Safety and Immunogenicity of Different Formulations of a Clostridium Difficile Toxoid Vaccine Administered at Three Different Schedules in Adults Aged 40 to 75 Years at Risk of C. Difficile Infection
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 650
- 试验地点
- 30
- 主要终点
- Information concerning the safety profile in terms of solicited and unsolicited reactions in participants following vaccination with ACAM-CDIFF™ Vaccine.
研究概览
简要总结
This study will further evaluate the ACAM-CDIFF™ vaccine in a population of middle-aged to elderly individuals at risk of exposure to Clostridium difficile because of impending hospitalization or residence in a care facility.
Primary Objectives:
- To describe the safety profile of subjects in each of the study groups.
- To describe the immune responses elicited by toxoid A and toxoid B of subjects in each of the study groups.
Observational Objective:
- To describe the occurrence of first-time Clostridium difficile infection (CDI) episodes.
详细描述
Participants will receive 3 doses of either one of 4 different formulations of ACAM-CDIFF™ vaccine or placebo, on one of 3 different schedules. The trial will have 2 stages. Stage I will test 4 different formulations of ACAM-CDIFF™ vaccine. Stage II will explore different vaccination schedules using one of these formulations.
Participants will be followed up for safety and immunogenicity; stool samples will also be provided in case of diarrhea.
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
- 40 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Aged 40 to 75 years on the day of inclusion
- •Informed consent form has been signed and dated
- •Able to attend all scheduled visits and to comply with all trial procedures
- •For a woman of childbearing potential, use of an effective method of contraception or abstinence from at least 4 weeks prior to the first vaccination until at least 4 weeks after the last vaccination
- •At risk for developing Clostridium difficile infection during the trial because of impending elective surgery or hospitalization within 60 days of enrollment, or current or impending residence in a long-term care facility or rehabilitation facility.
排除标准
- •Known pregnancy, or a positive urine pregnancy test
- •Currently breastfeeding a child
- •Participation in another clinical trial investigating a vaccine, drug, medical device, or medical procedure in the 4 weeks preceding the first trial vaccination
- •Planned participation in another clinical trial during the present trial period
- •Receipt of any vaccine in the 4 weeks preceding the first trial vaccination, except for influenza (seasonal or pandemic) and pneumococcal vaccine
- •Planned receipt of any vaccine in the 4 weeks following any trial vaccination, except for influenza (seasonal or pandemic) and pneumococcal vaccines
- •Previous vaccination against Clostridium difficile with either the trial vaccine or another vaccine
- •Current or prior Clostridium difficile infection (CDI) episode
- •Receipt of blood or blood-derived products in the past 3 months, which might interfere with assessment of the immune response
- •Known or suspected congenital or acquired immunodeficiency; or receipt of immunosuppressive therapy such as anti-cancer chemotherapy or radiation therapy within the preceding 6 months; or long-term systemic corticosteroid therapy (prednisone or equivalent for more than 2 consecutive weeks within the past 3 months)
- •Self-reported seropositivity for Human Immunodeficiency Virus (HIV), hepatitis B, or hepatitis C
- •Anticipated or current receipt of kidney dialysis treatment
- •Known systemic hypersensitivity to any of the vaccine components, or history of a life-threatening reaction to a vaccine containing any of the same substances
- •Self-reported thrombocytopenia, contraindicating intramuscular (IM) vaccination
- •Bleeding disorder, or receipt of anticoagulants in the 3 weeks preceding inclusion, contraindicating IM vaccination
- •Deprived of freedom by an administrative or court order, or in an emergency setting, or hospitalized involuntarily
- •Current alcohol abuse or drug addiction that might interfere with the ability to comply with trial procedures
- •Chronic illness that, in the opinion of the investigator, is at a stage where it might interfere with trial conduct or completion
- •Identified as a study site employee who is involved in the protocol and may have direct access to trial-related data
- •Subjects who have any history of intestinal diverticular bleeding
- •Subjects who have had surgery within the past three months for gastrointestinal (GI) malignancy.
研究组 & 干预措施
Group 7
Participants will receive a dose of High-dose ACAM-CDIFF™ vaccine with adjuvant on Day 0, 30, and 180, respectively.
干预措施: Clostridium difficile toxoids A and B (high-dose with adjuvant) (Biological)
Group 1
Participants will receive a dose Low-dose ACAM-CDIFF™ vaccine with adjuvant on Day 0, 7, and 30, respectively.
干预措施: Clostridium difficile toxoids A and B (Low-dose with adjuvant) (Biological)
Group 2
Participants will receive a dose Low-dose ACAM-CDIFF™ vaccine without adjuvant on Day 0, 7, and 30, respectively.
干预措施: Clostridium difficile toxoids A and B (Low-dose without adjuvant) (Biological)
Group 3
Participants will receive a dose High-dose ACAM-CDIFF™ vaccine with adjuvant on Day 0, 7, and 30, respectively.
干预措施: Clostridium difficile toxoids A and B (high-dose with adjuvant) (Biological)
Group 4
Participants will receive a dose High-dose ACAM-CDIFF™ vaccine without adjuvant on Day 0, 7, and 30, respectively.
干预措施: Clostridium difficile toxoids A and B (high-dose without adjuvant) (Biological)
Group 5
Participants will receive a dose Placebo (0.9% normal saline) on Day 0, 7, and 30, respectively.
干预措施: Placebo: 0.9% normal saline (Biological)
Group 6
Participants will receive a dose of High-dose ACAM-CDIFF™ vaccine with adjuvant on Day 0, 7, and 180, respectively.
干预措施: Clostridium difficile toxoids A and B (high-dose with adjuvant) (Biological)
结局指标
主要结局
Information concerning the safety profile in terms of solicited and unsolicited reactions in participants following vaccination with ACAM-CDIFF™ Vaccine.
时间窗: 6 days after each vaccination and up to 6 months post-vaccination 3
Serum antitoxin IgG concentrations to Clostridium difficile toxins A and B in participants vaccinated with ACAM-CDIFF™.
时间窗: Up to 6 months post-vaccination 3
次要结局
未报告次要终点