Clinical trial NCT05175625: Immunogenicity and Safety of a Booster Dose of the SpikoGen COVID-19 Vaccine
Official 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)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: COVID-19
Keywords: COVID-19
SARS-CoV-2
Recombinant protein
Spike
Advax-SM
Advax
Vaccine
Adjuvant
Lead sponsor: Cinnagen
Sponsor class: INDUSTRY
Collaborators: name: Vaxine Pty Ltd
First posted: 2022-01-04
Enrollment: 300
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: 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.


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
* 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.

Primary outcomes:
measure: Percentage of participants with seroconversion for SARS-CoV-2 neutralizing antibodies
timeFrame: 14 days after the booster dose
Secondary outcomes:
measure: Incidence of solicited adverse events
timeFrame: For 7 days after the booster dose
measure: Incidence of unsolicited adverse events
timeFrame: For 14 days after the booster dose
measure: Incidence of serious adverse events (SAEs) and suspected unexpected serious adverse reaction (SUSARs)
timeFrame: For 6 months after the booster dose
measure: Geometric mean concentration (GMC) for S1 binding IgG antibodies
timeFrame: Days 0, 14, 90, and 180
measure: Geometric mean fold rise (GMFR) for S1 binding IgG antibodies
timeFrame: 14 days after the booster dose
measure: Percentage of participants with seroconversion for S1 binding IgG antibodies
timeFrame: 14 days after the booster dose
measure: Percentage of participants with seroconversion for receptor-binding domain (RBD) binding IgG antibodies
timeFrame: 14 days after the booster dose
measure: Geometric mean concentration (GMC) for receptor-binding domain (RBD) binding IgG antibodies
timeFrame: Days 0, 14, 90, and 180
measure: Geometric mean fold rise (GMFR) for receptor-binding domain (RBD) binding IgG antibodies
timeFrame: 14 days after the booster dose
measure: Geometric mean concentration (GMC) for SARS-CoV-2 neutralizing antibodies
timeFrame: Days 0, 14, 90, and 180
measure: Geometric mean fold rise (GMFR) for SARS-CoV-2 neutralizing antibodies
timeFrame: 14 days after the booster dose
measure: Change in T-cell IFN-γ secretion from baseline to 14 days after the booster dose
timeFrame: Days 0 and 14
Other outcomes:
Locations:
city: Tehran
country: Iran, Islamic Republic of
facility: Orchid Life Department, Orchid Pharmed Company
Study officials:
affiliation: Shahid Beheshti University of Medical Sciences
name: Payam Tabarsi, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Tabarsi P, Anjidani N, Shahpari R, Roshanzamir K, Fallah N, Andre G, Petrovsky N, Barati S. Immunogenicity and safety of SpikoGen(R), an adjuvanted recombinant SARS-CoV-2 spike protein vaccine as a homologous and heterologous booster vaccination: A randomized placebo-controlled trial. Immunology. 2022 Nov;167(3):340-353. doi: 10.1111/imm.13540. Epub 2022 Jul 13.