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Completed

NCT Number: NCT04944368

Phase II Clinical Trial of CinnaGen COVID-19 Vaccine (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:

1. The adjuvanted COVID-19 vaccine candidate is safe and tolerable in adult subjects. 2. The adjuvanted COVID-19 vaccine candidate induces strong immunogenicity against SARS-CoV-2 in adult subjects.

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Key information

Conditions

Covid19 COVID-19 Coronaviridae Infections Coronavirus Infections Infections Lung Diseases Nidovirales Infections Pneumonia Pneumonia, Viral RNA Virus Infections Respiratory Tract Diseases Respiratory Tract Infections Virus Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Espinas Palace Hotel

Tehran, 1981846911, Iran

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

SARS-CoV-2 recombinant spike protein + Advax-SM adjuvant

Biological

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

Other names: SpikoGen

Saline placebo

Biological

0.9% sodium chloride (1 mL) injection in two doses with a 21-day interval administered with intramuscular injections in the non-dominant arm

Other names: Normal saline

Primary outcomes

  1. 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)

  2. 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)

  3. 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

  4. 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

  5. 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

  6. 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

Secondary outcomes

  1. 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)

    As measured by ELISA (sVNT)

  2. 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)

    As measured by cVNT

  3. Percentage of participants with seroconversion for SARS-CoV-2 neutralizing antibodies after the second injection

    Time frame: 14 days after the second dose

    As measured by ELISA (sVNT)

  4. Percentage of participants with seroconversion for SARS-CoV-2 neutralizing antibodies after the second injection

    Time frame: 14 days after the second dose

    As measured by cVNT

  5. 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)

    As measured by ELISA

  6. 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

    As measured by ELISA

  7. 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)

    As measured by ELISA

  8. Percentage of participants with seroconversion for S1 binding IgA antibodies after the second injection

    Time frame: 14 days after the second dose

    As measured by ELISA

  9. 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)

    As measured by ELISA

  10. 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

    As measured by ELISA

  11. 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)

    As measured by ELISA

  12. 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

    As measured by ELISA

  13. 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)

    As measured by ELISA

  14. Geometric mean fold rise (GMFR) for S1 binding IgG antibodies after the second injection

    Time frame: 14 days after the second dose

    As measured by ELISA

  15. 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)

    As measured by ELISA

  16. 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

    As measured by ELISA

  17. 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)

    As measured by ELISA (sVNT)

  18. Geometric mean fold rise (GMFR) for SARS-CoV-2 neutralizing antibodies after the second injection

    Time frame: 14 days after the second dose

    As measured by ELISA (sVNT)

  19. 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)

    As measured by ELISA (sVNT)

  20. 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

    As measured by ELISA (sVNT)

  21. 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)

    As measured by ELISA

  22. 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

    As measured by ELISA

  23. 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)

    As measured by ELISA

  24. Geometric mean fold rise (GMFR) for S1 binding IgA antibodies after the second injection

    Time frame: 14 days after the second dose

    As measured by ELISA

  25. Incidence of serious adverse events (SAEs) and suspected unexpected serious adverse reaction (SUSARs)

    Time frame: For 6 months after the second dose

    As defined using system organ classes and preferred terms of the Medical Dictionary for Regulatory Activities (MedDRA)

  26. 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)

    Evaluation of CD4+ and CD8+ T-cell proliferation responses as measured by flow cytometry

  27. 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

    Evaluation of CD4+ and CD8+ T-cell proliferation responses as measured by flow cytometry

  28. 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)

    As measured by IGRA

  29. 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

    As measured by IGRA

Sponsors and collaborators

Lead sponsor

Cinnagen

Industry

Collaborators

  • Vaxine Pty Ltd

Registry information

Official study 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)

Important dates

Study start
2021
Primary completion
2021
Study completion
2021
First posted
Jun 29, 2021
Registry last updated
Oct 13, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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