Safety and immunogenicity of SARS-CoV-2 inactivated vaccine (OSVID-19) in healthy volunteers aged 18 to 40 years: A clinical trial, phase 1, single arm

Osve pharmaceutical company0 个研究点目标入组 40 人开始时间: 待定最近更新: 2022年1月11日

适应症

试验速览

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•Volunteers between the ages of 18 and 40 of both sexes; Ability to provide informed written consent; Volunteers who are healthy and do not have any uncontrolled underlying disease; Appropriate general health and mental health as determined by the principal investigator (including: normal vital signs, heart rate between 60 and 100 (beat/ min); systolic blood pressure =90 mm Hg and <140 mm; Diastolic blood pressure = 60 mm Hg and <90 mm Hg; oral temperature less than 37.3 ° C (temperature less than 0.37 ° C digitally), physical examination and review of medical records); Expressing interest and availability to conduct studies and visits; For female participants of childbearing age, ensuring no plan for pregnancy / using a reliable method of contraception and not planning for pregnancy at least from the time of enrollment to 4 weeks after the second dose of vaccine; Males use a safe method of prevention such as condoms at least three months after the second dose of vaccination; The male volunteer agrees not to donate sperm for three months after the second vaccine; volunteers should refrain from donating blood or plasma from the recruitment until three months after the second dose of the vaccine; Volunteers agree not to participate in another clinical trial for the duration of the study; The volunteer agrees to stay in the study area for the entire duration of the study.

•Documented history of Covid-19 infection (principal investigator determines the final summary of the volunteer's history of infection by examining the set of clinical symptoms related to Covid-19 include: positive PCR test, pulmonary involvement documents, family members' history); History of participation in studies of other Covid-19 vaccines candidates; History of Covid-19 vaccine injection; Unacceptable laboratory abnormalities from screening (before the first vaccination), or immune assay, as follows: [Abnormal blood parameters (CBC), random blood sugar level, renal function, test (serum urea and creatinine) ), Liver function tests, urinalysis reports, or patients with a specific history of HIV infection; for women, positive pregnancy serum test (during screening within 45 days of enrollment); Temperatures above 37 ° C by digital thermometry and temperatures above 37.3 ° C by oral thermometry (in suspected cases) or symptoms such as upper respiratory tract infection or gastritis within three days before each Vaccine dose; Medical problems as a result of alcohol or drug use over the past 12 months.

发起方

Osve pharmaceutical company