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

NCT03460405 | Completed Phase 2 DMC

• 1 other identifier: Typhoid 0218
• Study Type: interventional
• Target: 600
• Locations: 1 country
• Sites: 2

Brief Summary

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

Conditions

Safety Issues; Immunogenicity

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• Adverse events after vaccination

  up to 28 days

• Serious adverse events after vaccination

  28 days

• Geometric Mean Titers (GMT)

  28 days

• Percentage of subjects with increasing antibody titer >= 4 times

  28 days

Study Arms (6)

VI-DT vaccine (adults,adolescent)

EXPERIMENTAL

1 dose of 0.5 ml Vi-DT vaccine

Biological: Vi-DT Vaccine

Vi polysaccharide (adults,adolescent)

ACTIVE COMPARATOR

1 dose of 0.5 ml Vi polysaccharide vaccine

Biological: Vi Polysaccharide Vaccine

VI-DT vaccine (children)

EXPERIMENTAL

1 dose of 0.5 ml Vi-DT vaccine

Biological: Vi-DT Vaccine

Vi polysaccharide vaccine (children)

ACTIVE COMPARATOR

1 dose of 0.5 ml Vi polysaccharide vaccine

Biological: Vi Polysaccharide Vaccine

VI-DT vaccine (infants)

EXPERIMENTAL

1 dose of 0.5 ml Vi-DT vaccine

Biological: Vi-DT Vaccine

IPV Vaccine (infants)

ACTIVE COMPARATOR

1 dose of 0.5 ml IPV vaccine

Biological: IPV Vaccine

Interventions

Vi-DT Vaccine BIOLOGICAL

1 dose of Vi-DT Vaccine

Also known as: Typhoid Conjugate Vaccine

VI-DT vaccine (adults,adolescent); VI-DT vaccine (children); VI-DT vaccine (infants)

Vi Polysaccharide Vaccine BIOLOGICAL

1 dose of Vi Polysaccharide Vaccine

Vi polysaccharide (adults,adolescent); Vi polysaccharide vaccine (children)

IPV Vaccine BIOLOGICAL

1 dose of IPV Vaccine

IPV Vaccine (infants)

Eligibility Criteria

• Age: 6 Months - 40 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.
• 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)

Sponsors & Collaborators

• PT Bio Farma: lead

Study Sites (2)

Puskesmas Jatinegara

Jakarta, Indonesia

Location

Puskesmas Senen

Jakarta, Indonesia

Location

Related Publications (3)

• Koesnoe S, Medise BE, Rengganis I, Hadinegoro SR, Puspita M, Sari RM, Yang JS, Sahastrabuddhe S, Soedjatmiko, Gunardi H, Sekartini R, Wirahmadi A, Kekalih A, Mukhi S, Satari HI, Bachtiar NS. A phase II clinical trial of a Vi-DT typhoid conjugate vaccine in healthy Indonesian adolescents and adults: one-month evaluation of safety and immunogenicity. Trop Dis Travel Med Vaccines. 2024 Feb 1;10(1):3. doi: 10.1186/s40794-023-00210-z.

  PMID: 38297337 DERIVED

• 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.

  PMID: 33059607 DERIVED

• 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.

  PMID: 32004693 DERIVED

MeSH Terms

Interventions

Vi polysaccharide vaccine, typhoid

Study Officials

• Bernie Endyarni, MD

  Faculty of Medicine, University of Indonesia

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: 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).
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: 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).

Study Record Dates

• First Submitted: March 4, 2018
• First Posted: March 9, 2018
• Study Start: July 16, 2018
• Primary Completion: December 31, 2019
• Study Completion: January 30, 2020
• Last Updated: February 20, 2020

Record last verified: 2020-02

Locations

ID (2)