Safety and Immunogenicity of Vi-DT Typhoid Conjugate Vaccine (Bio Farma) in Adults and Children (Phase I)

A Randomized, Observer Blinded, Comparative, Phase I Safety Study in Two Age De-escalating Cohorts to Assess the Safety and Immunogenicity of Vi-DT Typhoid Conjugate Vaccine (Bio Farma) in Adults and Children (Phase I)

This study is to assess the safety of Vi-DT vaccine in adults and children.

Study Overview

• Status: Completed
• Conditions: Safety Issues
• Intervention / Treatment: Biological: Vi-DT (Bio Farma); Biological: Vi polysaccharide vaccine; Biological: Influenzae vaccine; Biological: Pneumococcal conjugate vaccine

Detailed Description

To describe the safety of this vaccine following first and second dose immunization.

To assess preliminary information of immunogenicity following Vi-DT vaccine immunization.

• Study Type: Interventional
• Enrollment (Actual): 100
• Phase: Phase 1

Contacts and Locations

Study Locations

• Indonesia
  • Jakarta, Indonesia
    • Jatinegara Primary Health Center
  • DKI Jaya
    • Jakarta, DKI Jaya, Indonesia
      • Puskesmas Jatinegara

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 1 year to 36 years (Child, Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

1. Healthy
2. Subjects/Parents have been informed properly regarding the study and signed the informed consent form
3. Subject/Parents will commit to comply with the instructions of the investigator and the schedule of the trial

Exclusion Criteria:

1. Subject concomitantly enrolled or scheduled to be enrolled in another trial
2. Evolving mild, moderate or severe illness, especially infectious diseases or fever (axillary temperature ³ 37.5°C )
3. Known history of allergy to any component of the vaccines
4. History of uncontrolled coagulopathy or blood disorders contraindicating intramuscular injection
5. Subject who has received in the previous 4 weeks a treatment likely to alter the immune response (intravenous immunoglobulins, blood-derived products or long term corticotherapy (> 2 weeks).
6. Any abnormality or chronic disease which according to the investigator might interfere with the assessment of the trial objectives
7. Pregnancy & lactation (Adults)
8. Individuals who have previously received any vaccines against typhoid fever.
9. Subjects already immunized with any vaccine within 4 weeks prior and expect to receive other vaccines within 60 days following the first dose.
10. Individuals who have a previously ascertained typhoid fever.
11. History of alcohol or substance abuse.
12. Subject planning to move from the study area before the end of study period.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Vi-DT (Bio Farma); 2 dose of 0.5 ml of Vi-DT Conjugated typhoid vaccine	Biological: Vi-DT (Bio Farma); Typhoid Conjugate Vaccine
Active Comparator: Vi polysaccharide vaccine; 1 dose of 0.5 ml Vi polysaccharide vaccine + 1 dose of Influenzae Vaccine	Biological: Vi polysaccharide vaccine; Vi polysaccharide vaccine; Biological: Influenzae vaccine; 1 dose of Influenzae vaccine
Experimental: Vi-DT (Bio Farma) ~ Children; 2 dose of 0.5 ml of Vi-DT Conjugated typhoid vaccine	Biological: Vi-DT (Bio Farma); Typhoid Conjugate Vaccine
Active Comparator: Vi polysaccharide vaccine ~ Children; 1 dose of 0.5 ml Vi polysaccharide vaccine + 1 dose of Pneumococcal Conjugate Vaccine	Biological: Vi polysaccharide vaccine; Vi polysaccharide vaccine; Biological: Pneumococcal conjugate vaccine; 1 dose of Pneumococcal conjugate Vaccine

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Local reaction and systemic event after vaccination	Percentage of subjects with at least one immediate reaction (local reaction or systemic event) after vaccination.	28 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Adverse events after vaccination	Percentage of subjects with at least one of these adverse events, solicited or not, within 24 h, 48h, 72h and 28 days after each vaccination.	28 days
Serious adverse events after vaccination	Number and percentage of subjects with serious adverse event from inclusion until 28 day after vaccination and up to 6 months after the last vaccination.	28 days
Routine laboratory evaluation that probably related to the vaccination.	Deviation from routine blood laboratory, kidney and liver function laboratory evaluation that probably related to the vaccination.	7 days
Preliminary assessment of immunogenicity of typhoid conjugated vaccine (Vi-DT)	Percentage of subjects with > 4 times increasing antibody	28 days
Geometric Mean Titers (GMT) following immunization	Geometric Mean Titers (GMT) 28 days following immunization	28 days

Collaborators and Investigators

• Sponsor: PT Bio Farma
• Investigators: Principal Investigator: Bernie Endyarni, MD, Faculty of Medicine, University of Indonesia

Study record dates

Study Major Dates

• Study Start (Actual): April 18, 2017
• Primary Completion (Actual): September 28, 2017
• Study Completion (Actual): February 19, 2018

Study Registration Dates

• First Submitted: November 1, 2016
• First Submitted That Met QC Criteria: April 5, 2017
• First Posted (Actual): April 12, 2017

Study Record Updates

• Last Update Posted (Actual): March 6, 2018
• Last Update Submitted That Met QC Criteria: March 4, 2018
• Last Verified: July 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Infections; Gram-Negative Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Enterobacteriaceae Infections; Salmonella Infections; Typhoid Fever; Physiological Effects of Drugs; Immunologic Factors; Vaccines; Heptavalent Pneumococcal Conjugate Vaccine
• Other Study ID Numbers: Typhoid 0116

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No