Protocol summary

Study aim
Safety and immunogenicity of Covid 19 FAKHRAVAC (MIVAC) inactivated vaccine in healthy population 18-70 years
Design
Randomized, double blind, controlled trial with parallel design on 500 volunteers in 2 groups of 250, double blind and randomized.
Settings and conduct
Fakhra clinical trial center, Persian Gulf Hall, SASAD Sports Complex, Shahid Fakhrizadeh Street, Sayad Shirazi Highway, Tehran, Iran
Participants/Inclusion and exclusion criteria
Inclusion criteria: Age 18 to 70 years; Body mass index between 18 to 35; No current or previous infection with COVID-19; Use of safe methods of contraception; Signing informed consent form. Exclusion criteria: Current acute or chronic illness requiring regular medical or surgical attention; High-risk occupations exposed with Covid-19; serving in obligatory military service; Breastfeeding; Pregnancy.
Intervention groups
Group 1: vaccine strength of 10 micro gram, two doses at 14-day intervals Group 2: Receiving two doses placebo at 14-day intervals
Main outcome variables
Primary outcomes: Reactogenicity (vital signs and anaphylactic reactions 3 hours post-vaccination; Local and systemic adverse events within the first week post-vaccination; Serum IgG level for SARS-CoV-2 to N, S1-RBD antigens up to a year. Secondary outcomes: Abnormal laboratory findings one week after vaccine injection; SAEs, SUSARs, MAAEs up to six months after the last dose of the vaccine; Occurrence of Covid-19 disease two weeks after the second dose of the vaccine onward; Neutralizing antibody titres, and cell medicated immunity and safety of cell mediated immune response up to a year.

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20210206050259N2
Registration date: 2021-06-08, 1400/03/18
Registration timing: prospective

Last update: 2021-06-08, 1400/03/18
Update count: 0
Registration date
2021-06-08, 1400/03/18
Registrant information
Name
Ahmad Karimi Rahjerdi
Name of organization / entity
Stem Cell Technology Research Center
Country
Iran (Islamic Republic of)
Phone
+98 21 2208 2120
Email address
rahjerdi@strc.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-06-09, 1400/03/19
Expected recruitment end date
2021-07-23, 1400/05/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Phase 2 trial of safety and immunogenicity of 10 micro gram inactivated SARS-CoV-2 vaccine (FAKHRAVAC), two doses two weeks apart in adults aged 18-70 years: a randomized, double-blind, placebo-controlled, clinical trial
Public title
Trial of safety and immunogenicity of 10 micro gram inactivated SARS-CoV-2 vaccine FAKHRAVAC (MIVAC)
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
Age 18 to 70 years Body mass index between 18 and 35 kg per square meter No current or previous COVID-19 disease No pregnancy Using safe methods of contraception Signing the informed consent form Having Iranian citizenship Participants should be able to read and understand informed consent, preferably having education at diploma or higher level Temperatures less than or equal to 37.2 ° C sublingually measured by a digital thermometer Negative IgG and IgM antibody titers against COVID-19 N antigen Negative RT-PCR -test for SARS-CoV-2 IgG ELISA negative blood test against HIV Heart rate between 60 and 100 Systolic blood pressure (between 90 and 140 mm Hg), Diastolic blood pressure (between 60 and 90 mm Hg) Committing to observe requested behavioral protocol to reduce the risk of COVID-19 Negative pregnancy test for β-hCG on the day of screening and the day of vaccination Clinical trial participants should refrain from donating blood or plasma from the first vaccination until 3 months after the last vaccination. Participants should not enter any other trial while in this study Expressing a person's readiness to remain among the people monitored in the study for the entire study period until the research process is completed within 14 months Use one of a safe method of contraception in men and women up to 3 months after the last dose of the vaccine
Exclusion criteria:
Current acute or chronic symptomatic illness that requires ongoing medical or surgical care High-risk occupations regarding risk of acquiring COVID-19, including medical staff, occupations with close contacts with many client Serving in compulsory military service (soldiers) in the subdivisions of the Armed Forces Breastfeeding History of receiving any research vaccine during the 30 days prior to the day of screening History of transfusion of any blood product or immunoglobulin within the 3 months before the screening day History of long-term use of immunosuppressive drugs or systemic corticosteroids in the last 4 months leading up to screening day History of allergic diseases such as angioedema or anaphylactic reactions History of any allergy to drugs or vaccines History of cancer or chemotherapy in the last 5 years History of serious psychiatric illnesses History of blood disorders (Blood Dyscrasias, coagulation, platelet deficiency or disorder, etc) Having chronic obstructive pulmonary disease such as asthma and COPD, ischemic cardiovascular disease diagnosed and treated by a specialist Uncontrolled blood pressure (systolic higher than 140 and diastolic higher than 90) Uncontrolled diabetes (HbA1c higher than 6 or BS higher than 140) or diabetes treatment by insulin History of chronic neurological diseases (including seizures and epilepsy) Having thyroid disease or a history of thyroidectomy except controlled hypothyroidism Any history of drug/alcohol abuse (addiction) during the last 2 years Any grade 2 or higher toxicity in the hematology or biochemistry test results performed at the time of screening History of confirmed COVID-19 Acute or chronic hepatitis B and C Receiving prophylactic drug against tuberculosis History of syncope when seeing or giving blood Having splenectomy for any reason Any close contact with a definitively infected person with COVID-19 for a maximum of two weeks before the day of receiving the first dose
Age
From 18 years old to 70 years old
Gender
Both
Phase
2
Groups that have been masked
  • Participant
  • Care provider
  • Investigator
  • Outcome assessor
  • Data analyser
  • Data and Safety Monitoring Board
Sample size
Target sample size: 500
Randomization (investigator's opinion)
Randomized
Randomization description
In this study, the Block Randomization method with block size of 4 was used to assign each participant to the intervention groups. The rand() function of Excel software will be used to generate random sequence within each block. After determining the allocated intervention, a non-repetitive four-digit random code was assigned to each participant. Assigned codes will be delivered to the eligible participants via a software.
Blinding (investigator's opinion)
Double blinded
Blinding description
In this study, placebo will be used. Adjunct only IMP will be used as placebo. All people involved in the study will be blind to the type of IMP received except the epidemiologist responsible for unblinding. In cases of any serious adverse event or any trend in the occurrence of adverse events towards one of the groups, unblinding will occur by DSMB request. In other clinical occasions unblinding could occur by the principle investigators' approval
Placebo
Used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
National Research Ethics committee
Street address
Floor 13, Block A, Ministry of Health & Medical Education Headquarters, Between Zarafashan & South Falamak, Qods Town, Tehran, Iran
City
Tehran
Province
Tehran
Postal code
7334144696
Approval date
2021-06-07, 1400/03/17
Ethics committee reference number
IR.NREC.1400.003

