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: e0003809

Background 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 year...

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Bibliographic Details
Published in:PLoS neglected tropical diseases 2015-05, Vol.9 (5)
Main Authors: Kanungo, Suman, Desai, Sachin N, Saha, Jayanta, Nandy, Ranjan Kumar, Sinha, Anuradha, Kim, Deok Ryun, Bannerjee, Barnali, Manna, Byomkesh, Yang, Jae Seung, Ali, Mohammad, Sur, Dipika, Wierzba, Thomas F
Format: Article
Language:English
Subjects:
Age
Cholera
Immune response
Immunization
Immunogenicity
Mathematical models
Sanitation
Sewage disposal
Tropical diseases
Vaccines
Waterborne diseases
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Summary:Background 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. Methodology/Principal Findings 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. Conclusions/Significance 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.
ISSN:1935-2727
1935-2735
DOI:10.1371/journal.pntd.0003809