Long-Term Protection of Vi Antibodies Induced by Bio TCV in Indonesian Population Compared to PQed TCV

Not yet recruiting

• Conditions: Antibody Typhoid Vaccine

• Registration Number: NCT06921460
• Lead Sponsor: PT Bio Farma

Brief Summary

Typhoid fever is a serious systemic infection caused by the enteric pathogen Salmonella enterica serovar typhi. S typhi is spread by the fecal-oral route. Although largely an endemic disease, S. typhi has epidemic potential. This research aims to determine the long-term immune response after administration of one dose of Bio TCV and PQed TCV vaccines in the population in Indonesia. Research participants will be taken from research participants who complete the Bio TCV (Typhoid 0319) Phase III clinical trial research included in the Main Study Group I.

Detailed Description

Typhoid fever is a serious systemic infection caused by the enteric pathogen Salmonella enterica serovar typhi. S typhi is spread by the fecal-oral route. Although largely an endemic disease, S. typhi has epidemic potential. Data mainly from Asia, Africa and Latin America show that typhoid fever continues to be a public health problem in many developing countries, with school-age children (aged 5-15 years) disproportionately affected. In some endemic areas, children aged \< 5 years show incidence rates similar to, or exceeding those, of school age children. WHO conservatively estimates the annual global incidence of typhoid fever at 21 million cases, of which 1-4% ends fatally. An estimated 90% of these deaths occur in Asia. Increasing multidrug resistance of S. typhi reduces the effective treatment options, increases treatment costs and results in higher rates of serious complications and deaths.

This research aims to determine the long-term immune response after administration of one dose of Bio TCV and PQed TCV vaccines in the population in Indonesia. Research participants will be taken from research participants who complete the Bio TCV (Typhoid 0319) Phase III clinical trial research included in the Main Study Group I. During the research, participants will make one (1) research visit to the health center for examination and blood sampling. After 5 years of being given the Typhoid vaccine, participants will be contacted by telephone to be given information about the research that will be conducted on you/your child. The research team will ask questions about the willingness to participate in the research. If they agree, a visit will be scheduled to the research site. This research is conducted by the Department of Pediatrics, Cipto Mangunkusumo Hospital, Jakarta, Dr. Soetomo Hospital, Surabaya and PT Bio Farma.

Study Timeline

• Study First Submitted: 2024-11-06
• Status Verified: 2025-03
• Study Start: 2025-04-01
• Study First Submitted QC: 2025-04-08
• Last Update Submitted: 2025-04-08
• Study First Posted: 2025-04-10
• Last Update Posted: 2025-04-10
• Primary Completion: 2025-06-01
• Study Completion: 2025-12-31

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 624

Inclusion Criteria

• Healthy
• Subject/Parents/legal guardian(s) have been informed properly regarding the study and signed the informed consent form/and informed assent form.
• Subject/parents/legal guardian(s) will commit to comply with the instructions of the investigator and the schedule of the trial.

Exclusion Criteria

• History of uncontrolled coagulopathy or blood disorders contraindicating for phlebotomy.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
To evaluate antibody persistence 5 years after vaccination with one dose of Vi-DT vaccine (Bio TCV), compared to PQed TCV (Typbar)	5 years since got vaccination

Trial Locations

Locations (1)

Department of Child Health Dr. Soetomo Hospital/School of Medicine, Airlangga University, Surabaya, East Java; 🇮🇩 Jakarta, DKI Jakarta, Indonesia