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Background <p>Following the 2016 global cessation of oral poliovirus vaccine type 2, outbreaks of circulating vaccine-derived poliovirus type 2 have posed significant public health challenges. The novel oral poliovirus vaccine type 2 (nOPV2), developed for enhanced genetic stability, lacks comprehensive pediatric data.</p> Objective <p>To systematically evaluate nOPV2 immunogenicity and safety in under-immunized pediatric populations through Bayesian meta-analysis.</p> Methods <p>We searched five databases from 2015 to 2025 for RCTs and observational studies of nOPV2 in children under 18 years from under-immunized populations. Bayesian single-arm meta-analyses were performed.</p> Results <p>Five studies (four RCTs, one cohort) with 10,421 children from Bangladesh, The Gambia, and the Dominican Republic were included. Pooled seroconversion rates ranged from 65.8% to 81.5%. Severe adverse events after nOPV2 vaccination yielded a pooled proportion of 0.01 (95% CI: 0.00–0.02), mild events occurred in 7.8%, and viral shedding was 64.7%.</p> Conclusions <p>nOPV2 shows robust immunogenicity and excellent safety, supporting its role in outbreak control and global polio eradication.</p> Clinical trial number <p>Not applicable.</p>

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Immunogenicity and safety of novel oral polio vaccine type 2 (nOPV2) in pediatric populations: a systematic review and Bayesian meta-analysis

  • 期刊论文

  • 出版模式：

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  • 发表日期：

    2026年5月25日

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  • José Luís Boene,
  • Letícia Rocha Campos,
  • Gisella Chiara Carpi,
  • Monica Muhawenimana,
  • Sandra Helena Machado,
  • Nilsa de Deus,
  • Adilson Fernando Loforte Bauhofer

摘要

Background

Following the 2016 global cessation of oral poliovirus vaccine type 2, outbreaks of circulating vaccine-derived poliovirus type 2 have posed significant public health challenges. The novel oral poliovirus vaccine type 2 (nOPV2), developed for enhanced genetic stability, lacks comprehensive pediatric data.

Objective

To systematically evaluate nOPV2 immunogenicity and safety in under-immunized pediatric populations through Bayesian meta-analysis.

Methods

We searched five databases from 2015 to 2025 for RCTs and observational studies of nOPV2 in children under 18 years from under-immunized populations. Bayesian single-arm meta-analyses were performed.

Results

Five studies (four RCTs, one cohort) with 10,421 children from Bangladesh, The Gambia, and the Dominican Republic were included. Pooled seroconversion rates ranged from 65.8% to 81.5%. Severe adverse events after nOPV2 vaccination yielded a pooled proportion of 0.01 (95% CI: 0.00–0.02), mild events occurred in 7.8%, and viral shedding was 64.7%.

Conclusions

nOPV2 shows robust immunogenicity and excellent safety, supporting its role in outbreak control and global polio eradication.

Clinical trial number

Not applicable.