An Open Label Non-inferiority Trial Assessing Vibriocidal Response of a Killed Bivalent Oral Cholera Vaccine Regimen following a Five Year Interval in Kolkata, India

Suman Kanungo, Sachin N. Desai, Jayanta Saha, Ranjan Kumar Nandy, Anuradha Sinha, Deok Ryun Kim, Barnali Bannerjee, Byomkesh Manna, Jae Seung Yang, Mohammad Ali, Dipika Sur, Thomas F. Wierzba

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Abstract

The bivalent killed oral cholera vaccine (OCV) provides 65% cumulative protection over five years. It remains unknown whether a boosting regimen can maintain protection in previously immunized populations. This study examines the immunogenicity and safety of an OCV regimen given five years following initial dosing. An open label controlled trial was conducted in 426 healthy Indian participants previously enrolled in a large efficacy trial. To assess whether an OCV regimen given after five years can elicit an antibody response equal to that of a primary series, we compared vibriocidal antibody titers in previously immunized participants receiving a two dose booster regimen to participants receiving a primary two dose immunization series. Among participants receiving a two dose primary series of OCV (n = 186), 69% (95% CI 62%-76%) seroconverted. In the intervention arm (n = 184), 66% (95% CI 59%-73%) seroconverted following a two dose boosting schedule given five years following the initial series. Following a single boosting dose, 71% (95% CI 64%-77%) seroconverted. Children demonstrated 79% (95% CI 69%-86%) and 82% (95% CI 73%-88%) seroconversion after primary and boosting regimens, respectively. Administration of an OCV boosting regimen elicits an immune response similar to those receiving a primary series in endemic areas. Though a single boosting dose induces a strong immune response, further investigations are needed to measure if these findings translate to clinical protection.

Original languageEnglish (US)
Article numbere0003809
JournalPLoS neglected tropical diseases
Volume9
Issue number5
DOIs
StatePublished - May 29 2015

ASJC Scopus subject areas

  • Public Health, Environmental and Occupational Health
  • Infectious Diseases

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    Kanungo, S., Desai, S. N., Saha, J., Nandy, R. K., Sinha, A., Kim, D. R., Bannerjee, B., Manna, B., Yang, J. S., Ali, M., Sur, D., & Wierzba, T. F. (2015). An Open Label Non-inferiority Trial Assessing Vibriocidal Response of a Killed Bivalent Oral Cholera Vaccine Regimen following a Five Year Interval in Kolkata, India. PLoS neglected tropical diseases, 9(5), [e0003809]. https://doi.org/10.1371/journal.pntd.0003809