Immunogenicity of Co-administered Oral Polio Vaccine and Oral Cholera Vaccine

NCT03581734 | Unknown Phase 3 DMC FDA Drug

• 1 other identifier: PR-17120
• Study Type: interventional
• Target: 579
• Locations: 1 country
• Sites: 1

Brief Summary

Concomitant administration of multiple vaccines, including live attenuated immunizations, is safe and effective. Some restrictions apply for live vaccines; administering a live-virus vaccine within 4 weeks after administration of another live-virus vaccine can decrease immunogenicity to the second administered vaccine. Thus, it is recommended that live-virus vaccines should be administered the same day or ≥4 weeks apart. Data on co-administration of the currently available whole-cell killed Oral Cholera Vaccine (OCVs) with other oral vaccines, specifically, oral polio vaccines (OPV) is lacking. Although the risk of immunological interference due to co-administration of live vaccines with non-live vaccines is considered small if at all, a theoretical concern of interference has been raised. Given the substantial geographic correlation between polio- and cholera-affected and at-risk areas, which include some of the world's most impoverished and hard-to-reach populations, a strategy of co-administration of OCV with OPV to children targeted to receive OPVs has the potential to optimize the use of limited resources and improve coverage for both vaccines. The manufacturer recommendation for a two-week interval between administration of OPV and OCV precludes an integrated campaign or routine use in which OCV could be co-administered with OPV.

Conditions

Vaccine Reaction

Keywords

Oral Polio Vaccine; Oral Cholera Vaccine; Co-administration; Immunogenecity

Outcome Measures

Primary Outcomes (2)

• Anti-poliovirus antibodies

  Anti-poliovirus antibodies P1 and P3 microneutralization titer when OPV and OCV are administered separately, and when given together.

  One year

• Vibriocidal antibody response

  Vibriocidal antibody response to V. cholerae O1, serotype Ogawa and Inaba when OPV and OCV are administered separately, and when given together.

  One year

Secondary Outcomes (1)

• Safety: number of adverse events and serious adverse events

  One year

Study Arms (3)

OPV only

ACTIVE COMPARATOR

The vaccine will be available in prefilled vials containing 10 doses. Each vial will be labelled with the study ID of the participant. Therefore, for participants randomized to arm A and arm C, there will be 3 vials per participant for the 3 doses of the bOPV vaccine to be given 28 weeks apart. Any remaining, non-used doses of vaccine in the vial will be discarded.

Biological: Oral Polio Vaccine

Shanchol only

ACTIVE COMPARATOR

Each dose of vaccine is 1.5ml in volume. Each vial will be labelled with the study ID of the participant. One vial will be used per participant per study visit. OCV was studied in a double-blind, randomized, placebo-controlled trial in Kolkata, India. Participants were 1 year and above in age. In these studies, 100 children aged 1-17 were administered 2-doses of OCV or placebo separated by an interval of two weeks, with 80% of vaccinated showing over 4 fold rise in serum V. cholerae O1 antibody titers, showing that the 2-dose regimen was well-tolerated, safe and immunogenic

Biological: Oral Cholera Vaccine

OPV-OCV co-administered

EXPERIMENTAL

Our primary analysis will be to compare seroconversion (defined as a change of status from seronegative to seropositive titers, or a ≥4-fold rise in antibody titer) for OPV1 and OPV 3 antibodies between Arm A and Arm C, to determine whether seroconversion to bOPV when administered with Shanchol is non-inferior to seroconversion to bOPV when bOPV is administered alone. Our second objective will be to compare vibriocidal antibody seroconversion (also, ≥4-fold rise in antibody titers) to Shanchol when co-administered with OPV or when Shanchol is administered alone, Arm B compared to Arm C

Biological: Oral Polio Vaccine; Biological: Oral Cholera Vaccine

Interventions

Oral Polio Vaccine BIOLOGICAL

OPV is a mixture of live attenuated poliovirus strains of each of the three serotypes, selected by their ability to mimic the immune response following infection with wild polioviruses, but with a significantly reduced incidence of spreading to the central nervous system.

OPV only; OPV-OCV co-administered

Oral Cholera Vaccine BIOLOGICAL

Bivalent, Killed, Whole Cell Oral Cholera Vaccine

OPV-OCV co-administered; Shanchol only

Eligibility Criteria

• Age: 1 Year - 3 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• Apparently healthy children aged 1 to 3 years of age. Family able to understand and comply with planned study procedures and consents to be in the study.
• Have received either no dose or only one dose of OPV ( 0 - 1 dose) and has not received any dose of IPV or OCV at any time before enrollment based upon immunization card record or history from parents.

