Evidence map›Paper›PMID 39349494›Full record

ArticleScientific reports2024

Effects of age and gender on immunogenicity and reactogenicity of SpikoGen recombinant spike protein vaccine: a post-hoc analysis.

Nassim Anjidani, Ramin Shahpari, Hamidreza Kafi, Nikolai Petrovsky, Saghar Barati

Abstract read
In one paragraph

Article in Scientific reports, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 2 papers.

0numbers the graph read from it
0cells of the map it votes in
2citing papers in PubMed
–field-weighted citation impact
1 · What the graph read from 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.

2 · The registry

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.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

2 citing papers in PubMed.

  1. Article
  2. Article
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

5 authors.

Nassim AnjidaniMedical Department, Orchid Pharmed Company, No. 12 Asad Abadi Street, 70th Alley, Tehran, 1969955311, Iran.
Ramin ShahpariMedical Department, Orchid Pharmed Company, No. 12 Asad Abadi Street, 70th Alley, Tehran, 1969955311, Iran.
Hamidreza KafiMedical Department, Orchid Pharmed Company, No. 12 Asad Abadi Street, 70th Alley, Tehran, 1969955311, Iran.
Nikolai PetrovskyVaxine Pty Ltd, Bedford Park, Adelaide, 5042, Australia.
Saghar BaratiMedical Department, Orchid Pharmed Company, No. 12 Asad Abadi Street, 70th Alley, Tehran, 1969955311, Iran. Barati.S@orchidpharmed.com.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

SpikoGen® COVID-19 vaccine is based on the spike protein extracellular domain of the ancestral Wuhan-Hu-1 strain modified by removal of the furin cleavage site and addition of stabilising mutations expressed as a recombinant protein in insect cells. It is formulated with Advax-CpG55.2™ adjuvant to ensure optimal immunogenicity. In this study, data from several SpikoGen® clinical trials was retrospectively analysed to assess for any effect of gender or age on seroconversion, neutralizing antibody levels or the incidence of adverse events. Following the 1st dose, older age was associated with a reduced rate of fatigue (RR 0.97, p < 0.001), headache (RR 0.98, p = 0.034) and myalgia (RR 0.97, p=0.016), following the 2nd dose, the rate of fatigue (RR 0.98, p = 0.017) but following the 3rd dose no effect of age on adverse events was evident. Similarly, following the 1st dose, men reported a 19% lower incidence of fatigue, 36% lower incidence of headache and 28% lower incidence of myalgia when compared to women. Interestingly, there was no relationship between age or gender and serum neutralizing antibody levels, although after each vaccine dose there was a consistent trend to women having a higher seroconversion rate. There was no correlation between neutralizing antibody levels and adverse events. Unlike what is seen with mRNA vaccines, reactogenicity trended lower after each subsequent SpikoGen® dose. Overall, SpikoGen® exhibited positive immunogenicity and low reactogenicity, indicating that a low incidence of adverse events does not equate to poor immunogenicity. SpikoGen® remains a promising protein-based vaccine platform for COVID-19 protection.

Indexed as

Antibodies, NeutralizingAntibodies, ViralCOVID-19COVID-19 VaccinesImmunogenicity, VaccineSARS-CoV-2Spike Glycoprotein, CoronavirusAdultAgedAge FactorsFatigueFemaleHeadacheHumansMaleMiddle AgedAntibodies, NeutralizingAntibodies, ViralCOVID-19 VaccinesSpike Glycoprotein, Coronavirusspike protein, SARS-CoV-2Vaccines, Synthetic

Identifiers

PMID39349494
PMCPMC11442574

What Socratic holds

Textmetadata
LicenceCC BY-NC-ND
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Registered trials

None linked

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 Socratic graph.