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Vaccine. 2017 Jun 16;35(28):3591-3597. doi: 10.1016/j.vaccine.2017.04.041. Epub 2017 Apr 25.

Inactivated polio vaccines from three different manufacturers have equivalent safety and immunogenicity when given as 1 or 2 additional doses after bivalent OPV: Results from a randomized controlled trial in Latin America.

Author information

1
Department of Pediatrics, Universidad del Valle and Centro de Estudios en Infectología Pediátrica, Cali, Colombia.
2
Hospital Roosevelt and University Francisco Marroquin School of Medicine, Guatemala City, Guatemala.
3
Department of Pediatrics, University of Colorado School of Medicine, Aurora, CO, USA; Center for Global Health and Department of Epidemiology, Colorado School of Public Health, Aurora, CO, USA.
4
Bill & Melinda Gates Foundation, Seattle, WA, USA.
5
Fred Hutchinson Cancer Research Center, Seattle, WA, USA.
6
Centers for Disease Control and Prevention, Atlanta, GA, USA.
7
Fighting Infectious Diseases in Emerging Countries (FIDEC), Miami, FL, USA.
8
Department of Pediatrics, Harbor-UCLA Medical Center, Geffin School of Medicine, University of California at Los Angeles, CA, USA.
9
Global Research in Infectious Diseases (GRID), Rio de Janeiro, Brazil.
10
Department of Pediatrics, University of Colorado School of Medicine, Aurora, CO, USA; Center for Global Health and Department of Epidemiology, Colorado School of Public Health, Aurora, CO, USA. Electronic address: edwin.asturias@ucdenver.edu.

Abstract

BACKGROUND:

Since April 2016 inactivated poliovirus vaccine (IPV) has been the only routine source of polio type 2 protection worldwide. With IPV supply constraints, data on comparability of immunogenicity and safety will be important to optimally utilize available supplies from different manufacturers.

METHODS:

In this multicenter phase IV study, 900 Latin American infants randomly assigned to six study groups received three doses of bOPV at 6, 10 and 14weeks and either one IPV dose at 14weeks (groups SP-1, GSK-1 and BBio-1) or two IPV doses at 14 and 36weeks (groups SP-2, GSK-2 and BBio-2) from three different manufacturers. Children were challenged with mOPV2 at either 18 (one IPV dose) or 40weeks (two IPV doses) and stools were collected weekly for 4weeks to assess viral shedding. Serum neutralizing antibodies were measured at various time points pre and post vaccination. Serious adverse events and important medical events (SAE and IME) were monitored for 6months after last study vaccine.

RESULTS:

At week 18, 4weeks after one dose of IPV, overall type 2 seroconversion rates were 80.4%, 80.4% and 73.3% for SP-1, GSK-1 and BBio-1 groups, respectively; and 92.6%, 96.8% and 88.0% in those who were seronegative before IPV administration. At 40weeks, 4weeks after a second IPV dose, type 2 seroconversion rates were ≥99% for any of the three manufacturers. There were no significant differences in fecal shedding index endpoint (SIE) after one or two IPV doses (SP: 2.3 [95% CI: 2.1-2.6]); GSK: 2.2 [1.7-2.5]; BBio 1.8 [1.5-2.3]. All vaccines appeared safe, with no vaccine-related SAE or IME.

CONCLUSION:

Current WHO prequalified IPV vaccines are safe and induce similar humoral and intestinal immunity after one or two doses. The parent study was registered with ClinicalTrials.gov, number NCT01831050.

KEYWORDS:

Humoral immunity; Intestinal immunity; Poliovirus; Vaccination

PMID:
28455172
PMCID:
PMC5464088
DOI:
10.1016/j.vaccine.2017.04.041
[Indexed for MEDLINE]
Free PMC Article

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