Covid19Phase 2NCT04944368
Phase II Clinical Trial of CinnaGen COVID-19 Vaccine (SpikoGen)
A Phase 2 study testing SARS-CoV-2 recombinant spike protein + Advax-SM adjuvant in people with Covid19, run by Cinnagen at 1 site in Iran.
Trial summary
This is a phase II, randomized, two-armed, double-blind, placebo-controlled trial designed to evaluate the safety, tolerability, and immunogenicity of a candidate adjuvanted recombinant SARS-CoV-2 spike (S) protein subunit vaccine (SpikoGen) produced by CinnaGen Co. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Covid19
- What is being tested?
- SARS-CoV-2 recombinant spike protein + Advax-SM adjuvant
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 400 participants
- Where
- 1 siteIran
- Study dates
- 30 May 2021to 30 Dec 2021
- Phase
- Phase 2
- 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
- Healthy volunteers accepted
- 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, interventions, and laboratory tests
- Healthy adults or adults in a stable medical condition, defined as not being hospitalized within 3 months prior to the screening visit
- Females must not be pregnant or breastfeeding
Who cannot join
- Subjects with signs of active SARS-COV-2 infection at the screening visit.
- Subjects with body temperature of 38 degrees Celsius or greater at the screening visit or within 72 hours prior to the screening visit.
- Subjects with a history of any progressive or severe neurological disorders, seizure, or Guillain-Barre syndrome.
- Subjects who receive immunosuppressive or cytotoxic medications.
- Female Subjects who are pregnant or breastfeeding or have planned to become pregnant during the study period.
- 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 13Show 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 been vaccinated with any vaccine or vaccine candidate against SARS-CoV-2.
- Subjects who have received any vaccines within 28 days prior to the screening visit or intend to receive any vaccines up to 14 days after the second dose of the study injection.
- Subjects who have any known bleeding disorders or, in the investigator's opinion, have any contraindications for an intramuscular injection.
- Subjects who have received any blood, plasma, or immunoglobulin products from 90 days prior to the screening visit or intend to receive during the study period.
- 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.
- Subjects who have donated ≥450 mL of blood or blood products within 28 days prior to the screening visit.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase II, Randomized, Two-armed, Double-blind, Placebo-controlled Trial to Evaluate the Safety, Tolerability, and Immunogenicity of an Adjuvanted Recombinant SARS-CoV-2 Spike (S) Protein Subunit Vaccine Candidate (SpikoGen)
This is a phase II, randomized, two-armed, double-blind, placebo-controlled trial designed to evaluate the safety, tolerability, and immunogenicity of a candidate adjuvanted recombinant SARS-CoV-2 spike (S) protein subunit vaccine (SpikoGen) produced by CinnaGen Co. 400 adult individuals receive either SARS-CoV-2 recombinant spike protein (25 µg) with Advax-SM adjuvant (15 mg) or saline placebo in a 3:1 ratio. The injection is given in two doses with a 21-day interval in the deltoid muscle of the non-dominant arm. The randomization was stratified by age (<65 or ≥65) and health conditions of potential risk for severe COVID-19. Participants will be visited at two weeks and will be followed up for six months after the second dose of the study intervention.
Study hypotheses include:
- The adjuvanted COVID-19 vaccine candidate is safe and tolerable in adult subjects.
- The adjuvanted COVID-19 vaccine candidate induces strong immunogenicity against SARS-CoV-2 in adult subjects.
