COVID-19NCT05285384
Immunogenicity and Safety of a Booster Dose of the SpikoGen Vaccine in Kidney Transplant Recipients After Two Doses of Sinopharm Vaccine
A study testing SARS-CoV-2 recombinant spike protein + Advax-SM adjuvant in people with COVID-19, run by Cinnagen at 1 site in Iran.
Trial summary
This is an open-label, single-arm clinical trial designed to evaluate the immunogenicity and safety of a booster dose of an adjuvanted recombinant SARS-CoV-2 spike protein subunit vaccine (SpikoGen) produced by CinnaGen Co. in kidney transplant recipients after two doses of Sinopharm's inactivated virus vaccine. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- COVID-19
- What is being tested?
- SARS-CoV-2 recombinant spike protein + Advax-SM adjuvant
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 43 participants
- Where
- 1 siteIran
- Study dates
- 4 Feb 2022to 30 Mar 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male or female ≥18 years
- Willing and able to comply with all study requirements, including scheduled visits, intervention, and laboratory tests
- Kidney transplant recipients who had received two doses of Sinopharm vaccine after transplantation
- Females must not be pregnant or breastfeeding
- At least six months should have passed from the time of transplantation
- Between 1 to 3 months should have passed from the second dose of Sinopharm vaccine
Who cannot join
- Subjects with signs of active SARS-CoV-2 infection at the screening visit
- Subjects with a history of SARS-CoV-2 infection based on a positive PCR test result after the second dose of the primary vaccination
- Subjects with an active CMV infection that requires treatment
- Subjects who have received rituximab within 6 months prior to the screening visit
- Subjects who have received intravenous immune globulin (IVIG) within 6 months prior to the screening visit
- Subjects who have a history of severe allergic reactions (e.g., anaphylaxis) to the study vaccine, any components of the study interventions, or any pharmaceutical products.
Show all 9Show fewer
- Subjects who have received any other investigational products within 30 days prior to the screening visit or intend to participate in any other clinical studies during the period of this study.
- Subjects who have experienced transplant rejection within 30 days prior to the screening visit
- Subjects with any condition that may increase the risk of participating in the study or may interfere with the evaluation of the primary endpoints of the study in the investigator's opinion.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: An Open-Label, Single-Arm Clinical Trial to Evaluate the Immunogenicity and Safety of a Booster Dose of an Adjuvanted Recombinant Spike Protein COVID-19 Vaccine (SpikoGen) in Kidney Transplant Recipients After Two Doses of Sinopharm COVID-19 Vaccine
This is an open-label, single-arm clinical trial designed to evaluate the immunogenicity and safety of a booster dose of an adjuvanted recombinant SARS-CoV-2 spike protein subunit vaccine (SpikoGen) produced by CinnaGen Co. in kidney transplant recipients after two doses of Sinopharm's inactivated virus vaccine. A total of 100 adult individuals receive a single dose of the SpikoGen COVID-19 vaccine at 1 to 3 months after the second dose of the Sinopharm COVID-19 vaccine. The injection is given in the deltoid muscle of the non-dominant arm. For immunogenicity assessments, blood samples will be collected one month after the booster injection. For safety assessments, all participants will be followed up for one month.
Study hypotheses include:
- A booster dose of the SpikoGen COVID-19 vaccine induces strong immunogenicity against SARS-CoV-2 in adult kidney transplant recipients who were fully vaccinated with Sinopharm COVID-19 vaccine.
- A booster dose of the SpikoGen COVID-19 vaccine is safe and tolerable in adult kidney transplant recipients who were fully vaccinated with Sinopharm COVID-19 vaccine.
