search
Back to results

Phase II Clinical Trial of CinnaGen COVID-19 Vaccine (SpikoGen)

Primary Purpose

Covid19

Status
Completed
Phase
Phase 2
Locations
Iran, Islamic Republic of
Study Type
Interventional
Intervention
SARS-CoV-2 recombinant spike protein + Advax-SM adjuvant
Saline placebo
Sponsored by
Cinnagen
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Covid19 focused on measuring COVID-19, SARS-COV-2, Recombinant protein, Spike, Advax-SM, Advax, Vaccine, Adjuvant

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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.
  • 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.

Sites / Locations

  • Espinas Palace Hotel

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Vaccine candidate

Saline placebo

Arm Description

Outcomes

Primary Outcome Measures

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)
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)
Percentage of participants with seroconversion for S1 binding IgG antibodies after the first injection
As measured by ELISA
Percentage of participants with seroconversion for S1 binding IgG antibodies after the second injection
As measured by ELISA
Change in geometric mean concentration (GMC) for S1 binding IgG antibodies from baseline to 21 days after the first injection
As measured by ELISA
Change in geometric mean concentration (GMC) for S1 binding IgG antibodies from baseline to 14 days after the second injection
As measured by ELISA

Secondary Outcome Measures

Percentage of participants with seroconversion for SARS-CoV-2 neutralizing antibodies after the first injection
As measured by ELISA (sVNT)
Percentage of participants with seroconversion for SARS-CoV-2 neutralizing antibodies after the first injection
As measured by cVNT
Percentage of participants with seroconversion for SARS-CoV-2 neutralizing antibodies after the second injection
As measured by ELISA (sVNT)
Percentage of participants with seroconversion for SARS-CoV-2 neutralizing antibodies after the second injection
As measured by cVNT
Percentage of participants with seroconversion for receptor-binding domain (RBD) binding IgA antibodies after the first injection
As measured by ELISA
Percentage of participants with seroconversion for receptor-binding domain (RBD) binding IgA antibodies after the second injection
As measured by ELISA
Percentage of participants with seroconversion for S1 binding IgA antibodies after the first injection
As measured by ELISA
Percentage of participants with seroconversion for S1 binding IgA antibodies after the second injection
As measured by ELISA
Percentage of participants with seroconversion for receptor-binding domain (RBD) binding IgG antibodies after the first injection
As measured by ELISA
Percentage of participants with seroconversion for receptor-binding domain (RBD) binding IgG antibodies after the second injection
As measured by ELISA
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
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
Geometric mean fold rise (GMFR) for S1 binding IgG antibodies after the first injection
As measured by ELISA
Geometric mean fold rise (GMFR) for S1 binding IgG antibodies after the second injection
As measured by ELISA
Geometric mean fold rise (GMFR) for receptor-binding domain (RBD) binding IgG antibodies after the first injection
As measured by ELISA
Geometric mean fold rise (GMFR) for receptor-binding domain (RBD) binding IgG antibodies after the second injection
As measured by ELISA
Geometric mean fold rise (GMFR) for SARS-CoV-2 neutralizing antibodies after the first injection
As measured by ELISA (sVNT)
Geometric mean fold rise (GMFR) for SARS-CoV-2 neutralizing antibodies after the second injection
As measured by ELISA (sVNT)
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)
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)
Change in geometric mean concentration (GMC) for S1 binding IgA antibodies from baseline to 21 days after the first injection
As measured by ELISA
Change in geometric mean concentration (GMC) for S1 binding IgA antibodies from baseline to 14 days after the second injection
As measured by ELISA
Geometric mean fold rise (GMFR) for S1 binding IgA antibodies after the first injection
As measured by ELISA
Geometric mean fold rise (GMFR) for S1 binding IgA antibodies after the second injection
As measured by ELISA
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)
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
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
Change in T-cell IFN-γ secretion from baseline to 21 days after the first injection
As measured by IGRA
Change in T-cell IFN-γ secretion from baseline to 14 days after the second injection
As measured by IGRA

Full Information

First Posted
June 19, 2021
Last Updated
October 11, 2022
Sponsor
Cinnagen
Collaborators
Vaxine Pty Ltd
search

1. Study Identification

Unique Protocol Identification Number
NCT04944368
Brief Title
Phase II Clinical Trial of CinnaGen COVID-19 Vaccine (SpikoGen)
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)
Study Type
Interventional

