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

Phase 2

Active, not recruiting

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

• Registration Number: NCT04741828
• Lead Sponsor: PT Bio Farma

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.

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 Timeline

• Study First Submitted: 2021-01-27
• Study First Submitted QC: 2021-02-03
• Study First Posted: 2021-02-05
• Study Start: 2021-05-03
• Status Verified: 2022-09
• Last Update Submitted: 2022-09-15
• Last Update Posted: 2022-09-19
• Primary Completion: 2024-10-28
• Study Completion: 2024-12-30

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 188

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
To evaluate antibody persistence 2 years after vaccination with one dose of Vi-DT in adults, adolescent, children and infants	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 Outcome Measures

Name	Time	Method
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	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.
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)	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.	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.	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.

Trial Locations

Locations (2)

Puskesmas Jatinegara; 🇮🇩 Jakarta, Indonesia

Puskesmas Senen; 🇮🇩 Jakarta, Indonesia