Molecular analysis of the bacille Calmette-Guérin vaccine strain currently being used in Iran

Fallah, Fatemeh; Karimi, Abdollah; Abdolghafoorian, Hamed; Mohammadzadeh, Abdolmajid; Zahraei, Seyed Mohsen; Goudarzi, Hossein; Fallah, M

doi:10.5588/ijtld.15.0434

Cited by 5 publications

(9 citation statements)

References 16 publications

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“…The amplicons were subjected to Sanger sequencing and the sequence data confirmed the identity of the vaccine strain as Pasteur 1173P2. This finding was accordant to the previous study (Fallah et al, 2016) and also the registered strain in the BCG World Atlas (Zwerling et al, 2011).…”

Section: Resultssupporting

confidence: 93%

“…Hence, it was decided to clarify the genomic status of the vaccine batches produced in Iran and answer this query. In the previous study, Fallah et al (2016) reported the genetic stability of the vaccine strain used in Iran in 39 ready‐for‐injection vials by examining the mutations in particular regions of difference using multiplex PCR. As this method is unable to detect the minor genetic events which may have came to pass in the vaccine batches, it is of prime importance to apply a method that makes it possible to track small sequence differences.…”

Section: Discussionmentioning

confidence: 99%

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Genomic evidence for stability of the Bacillus Calmette-Guérin (BCG) vaccine strain (Pasteur 1173P2) from different batches in Iran

Asadian

Safarchi

Hassanzadeh

et al. 2022

Journal of Applied Microbiology

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Aims Investigate the genetic stability of the BCG vaccine produced in Iran from different batches compared to the reference strain. Methods and results We comparatively analyzed the whole genome sequences of the vaccine batches from different years. Eleven vials of different batches from 2010, 2018, and 2019 were included. Complete genome analyses revealed no difference between the old (2010) and new (2018 and 2019) vaccine batches. Additionally, minor genetic changes include five single nucleotide polymorphisms (SNPs) and insertions/deletions (indels) were observed compared to the BCG Pasteur 1173P2 reference strain, which were shared among all batches. Besides, the batches were identical to the reference strain in terms of antibiotic resistance genes, prophage sequences, and clustered regularly interspaced short palindromic repeats (CRISPR)‐CRISPR‐associated (Cas) systems. Conclusions High genetic stability of the BCG vaccine used in the national immunization program was confirmed, which indicates the optimal conditions in the vaccine production process. Significance and Impact of the Study Genetic differences within and between vaccine strains have been declared as one of the main parameters related to the BCG vaccine variable protective efficacy. No study has been done to investigate the genetic variations of the vaccine batches at the single‐base level.

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Section: Resultssupporting

confidence: 93%

Section: Discussionmentioning

confidence: 99%

Genomic evidence for stability of the Bacillus Calmette-Guérin (BCG) vaccine strain (Pasteur 1173P2) from different batches in Iran

Asadian

Safarchi

Hassanzadeh

et al. 2022

Journal of Applied Microbiology

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“…In Iran, despite the existence of effective control programs, TB continues to be a major challenge with an estimated 10,000 notified cases in 2016 [1]. Vaccination with the Bacillus Calmette-Guerin (BCG) is among the most important TB control strategies in Iran [2]. According to Iranian neonatal vaccination policy, BCG has been given as a single dose at children aged <6 years, shortly after birth or at first contact with the health services [3].…”

mentioning

confidence: 99%

“…Despite the fact that adverse reactions after BCG vaccination are well described, studies report very different rates. This could be due to different vaccination procedures and BCG vaccine strains [2], [9]. There are a number of distinct BCG vaccines in the world, including six that are currently in use: Pasteur 1173 P2, the Danish 1331, the Glaxo 1077, the Tokyo 172-1, the Russian BCG-I, and the Moreau RDJ strains [10].…”

mentioning

confidence: 99%

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Bacillus Calmette-Guerin (BCG) vaccine in Iran

Fallah

Nasiri

Pormohammad

2018

Journal of Clinical Tuberculosis and Other Mycobacterial Diseas

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The whole genome sequence of Polish vaccine strain Mycobacterium bovis BCG Moreau

Krysztopa-Grzybowska,

Lach,

Polak

et al. 2024

Microbiol Spectr

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Currently, tuberculosis immunoprophylaxis is based solely on Bacillus Calmette-Guérin (BCG) vaccination, and some of the new potential tuberculosis vaccines are based on the BCG genome. Therefore, it is reasonable to analyze the genomes of individual BCG substrains. The aim of this study was the genetic characterization of the BCG-Moreau Polish (PL) strain used for the production of the BCG vaccine in Poland since 1955. Sequencing of different BCG lots showed that the strain was stable over a period of 59 years. As a result of comparison, BCG-Moreau PL with BCG-Moreau Rio de Janeiro (RDJ) 143 single nucleotide polymorphisms (SNPs) and 32 insertion/deletion mutations (INDELs) were identified. However, the verification of these mutations showed that the most significant were accumulated in the BCG-Moreau RDJ genome. The mutations unique to the Polish strain genome are 1 SNP and 2 INDEL. The strategy of combining short-read sequencing with long-read sequencing is currently the most optimal approach for sequencing bacterial genomes. With this approach, the only available genomic sequence of BCG-Moreau PL was obtained. This sequence will primarily be a reference point in the genetic control of the stability of the vaccine strain in the future. The results enrich knowledge about the microevolution and attenuation of the BCG vaccine substrains. IMPORTANCE The whole genome sequence obtained is the only genomic sequence of the strain that has been used for vaccine production in Poland since 1955. Sequencing of different BCG lots showed that the strain was stable over a period of 59 years. The comprehensive genomic analysis performed not only enriches knowledge about the microevolution and attenuation of the BCG vaccine substrains but also enables the utilization of identified markers as a reference point in the genetic control and identity tests of the stability of the vaccine strain in the future.

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Molecular analysis of the bacille Calmette-Guérin vaccine strain currently being used in Iran

Abstract: All of the BCG strains studied were recognised as the BCG-Pasteur 1173p2 strain. No genetic diversity among stocks and ready-for-use vaccine vials were detected.

Cited by 5 publications

References 16 publications

Genomic evidence for stability of the Bacillus Calmette-Guérin (BCG) vaccine strain (Pasteur 1173P2) from different batches in Iran

Genomic evidence for stability of the Bacillus Calmette-Guérin (BCG) vaccine strain (Pasteur 1173P2) from different batches in Iran

Bacillus Calmette-Guerin (BCG) vaccine in Iran

The whole genome sequence of Polish vaccine strain Mycobacterium bovis BCG Moreau

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