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

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. Identifier: NCT01478893
Recruitment Status : Completed
First Posted : November 23, 2011
Last Update Posted : January 7, 2016
Information provided by (Responsible Party):
Selecta Biosciences, Inc.

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.

Condition or disease Intervention/treatment Phase
Smoking Cessation Biological: SEL-068 Biological: Saline Phase 1

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 82 participants
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
Study Start Date : November 2011
Actual Primary Completion Date : January 2013
Actual Study Completion Date : March 2013

Arm Intervention/treatment
Experimental: SEL-068 Biological: SEL-068
Sub-cutaneous injection, multiple dose
Placebo Comparator: Saline Biological: Saline
Sub-cutaneous injection, multiple dose

Primary Outcome Measures :
  1. 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 :
  1. Immunogenicity of SEL-068 by measuring anti-nicotine antibody titers by Enzyme-Linked Immunosorbent Assay (ELISA). [ Time Frame: 36 weeks ]

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.

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 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

Responsible Party: Selecta Biosciences, Inc. Identifier: NCT01478893     History of Changes
Other Study ID Numbers: SEL-068/101
2011-003272-37 ( EudraCT Number )
First Posted: November 23, 2011    Key Record Dates
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