A single armed, open label, clinical trial to evaluate the immunogenicity of SpikoGen® vaccine as booster dose (Spike protein, produced by CinnaGen company) in kidney transplant patients being fully vaccinated with Sinopharm vaccine
Evaluation immunogenicity of SpikoGen vaccine as booster dose in patients with a history of kidney transplantation and receiving 2 doses of Sinopharm
Design
A singe armed,open Label,non-randomized clinical trial in 100 kidney transplant patients who received two doses of sinopharm vaccine after transplantation
Settings and conduct
A singla-arm clinical trial in kidney transplant patients who received 2 doses of Sinopharm vaccine after transplantation will receive SpikoGen as booster dose in Shahid Labbafinejad Clinic. Blood samples are taken before and after the injection to check for immunogenicity
Participants/Inclusion and exclusion criteria
Inclusion:Men and women older than 18;Patients with history of kidney transplantation who vaccinated with two doses Sinopharm vaccine after transplantation;Women who are not pregnant or breast-feeding;People who have been transplanted for more than 6 months;Exclusion:Subjects with active infection with signs of SARS-COV-2 at screening visit;History of covid-19 based on a previous positive PCR;Treatment of active CMV infection;History of receiving rituximab during the past 6 months;History of receiving IVIg during the past 6 months;People with history of severe adverse reactions to the study vaccine;who participated in clinical trials within 30 days before screening until end of the study;History of transplant rejection during the past 30 days;Subjects with special circumstances who, may increase the risk of participating in the study according to researcher's opinion
Intervention groups
1IM injection of 25 µg Spikogen vaccine with Advax-CpG adjuvant
Main outcome variables
Evaluation of seroconversion in antibody against Spike protein one month after receiving booster dose; Evaluation of seroconversion in neutralizing antibodies one month after receiving booster dose
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20150303021315N28
Registration date:2022-02-02, 1400/11/13
Registration timing:prospective
Last update:2022-02-02, 1400/11/13
Update count:0
Registration date
2022-02-02, 1400/11/13
Registrant information
Name
Nassim Anjidani
Name of organization / entity
Orchid Pharmed
Country
Iran (Islamic Republic of)
Phone
+98 21 4347 3000
Email address
amini@orchidpharmed.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2022-02-04, 1400/11/15
Expected recruitment end date
2022-03-16, 1400/12/25
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
A single armed, open label, clinical trial to evaluate the immunogenicity of SpikoGen® vaccine as booster dose (Spike protein, produced by CinnaGen company) in kidney transplant patients being fully vaccinated with Sinopharm vaccine
Public title
SpikoGen® vaccine as booster dose in kidney transplant patients
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
Men and women older than 18
Patients with history of kidney transplantation who vaccinated with two doses Sinopharm vaccine after transplantation
Women who are not pregnant or breast-feeding
People who have been transplanted for more than 6 months
Exclusion criteria:
Subjects with active infection with signs of SARS-COV-2 at screening visit
History of covid-19 based on a previous positive PCR
Treatment of active Cytomegalovirus (CMV) infection
History of receiving rituximab during the past 6 months
History of receiving IVIg during the past 6 months
Subjects who have a history of severe allergic reactions (e.g. anaphylaxis) to the study vaccine or any components of the vaccine or any other drugs
Subjects who have received any other investigational product within 30 days prior to the screening visit or intend to participate in other clinical studies during this trial
History of transplant rejection during the past 30 days
Subjects with special circumstances who, may increase the risk of participating in the study or interfering with the evaluation of the primary endpoints of the study according to researcher's opinion
Age
From 18 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
100
Randomization (investigator's opinion)
Not randomized
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
Ethics Committee of Urology and Nephrology Research Center-Shahid Beheshti university of medical sci
Street address
N0.103, 9th Boostan, Pasdaran Ave.
