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

NCT04944368 | Completed Phase 2

• 2 other identifiers: VAC.CIN.PT.IIIRCT20150303021315N23
• Study Type: interventional
• Target: 400
• Locations: 1 country
• Sites: 1

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:

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

Conditions

Covid19

Keywords

COVID-19; SARS-COV-2; Recombinant protein; Spike; Advax-SM; Advax; Vaccine; Adjuvant

Outcome Measures

Primary Outcomes (6)

• 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)

  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)

  For 28 days after each dose

• Percentage of participants with seroconversion for S1 binding IgG antibodies after the first injection

  As measured by ELISA

  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

  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

  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

  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

  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

  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

  14 days after the second dose

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

  14 days after the second dose

• Percentage of participants with seroconversion for receptor-binding domain (RBD) binding IgA antibodies after the first injection

  21 days after the first dose (on the day of the second dose)

Study Arms (2)

Vaccine candidate

EXPERIMENTAL

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

Saline placebo

PLACEBO COMPARATOR

Biological: Saline placebo

Interventions

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

Also known as: SpikoGen

Vaccine candidate

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

Also known as: Normal saline

Saline placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Cinnagen: lead
• Vaxine Pty Ltd: collaborator

Study Sites (1)

Espinas Palace Hotel

Tehran, 1981846911, Iran

Location

Related Publications (1)

• 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.

  PMID: 35436611 RESULT

MeSH Terms

Conditions

COVID-19

Interventions

SARS-CoV-2 recombinant spike protein with delta inulin and CpG-ODN adjuvant vaccine; Saline Solution

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations

Study Officials

• Payam Tabarsi, M.D.

  Shahid Beheshti University of Medical Sciences

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 19, 2021
• First Posted: June 29, 2021
• Study Start: May 30, 2021
• Primary Completion: July 19, 2021
• Study Completion: December 30, 2021
• Last Updated: October 13, 2022

Record last verified: 2022-01

Data Sharing

• IPD Sharing: Will not share

Locations

IR (1)