Protocol summary
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Study aim
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Evaluation of immunogenicity and safety of pastocovac vaccine as a booster dose in comparison with sinopharm and pastocovac Plus boosters among Iranian adults aged from 18 to 80 who received 2 doses of Sinopharm vaccine
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Design
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Healthy or with controlled diseases, 18-80 years. Three types of boosters will be compared: Sinofarm (75 people), Pasteucovac (75 people), and Pasteucovac Plus (75 people). This is a phase 2 non-randomized open-label parallel-group trial.
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Settings and conduct
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Location: Pasteur Institute of Iran. Candidates choose the booster type. Blood samples are taken on days 0, 21,60, 90, and 180 (immunogenicity). Side effects: half-hour after injection, and on days 7, 21, 60, 90, and 180.
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Participants/Inclusion and exclusion criteria
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Inclusion: 18-80 years who have received two doses of Sinopharm 3-6 months before enrolment. Non-inclusion: Unstable underlying disease, receipt of other Covid-19 vaccines, Covid-19 infection after Sinopharm vaccination.
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Intervention groups
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Intervention: 1 dose of Pastocovac (Produced by the Pasteur Institute of Iran), 3-6 months after receiving 2 doses of Sinopharm. 0.5 ml, containing 25 micrograms RBD-TT, IM.
Control 1: 1 dose of Pastocovac-Plus (Produced by the Pasteur Institute of Iran), 3-6 months after receiving 2 doses of Sinopharm. 0.5 ml, containing 50 micrograms RBD-d, IM.
Control 2: 1 dose of Sinopharm (produced by the Beijing Institute of Biological Products), 3-6 months after receiving 2 doses of Sinopharm. 0.5 ml, containing 6.5 units of inactivated virus, IM.
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Main outcome variables
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SARS-CoV-2 Anti SPIKE IgG; SARS-CoV-2 Anti RBD IgG; Virus Neutralizing Test
General information
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Reason for update
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Updating protocol according to first DSMB committee meeting
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Acronym
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IRCT registration information
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IRCT registration number:
IRCT20131221015878N4
Registration date:
2022-02-26, 1400/12/07
Registration timing:
registered_while_recruiting
Last update:
2022-06-21, 1401/03/31
Update count:
2
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Registration date
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2022-02-26, 1400/12/07
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Registrant information
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Recruitment status
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Recruitment complete
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Funding source
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Expected recruitment start date
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2022-02-26, 1400/12/07
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Expected recruitment end date
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2022-09-29, 1401/07/07
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Actual recruitment start date
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empty
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Actual recruitment end date
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empty
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Trial completion date
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empty
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Scientific title
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Immunogenicity and safety of pastocovac vaccine as a booster dose in comparison with sinopharm and pastocovac Plus boosters in Iranian adults aged 18 to 80 who received 2 doses of Sinopharm vaccine: a parallel group clinical trial
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Public title
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Immunogenicity and safety of pastocovac vaccine as a booster dose in recipients of 2 doses of Sinopharm vaccine
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Purpose
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Prevention
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Inclusion/Exclusion criteria
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Inclusion criteria:
Signed written informed consent
Able to follow the vaccination schedules, visits and tests
General health or having controlled underlying diseases (based on the physician's diagnosis)
Iranian citizenship
Residents of Tehran
Both sexes (male and female)
Aged 18-80 years
Receiving the initial 2 doses of Sinopharm within a 28±5 days interval
Completion of the 2-dose Sinopharm vaccination course within 3-6 months prior enrollment.
