Parasitism & COVID19 Vaccines: New Challenge.

Protozoan Infections Clinical Trial

Official title:

Evaluation of Blood Elements Changes and Different Cytokines in Helminthic and Protozoan Infected Patients in Relation to COVID19 Vaccines.

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05185778
• Other study ID #: parasitism & COVID19 vaccines
• Status: Not yet recruiting
• Start date: April 1, 2022
• Est. completion date: October 30, 2025

Study information

• Verified date: March 2022
• Source: Assiut University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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).

Description:

• Parasitic infection is a serious public health problem throughout the world particularly in developing countries including Egypt.

• Stool examination and CBC(complete blood count) are considered as the most easily, affordable and accessible diagnostic tool to suspect the presence of parasitic infection.

• One of the most important laboratory findings in many helminthic and protozoan infections is the high rate of peripheral blood eosinophilia. Giardia lamblia cause increased number of lymphocytes.

• The individuals infected with helminths are responding to the parasite infections by a specific Th2 type innate and adaptive immune responses. The Th2 pattern cytokines predominate in long-term helminth infected individuals.

• During chronic helminths infection, there is increased production of interleukin-4 (IL-4) and interleukin-10 (IL-10) as anti-inflammatory cytokines, as well as increased activation and expansion of eosinophils, mast cells and basophils.

• In addition, IFNγ have an important inflammatory role in many protozoan parasites as Cryptosporidium, Microsporidia, Entamoeba histolytica.

• 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).

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 128
• Est. completion date: October 30, 2025
• Est. primary completion date: October 30, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 15 Years and older

Eligibility

Inclusion Criteria:

• 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.

Exclusion Criteria:

• Bleeding disorders that may alter CBC results.

Related Conditions & MeSH terms

• Communicable Diseases
• Helminthiasis
• Helminths Infection
• Infections
• Protozoan Infections

Intervention

Biological:
• stool examination, blood sample collected
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 (IFN?, TNFa) and antiinflammatory cytokines (IL4, IL10) by Real-time PCR(polymerase chain reaction).

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Assiut University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	-Evaluation of CBC changes associated with some helminths and protozoan infected patients.		3 years
Primary	- Estimation of cytokines level in some helminths and protozoan infected patients.		3 years
Primary	- Correlation of CBC changes and cytokines level with COVID-19 vaccine administration.		3 years
Secondary	- study parasitic prevalence in community after COVID changes.		3 years