NCT00473967终止1 期
Double-blind, Randomized, Controlled Phase 1 Study of the Safety and Immunogenicity of Na-ASP-2 Hookworm Vaccine in Previously-Infected Brazilian Adults
Albert B. Sabin Vaccine Institute1 个研究点 分布在 1 个国家目标入组 9 人开始时间: 2007年5月1日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 终止
- 发起方
- 入组人数
- 9
- 试验地点
- 1
- 主要终点
- To determine the frequency of vaccine-related adverse events, graded by severity, for each dose of the Na-ASP-2 Hookworm Vaccine
研究概览
简要总结
Na-ASP-2 is a protein expressed during the larval stage of the N. americanus hookworm life cycle. Vaccination with recombinant ASP-2 has protected dogs and hamsters from infection in challenge studies. In a clinical study in hookworm-uninfected adults in the USA, Na-ASP-2 Hookworm Vaccine was safe and immunogenic. This study will evaluate its safety and immunogenicity in individuals living in an area of endemic hookworm infection.
详细描述
- Double-blind, randomized, controlled Phase 1 clinical trial.
- Study site: Americaninhas, Minas Gerais, Brazil.
- Number of participants: 48 in three groups of 16, randomized to receive either Na-ASP-2 Hookworm Vaccine (n=36) or Butang® hepatitis B vaccine (n=12).
- Study duration: 48 weeks; each participant will be followed for a total of 42 weeks.
- Immunization schedule: Study days 0, 56 and 112.
- Route: IM in the deltoid muscle.
- Dose of Na-ASP-2: 10, 50 and 100 µg for the first, second and third dose cohort, respectively.
- Dose of Alhydrogel®: 800 µg for each dose of Na-ASP-2.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 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 45 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Males or females between 18 and 45 years, inclusive.
- •Known residents of the Municipality of Novo Oriente de Minas, Minas Gerais, Brazil.
- •Good general health as determined by means of the screening procedure.
- •Completed a 3-dose albendazole treatment for documented hookworm infection during the previous 3 months.
- •Available for the duration of the trial (42 weeks).
- •Willingness to participate in the study as evidenced by signing the informed consent document.
排除标准
- •Pregnancy as determined by a positive urine β-hCG (if female).
- •Participant unwilling to use reliable contraception methods up until one month following the third immunization (if female).
- •Currently lactating and breast-feeding (if female).
- •Inability to correctly answer all questions on the informed consent comprehension questionnaire.
- •Evidence of clinically significant neurologic, cardiac, pulmonary, hepatic, rheumatologic, autoimmune, or renal disease by history, physical examination, and/or laboratory studies.
- •Behavioral, cognitive, or psychiatric disease that in the opinion of the investigator affects the ability of the volunteer to understand and cooperate with the study protocol.
- •Laboratory evidence of liver disease (alanine aminotransferase [ALT] greater than 64 U/l [females] or greater than 58 U/l [males]).
- •Laboratory evidence of renal disease (serum creatinine greater than 1.1 mg/dl [females] or greater than 1.3 mg/dl [males], or more than trace protein or blood on urine dipstick testing).
- •Laboratory evidence of hematologic disease (absolute leukocyte count <3000/mm3 or >12.5 x 103/mm3; hemoglobin <10.3 g/dl [females] or <11.0 g/dl [males]; absolute lymphocyte count <900/mm3; or platelet count <120,000/mm3).
- •Other condition that in the opinion of the investigator would jeopardize the safety or rights of a volunteer participating in the trial or would render the subject unable to comply with the protocol.
- •Participation in another investigational vaccine or drug trial within 30 days of starting this study.
- •Volunteer has had medical, occupational, or family problems as a result of alcohol or illicit drug use during the past 12 months.
- •History of a severe allergic reaction or anaphylaxis.
- •Severe asthma as defined by the need for regular use of inhalers or emergency clinic visit or hospitalization within the last 6 months.
- •Positive ELISA for HCV.
- •Positive ELISA for HBsAg.
- •Known immunodeficiency syndrome.
- •Use of corticosteroids (excluding topical or nasal) or immunosuppressive drugs within 30 days of starting this study.
- •Receipt of a live vaccine within past 4 weeks or a killed vaccine within past 2 weeks prior to entry into the study.
- •History of a surgical splenectomy.
- •Receipt of blood products within the past 6 months.
- •Previous receipt of a primary series of any hepatitis B vaccine.
- •History of allergy to yeast.
结局指标
主要结局
To determine the frequency of vaccine-related adverse events, graded by severity, for each dose of the Na-ASP-2 Hookworm Vaccine
时间窗: For the duration of the study
次要结局
- To determine the dose of Na-ASP-2 that generates the highest antibody response as determined by an indirect enzyme-linked immunosorbent assay (ELISA)(2 weeks after the third injection)
- To assess and compare the duration of antibody response to Na-ASP-2(For the duration of the study)
- To perform exploratory studies of the cellular immune responses to the Na-ASP-2 antigen both before and after immunization(For the duration of the study)
研究者
研究点 (1)
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