ACE393-103 Vaccination Challenge Study

A Randomized, Double-Blind, Placebo Controlled Vaccination-Challenge Study of ACE393 to Determine Efficacy Against the Symptoms of Moderate to Severe Campylobacter Jejuni Infection in Normal Healthy Volunteers

Status

UNKNOWN

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00859716

Acronym

ACE393-103VC

Enrollment

Registered

2009-03-11

Start date

2008-10-31

Completion date

2009-07-31

Last updated

2009-03-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Campylobacter Infection

Keywords

Vaccination, Diarrhea, Traveler's Diarrhea, Campylobacter jejuni, C. jejuni, Campylobacter, Campy

Brief summary

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

Detailed description

This study is a randomized, double blind, parallel group, placebo controlled study, in which subjects, with no evidence of prior C.jejuni infections or immunity, will be vaccinated with ACE393, a protein sub-unit vaccine, or placebo, and then subsequently challenged with C.jejuni. The study will include vaccination of approximately 72 subjects, with the aim of challenging a total of 60 subjects. ACE393 or placebo will be administered twice by intramuscular injection on an outpatient basis, three weeks apart and then the subjects will be challenged three weeks later with C.jejuni. During the inpatient monitoring period, volunteers will be evaluated daily for safety, clinical signs and symptoms of disease and stool microbiology). Criteria for early institution of oral hydration, intravenous fluids, serum electrolyte monitoring, blood cultures, and/or antibiotics are predefined. All volunteers will receive antibiotic therapy 6 days after challenge (unless treated early). Discharge criteria are predefined. Post-discharge follow-up will further monitor safety, confirm C .jejuni eradication after antibiotic therapy, and assess immunologic response.

Interventions

BIOLOGICALACE393

ACE393 250 micrograms as intra muscular injection at day 0 and day 21

BIOLOGICALPlacebo vaccine

Placebo 500 micrograms Alhydrogel as intra muscular injection at day 0 and day 21

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

PREVENTION

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to 50 Years

Healthy volunteers

Yes

Inclusion criteria

(selected): * Male or female between 18 and 50 years of age. * General good health, without significant medical illness, abnormal physical examination findings or clinical laboratory abnormalities as determined by the principal investigator or the principal investigator in consultation with the medical monitor and sponsor. * Negative serum pregnancy test at screening.

Exclusion criteria

(selected): * Immunosuppressive illness or clinically significant IgA deficiency. * Positive serology results for HIV, HBsAg, or HCV antibodies. * Evidence of inflammatory arthritis on examination and/or HLA-B27 positive. * Allergy or prior intolerance to selected antibiotics (specified in the protocol) * Fewer than 3 stools per week or more than 3 stools per day as the usual frequency; or passing of loose or liquid stools other than on an occasional basis. * History of diarrhea. * Stool culture positive for Campylobacter, other bacterial enteropathogens and intestinal parasites. * History of microbiologically confirmed Campylobacter infection. * History of vaccination for or ingestion of Campylobacter. * Immunologic evidence of Campylobacter exposure * Serologic evidence of prior Campylobacter infection. * Cell mediated immune response evidence of prior Campylobacter infection. * Fever within 48 hours preceding challenge. * Presence of any signs or symptoms indicative of active infection. * Diarrhea occurring in the 7 days prior to challenge. * Stool culture positive for Campylobacter, other bacterial enteric pathogens or intestinal parasites.

Design outcomes

Primary

Measure	Time frame
Incidence of Moderate or Severe Diarrhea	20 weeks

Secondary

Measure	Time frame
Median Total (individual) stool number (grade 3-5 stools, diarrheal episodes only)	20 Weeks
Median Total (individual) stool volume (grade 3-5 stools, diarrheal episodes only)	20 weeks
Maximum stool number and volume in a 24 hr period (grade 3-5 stools, diarrheal episodes only)	20 weeks
Incidence of severe diarrhea	20 weeks

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026