Clinical Trials Register

Summary
EudraCT Number:	2018-000215-24
Sponsor's Protocol Code Number:	GeSIDA10017
National Competent Authority:	Spain - AEMPS
Clinical Trial Type:	EEA CTA
Trial Status:	Completed
Date on which this record was first entered in the EudraCT database:	2018-05-21
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

Spain - AEMPS

A.2

EudraCT number

2018-000215-24

A.3

Full title of the trial

A single-arm, open-label and multicentre phase IV trial to evaluate the immunogenicity of the nonavalent vaccine against human papillomavirus in HIV-infected men who have sex with men. GESIDA 10017 Study

Ensayo clínico fase IV, abierto, de brazo único y multicéntrico sobre la inmunogenicidad de la vacuna nonavalente frente al virus del papiloma humano en hombres infectados por el VIH que tienen sexo con hombres. Estudio GESIDA 10017

A.3.1

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

A trial to evaluate the immunogenicity of vaccine against human papillomavirus in HIV-infected men who have sex with men. GESIDA 10017 Study

Ensayo clínico sobre la inmunogenicidad de la vacuna frente al virus del papiloma humano en hombres infectados por el VIH que tienen sexo con hombres. Estudio GESIDA 10017

A.4.1

Sponsor's protocol code number

GeSIDA10017

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	Fundacion SEIMC-GESIDA
B.1.3.4	Country	Spain
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
B.4.2	Country	Spain
B.5 Contact point designated by the sponsor for further information on the trial
B.5.1	Name of organisation	Fundación SEIMC-GESIDA
B.5.2	Functional name of contact point	Maria Yllescas
B.5.3	Address:
B.5.3.1	Street Address	C/ Agustin de Betancourt nº 13, entreplanta
B.5.3.2	Town/ city	Madrid
B.5.3.3	Post code	28003
B.5.3.4	Country	Spain
B.5.4	Telephone number	0034915568025
B.5.5	Fax number	0034915542283
B.5.6	E-mail	myllescas@f-sg.org

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	Gardasil 9
D.2.1.1.2	Name of the Marketing Authorisation holder	MSD VACCINS, 162 avenue Jean Jaurès, 69007 Lyon, Francia
D.2.1.2	Country which granted the Marketing Authorisation	Spain
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 in pre-filled syringe
D.3.4.1	Specific paediatric formulation	No
D.3.7	Routes of administration for this IMP	In vitro use (Noncurrent) Intramuscular use
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	HUMAN PAPILLOMAVIRUS TYPE 6 L1 PROTEIN
D.3.9.3	Other descriptive name	HUMAN PAPILLOMAVIRUS TYPE 6 L1 PROTEIN
D.3.9.4	EV Substance Code	SUB22591
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	HUMAN PAPILLOMAVIRUS TYPE 11 L1 PROTEIN
D.3.9.3	Other descriptive name	HUMAN PAPILLOMAVIRUS TYPE 11 L1 PROTEIN
D.3.9.4	EV Substance Code	SUB22592
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	40
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	HUMAN PAPILLOMAVIRUS TYPE 16 L1 PROTEIN
D.3.9.3	Other descriptive name	HUMAN PAPILLOMAVIRUS TYPE 16 L1 PROTEIN
D.3.9.4	EV Substance Code	SUB22593
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	60
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	HUMAN PAPILLOMAVIRUS TYPE 18 L1 PROTEIN
D.3.9.3	Other descriptive name	HUMAN PAPILLOMAVIRUS TYPE 18 L1 PROTEIN
D.3.9.4	EV Substance Code	SUB22594
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	40
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	HUMAN PAPILLOMAVIRUS TYPE 31 L1 PROTEIN
D.3.9.3	Other descriptive name	HUMAN PAPILLOMAVIRUS TYPE 31 L1 PROTEIN
D.3.9.4	EV Substance Code	SUB91674
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	HUMAN PAPILLOMAVIRUS TYPE 33 L1 PROTEIN
D.3.9.3	Other descriptive name	HUMAN PAPILLOMAVIRUS TYPE 33 L1 PROTEIN
D.3.9.4	EV Substance Code	SUB91675
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	HUMAN PAPILLOMAVIRUS TYPE 45 L1 PROTEIN
D.3.9.3	Other descriptive name	HUMAN PAPILLOMAVIRUS TYPE 45 L1 PROTEIN
D.3.9.4	EV Substance Code	SUB91676
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	HUMAN PAPILLOMAVIRUS TYPE 52 L1 PROTEIN
D.3.9.3	Other descriptive name	HUMAN PAPILLOMAVIRUS TYPE 52 L1 PROTEIN
D.3.9.4	EV Substance Code	SUB91677
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	HUMAN PAPILLOMAVIRUS TYPE 58 L1 PROTEIN
D.3.9.3	Other descriptive name	HUMAN PAPILLOMAVIRUS TYPE 58 L1 PROTEIN
D.3.9.4	EV Substance Code	SUB91678
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	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

E. General Information on the Trial

E.1 Medical condition or disease under investigation

E.1.1

Medical condition(s) being investigated

AIDS

SIDA

E.1.1.1

Medical condition in easily understood language

AIDS

SIDA

E.1.1.2

Therapeutic area

Diseases [C] - Immune System Diseases [C20]

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 evaluate the immunogenicity of the HPV9v vaccine in men with HIV infection (HIV +) who have sex with men by determining, in
two age groups, of the incidence of seroconversion for each of the HPV genotypes included in the HPV9v vaccine from baseline to month 7 and month 24.

