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

Primary Purpose

Safety Issues, Immunogenicity

Status

Completed

Phase

Phase 2

Locations

Indonesia

Study Type

Interventional

Intervention

Vi-DT Vaccine

Vi Polysaccharide Vaccine

IPV Vaccine

About this trial

This is an interventional treatment trial for Safety Issues

Eligibility Criteria

6 Months - 40 Years (Child, Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

Healthy
Subjects/Parents have been informed properly regarding the study and signed the informed consent form
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:

Subject concomitantly enrolled or scheduled to be enrolled in another trial
Evolving mild, moderate or severe illness, especially infectious diseases or fever (axillary temperature ³ 37.5°C)
Known history of allergy to any component of the vaccines
History of uncontrolled coagulopathy or blood disorders contraindicating intramuscular injection
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).
Any abnormality or chronic disease which according to the investigator might interfere with the assessment of the trial objectives
Pregnancy & lactation (Adults)
Individuals who have previously received any vaccines against typhoid fever.
Subjects already immunized with any vaccine within 1 month prior and expect to receive other vaccines within 1 month following immunization.
Individuals who have a previously ascertained typhoid fever within 3 months prior to immunization.
History of substance abuse (Adults).
Subject planning to move from the study area before the end of study period.

Exclusion Criteria for infants:

Subject concomitantly enrolled or scheduled to be enrolled in another trial
Mother less than 18 years of age at the age of enrollment of the infant
Evolving mild, moderate or severe illness, especially infectious diseases or fever (axillary temperature ³ 37.5°C)
Known history of allergy to any component of the vaccines
History of uncontrolled coagulopathy or blood disorders contraindicating intramuscular injection
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).
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.
Individuals who have previously received any vaccines against typhoid fever.
Subjects already immunized with any vaccine within 1 month prior and expect to receive other vaccines within 1 month following immunization, except MR vaccine.
Individuals who have a previously ascertained typhoid fever within 3 months prior to immunization.
Subject planning to move from the study area before the end of study period.

Sites / Locations

Puskesmas Jatinegara
Puskesmas Senen

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm 6

Arm Type

Experimental

Active Comparator

Experimental

Active Comparator

Experimental

Active Comparator

Arm Label

VI-DT vaccine (adults,adolescent)

Vi polysaccharide (adults,adolescent)

VI-DT vaccine (children)

Vi polysaccharide vaccine (children)

VI-DT vaccine (infants)

IPV Vaccine (infants)

Arm Description

1 dose of 0.5 ml Vi-DT vaccine

1 dose of 0.5 ml Vi polysaccharide vaccine

1 dose of 0.5 ml Vi-DT vaccine

1 dose of 0.5 ml Vi polysaccharide vaccine

1 dose of 0.5 ml Vi-DT vaccine

1 dose of 0.5 ml IPV vaccine

Outcomes

Primary Outcome Measures

Local reaction and systemic event after vaccination

Percentage of subjects with at least one immediate reaction (local reaction or systemic event) after vaccination.

Secondary Outcome Measures

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.

Serious adverse events after vaccination

Number and percentage of subjects with serious adverse event from inclusion until 28 day after vaccination

Geometric Mean Titers (GMT)

Geometric Mean Titers (GMT) 28 days following immunization

Percentage of subjects with increasing antibody titer >= 4 times

Percentage of subjects with increasing antibody titer >= 4 times in all subjects

Full Information

NCT ID

NCT03460405

First Posted

March 4, 2018

Last Updated

February 18, 2020

Sponsor

PT Bio Farma

1. Study Identification

Unique Protocol Identification Number

NCT03460405

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

February 2020

Overall Recruitment Status

Completed

Study Start Date

July 16, 2018 (Actual)

Primary Completion Date

December 31, 2019 (Actual)

Study Completion Date

January 30, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

PT Bio Farma

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Safety Issues, Immunogenicity

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

Model Description

Subject aged 2 - 40 years old: Randomized, observer-blind, superiority design compared to Vi polysaccharide vaccine. Subject aged 6-23 months old: Randomized, observer-blind, superiority design compared to Inactivated Poliomyelitis Vaccine (IPV).

Masking

ParticipantInvestigator

Masking Description

Subject aged 2 - 40 years old: Randomized, observer-blind, superiority design compared to Vi polysaccharide vaccine. Subject 6-23 months old: Randomized, observer-blind, superiority design compared to Inactivated Poliomyelitis Vaccine (IPV).