You may not qualify if:

• Parents and children who are unable / unwilling to participate in the full length of the study for any reason.
• Child / family planning on moving away from the study area during the study period
• A diagnosis, suspicion of, or clinical condition consistent with an immunodeficiency disorder (either in the child or in a member of the immediate family) or is on long-term (\>3 months) of immunosuppressive therapy.
• A suspicion or known history of bleeding disorder that would contraindicate venipuncture.
• Acute diarrhea, infection or illness at the time of the first visit that would require the child's admission to a hospital or would contraindicate provision of OPV per country guidelines.
• History of severe allergic reaction to component of study vaccine
• Acute vomiting or diarrhea within 24 hours before the first visit.
• Severely malnourished children (Weight-for-age with z-score \< - 3 below the median of the WHO child growth standards.)
• Previously received 3 doses of OPV or single dose of IPV or OCV at any time before enrollment based upon immunization card record.

Sponsors & Collaborators

• International Centre for Diarrhoeal Disease Research, Bangladesh: lead
• Centers for Disease Control and Prevention: collaborator
• Stanford University: collaborator

Study Sites (1)

Hazaribagh Field Clinic

Dhaka, 1212, Bangladesh

RECRUITING

Related Publications (4)

• Patel M, Steele AD, Parashar UD. Influence of oral polio vaccines on performance of the monovalent and pentavalent rotavirus vaccines. Vaccine. 2012 Apr 27;30 Suppl 1:A30-5. doi: 10.1016/j.vaccine.2011.11.093.

  PMID: 22520134 RESULT

• Taniuchi M, Platts-Mills JA, Begum S, Uddin MJ, Sobuz SU, Liu J, Kirkpatrick BD, Colgate ER, Carmolli MP, Dickson DM, Nayak U, Haque R, Petri WA Jr, Houpt ER. Impact of enterovirus and other enteric pathogens on oral polio and rotavirus vaccine performance in Bangladeshi infants. Vaccine. 2016 Jun 8;34(27):3068-3075. doi: 10.1016/j.vaccine.2016.04.080. Epub 2016 May 3.

  PMID: 27154394 RESULT

• Emperador DM, Velasquez DE, Estivariz CF, Lopman B, Jiang B, Parashar U, Anand A, Zaman K. Interference of Monovalent, Bivalent, and Trivalent Oral Poliovirus Vaccines on Monovalent Rotavirus Vaccine Immunogenicity in Rural Bangladesh. Clin Infect Dis. 2016 Jan 15;62(2):150-6. doi: 10.1093/cid/civ807. Epub 2015 Sep 8.

  PMID: 26349548 RESULT

• Islam MT, Date K, Khan AI, Bhuiyan TR, Khan ZH, Ahmed S, Hossain M, Khaton F, Zaman K, McMillan NAJ, Anand A, An Q, Zhang C, Weldon WC, Yu A, Luby S, Qadri F. Co-administration of Oral Cholera Vaccine With Oral Polio Vaccine Among Bangladeshi Young Children: A Randomized Controlled Open Label Trial to Assess Interference. Clin Infect Dis. 2023 Jan 13;76(2):263-270. doi: 10.1093/cid/ciac782.

  PMID: 36136760 DERIVED

MeSH Terms

Interventions

Poliovirus Vaccine, Oral; Cholera Vaccines

Intervention Hierarchy (Ancestors)

Poliovirus Vaccines; Viral Vaccines; Vaccines; Biological Products; Complex Mixtures; Bacterial Vaccines

Study Officials

• Dr. Firdausi Qadri, PhD

  International Centre for Diarrhoeal Disease Research, Bangladesh

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Dr. Firdausi Qadri, PhD

CONTACT

029827001-10; fqadri@icddrb.org

Dr. Ashraful I Khan, PhD

CONTACT

029827001-10; ashrafk@icddrb.org

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Laboratory staff will remain blinded throughout the study
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: We propose to conduct an open-label, randomized controlled study in Dhaka, Bangladesh, among healthy children aged 1 - 3 years old who have received either no dose or one dose 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 after full informed consent. Participants will be randomized to one of three groups ; (i) OPV only, (ii) OCV only, or (iii) co-administered OPV and OCV

Study Record Dates

• First Submitted: June 25, 2018
• First Posted: July 10, 2018
• Study Start: July 1, 2018
• Primary Completion: October 25, 2022
• Study Completion: October 25, 2022
• Last Updated: March 31, 2022

Record last verified: 2022-03

Locations

BA (1)