Parasitism & COVID19 Vaccines: New Challenge.

Sponsor
Assiut University (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05185778
Collaborator
(none)
128
43

Study Details

Study Description

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).
Condition or Disease Intervention/Treatment Phase
  • 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 Design

Study Type:
Observational
Anticipated Enrollment :
128 participants
Observational Model:
Cohort
Time Perspective:
Cross-Sectional
Official Title:
Evaluation of Blood Elements Changes and Different Cytokines in Helminthic and Protozoan Infected Patients in Relation to COVID19 Vaccines.
Anticipated Study Start Date :
Apr 1, 2022
Anticipated Primary Completion Date :
Oct 30, 2024
Anticipated Study Completion Date :
Oct 30, 2025

Arms and Interventions

Arm 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).

Outcome Measures

Primary Outcome Measures

  1. -Evaluation of CBC changes associated with some helminths and protozoan infected patients. [3 years]

  2. - Estimation of cytokines level in some helminths and protozoan infected patients. [3 years]

  3. - Correlation of CBC changes and cytokines level with COVID-19 vaccine administration. [3 years]

Secondary Outcome Measures

  1. - study parasitic prevalence in community after COVID changes. [3 years]

Eligibility Criteria

Criteria

Ages Eligible for Study:
15 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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.

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

  • Assiut University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Reham Hany Mohammed, Principal Investigator, Assiut University
ClinicalTrials.gov Identifier:
NCT05185778
Other Study ID Numbers:
  • parasitism & COVID19 vaccines
First Posted:
Jan 11, 2022
Last Update Posted:
Apr 1, 2022
Last Verified:
Mar 1, 2022
Individual Participant Data (IPD) Sharing Statement:
Yes
Plan to Share IPD:
Yes
Studies a U.S. FDA-regulated Drug Product:
Yes
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Apr 1, 2022