Allocation

Randomized

Enrollment

600 (Actual)

8. Arms, Groups, and Interventions

Arm Title

VI-DT vaccine (adults,adolescent)

Arm Type

Experimental

Arm Description

1 dose of 0.5 ml Vi-DT vaccine

Arm Title

Vi polysaccharide (adults,adolescent)

Arm Type

Active Comparator

Arm Description

1 dose of 0.5 ml Vi polysaccharide vaccine

Arm Title

VI-DT vaccine (children)

Arm Type

Experimental

Arm Description

1 dose of 0.5 ml Vi-DT vaccine

Arm Title

Vi polysaccharide vaccine (children)

Arm Type

Active Comparator

Arm Description

1 dose of 0.5 ml Vi polysaccharide vaccine

Arm Title

VI-DT vaccine (infants)

Arm Type

Experimental

Arm Description

1 dose of 0.5 ml Vi-DT vaccine

Arm Title

IPV Vaccine (infants)

Arm Type

Active Comparator

Arm Description

1 dose of 0.5 ml IPV vaccine

Intervention Type

Biological

Intervention Name(s)

Vi-DT Vaccine

Other Intervention Name(s)

Typhoid Conjugate Vaccine

Intervention Description

1 dose of Vi-DT Vaccine

Intervention Type

Biological

Intervention Name(s)

Vi Polysaccharide Vaccine

Intervention Description

1 dose of Vi Polysaccharide Vaccine

Intervention Type

Biological

Intervention Name(s)

IPV Vaccine

Intervention Description

1 dose of IPV Vaccine

Primary Outcome Measure Information:

Title

Local reaction and systemic event after vaccination

Description

Percentage of subjects with at least one immediate reaction (local reaction or systemic event) after vaccination.

Time Frame

28 days

Secondary Outcome Measure Information:

Title

Adverse events after vaccination

Description

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.

Time Frame

up to 28 days

Title

Serious adverse events after vaccination

Description

Number and percentage of subjects with serious adverse event from inclusion until 28 day after vaccination

Time Frame

28 days

Title

Geometric Mean Titers (GMT)

Description

Geometric Mean Titers (GMT) 28 days following immunization

Time Frame

28 days

Title

Percentage of subjects with increasing antibody titer >= 4 times

Description

Percentage of subjects with increasing antibody titer >= 4 times in all subjects

Time Frame

28 days

10. Eligibility

Sex

All

Minimum Age & Unit of Time

6 Months

Maximum Age & Unit of Time

40 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Healthy Subjects/Parents have been informed properly regarding the study and signed the informed consent form 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: Subject concomitantly enrolled or scheduled to be enrolled in another trial Evolving mild, moderate or severe illness, especially infectious diseases or fever (axillary temperature ³ 37.5°C) Known history of allergy to any component of the vaccines History of uncontrolled coagulopathy or blood disorders contraindicating intramuscular injection 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). Any abnormality or chronic disease which according to the investigator might interfere with the assessment of the trial objectives Pregnancy & lactation (Adults) Individuals who have previously received any vaccines against typhoid fever. Subjects already immunized with any vaccine within 1 month prior and expect to receive other vaccines within 1 month following immunization. Individuals who have a previously ascertained typhoid fever within 3 months prior to immunization. History of substance abuse (Adults). Subject planning to move from the study area before the end of study period. Exclusion Criteria for infants: Subject concomitantly enrolled or scheduled to be enrolled in another trial Mother less than 18 years of age at the age of enrollment of the infant Evolving mild, moderate or severe illness, especially infectious diseases or fever (axillary temperature ³ 37.5°C) Known history of allergy to any component of the vaccines History of uncontrolled coagulopathy or blood disorders contraindicating intramuscular injection 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). 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. Individuals who have previously received any vaccines against typhoid fever. Subjects already immunized with any vaccine within 1 month prior and expect to receive other vaccines within 1 month following immunization, except MR vaccine. Individuals who have a previously ascertained typhoid fever within 3 months prior to immunization. Subject planning to move from the study area before the end of study period.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Bernie Endyarni, MD

Organizational Affiliation

Faculty of Medicine, University of Indonesia

Official's Role

Principal Investigator

Facility Information:

Facility Name

Puskesmas Jatinegara

City

Jakarta

Country

Indonesia

Facility Name

Puskesmas Senen

City

Jakarta

Country

Indonesia

12. IPD Sharing Statement

Citations:

PubMed Identifier

33059607

Citation

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.

Results Reference

derived

PubMed Identifier

32004693

Citation

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.

Results Reference

derived

Learn more about this trial

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

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