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

PT Bio Farma188 enrolled

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.

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

Allocation

Purpose

PREVENTION

Masking

NONE

Enrollment

188

Conditions

Vaccine

Interventions

Vi-DT Typhoid Conjugate VaccineDRUG

Typhoid Conjugate Vaccine

Eligibility

Sex: ALLMin age: 6 MonthsMax age: 40 YearsHealthy volunteers:

Medical Language ↔ Plain English

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.

Locations (2)

Puskesmas Jatinegara

Jakarta, Indonesia

Puskesmas Senen

Jakarta, Indonesia

Outcomes

Primary Outcomes

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.

Time frame: 2 years + 2 months after primary dose

Secondary Outcomes

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.

Time frame: 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.

Time frame: 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.

Time frame: 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.

Time frame: 3 years

Data from ClinicalTrials.gov

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