Parasitism & COVID19 Vaccines: New Challenge.

NCT ID: NCT05185778

Last Updated: 2022-04-01

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 128 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2022-04-01
• Study Completion Date: 2025-10-30

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).

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).

Conditions

Helminths Infection; Protozoan Infections

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: CROSS_SECTIONAL

Study Groups

parasitic infected individuals received COVID-19 vaccine

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

stool examination, blood sample collected

Intervention Type: 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 with helminthic or protozoan who don't receive COVID-19 vaccines of any type

stool examination, blood sample collected

Intervention Type: 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).

Interventions

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).

Intervention Type: BIOLOGICAL

Eligibility Criteria

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.

• Minimum Eligible Age: 15 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Assiut University

OTHER

Sponsor Role: lead

Responsible Party

Reham Hany Mohammed

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Other Identifiers

parasitism & COVID19 vaccines

Identifier Type: -

Identifier Source: org_study_id