- Conditions
- Covid19
- Being tested
- SARS-CoV-2 recombinant spike protein + Advax-SM adjuvant, Saline placebo
- Keywords
- COVID-19, SARS-COV-2, Recombinant protein, Spike, Advax-SM, Advax, Vaccine, Adjuvant
- 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
SARS-CoV-2 recombinant spike protein (25 µg) with Advax-SM adjuvant (15 mg) in two doses with a 21-day interval administered with intramuscular injections in the non-dominant arm
Saline placeboBiological
Also called Normal saline
0.9% sodium chloride (1 mL) injection in two doses with a 21-day interval administered with intramuscular injections in the non-dominant arm
| Study group | Role | What they receive |
|---|---|---|
| Vaccine candidate | Experimental | Not described Receives: Biological: SARS-CoV-2 recombinant spike protein + Advax-SM adjuvant |
| Saline placebo | Placebo comparator | Not described Receives: Biological: Saline placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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 each 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 28 days after each dose
Percentage of participants with seroconversion for S1 binding IgG antibodies after the first injection
As measured by ELISA
Measured: 21 days after the first dose (on the day of the second dose)
Percentage of participants with seroconversion for S1 binding IgG antibodies after the second injection
As measured by ELISA
Measured: 14 days after the second dose
Change in geometric mean concentration (GMC) for S1 binding IgG antibodies from baseline to 21 days after the first injection
As measured by ELISA
Measured: On the day of the first dose and 21 days after the first dose (on the day of the second dose)
Change in geometric mean concentration (GMC) for S1 binding IgG antibodies from baseline to 14 days after the second injection
As measured by ELISA
Measured: On the day of the first dose and 14 days after the second dose
Secondary outcomes (29)
Percentage of participants with seroconversion for SARS-CoV-2 neutralizing antibodies after the first injection
As measured by ELISA (sVNT)
Measured: 21 days after the first dose (on the day of the second dose)
Percentage of participants with seroconversion for SARS-CoV-2 neutralizing antibodies after the first injection
As measured by cVNT
Measured: 21 days after the first dose (on the day of the second dose)
Percentage of participants with seroconversion for SARS-CoV-2 neutralizing antibodies after the second injection
As measured by ELISA (sVNT)
Measured: 14 days after the second dose
Percentage of participants with seroconversion for SARS-CoV-2 neutralizing antibodies after the second injection
As measured by cVNT
Measured: 14 days after the second dose
Percentage of participants with seroconversion for receptor-binding domain (RBD) binding IgA antibodies after the first injection
As measured by ELISA
Measured: 21 days after the first dose (on the day of the second dose)
Percentage of participants with seroconversion for receptor-binding domain (RBD) binding IgA antibodies after the second injection
As measured by ELISA
Measured: 14 days after the second dose
Percentage of participants with seroconversion for S1 binding IgA antibodies after the first injection
As measured by ELISA
Measured: 21 days after the first dose (on the day of the second dose)
Percentage of participants with seroconversion for S1 binding IgA antibodies after the second injection
As measured by ELISA
Measured: 14 days after the second dose
Percentage of participants with seroconversion for receptor-binding domain (RBD) binding IgG antibodies after the first injection
As measured by ELISA
Measured: 21 days after the first dose (on the day of the second dose)
Percentage of participants with seroconversion for receptor-binding domain (RBD) binding IgG antibodies after the second injection
As measured by ELISA
Measured: 14 days after the second dose
Change in geometric mean concentration (GMC) for receptor-binding domain (RBD) binding IgG antibodies from baseline to 21 days after the first injection
As measured by ELISA
Measured: On the day of the first dose and 21 days after the first dose (on the day of the second dose)
Change in geometric mean concentration (GMC) for receptor-binding domain (RBD) binding IgG antibodies from baseline to 14 days after the second injection
As measured by ELISA
Measured: On the day of the first dose and 14 days after the second dose
Geometric mean fold rise (GMFR) for S1 binding IgG antibodies after the first injection
As measured by ELISA
Measured: 21 days after the first dose (on the day of the second dose)
Geometric mean fold rise (GMFR) for S1 binding IgG antibodies after the second injection
As measured by ELISA
Measured: 14 days after the second dose
Geometric mean fold rise (GMFR) for receptor-binding domain (RBD) binding IgG antibodies after the first injection
As measured by ELISA
Measured: 21 days after the first dose (on the day of the second dose)
Geometric mean fold rise (GMFR) for receptor-binding domain (RBD) binding IgG antibodies after the second injection
As measured by ELISA
Measured: 14 days after the second dose
Geometric mean fold rise (GMFR) for SARS-CoV-2 neutralizing antibodies after the first injection
As measured by ELISA (sVNT)
Measured: 21 days after the first dose (on the day of the second dose)
Geometric mean fold rise (GMFR) for SARS-CoV-2 neutralizing antibodies after the second injection
As measured by ELISA (sVNT)
Measured: 14 days after the second dose
