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

This study has been completed.
Information provided by (Responsible Party):
Selecta Biosciences, Inc. Identifier:
First received: November 18, 2011
Last updated: January 5, 2016
Last verified: January 2016
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.

Condition Intervention Phase
Smoking Cessation
Biological: SEL-068
Biological: Saline
Phase 1

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

Resource links provided by NLM:

Further study details as provided by Selecta Biosciences, Inc.:

Primary Outcome Measures:
  • 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 [ Time Frame: 36 weeks ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Immunogenicity of SEL-068 by measuring anti-nicotine antibody titers by Enzyme-Linked Immunosorbent Assay (ELISA). [ Time Frame: 36 weeks ] [ Designated as safety issue: No ]

Enrollment: 82
Study Start Date: November 2011
Study Completion Date: March 2013
Primary Completion Date: January 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: SEL-068 Biological: SEL-068
Sub-cutaneous injection, multiple dose
Placebo Comparator: Saline Biological: Saline
Sub-cutaneous injection, multiple dose


Ages Eligible for Study:   18 Years to 60 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes

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.
  Contacts and Locations
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Please refer to this study by its identifier: NCT01478893

SGS LSS Clinical Pharmacology Unit
Antwerpen, Belgium
Sponsors and Collaborators
Selecta Biosciences, Inc.
Principal Investigator: Eva Vets, MD SGS LSS Clinical Pharmacology Unit - Antwerpen
  More Information

Responsible Party: Selecta Biosciences, Inc. Identifier: NCT01478893     History of Changes
Other Study ID Numbers: SEL-068/101  2011-003272-37 
Study First Received: November 18, 2011
Last Updated: January 5, 2016
Health Authority: Belgium: Federal Agency for Medicinal Products and Health Products

Keywords provided by Selecta Biosciences, Inc.:
nicotine vaccine
smoking vaccine
smoking cessation
SEL-068 processed this record on May 25, 2016