title: Effect of buffer on the immune response to trivalent oral poliovirus vaccine in Bangladesh: a community based randomized controlled trial.
abstract: BACKGROUND
  Polio eradication efforts have been hampered by low responses to trivalent oral poliovirus vaccine (tOPV) in some developing countries. Since stomach acidity may neutralize vaccine viruses, we assessed whether administration of a buffer solution could improve the immunogenicity of tOPV.
  
  
  METHODS
  Healthy infants 4-6 weeks old in Sylhet, Bangladesh, were randomized to receive tOPV with or without a sodium bicarbonate and sodium citrate buffer at age 6, 10, and 14 weeks. Levels of serum neutralizing antibodies for poliovirus types 1, 2, and 3 were measured before and after vaccination, at 6 and 18 weeks of age, respectively.
  
  
  RESULTS
  Serologic response rates following 3 doses of tOPV for buffer recipients and control infants were 95% and 88% (P=.065), respectively, for type 1 poliovirus; 95% and 97% (P=.543), respectively, for type 2 poliovirus; and 90% and 89% (P=.79), respectively, for type 3 poliovirus.
  
  
  CONCLUSIONS
  Administration of a buffer solution prior to vaccination was not associated with statistically significant increases in the immune response to tOPV; however, a marginal 7% increase (P=.065) in serologic response to poliovirus type 1 was observed.
  
  
  BACKGROUND
  NCT01579825.
authors.affiliation: Department of International Health, Johns Hopkins Bloomberg School of Public Health, Baltimore, Maryland.
authors.forename: Subhash
authors.initials: S
authors.lastname: Chandir
authors.affiliation: Shimantik, Dhaka, Bangladesh.
authors.forename: Kabir U
authors.initials: KU
authors.lastname: Ahamed
authors.affiliation: Department of International Health, Johns Hopkins Bloomberg School of Public Health, Baltimore, Maryland.
authors.forename: Abdullah H
authors.initials: AH
authors.lastname: Baqui
authors.affiliation: Polio Operations and Research Department, World Health Organization, Geneva, Switzerland.
authors.forename: Roland W
authors.initials: RW
authors.lastname: Sutter
authors.affiliation: Polio Operations and Research Department, World Health Organization, Geneva, Switzerland.
authors.forename: Hiromasa
authors.initials: H
authors.lastname: Okayasu
authors.affiliation: Centers for Disease Control and Prevention, Atlanta, Georgia.
authors.forename: Mark A
authors.initials: MA
authors.lastname: Pallansch
authors.affiliation: Centers for Disease Control and Prevention, Atlanta, Georgia.
authors.forename: Mark S
authors.initials: MS
authors.lastname: Oberste
authors.affiliation: Department of International Health, Johns Hopkins Bloomberg School of Public Health, Baltimore, Maryland.
authors.forename: Lawrence H
authors.initials: LH
authors.lastname: Moulton
authors.affiliation: Department of International Health, Johns Hopkins Bloomberg School of Public Health, Baltimore, Maryland.
authors.forename: Neal A
authors.initials: NA
authors.lastname: Halsey
mesh_terms: D057134:Antibodies, Neutralizing / Q000097:blood; D000914:Antibodies, Viral / Q000097:blood; D001459:Bangladesh; D002021:Buffers; D002951:Citrates; D005079:Excipients / Q000494:pharmacology*; D005260:Female; D006801:Humans; D007223:Infant; D008297:Male; D011051:Poliomyelitis / Q000517:prevention & control*; D011055:Poliovirus Vaccine, Oral / Q000008:administration & dosage / Q000276:immunology*; D017693:Sodium Bicarbonate; D000077559:Sodium Citrate
chemical_list: D057134:Antibodies, Neutralizing; D000914:Antibodies, Viral; D002021:Buffers; D002951:Citrates; D005079:Excipients; D011055:Poliovirus Vaccine, Oral; D000077559:Sodium Citrate; D017693:Sodium Bicarbonate
keywords: buffer; immunogenicity; oral poliovirus vaccine; serologic response