COVID-19 trials registries data warehouse

http://en.irct.ir/trial/60240

Dr Mahdi Bakhshayesh

info@osvahpharma.com

2021-12-30

Completed

nonRCT

Non-randomized

Single group assignment

Open label

single-center

Prevention

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.

1

Osve pharmaceutical company

18

40

Iran

Healthy volunteers

N/A

40

immediate reaction after injection Local reactions at the injection site Systemic reactions Abnormal results of laboratory findings Incidence of any adverse event (serious or non-serious) Neutralizing Antibody titer/ activity

Phase 1

[{"arm_notes": "5\u03bcg;2;Days0-28;IM", "treatment_id": 2100, "treatment_name": "Osvid-19", "treatment_type": "Inactivated virus", "pharmacological_treatment": "Vaccine"}]