Immune Response Elicited by Concomitant Administration of Oral Typhoid Fever (Vivotif®) and Cholera (Dukoral®) Vaccines
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 65
- 试验地点
- 1
- 主要终点
- Magnitude of antigen-specific plasmablast responses to oral typhoid fever (Vivotif®) and cholera (Dukoral®) vaccines (ASCs/million PBMCs)
研究概览
简要总结
The goal of this clinical trial is to explore the coadministration of oral typhoid fever (Vivotif®) and cholera (Dukoral®) vaccines in healthy volunteers aged 18-65 years. The main question it aims to answer is:
• Does coadministration impact the immune responses to Vivotif® and Dukoral® vaccines
Participants will:
- receive either oral typhoid fever (Vivotif®) or oral cholera (Dukoral®) vaccines or both simultaneously
- give blood samples for immunogenicity analyses
- participate in adverse event follow up
Researchers will compare those receiving only one of the vaccines to those receiving both simultaneously to see if coadministration has an impact on antigen-specific responses measured with:
- ELISPOT (plasmablast responses specific to Salmonella typhi, Vibrio Cholerae and Enterotoxigenic Escherichia coli)
- ELISA (antibodies in lymphocyte supernatants (ALS) and serum antibodies specific to vaccine antigens)
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
- None
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Male or female subjects aged ≥18 to ≤65 years.
- •General good health as established by medical history and physical examination.
- •Written informed consent.
- •Females of childbearing potential must agree to use an efficacious hormonal or barrier method of birth control during the study (14 days before immunization to day 28 ± 3). Abstinence is acceptable.
- •Available for all visits scheduled in this study.
排除标准
- •Vaccination against typhoid fever or cholera within 5 years before dosing.
- •History of clinical typhoid fever or cholera.
- •Immunization with any other vaccine (oral or parenteral) within 4 weeks prior to study period or vaccination planned during it.
- •Current intake of antibiotics or end of antibiotic therapy <8 days before first IMP administration.
- •Chronic (longer than 14 days) administration of immunosuppressants or other immunemodifying drugs within 6 months before the first dose of IMP; oral corticosteroids in dosages of ≥0.5 mg/kg/d prednisolone or equivalent are excluded; inhaled or topical steroids allowed.
- •Acute or chronic clinically significant gastrointestinal disease.
- •Any confirmed or suspected immunosuppressive or immunodeficient condition, including human immunodeficiency virus (HIV) infection.
- •Pregnancy or lactation.
- •Acute disease at the time of enrolment (defined as the presence of a moderate or severe illness with or without fever (fever defined as body temperature of ≥38 °C).
- •Alcohol or drug abuse.
- •Suspected non-compliance.
- •Use of any investigational drug or vaccine within 30 days preceding the first dose of study vaccine, or planned use during the study period.
- •Any clinically significant history of known or suspected anaphylaxis or hypersensitivity reaction based on the judgement of the investigator.
- •Employee at the investigational site or relative or spouse of the investigator.
- •Any other criteria which, in the investigator's opinion, would compromise the ability of a subject to participate in the study, a subject's well-being, or the outcome of the study.
研究组 & 干预措施
Vivotif
Three oral doses of typhoid fever vaccine (Vivotif®).
干预措施: Oral typhoid fever vaccine (Biological)
Dukoral
Two oral doses of cholera vaccine (Dukoral®).
干预措施: Oral cholera vaccine (Biological)
Dukoral+Vivotif
Oral typhoid fever and cholera vaccines (Vivotif® and Dukoral®) administered simultaneously.
干预措施: Oral typhoid fever vaccine (Biological)
Dukoral+Vivotif
Oral typhoid fever and cholera vaccines (Vivotif® and Dukoral®) administered simultaneously.
干预措施: Oral cholera vaccine (Biological)
结局指标
主要结局
Magnitude of antigen-specific plasmablast responses to oral typhoid fever (Vivotif®) and cholera (Dukoral®) vaccines (ASCs/million PBMCs)
时间窗: Blood samples on Days 0-7 for all participants and Days 12-14 for participants in Dukoral and Dukoral+Vivotif arms.
Measurement of IgA -, IgG- and IgM-secreting antibody cells (ASC ELISPOT) specific to Salmonella typhi (whole cell), Vibrio cholerae (whole cell and CTB-toxin) and Enterotoxigenic Escherichia coli (ETEC whole cell and LTB-toxin).
次要结局
- Titer of antigen-specific antibodies in lymphocyte supernatants (ALS) to oral typhoid fever (Vivotif®) and cholera (Dukoral®) vaccines.(Blood samples on Days 0-7 for all participants and Days 12-14 for participants in Dukoral and Dukoral+Vivotif arms.)
研究者
Anu Kantele
MD, PhD, Professor of Infectious Diseases
Helsinki University Central Hospital