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

This study has been completed.
ClinicalTrials.gov Identifier:
First Posted: November 23, 2011
Last Update Posted: January 7, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Selecta Biosciences, Inc.
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
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, 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

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 ]

Secondary Outcome Measures:
  • Immunogenicity of SEL-068 by measuring anti-nicotine antibody titers by Enzyme-Linked Immunosorbent Assay (ELISA). [ Time Frame: 36 weeks ]

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


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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.
ClinicalTrials.gov Identifier: NCT01478893     History of Changes
Other Study ID Numbers: SEL-068/101
2011-003272-37 ( EudraCT Number )
First Submitted: November 18, 2011
First Posted: November 23, 2011
Last Update Posted: January 7, 2016
Last Verified: January 2016

Keywords provided by Selecta Biosciences, Inc.:
nicotine vaccine
smoking vaccine
smoking cessation

Additional relevant MeSH terms:
Immunologic Factors
Physiological Effects of Drugs