Safety and Pharmacodynamics of SEL-068 Vaccine in Smokers... | NCT01478893

Studies
Safety and Pharmacodynamics of SEL-068 Vaccine in Smokers and Non-Smokers

NCT01478893

Sponsor

Selecta Biosciences, Inc.

Status

Completed

Last Update Posted

Jan 7, 2016Estimated

Enrollment

82Actual

Phase

Phase 1

Conditions

Smoking Cessation

Interventions

SEL-068
Saline

Countries

Belgium

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

ID	Type	Description	Link
2011-003272-37	EudraCT Number

Status Module

Record Verification Date

Jan 2016

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Nov 2011

Primary Completion Date

Jan 2013Actual

Completion Date

Mar 2013Actual

First Submitted Date

Nov 18, 2011

First Submission Date that Met QC Criteria

Nov 21, 2011

First Posted Date

Nov 23, 2011Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jan 5, 2016

Last Update Posted Date

Jan 7, 2016Estimated

Description Module

Brief Summary

The purpose of this study is to evaluate the safety and pharmacodynamics of SEL-068. Increasing subcutaneous doses of SEL-068 will be administered to healthy non-smoker and smoker volunteers. The resulting safety profile and anti-nicotine antibody levels will be evaluated.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 1

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

82Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
SEL-068	Experimental		Biological: SEL-068
Saline	Placebo Comparator		Biological: Saline

Interventions

Name	Type	Description	Arm Group Labels	Other Names
SEL-068	Biological	Sub-cutaneous injection, multiple dose	SEL-068

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
To assess the safety and tolerability of multiple subcutaneous injections of SEL-068 as assessed by frequency of vaccine related adverse events, graded by severity		36 weeks

Secondary Outcomes

Measure	Description	Time Frame
Immunogenicity of SEL-068 by measuring anti-nicotine antibody titers by Enzyme-Linked Immunosorbent Assay (ELISA).		36 weeks

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Primary Inclusion Criteria:

Healthy Smokers
Healthy non-smokers
Written informed consent

Primary Exclusion Criteria:

Prior exposure to nicotine vaccines
Female subjects of childbearing potential
Current use of immunosuppressive agents
History of or current autoimmune disorder of immunosuppressive condition (e.g. HIV infection)
Concurrent participation or participation within 8 weeks prior to the initial study drug administration in a drug/device or biologic investigational research study.

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

60 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Eva Vets, MD	SGS LSS Clinical Pharmacology Unit - Antwerpen	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
SGS LSS Clinical Pharmacology Unit		Antwerp			Belgium

Condition Browse Module

MeSH Terms

ID	Term
D016540	Smoking Cessation

Ancestor Terms

ID	Term
D015438	Health Behavior
D001519	Behavior

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D012965	Sodium Chloride

Ancestor Terms

ID	Term
D002712	Chlorides
D006851	Hydrochloric Acid
D017606	Chlorine Compounds
D007287	Inorganic Chemicals

Browse Leaves

Not provided

Browse Branches

Not provided