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

Vaccine Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04741828
• Other study ID #: Typhoid 0220
• Status: Active, not recruiting
• Phase: Phase 2/Phase 3
• Start date: May 3, 2021
• Est. completion date: December 30, 2024

Study information

• Verified date: September 2022
• Source: PT Bio Farma
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 188
• Est. completion date: December 30, 2024
• Est. primary completion date: October 28, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 6 Months to 40 Years

Eligibility

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.

Related Conditions & MeSH terms

• Vaccine

Intervention

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

Locations

Country	Name	City	State
Indonesia	Puskesmas Jatinegara	Jakarta
Indonesia	Puskesmas Senen	Jakarta

Sponsors (2)

Lead Sponsor	Collaborator
PT Bio Farma	Indonesia University

Country where clinical trial is conducted

Indonesia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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)
Secondary	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)
Secondary	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
Secondary	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