Trial reportClinical microbiology and infection : the official publication of the European Society of Clinical Microbiology and Infectious Diseases2022
Safety and immunogenicity of SpikoGen®, an Advax-CpG55.2-adjuvanted SARS-CoV-2 spike protein vaccine: a phase 2 randomized placebo-controlled trial in both seropositive and seronegative populations.
Trial report in Clinical microbiology and infection : the official publication of the European Society of Clinical Microbiology and Infectious Diseases, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to 3 registered trials, which are not on this map. Cited by 27 papers, 1 of them a synthesis that pooled it.
What it found
Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.
The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
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)
A Phase 2b Study to Assess the Effect of Dose Interval on the Effectiveness of a Protein-based Covid-19 Vaccine (Spikogen® Vaccine)
Immunogenicity and Safety Study in Ambulatory Adults of a Single Intramuscular Dose of SpikoGen Vaccine as a Heterologous or Homologous Booster Dose Following Completion of a Primary Course of Covid-19 Vaccine
Who cites it
27 citing papers in PubMed, 1 synthesis or guideline pooled it.
- Adverse events following COVID-19 vaccination: A systematic review and meta-analysis.International immunopharmacology · 2022Pooled it
- Trial
- Ability of SpikoGen®, an Advax-CpG adjuvanted recombinant spike protein vaccine, to induce cross-neutralising antibodies against SARS-CoV-2 variants.Immunology · 2023Trial
- Evaluating the efficacy and safety of SpikoGen®, an Advax-CpG55.2-adjuvanted severe acute respiratory syndrome coronavirus 2 spike protein vaccine: a phase 3 randomized placebo-controlled trial.Clinical microbiology and infection : the official publication of the European Society of Clinical Microbiology and Infectious Diseases · 2023Trial
- Immunogenicity and Safety of SpikoGen, an Adjuvanted Recombinant SARS-CoV-2 Spike Protein, as a Heterologous Third Booster Dose in Kidney Transplant Patients: A Single-arm Clinical Trial.Clinical therapeutics · 2022Trial
- Progress in the development of an Advax-adjuvanted protein capsular matrix vaccine against typhoid fever.Microbes & immunity · 2025Article
- Clinical development of SpikoGen®, an Advax-CpG55.2 adjuvanted recombinant spike protein vaccine.Human vaccines & immunotherapeutics · 2024Review
- Effect of SpikoGen subunit vaccine administration during pregnancy on fetal development of rats.Clinical and experimental vaccine research · 2024Article
- Effects of age and gender on immunogenicity and reactogenicity of SpikoGen recombinant spike protein vaccine: a post-hoc analysis.Scientific reports · 2024Article
- Dendritic cell-specific intercellular adhesion molecule-3-grabbing nonintegrin (DC-SIGN) is a cellular receptor for delta inulin adjuvant.Immunology and cell biology · 2024Article
- Review
- Lessons Learned from COVID-19 Pandemic Management in Iran; a Commentary.Archives of academic emergency medicine · 2024Article
- Revolutionizing adjuvant development: harnessing AI for next-generation cancer vaccines.Frontiers in immunology · 2024Review
- Review
- Article
- 'Spikeopathy': COVID-19 Spike Protein Is Pathogenic, from Both Virus and Vaccine mRNA.Biomedicines · 2023Review
- Evaluation of a SARS-CoV-2 spike protein ectodomain subunit vaccine with a squalene emulsion adjuvant in rodents and rhesus macaques.Human vaccines & immunotherapeutics · 2023Article
- An intranasal vaccine comprising SARS-CoV-2 spike receptor-binding domain protein entrapped in mannose-conjugated chitosan nanoparticle provides protection in hamsters.Scientific reports · 2023Article
- Safety and immunogenicity of a modified COVID-19 mRNA vaccine, SYS6006, as a fourth-dose booster following three doses of inactivated vaccines in healthy adults: an open-labeled Phase 1 trial.Life metabolism · 2023Article
- An overview of the vaccine platforms to combat COVID-19 with a focus on the subunit vaccines.Progress in biophysics and molecular biology · 2023Review
Corrections and comments
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Authors and funding
12 authors.
Funding
Abstract
objectiveWe aimed to investigate the immunogenicity and safety of SpikoGen®, a subunit COVID-19 vaccine composed of a recombinant prefusion-stabilized SARS-CoV-2 spike protein combined with the Advax-CpG55.2™ adjuvant, in seronegative and seropositive populations as primary vaccination.
methodsThis randomized, placebo-controlled, double-blind phase 2 trial was conducted on 400 participants randomized 3:1 to receive two doses of 25 μg of SpikoGen® 3 weeks apart or the placebo. The primary safety outcomes were the incidence of solicited adverse events up to 7 days after each dose and unsolicited adverse events up to 28 days after the second dose. The primary immunogenicity outcomes were seroconversion against the S
resultsThe SpikoGen® vaccine was well tolerated and no serious adverse events were recorded. The most common solicited adverse events were injection site pain and fatigue, largely graded as mild and transient. By day 35 (2 weeks post second dose), the seroconversion rate against S DISCUSSION: SpikoGen® had an acceptable safety profile and induced promising humoral and cellular immune responses against SARS-CoV-2.
Indexed as
Identifiers
What OpenQuestion holds
Registered trials
Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.