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

NCT04741828 | Completed Phase 2

• 1 other identifier: Typhoid 0220
• Study Type: interventional
• Target: 188
• Locations: 1 country
• Sites: 2

Brief Summary

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.

Conditions

Vaccine

Keywords

Vi-DT Typhoid Conjugate Vaccine

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• To evaluate immunogenicity one month after booster dose of Vi-DT in subject aged 6-23 months when receiving the primary dose.

  28 days (-4/+14D)

• To assess the safety following booster vaccination in subject aged 6-23 months when receiving the primary 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.

  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.

  3 years

Study Arms (1)

Vi-DT Typhoid Conjugate Vaccine

EXPERIMENTAL

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

Drug: Vi-DT Typhoid Conjugate Vaccine

Interventions

Vi-DT Typhoid Conjugate Vaccine DRUG

Typhoid Conjugate Vaccine

Vi-DT Typhoid Conjugate Vaccine

Eligibility Criteria

• Age: 6 Months - 40 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• PT Bio Farma: lead
• Indonesia University: collaborator

Study Sites (2)

Puskesmas Jatinegara

Jakarta, Indonesia

Location

Puskesmas Senen

Jakarta, Indonesia

Location

Study Officials

• Bernie E Medise, MD

  Department of Child Health, School of Medicine, University of Indonesia

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: One dose Vi-DT vaccine in clinical trial subjects which is received primary dose at 6-23 months old.

Study Record Dates

• First Submitted: January 27, 2021
• First Posted: February 5, 2021
• Study Start: May 3, 2021
• Primary Completion: October 28, 2024
• Study Completion: December 30, 2024
• Last Updated: June 3, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

ID (2)