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Completed

NCT Number: NCT05175625

Immunogenicity and Safety of a Booster Dose of the SpikoGen COVID-19 Vaccine

This was a randomized, two-armed, double-blind, placebo-controlled trial designed to evaluate the safety and immunogenicity of a booster dose of an adjuvanted recombinant SARS-CoV-2 spike protein subunit vaccine (SpikoGen) produced by CinnaGen Co. A total of 300 adult individuals received a single dose of either the SpikoGen vaccine or the saline placebo in a 5:1 ratio at 4 to 9 months after the second dose of a COVID-19 vaccine of any type. The injection was given in the deltoid muscle of the non-dominant arm. On day 14, the trial was unblinded, and the participants in the placebo group received a booster dose of the SpikoGen vaccine. For immunogenicity assessments, blood samples were collected on days 0 and 14 from all participants and on days 90 and 180 from those in the vaccine group only. For safety assessments, all participants were followed up for six months.

Study hypotheses included:

1. A booster dose of the SpikoGen COVID-19 vaccine is safe and tolerable in adult subjects. 2. A booster dose of the SpikoGen COVID-19 vaccine induces strong immunogenicity against SARS-CoV-2 in adult subjects.

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Key information

Conditions

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 3

Primary location

Orchid Life Department, Orchid Pharmed Company

Tehran, 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
  • Subjects who have received two doses of a COVID-19 vaccine of any type between 4 to 9 months before the screening visit

Exclusion criteria

  • Subjects with signs of active SARS-CoV-2 infection at the screening visit or within 72 hours prior to the screening visit
  • Subjects who have been diagnosed with a breakthrough infection after receiving two doses of a COVID-19 vaccine
  • Subjects with epilepsy or a history of febrile seizures
  • Subjects who receive immunosuppressive or cytotoxic medications.
  • 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 received any vaccines within 28 days prior to the screening visit or intend to receive any vaccines up to day 14 of the study.
  • Subjects who have any known bleeding disorders or, in the investigator's opinion, have any contraindications for an intramuscular injection.
  • Female Subjects who are pregnant or breastfeeding or have planned to become pregnant within one month after the study 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); a single intramuscular injection into the deltoid muscle of the non-dominant arm

Other names: COVAX-19

Saline placebo

Biological

0.9% sodium chloride (1 mL); a single intramuscular injection into the deltoid muscle of the non-dominant arm

Primary outcomes

  1. Percentage of participants with seroconversion for SARS-CoV-2 neutralizing antibodies

    Time frame: 14 days after the booster dose

    As measured by ELISA

Secondary outcomes

  1. Incidence of solicited adverse events

    Time frame: For 7 days after the booster 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 14 days after the booster 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. Incidence of serious adverse events (SAEs) and suspected unexpected serious adverse reaction (SUSARs)

    Time frame: For 6 months after the booster dose

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

  4. Geometric mean concentration (GMC) for S1 binding IgG antibodies

    Time frame: Days 0, 14, 90, and 180

    As measured by ELISA

  5. Geometric mean fold rise (GMFR) for S1 binding IgG antibodies

    Time frame: 14 days after the booster dose

    As measured by ELISA

  6. Percentage of participants with seroconversion for S1 binding IgG antibodies

    Time frame: 14 days after the booster dose

    As measured by ELISA

  7. Percentage of participants with seroconversion for receptor-binding domain (RBD) binding IgG antibodies

    Time frame: 14 days after the booster dose

    As measured by ELISA

  8. Geometric mean concentration (GMC) for receptor-binding domain (RBD) binding IgG antibodies

    Time frame: Days 0, 14, 90, and 180

    As measured by ELISA

  9. Geometric mean fold rise (GMFR) for receptor-binding domain (RBD) binding IgG antibodies

    Time frame: 14 days after the booster dose

    As measured by ELISA

  10. Geometric mean concentration (GMC) for SARS-CoV-2 neutralizing antibodies

    Time frame: Days 0, 14, 90, and 180

    As measured by ELISA

  11. Geometric mean fold rise (GMFR) for SARS-CoV-2 neutralizing antibodies

    Time frame: 14 days after the booster dose

    As measured by ELISA

  12. Change in T-cell IFN-γ secretion from baseline to 14 days after the booster dose

    Time frame: Days 0 and 14

    As measured by IGRA

Sponsors and collaborators

Lead sponsor

Cinnagen

Industry

Collaborators

  • Vaxine Pty Ltd

Registry information

Official study title

A Randomized, Two-Armed, Placebo-Controlled, Double-Blind, Parallel-Group Clinical Trial to Evaluate the Immunogenicity and Safety of a Booster Dose of an Adjuvanted Recombinant Spike Protein COVID-19 Vaccine (SpikoGen)

Important dates

Study start
2021
Primary completion
2021
Study completion
2022
First posted
Jan 4, 2022
Registry last updated
Oct 14, 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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