2. Study Status

Record Verification Date
January 2022
Overall Recruitment Status
Completed
Study Start Date
May 30, 2021 (Actual)
Primary Completion Date
July 19, 2021 (Actual)
Study Completion Date
December 30, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Cinnagen
Collaborators
Vaxine Pty Ltd

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief 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. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Covid19
Keywords
COVID-19, SARS-COV-2, Recombinant protein, Spike, Advax-SM, Advax, Vaccine, Adjuvant

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
400 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Vaccine candidate
Arm Type
Experimental
Arm Title
Saline placebo
Arm Type
Placebo Comparator
Intervention Type
Biological
Intervention Name(s)
SARS-CoV-2 recombinant spike protein + Advax-SM adjuvant
Other Intervention Name(s)
SpikoGen
Intervention Description
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
Intervention Type
Biological
Intervention Name(s)
Saline placebo
Other Intervention Name(s)
Normal saline
Intervention Description
0.9% sodium chloride (1 mL) injection in two doses with a 21-day interval administered with intramuscular injections in the non-dominant arm
Primary Outcome Measure Information:
Title
Incidence of solicited adverse events
Description
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)
Time Frame
For 7 days after each dose
Title
Incidence of unsolicited adverse events
Description
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)
Time Frame
For 28 days after each dose
Title
Percentage of participants with seroconversion for S1 binding IgG antibodies after the first injection
Description
As measured by ELISA
Time Frame
21 days after the first dose (on the day of the second dose)
Title
Percentage of participants with seroconversion for S1 binding IgG antibodies after the second injection
Description
As measured by ELISA
Time Frame
14 days after the second dose
Title
Change in geometric mean concentration (GMC) for S1 binding IgG antibodies from baseline to 21 days after the first injection
Description
As measured by ELISA
Time Frame
On the day of the first dose and 21 days after the first dose (on the day of the second dose)
Title
Change in geometric mean concentration (GMC) for S1 binding IgG antibodies from baseline to 14 days after the second injection
Description
As measured by ELISA
Time Frame
On the day of the first dose and 14 days after the second dose
Secondary Outcome Measure Information:
Title
Percentage of participants with seroconversion for SARS-CoV-2 neutralizing antibodies after the first injection
Description
As measured by ELISA (sVNT)
Time Frame
21 days after the first dose (on the day of the second dose)
Title
Percentage of participants with seroconversion for SARS-CoV-2 neutralizing antibodies after the first injection
Description
As measured by cVNT
Time Frame
21 days after the first dose (on the day of the second dose)
Title
Percentage of participants with seroconversion for SARS-CoV-2 neutralizing antibodies after the second injection
Description
As measured by ELISA (sVNT)
Time Frame
14 days after the second dose
Title
Percentage of participants with seroconversion for SARS-CoV-2 neutralizing antibodies after the second injection
Description
As measured by cVNT
Time Frame
14 days after the second dose
Title
Percentage of participants with seroconversion for receptor-binding domain (RBD) binding IgA antibodies after the first injection
Description
As measured by ELISA
Time Frame
21 days after the first dose (on the day of the second dose)
Title
Percentage of participants with seroconversion for receptor-binding domain (RBD) binding IgA antibodies after the second injection
Description
As measured by ELISA
Time Frame
14 days after the second dose
Title
Percentage of participants with seroconversion for S1 binding IgA antibodies after the first injection
Description
As measured by ELISA
Time Frame
21 days after the first dose (on the day of the second dose)
Title
Percentage of participants with seroconversion for S1 binding IgA antibodies after the second injection
Description
As measured by ELISA
Time Frame
14 days after the second dose
Title
Percentage of participants with seroconversion for receptor-binding domain (RBD) binding IgG antibodies after the first injection
Description
As measured by ELISA
Time Frame
21 days after the first dose (on the day of the second dose)
Title
Percentage of participants with seroconversion for receptor-binding domain (RBD) binding IgG antibodies after the second injection
Description
As measured by ELISA
Time Frame
14 days after the second dose
Title
Change in geometric mean concentration (GMC) for receptor-binding domain (RBD) binding IgG antibodies from baseline to 21 days after the first injection
Description
As measured by ELISA
Time Frame
On the day of the first dose and 21 days after the first dose (on the day of the second dose)