City
Tehran
Province
Tehran
Postal code
1985717443
Approval date
2022-01-22, 1400/11/02
Ethics committee reference number
IR.SBMU.UNRC.REC.1400.017
Health conditions studied
1
Description of health condition studied
Covid-19
ICD-10 code
U07.1
ICD-10 code description
COVID-19, virus identified
Primary outcomes
1
Description
Evaluation of seroconversion of antibody against spike protein
Timepoint
One month after booster dose
Method of measurement
ELISA and statistical analysis
2
Description
Evaluation of seroconversion of neutralizing antibodies
Timepoint
One month after booster dose
Method of measurement
ELISA and statistical analysis
Secondary outcomes
1
Description
Evaluation GMFR of antibodies against S protein
Timepoint
One month after booster dose
Method of measurement
ELISA test and statistical analysis
2
Description
Evaluation of GMFR for neutralizing antibodies
Timepoint
One month after booster dose
Method of measurement
ELISA test and statistical analysis
3
Description
Evaluation GMFR of antibody against S protein in subgroups with initial response and no initial response to Sinopharm vaccine
Timepoint
One month after booster dose
Method of measurement
ELISA test and statistical analysis
4
Description
Evaluation GMFR of neutralizing antibodies in subgroups with initial humoral response and no initial humoral response to Sinopharm vaccine
Timepoint
One month after booster dose
Method of measurement
ELISA test and statistical analysis
5
Description
Evaluation of seroconversion against S protein in subgroups with initial humoral response and no initial humoral response to Sinopharm vaccine
Timepoint
One month after booster dose
Method of measurement
ELISA test and statistical analysis
6
Description
Evaluation of seroconversion of neutralizing antibodies in subgroups with initial humoral response and no initial humoral response to Sinopharm vaccine
Timepoint
One month after booster dose
Method of measurement
ELISA test and statistical analysis
7
Description
Evaluation of cellular immune response
Timepoint
One month after booster dose
Method of measurement
SARS-CoV-2 QuantiFERON Kit
8
Description
Occurrence of solicited adverse events
Timepoint
Up to 7 days after booster dose
Method of measurement
Checkup, history checking and participants reports based on adverse event reporting system
9
Description
Occurrence of unsolicited adverse events
Timepoint
One month after booster dose
Method of measurement
Checkup, history checking and participants reports based on adverse event reporting system
Intervention groups
1
Description
Intervention group: Injecting one dose of 1 ml solution of SpikoGen® vaccine containing recombinant SARS-CoV-2-S protein and Advax™ and CpG adjuvants in the non-dominant arm
Category
Prevention
Recruitment centers
1
Recruitment center
Name of recruitment center
Shahid Labbafinezhad clinic
Full name of responsible person
Mohsen Nafar
Street address
Between 8th Neyestan and 9th Boostan St, Pasdaran Ave.
City
Tehran
Province
Tehran
Postal code
1666650003
Phone
+98 21 2259 0607
Email
labafinejad.hos@tamin.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shahid Beheshti university of medical sciences Urology and Nephrology Research Center
Full name of responsible person
Abbas Basiri
Street address
No.101, 9th Boostan, Pasdaran Ave.
City
Tehran
Province
Tehran
Postal code
1666677951
Phone
+98 21 2256 7222
Email
research@unrc.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shahid Beheshti university of medical sciences Urology and Nephrology Research Center
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
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Shiva Samavat
Position
Associate Professor
Latest degree
Subspecialist
Other areas of specialty/work
Others
Street address
Between 8th Neyestan and 9th Boostan St, Pasdaran Ave.
City
Tehran
Province
Tehran
Postal code
1666650003
Phone
+98 21 2259 0607
Email
shsamavat @gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Mohsen Nafar
Position
Professor
Latest degree
Subspecialist
Other areas of specialty/work
Others
Street address
9th Boostan Alley, Pasdaran St.
City
Tehran
Province
Tehran
Postal code
1666650003
Phone
+98 21 2259 0607
Email
mohsen.nafar.sbmu@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Shiva Samavat
Position
Associate professor
Latest degree
Subspecialist
Other areas of specialty/work
Others
Street address
Between 8th Neyestan and 9th Boostan St, Pasdaran Ave.
City
Tehran
Province
Tehran
Postal code
1666650003
Phone
+98 21 2259 0607
Email
shsamavat @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
Yes - There is 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
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Not applicable
Data Dictionary
Not applicable
Title and more details about the data/document
Participants' data will be available for regulatory and ethics committee for decisions
When the data will become available and for how long
Documents including study protocol and the results will be available to the public after the study ends
To whom data/document is available
The regulatory body and the ethics committee will have access to the study data. The monitoring team will have access to the study data during the conduct.
Under which criteria data/document could be used
With the permission of the sponsor and the approval of regulatory
From where data/document is obtainable
The study sponsor is responding to this request
What processes are involved for a request to access data/document
After contacting the principal investigator and obtaining permission from the sponsor