CTRI/2020/03/023739Other1 期
A Phase I, randomized, controlled, dose escalating, single blind, clinical trial to assess the safety, tolerability and immunogenicity of Bivalent (JAIVAC-2: PfMSPFu24 +PfF2/ Alhydrogel) P. falciparum malaria vaccine in malaria naive healthy Indian adult males
试验速览
- 阶段
- 1 期
- 状态
- Other
- 发起方
- ICGEB
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. Male subject 18 to 45 years of age at the time of informed consent (both years inclusive).
- •2. Willing and having the capacity to provide voluntary free informed consent for participation evidenced by signing of the IEC approved informed consent document.
- •3. Subject is in good general health and is free from clinically significant health problems as determined by medical history, physical examination including vital parameters and clinical laboratory evaluations that include haematology, chemistry, urinalysis and serology.
- •4. Willing to be available for the duration of the study with no plans to travel outside the study area, reachable by phone.
- •5. Capable and willing to complete and return diary cards
- •6. Able to participate during the whole study period and to attend all follow-up visits
- •7. Willing to undergo HIV test
- •8. 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)
- •9. Willing to take intramuscular injection
排除标准
- •1. Any past history of malaria
- •2. Simultaneous participation in any other intervention clinical trial
- •3. Subject with evidence of IgG antibodies against PfMSP119, PfMSP311 and PfF2 antigens as measured by ELISA
- •4. Has prior history of immunisation with Hepatitis B vaccine
- •5. Previous history of receipt of any other malaria vaccine
- •6. HbA1c value reported > 6% at Screening visit
- •7. 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
- •8. Use of an investigational or non-registered drug or vaccine within ninety (90) days prior to enrolment or expects to receive such an agent during the study period.
- •9. Clinical or laboratory evidence of significant systemic disease, including hepatic, renal, cardiac, immunologic or haematological disease, HIV positive or have any other known immunodeficiency
- •10. Have a history of autoimmune disease (including inflammatory bowel disease, haemolytic anaemia, autoimmune hepatitis, rheumatoid arthritis, lupus, etc.) or connective tissue disease or have any other serious underlying medical condition. Includes the conditions and diagnoses defined as AESI (Adverse Events of Special Interest)
- •11. 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.
- •12. Received a blood transfusion within the past 3 months
- •13. History of splenectomy
- •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
- •17. Subject with an abnormal Chest X-Ray associated with relevant clinical symptoms/signs of respiratory pathology at screening/ anytime in the past 6 months.
- •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
相似试验
已完成
1 期
Phase 1 Clinical study to test the safety of Plasmodium Vivax (Malaria) Vaccine in Healthy Volunteers.CTRI/2016/09/007289International Centre for Genetic Engineering and Biotechnology36
已完成
1 期
A first-in-man clinical trial to evaluate the safety and immunogenicity of different doses of a malaria Vaccine (JAIVAC-1) in healthy Indian Male Subjects between 18 to 45 years of ageCTRI/2010/091/000301International Center for Genetic Engineering and Biotechnology MVDP45
进行中（未招募）
不适用
A phase 1 dose-escalating study for CT-P27 on its own and in combination with TamifluDiseases of th respiratory systemKCT0001617Celltrion36
进行中（未招募）
1 期
A Phase I/IIa gene therapy clinical trial in LHON patientseber Hereditary Optic Neuropathy due to mutations in the mitochondrial NADH Dehydrogenase 4 geneMedDRA version: 16.1Level: LLTClassification code 10062951Term: Leber's hereditary optic atrophy neuropathySystem Organ Class: 100000004850EUCTR2013-001405-90-FRGENSIGHT-BIOLOGICS22
已完成
不适用
A phase I, placebo controlled, dose escalation safety andpharmacokinetic study of Topical Endoxifen in healthy male volunteers.Metabolic and Endocrine - Other endocrine disordersGynecomastiaACTRN12618000569202Atossa Genetics, Inc.24