Change in geometric mean concentration (GMC) for SARS-CoV-2 neutralizing antibodies from baseline to 21 days after the first injection
As measured by ELISA (sVNT)
Measured: On the day of the first dose and 21 days after the first dose (on the day of the second dose)
Change in geometric mean concentration (GMC) for SARS-CoV-2 neutralizing antibodies from baseline to 14 days after the second injection
As measured by ELISA (sVNT)
Measured: On the day of the first dose and 14 days after the second dose
Change in geometric mean concentration (GMC) for S1 binding IgA antibodies from baseline to 21 days after the first injection
As measured by ELISA
Measured: On the day of the first dose and 21 days after the first dose (on the day of the second dose)
Change in geometric mean concentration (GMC) for S1 binding IgA antibodies from baseline to 14 days after the second injection
As measured by ELISA
Measured: On the day of the first dose and 14 days after the second dose
Geometric mean fold rise (GMFR) for S1 binding IgA antibodies after the first injection
As measured by ELISA
Measured: 21 days after the first dose (on the day of the second dose)
Geometric mean fold rise (GMFR) for S1 binding IgA antibodies after the second injection
As measured by ELISA
Measured: 14 days after the second dose
Incidence of serious adverse events (SAEs) and suspected unexpected serious adverse reaction (SUSARs)
As defined using system organ classes and preferred terms of the Medical Dictionary for Regulatory Activities (MedDRA)
Measured: For 6 months after the second dose
Change in T-cell proliferation responses from baseline to 21 days after the first injection
Evaluation of CD4+ and CD8+ T-cell proliferation responses as measured by flow cytometry
Measured: On the day of the first dose and 21 days after the first dose (on the day of the second dose)
Change in T-cell proliferation responses from baseline to 14 days after the second injection
Evaluation of CD4+ and CD8+ T-cell proliferation responses as measured by flow cytometry
Measured: On the day of the first dose and 14 days after the second dose
Change in T-cell IFN-γ secretion from baseline to 21 days after the first injection
As measured by IGRA
Measured: On the day of the first dose and 21 days after the first dose (on the day of the second dose)
Change in T-cell IFN-γ secretion from baseline to 14 days after the second injection
As measured by IGRA
Measured: On the day of the first dose and 14 days after the second dose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jun 2021
- Study start30 May 2021
- Primary completion19 Jul 2021
- Study completion30 Dec 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Covid19Studies 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 2
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 400 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cinnagen
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Vaxine Pty Ltd
- Responsible party
- Sponsor
- Investigators
- Payam Tabarsi, M.D., Principal investigator, Shahid Beheshti University of Medical Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04944368
- Sponsor's protocol ID
- VAC.CIN.PT.II
- Other IDs
- IRCT20150303021315N23
- Status last verified
- Jan 2022
- First submitted
- 19 Jun 2021
- Last updated
- 13 Oct 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Tabarsi P, Anjidani N, Shahpari R, Mardani M, Sabzvari A, Yazdani B, Roshanzamir K, Bayatani B, Taheri A, Petrovsky N, Li L, Barati S. Safety and immunogenicity of SpikoGen(R), an Advax-CpG55.2-adjuvanted SARS-CoV-2 spike protein vaccine: a phase 2 randomized placebo-controlled trial in both seropositive and seronegative populations. Clin Microbiol Infect. 2022 Sep;28(9):1263-1271. doi: 10.1016/j.cmi.2022.04.004. Epub 2022 Apr 15.
PubMed 35436611
Study at a glance
From the registry record, last updated by the sponsor on 13 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II, Randomized, Two-armed, Double-blind, Placebo-controlled Trial to Evaluate the Safety, Tolerability, and Immunogenicity of an Adjuvanted Recombinant SARS-CoV-2 Spike (S) Protein Subunit Vaccine Candidate (SpikoGen)
- ClinicalTrials.gov ID
- NCT04944368
- Acronym / sponsor ID
- VAC.CIN.PT.II
- Conditions
- Covid19
- Keywords
- COVID-19, SARS-COV-2, Recombinant protein, Spike, Advax-SM, Advax, Vaccine, Adjuvant
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 400 participants (actual)
- Lead sponsor
- CinnagenIndustry (pharma, biotech, devices)
- Collaborators
- Vaxine Pty Ltd
- Study start
- 30 May 2021 (actual)
- Primary completion
- 19 Jul 2021 (actual)
- Study completion
- 30 Dec 2021 (actual)
- First posted
- 29 Jun 2021 (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 a phase II, randomized, two-armed, double-blind, placebo-controlled trial designed to evaluate the safety, tolerability, and immunogenicity of a candidate adjuvanted recombinant SARS-CoV-2 spike (S) protein subunit vaccine (SpikoGen) produced by CinnaGen Co. 400 adult individuals receive either SARS-CoV-2 recombinant spike protein (25 µg) with Advax-SM adjuvant (15 mg) or saline placebo in a 3:1 ratio. The injection is given in two doses with a 21-day interval in the deltoid muscle of the non-dominant arm. The randomization was stratified by age (<65 or ≥65) and health conditions of potential risk for severe COVID-19. Participants will be visited at two weeks and will be followed up for six months after the second dose of the study intervention.