Title
Change in geometric mean concentration (GMC) for receptor-binding domain (RBD) binding IgG antibodies from baseline to 14 days after the second injection
Description
As measured by ELISA
Time Frame
On the day of the first dose and 14 days after the second dose
Title
Geometric mean fold rise (GMFR) for S1 binding IgG antibodies after the first injection
Description
As measured by ELISA
Time Frame
21 days after the first dose (on the day of the second dose)
Title
Geometric mean fold rise (GMFR) for S1 binding IgG antibodies after the second injection
Description
As measured by ELISA
Time Frame
14 days after the second dose
Title
Geometric mean fold rise (GMFR) for receptor-binding domain (RBD) binding IgG antibodies after the first injection
Description
As measured by ELISA
Time Frame
21 days after the first dose (on the day of the second dose)
Title
Geometric mean fold rise (GMFR) for receptor-binding domain (RBD) binding IgG antibodies after the second injection
Description
As measured by ELISA
Time Frame
14 days after the second dose
Title
Geometric mean fold rise (GMFR) for SARS-CoV-2 neutralizing antibodies after the first injection
Description
As measured by ELISA (sVNT)
Time Frame
21 days after the first dose (on the day of the second dose)
Title
Geometric mean fold rise (GMFR) for SARS-CoV-2 neutralizing antibodies after the second injection
Description
As measured by ELISA (sVNT)
Time Frame
14 days after the second dose
Title
Change in geometric mean concentration (GMC) for SARS-CoV-2 neutralizing antibodies from baseline to 21 days after the first injection
Description
As measured by ELISA (sVNT)
Time Frame
On the day of the first dose and 21 days after the first dose (on the day of the second dose)
Title
Change in geometric mean concentration (GMC) for SARS-CoV-2 neutralizing antibodies from baseline to 14 days after the second injection
Description
As measured by ELISA (sVNT)
Time Frame
On the day of the first dose and 14 days after the second dose
Title
Change in geometric mean concentration (GMC) for S1 binding IgA antibodies from baseline to 21 days after the first injection
Description
As measured by ELISA
Time Frame
On the day of the first dose and 21 days after the first dose (on the day of the second dose)
Title
Change in geometric mean concentration (GMC) for S1 binding IgA antibodies from baseline to 14 days after the second injection
Description
As measured by ELISA
Time Frame
On the day of the first dose and 14 days after the second dose
Title
Geometric mean fold rise (GMFR) for S1 binding IgA antibodies after the first injection
Description
As measured by ELISA
Time Frame
21 days after the first dose (on the day of the second dose)
Title
Geometric mean fold rise (GMFR) for S1 binding IgA antibodies after the second injection
Description
As measured by ELISA
Time Frame
14 days after the second dose
Title
Incidence of serious adverse events (SAEs) and suspected unexpected serious adverse reaction (SUSARs)
Description
As defined using system organ classes and preferred terms of the Medical Dictionary for Regulatory Activities (MedDRA)
Time Frame
For 6 months after the second dose
Title
Change in T-cell proliferation responses from baseline to 21 days after the first injection
Description
Evaluation of CD4+ and CD8+ T-cell proliferation responses as measured by flow cytometry
Time Frame
On the day of the first dose and 21 days after the first dose (on the day of the second dose)
Title
Change in T-cell proliferation responses from baseline to 14 days after the second injection
Description
Evaluation of CD4+ and CD8+ T-cell proliferation responses as measured by flow cytometry
Time Frame
On the day of the first dose and 14 days after the second dose
Title
Change in T-cell IFN-γ secretion from baseline to 21 days after the first injection
Description
As measured by IGRA
Time Frame
On the day of the first dose and 21 days after the first dose (on the day of the second dose)
Title
Change in T-cell IFN-γ secretion from baseline to 14 days after the second injection
Description
As measured by IGRA
Time Frame
On the day of the first dose and 14 days after the second dose

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: 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 Exclusion Criteria: 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. 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Payam Tabarsi, M.D.
Organizational Affiliation
Shahid Beheshti University of Medical Sciences
Official's Role
Principal Investigator
Facility Information:
Facility Name
Espinas Palace Hotel
City
Tehran
ZIP/Postal Code
1981846911
Country
Iran, Islamic Republic of

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
35436611
Citation
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.
Results Reference
result

Learn more about this trial

Phase II Clinical Trial of CinnaGen COVID-19 Vaccine (SpikoGen)

We'll reach out to this number within 24 hrs