Safety Study of a Capsule-Conjugate Vaccine to Prevent Campylobacter-Caused Diarrhea
Condition: Campylobacter Infection
MeSH terms: Campylobacter Infections
Intervention: Capsule-Conjugate Campylobacter Vaccine (CJCV1); Alhydrogel®, aluminum hydroxide adjuvant (alum)
Intervention description: The capsule of Campylobacter jejuni strain 81-176 (CPS81-176) conjugated to the mutated diphtheria toxin cross-reacting material 197 (CRM197) (lyophilized CPS-CRM197 conjugate) (CJCV1)
Intervention MeSH terms: Aluminum Hydroxide
Phase: Phase 1
Study type: Interventional
Primary purpose: Prevention
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 48.0
Sex: All
Minimum age: 18 Years
Maximum age: 50 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Campylobacter jejuni

Summary:

      The purpose of this study is to assess the safety of increasing doses of a potential vaccine
      against Campylobacter with and without Alhydrogel®, an aluminum hydroxide adjuvant. This
      study will also assess immune responses induced by the vaccine.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Healthy adult, male or female, age 18 to 50 years (inclusive) at the time of
             enrollment.

          -  Completion and review of comprehension test (achieved 70% accuracy).

          -  Signed informed consent document.

          -  Available for the required follow-up period and scheduled clinic visits and telephone
             follow-up.

          -  Women: Negative pregnancy test with understanding (through informed consent) to not
             become pregnant during the study or within three months after the last vaccine dose
             (Day 28). Sexually active females, unless surgically sterile or at least one year
             postmenopausal, must have used an effective method of avoiding pregnancy (including
             oral or implanted contraceptives, intrauterine device (IUD), female condom, diaphragm
             with spermicide, cervical cap, abstinence, use of a condom by the sexual partner, or
             sterile sexual partner) prior to dosing of study vaccine. Female subjects unable to
             bear children must have a note from a primary care provider or obstetrics and
             gynaecology (OB/GYN) as proof of documentation (eg, tubal ligation or hysterectomy).
             If a volunteer becomes pregnant during the study, the PI will notify the study
             monitor, the sponsor, and the local institutional review board (IRB). The volunteer
             will be asked to provide serial follow-ups, including copies of clinic visits on the
             status of her pregnancy as well as health information on her infant following
             delivery.

        Exclusion Criteria:

        Health

          1. Health problems affecting study participation from medical history (specifically to
             include chronic medical conditions such as diabetes mellitus and hypertension or any
             other condition requiring daily therapy that would place the volunteer at increased
             risk of adverse events (AEs). Study clinicians, in consultation with the PI, will use
             clinical judgment on a case-by-case basis to assess safety risks under this criterion.
             The PI will consult with the research monitor as appropriate.

          2. Clinically significant abnormalities on physical examination

          3. Use of immunosuppressive drugs, such as corticosteroids and chemotherapy, during the
             course of the study or immunosuppressive illness, including IgA deficiency (defined by
             serum IgA below level of detection)

          4. Women who are pregnant or planning to become pregnant during the study period plus 3
             months beyond the last vaccine dose and currently nursing women

          5. Participation in research involving another investigational product 30 days before the
             planned date of first vaccination until the last study safety visit.

          6. Positive blood test for HIV-1 (the human immunodeficiency virus and cause of AIDS)

          7. Positive blood test for hepatitis B surface antigen (HBsAG; the virus causing
             hepatitis B)

          8. Positive blood test for anti-HCV antibody (the virus causing hepatitis C)

          9. Clinically significant abnormalities on basic laboratory screening

         10. Presence of significant unexplained laboratory abnormalities that in the opinion of
             the PI may potentially confound the analysis of the study results Research Specific

         11. Regular use (weekly or more often) of anti-diarrheal, anti-constipation, or antacid
             therapy

         12. Abnormal bowel habits as defined by fewer than 3 stools per week or more than 3
             loose/liquid stools per day

         13. Personal or family history of inflammatory arthritis

         14. Personal history of irritable bowel syndrome

         15. Positive blood test for HLA-B27

         16. History of allergy to any vaccine

         17. History of allergy to alum

         18. History of Guillain-Barré Syndrome or other neuroimmunological disorders Prior
             Exposure to Campylobacter

         19. History of travelers' diarrhea or residence (> 2 months) in the past 3 years in a
             country with potentially higher Campylobacter rates to include Africa, South America,
             Central America, and Asia (except Japan).

         20. Occupation involving handling of Campylobacter bacteria or vaccine products currently
             or in the past 3 years.

         21. History of microbiologically confirmed Campylobacter infection.

         22. Received previous experimental Campylobacter vaccine or live Campylobacter challenge.