Health conditions studied

1

Description of health condition studied
SARS-CoV-2
ICD-10 code
U07.1 COVI
ICD-10 code description
U07.1 COVID-19, virus identified

Primary outcomes

1

Description
Abnormal vital signs and anaphylactic reactions immediately after vaccination. Vital signs include body temperature, respiratory rate, heart rate, systolic and diastolic blood pressure before and immediately after vaccination
Timepoint
In the first three hours after each vaccine dose
Method of measurement
Temperature is measured using a digital thermometer. Heart rate and respiratory rate will be counted by the research staff in one minute. Blood pressure will be measured by a digital sphygmomanometer while sitting

2

Description
Local adverse events within the first week post-vaccination including pain, tenderness, erythema and redness, and swelling and stiffness
Timepoint
For the first 7 days after each vaccine dose
Method of measurement
Study staff will contact participants daily for seven days and complete a local adverse event form

3

Description
Systemic adverse event within the first week post-vaccination including nausea and vomiting, diarrhea, headache, fatigue, muscle pain, and other illnesses or clinical complications
Timepoint
For the first 7 days after each vaccine dose and then monthly for up to six months
Method of measurement
Study staff will contact participants daily for seven days and complete a systemic adverse event form

4

Description
Serum IgG level for SARS-CoV-2 N, S1-RBD antigens
Timepoint
on days zero, second injection day, two weeks after second injection and at 3, 6, 9, 12 months after the first vaccination.
Method of measurement
ELISA method

Secondary outcomes

1

Description
Serious Adverse Event/Reaction(SAEs) , Suspected Unexpected Serious Adverse Reaction (SUSARs), Medically Attended Adverse Events (MAAEs)
Timepoint
Up to six months after the last dose of the vaccine
Method of measurement
adverse events will be assessed monthly up to 6 months

2

Description
Occurrence of Covid-19 disease two weeks after the second vaccination dose confirmed by PCR
Timepoint
Two weeks after the second dose of the vaccine up to 6 months
Method of measurement
Clinical assessments and PCR test

3

Description
Neutralizing antibody activity
Timepoint
on days zero, second injection day, two weeks after second injection and at 3, 6, 9, 12 months after the first vaccination.
Method of measurement
SARS-CoV-2 virus neutralizing antibody titer measured using a biosafety level III

4

Description
Cell-mediated immunity and safety of cell mediated immune response
Timepoint
on days zero, second injection day, two weeks after second injection and at 3, 6, 9, 12 months after the first vaccination.
Method of measurement
Evaluation of T lymphocyte proliferative response against S antigen, Evaluation of IFN-ɣ and TNF-ɑ cytokines in PBMC cell soup stimulated by S antigen.

