Typhoid Clinical Trial
Official title:
A Phase II, Randomized, Dose-scheduling, Observer-Blinded Study to Assess the Safety, Reactogenicity and Immunogenicity of Vi-DT Conjugate Vaccine in 6-23-Month Old Healthy Filipino Infants and Toddlers
Verified date | April 2020 |
Source | International Vaccine Institute |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
This is a randomized, observer-blinded Phase 2 study in healthy infants and toddlers 6-23 months of age at the time of the first vaccine dose. The purpose of this study is to assess the safety and immunogenicity of the Vi-DT vaccine in age group 6-23months of age. The Vi-DT vaccine is administered at 25 µg either as a single dose, or two doses given 6 months apart.
Status | Completed |
Enrollment | 285 |
Est. completion date | January 19, 2021 |
Est. primary completion date | July 28, 2018 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 6 Months to 23 Months |
Eligibility | Inclusion Criteria: - Healthy infants and children 6-23 months of age at enrollment as determined by medical history, physical examination and clinical judgment of the investigator - Birth weight = 2500 g - = 37 weeks of pregnancy or judge to be full-term by the midwife or birth attendant - Parents aged 18 years and above and legal guardians aged 21 years and above as per the legal authorization in the Philippines, who have voluntarily given informed consent - Parents/ legal guardians willing to follow the study procedures of the study and available for the entire duration of the study Exclusion Criteria: - Child with a congenital abnormality - Subject with abnormal routine biological values at screening - Subject concomitantly enrolled or scheduled to be enrolled in another trial - Acute illness, in particular infectious disease or fever (axillary temperature =37.5°C), within three days prior to enrolment and vaccination - 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 - Child with a previously ascertained or suspected disease caused by S. typhi - Child who have had household contact with/and or intimate exposure to an individual with laboratory-confirmed S. typhi - Known history or allergy to vaccines or other medications - Know history of allergy to eggs, chicken protein, neomycin and formaldehyde - History of uncontrolled coagulopathy or blood disorders - Mother has known HIV infection or other immune function disorders - Any abnormality or chronic disease which in the opinion of the investigator might be detrimental for the safety of the subject and interfere with the assessment of the study objectives - Child whose parents or legal guardian planning to move from the study area before the end of study period |
Country | Name | City | State |
---|---|---|---|
Philippines | Research Institute for Tropical Medicine(RITM) | Alabang | Muntinlupa City |
Lead Sponsor | Collaborator |
---|---|
International Vaccine Institute | Bill and Melinda Gates Foundation, SK Bioscience Co., Ltd. |
Philippines,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Exploratory Endpoints | Seroconversion rates of Measles, Mumps and Rubella will be determined 4 week after MMR vaccination. Serum titers will be measured by routinely used commercially available ELISA kits. Kit-specific threshold of positivity will be used to determine specific seroconversion rates. | At week 4, 4 week after MMR vaccination | |
Other | Exploratory Endpoints | Serum bactericidal titers will be determined using in-house functional assay assessing the number of survived S. Typhi Ty2 strain colony on Luria-Bertani plate. Serum bactericidal titer is defined as the highest dilution of serum that gives 50% of inhibition of colony formation of S. Typhi. | At week 28, 4 weeks after the second vaccination and at week 96 after the booster dose in selected group. | |
Primary | Safety endpoints: solicited and unsolicited adverse events and serious adverse events | Frequency (percentage) of solicited local reactions at the injection site: Pain, tenderness, erythema/redness, swelling/induration and pruritus local
Frequency (percentage) of solicited systemic reactions: Fever, lethargy, irritability, vomiting, diarrhea, drowsiness, loss of appetite, persistent crying, rash and nasopharyngitis Frequency (percentage) of unsolicited adverse events Frequency (percentage) of serious adverse events |
Solicited AE: during 7 days after each vaccination. Unsolicited AE: after the first vaccination until 4 weeks after the second vaccination. SAE will be captured after the first vaccination up to week 100 for Group A, week 96 for Group B, week 36 Group C | |
Secondary | Immunogenicity Endpoints | Seroconversion rate of anti-Vi IgG by Geometric Mean Titers (GMT) will be measured 4 weeks after the second vaccination using an in-house ELISA assay using standardized reagents and reference serum. The level of the specific anti-Vi IgG in ELISA units for each serum sample is determined by comparison to a reference serum. The number of anti-Vi IgG positive sera will be used to calculate the seroconversion rates. | At week 28, 4 weeks after the second vaccination |
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