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

Smoking Cessation Clinical Trial

Official title:

A Phase 1 Randomized, Double-Blind, Placebo-Controlled Study to Assess the Safety and Pharmacodynamics of Increasing Subcutaneous Doses of SEL-068 in Healthy Non-Smoker and Smoker Adults

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01478893
• Other study ID #: SEL-068/101
• Secondary ID: 2011-003272-37
• Status: Completed
• Phase: Phase 1
• First received: November 18, 2011
• Last updated: January 5, 2016
• Start date: November 2011
• Est. completion date: March 2013

Study information

• Verified date: January 2016
• Source: Selecta Biosciences, Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: Belgium: Federal Agency for Medicinal Products and Health Products
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 82
• Est. completion date: March 2013
• Est. primary completion date: January 2013
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 60 Years

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Smoking Cessation

Intervention

Biological:
• SEL-068
Sub-cutaneous injection, multiple dose
• Saline
Sub-cutaneous injection, multiple dose

Locations

Country	Name	City	State
Belgium	SGS LSS Clinical Pharmacology Unit	Antwerpen

Sponsors (1)

Lead Sponsor	Collaborator
Selecta Biosciences, Inc.

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Yes
Secondary	Immunogenicity of SEL-068 by measuring anti-nicotine antibody titers by Enzyme-Linked Immunosorbent Assay (ELISA).		36 weeks	No