Clinical trial NCT04741828: Persistence and Long-Term Protection of Vi Antibodies Induced by Vi-DT Conjugate Vaccines in Indonesian
Official title: Persistence and Long-Term Protection of Vi Antibodies Induced by Vi-DT Conjugate Vaccines in Indonesian Adults, Adolescent, Children and Infants
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
PHASE3
Conditions: Vaccine
Keywords: Vi-DT Typhoid Conjugate Vaccine
Lead sponsor: PT Bio Farma
Sponsor class: INDUSTRY
Collaborators: name: Indonesia University
First posted: 2021-02-05
Enrollment: 188
Sex: ALL
Minimum age (years): 6
Maximum age (years): 40
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: One dose Vi-DT vaccine in clinical trial subjects which is received primary dose at 6-23 months old.
Primary purpose: PREVENTION

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.

Eligibility criteria: 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.

Primary outcomes:
measure: To evaluate antibody persistence 2 years after vaccination with one dose of Vi-DT in adults, adolescent, children and infants
timeFrame: 2 years + 2 months after primary dose
Secondary outcomes:
measure: To evaluate immunogenicity one month after booster dose of Vi-DT in subject aged 6-23 months when receiving the primary dose.
timeFrame: 28 days (-4/+14D)
measure: To assess the safety following booster vaccination in subject aged 6-23 months when receiving the primary dose.
timeFrame: 28 days (-4/+14D)
measure: To evaluate antibody persistence 3, 4 and 5 years after vaccination with one dose of Vi-DT in adults, adolescents, and children groups.
timeFrame: 5 years
measure: To evaluate antibody persistence 1, 2 and 3 years after booster vaccination in subject aged 6-23 months when receiving the primary dose.
timeFrame: 3 years
Other outcomes:
Locations:
city: Jakarta
country: Indonesia
facility: Puskesmas Jatinegara
city: Jakarta
country: Indonesia
facility: Puskesmas Senen
Study officials:
affiliation: Department of Child Health, School of Medicine, University of Indonesia
name: Bernie E Medise, MD
role: PRINCIPAL_INVESTIGATOR
References: