Inactivated poliovirus vaccine given alone or in a sequential schedule with bivalent oral poliovirus vaccine in Chilean infants: a randomised, controlled, open-label, phase 4, non-inferiority study

O’Ryan, Miguel; Bandyopadhyay, Ananda S; Villena, Rodolfo; Espinoza, Mónica; Nóvoa, José; Weldon, William C.; Oberste, M. Steven; Self, Steve; Borate, Bhavesh; Asturias, Edwin J.; Clemens, Ralf; Orenstein, Walter A.; Jimeno, J.; Rüttimann, Ricardo; Clemens, Sue Ann Costa

doi:10.1016/s1473-3099(15)00219-4

Cited by 71 publications

(93 citation statements)

References 14 publications

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“…We previously showed one dose of SP IPV has a small but significant decrease in shedding of poliovirus 2 compared with controls given bOPV only [6], [7]. Doses of SP and GSK IPVs showed similar decreases in type 2 viral shedding following mOPV2 challenge, an effect that was most pronounced after the second dose as previously reported [6].…”

Section: Discussionsupporting

confidence: 71%

“…Serum neutralizing antibodies, measured at the Polio and Picornavirus Laboratory, Centers for Disease Control and Prevention, Atlanta, USA, were expressed as median log 2 titers, seropositivity rates (group proportions with titer ≥8), and seroconversion rates, as described previously [6]. The overall study seroconversion rate was defined as the proportion of seronegative infants who became seropositive, and of pre-vaccination seropositive infants having titers ≥4-fold higher than expected levels of maternally-derived antibody, assuming an exponential decay with a half-life of 24 days [7]. The specific IPV seroconversion rate was defined as a 4-fold or greater rise among seroprotected or titers ≥8 among 14-week seronegative, at 4, 22 or 26 weeks after administration of one or two IPV depending on the schedule.…”

Section: Methodsmentioning

confidence: 99%

See 1 more Smart Citation

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

López‐Medina

Melgar

Gaensbauer

et al. 2017

Vaccine

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HighlightsSince April 2016 type 2 polio immunization is only possible with inactivated polio vaccines (IPV).Global IPV supply is currently under pressure, being supplied by only four manufacturers.We previously confirmed the effectiveness of mixed bOPV and IPV schedules from one manufacturer.We compared intestinal and humoral immunity of IPV from 3 WHO prequalified manufacturers.All three WHO prequalified IPV were similarly immunogenic when 1 or 2 doses were given with bOPV.

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Section: Discussionsupporting

confidence: 71%

Section: Methodsmentioning

confidence: 99%

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

López‐Medina

Melgar

Gaensbauer

et al. 2017

Vaccine

Self Cite

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“…Increased replication fidelity has been associated with decreased replicative fitness (62,63), and thus, this observation may also help explain the higher rate of cVDPV emergence due to type 2. Differences in diversification rates could also be due to differences in the viral population ecology within the gut, which is affected by immune status (41,(64)(65)(66)). An alternative hypothesis that we cannot rule out is that our assumption that most of the samples are from primary vaccine recipients is more often false for type 2 due to higher levels of secondary spread of type 2 (6), and so we may be underestimating the range of times from the time of exposure to the time of sampling and, thus, overestimating the diversification rate.…”

Section: Per Base Substitution Rates For Nonrecombinant Samplesmentioning

confidence: 99%

Sabin Vaccine Reversion in the Field: a Comprehensive Analysis of Sabin-Like Poliovirus Isolates in Nigeria

Famulare

Chang

Iber

et al. 2016

J Virol

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To assess the dynamics of genetic reversion of live poliovirus vaccine in humans, we studied molecular evolution in Sabin-like poliovirus isolates from Nigerian acute flaccid paralysis cases obtained from routine surveillance. We employed a novel modeling approach to infer substitution and recombination rates from whole-genome sequences and information about poliovirus infection dynamics and the individual vaccination history. We confirmed observations from a recent vaccine trial that VP1 substitution rates are increased for Sabin-like isolates relative to the rate for the wild type due to increased nonsynonymous substitution rates. We also inferred substitution rates for attenuating nucleotides and confirmed that reversion can occur in days to weeks after vaccination. We combine our observations for Sabin-like virus evolution with the molecular clock for VP1 of circulating wild-type strains to infer that the mean time from the initiating vaccine dose to the earliest detection of circulating vaccine-derived poliovirus (cVDPV) is 300 days for Sabin-like virus type 1, 210 days for Sabin-like virus type 2, and 390 days for Sabin-like virus type 3. Phylogenetic relationships indicated transient local transmission of Sabin-like virus type 3 and, possibly, Sabin-like virus type 1 during periods of low wild polio incidence. Comparison of Sabin-like virus recombinants with known Nigerian vaccine-derived poliovirus recombinants shows that while recombination with non-Sabin enteroviruses is associated with cVDPV, the recombination rates are similar for Sabin isolate-Sabin isolate and Sabin isolate-non-Sabin enterovirus recombination after accounting for the time from dosing to the time of detection. Our study provides a comprehensive picture of the evolutionary dynamics of the oral polio vaccine in the field. IMPORTANCEThe global polio eradication effort has completed its 26th year. Despite success in eliminating wild poliovirus from most of the world, polio persists in populations where logistical, social, and political factors have not allowed vaccination programs of sustained high quality. One issue of critical importance is eliminating circulating vaccine-derived polioviruses (cVDPVs) that have properties indistinguishable from those of wild poliovirus and can cause paralytic disease. cVDPV emerges due to the genetic instability of the Sabin viruses used in the oral polio vaccine (OPV) in populations that have low levels of immunity to poliovirus. However, the dynamics responsible are incompletely understood because it has historically been difficult to gather and interpret data about evolution of the Sabin viruses used in OPV in regions where cVDPV has occurred. This study is the first to combine whole-genome sequencing of poliovirus isolates collected during routine surveillance with knowledge about the intrahost dynamics of poliovirus to provide quantitative insight into polio vaccine evolution in the field. O ver the last 50 years, mass vaccination campaigns with oral polio vaccine (OPV) have been a key fa...

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“…The clinical evidence-base generated from these studies has contributed to the global policy formulation for the polio endgame. (10)(11)(12)(13)(14)(15) To commemorate the 40 th anniversary of EPI in the Americas, this supplement of the Pan American Journal of Public Health summarizes the past, provides a critical analysis of the present, and offers new perspectives on future challenges and opportunities. The call for specific articles was well received: original articles, reviews, opinion pieces, and special reports were submitted reflecting regional, subregional, and country-specific perspectives.…”

Section: Immunization Policiesmentioning

confidence: 99%

The past, present, and future of immunization in the Americas

Andrus

Bandyopadhyay

Danovaro-Holliday

et al. 2017

Rev Panam Salud Publica

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Inactivated poliovirus vaccine given alone or in a sequential schedule with bivalent oral poliovirus vaccine in Chilean infants: a randomised, controlled, open-label, phase 4, non-inferiority study

Cited by 71 publications

References 14 publications

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

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

Sabin Vaccine Reversion in the Field: a Comprehensive Analysis of Sabin-Like Poliovirus Isolates in Nigeria

The past, present, and future of immunization in the Americas

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