Clinical Trials Register

Summary
EudraCT Number:	2013-002918-12
Sponsor's Protocol Code Number:	1-2013-HU
National Competent Authority:	Hungary - National Institute of Pharmacy
Clinical Trial Type:	EEA CTA
Trial Status:	Prematurely Ended
Date on which this record was first entered in the EudraCT database:	2013-08-06
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
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

Hungary - National Institute of Pharmacy

A.2

EudraCT number

2013-002918-12

A.3

Full title of the trial

Randomized, prospective, double blind clinical study to evaluate the effectiveness, dosage and safety of lactobacillus vaccine for management of bacterial vaginosis in a non-selected patient population

Randomizált, prospektív, kettős vak klinikai vizsgálat a laktobacillus vakcináció bakteriális vaginózisban való hatékonyságának, biztonságosságának és adagolásának megállapítására válogatás nélküli beteganyagon

A.3.1

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

LATVAC (Lactobacilli Therapeutic Vaccine study)

LATVAC Laktobacillus vakcina terápiás vizsgálat

A.3.2

Name or abbreviated title of the trial where available

LATVAC

A.4.1

Sponsor's protocol code number

1-2013-HU

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	Amvac Kft
B.1.3.4	Country	Hungary
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	Amvac Kft
B.4.2	Country	Hungary
B.5 Contact point designated by the sponsor for further information on the trial
B.5.1	Name of organisation	Amvac Kft
B.5.2	Functional name of contact point	Amvac Kft
B.5.3	Address:
B.5.3.1	Street Address	József nádor tér 5-6
B.5.3.2	Town/ city	Budapest
B.5.3.3	Post code	1051
B.5.3.4	Country	Hungary
B.5.4	Telephone number	3612660881

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	Gynevac suspension for injection
D.2.1.1.2	Name of the Marketing Authorisation holder	Vaccina Kft
D.2.1.2	Country which granted the Marketing Authorisation	Hungary
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	Gynevac
D.3.2	Product code	NA
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	No
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
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

Bacterial vaginosis (Nugent score 4 or above)

Bakteriális vaginózis (4-esnél rosszabb Nugent score)

E.1.1.1

Medical condition in easily understood language

Vaginal infection due to changed vaginal flora

Hüvelyfertőzés megváltozott flóra miatt

E.1.1.2

Therapeutic area

Diseases [C] - Female diseases of the urinary and reproductive systems and pregancy complications [C13]

MedDRA Classification

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 establish the efficacy and safety of a 5-shot treatment period with lactobacilli vaccination in patients with bacterial vaginosis and gathering information about dosage regimen

A hatásosság és biztonságosság megítélése a bacteriális vaginosisban szenvedő betegek 5 hetes lactobacillus vakcinációval történő kezelési periódusa alatt és információgyűjtés az adagolási módról

E.2.2

Secondary objectives of the trial

Secondary endpoint is the change of vaginal pH during the treatment period.
Other secondary endpoints are the patients subjective evaluation and changes in IgA levels (Microbe specific immunoglobulin answer)

Másodlagos végpont a hüvelyi pH változása a kezelési periódus alatt. Egyéb másodlagos végpont: a beteg szubjektív megítélése és változások az IgA-ban.

E.2.3

Trial contains a sub-study

E.3

Principal inclusion criteria

1. 18 years or above
2. Mentally competent
3. Written informed consent
4. Being able to comply with the protocol

1. 18 éves kor vagy fölötte
2. Épelméjű
3. Beleegyező nyilatkozatot aláírta
4. Képes együttműködni

E.4

Principal exclusion criteria

1. Hypersensitivity to formaldehyde, or any other of the components of Gynevac
2. Fever
3. Acute infectious disease
4. Immunosuppression
5. Acute polyarthritis
6. Serious cardiac, liver or kidney diseases
7. Abnormalities of the blood circulation or of the hemopoetic system
8. Ongoing antibiotic treatment
9. Use of any investigational drug within 30 days of V0
10. No former antibiotic treatment for any reasons in 14 days before study entry

1. túlérzékenység valamely összetevőre
2. Láz
3. Akut fertőző betegség
4. Immunsuppressio
5. Akut poliartritisz
6. súlyos máj, vese vagy szívbetegség
7. keringési vagy vérképzési zavar
8. antibiotikus kezelés
9. bármely vizsgálati készítmény alkalmazása az elmúlt 30 napban
10. AB kezelés 14 nappal a vizsgálatot megelőzően

E.5 End points

E.5.1

Primary end point(s)

Nugent score changes in Vaginal smear

Nugent-score változás a hüvelykenetben

E.5.1.1

Timepoint(s) of evaluation of this end point

63 days

63 nap

E.5.2

Secondary end point(s)

vaginal pH change,

Hüvelyi pH változás

E.5.2.1

Timepoint(s) of evaluation of this end point

63 days

63 nap

E.6 and E.7 Scope of the trial

E.6

Scope of the trial

E.6.1

Diagnosis

E.6.2

Prophylaxis

E.6.3

Therapy

Yes

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)

E.7.3

Therapeutic confirmatory (Phase III)

Yes

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

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

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

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

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

Last visit of the last subject

az utolsó bevont beteg

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

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:

400

F.1.3

Elderly (>=65 years)

F.2 Gender

F.2.1

Female

Yes

F.2.2

Male

F.3 Group of trial subjects

F.3.1

Healthy volunteers

F.3.2

Patients

Yes

F.3.3

Specific vulnerable populations

F.3.3.1

Women of childbearing potential not using contraception

F.3.3.2

Women of child-bearing potential using contraception

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

400

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)

Not different from the normal treatment of the condition

Nem különbözik a normál BV kezeléstől

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

2014-05-12

Ethics Committee Opinion of the trial application

Favourable

Ethics Committee Opinion: Reason(s) for unfavourable opinion

Date of Ethics Committee Opinion

P. End of Trial
P.	End of Trial Status	Prematurely Ended

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