Parasitism & COVID19 Vaccines: New Challenge.

NCT05185778 | Unknown FDA Drug

• 1 other identifier: parasitism & COVID19 vaccines
• Study Type: observational
• Target: 128
• Locations: 0 countries
• Sites: N/A

Brief Summary

\- Parasitic infection is a serious public health problem throughout the world particularly in developing countries including Egypt. The individuals infected with helminths are responding to the parasite infections by a specific Th2 type innate and adaptive immune responses. The Coronavirus Disease 2019 pandemic has affected over 169 million people and caused the death of millions worldwide. COVID vaccines with up to 95% of efficacy and effectiveness have been developed and approved by the Food and Drug Administration (FDA), USA. Moreover, it's reported that vaccination against COVID may lead to Cytokine Storm Syndrome in some vaccinated people with release of large amounts of cytokines as (IFNγ, IL-12, TNFα).

Conditions

Helminths Infection; Protozoan Infections

Outcome Measures

Primary Outcomes (3)

• -Evaluation of CBC changes associated with some helminths and protozoan infected patients.

  3 years

• - Estimation of cytokines level in some helminths and protozoan infected patients.

  3 years

• - Correlation of CBC changes and cytokines level with COVID-19 vaccine administration.

  3 years

Secondary Outcomes (1)

• - study parasitic prevalence in community after COVID changes.

  3 years

Study Arms (2)

parasitic infected individuals received COVID-19 vaccine

parasitic infected individuals with helminthic or protozoan who received COVID-19 vaccines of any type

Biological: stool examination, blood sample collected

parasitic infected individuals not received COVID-19 vaccine

parasitic infected individuals with helminthic or protozoan who don't receive COVID-19 vaccines of any type

Biological: stool examination, blood sample collected

Interventions

stool examination, blood sample collected BIOLOGICAL

Stool examination macroscopically for consistency, color, and presence of blood and/or mucus and microscopically using the following methods: * Saline and iodine wet mount. * Formalin-ethyl acetate sedimentation method. * Modified Ziehl-Nielsen staining : It was done to all cases with manifestations suggestive of protozoa. * Collection of peripheral blood samples for Automated CBC and blood indices evaluation. * Molecular detection of inflammatory cytokines level (IFNγ, TNFα) and antiinflammatory cytokines (IL4, IL10) by Real-time PCR(polymerase chain reaction).

parasitic infected individuals not received COVID-19 vaccine; parasitic infected individuals received COVID-19 vaccine

Eligibility Criteria

• Age: 15 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Vaccinated and non-vaccinated individuals with COVID-19 vaccines who are known to have different parasitic infections (helminths and protozoan) and admitted to Assiut city hospitals.

You may qualify if:

• Vaccinated and non-vaccinated individuals with COVID-19 vaccines who are known to have different parasitic infections (helminths and protozoan) and admitted to Assiut city hospitals.

You may not qualify if:

• Bleeding disorders that may alter CBC results.

Sponsors & Collaborators

• Assiut University: lead

Biospecimen

Retention: SAMPLES WITH DNA

peripheral blood samples

MeSH Terms

Conditions

Protozoan Infections

Condition Hierarchy (Ancestors)

Parasitic Diseases; Infections

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: January 9, 2022
• First Posted: January 11, 2022
• Study Start: April 1, 2022
• Primary Completion: October 30, 2024
• Study Completion: October 30, 2025
• Last Updated: April 1, 2022

Record last verified: 2022-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL