Flexibility of Oral Cholera Vaccine Dosing—A Randomized Controlled Trial Measuring Immune Responses Following Alternative Vaccination Schedules in a Cholera Hyper-Endemic Zone

Suman Kanungo, Sachin N. Desai, Ranjan Kumar Nandy, Mihir Kumar Bhattacharya, Deok Ryun Kim, Anuradha Sinha, Tanmay Mahapatra, Jae Seung Yang, Anna Lena Lopez, Byomkesh Manna, Barnali Bannerjee, Mohammad Ali, Mandeep Singh Dhingra, Ananga Mohan Chandra, John D. Clemens, Dipika Sur, Thomas F. Wierzba

Research output: Contribution to journalArticle

Abstract

Background: A bivalent killed whole cell oral cholera vaccine has been found to be safe and efficacious for five years in the cholera endemic setting of Kolkata, India, when given in a two dose schedule, two weeks apart. A randomized controlled trial revealed that the immune response was not significantly increased following the second dose compared to that after the first dose. We aimed to evaluate the impact of an extended four week dosing schedule on vibriocidal response. Methodology/Principal Findings: In this double blind randomized controlled non-inferiority trial, 356 Indian, non-pregnant residents aged 1 year or older were randomized to receive two doses of oral cholera vaccine at 14 and 28 day intervals. We compared vibriocidal immune responses between these schedules. Among adults, no significant differences were noted when comparing the rates of seroconversion for V. cholerae O1 Inaba following two dose regimens administered at a 14 day interval (55%) vs the 28 day interval (58%). Similarly, no differences in seroconversion were demonstrated in children comparing the 14 (80%) and 28 day intervals (77%). Following 14 and 28 day dosing intervals, vibriocidal response rates against V. cholerae O1 Ogawa were 45% and 49% in adults and 73% and 72% in children respectively. Responses were lower for V. cholerae O139, but similar between dosing schedules for adults (20%, 20%) and children (28%, 20%). Conclusions/Significance: Comparable immune responses and safety profiles between the two dosing schedules support the option for increased flexibility of current OCV dosing. Further operational research using a longer dosing regimen will provide answers to improve implementation and delivery of cholera vaccination in endemic and epidemic outbreak scenarios.

Original languageEnglish (US)
JournalPLoS Neglected Tropical Diseases
Volume9
Issue number3
DOIs
StatePublished - Mar 12 2015

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Cholera Vaccines
Cholera
Appointments and Schedules
Vaccination
Randomized Controlled Trials
Disease Outbreaks
India
Safety
Research

ASJC Scopus subject areas

  • Infectious Diseases
  • Public Health, Environmental and Occupational Health
  • Pharmacology, Toxicology and Pharmaceutics(all)

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Flexibility of Oral Cholera Vaccine Dosing—A Randomized Controlled Trial Measuring Immune Responses Following Alternative Vaccination Schedules in a Cholera Hyper-Endemic Zone. / Kanungo, Suman; Desai, Sachin N.; Nandy, Ranjan Kumar; Bhattacharya, Mihir Kumar; Kim, Deok Ryun; Sinha, Anuradha; Mahapatra, Tanmay; Yang, Jae Seung; Lopez, Anna Lena; Manna, Byomkesh; Bannerjee, Barnali; Ali, Mohammad; Dhingra, Mandeep Singh; Chandra, Ananga Mohan; Clemens, John D.; Sur, Dipika; Wierzba, Thomas F.

In: PLoS Neglected Tropical Diseases, Vol. 9, No. 3, 12.03.2015.

Research output: Contribution to journalArticle

Kanungo, S, Desai, SN, Nandy, RK, Bhattacharya, MK, Kim, DR, Sinha, A, Mahapatra, T, Yang, JS, Lopez, AL, Manna, B, Bannerjee, B, Ali, M, Dhingra, MS, Chandra, AM, Clemens, JD, Sur, D & Wierzba, TF 2015, 'Flexibility of Oral Cholera Vaccine Dosing—A Randomized Controlled Trial Measuring Immune Responses Following Alternative Vaccination Schedules in a Cholera Hyper-Endemic Zone', PLoS Neglected Tropical Diseases, vol. 9, no. 3. https://doi.org/10.1371/journal.pntd.0003574
Kanungo, Suman ; Desai, Sachin N. ; Nandy, Ranjan Kumar ; Bhattacharya, Mihir Kumar ; Kim, Deok Ryun ; Sinha, Anuradha ; Mahapatra, Tanmay ; Yang, Jae Seung ; Lopez, Anna Lena ; Manna, Byomkesh ; Bannerjee, Barnali ; Ali, Mohammad ; Dhingra, Mandeep Singh ; Chandra, Ananga Mohan ; Clemens, John D. ; Sur, Dipika ; Wierzba, Thomas F. / Flexibility of Oral Cholera Vaccine Dosing—A Randomized Controlled Trial Measuring Immune Responses Following Alternative Vaccination Schedules in a Cholera Hyper-Endemic Zone. In: PLoS Neglected Tropical Diseases. 2015 ; Vol. 9, No. 3.
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abstract = "Background: A bivalent killed whole cell oral cholera vaccine has been found to be safe and efficacious for five years in the cholera endemic setting of Kolkata, India, when given in a two dose schedule, two weeks apart. A randomized controlled trial revealed that the immune response was not significantly increased following the second dose compared to that after the first dose. We aimed to evaluate the impact of an extended four week dosing schedule on vibriocidal response. Methodology/Principal Findings: In this double blind randomized controlled non-inferiority trial, 356 Indian, non-pregnant residents aged 1 year or older were randomized to receive two doses of oral cholera vaccine at 14 and 28 day intervals. We compared vibriocidal immune responses between these schedules. Among adults, no significant differences were noted when comparing the rates of seroconversion for V. cholerae O1 Inaba following two dose regimens administered at a 14 day interval (55{\%}) vs the 28 day interval (58{\%}). Similarly, no differences in seroconversion were demonstrated in children comparing the 14 (80{\%}) and 28 day intervals (77{\%}). Following 14 and 28 day dosing intervals, vibriocidal response rates against V. cholerae O1 Ogawa were 45{\%} and 49{\%} in adults and 73{\%} and 72{\%} in children respectively. Responses were lower for V. cholerae O139, but similar between dosing schedules for adults (20{\%}, 20{\%}) and children (28{\%}, 20{\%}). Conclusions/Significance: Comparable immune responses and safety profiles between the two dosing schedules support the option for increased flexibility of current OCV dosing. Further operational research using a longer dosing regimen will provide answers to improve implementation and delivery of cholera vaccination in endemic and epidemic outbreak scenarios.",
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AU - Nandy, Ranjan Kumar

AU - Bhattacharya, Mihir Kumar

AU - Kim, Deok Ryun

AU - Sinha, Anuradha

AU - Mahapatra, Tanmay

AU - Yang, Jae Seung

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AU - Ali, Mohammad

AU - Dhingra, Mandeep Singh

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AU - Wierzba, Thomas F.

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