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: 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
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.
- 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
- 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.
- 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
- 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
- Lead Sponsor
- PT Bio Farma
- Indonesia University
- Provider of Information About this Clinical Study
- 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, email@example.com
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