Clinical Trials Register

Summary
EudraCT Number:	2014-000944-13
Sponsor's Protocol Code Number:	GEN-004-002
National Competent Authority:	UK - MHRA
Clinical Trial Type:	EEA CTA
Trial Status:	Completed
Date on which this record was first entered in the EudraCT database:	2014-06-25
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

UK - MHRA

A.2

EudraCT number

2014-000944-13

A.3

Full title of the trial

A Phase 2, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety, Tolerability, and Efficacy of GEN-004, a Pneumococcal Protein Subunit Vaccine, on Colonization Following Intranasal Challenge with S. pneumoniae

A.3.1

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

Safety, Tolerability, and Efficacy Study of Pneumococcal Vaccine following S. pneumoniae Challenge

A.4.1

Sponsor's protocol code number

GEN-004-002

A.5.2

US NCT (ClinicalTrials.gov registry) number

NCT02116998

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	Genocea Biosciences, Inc.
B.1.3.4	Country	United States
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	Genocea Biosciences, Inc.
B.4.2	Country	United States
B.5 Contact point designated by the sponsor for further information on the trial
B.5.1	Name of organisation	TMC Pharma Services
B.5.2	Functional name of contact point	Director of Regulatory Sciences
B.5.3	Address:
B.5.3.1	Street Address	Lodge Farm Barn, Elvetham Park Estate, Fleet Road
B.5.3.2	Town/ city	Hartley Wintney, Hants
B.5.3.3	Post code	RG27 8AS
B.5.3.4	Country	United Kingdom
B.5.4	Telephone number	4401252842255
B.5.5	Fax number	4401252842277
B.5.6	E-mail	Allison.Gillespie@TMCPharma.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	GEN-004 Recombinant Streptococcus pneumonia Protein Subunit Vaccine
D.3.2	Product code	GEN-004
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	GB104
D.3.9.2	Current sponsor code	GB104
D.3.9.3	Other descriptive name	GB104
D.3.9.4	EV Substance Code	SUB166599
D.3.10	Strength
D.3.10.1	Concentration unit	µg/ml microgram(s)/millilitre
D.3.10.2	Concentration type	equal
D.3.10.3	Concentration number	350
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	GB144
D.3.9.2	Current sponsor code	GB144
D.3.9.3	Other descriptive name	GB144
D.3.9.4	EV Substance Code	SUB166600
D.3.10	Strength
D.3.10.1	Concentration unit	µg/ml microgram(s)/millilitre
D.3.10.2	Concentration type	equal
D.3.10.3	Concentration number	350
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	GB152
D.3.9.2	Current sponsor code	GB152
D.3.9.3	Other descriptive name	GB152
D.3.9.4	EV Substance Code	SUB166601
D.3.10	Strength
D.3.10.1	Concentration unit	µg/ml microgram(s)/millilitre
D.3.10.2	Concentration type	equal
D.3.10.3	Concentration number	350
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	Aluminum Hydroxide Adjuvant
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	Aluminium Hydroxide
D.3.9.3	Other descriptive name	ALUMINIUM HYDROXIDE
D.3.9.4	EV Substance Code	SUB33625
D.3.10	Strength
D.3.10.1	Concentration unit	mg/ml milligram(s)/millilitre
D.3.10.2	Concentration type	equal
D.3.10.3	Concentration number	5
D.3.11 The IMP contains an:
D.3.11.1	Active substance of chemical origin	Yes
D.3.11.2	Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP)	No
	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)	No
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

Pneumococcal Nasal Carriage

E.1.1.1

Medical condition in easily understood language

Pneumococcal bacteria carriage in the nose

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	17.0
E.1.2	Level	LLT
E.1.2	Classification code	10069594
E.1.2	Term	Pneumococcal immunization
E.1.2	System Organ Class	100000004865

E.1.3

Condition being studied is a rare disease

E.2 Objective of the trial

E.2.1

Main objective of the trial

The primary objective of this study is to evaluate the efficacy of GEN-004 with aluminum hydroxide in healthy adult subjects to reduce nasopharyngeal colonization following intranasal inoculation with S. pneumoniae serotype 6B as measured by proportion of colonized subjects.

E.2.2

Secondary objectives of the trial

Secondary objectives include the following:
• To evaluate the impact of GEN-004 on the magnitude of colonization as measured by S. pneumoniae colony forming units (CFUs) post-inoculation.
• To evaluate the duration of S. pneumoniae colonization through 14 days after inoculation.
• To evaluate the immunogenicity of GEN-004 with aluminum hydroxide, as measured by TH17 (IL-17) and IgG responses to the vaccine antigens.
• To evaluate the safety and tolerability of GEN-004 with aluminum hydroxide.

E.2.3

Trial contains a sub-study

E.3

Principal inclusion criteria

1. Males and non-pregnant females, ages 18 to 55 years inclusive.
2. Willing and able to provide written informed consent.
3. Fluent English speakers only (for safety reasons)
4. Willing to perform and comply with all study procedures including attending clinic visits as scheduled.

