se of Bexsero immunization to detect cross-reactive antigens and anti-gonococcal antibodies in key populations in Kenya

niversity of Oxford0 个研究点目标入组 50 人开始时间: 2020年8月17日最近更新: 2023年5月29日

适应症

试验速览

暂无简介。

•Minimum Age: 18 Years
•Maximum Age: 25 Years
•Gender Based: No
•Accepts Healthy Volunteers: Yes
•Criteria: Inclusion Criteria:
•Healthy male and female as assessed by a medical history, physical exam,
•and laboratory tests.
•HIV-positive participants who are adherent to ART and virally suppressed (viral load <200 copies per ml) are considered healthy .
•At least 18 years of age on the day of screening and will not reach 26th birthday on the day of the second vaccination (approximately 6 weeks after enrolment)
•Willing and able to give informed consent for participation in the trial before
•any study-related procedures are performed.
•Willing to donate blood samples for immunogenicity assessments.

•Exclusion Criteria:
•Any clinically significant acute or chronic medical condition that is considered progressive that, in the opinion of the Principal Investigator or designee, makes the volunteer unsuitable for participation in the trial
•Pregnancy
•Participation in another clinical trial (i.e. investigational HIV vaccine candidate), within the previous 3 months or expected participation during the study
•Bleeding disorder diagnosed by a physician (e.g., factor deficiency, coagulopathy or platelet disorder that requires special precautions).
•History of severe local or systemic reactogenicity to vaccines (e.g., anaphylaxis, respiratory difficulty, angioedema).

发起方