Study hypotheses include:
- The adjuvanted COVID-19 vaccine candidate is safe and tolerable in adult subjects.
- The adjuvanted COVID-19 vaccine candidate induces strong immunogenicity against SARS-CoV-2 in adult subjects.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Vaccine candidate | Experimental | Biological: SARS-CoV-2 recombinant spike protein + Advax-SM adjuvant |
| Saline placebo | Placebo comparator | Biological: Saline placebo |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Male or female ≥18 years
- Willing and able to comply with all study requirements, including scheduled visits, interventions, and laboratory tests
- Healthy adults or adults in a stable medical condition, defined as not being hospitalized within 3 months prior to the screening visit
- Females must not be pregnant or breastfeeding
Key exclusion criteria (13 listed)
- Subjects with signs of active SARS-COV-2 infection at the screening visit.
- Subjects with body temperature of 38 degrees Celsius or greater at the screening visit or within 72 hours prior to the screening visit.
- Subjects with a history of any progressive or severe neurological disorders, seizure, or Guillain-Barre syndrome.
- Subjects who receive immunosuppressive or cytotoxic medications.
- Female Subjects who are pregnant or breastfeeding or have planned to become pregnant during the study period.
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: SpikoGenSARS-CoV-2 recombinant spike protein (25 µg) with Advax-SM adjuvant (15 mg) in two doses with a 21-day interval administered with intramuscular injections in the non-dominant arm | Biological | Vaccine candidate |
| Saline placeboAlso: Normal saline0.9% sodium chloride (1 mL) injection in two doses with a 21-day interval administered with intramuscular injections in the non-dominant arm | Biological | Saline placebo |
Primary outcome
Incidence of solicited adverse events
Time frame: For 7 days after each dose
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)
Incidence of unsolicited adverse events
Time frame: For 28 days after each dose
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)
Percentage of participants with seroconversion for S1 binding IgG antibodies after the first injection
Time frame: 21 days after the first dose (on the day of the second dose)
As measured by ELISA
Percentage of participants with seroconversion for S1 binding IgG antibodies after the second injection
Time frame: 14 days after the second dose
As measured by ELISA
Change in geometric mean concentration (GMC) for S1 binding IgG antibodies from baseline to 21 days after the first injection
Time frame: On the day of the first dose and 21 days after the first dose (on the day of the second dose)
As measured by ELISA
Change in geometric mean concentration (GMC) for S1 binding IgG antibodies from baseline to 14 days after the second injection
Time frame: On the day of the first dose and 14 days after the second dose
As measured by ELISA
29 secondary outcomes
Percentage of participants with seroconversion for SARS-CoV-2 neutralizing antibodies after the first injection
Time frame: 21 days after the first dose (on the day of the second dose)
Percentage of participants with seroconversion for SARS-CoV-2 neutralizing antibodies after the first injection
Time frame: 21 days after the first dose (on the day of the second dose)
Percentage of participants with seroconversion for SARS-CoV-2 neutralizing antibodies after the second injection
Time frame: 14 days after the second dose
Percentage of participants with seroconversion for SARS-CoV-2 neutralizing antibodies after the second injection
Time frame: 14 days after the second dose
Percentage of participants with seroconversion for receptor-binding domain (RBD) binding IgA antibodies after the first injection
Time frame: 21 days after the first dose (on the day of the second dose)
Percentage of participants with seroconversion for receptor-binding domain (RBD) binding IgA antibodies after the second injection
Time frame: 14 days after the second dose
Percentage of participants with seroconversion for S1 binding IgA antibodies after the first injection
Time frame: 21 days after the first dose (on the day of the second dose)
Percentage of participants with seroconversion for S1 binding IgA antibodies after the second injection
Time frame: 14 days after the second dose
Percentage of participants with seroconversion for receptor-binding domain (RBD) binding IgG antibodies after the first injection
Time frame: 21 days after the first dose (on the day of the second dose)
Percentage of participants with seroconversion for receptor-binding domain (RBD) binding IgG antibodies after the second injection
