Non-inferiority Trial of Locally Manufactured Typhoid Conjugate Vaccine 'Typhocon' in Bangladesh

Sponsored by International Centre for Diarrhoeal Disease Research, Bangladesh

About this trial

Last updated a year ago

Study ID

PR-22013

Status

Completed

Type

Interventional

Phase

Phase 1

Placebo

Accepting

6 to 60 Years

All Sexes

Trial Timing

Ended 3 years ago

What is this trial about?

This is a double blinded, randomized-controlled, non-inferiority trial of a typhoid conjugate vaccine, Typhocon (Vi- polysaccharide conjugated to diphtheria toxoid, Vi-DT), manufactured by a local company, Incepta Vaccine Limited. The vaccine will be tested among individuals from 6 months to 60 years of age residing in Mirpur area of Dhaka city. The Typbar-TCV (Vi-polysaccharide conjugated to tetanus toxoid, Vi-TT), manufactured by Bharat Biotech International Limited will be used as a reference vaccine in this study. In Phase I the Typhocon vaccine will be tested in 30 adults. Safety and immunogenicity data of the vaccine for 30 adults will be submitted to the Data Safety Monitoring Board (DSMB), IRB and Directorate General of Drug Administration (DGDA). Upon receiving approval letter, the investigators will initiate the Phase II study including 600 individuals. The Phase II study will be conducted in age de-escalation manner (6-23 months, 2-5 years, 6-17 years and 18-60 years). Equal number of participants of all age groups will be enrolled for vaccination. Blood specimens will also be collected for carrying out the clinical chemistry (complete blood count with differential for white blood count, hemoglobin, absolute neutrophil count, platelet count, serum alanine transaminase, serum creatinine) on day -7 to day -2 for screening of participants before vaccination and on day 28, postvaccination. Based on blood reports of clinical chemistry, 600 participants will be randomized in a 1:1 ratio to allocate Typhocon or Typbar-TCV vaccine. Memory aid will be used to collect solicited adverse events following vaccination (AEFI) data up to day 7. Data on unsolicited AEFI and serious adverse events (SAEs) will be collected up to 28 days after vaccination. All study update including adverse events and serious adverse events will be reported to the DSMB. Blood specimen will be obtained on day 0 before vaccination, and day 28 for carrying out Enzyme-linked Immunosorbent Assay (ELISA) to determine anti-Vi-IgG antibody.

What are the participation requirements?

Inclusion Criteria

1. Provide informed written consent from participants or if minor from their parent/legal guardian

2. Healthy participants aged 6 months to 60 years

3. Family does not have any plan to move from the study area during study period.

Exclusion Criteria

1. History of hypersensitivity reaction to any component of the study vaccines.

2. History of typhoid vaccination within the last three years.

3. Fever of any origin or infections of more than 3 days within the past month.

4. Subjects with febrile illness (temperature >37.9 C) at the time of enrollment.

5. History of any vaccination within the past 30 days.

6. Clinically significant systemic disorder such as cardiovascular, respiratory, neurologic, gastrointestinal, hepatic, renal, endocrine, hematological or immunological disorder.

7. Participants with abnormalities in screening hematological and biochemical tests will be excluded for vaccination

8. Subjects with confirmed or suspected immunosuppressive or immunodeficiency disorder; or subjects on any immunosuppressive or immunostimulant therapy.

9. Known case of thrombocytopenia or any coagulation disorder, or subjects on anticoagulation therapy.

10. Subjects administered blood, blood containing products or immunoglobulins within the last 3 months or planned administration during the study.

11. Urine dipstick pregnancy test verified as positive

12. Pregnant* and lactating women & female subjects not using acceptable contraceptive measures (double barrier methods, oral or injectable hormonal contraceptives or surgical sterilization).

* Urine pregnancy test (UPT) will be performed in all married females prior to vaccination