Exclusion criteria:
Having a history of vaccination against Covid-19 with other vaccines (in addition to 2 doses of Sinopharm)
History of COVID-19 based on laboratory or clinical evidence after receiving 2 doses of Sinopharm
History of any vaccinations except COVID-19 within 3 months prior to enrollment
Pregnant or breastfeeding women or those who intend to become pregnant up to 3 months after the booster dose injection
Lifetime history of severe allergic reactions (anaphylaxis) to the vaccine
Coagulation disorders that contraindicate with intramuscular injection
History of treatment with immunosuppressive drugs 1 month before the booster injection (including oral and inhaled steroids (does not include topical steroids), cytostatic, interferon, immunoferon, transfer factor, Biomodulin T, any type of gammaglobin, levamisole , Heberferon, thymosin or any other immunomodulatory drug (including patients taking the above drugs due to an underlying disease)
Having a fever or acute illness during the 7 days before the injection or on the day of the booster injection Suffering from an unstable heart disease
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Age
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From 18 years old to 80 years old
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Gender
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Both
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Phase
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N/A
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Groups that have been masked
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No information
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Sample size
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Target sample size:
225
More than 1 sample in each individual
Number of samples in each individual:
0
Sample of Zero,21,60,90,180
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Randomization (investigator's opinion)
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N/A
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Randomization description
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Blinding (investigator's opinion)
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Not blinded
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Blinding description
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Placebo
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Not used
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Assignment
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Parallel
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Other design features
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Ethics committees
1
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Ethics committee
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Approval date
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2022-02-06, 1400/11/17
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Ethics committee reference number
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IR.NREC.1400.020
Health conditions studied
1
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Description of health condition studied
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COVID-19
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ICD-10 code
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U11
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ICD-10 code description
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Need for immunization against COVID-19
2
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Description of health condition studied
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COVID-19
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ICD-10 code
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U07
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ICD-10 code description
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COVID-19, virus identified & not identified
Primary outcomes
1
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Description
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Increased Anti-Spike headline
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Timepoint
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At the beginning of the study (before the intervention) and 21,60,90,180 days after the intervention (receiving a booster dose)
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Method of measurement
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Antibody titer with ELISA Kit Anti-SARS-CoV-2 QuantiVac ELISA (IgG) Kit, Euroimmun co.
2
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Description
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Increased Anti RBD headline
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Timepoint
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At the beginning of the study (before the intervention) and 21,60,90,180 days after the intervention (receiving a booster dose)
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Method of measurement
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Quanti-SARS-CoV-Anti-RBD ELISA (IgG) Kit, Pishtaz co.
3
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Description
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Increased cVNT headline
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Timepoint
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At the beginning of the study (before the intervention) and 21,60,90,180 days after the intervention (receiving a booster dose)
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Method of measurement
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SARS-CoV-2 Neutralizing Ab Elisa kit
Secondary outcomes
1
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Description
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Vaccine safety assessment
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Timepoint
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At the beginning of the study (before the intervention) and 7,21,60,90,180 days after the intervention (receiving a booster dose)
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Method of measurement
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Compilation form, clinical examination and telephone follow-up
Intervention groups
1
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Description
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Intervention group: Injection of 1 dose of Pastocovac vaccine as a booster dose, 3-6 months after receiving 2 doses of Sinopharm vaccine. The Pastocovac vaccine, produced by the Pasteur Institute of Iran, is injected intramuscularly into the deltoid muscle (0.5 ml, containing 25 micrograms of RBD conjugated with tetanus).
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Category
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Prevention
2
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Description
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Control group 1: injection of 1 dose of Pastocovac-Plus vaccine as a booster dose, 3-6 months after receiving 2 doses of Sinopharm vaccine. Pastocovac vaccine, produced by the Pasteur Institute of Iran, is injected intramuscularly into the deltoid muscle (0.5 ml, containing 50 micrograms of RBD dimer).
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Category
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Prevention
3
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Description
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Control group 2: injection of 1 dose of Sinopharm vaccine as a booster dose, 3-6 months after receiving 2 doses of Sinopharm vaccine. The Sinopharm vaccine, produced by the Beijing Institute of Biological Products, is injected intramuscularly into the deltoid muscle (containing 6.5 units of inactivated virus).
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Category
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Prevention
1
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Sponsor
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Grant name
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Grant code / Reference number
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Is the source of funding the same sponsor organization/entity?
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Yes
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Title of funding source
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Pasture Institute of Iran
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Proportion provided by this source
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100
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Public or private sector
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Public
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Domestic or foreign origin
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Domestic
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Category of foreign source of funding
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empty
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Country of origin
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Type of organization providing the funding
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Academic
Sharing plan
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Deidentified Individual Participant Data Set (IPD)
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Undecided - It is not yet known if there will be a plan to make this available
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Study Protocol
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Undecided - It is not yet known if there will be a plan to make this available
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Statistical Analysis Plan
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Undecided - It is not yet known if there will be a plan to make this available
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Informed Consent Form
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Undecided - It is not yet known if there will be a plan to make this available
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Clinical Study Report
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Undecided - It is not yet known if there will be a plan to make this available
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Analytic Code
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Undecided - It is not yet known if there will be a plan to make this available
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Data Dictionary
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Undecided - It is not yet known if there will be a plan to make this available