- Conditions
- COVID-19
- Being tested
- SARS-CoV-2 recombinant spike protein + Advax-SM adjuvant
- Keywords
- COVID-19, SARS-COV-2, Recombinant protein, Spike, Advax-SM, Advax, Vaccine, Adjuvant, Kidney Transplant
- Medical subject headings
- COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SARS-CoV-2 recombinant spike protein + Advax-SM adjuvantBiological
Also called SpikoGen, COVAX-19
SARS-CoV-2 recombinant spike protein (25 μg) with Advax-SM adjuvant (15 mg); a single intramuscular injection into the deltoid muscle of the non-dominant arm
| Study group | Role | What they receive |
|---|---|---|
| SpikoGen COVID-19 Vaccine | Experimental | Not described Receives: Biological: SARS-CoV-2 recombinant spike protein + Advax-SM adjuvant |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of participants with seroconversion for S1 binding IgG antibodies
As measured by ELISA
Measured: One month after the booster dose
Percentage of participants with seroconversion for SARS-CoV-2 neutralizing antibodies
As measured by ELISA
Measured: One month after the booster dose
Secondary outcomes (9)
Geometric mean fold rise (GMFR) for S1 binding IgG antibodies
As measured by ELISA
Measured: One month after the booster dose
Geometric mean fold rise (GMFR) for S1 binding IgG antibodies in subjects either with or without antibody responses at baseline
As measured by ELISA
Measured: One month after the booster dose
Percentage of participants with seroconversion for S1 binding IgG antibodies in subjects either with or without antibody responses at baseline
As measured by ELISA
Measured: One month after the booster dose
Geometric mean fold rise (GMFR) for SARS-CoV-2 neutralizing antibodies
As measured by ELISA
Measured: One month after the booster dose
Geometric mean fold rise (GMFR) for SARS-CoV-2 neutralizing antibodies in subjects either with or without antibody responses at baseline
As measured by ELISA
Measured: One month after the booster dose
Percentage of participants with seroconversion for SARS-CoV-2 neutralizing antibodies in subjects either with or without antibody responses at baseline
As measured by ELISA
Measured: One month after the booster dose
Change in T-cell IFN-γ secretion from baseline to one month after the booster dose
As measured by IGRA
Measured: Baseline and one month after the booster dose
Incidence of solicited adverse events
Injection site pain, erythema, swelling, and induration, axillary swelling or tenderness ipsilateral to the side of injection, fever (oral temperature), headache, fatigue, myalgia, arthralgia, nausea, vomiting, and chills, as reported by the study participants on electronic diaries, and as defined using system organ classes and preferred terms of the Medical Dictionary for Regulatory Activities (MedDRA)
Measured: For 7 days after the booster dose
Incidence of unsolicited adverse events
As reported by the study participants on electronic diaries, and as defined using system organ classes and preferred terms of the Medical Dictionary for Regulatory Activities (MedDRA)
Measured: For one month after the booster dose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Mar 2022
- Study start4 Feb 2022
- Primary completion30 Mar 2022
- Study completion30 Mar 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for COVID-19Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 43 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cinnagen
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Shahid Beheshti University of Medical Sciences, Vaxine Pty Ltd
- Responsible party
- Sponsor
- Investigators
- Mohsen Nafar, M.D., Principal investigator, Shahid Beheshti University of Medical Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05285384
- Sponsor's protocol ID
- VAC.CIN.PT.BOOSTER.KTR
- Other IDs
- IRCT20150303021315N28
- Status last verified
- Aug 2023
- First submitted
- 9 Mar 2022
- Last updated
- 31 Aug 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-Label, Single-Arm Clinical Trial to Evaluate the Immunogenicity and Safety of a Booster Dose of an Adjuvanted Recombinant Spike Protein COVID-19 Vaccine (SpikoGen) in Kidney Transplant Recipients After Two Doses of Sinopharm COVID-19 Vaccine
- ClinicalTrials.gov ID
- NCT05285384
- Acronym / sponsor ID
- VAC.CIN.PT.BOOSTER.KTR
- Conditions
- COVID-19
- Keywords
- COVID-19, SARS-COV-2, Recombinant protein, Spike, Advax-SM, Advax, Vaccine, Adjuvant
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 43 participants (actual)
- Lead sponsor
- CinnagenIndustry (pharma, biotech, devices)
- Collaborators
- Shahid Beheshti University of Medical Sciences, Vaxine Pty Ltd
- Study start
- 4 Feb 2022 (actual)
- Primary completion
- 30 Mar 2022 (actual)
- Study completion
- 30 Mar 2022 (actual)
- First posted
- 17 Mar 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is an open-label, single-arm clinical trial designed to evaluate the immunogenicity and safety of a booster dose of an adjuvanted recombinant SARS-CoV-2 spike protein subunit vaccine (SpikoGen) produced by CinnaGen Co. in kidney transplant recipients after two doses of Sinopharm's inactivated virus vaccine. A total of 100 adult individuals receive a single dose of the SpikoGen COVID-19 vaccine at 1 to 3 months after the second dose of the Sinopharm COVID-19 vaccine. The injection is given in the deltoid muscle of the non-dominant arm. For immunogenicity assessments, blood samples will be collected one month after the booster injection. For safety assessments, all participants will be followed up for one month.
