Co-administration Study of OCV, TCV and MR

NCT05771779 | Unknown Phase 3 DMC

• 1 other identifier: PR-23003
• Study Type: interventional
• Target: 2,117
• Locations: 0 countries
• Sites: N/A

Brief Summary

An open-label, randomized controlled, non-inferiority study of co-administration of OCV, TCV and MR vaccines among children 12 to 59 months of age in Dhaka, Bangladesh will be conducted. Children who did not receive any of the aforementioned vaccines will be included in the study. This study will be conducted among 2117 children of 12-59 months of age residing in Mirpur area (wards 4, and 6-16) of Dhaka north and Kamrangirchar, Hazaribag and Rayerbazar areas (wards 14, 22, 56, 57, and 58) of Dhaka south to enroll the required number of participants. Only children who have not previously received the vaccines will be enrolled. The findings of this study are likely to have a significant impact on vaccine co-administration strategies for campaign and routine immunization programs. The participants will be randomly assigned to one of the six arms. The numbers are defined for each arm based on the sample size calculation. A list of children who did not receive MR, OCV and TCV will be prepared before enrollment by trained study staff (TSS). The TSSs will visit households in the defined study area and ask if the parents/guardians of children aged 12-59 months are willing to participate in the study. If they show willingness to participate, the TSSs will check their vaccination cards (if available) and prepare the list of potentially eligible children who have not received OCV, TCV and MR based on their vaccination card status and verbal statement (if vaccination card is not available). The investigators will enroll the participants after obtaining informed written consent and collect around 2-3 ml blood from each participant at different time points.

Conditions

Typhoid; Cholera; Measles; Rubella

Keywords

Co-administration; Immunogenicity; Safety; Typhoid fever; Cholera; Measles and Rubella; Conjugate vaccine

Outcome Measures

Primary Outcomes (4)

• Vibriocidal antibody response for OCV

  * Vibriocidal antibody response for OCV when administered individually versus when co-administered with TCV on days 28 and 56 * Vibriocidal antibody response for OCV when administered individually versus when co-administered with MR on days 28 and 56

  Two months

• Seroconversion for TCV

  * Seroconversion (≥4 fold rise of anti-Vi-IgG antibody titres compared to pre-vaccination) for TCV when administered individually versus when co-administered with OCV on day 28 * Seroconversion (≥4 fold rise of anti-Vi-IgG antibody titres compared to pre-vaccination) for TCV when administered individually versus when co-administered with MR on day 28

  One Year

• Seroconversion for MR vaccine

  * Seroconversion (≥4 fold rise of measles IgG antibody titres compared to pre-vaccination) for MR when administered individually versus when co-administered with OCV on days 28 and 208 * Seroconversion (≥4 fold rise of measles IgG antibody titres compared to pre-vaccination) for MR when administered individually versus when co-administered with TCV on days 28 and 208 * Seroconversion (≥4 fold rise of measles IgG antibody titres compared to pre-vaccination) for MR when administered individually versus when administered after OCV on days 84 and 264

  One year

• Safety: number of adverse events and serious adverse events

  Number of adverse events and serious adverse events when OCV, TCV and MR vaccines are co-administered versus given alone.

  One year

Study Arms (6)

Arm A: Oral Cholera Vaccine (OCV) only

EXPERIMENTAL

Based on randomization (n= 413) Potential participants will be vaccinated with OCV on Day 0 and Day 28. Two doses of MR vaccine will be given on day 56 and day 236. A blood sample (2-3 ml) will be collected for immunological assay on Day 0, Day 28, Day 56, Day 84 and Day 264 . All details will be recorded in the eCRF.

Biological: Oral Cholera Vaccine (OCV); Biological: Measles and Rubella (MR)

Arm B: Typhoid Conjugate Vaccine (TCV) only

EXPERIMENTAL

Based on randomization (n= 314) Potential participants will be vaccinated with TCV on Day 0 and two doses of MR vaccine will be given on Day 56 and Day 236. A blood sample (2-3 ml) will be collected for immunological assay on Day 0, Day 28, Day 84 and Day 264 . All details will be recorded in the eCRF.

Biological: Typhoid Conjugate Vaccine (TCV); Biological: Measles and Rubella (MR)

Arm C: Measles and Rubella (MR) only

EXPERIMENTAL

Based on randomization (n= 250) Potential participants will be vaccinated with MR on Day 0 and Day 180. A blood sample (2-3 ml) will be collected for immunological assay on Day 0, Day 28 and Day 208 . All details will be recorded in the eCRF.

Biological: Measles and Rubella (MR)

Arm D: Co-administration of Measles and Rubella (MR) and Typhoid Conjugate Vaccine (TCV)

EXPERIMENTAL

Based on randomization (n= 314) Potential participants will be vaccinated with TCV on Day 0 and two doses of MR vaccine will be given on Day 0 and Day 180 . A blood sample (2-3 ml) will be collected for immunological assay on Day 0, Day 28 and Day 208 . All details will be recorded in the eCRF.

Biological: Typhoid Conjugate Vaccine (TCV); Biological: Measles and Rubella (MR)

Arm E: Co-administration of Measles and Rubella (MR) and Oral Cholera Vaccine (OCV)

EXPERIMENTAL

Based on randomization (n= 413) Potential participants will be vaccinated with OCV on Day 0 and Day 28 . Two doses of MR vaccine will be given on Day 0 and Day 180 . A blood sample (2-3 ml) will be collected for immunological assay on Day 0, Day 28 , Day 56 and Day 208 . All details will be recorded in the eCRF.

