Safety and Immunogenicity of Vi-DT Typhoid Conjugate Vaccine in Indonesian Adults, Adolescents, Children and Infants

Safety and Immunogenicity of Vi-DT Typhoid Conjugate Vaccine (Bio Farma) in Indonesian Adults, Adolescents, Children and Infants (Phase II)

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

Study Overview

• Status: Completed
• Conditions: Safety Issues; Immunogenicity
• Intervention / Treatment: Biological: Vi-DT Vaccine; Biological: Vi Polysaccharide Vaccine; Biological: IPV Vaccine

Detailed Description

To describe the safety of this vaccine following one dose immunization in adults, adolescent, children and infants.

To assess immunogenicity following one dose of Vi-DT vaccine immunization. To compare the safety and immunogenicity of Vi-DT to Vi polysaccharide vaccine in adults, adolescents, and children groups.

To compare the safety and immunogenicity of Vi-DT to IPV vaccine in infants groups.

Kinetics of Vi-specific IgG antibodies up to 6 months and 1 year after administration of 1 dose of vaccine.

To evaluate the safety and immunogenicity of Vi-DT co-administered with MR vaccine in infants (≥ 9months -23 months old).

To evaluate the safety and immunogenicity of MR vaccine co-administered with Vi-DT vaccine in infants (≥ 9months -23 months old).

• Study Type: Interventional
• Enrollment (Actual): 600
• Phase: Phase 2

Contacts and Locations

Study Locations

• Indonesia
  • Jakarta, Indonesia
    • Puskesmas Jatinegara
  • Jakarta, Indonesia
    • Puskesmas Senen

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 6 months to 40 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/legal guardians will commit themselves to comply with the instructions of the investigator and the schedule of the trial.

Exclusion Criteria For adults-adolescent-children:

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, corticosteroid therapy and other immunosuppresant).
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 1 month prior and expect to receive other vaccines within 1 month following immunization.
10. Individuals who have a previously ascertained typhoid fever within 3 months prior to immunization.
11. History of substance abuse (Adults).
12. Subject planning to move from the study area before the end of study period.

Exclusion Criteria for infants:

1. Subject concomitantly enrolled or scheduled to be enrolled in another trial
2. Mother less than 18 years of age at the age of enrollment of the infant
3. Evolving mild, moderate or severe illness, especially infectious diseases or fever (axillary temperature ³ 37.5°C)
4. Known history of allergy to any component of the vaccines
5. History of uncontrolled coagulopathy or blood disorders contraindicating intramuscular injection
6. Subject who has received in the previous 4 weeks a treatment likely to alter the immune response (intravenous immunoglobulins, blood-derived products, corticosteroid therapy and other immunosuppresant).
7. 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.
8. Individuals who have previously received any vaccines against typhoid fever.
9. Subjects already immunized with any vaccine within 1 month prior and expect to receive other vaccines within 1 month following immunization, except MR vaccine.
10. Individuals who have a previously ascertained typhoid fever within 3 months prior to immunization.
11. 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: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

6

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: VI-DT vaccine (adults,adolescent); 1 dose of 0.5 ml Vi-DT vaccine	Biological: Vi-DT Vaccine; 1 dose of Vi-DT Vaccine; Other Names: Typhoid Conjugate Vaccine
Active Comparator: Vi polysaccharide (adults,adolescent); 1 dose of 0.5 ml Vi polysaccharide vaccine	Biological: Vi Polysaccharide Vaccine; 1 dose of Vi Polysaccharide Vaccine
Experimental: VI-DT vaccine (children); 1 dose of 0.5 ml Vi-DT vaccine	Biological: Vi-DT Vaccine; 1 dose of Vi-DT Vaccine; Other Names: Typhoid Conjugate Vaccine
Active Comparator: Vi polysaccharide vaccine (children); 1 dose of 0.5 ml Vi polysaccharide vaccine	Biological: Vi Polysaccharide Vaccine; 1 dose of Vi Polysaccharide Vaccine
Experimental: VI-DT vaccine (infants); 1 dose of 0.5 ml Vi-DT vaccine	Biological: Vi-DT Vaccine; 1 dose of Vi-DT Vaccine; Other Names: Typhoid Conjugate Vaccine
Active Comparator: IPV Vaccine (infants); 1 dose of 0.5 ml IPV vaccine	Biological: IPV Vaccine; 1 dose of IPV 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 1 dose vaccination.	up to 28 days
Serious adverse events after vaccination	Number and percentage of subjects with serious adverse event from inclusion until 28 day after vaccination	28 days
Geometric Mean Titers (GMT)	Geometric Mean Titers (GMT) 28 days following immunization	28 days
Percentage of subjects with increasing antibody titer >= 4 times	Percentage of subjects with increasing antibody titer >= 4 times in all subjects	28 days

Collaborators and Investigators

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

Publications and helpful links

General Publications

• Medise BE, Soedjatmiko S, Gunardi H, Sekartini R, Satari HI, Hadinegoro SR, Wirahmadi A, Puspita M, Sari RM, Yang JS, Sil A, Sahastrabuddhe S, Bachtiar NS. A novel Vi-diphtheria toxoid typhoid conjugate vaccine is safe and can induce immunogenicity in healthy Indonesian children 2-11 years: a phase II preliminary report. BMC Pediatr. 2020 Oct 15;20(1):480. doi: 10.1186/s12887-020-02375-4.
• Medise BE, Soedjatmiko S, Gunardi H, Sekartini R, Satari HI, Hadinegoro SR, Wirahmadi A, Puspita M, Sari RM, Yang JS, Sil A, Sahastrabuddhe S, Bachtiar NS. One-month follow up of a randomized clinical trial-phase II study in 6 to <24 months old Indonesian subjects: Safety and immunogenicity of Vi-DT Typhoid Conjugate Vaccine. Int J Infect Dis. 2020 Apr;93:102-107. doi: 10.1016/j.ijid.2020.01.045. Epub 2020 Jan 28.

Study record dates

Study Major Dates

• Study Start (Actual): July 16, 2018
• Primary Completion (Actual): December 31, 2019
• Study Completion (Actual): January 30, 2020

Study Registration Dates

• First Submitted: March 4, 2018
• First Submitted That Met QC Criteria: March 4, 2018
• First Posted (Actual): March 9, 2018

Study Record Updates

• Last Update Posted (Actual): February 20, 2020
• Last Update Submitted That Met QC Criteria: February 18, 2020
• Last Verified: February 1, 2020

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
• Other Study ID Numbers: Typhoid 0218

Drug and device information, study documents

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