Study hypotheses include:
- A booster dose of the SpikoGen COVID-19 vaccine induces strong immunogenicity against SARS-CoV-2 in adult kidney transplant recipients who were fully vaccinated with Sinopharm COVID-19 vaccine.
- A booster dose of the SpikoGen COVID-19 vaccine is safe and tolerable in adult kidney transplant recipients who were fully vaccinated with Sinopharm COVID-19 vaccine.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| SpikoGen COVID-19 Vaccine | Experimental | Biological: SARS-CoV-2 recombinant spike protein + Advax-SM adjuvant |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Male or female ≥18 years
- Willing and able to comply with all study requirements, including scheduled visits, intervention, and laboratory tests
- Kidney transplant recipients who had received two doses of Sinopharm vaccine after transplantation
- Females must not be pregnant or breastfeeding
- At least six months should have passed from the time of transplantation
Key exclusion criteria (9 listed)
- Subjects with signs of active SARS-CoV-2 infection at the screening visit
- Subjects with a history of SARS-CoV-2 infection based on a positive PCR test result after the second dose of the primary vaccination
- Subjects with an active CMV infection that requires treatment
- Subjects who have received rituximab within 6 months prior to the screening visit
- Subjects who have received intravenous immune globulin (IVIG) within 6 months prior to the screening visit
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SARS-CoV-2 recombinant spike protein + Advax-SM adjuvantAlso: SpikoGen, COVAX-19SARS-CoV-2 recombinant spike protein (25 μg) with Advax-SM adjuvant (15 mg); a single intramuscular injection into the deltoid muscle of the non-dominant arm | Biological | SpikoGen COVID-19 Vaccine |
Primary outcome
Percentage of participants with seroconversion for S1 binding IgG antibodies
Time frame: One month after the booster dose
As measured by ELISA
Percentage of participants with seroconversion for SARS-CoV-2 neutralizing antibodies
Time frame: One month after the booster dose
As measured by ELISA
9 secondary outcomes
Geometric mean fold rise (GMFR) for S1 binding IgG antibodies
Time frame: One month after the booster dose
Geometric mean fold rise (GMFR) for S1 binding IgG antibodies in subjects either with or without antibody responses at baseline
Time frame: One month after the booster dose
Percentage of participants with seroconversion for S1 binding IgG antibodies in subjects either with or without antibody responses at baseline
Time frame: One month after the booster dose
Geometric mean fold rise (GMFR) for SARS-CoV-2 neutralizing antibodies
Time frame: One month after the booster dose
Geometric mean fold rise (GMFR) for SARS-CoV-2 neutralizing antibodies in subjects either with or without antibody responses at baseline
Time frame: One month after the booster dose
Percentage of participants with seroconversion for SARS-CoV-2 neutralizing antibodies in subjects either with or without antibody responses at baseline
Time frame: One month after the booster dose
Change in T-cell IFN-γ secretion from baseline to one month after the booster dose
Time frame: Baseline and one month after the booster dose
Incidence of solicited adverse events
Time frame: For 7 days after the booster dose
Incidence of unsolicited adverse events
Time frame: For one month after the booster dose
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Aug 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mohsen Nafar, M.D. principal investigator
Shahid Beheshti University of Medical Sciences
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing SARS-CoV-2 recombinant spike protein + Advax-SM adjuvant in people with COVID-19, run by Cinnagen at 1 site in Iran.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 31 Aug 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Iran. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of participants with seroconversion for S1 binding IgG antibodies (time frame: One month after the booster dose). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Aug 2023.