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

Sponsor

PT Bio Farma (Industry)

Overall Status

Recruiting

CT.gov ID

NCT04741828

Collaborator

Indonesia University (Other)

188

Enrollment

Locations

Arm

43.9

Anticipated Duration (Months)

Patients Per Site

2.1

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Vaccine	Drug: Vi-DT Typhoid Conjugate Vaccine	Phase 2/Phase 3

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 Design

Study Type:

Interventional

Anticipated Enrollment :

188 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Intervention Model Description:

One dose Vi-DT vaccine in clinical trial subjects which is received primary dose at 6-23 months old.One dose Vi-DT vaccine in clinical trial subjects which is received primary dose at 6-23 months old.

Masking:

None (Open Label)

Primary Purpose:

Prevention

Official Title:

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

Actual Study Start Date :

May 3, 2021

Anticipated Primary Completion Date :

Oct 28, 2024

Anticipated Study Completion Date :

Dec 30, 2024

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Vi-DT Typhoid Conjugate Vaccine Participants receive 1 dose (0.5ml) Vi-DT Typhoid Conjugate Vaccine, intramuscularly.	Drug: Vi-DT Typhoid Conjugate Vaccine Typhoid Conjugate Vaccine

Arm

Intervention/Treatment

Experimental: Vi-DT Typhoid Conjugate Vaccine

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

Drug: Vi-DT Typhoid Conjugate Vaccine

Typhoid Conjugate Vaccine

Outcome Measures

Primary Outcome Measures

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

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.
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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

6 Months to 40 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Puskesmas Jatinegara	Jakarta		Indonesia
2	Puskesmas Senen	Jakarta		Indonesia

Sponsors and Collaborators

PT Bio Farma
Indonesia University

Investigators

Principal Investigator: Bernie E Medise, MD, Department of Child Health, School of Medicine, University of Indonesia

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

PT Bio Farma

ClinicalTrials.gov Identifier:

NCT04741828

Other Study ID Numbers:

Typhoid 0220

First Posted:

Feb 5, 2021

Last Update Posted:

Jul 19, 2021

Last Verified:

Jul 1, 2021

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by PT Bio Farma

Vi-DT Typhoid Conjugate Vaccine

Study Results

No Results Posted as of Jul 19, 2021