Cryptosporidiosis
Conditions
Brief summary
The purpose of this study is to explore the role of anti-parasite antibody in protection of children from the parasitic infection cryptosporidiosis. This work has the promise of identifying immune pathways important for protection from parasitic infections of the gut, and will help with designing a vaccine to prevent this infection estimated to cause, from diarrhea and malnutrition, an overall burden of 12 million disability-adjusted life-years in children.
Interventions
None listed
Sponsors
International Centre for Diarrhoeal Disease Research, Bangladesh
National Institutes of Health (NIH)
University of Virginia
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
1 Days to 7 Days
Healthy volunteers
Yes
Inclusion criteria
* Mother willing to sign informed consent form. * Healthy infant * No obvious congenital abnormalities or birth defects. * Stable household with no plans to leave the area for the next one year.
Exclusion criteria
* Parents are not willing to have child's blood drawn. * Parents are planning to enroll child into another interventional clinical study during the time period of this trial that could affect the outcomes of this study. * Mother not willing to have blood drawn and breast milk extracted. * Parents not willing to have field research assistant in home two times per week. * History of seizures or other apparent neurologic disorders. * Infant has any sibling currently or previously enrolled in this study, including a twin.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Functional characterization of anti-Cryptosporidium antibodies associated with protection | Birth until 4 years | Measure antibody isotype and subclass, mucosal (stool) vs systemic (plasma), complement fixation and opsonophagocytosis using bead-based multiplex immunoassays. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Polymerase chain reaction (PCR) testing for diarrheal pathogens during acute infection | Birth to 4 years old | To be conducted on children's acute and convalescent stool during diarrheal episodes. |
| Determine the role of circulating T follicular helper (cTfh) cells in induction of antibody response | Through collection of blood specimens on day 0, 14 and 28 during acute infection. | Use Activation Induced Marker (AIM) assays to test parasite infection-dependent changes in the activation, frequency, and immunophenotype of circulating Tfh cells. |
| Determination of maternal humoral response and impact on child infection/immunity | On enrollment (all) and 4 months (breast milk only). | Collect mother blood, stool and breast milk on enrollment. Collect second breast milk at 4 months. |
| In depth characterization of Cryptosporidium antigens recognized by the child humoral immune response | Birth until 4 years. | Utilize this longitudinal study of children and a Cryptosporidium protein microarray to probe plasma for the breadth of antigens recognized as well as the specific antigens to which children respond as they develop protective immunity. |
| Determine child anthropometric measures | Every 6 months until 4 years | Collect height, weight, mid-upper arm circumference. |
| Socioeconomic status questionnaire | At enrollment | To be conducted on mothers. |
| Household sanitation questionnaire | At enrollment | To be conducted on mothers. |
| Surveillance polymerase chain reaction (PCR) testing for diarrheal pathogens | Birth until 4 years. | To be conducted on child non diarrheal stool collected twice monthly. |
Countries
Bangladesh
Outcome results
None listed