In Brief | Immunogenicity of novel oral poliovirus vaccine type 2 administered concomitantly with bivalent oral poliovirus vaccine: an open-label, non-inferiority, randomised, controlled trial

Originally published In The Lancet Infectious Diseases: September 2023
 

This open-label, non-inferiority, randomized, controlled trial aimed to evaluate potential immunological interference when nOPV2 and bOPV are administered together.

Healthy infants aged 6 weeks were randomly assigned (1:1:1) to receive nOPV2 only, nOPV2 plus bOPV, or bOPV only, at the ages of 6 weeks, 10 weeks, and 14 weeks.

• 244 received nOPV2 only 

• 246 received nOPV2 plus bOPV, and

• 246 received bOPV only 

The primary objective was to assess the cumulative immune response to all three poliovirus types at 14 weeks following two doses of the respective vaccine.

The following findings were recorded after the two doses:

• 209 (86%) participants in the nOPV2-only group and 159 (65% ) participants in the nOPV2 plus bOPV group had a type 2 poliovirus immune response

• 227 (92%) participants in the nOPV2 plus bOPV group and 229 (93%) participants in the bOPV-only group had a type 1 response

• 216 (88%;) participants in the nOPV2 plus bOPV group and 212 (86%) participants in the bOPV only group had a type 3 response

• Co-administration was non-inferior to single administration for types 1 and 3 but not for type 2

• There were 15 serious adverse events (including three deaths, one in each group, all attributable to sudden infant death syndrome); none were attributed to vaccination.

The findings revealed that the simultaneous administration of nOPV2 and bOPV had an impact on the immunogenicity specifically related to poliovirus Type 2, but did not affect Types 1 and 3. The diminished immunogenicity observed with nOPV2 when co-administered raises concerns about the feasibility of employing this strategy for vaccination purposes.

 

Access the original article 

Wilkinson A.L., Zaman K., Hoque M., et al. Immunogenicity of novel oral poliovirus vaccine type 2 administered concomitantly with bivalent oral poliovirus vaccine: an open-label, non-inferiority, randomised, controlled trial. The Lancet Infectious Diseases, ISSN: 1473-3099, 23 (9): 1062-1071

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