Evaluar la inmunogenicidad de la vacuna VPH9v en hombres con infección por VIH (VIH+) que tienen sexo con hombres (HSH) mediante la determinación, en dos grupos de edad, de la incidencia de seroconversión para cada uno de los genotipos de VPH incluidos en la vacuna VPH9v desde el momento basal al mes 7 y 24.

E.2.2

Secondary objectives of the trial

- To evaluate as predictive factors of the immunogenicity of the HPV9 vaccine to: age group, CD4 / CD8 index and the anal microbiome.
- Determine mechanisms derived from the anal microbiome associated with the immunogenicity of the HPV9 vaccine.

- Evaluar como factores predictores de la inmunogenicidad de la vacuna VPHv9 a los siguientes: grupo de edad, índice CD4/CD8 y el microbioma anal.
– Determinar mecanismos derivados del microbioma anal asociados con la inmunogenicidad de la vacuna VPHv9.

E.2.3

Trial contains a sub-study

E.3

Principal inclusion criteria

- Patients able to give their written consent to participate in the study.
- Understand the purpose of the study and be available to perform the visits stipulated in the protocol.
- Be ≥18 years and <of 36 years.
- Patient with chronic infection with HIV-1.
- Viral HIV load <50 copies / ml and CD4> 200 cells / uL for at least the last six months.
- Transgender men or women who have had insertive or receptive anal sex with other men

- Pacientes capaces de otorgar su consentimiento escrito para participar en el estudio.
- Entender el propósito del estudio y estar disponibles para realizar las visitas estipuladas en el protocolo.
- Ser ≥18 años y < de 36 años.
- Paciente con infección crónica con el VIH-1.
- Carga vírica del VIH <50 copias/ml y CD4 >200 células/uL durante al menos los seis últimos meses.
- Hombres o mujeres transgénero que han mantenido relaciones sexuales anales insertivas o receptivas con otros hombres

E.4

Principal exclusion criteria

- Previous history of anal cancer.
- Have previously received any vaccine against HPV.

- Historia previa de cáncer anal.
- Haber recibido previamente cualquier vacuna frente a VPH.

E.5 End points

E.5.1

Primary end point(s)

- Percentage of sero-converting subjects for each of the following HPV genotypes studied (6/11/16/18/31/33/45/52/58) from the baseline visit to week 28 and 96. The points of cut to determine serostatus will be 30, 16, 20, 24, 10, 8, 8, 8, and 8 units / mL for HPV genotypes 6, 11, 16, 18, 31, 33, 45, 52, and 58, respectively [1].
- Ratio of the geometric mean of antibody titers from baseline to week 96 for HPV 6/11/16/18/31/33/45/52/58.

- Porcentaje de sujetos que sero-convierten para cada uno de los siguientes genotipos de VPH estudiados (6/11/16/18/31/33/45/52/58) desde la visita basal a la semana 28 y 96. Los puntos de corte para determinar el serostatus serán 30, 16, 20, 24, 10, 8, 8, 8, y 8 unidades/mL para los genotipos de VPH 6, 11, 16, 18, 31, 33, 45, 52, y 58, respectivamente [1].
- Cociente de la media geométrica de los títulos de anticuerpos desde la visita basal hasta la semana 96 para VPH 6/11/16/18/31/33/45/52/58.

E.5.1.1

Timepoint(s) of evaluation of this end point

Basal visit, week 28 and week 96

Visita basal, semana 28 y semana 96

E.5.2

Secondary end point(s)

- Persistent anal infection by HPV 6/11/16/18/31/33/45/52/58.
- Detection of HPV DNA in the anal brushing of the final visit in those free of infection at the baseline visit.
- Combined variable: persistent HPV infection 6/11/16/18/31/33/45/52/58 or isolated DNA detection at the final visit in those free of infection at the baseline visit

- Infección anal persistente por VPH 6/11/16/18/31/33/45/52/58.
- Detección de ADN de VPH en el cepillado anal de la visita final en aquellos libres de infección en la visita basal.
- Variable combinada: infección persistente por VPH 6/11/16/18/31/33/45/52/58 o detección aislada de ADN en la visita final en aquellos libres de infección en la visita basal

E.5.2.1

Timepoint(s) of evaluation of this end point

Basal visit, week 28 and week 96

Visita basal, semana 28 y semana 96

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

E.6.4

Safety

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)

E.7.4

Therapeutic use (Phase IV)

Yes

E.8 Design of the trial

E.8.1

Controlled

E.8.1.1

Randomised

E.8.1.2

Open

Yes

E.8.1.3

Single blind

E.8.1.4

Double blind

E.8.1.5

Parallel group

E.8.1.6

Cross over

E.8.1.7

Other

Yes

E.8.1.7.1

Other trial design description

Brazo único

Single arm

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

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 patint last visit

última visita del último paciente

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:

166

F.1.3

Elderly (>=65 years)

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.4.1

In the member state

166

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)

Treatment according the clinical practic

Tratamiento de acuerdo a la práctica clínica habitual

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

2018-06-05

Ethics Committee Opinion of the trial application

Favourable

Ethics Committee Opinion: Reason(s) for unfavourable opinion

Date of Ethics Committee Opinion

2018-06-01

P. End of Trial
P.	End of Trial Status	Completed

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