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Campylobacter Infection | Safety Study of a Capsule-Conjugate Vaccine to Prevent Campylobacter-Caused Diarrhea

Campylobacter Infection research study

What is the primary objective of this study?

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.

Who is eligible to participate?

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.

Which medical condition, disease, disorder, syndrome, illness, or injury is researched?

Campylobacter Infection

Study Interventions

Interventions can include giving participants drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available or noninvasive approaches such as surveys, education, and interviews.

Biological:Capsule-Conjugate Campylobacter Vaccine (CJCV1)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)

Drug:Alhydrogel®, aluminum hydroxide adjuvant (alum)

Study Arms

Research studies and clinical trials typically have two or more research arms. An arm is a group of people who receive the same treatment in the study.

CJCV1 2 μg / Alum 0 μg (1A)Two vaccinations (one on Day 0 and one on Day 28) with an intramuscular dose of Capsule-Conjugate Campylobacter Vaccine (CJCV1) equivalent to 2 μg of polysaccharide and 0 μg of Alhydrogel®, aluminum hydroxide adjuvant (Alum)

CJCV1 2 μg / Alum 125 μg (1B)Two vaccinations (one on Day 0 and one on Day 28) with an intramuscular dose of Capsule-Conjugate Campylobacter Vaccine (CJCV1) equivalent to 2 μg of polysaccharide and 125 μg of Alhydrogel®, aluminum hydroxide adjuvant (Alum)

CJCV1 5 μg / Alum 0 μg (2A)Two vaccinations (one on Day 0 and one on Day 28) with an intramuscular dose of Capsule-Conjugate Campylobacter Vaccine (CJCV1) equivalent to 5 μg of polysaccharide and 0 μg of Alhydrogel®, aluminum hydroxide adjuvant (Alum)

CJCV1 5 μg / Alum 125 μg (2B)Two vaccinations (one on Day 0 and one on Day 28) with an intramuscular dose of Capsule-Conjugate Campylobacter Vaccine (CJCV1) equivalent to 5 μg of polysaccharide and 125 μg of Alhydrogel®, aluminum hydroxide adjuvant (Alum)

CJCV1 10 μg / Alum 0 μg (3A)Two vaccinations (one on Day 0 and one on Day 28) with an intramuscular dose of Capsule-Conjugate Campylobacter Vaccine (CJCV1) equivalent to 10 μg of polysaccharide and 0 μg of Alhydrogel®, aluminum hydroxide adjuvant (Alum)

CJCV1 10 μg / Alum 125 μg (1A)Two vaccinations (one on Day 0 and one on Day 28) with an intramuscular dose of Capsule-Conjugate Campylobacter Vaccine (CJCV1) equivalent to 10 μg of polysaccharide and 125 μg of Alhydrogel®, aluminum hydroxide adjuvant (Alum)

Study Status

Completed

Start Date: April 21, 2014

Completed Date: January 22, 2016

Phase: Phase 1

Type: Interventional

Design:

Primary Outcome: Safety: Presence of Related/Not Related Local and/or Systemic Reactogenicity (Adverse Events)

Secondary Outcome: Frequency (%) of Vaccine-specific Immune Responses by Assay and Antigen Using Enzyme-linked Immunosorbent Assay (ELISA)

Study sponsors, principal investigator, and references

Principal Investigator: Ramiro Gutierrez, MD

Lead Sponsor: U.S. Army Medical Research and Development Command

Collaborator: Walter Reed Army Institute of Research (WRAIR)

More information:https://clinicaltrials.gov/show/NCT02067676

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