ACTRN12613000030774已完成1 期
A Randomized, Double Blinded Within Dose, Controlled, Safety and Immunogenicity Study of Group A Streptococcus Vaccine Candidate in Healthy Participants
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 20
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomised controlled trial
- 主要目的
- Treatment
- 盲法
- Blinded (masking used)
入排标准
- 年龄范围
- 18 Years 至 45 Years（—）
- 性别
- All
入选标准
- •1. Able to understand the purpose and the procedures involved in this study and sign the informed consent form;
- •2.Male or non-pregnant female adults, 18-45 years of age inclusive;
- •3.Non smokers and in good general health, as determined by screening evaluation, no greater than 28 days before the first dose in the form of medical history, clinical laboratory tests and physical examination;
- •4. Normal Electrocardiogram (ECG);
- •5.Echocardiogram (ECHO) that is normal or with findings that are considered trivial and clinically insignificant such as: 'Clinically insignificant/trivial mitral regurgitation (E 662 ROA of <10mm2,) ;
- •6.Women must agree not to become pregnant for the first 180 days of the trial. If they are sexually active, they must use an effective method of birth control, e.g. insertable, injectable, transdermal, or combination oral contraceptive approved by the US FDA or TGA combined with a barrier contraceptive and have negative results on a serum or urine pregnancy test done before administration of study medication;
- •7.Intention to reside in the geographical area for next 12 months and not intending to travel overseas for at least 30 days following the last study vaccine administration;
- •8. Agree not to participate in any other clinical trial during the trial;
- •9.Agree not to donate blood for the first 180 days of the trial;
- •10.Agree to restrain from intensive physical exercise i.e. exercise that varies significantly from an every day exercise routine, 3 days before and after (+/-3 days) administration of each dose, including each interim visit for blood sample collection.
排除标准
- •1.Personal or family history of post-streptococcal disease (rheumatic fever or glomerulonephritis), or collagen-vascular disease;
- •2.Evidence of increased cardiovascular disease risk;
- •3. Previous use of phentermine (appetite suppressant of the amphetamine and phenethylamine class), fenfluramine or dexfenfluramine known as Fen-Phen, anti-obesity medications (possible association with cardiac valvular abnormalities)
- •4.Clinical diagnosis or evidence of recent group A streptococcal infection;
- •5.Positive group A streptococcus throat culture at screening visit or positive rapid antigen test result on day of study product administration;
- •6.Presence of significant acute infections requiring systemic antibiotic treatment within the 14 days prior to each product administration;
- •7.Pregnant or breast feeding (all women will have a negative pregnancy test result prior to each study product administered;
- •8.Immunized or intent to immunize with any vaccine or investigational agents within 30 days prior to enrollment through to 30 days following the last study vaccine administration, with the exception of licensed inactivated influenza vaccines;
- •9.Receipt of diphtheria toxoid containing vaccine within the previous 5 years (such as DTP,Hepatitis A, Boostrix, Adacel or Menactra);
- •10.Past significant reaction following any previous vaccination;
- •11.History of hypersensitivity to any diphtheria toxoid containing vaccine;
- •12.Presence of acute infectious disease or fever;
- •13.Presence of current or suspected serious chronic diseases
- •14.Evidence and any history of leukaemia, lymphoma or neoplasm;
- •15. Presence or suspicion of impaired immune system function
- •16.Received blood, blood products or a parenteral immunoglobulin preparation in the past 12 weeks;
- •17.Evidence of bleeding diathesis or any condition that may be associated with a prolonged bleeding time;
- •18.Known inherited genetic anomaly (known as cytogenic disorders) e.g., Down’s syndrome;
- •19.Findings of definite, probable or possible rheumatic heart disease (RHD), definite or probable acute rheumatic fever (ARF)
- •20.Clinical significant abnormal laboratory results;
- •21.The participant has a diagnosis of schizophrenia, bi-polar disease, or other severe(disabling) chronic psychiatric diagnosis;
- •22.The participant has been hospitalized within the past 5 years prior to enrollment for psychiatric illness, history of suicide attempt or confinement for danger to self or others;
- •23.The participant is receiving psychiatric drugs. Participants who are receiving a single antidepressant drug and are stable for at least 3 months prior to enrollment without decompensating are allowed enrollment into the study;
- •24.The participant has a history of alcohol or drug abuse in the 5 years prior to enrolment.
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