A Phase II trial to assess the safety and immunogenicity of DNA priming

Swedish Institute for Infectious Disease Control0 个研究点目标入组 198 人开始时间: 2012年10月15日最近更新: 2023年5月29日

试验速览

暂无简介。

•Age: 18 to 40 years
•Willing to undergo counselling and HIV testing
•Have a negative antigen/antibody ELISA for HIV infection
•Able to give informed consent
•Basic abilities to read and write.
•Satisfactory completion of an assessment of understanding prior to enrolment defined
•as 90% correct answers after three opportunities to take test.
•Resident in Dar es Salaam, Mbeya or Maputo catchment areas, and willing to remain so
•for the duration of the study
•At low risk of HIV infection, defined as the absence of an identifiable risk factor/
•behaviour according to a risk assessment questionniare.
•Verbal assurances that adequate birth control measures are used not to conceive/father
•a child during the study and up to 3 months after the last vaccine injection.
•Women shall have a negative urinary pregnancy test
•Be willing to practice safe sex for the duration of the study to avoid sexually transmitted
•infections including HIV
•Good health as determined by medical history, physical examination, clinical judgment
•and by key laboratory parameters as judged by the study physician.
•Laboratory criteria within 8 weeks prior to enrollment

•At risk of HIV infection as mentioned above in the inclusion criteria
•Active tuberculosis or other systemic infectious process elicited by review of systems,
•physical examination and laboratory detection (for example detection of Hepatitis B
•surface antigen or active syphilis).
•A history of immunodeficiency, ongoing medical and/or psychiatric condition and/or
•chronic illness requiring continuous or frequent medical intervention
•Autoimmune disease by history and physical examination.
•Hives or recurrent hives and severe eczema
•Substance abuse problems (including traditional medicine) during the past 12 months
•that in the opinion of the investigator would preclude participation
•History of grand-mal epilepsy, or currently taking anti-epileptics
•Received blood or blood products or immunoglobulins in the past 3 months.
•Receiving immunosuppressive therapy such as systemic corticosteroids or cancer
•chemotherapy.
•Use of experimental therapeutic agents within 30 days of study entry.
•Reception of any live, attenuated vaccine within 60 days of study entry. Medically
•indicated subunit or killed vaccines (e.g., Hepatitis A or Hepatitis B) are not exclusionary
•but should be given at least 2 weeks before or after HIV immunisation to avoid potential
•confusion of adverse reactions.
•History of cardiac disease

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