Protocol summary

Study aim
Safety and immunogenicity of the inactivated vaccine Osvid-19 at a dose of 0.5 ml and 28 days within two intramuscular injections in a healthy population of 18 to 40 years
Design
Phase I clinical trial, single arm without blinding and randomization with a sample size of 40 healthy volunteers aged 18 to 40 years
Settings and conduct
The study will be performed on 40 healthy volunteers aged 18 to 40 years at the site provided by Osve Pharmaceutical Company. After screening the volunteers and confirming their eligibility to recruit to the study, Osvid-19 vaccine candidate is injected in 0.5 ml dose twice on days 0 and 28, and safety and immunogenicity is followed.
Participants/Inclusion and exclusion criteria
Inclusion Criteria: Healthy volunteer 18 to 40 years, both sexes, written informed consent; without any uncontrolled underlying disease; Appropriate general health and mental health; not to participate in another clinical trial for the duration of the study; Exclusion criteria: Documented history of Covid-19 infection; History of covid-19 vaccine/ vaccine candidate Injection ; Unacceptable laboratory finding/ abnormalities at screening; temperature more than 37 C; For women, positive pregnancy serum test
Intervention groups
Two dose of 5 micrograms Osivd-19 vaccine candidate with an interval of 4 weeks
Main outcome variables
incidence of immediately reaction after injection of the vaccine, local reactions at the injection site, systemic reactions seven days after injection (including fever, headache, chills, nausea, vomiting, diarrhea, muscle pain in the joints, etc.), incidence of any Serious / non-serious adverse event during follow-up, abnormal results of laboratory findings, IgM and IgG antibody titers, evaluation of neutralizing antibody activity, cytokines evaluation: interleukins 2, 4, 5 and 6, IFN-γ, TNF-α, incidence And severity of symptomatic and asymptomatic SARS-COV-2

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20210622051670N1
Registration date: 2021-12-30, 1400/10/09
Registration timing: prospective

Last update: 2021-12-30, 1400/10/09
Update count: 0
Registration date
2021-12-30, 1400/10/09
Registrant information
Name
Ali Asghar Akhlaghi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 6653 0487
Email address
ceo@cellechco.com
Recruitment status
recruiting
Funding source
Expected recruitment start date
2022-01-10, 1400/10/20
Expected recruitment end date
2023-03-11, 1401/12/20
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
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
Public title
Phase I clinical trial of Osvid-19 inactivated vaccine for Covid-19 (Osve Pharmaceutical Company)
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
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.
Exclusion criteria:
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.
Age
From 18 years old to 40 years old
Gender
Both
Phase
1
Groups that have been masked
No information
Sample size
Target sample size: 40
Randomization (investigator's opinion)
N/A
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Single
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
National Research Ethics Committee
Street address
13th floor, Block A, Ministry of health, Simaye Iran street, Shahrake ghods(qarb)
City
Tehran
Province
Tehran
Postal code
1417993337
Approval date
2021-11-13, 1400/08/22
Ethics committee reference number
IR.NREC.1400.011

Health conditions studied

1

Description of health condition studied
COVID-19 disease
ICD-10 code
U07.1
ICD-10 code description
COVID-19, virus identified

Primary outcomes

1

Description
immediate reaction after injection
Timepoint
0-3 hours after injection
Method of measurement
Close observation/ monitoring

2

Description
Local reactions at the injection site
Timepoint
0-7 days after injection
Method of measurement
Close observation/ monitoring

3

Description
Systemic reactions
Timepoint
0-7 days after injection
Method of measurement
Close observation/ monitoring

4

Description
Abnormal results of laboratory findings
Timepoint
Baseline and 2 weeks after inejection
Method of measurement
Blood and urine sampling, lab tests

5

Description
Incidence of any adverse event (serious or non-serious)
Timepoint
0, 2 weeks, 4 weeks ,6 weeks, 3, 6 and 12 months
Method of measurement
Examination, history, and report of the study participant/ Medical dictionary

6

Description
Neutralizing Antibody titer/ activity
Timepoint
0, 2 weeks, 4 weeks, 6 weeks, 3, 6 and 12 months
Method of measurement
ELISA

Secondary outcomes

1

Description
Cytokines; IL2, IL4, IL5 and IL6, IFN-γ, TNF-α
Timepoint
Baseline, 4 weeks, 6 weeks
Method of measurement
ELISA

2

Description
Incidence and severity of symptomatic and asymptomatic SARS-COV-2
Timepoint
Baseline, 4 weeks, 6 weeks, 3 months, 6 months, 12 months
Method of measurement
PCR, severity grading

3

Description
Seroconversion
Timepoint
Baseline, 4 weeks, 6 weeks, 3 months, 6 months, 12 months
Method of measurement
ELISA

Intervention groups

1

Description
Intervention group: COVID-19 vaccine candidate; two dose of 5 micrograms with an interval of 4 weeks; Intramuscular injection (deltoid muscle)
Category
Prevention

Recruitment centers

1

Recruitment center
Name of recruitment center
Osve pharmaceutical company recruitment site
Full name of responsible person
Dr Morteza Izadi
Street address
No. 35, West Saeb Tabrizi St., Sheikh Bahaei St.,
City
Tehran
Province
Tehran
Postal code
1993625361
Phone
+98 21 8803 3160
Email
biotechmng@osvahpharma.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Osve pharmaceutical company
Full name of responsible person
Dr Mahdi Bakhshayesh
Street address
17 Shahrivar street, Shad Abad, before Pasteurized milk intersection, km 4 of Karaj old road, Tehran
City
Tehran
Province
Tehran
Postal code
1371845311
Phone
+98 21 6680 1075
Email
info@osvahpharma.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Osve pharmaceutical company
Proportion provided by this source
100
Public or private sector
Private
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Industry

Person responsible for general inquiries

Contact
Name of organization / entity
Osve pharmaceutical company
Full name of responsible person
Dr Negar Mohseni
Position
Pharm D
Latest degree
Medical doctor
Other areas of specialty/work
Medical Pharmacy
Street address
17 Shahrivar St., before Pasteurized Milk Three Ways, Shad Abad, 4 km of Karaj Old Road, Tehran
City
Tehran
Province
Tehran
Postal code
1371849311
Phone
+98 21 8803 9036
Email
biotechmng@osvahpharma.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Bagheiat-allah University of Medical Sciences
Full name of responsible person
Dr Morteza Izadi
Position
Professor
Latest degree
Specialist
Other areas of specialty/work
Infectious diseases
Street address
Ozone Therapy Center (First Floor); No.2; Azam alley; Sheikh Baha'i St. South; Mulla Sadra St.; Vanak Square
City
Tehran
Province
Tehran
Postal code
1435915371
Phone
+98 21 8804 6515
Email
Morteza_Izadi@yahoo.com

Person responsible for updating data

Contact
Name of organization / entity
Zistfan Daru Donyan company
Full name of responsible person
Ali Asghar Akhlaghi
Position
Methodologist
Latest degree
Ph.D.
Other areas of specialty/work
Biostatistics
Street address
Unit 2, No. 12, Arab Najafi Alley, Tehran Villa Three Ways, Sattar Khan St.
City
Tehran
Province
Tehran
Postal code
123
Phone
+98 21 6653 0487
Email
akhlaghi90@gmail.com

Sharing plan

Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available
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