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

Persistence and Long-Term Protection of Vi Antibodies Induced by Vi-DT Conjugate Vaccines in Indonesian Adults, Adolescent, Children and Infants

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Vaccine
• Intervention / Treatment: Drug: Vi-DT Typhoid Conjugate Vaccine

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.

• Study Type: Interventional
• Enrollment (Actual): 188
• Phase: Phase 2; Phase 3

Contacts and Locations

Study Locations

• Indonesia
  • Jakarta, Indonesia
    • Puskesmas Jatinegara
  • Jakarta, Indonesia
    • Puskesmas Senen

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 6 months to 40 years (Child, Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Vi-DT Typhoid Conjugate Vaccine; Participants receive 1 dose (0.5ml) Vi-DT Typhoid Conjugate Vaccine, intramuscularly.	Drug: Vi-DT Typhoid Conjugate Vaccine; Typhoid Conjugate Vaccine

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
To evaluate antibody persistence 2 years after vaccination with one dose of Vi-DT in adults, adolescent, children and infants	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.	2 years + 2 months after primary dose

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
To evaluate immunogenicity one month after booster dose of Vi-DT in subject aged 6-23 months when receiving the primary dose.	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.	28 days (-4/+14D)
To assess the safety following booster vaccination in subject aged 6-23 months when receiving the primary dose.	Percentage of subject with at least one adverse event, solicited or unsolicited, within 30 minutes, 72hours, 7 days and 28 days after booster dose.	28 days (-4/+14D)
To evaluate antibody persistence 3, 4 and 5 years after vaccination with one dose of Vi-DT in adults, adolescents, and children groups.	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.	5 years
To evaluate antibody persistence 1, 2 and 3 years after booster vaccination in subject aged 6-23 months when receiving the primary dose.	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.	3 years

Collaborators and Investigators

• Sponsor: PT Bio Farma
• Collaborators: Indonesia University
• Investigators: Principal Investigator: Bernie E Medise, MD, Department of Child Health, School of Medicine, University of Indonesia

Study record dates

Study Major Dates

• Study Start (Actual): May 3, 2021
• Primary Completion (Anticipated): October 28, 2024
• Study Completion (Anticipated): December 30, 2024

Study Registration Dates

• First Submitted: January 27, 2021
• First Submitted That Met QC Criteria: February 3, 2021
• First Posted (Actual): February 5, 2021

Study Record Updates

• Last Update Posted (Actual): September 19, 2022
• Last Update Submitted That Met QC Criteria: September 15, 2022
• Last Verified: September 1, 2022

More Information

Terms related to this study

• Keywords: Vi-DT Typhoid Conjugate Vaccine
• Other Study ID Numbers: Typhoid 0220

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No