Typhoid Conjugate Vaccine Trial Among Children Younger Than 2 Years in Ouagadougou, Burkina Faso

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Brief Title

Typhoid Conjugate Vaccine Trial Among Children Younger Than 2 Years in Ouagadougou, Burkina Faso

Official Title

A Phase 2 Randomized, Double-Blind, Controlled Trial of the Safety and Immunogenicity of Typhoid Conjugate Vaccine (Vi-TCV) Among Children Younger Than 2 Years in Ouagadougou, Burkina Faso

Brief Summary

      Typhoid fever is an illness that may cause mild effects in children, such as fever and
      feeling tired, or it may cause serious effects-- even death. A new typhoid vaccine has
      recently been recommended by the World Health Organization (WHO) to prevent typhoid in
      children. But this new typhoid vaccine has not been tested with all of the vaccines given to
      children in Burkina Faso. The investigators want to look at this new vaccine, and study how
      safe it is in children in Burkina Faso and how their immune systems respond to the vaccine
      when given with other vaccines, such as yellow fever and meningitis A vaccines.

      The investigators plan to vaccinate 100 children between the ages of 9-11 months, and 150
      children between the ages of 15 months and 2 years, in Ouagadougou, Burkina Faso, with either
      the typhoid vaccine or a vaccine against another illness called polio.

      Children will have follow-up visits on days 3, 7, 28 and 180. One teaspoon of blood will be
      collected on days 0 and 28.
    

Detailed Description

      This study will be divided into two cohorts, by age, with separate study designs. The first
      cohort will include children 9 through 11 months of age. The second cohort will comprise
      children 15 through 23 months of age. The purpose of this detailed evaluation of safety and
      immunogenicity is to assess the reactogenicity of the vaccine and the immune responses to
      Vi-TCV. Serum specimens will be collected from all participants on study day 0 (before
      vaccination) and on post-vaccination study day 28 to quantify anti-Vi and anti-tetanus toxoid
      antibodies. All children will have an additional 0.5 mL of blood collected on study day 0
      before study vaccination to test for the presence of malaria parasitemia at baseline.

      Children 9 through 11 months of age in the Ouagadougou study area will be eligible for the
      first age cohort, which will be a double-blind, individually randomized, controlled trial. Up
      to 100 children in this cohort will be randomized in a 1:1 ratio to receive Vi-TCV (Group 1)
      or IPV (Group 2). Participants will be unaware of which study vaccine, Vi-TCV or IPV, is
      received. Vi-TCV or IPV will be administered with measles-rubella vaccine (MR) and YFV, as
      per Burkina Faso Expanded Programme on Immunization (EPI) schedule. These 9 through
      11-month-old children will have immunogenicity to Vi-TCV, YFV, and tetanus toxoid assessed on
      study days 0 and 28.

      Children 15 through 23 months of age in the Ouagadougou study area will be eligible for the
      second cohort, a randomized study of the safety and immunogenicity of Vi-TCV when
      co-administered with routine Expanded Programme on Immunisation (EPI) vaccines (MAV and MR)
      or given alone, and MAV immunogenicity when co-adminstered or given alone. Participants in
      this cohort (up to 150) will be randomized 1:1:1 to one of three treatment groups, as
      follows. The first group of participants (Group A) will receive Vi-TCV and IPV at study day
      0, with a subsequent dose of MAV at study day 28; the second group of participants (Group B)
      will receive MAV and Vi-TCV at study day 0; the third group (Group C) will receive MAV and
      IPV at study day 0. All children will receive MR at study day 0. Cohort 1 will be unblinded
      on day 28 for safety and follow-up and to ensure MAV receipt in Group A. These 15 through
      23-month-old children will have antibody to meningococcal A vaccine, anti-Vi antibody, and
      tetanus toxoid antibody assessed on study days 0 and 28.

      Participants in both cohorts will have home or clinic visits on days 3 and 7 following
      vaccination for solicitation of local and systemic adverse events. Non-serious adverse events
      will be assessed up until the study day 28 visit. Serious adverse events will be captured
      throughout study follow-up and actively during the study day 180 visit.
    

Study Phase

Phase 2

Study Type

Interventional


Primary Outcome

Safety of Vi-TCV After 7 Days

Secondary Outcome

 Noninterference Vi-TCV with Yellow Fever Vaccine

Condition

Typhoid

Intervention

Vi-Typhoid Conjugate Vaccine (Vi-TCV)

Study Arms / Comparison Groups

 Vi-Typhoid Conjugate Vaccine (Vi-TCV)
Description:  Children will receive a single 0.5-ml dose of Vi-TCV administered by the intramuscular route.

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information


Recruitment Status

Biological

Estimated Enrollment

251

Start Date

December 3, 2018

Completion Date

August 22, 2019

Primary Completion Date

August 22, 2019

Eligibility Criteria

        Inclusion Criteria: Each subject receiving study vaccine (Vi-TCV or IPV) must satisfy the
        following inclusion criteria at study entry:

          -  Male or female child 9 through11 months of age for cohort 1, or 15 months through 23
             months of age for cohort 2, and in good health at the time of study vaccination.

          -  A child whose parent or guardian resides primarily within the study area at the time
             of study vaccinations and who intends to be present in the area for the duration of
             the trial.

          -  A child whose parent or guardian has voluntarily given informed consent.

        Exclusion Criteria: No subject receiving study vaccine (Vi-TCV or IPV) may have any of the
        following exclusion criteria at study entry:

          -  History of documented hypersensitivity to any component of the vaccine.

          -  Prior receipt of any typhoid vaccine.

          -  History of severe allergic reaction with generalized urticaria, angioedema, or
             anaphylaxis.

          -  Known history of diabetes, tuberculosis, cancer, chronic kidney, heart, or liver
             disease, progressive neurological disorders, poorly controlled seizures, or terminal
             illness.

          -  Severe malnutrition as determined by a MUAC < 12.5 cm.

          -  Receipt of any other investigational intervention in the last 6 months or anticipated
             during the course of the study.

          -  Receipt of blood products in the last 6 months.

          -  Known HIV infection or exposure or other immunosuppressive conditions.

          -  Receipt of systemic immunosuppressant or systemic corticosteroids.

          -  Receipt of any measles-rubella-containing vaccine for children younger than 1 year of
             age.

          -  Any condition determined by the investigator likely to interfere with evaluation of
             the vaccine or to be a significant potential health risk to the child or make it
             unlikely that the child would complete the study.

        Temporary Exclusion Criteria: The following will be considered a temporary contraindication
        to enrollment and vaccination. If this applies, the participant will be temporarily
        excluded for vaccination until 48 hours has passed. A re-assessment will be needed to
        ensure the temporary exclusion criteria no longer exist:

        • Reported fever within 24 hours before vaccination.

        An additional temporary exclusion criteria for cohort 2 will be:

        • Receipt of measles-rubella vaccine in the one month before enrollment, as determined by
        parental history or vaccination card. A child may be reassessed after 30 days has passed
        since receipt of MR vaccine.
      

Gender

All

Ages

9 Months - 23 Months

Accepts Healthy Volunteers

Accepts Healthy Volunteers

Contacts

Neuzil Kathleen, MD, MPH, , 

Location Countries

Burkina Faso

Location Countries

Burkina Faso

Administrative Informations


NCT ID

NCT03614533

Organization ID

HP-00081030


Responsible Party

Principal Investigator

Study Sponsor

University of Maryland, Baltimore

Collaborators

 Bill and Melinda Gates Foundation

Study Sponsor

Neuzil Kathleen, MD, MPH, Principal Investigator, University of Maryland, Baltimore


Verification Date

March 2020