Time frame: 14 days after the second dose
Change in geometric mean concentration (GMC) for receptor-binding domain (RBD) binding IgG antibodies from baseline to 21 days after the first injection
Time frame: On the day of the first dose and 21 days after the first dose (on the day of the second dose)
Change in geometric mean concentration (GMC) for receptor-binding domain (RBD) binding IgG antibodies from baseline to 14 days after the second injection
Time frame: On the day of the first dose and 14 days after the second dose
Geometric mean fold rise (GMFR) for S1 binding IgG antibodies after the first injection
Time frame: 21 days after the first dose (on the day of the second dose)
Geometric mean fold rise (GMFR) for S1 binding IgG antibodies after the second injection
Time frame: 14 days after the second dose
Geometric mean fold rise (GMFR) for receptor-binding domain (RBD) binding IgG antibodies after the first injection
Time frame: 21 days after the first dose (on the day of the second dose)
Geometric mean fold rise (GMFR) for receptor-binding domain (RBD) binding IgG antibodies after the second injection
Time frame: 14 days after the second dose
Geometric mean fold rise (GMFR) for SARS-CoV-2 neutralizing antibodies after the first injection
Time frame: 21 days after the first dose (on the day of the second dose)
Geometric mean fold rise (GMFR) for SARS-CoV-2 neutralizing antibodies after the second injection
Time frame: 14 days after the second dose
Change in geometric mean concentration (GMC) for SARS-CoV-2 neutralizing antibodies from baseline to 21 days after the first injection
Time frame: On the day of the first dose and 21 days after the first dose (on the day of the second dose)
Change in geometric mean concentration (GMC) for SARS-CoV-2 neutralizing antibodies from baseline to 14 days after the second injection
Time frame: On the day of the first dose and 14 days after the second dose
Change in geometric mean concentration (GMC) for S1 binding IgA antibodies from baseline to 21 days after the first injection
Time frame: On the day of the first dose and 21 days after the first dose (on the day of the second dose)
Change in geometric mean concentration (GMC) for S1 binding IgA antibodies from baseline to 14 days after the second injection
Time frame: On the day of the first dose and 14 days after the second dose
Geometric mean fold rise (GMFR) for S1 binding IgA antibodies after the first injection
Time frame: 21 days after the first dose (on the day of the second dose)
Geometric mean fold rise (GMFR) for S1 binding IgA antibodies after the second injection
Time frame: 14 days after the second dose
Incidence of serious adverse events (SAEs) and suspected unexpected serious adverse reaction (SUSARs)
Time frame: For 6 months after the second dose
Change in T-cell proliferation responses from baseline to 21 days after the first injection
Time frame: On the day of the first dose and 21 days after the first dose (on the day of the second dose)
Change in T-cell proliferation responses from baseline to 14 days after the second injection
Time frame: On the day of the first dose and 14 days after the second dose
Change in T-cell IFN-γ secretion from baseline to 21 days after the first injection
Time frame: On the day of the first dose and 21 days after the first dose (on the day of the second dose)
Change in T-cell IFN-γ secretion from baseline to 14 days after the second injection
Time frame: On the day of the first dose and 14 days after the second 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 13 Oct 2022.
- Results publication: PubMed 35436611Tabarsi P, Anjidani N, Shahpari R, Mardani M, Sabzvari A, Yazdani B, Roshanzamir K, Bayatani B, Taheri A, Petrovsky N, Li L, Barati S. Safety and immunogenicity of SpikoGen(R), an Advax-CpG55.2-adjuvanted SARS-CoV-2 spike protein vaccine: a phase 2 randomized placebo-controlled trial in both seropositive and seronegative populations. Clin Microbiol Infect. 2022 Sep;28(9):1263-1271. doi: 10.1016/j.cmi.2022.04.004. Epub 2022 Apr 15.
- 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.
Payam Tabarsi, 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 Phase 2 study testing SARS-CoV-2 recombinant spike protein + Advax-SM adjuvant in people with Covid19, 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 4 inclusion and 13 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 13 Oct 2022. 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Incidence of solicited adverse events (time frame: For 7 days after each dose). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04944368, which also lists 1 linked publication.
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 13 Oct 2022.