CTRI/2016/09/007289已完成1 期
A Phase-I,randomised, controlled, dose escalating, single blind clinical trial to evaluate the safety and immunogenicity of PvDBPII vaccine (Plasmodium vivax Duffy Binding Protein RegionII) formulated with adjuvant GLA-SE in healthy Indian male subjects - None
International Centre for Genetic Engineering and Biotechnology0 个研究点目标入组 36 人开始时间: 待定最近更新:
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 36
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
入选标准
- •1.A Male between the ages of 18 to 45 years (both inclusive) (age at informed consent).
- •2.Willing and having the capacity to provide voluntary free informed consent for participation evidenced by signing of the IRB/IEC approved informed consent
- •3. Subject is in good general health and is free from clinically significant health problems as determined by medical history, physical examination and clinical laboratory evaluation.
- •4. Willing to be available for the duration of the study, contactable by phone.
- •5. Capable and willing to complete and return subject diary cards, and to attend all follow-up visits, including unscheduled visits.
- •6. Willing to undergo HIV test
- •7. Must agree to use one of the following medically-acceptable birth control measures throughout the duration of the study (birth control counselling and measures will be provided by clinical trial site as required)
- •Double barrier method (e.g. condom with spermicidal jelly) OR
- •Subjects must be surgically sterile (undergone vasectomy)
- •8. Willing to take Intramuscular injection.
排除标准
- •1. Any past history of malaria
- •2. Simultaneous participation in any other intervention clinical trial at the CRO
- •3. Subject with evidence of previous exposure to vivax malaria parasite as determined by presence of IgG antibodies against PvDBPIl (ELISA).
- •4. Has prior history of immunisation with Hepatitis B vaccine.
- •5. History of receipt of any other candidate malaria vaccine.
- •6. History of allergic reactions,hypersensitivity or anaphylaxis to immunizations, to any of the components of the study vaccines (including adjuvant or peptide) or of serious allergic reactions that required hospitalisation or emergency medical care.
- •7. Use of an investigational or non-registered drug or vaccine within thirty (30) days prior to enrolment or expects to receive such an agent during the study period.
- •8. Administration of any vaccination or gamma globulin during the three-month period prior to the first Immunization or planned use during the study.
- •9. Chronic administration (defined as more than 14 days) of immuno-suppressants or other immune-modifying drugs or cytotoxic therapies(chemotherapy or radiotherapy) within six months prior to the first Immunization. This includes any dose level of oral steroids or inhaled steroids, but not topical steroids.
- •10. Received a blood transfusion within the past 3 months
- •11. Evidence of any acute or chronic illness (including cardiovascular, pulmonary,
- •neurological, hepatic, rheumatic,haematological, immunological, metabolic, or renal disorders), as determined by history or clinical examination or laboratory screening.
- •12. History of splenectomy
- •13. Has a history of autoimmune disease (including inflammatory bowel disease,haemolytic anaemia, autoimmune hepatitis, rheumatoid arthritis, lupus, etc.) or connective tissue disease.
- •14. Subject has clinically Significant laboratory abnormalities, which will include haematology, biochemistry, urinalysis, at the time of screening as determined by the Investigator.
- •15. Clinical or laboratory presence of Hepatitis B, C or HIV infection or Syphilis.
- •16. Subject with an abnormal 12-lead ECG at screening associated with relevant clinical symptoms/signs suggestive of cardiac pathology (including conduction disturbances).
- •17. Subject with an abnormal Chest X-Ray associated with relevant clinical
- •symptoms/signs of respiratory pathology at screening/ anytime in the past 6
- •18. Subject gives a history of social, occupational and/ or family problems due to
- •illicit alcohol or drug abuse (to be determined by Urine Drug Screen) within the past 12 months.
- •19. Has any other condition that, in the opinion of the Principal Investigator, may jeopardise the safety and rights of the volunteer, may interfere with the capacity to provide free and willing informed consent or render the subject unable to comply with the requirements of the study protocol.
研究者
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