E.4

Principal exclusion criteria

1. Prior vaccination with pneumococcal vaccine.
2. History of invasive pneumococcal disease (i.e., sepsis, meningitis or pneumonia with bacteremia).
3. Close contact with at-risk individuals (e.g., children under 5 years, immunosuppressed adults, elderly, chronic ill health).
4. Current smoker or significant smoking history (>10 pack years).
5. Pregnant or breast-feeding woman.
6. Women of child-bearing potential (WOCBP), defined as not surgically sterile or post-menopausal defined as age > 40 years without menses for ≥ 2 years, and who are deemed not to have sufficient, effective birth control in place for 28 days prior to first dose of Investigational Product and 28 days after the final dose of Investigational Product.
7. Allergy to penicillin or amoxicillin.
8. Any screening laboratory value > Grade 1
9. Positive serologic test for HIV-1 or hepatitis C infection; positive hepatitis B surface antigen (HBsAg).
10. Asthma (on regular medication) or other respiratory disease.
11. Immunocompromised individuals, including those receiving corticosteroids or other immunosuppressive agents.
12. Presence or history of auto-immune disease (refer to Appendix 6) regardless of current treatment.
13. Antibiotic treatment within 1 week of inoculation
14. Previous involvement in an experimental human pneumococcal carriage (EHPC) study and inoculated with pneumococcal bacteria
15. Involvement in any other clinical trial unless in observational stage or follow-up
16. Diabetes, type 1 or type 2.
17. Other active, uncontrolled co-morbidities that, in the opinion of the Investigator would make the subject unsuitable for the study or unable to comply with the study requirements.
NOTE: Subjects who are taking a medication to control an underlying co-morbidity may be enrolled if there have been no changes to their medication within 60 days prior to first dose of Investigational Product.
18. Any acute illness including, fever (> 100.4 F [> 38 C]) within 3 days prior to the first dose of Investigational Product.
19. Receipt of any investigational drug within 30 days prior to the first dose of Investigational Product.
20. Receipt of blood products within 90 days prior to the first dose of Investigational Product.
21. Donation of blood or plasma within 90 days prior to Screening.
22. Receipt of a live vaccine within 28 days prior or a subunit vaccine within 14 days prior to the first dose of Investigational Product or planned vaccination within 30 days following the last dose of Investigational Product.
23. History of hypersensitivity to any component of the vaccine or history of an allergic reaction to an immunization.
24. History of drug or alcohol abuse that, in the opinion of the Investigator, would interfere with the subject’s ability to comply with the study requirements.
25. Any other condition that, in the opinion of the Investigator would make the subject unsuitable for the study or unable to comply with the study requirements.

E.5 End points

E.5.1

Primary end point(s)

The primary endpoint is measured as the efficacy of GEN-003 as measured by reduction in nasopharyngeal colonization.
The primary endpoint, i.e. the proportion of subjects who become colonized in each treatment group, will be compared using Fisher’s exact test. Colonization is defined as detection of S. pneumoniae by microbiological culture and latex agglutination.
The magnitude of colonization will be analyzed using mixed model for repeat measures with treatment and visit as fixed effect, and subject as random effect, details will be contained in the statistical analysis plan.

E.5.1.1

Timepoint(s) of evaluation of this end point

The primary endpoint will be evaluated at the end of the dosing period (Day 64) during the inoculation period (Days 73, 78 and 85) and during the optional follow up period (Days 225 and 393) if applicable.

E.5.2

Secondary end point(s)

Evaluation of the safety and tolerability of GEN-004 with aluminum hydroxide as measured by frequency and severity of Adverse Events

Evaluation of the duration of S. pneumoniae colonization through 14 days after inoculation

Evaluation of the immunogenicity of GEN-004 with aluminum hydroxide, as measured by TH17 (IL-17) and IgG responses to the antigens.

E.5.2.1

Timepoint(s) of evaluation of this end point

The following secondary endpoints will be measured on the following treatment days for each endpoint:
1. Safety and Tolerability will be evaluated at each visit for dosing, inoculation and follow up period (i.e. Days 1, 8, 29, 36, 57, 64, 71, 73, 78, 85, 141, 225, 309 and 393)

2. Duration of colonization will be evaluated at the end of the inoculation period, on day 85

3. Immunogenicity will be evaluated at the screening visit, during the first dosing visit (day 1), at the start and end of the inoculation visits (days 71 and 85) and during the optional follow up period on days 225 and 393.

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

The trial involves single site in the Member State concerned

Yes

E.8.4

The trial involves multiple sites in the 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

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

12 months following the last IMP administration

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:

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

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

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

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

Competent Authority Decision

Authorised

Date of Competent Authority Decision

2014-07-18

Ethics Committee Opinion of the trial application

Favourable

Ethics Committee Opinion: Reason(s) for unfavourable opinion

Date of Ethics Committee Opinion

2014-07-30

P. End of Trial
P.	End of Trial Status	Completed
P.	Date of the global end of the trial	2016-04-25

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