Campylobacter Jejuni Challenge Model Development: Assessment of Homologous Protection

2014-08-27 03:16:41 | BioPortfolio


The goal of this research is to continue to develop a model of infection with Campylobacter jejuni, a bacterium that causes food and water-borne disease (mainly diarrhea). The objectives are to 1) determine if healthy subjects develop short-term (<6 month) protection to reinfection with C. jejuni; and 2) characterize the immune responses to C. jejuni infection. Information obtained will be used in development of a vaccine against Campylobacter infections.

Volunteers will be screened for eligibility within 60 days prior to enrollment. Screening will include obtaining informed consent prior to any study procedure. This will be followed by medical history, physical examination, review of current medications, blood samples for safety labs (WBC, Hct, Hgb, platelet count; chemistry panel; screening for HIV, HLA-B27, HBV, and HCV); urine pregnancy testing for females. Stool will be tested for infection.

Eligible volunteers will be enrolled in the study and admitted to the GCRC on Day -1. They will drink a measured dose of C. jejuni on Day 0, and followed for approximately 9 inpatient days, during which time the investigators expect at least 75% to develop a diarrheal illness, which will be promptly treated with replacement fluids (oral or IV, as indicated) and antibiotics. During the inpatient period, subjects will be assessed for any adverse events, and blood and stool specimens will be analyzed for markers of infection and markers of immune response. Subjects must have resolved or resolving symptoms and two negative stool cultures ≥12 hours apart to be eligible for discharge, and will be seen in outpatient follow-up at 21, 28, 35, 60, and 90 days for additional AE assessments and blood and stool analysis.

Eight subjects will return for redosing approximately 98 days after the initial dose, with the same inpatient and outpatient follow-up as above. Few or none should develop a diarrheal illness. Four naïve (previously unexposed) subjects will also receive the dose on Day 98 to confirm a 75% illness rate with this dose. They will be followed as the initial group was. All participants will be assessed by phone 6 months after the final dose they received.

Study Design

Allocation: Non-Randomized, Control: Uncontrolled, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention


Campylobacter Infections


Campylobacter jejuni strain CG8421


Navy Medical Research Center
Silver Spring
United States




University of Vermont

Results (where available)

View Results


Published on BioPortfolio: 2014-08-27T03:16:41-0400

Clinical Trials [412 Associated Clinical Trials listed on BioPortfolio]

Evaluation of Immunochromatographic Tests for Campylobacter Detection in Stools

For a long time, culture was the only way to detect Campylobacter. It appears that rapid immunochromatographic tests (ICT) have detected more positive cases compared to culture, ELISA and...

Mucosal and Microbiota Changes During Acute Campylobacteriosis

Gastrointestinal (GI) infection with Campylobacter causes inflammation in the bowel and can change bacteria in the gut. Certain individuals with Campylobacter infection are also known to d...

Evaluation of a Diagnostic Enteric Card for Management of Diarrhea

PATH is a member of a consortium that is developing a Diagnostic Enterics Card (DEC) which will allow clinicians to diagnose a group of diarrheagenic pathogens linked to morbidity and mort...

ACE393-103 Vaccination Challenge Study

The purpose of this study is to determine whether ACE393 vaccination can protect against Campylobacteriosis in a challenge model.

Intranasal Recombinant Flagellin Subunit Campylobacter Vaccine (rFla-MBP) Dose-Ranging Study

This study is an open-labeled dose escalating trial in which a total of 32 subjects will receive one of four intranasal rFla-MBP vaccine doses.

PubMed Articles [6015 Associated PubMed Articles listed on BioPortfolio]

Characterization of Campylobacter jejuni, Campylobacter upsaliensis, and a novel Campylobacter sp. in a captive non-human primate zoological collection.

The aim of this study was to longitudinally investigate the prevalence and characterization of Campylobacter spp. from non-human primates primate (NHP) with a history of endemic diarrhea housed at Com...

Campylobacter in recreational lake water in southern Quebec, Canada: presence, concentration, and association with precipitation and ruminant farm proximity.

Campylobacter is an important cause of gastrointestinal illness and exposure to recreational water is one potential source of infection. The objective of this study was to investigate the presence and...

Ciprofloxacin resistance among Campylobacter jejuni isolates obtained from shelter dogs in Texas.

There are few epidemiologic studies on the shedding of Campylobacter among dogs in the United States, despite the potential public health implications. Our objectives were to estimate the prevalence o...

Genetic characterization and epidemiological implications of Campylobacter isolates from wild birds in South Korea.

In this study, we genotyped Campylobacter isolates from wild birds by multilocus sequence typing (MLST) and analysed their virulence genes by PCR with the aim to gain a deeper understanding of the epi...

Lack of Evidence for erm(B) Infiltration Into Erythromycin-Resistant Campylobacter coli and Campylobacter jejuni from Commercial Turkey Production in Eastern North Carolina: A Major Turkey-Growing Region in the United States.

In Campylobacter spp., resistance to erythromycin and other macrolides has typically implicated ribosomal mutations, especially substitutions in the 23S rRNA genes. However, in 2014, the macrolide res...

Medical and Biotech [MESH] Definitions

Infections with bacteria of the genus CAMPYLOBACTER.

A species of CAMPYLOBACTER isolated from DOGS; CATS; and humans.

A species of thermophilic CAMPYLOBACTER found in healthy seagulls and causing ENTERITIS in humans.

A species of CAMPYLOBACTER isolated from cases of human PERIODONTITIS. It is a microaerophile, capable of respiring with OXYGEN.

A species of CAMPYLOBACTER comprised of three biovars based on their reaction to CATALASE and UREASE. They have been isolated from humans, CATTLE, and SHEEP.

More From BioPortfolio on "Campylobacter Jejuni Challenge Model Development: Assessment of Homologous Protection"

Quick Search


Relevant Topics

Antiretroviral Therapy Clostridium Difficile Ebola HIV & AIDS Infectious Diseases Influenza Malaria Measles Sepsis Swine Flu Tropical Medicine Tuberculosis Infectious diseases are caused by pathogenic...

Food is any substance consumed to provide nutritional support for the body. It is usually of plant or animal origin, and contains essential nutrients, such as carbohydrates, fats, proteins, vitamins, or minerals. The substance is ingested by an organism ...

Within medicine, nutrition (the study of food and the effect of its components on the body) has many different roles. Appropriate nutrition can help prevent certain diseases, or treat others. In critically ill patients, artificial feeding by tubes need t...

Searches Linking to this Trial