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

Phase 2

Completed

• Conditions: Safety Issues; Immunogenicity
• Interventions: Biological: Vi Polysaccharide Vaccine; Biological: Vi-DT Vaccine; Biological: IPV Vaccine

• Registration Number: NCT03460405
• Lead Sponsor: PT Bio Farma

Brief Summary

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

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 Timeline

• Study First Submitted: 2018-03-04
• Study First Submitted QC: 2018-03-04
• Study First Posted: 2018-03-09
• Study Start: 2018-07-16
• Primary Completion: 2019-12-31
• Study Completion: 2020-01-30
• Status Verified: 2020-02
• Last Update Submitted: 2020-02-18
• Last Update Posted: 2020-02-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 600

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.

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Vi polysaccharide vaccine (children)	Vi Polysaccharide Vaccine	1 dose of 0.5 ml Vi polysaccharide vaccine
VI-DT vaccine (infants)	Vi-DT Vaccine	1 dose of 0.5 ml Vi-DT vaccine
VI-DT vaccine (children)	Vi-DT Vaccine	1 dose of 0.5 ml Vi-DT vaccine
Vi polysaccharide (adults,adolescent)	Vi Polysaccharide Vaccine	1 dose of 0.5 ml Vi polysaccharide vaccine
VI-DT vaccine (adults,adolescent)	Vi-DT Vaccine	1 dose of 0.5 ml Vi-DT vaccine
IPV Vaccine (infants)	IPV Vaccine	1 dose of 0.5 ml IPV vaccine

Primary Outcome Measures

Name	Time	Method
Local reaction and systemic event after vaccination	28 days	Percentage of subjects with at least one immediate reaction (local reaction or systemic event) after vaccination.

Secondary Outcome Measures

Name	Time	Method
Adverse events after vaccination	up to 28 days	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.
Serious adverse events after vaccination	28 days	Number and percentage of subjects with serious adverse event from inclusion until 28 day after vaccination
Geometric Mean Titers (GMT)	28 days	Geometric Mean Titers (GMT) 28 days following immunization
Percentage of subjects with increasing antibody titer >= 4 times	28 days	Percentage of subjects with increasing antibody titer \>= 4 times in all subjects

Trial Locations

Locations (2)

Puskesmas Jatinegara; 🇮🇩 Jakarta, Indonesia

Puskesmas Senen; 🇮🇩 Jakarta, Indonesia