Assessing the immunogenicity of three different inactivated polio vaccine schedules for use after oral polio vaccine cessation, an open label, phase IV, randomized controlled trial

Details

• Alternative Title:
  Vaccine
• Personal Author:
  Zaman, Khalequ ; Kovacs, Stephanie D. ; Vanderende, Kristin ; Aziz, Asma ; Yunus, Mohammed ; Khan, Sara ; Snider, Cynthia J. ; An, Qian ; Estivariz, Concepcion F. ; Oberste, M. Steven ; Pallansch, Mark A. ; Anand, Abhijeet
• Description:
  Background:
  
  After global oral poliovirus vaccine (OPV) cessation, the Strategic Advisory Group of Experts on Immunization (SAGE) currently recommends a two-dose schedule of inactivated poliovirus vaccine (IPV) beginning ≥14-weeks of age to achieve at least 90% immune response. We aimed to compare the immunogenicity of three different two-dose IPV schedules started before or at 14-weeks of age.
  
  Methods:
  
  We conducted a randomized, controlled, open-label, inequality trial at two sites in Dhaka, Bangladesh. Healthy infants at 6-weeks of age were randomized into one of five arms to receive two-dose IPV schedules at different ages with and without OPV. The three IPV-only arms are presented: Arm C received IPV at 14-weeks and 9-months; Arm D received IPV at 6-weeks and 9-months; and Arm E received IPV at 6 and 14-weeks. The primary outcome was immune response defined as seroconversion from seronegative (<1:8) to seropositive (≥1:8) after vaccination, or a four-fold rise in antibody titers and median reciprocal antibody titers to all three poliovirus types measured at 10-months of age.
  
  Findings:
  
  Of the 987 children randomized to Arms C, D, and E, 936 were included in the intention-to-treat analysis. At 10-months, participants in Arm C (IPV at 14-weeks and 9-months) had ≥99% cumulative immune response to all three poliovirus types which was significantly higher than the 77–81% observed in Arm E (IPV at 6 and 14-weeks). Participants in Arm D (IPV at 6-weeks and 9-months) had cumulative immune responses of 98–99% which was significantly higher than that of Arm E (p value < 0.0001) but not different from Arm C.
  
  Interpretation:
  
  Results support current SAGE recommendations for IPV following OPV cessation and provide evidence that the schedule of two full IPV doses could begin as early as 6-weeks.
  
  
• Subjects:
  Antibodies, Viral Bangladesh Child Humans Infant Poliomyelitis Poliovirus Vaccine, Inactivated Poliovirus Vaccine, Oral
• Keywords:
  Immunization Schedule Inactivated Poliovirus Vaccine Poliovirus
• Source:
  Vaccine. 39(40):5814-5821
• Pubmed ID:
  34481702
• Pubmed Central ID:
  PMC9059229
• Document Type:
  Journal Article
• Funding:
  CC999999/ImCDC/Intramural CDC HHSUnited States/
• Volume:
  39
• Issue:
  40
• Collection(s):
  CDC Public Access
• Main Document Checksum:
  urn:sha-512:254a4c4581cc5a325fa9afda0e8b7f6b92a157cc3581f90af0b33f30057694d0d7ddc2f921f538a562cff5463961e585466c93b686983c2a0a3138e3afa75afd
• Download URL:
  https://stacks.cdc.gov/view/cdc/116941/cdc_116941_DS1.pdf
• File Type:
  [PDF - 682.33 KB ]