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
试验速览
- 阶段
- 2 期
- 入组人数
- 72
- 试验地点
- 1
- 主要终点
- Incidence of Moderate or Severe Diarrhea
研究概览
简要总结
The purpose of this study is to determine whether ACE393 vaccination can protect against Campylobacteriosis in a challenge model.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 50 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •(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.
排除标准
- •(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.
研究组 & 干预措施
1
vaccination with ACE393 followed by challenge with campylobacter jejuni
干预措施: ACE393 (Biological)
2
Placebo vaccination followed by challenge with campylobacter jejuni
干预措施: Placebo vaccine (Biological)
结局指标
主要结局
Incidence of Moderate or Severe Diarrhea
时间窗: 20 weeks
次要结局
- 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)