5

Description
Abnormal laboratory findings including Hemoglobin, WBC, Lymphocytes cell, Neutrophils, Eosinophils, Platelets, ESR, CRP, LDH, CPK, RT-PCR for SARS-CoV-2, Sodium, Potassium, BUN , Creatinine, Alkaline phosphatase, ALT, AST, Bilirubin (total), U/A, Urine protein, Urine glucose, Urine RBC, IL-6
Timepoint
7 days after each vaccination, IL-6 will be measured at day zero as well
Method of measurement
Each test will be performed using the appropriate kit

Intervention groups

1

Description
Intervention group: Two doses of 10 micro gram vaccine injected in the deltoid muscle (IM) at 14 days interval
Category
Prevention

2

Description
Control group:Two doses of placebo injected in the deltoid muscle (IM) at 14 days interval
Category
Placebo

Recruitment centers

1

Recruitment center
Name of recruitment center
Fakhra clinical trial center
Full name of responsible person
Mohsen Forughizadeh Moghadam
Street address
Fakhra clinical trial center, Persian Gulf Hall, SASAD Sports Complex, Shahid Fakhrizadeh Street, Sayad Shirazi Highway, Tehran, Iran
City
Tehran
Province
Tehran
Postal code
1986936911
Phone
+98 21 2610 1694
Email
Foroughizadeh@modares.ac.ir
Web page address
http://www.fakhravac.ir

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Organization of Defensive Innovation and Research
Full name of responsible person
Ahmad Karimi Rahjerdi
Street address
NO.9, Unit 3, Mirsharifi, Valiasr St.
City
Tehran
Province
Tehran
Postal code
1986936911
Phone
+98 21 2265 8405
Fax
+98 21 2265 8404
Email
Rahjerdi@strc.ac.ir
Web page address
http://miladpharmaceuticsco.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
No
Title of funding source
Organization of Defensive Innovation and Research
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Other

Person responsible for general inquiries

Contact
Name of organization / entity
Malek Ashtar University
Full name of responsible person
Mohsen ForughiZadeh Moghadam
Position
Assistant professor
Latest degree
Ph.D.
Other areas of specialty/work
Medical Genetics
Street address
Malek Ashtar University, Shabanloo St., Lavizan
City
Tehran
Province
Tehran
Postal code
1955737134
Phone
+98 21 8008 6783
Email
Foroughizadeh@modares.ac.ir

Person responsible for scientific inquiries

Contact
Name of organization / entity
Artesh University of Medical Sciences
Full name of responsible person
Ramin Hamidi Farahani
Position
Associate professor
Latest degree
Specialist
Other areas of specialty/work
Infectious diseases
Street address
NO.9, Unit 3, Mirsharifi, Valiasr St.
City
Tehran
Province
Tehran
Postal code
1986936911
Phone
+98 21 8833 7912
Email
Rgsramin@yahoo.com

Person responsible for updating data

Contact
Name of organization / entity
Milad Daro Noor Pharmaceutical Co.
Full name of responsible person
Kosar Naderi
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Biology
Street address
NO.9, Unit 3, Mirsharifi, Valiasr St.
City
Tehran
Province
Tehran
Postal code
1986936911
Phone
+98 21 2265 8405
Email
k.naderi@strc.ac.ir

Sharing plan

Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Yes - There is a plan to make this available
Data Dictionary
Not applicable
Title and more details about the data/document
Deidentified IPD on study outcomes could be shared.
When the data will become available and for how long
After completion of the study and publication of the results, data could be shared for 2 years
To whom data/document is available
Data is available only to members of academic institutions within joint projects with MILAD Daru Nour Co.
Under which criteria data/document could be used
Proposal should be presented to MILAD Daru Nour Co and its necessity and scientific validity should be approved by the company
From where data/document is obtainable
You can contact Ms Kousar Naderi at k.naderi@strc.ac.ir
What processes are involved for a request to access data/document
Request for data will be made available within the approved joint projects
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