Safety and Immunogenicity Evaluation of an Intramuscular Capsule-Conjugate Campylobacter Vaccine (CJCV1)

U.S. Army Medical Research and Development Command1 site in 1 country48 target enrollmentApril 21, 2014

ConditionsCampylobacter Infection

InterventionsCapsule-Conjugate Campylobacter Vaccine (CJCV1)Alhydrogel®, aluminum hydroxide adjuvant (alum)

DrugsAlhydrogel®, aluminum hydroxide adjuvant (alum)

Overview

Phase: Phase 1
Intervention: Capsule-Conjugate Campylobacter Vaccine (CJCV1)
Conditions: Campylobacter Infection
Sponsor: U.S. Army Medical Research and Development Command
Enrollment: 48
Locations: 1
Primary Endpoint: Safety: Presence of Related/Not Related Local and/or Systemic Reactogenicity (Adverse Events)
Status: Completed
Last Updated: 8 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

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.

Detailed Description

This is an open-label, dose-escalating study in which a total of 48 healthy volunteers will receive 2 vaccinations (one on Day 0 and one on Day 28 ± 2 days). There are 3 cohorts (dose levels) with 2 groups of 8 volunteers in each cohort. A cohort will be administered one of 3 intramuscular (IM) doses at 2 μg, 5 μg, or 10 μg of Capsule-Conjugate Campylobacter Vaccine (CJCV1) with or without Alhydrogel®, aluminum hydroxide adjuvant (alum) at 125 μg. An interval no less than 1 week will separate the last dose of a volunteer group from the first dose of the next volunteer group (receiving different CJCV1 doses). Blood specimens will be collected at intervals to examine systemic and mucosal antigen-specific immune responses. Vaccine safety will be actively monitored during vaccination and for 28 days (± 2 days) following the second vaccination and complete the study with a telephone follow-up approximately 6 months (± 1 month) after the first vaccination. The total duration of participation in this study is up to 270 days (including screening).

Registry

clinicaltrials.gov

Start Date

April 21, 2014

End Date

January 22, 2016

Last Updated

8 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

U.S. Army Medical Research and Development Command

Responsible Party

Sponsor

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 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

Arms & Interventions

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)