Parasitism & COVID19 Vaccines: New Challenge.

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

- 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).

Study Overview

• Status: Not yet recruiting
• Conditions: Protozoan Infections; Helminths Infection
• Intervention / Treatment: Biological: stool examination, blood sample collected

Detailed 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).

• Study Type: Observational
• Enrollment (Anticipated): 128

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 15 years and older (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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.

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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; 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 with helminthic or protozoan who don't receive COVID-19 vaccines of any type	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 (IFNγ, TNFα) and antiinflammatory cytokines (IL4, IL10) by Real-time PCR(polymerase chain reaction).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
-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 Outcome Measures

Outcome Measure	Time Frame
- study parasitic prevalence in community after COVID changes.	3 years

Collaborators and Investigators

• Sponsor: Assiut University

Study record dates

Study Major Dates

• Study Start (Anticipated): April 1, 2022
• Primary Completion (Anticipated): October 30, 2024
• Study Completion (Anticipated): October 30, 2025

Study Registration Dates

• First Submitted: January 9, 2022
• First Submitted That Met QC Criteria: January 9, 2022
• First Posted (Actual): January 11, 2022

Study Record Updates

• Last Update Posted (Actual): April 1, 2022
• Last Update Submitted That Met QC Criteria: March 20, 2022
• Last Verified: March 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Disease Attributes; Parasitic Diseases; Infections; Communicable Diseases; Helminthiasis; Protozoan Infections
• Other Study ID Numbers: parasitism & COVID19 vaccines

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No