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

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

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01478893

Enrollment

Registered

2011-11-23

Start date

2011-11-30

Completion date

2013-03-31

Last updated

2016-01-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Smoking Cessation

Keywords

nicotine vaccine, smoking vaccine, smoking cessation, SEL-068

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.

Interventions

BIOLOGICALSEL-068

Sub-cutaneous injection, multiple dose

BIOLOGICALSaline

Sub-cutaneous injection, multiple dose

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to 60 Years

Healthy volunteers

Yes

Inclusion 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.

Design outcomes

Primary

Measure	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

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

Countries

Belgium

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026