A Phase I First in Human, Double-blind, Parallel, Randomised and Placebo Controlled Clinical Trial of the Safety of SSI's Adjuvanted Chlamydia Vaccine CTH522 in Healthy Women Aged 18 to 45 Years
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 35
- 试验地点
- 2
- 主要终点
- Evaluation of adverse events/reactions and laboratory safety of adjuvanted chlamydia vaccine
研究概览
简要总结
The present trial is a phase I first in human, double blind, parallel and placebo controlled trial of SSI's adjuvanted chlamydia vaccine CTH522: CTH522-CAF01 (CAF01 is an adjuvant system) and CTH522-Al(OH)3. The trial will be conducted at Imperial College Research site in the United Kingdom.
Subjects are randomly assigned to one of the following three treatment groups in a ratio of 3:3:1.
This trial consisted of 10 visits and 5 telephonic interviews
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 45 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Is a healthy female between 18 and 45 years of age on the day of first trial vaccination
- •Has provided signed informed consent
- •Is willing and likely to comply with the trial procedures
- •Is prepared to grant authorised persons access to their medical record
- •Willing to use acceptable contraceptive measures* during the trial (2 weeks before and 2 weeks after the trial)
- •Heterosexually active female capable of becoming pregnant must (in addition to requiring male partner to use condoms) agree to use hormonal contraception, or to complete abstinence, from at least 2 weeks before the first vaccination until at least 2 weeks after the last. (Note: Periodic abstinence [e.g. calendar, ovulation, symptothermal, post-ovulation methods] and withdrawal and intrauterine device or intrauterine hormone releasing system and progestogen-only oral hormonal contraception, where inhibition of ovulation is not the primary mode of action, are not acceptable methods of contraception)
排除标准
- •Has confirmed history of Pelvic Inflammatory Disease or significant gynaecological diseases
- •Is positive for C. trachomatis (PCR)
- •Is positive for gonorrhoea (urine), HIV, Hepatitis B/C, syphilis (blood)
- •Has a positive pregnancy test
- •Has a significant active disease - such as cardiac, liver, immunological, neurological, psychiatric; or clinically significant abnormality of haematological or biochemical parameters.
- •Has BMI of 35 kg/m2 or greater
- •Is currently participating in another clinical trial with an investigational or noninvestigational drug or device
- •Has received, or plans to receive, an active immunisation within 14 days of the start of the trial or any of the immunisation visits in this trial
- •Is currently receiving treatment with immunosuppressive agents e.g. oral, inhaled, nasal or injected corticosteroids. (Topical steroids are allowed, unless applied to the IM injection site.)
- •Is using an intrauterine device
- •Has a condition which in the opinion of the investigator is not suitable for participation in the trial
- •Known or confirmed allergy to any of the vaccine constituents -
研究组 & 干预措施
CTH522-CAF01
CTH522-CAF01: CTH522 chlamydia antigen adjuvanted with CAF01 for IM administration (preferably the non-dominant arm)
CTH522 chlamydia antigen diluted with Tris buffer for IN administration
干预措施: CTH522-CAF01 (Biological)
CTH522-Al(OH)3
CTH522-Al(OH)3: CTH522 chlamydia antigen adjuvanted with aluminium hydroxide, Al(OH)3 , for IM administration (preferably the non-dominant arm)
CTH522 chlamydia antigen diluted with Tris buffer for IN administration
干预措施: CTH522-Al(OH)3 (Biological)
Placebo
Saline for IM and In administrations
干预措施: Placebo (Biological)
结局指标
主要结局
Evaluation of adverse events/reactions and laboratory safety of adjuvanted chlamydia vaccine
时间窗: Through study completion (Day 0 to Day 168)
Solicited local injection site reactions (recorded at any visit) after intramuscular (IM) administration (pain, erythema, tenderness, pruritus, warmth, stiffness and swelling) Solicited local reactions (recorded at any visit) after IN administration (discharge, including bleeding, congestion, discomfort, sneezing and cough) Solicited systemic reactions (recorded at any visit) after IM and IN administration (abnormally raised temperature, chills, myalgia, malaise, fatigue, rash, headache, nausea and vomiting, and clinically significant abnormal values among full blood count, liver function test and renal profile results)
次要结局
- Serum immunoglobulin G antibody responses after vaccination with CTH522(At Days 0, 28, 112, 126, 140, 154 and 168)