Study on the immunogenicity of Oral Polio Vaccine (OPV) and Oral Cholera Vaccine (OCV) when co-administered

In 2012, the 65th World Health Assembly (WHA) declared the completion of poliomyelitis (polio) eradication to be a programmatic emergency for global public health. Cholera, another life-threatening infectious disease, is highly endemic and epidemic in many of the same parts of the world affected by polio.

Currently, no studies have been conducted to determine if any of the OPV and OCV can be co-administered without impacting the immunogenicity of either vaccine. Data on co-administration of the currently available whole-cell killed OCVs with other oral vaccines, specifically, oral polio vaccines is lacking.

Effective immunization with high coverage remains the key for interruption of polio transmission, and vaccination is a vital complementary strategy for cholera control. Given that OPV campaigns in most polio priority settings target a largely overlapping population as OCV campaigns, the results of this study are crucial and highly relevant for OPV-OCV vaccine administration policies. If able to be co-administered safely and effectively, combined OPV-OCV campaigns may potentially outline large cost-savings and eliminate potentially redundant administration costs and improve adherence.

Co-administration of oral polio vaccine (OPV) and oral cholera vaccine (OCV) will not decrease immunogenicity of either vaccine among children 1 – 3 years old.

Objectives

Primary

• To compare seroconversion for OPV types P1 and P3 when administered alone versus when administered with OCV on day 28 and 56 after vaccination.
• To compare vibriocidal antibody response (based on a ≥ 4-fold rise) to OCV when administered alone versus when co-administered with OPV on day 28 and day 56 after vaccination.

Secondary

• To determine safety of co-administration of OPV with OCV compared to OPV or OCV alone.

Methods

We propose to conduct an open-label, randomized controlled study in Dhaka, Bangladesh, among healthy children aged 1 – 3 years old who have received < 3 doses of OPV and has not received any dose of IPV or OCV at any time before enrolment based upon immunization card record or history from parents.

Outcome measures/variables

Primary

• Anti-polio virus antibodies type 1 and type 3 microneutralization titer when OPV and OCV are administered separately, and when given together.
• Vibriocidal antibody response to V. cholerae O1, serotype Ogawa and Inaba when OPV and OCV are administered separately and when given together.

Secondary

• Number of adverse events and serious adverse events between OPV and OCV when given alone versus when given concomitantly.

Effective immunization with high coverage remains the key for interruption of polio transmission, and vaccination is a vital complementary strategy for cholera control. Given that OPV campaigns in most polio priority settings target a largely overlapping population as OCV campaigns, the results of this study are crucial and highly relevant for OPV-OCV vaccine administration policies. If able to be co-administered safely and effectively, combined OPV-OCV campaigns may potentially outline large cost-savings and eliminate potentially redundant administration costs and improve adherence. Therefore, the main objectives of the study are:

• To compare seroconversion for OPV types P1 and P3 when administered alone versus when administered with OCV on day 28 and 56 after vaccination.
• To compare vibriocidal antibody response (based on a ≥ 4-fold rise) to OCV when administered alone versus when co-administered with OPV on day 28 and day 56 after vaccination.

• Anti-polio virus antibodies type 1 and type 3 microneutralization titer when OPV and OCV are administered separately, and when given together.
• Vibriocidal antibody response to V. cholerae O1, serotype Ogawa and Inaba when OPV and OCV are administered separately and when given together.