Persistence and Long-Term Protection of Vi Antibodies Induced by Vi-DT Conjugate Vaccines in Indonesian

Overview

Vi-DT Typhoid vaccine is a novel vaccine. This study will be done to know the long-term protection and persistent antibody by measured the antibody titer after 2,3,4 and 5 years after immunization.

Full Title of Study: “Persistence and Long-Term Protection of Vi Antibodies Induced by Vi-DT Conjugate Vaccines in Indonesian Adults, Adolescent, Children and Infants”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: N/A
    • Intervention Model: Single Group Assignment
    • Primary Purpose: Prevention
    • Masking: None (Open Label)
  • Study Primary Completion Date: October 28, 2024

Detailed Description

This study will be done to know the long-term protection and persistent antibody, by measured the antibody titer after 2,3,4 and 5 years after immunization.

Interventions

  • Drug: Vi-DT Typhoid Conjugate Vaccine
    • Typhoid Conjugate Vaccine

Arms, Groups and Cohorts

  • Experimental: Vi-DT Typhoid Conjugate Vaccine
    • Participants receive 1 dose (0.5ml) Vi-DT Typhoid Conjugate Vaccine, intramuscularly.

Clinical Trial Outcome Measures

Primary Measures

  • To evaluate antibody persistence 2 years after vaccination with one dose of Vi-DT in adults, adolescent, children and infants
    • Time Frame: 2 years + 2 months after primary dose
    • Percentage of adults, adolescent, children and infants with seroconversion defined as >= 4 fold in antibody titer of anti Vi IgG 2 years after vaccination compared to baseline.

Secondary Measures

  • To evaluate immunogenicity one month after booster dose of Vi-DT in subject aged 6-23 months when receiving the primary dose.
    • Time Frame: 28 days (-4/+14D)
    • Percentage of subject aged 6-23 months old at primary dose with seroconversion defined as >= 4 fold in antibody titer 28 days after booster dose compared to pre booster dose.
  • To assess the safety following booster vaccination in subject aged 6-23 months when receiving the primary dose.
    • Time Frame: 28 days (-4/+14D)
    • Percentage of subject with at least one adverse event, solicited or unsolicited, within 30 minutes, 72hours, 7 days and 28 days after booster dose.
  • To evaluate antibody persistence 3, 4 and 5 years after vaccination with one dose of Vi-DT in adults, adolescents, and children groups.
    • Time Frame: 5 years
    • Percentage of adults, adolescents and children with seroconversion defined as ≥ 4-fold in antibody titer of anti-Vi IgG 3,4 and 5 years after vaccination compared to baseline.
  • To evaluate antibody persistence 1, 2 and 3 years after booster vaccination in subject aged 6-23 months when receiving the primary dose.
    • Time Frame: 3 years
    • Percentage of adults, adolescents and children with seroconversion defined as ≥ 4-fold in antibody titer of anti-Vi IgG 3,4 and 5 years after vaccination compared to before booster.

Participating in This Clinical Trial

Inclusion Criteria

  • Healthy. – Subject who completed the phase II Vi-DT study (Typhoid 0218) – Subjects/Parents have been informed properly regarding the study and signed the informed consent form. – Subject/parents/legal guardians will commit to comply with the instructions of the investigator and the schedule of the trial. Exclusion Criteria:

  • Subject concomitantly enrolled or scheduled to be enrolled in another trial. – Evolving mild, moderate or severe illness, especially infectious diseases or fever (axillary temperature ≥ 37.5oC). – Known history of allergy to any component of the vaccines. – History of uncontrolled coagulopathy or blood disorders contraindicating intramuscular injection. – Any abnormality or chronic disease which according to the investigator might be compromised by the vaccination and/or interfere with the assessment of the trial objectives.

Gender Eligibility: All

Minimum Age: 6 Months

Maximum Age: 40 Years

Are Healthy Volunteers Accepted: Accepts Healthy Volunteers

Investigator Details

  • Lead Sponsor
    • PT Bio Farma
  • Collaborator
    • Indonesia University
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Bernie E Medise, MD, Principal Investigator, Department of Child Health, School of Medicine, University of Indonesia
  • Overall Contact(s)
    • Novilia S Bachtiar, MD, +622033755, novilia@biofarma.co.id

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