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

NCT02067676 | Completed Phase 1 Results FDA Drug

• 2 other identifiers: S-13-09NMRC.2013.0021
• Study Type: interventional
• Target: 48
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Campylobacter Infection

Keywords

Campylobacter jejuni

Outcome Measures

Primary Outcomes (1)

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

  Vaccine safety will be assessed by evaluating post-vaccination local and systemic reactions through targeted physical exams, symptom surveys, and other adverse event (AE) monitoring. All subjects will be observed in the clinic for at least 30 minutes after receipt of the investigational product. Approximately 48 hours after vaccination, subjects will return to the Clinical Trials Center for observation and reporting of any local and/or systemic AEs. Seven days after vaccine administration, subjects will return to the Clinical Trials Center to review their memory aids with study personnel and to report any AEs. In addition to planned visits, if a subject experiences any unanticipated AE, the subject will be seen by one of the study investigators. All AEs will be coded for onset date, duration, severity, and potential relationship to the investigational product.

  up to 7 days

Secondary Outcomes (4)

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

  Study Days 0-56

• Vaccine-specific Geometric Mean Titers (GMT) of Anti-CPS IgG Antibody-secreting Cells

  Study Days 0-56

• Vaccine-specific Anti-CRM^197 IgA Antibody-secreting Cell (ASC) Responses

  Study Days 0-56

• Interferon Titers Among All Cohorts

  Day 0, 28 and 56

Study Arms (6)

CJCV1 2 μg / Alum 0 μg (1A)

EXPERIMENTAL

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)

Biological: Capsule-Conjugate Campylobacter Vaccine (CJCV1)

CJCV1 2 μg / Alum 125 μg (1B)

EXPERIMENTAL

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)

Biological: Capsule-Conjugate Campylobacter Vaccine (CJCV1); Drug: Alhydrogel®, aluminum hydroxide adjuvant (alum)

CJCV1 5 μg / Alum 0 μg (2A)

EXPERIMENTAL

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)

Biological: Capsule-Conjugate Campylobacter Vaccine (CJCV1)

CJCV1 5 μg / Alum 125 μg (2B)

EXPERIMENTAL

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)

Biological: Capsule-Conjugate Campylobacter Vaccine (CJCV1); Drug: Alhydrogel®, aluminum hydroxide adjuvant (alum)

CJCV1 10 μg / Alum 0 μg (3A)

EXPERIMENTAL

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)

Biological: Capsule-Conjugate Campylobacter Vaccine (CJCV1)

CJCV1 10 μg / Alum 125 μg (1A)

EXPERIMENTAL

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)

Biological: Capsule-Conjugate Campylobacter Vaccine (CJCV1); Drug: Alhydrogel®, aluminum hydroxide adjuvant (alum)

Interventions

Capsule-Conjugate Campylobacter Vaccine (CJCV1) BIOLOGICAL

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)

CJCV1 10 μg / Alum 0 μg (3A); CJCV1 10 μg / Alum 125 μg (1A); CJCV1 2 μg / Alum 0 μg (1A); CJCV1 2 μg / Alum 125 μg (1B); CJCV1 5 μg / Alum 0 μg (2A); CJCV1 5 μg / Alum 125 μg (2B)

Alhydrogel®, aluminum hydroxide adjuvant (alum) DRUG

CJCV1 10 μg / Alum 125 μg (1A); CJCV1 2 μg / Alum 125 μg (1B); CJCV1 5 μg / Alum 125 μg (2B)

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• Health
• 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.
• Clinically significant abnormalities on physical examination
• 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)
• 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
• Participation in research involving another investigational product 30 days before the planned date of first vaccination until the last study safety visit.
• Positive blood test for HIV-1 (the human immunodeficiency virus and cause of AIDS)
• Positive blood test for hepatitis B surface antigen (HBsAG; the virus causing hepatitis B)
• Positive blood test for anti-HCV antibody (the virus causing hepatitis C)
• Clinically significant abnormalities on basic laboratory screening
• Presence of significant unexplained laboratory abnormalities that in the opinion of the PI may potentially confound the analysis of the study results Research Specific
• Regular use (weekly or more often) of anti-diarrheal, anti-constipation, or antacid therapy
• Abnormal bowel habits as defined by fewer than 3 stools per week or more than 3 loose/liquid stools per day
• Personal or family history of inflammatory arthritis
• Personal history of irritable bowel syndrome

Sponsors & Collaborators

• U.S. Army Medical Research and Development Command: lead
• Walter Reed Army Institute of Research (WRAIR): collaborator

Study Sites (1)

Walter Reed Army Institute of Research

Silver Spring, Maryland, 20910, United States

Location

MeSH Terms

Conditions

Campylobacter Infections

Interventions

Aluminum Hydroxide; aluminum sulfate

Condition Hierarchy (Ancestors)

Gram-Negative Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Infections

Intervention Hierarchy (Ancestors)

Hydroxides; Alkalies; Inorganic Chemicals; Aluminum Compounds; Anions; Ions; Electrolytes

Results Point of Contact

• Title: Ramiro Gutierrez, MD
• Organization: Enteric Disease Department, Naval Medical Research Center

ramiro.l.gutierrez.mil@mail.mil

301-319-3193

Study Officials

• Ramiro Gutierrez, MD

  Enteric Disease Department, Naval Medical Research Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: FED
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 18, 2014
• First Posted: February 20, 2014
• Study Start: April 21, 2014
• Primary Completion: September 24, 2014
• Study Completion: January 22, 2016
• Last Updated: February 23, 2018
• Results First Posted: January 25, 2018

Record last verified: 2018-01

Data Sharing

• IPD Sharing: Will share

Locations

US (1)