Biological: Oral Cholera Vaccine (OCV); Biological: Measles and Rubella (MR)

Arm F: Co-administration of Typhoid Conjugate Vaccine (TCV) and Oral Cholera Vaccine (OCV)

EXPERIMENTAL

Based on randomization (n= 413) Potential participants will be vaccinated with TCV on Day 0 . Two doses of OCV vaccine will be given on Day 0 and Day 28. Also two doses of MR vaccine will be given on Day 56 and Day 236. A blood sample (2-3 ml) will be collected for immunological assay on Day 0, Day 28 , Day 56 , Day 84 and Day 264 . All details will be recorded in the eCRF.

Biological: Oral Cholera Vaccine (OCV); Biological: Typhoid Conjugate Vaccine (TCV); Biological: Measles and Rubella (MR)

Interventions

Oral Cholera Vaccine (OCV) BIOLOGICAL

Bivalent, Killed, Whole Cell Oral Cholera Vaccine

Arm A: Oral Cholera Vaccine (OCV) only; Arm E: Co-administration of Measles and Rubella (MR) and Oral Cholera Vaccine (OCV); Arm F: Co-administration of Typhoid Conjugate Vaccine (TCV) and Oral Cholera Vaccine (OCV)

Typhoid Conjugate Vaccine (TCV) BIOLOGICAL

Vi-polysaccharide conjugated to tetanus toxoid, Vi-TT

Arm B: Typhoid Conjugate Vaccine (TCV) only; Arm D: Co-administration of Measles and Rubella (MR) and Typhoid Conjugate Vaccine (TCV); Arm F: Co-administration of Typhoid Conjugate Vaccine (TCV) and Oral Cholera Vaccine (OCV)

Measles and Rubella (MR) BIOLOGICAL

Live attenuated vaccine

Arm A: Oral Cholera Vaccine (OCV) only; Arm B: Typhoid Conjugate Vaccine (TCV) only; Arm C: Measles and Rubella (MR) only; Arm D: Co-administration of Measles and Rubella (MR) and Typhoid Conjugate Vaccine (TCV); Arm E: Co-administration of Measles and Rubella (MR) and Oral Cholera Vaccine (OCV); Arm F: Co-administration of Typhoid Conjugate Vaccine (TCV) and Oral Cholera Vaccine (OCV)

Eligibility Criteria

• Age: 12 Months - 59 Months
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• Provide informed written consent from participants parent/legal guardian
• Participants aged 12 months to 59 months
• Family does not have any plan to move from the study area during study period
• No history of receipt of MR (Measles and Rubella) or TCV or OCV

You may not qualify if:

• Child live outside of the study area
• Participant with confirmed or suspected immunosuppressive or immunodeficiency disorder; or participant on any immunosuppressive or immunostimulant therapy
• Known case of thrombocytopenia or any coagulation disorder, or participant on anticoagulation therapy
• History of hypersensitivity reaction to any component of the study vaccines
• Participant with febrile illness (temperature \>37.9oC) at the time of enrollment
• Participant with acute diarrhea and/or vomiting at the time of enrollment
• Participant with acute infection or illness at the time of enrollment
• Participant is severely malnourished

Sponsors & Collaborators

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

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MeSH Terms

Conditions

Typhoid Fever; Cholera; Measles; Rubella

Interventions

Cholera Vaccines

Condition Hierarchy (Ancestors)

Salmonella Infections; Enterobacteriaceae Infections; Gram-Negative Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Infections; Vibrio Infections; Morbillivirus Infections; Paramyxoviridae Infections; Mononegavirales Infections; RNA Virus Infections; Virus Diseases; Rubivirus Infections; Togaviridae Infections

Intervention Hierarchy (Ancestors)

Bacterial Vaccines; Vaccines; Biological Products; Complex Mixtures

Study Officials

• Md Taufiqul Islam, MBBS, MPH

  International Centre for Diarrhoeal Disease Research, Bangladesh

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Md Taufiqul Islam, MBBS, MPH

CONTACT

+8801857597139; taufiqulislam@icddrb.org

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: This is a open-label, randomized controlled, non-inferiority study. Study investigators along with study staff involved in safety evaluation and laboratory analysis will be blinded regarding the assigned treatment of the participant. The vaccine administration team will be un-blinded to the treatment assignment list. The vaccine administrator team members will not be involved in the evaluation of vaccine safety and laboratory analysis. The DSMB will be responsible for un-blinding the randomization number codes in the event of severe putative vaccine reactions. Otherwise, the codes will not be revealed until the end of the trial and until the computerized dataset has been frozen. If the intervention assignment is un-blinded, all study collaborators will be notified immediately. If deemed necessary, the DSMBs will recommend unblinding to the IRB and contact the study statistician responsible for providing information on the vaccine received by the individual in question.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: An open-label, randomized controlled, non-inferiority study of co-administration of OCV, TCV and MR vaccines among children 12 to 59 months of age in Dhaka, Bangladesh will be conducted. Children who did not receive any of the aforementioned vaccines will be included in the study.

Study Record Dates

• First Submitted: February 15, 2023
• First Posted: March 16, 2023
• Study Start: October 14, 2023
• Primary Completion: May 1, 2025
• Study Completion: May 1, 2025
• Last Updated: October 13, 2023

Record last verified: 2023-08

Data Sharing

• IPD Sharing: Will not share