the Member State concerned days

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

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)

F.1.2

Adults (18-64 years)

Yes

F.1.2.1

Number of subjects for this age range:

649

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

F.3.3.7

Others

F.4 Planned number of subjects to be included

F.4.1

In the member state

240

F.4.2

For a multinational trial

F.4.2.1

In the EEA

650

F.4.2.2

In the whole clinical trial

650

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)

Only healthy subjects will be included in the trial.
They will be observed at least 180 days after the last vaccination has taken place. Nothing else is planned beyond this observation period.

G. Investigator Networks to be involved in the Trial

N. Review by the Competent Authority or Ethics Committee in the country concerned

Competent Authority Decision

Authorised

Date of Competent Authority Decision

2011-02-09

Ethics Committee Opinion of the trial application

Favourable

Ethics Committee Opinion: Reason(s) for unfavourable opinion

Date of Ethics Committee Opinion

2011-01-11

P. End of Trial
P.	End of Trial Status	Completed
P.	Date of the global end of the trial	2014-02-28

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Orphan Designation Number:
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