Typhoid Clinical Trial
Official title:
A Randomized, Observer-Blinded, Phase I Study to Assess the Safety and Immunogenicity of Vi-DT Conjugate Vaccine Compared to Vi-Polysaccharide (Typhim Vi®, Sanofi Pasteur) Typhoid Vaccine in Healthy Filipino Adults and Children
Verified date | February 2018 |
Source | International Vaccine Institute |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
This is a Phase I, Randomized, observer-blinded, age de-escalating study.
The study objectives are:
1. To evaluate the safety of 25 μg of Vi-DT typhoid conjugate vaccine administered at 0 and
4 weeks.
2. To assess the immunogenicity of 25 μg of Vi-DT typhoid conjugate vaccine administered at
0 and 4 weeks.
3. To compare the safety and immunogenicity of Vi-DT and Vi-Polysaccharide typhoid
vaccines.
Status | Completed |
Enrollment | 144 |
Est. completion date | February 9, 2017 |
Est. primary completion date | February 9, 2017 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 2 Years to 45 Years |
Eligibility |
Inclusion Criteria: 1. Healthy male and female individual 2-45 years of age 2. Participants/Parents who have voluntarily given informed consent and/or assent. 3. Participants/Parents willing to commit complying with the study procedures of the investigator and available for the entire duration of study Exclusion Criteria: 1. Participants concomitantly enrolled or scheduled to be enrolled in another trial 2. Acute illness, in particular infectious diseases or fever (axillary temperature > 38°C), with in three days prior to enrollment and vaccination. 3. Known history of allergy to vaccines or other medications 4. Known history of allergy to egg, chiken protein, neomycin and formaldehyde. 5. History of uncontrolled coagulopathy or blood disorders 6. Known history of immune function disorders including immunodeficiency diseases, or chronic use of systemic steroids (> 20 mg/day prednisone equivalent for periods exceeding 10 days), cytotoxic or other immunosuppressive drugs 7. Any abnormality or chronic disease which in the opinion of the investigator might be detrimental for the safety of the participant and interfere with the assessment of the trial objectives 8. Pregnancy & Lactation (female adults) 9. Female with child-bearing potential during the study period. i.e., sexually active and not practicing effective acceptable contraceptive method 10. Individuals who have previously received any vaccines against typhoid fever 11. Individuals already immunized with any licensed vaccine within 4 weeks prior to enrolment/vaccination (day 0) and expected to receive other licensed vaccines within 60 days following the first dose (day 0), except for tetanus toxoid vaccine 12. Individuals who have a previously ascertained or suspected disease caused by S. typhi. 13. Individuals who have had household contact with/and or intimate exposure to an individual with laboratory-confirmed S. typhi 14. History of alcohol or substance abuse 15. Subject planning to move from the study area before the end of study period |
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
International Vaccine Institute | SK Chemicals Co., Ltd. |
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Safety endpoints for solicited adverse events (reactogenicity) and serious adverse events | Proportion of participants with local and systemic solicited adverse events (reactogenicity) and Proportion of participant with Serious Adverse Events (SAEs) | 4 weeks post first and second vaccination | |
Secondary | Proportion of participants with sero-conversion | Defined as a four-fold rise in anti-Vi antibody titers compared to baseline measured by anti-Vi IgG ELISA and Serum Bactericidal Assay | 4 weeks post first and second injections of Vi-DT and one injection of Vipolysaccharide | |
Secondary | Geometric Mean Titers (GMT) | Measurement of the Geometric Mean Titers (GMT) following 4 weeks post first and second injections of Vi-DT and one injection of Vi-polysaccharide vaccine | 4 weeks post first and second vaccination |
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