Typhoid Clinical Trial
Official title:
A Phase 2 Randomized, Double-Blind, Controlled Trial of the Safety and Immunogenicity of Typhoid Conjugate Vaccine (Vi-TCV) Among Children Younger Than 2 Years in Ouagadougou, Burkina Faso
Verified date | July 2021 |
Source | University of Maryland, Baltimore |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
Typhoid fever is an illness that may cause mild effects in children, such as fever and feeling tired, or it may cause serious effects-- even death. A new typhoid vaccine has recently been recommended by the World Health Organization (WHO) to prevent typhoid in children. But this new typhoid vaccine has not been tested with all of the vaccines given to children in Burkina Faso. The investigators want to look at this new vaccine, and study how safe it is in children in Burkina Faso and how their immune systems respond to the vaccine when given with other vaccines, such as yellow fever and meningitis A vaccines. The investigators plan to vaccinate 100 children between the ages of 9-11 months, and 150 children between the ages of 15 months and 2 years, in Ouagadougou, Burkina Faso, with either the typhoid vaccine or a vaccine against another illness called polio. Children will have follow-up visits on days 3, 7, 28 and 180. One teaspoon of blood will be collected on days 0 and 28.
Status | Completed |
Enrollment | 251 |
Est. completion date | August 22, 2019 |
Est. primary completion date | August 22, 2019 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 9 Months to 23 Months |
Eligibility | Inclusion Criteria: Each subject receiving study vaccine (Vi-TCV or IPV) must satisfy the following inclusion criteria at study entry: - Male or female child 9 through11 months of age for cohort 1, or 15 months through 23 months of age for cohort 2, and in good health at the time of study vaccination. - A child whose parent or guardian resides primarily within the study area at the time of study vaccinations and who intends to be present in the area for the duration of the trial. - A child whose parent or guardian has voluntarily given informed consent. Exclusion Criteria: No subject receiving study vaccine (Vi-TCV or IPV) may have any of the following exclusion criteria at study entry: - History of documented hypersensitivity to any component of the vaccine. - Prior receipt of any typhoid vaccine. - History of severe allergic reaction with generalized urticaria, angioedema, or anaphylaxis. - Known history of diabetes, tuberculosis, cancer, chronic kidney, heart, or liver disease, progressive neurological disorders, poorly controlled seizures, or terminal illness. - Severe malnutrition as determined by a MUAC < 12.5 cm. - Receipt of any other investigational intervention in the last 6 months or anticipated during the course of the study. - Receipt of blood products in the last 6 months. - Known HIV infection or exposure or other immunosuppressive conditions. - Receipt of systemic immunosuppressant or systemic corticosteroids. - Receipt of any measles-rubella-containing vaccine for children younger than 1 year of age. - Any condition determined by the investigator likely to interfere with evaluation of the vaccine or to be a significant potential health risk to the child or make it unlikely that the child would complete the study. Temporary Exclusion Criteria: The following will be considered a temporary contraindication to enrollment and vaccination. If this applies, the participant will be temporarily excluded for vaccination until 48 hours has passed. A re-assessment will be needed to ensure the temporary exclusion criteria no longer exist: • Reported fever within 24 hours before vaccination. An additional temporary exclusion criteria for cohort 2 will be: • Receipt of measles-rubella vaccine in the one month before enrollment, as determined by parental history or vaccination card. A child may be reassessed after 30 days has passed since receipt of MR vaccine. |
Country | Name | City | State |
---|---|---|---|
Burkina Faso | Groupe de Recherche Action en Santé (GRAS) | Ouagadougou |
Lead Sponsor | Collaborator |
---|---|
University of Maryland, Baltimore | Bill and Melinda Gates Foundation, Groupe de Recherche Action en Sante |
Burkina Faso,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Safety of Vi-TCV After 7 Days | The proportion of participants who develop adverse events detected in the first 7 days after vaccination. | Within 7 days after vaccination | |
Primary | Safety of Vi-TCV After 6 Months | The proportion of participants who experience serious adverse events within 6 months of vaccination in all participants. | Within 6 months after vaccination | |
Primary | Safety of Vi-TCV After 28 Days | The proportion of participants who experience other non-serious adverse events up to 28 days following vaccination, in a subset of participants. | Within 28 days after vaccination | |
Secondary | Noninterference Vi-TCV with Yellow Fever Vaccine | The immunogenicity of YF when given with and without Vi-TCV, measured by yellow fever plaque reduction neutralization test at study days 0 and 28 among children in cohort 1, groups 1 and 2. | At days 0 and 28 | |
Secondary | Noninterference of Vi-TCV with Meningitis A Vaccine | The immunogenicity of MAV when given with and without Vi-TCV, measured by serum bactericidal antibody at study days 0 and 28 among children in cohort 2, groups 4 and 5. | At days 0 and 28 | |
Secondary | Noninterference of Yellow Fever Vaccine with Vi-TCV | The immunogenicity of Vi-TCV when given with YF, measured by ELISA for anti-Vi percent seroconversion (>4-fold increase in geometric mean titer (GMT)) and GMT at study days 0 and 28 among children in cohort 1, groups 1 and 2. | At days 0 and 28 | |
Secondary | Noninterference of Meningitis A Vaccine with Vi-TCV | The immunogenicity of Vi-TCV when given with and without MAV, measured by ELISA for anti-Vi percent seroconversion (>4-fold increase in GMT) and GMT at study days 0 and 28 among children in cohort 2, groups 3 and 4. | At days 0 and 28 |
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