Hepatitis AHepatitis ANCT06942962
Immunity With Acute Hepatits A
An observational study of Hepatitis A and Hepatitis A Virus, run by Assiut University.
Trial summary
Hepatitis A Virus (HAV) is a public health concern in Egypt, especially among children. Historically highly endemic, recent studies suggest a changing epidemiology. While improved socioeconomic conditions have reduced its spread, HAV remains prevalent, with over 50% of Egyptians exposed by age 15. Read more about this study
- Who is it for?
- Ages 1 year to 15 years
- Conditions the study is for
- Hepatitis A, Hepatitis A Virus
- How many people
- 50 participants
- Where
- No sites listed yet
- Study dates
- 1 Oct 2025to 1 Nov 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 1 year to 15 years
- All sexes
- No healthy volunteers
- Child
Study population: Children aged 1-15 years
Who may be able to join
- Children aged 1-15 years
- Confirmed diagnosis of acute hepatitis A infection (positive anti-HAV IgM)
- Admitted to the hospital for management of acute hepatitis A
- Parental/guardian consent and child assent (where appropriate) obtained
Who cannot join
- Known pre-existing liver disease or chronic hepatitis
- Immunodeficiency disorders or current immunosuppressive therapy
- Coinfection with other hepatotropic viruses (HBV, HCV, HEV)
- Severe malnutrition
- Recent blood transfusion (within 3 months)
About this study
Official title: Assessment of Lymphocyte Subset Functions in Children Admitted to Assiut University Children Hospital With Acute Hepatitis A Infection
Hepatitis A Virus (HAV) is a public health concern in Egypt, especially among children. Historically highly endemic, recent studies suggest a changing epidemiology. While improved socioeconomic conditions have reduced its spread, HAV remains prevalent, with over 50% of Egyptians exposed by age 15. Infection is often asymptomatic or mild in children but can be more severe with age. Prevention relies on improved sanitation and hygiene, with vaccin and recov
Read the detailed description
Introduction
Hepatitis A virus (HAV) infection remains a significant public health concern in Egypt, particularly among children. Egypt has historically been considered an area of high endemicity for HAV infection, with the highest prevalence occurring in early childhood. Recent studies, however, suggest a shifting epidemiological pattern. An estimated 8-10 million people suffer from viral hepatitis in Egypt, with HAV being one of the major causative agents.
The seroprevalence of HAV antibodies among Egyptian children has shown significant variability in recent years, reflecting changes in socioeconomic conditions and public health measures.
A study conducted in 2008 found that 61.4% of Egyptian children aged 2.5-18 years were seropositive for HAV antibodies. This study revealed a significant increase in HAV seroprevalence with higher age and lower social class. (WHO EMRO | Seroprevalence of Hepatitis A Virus, n.d.)Notably, among children under 6 years old, 72.7% from high social classes were seronegative for HAV antibodies, compared to only 19.0% from low social classes. These findings suggest that improvements in socioeconomic conditions may be altering the epidemiological landscape of HAV in Egypt.
More recent data indicate that HAV infection remains prevalent in Egypt, with 50% or more of the Egyptian population exposed to HAV by the age of 15. This high rate of early childhood exposure has important implications for public health strategies and vaccination policies.
Hepatitis A in children is often asymptomatic or presents with mild, non-specific symptoms. However, the severity of the disease tends to increase with age. In symptomatic cases, children may experience fever, fatigue, nausea, abdominal pain, and jaundice. While most cases resolve spontaneously without complications, severe manifestations such as fulminant hepatitis and liver failure have been reported in Egypt.
The risk of complications appears to be influenced by various factors, including age, nutritional status, and pre-existing liver conditions. In Egypt, where chronic liver diseases due to hepatitis B and C are prevalent, superinfection with HAV can lead to more severe outcomes.
Given the high prevalence of HAV in Egypt, prevention strategies are crucial. Improved sanitation and hygiene practices have contributed to reducing HAV transmission. However, vaccination remains the most effective preventive measure.
Currently, hepatitis A vaccination is not part of the standard immunization program in Egypt. The decision to implement universal vaccination should be based on cost-effectiveness analyses and the changing epidemiology of HAV in the country. Some experts recommend vaccination for high social class children at the preschool period without prior testing for HAV antibodies, while for middle social class children, vaccination after testing for HAV antibodies is suggested The immune response to HAV infection plays a crucial role in disease progression and resolution. In acute HAV infection, both innate and adaptive immune responses are activated. Natural Killer (NK) cells, part of the innate immune system, show a significant increase in the initial phase of acute hepatitis A, suggesting an important role in the first line of defense.
The adaptive immune response, particularly T cell-mediated immunity, is critical for viral clearance and long-term protection. Recent studies have highlighted the dominance of CD4+ T helper cell responses during acute resolving HAV infection.
CD4+ T cells produce multiple cytokines when viremia first declines and play a crucial role in the termination of HAV infection. In contrast, HAV-specific CD8+ T cells often fail to display effector functions until after viremia and hepatitis begin to subside.
Humoral immunity also plays a significant role in HAV infection. IgM anti-HAV antibodies appear within a few days of symptom onset and generally become undetectable within 4 months. Anti-HAV IgG antibodies, on the other hand, persist for life, providing long-term protection against reinfection.
- Conditions
- Hepatitis A, Hepatitis A Virus
- Keywords
- Immunity with hepatitis A in children, Lymphocyte subset function in hepatitis A
- Medical subject headings
- Hepatitis A, Hepatitis
What is being measured
The primary outcome is the main question the study is designed to answer.
Correlation between lymphocyte subset levels and development of hepatic encephalopathy or fulminant hepatic failure
Measured: One year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Apr 2025
- Study start1 Oct 2025 (estimated)
- Primary completion1 Oct 2026 (estimated)
- Study completion1 Nov 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for Hepatitis AStudies of the same condition, open and under way.
- More trials run by Assiut UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Martina Adel Attia Massod, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06942962
- Sponsor's protocol ID
- Lymphocyte subset functions
- Acronym
- Hepatitis A
- Status last verified
- Apr 2025
- First submitted
- 17 Apr 2025
- Last updated
- 24 Apr 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Yigit M, Kalayci F. Vaccination status and hepatitis A immunity in children: insights from a large-scale study in Turkey. BMC Infect Dis. 2025 Jan 14;25(1):61. doi: 10.1186/s12879-025-10458-9.
PubMed 39810097Malik H, Malik H, Uderani M, Berhanu M, Soto CJ, Saleem F. Fulminant Hepatitis A and E Co-infection Leading to Acute Liver Failure: A Case Report. Cureus. 2023 Apr 25;15(4):e38101. doi: 10.7759/cureus.38101. eCollection 2023 Apr.
PubMed 37252544Gabrielli F, Alberti F, Russo C, Cursaro C, Seferi H, Margotti M, Andreone P. Treatment Options for Hepatitis A and E: A Non-Systematic Review. Viruses. 2023 Apr 28;15(5):1080. doi: 10.3390/v15051080.
PubMed 37243166Fouad HM, Reyad EM, El-Din AG. Acute hepatitis A is the chief etiology of acute hepatitis in Egyptian children: a single-center study. Eur J Clin Microbiol Infect Dis. 2018 Oct;37(10):1941-1947. doi: 10.1007/s10096-018-3329-0. Epub 2018 Jul 20.
PubMed 30030693El-Mokhtar MA, Elkhawaga AA, Ahmed MSH, El-Sabaa EMW, Mosa AA, Abdelmohsen AS, Moussa AM, Salama EH, Aboulfotuh S, Ashmawy AM, Seddik AI, Sayed IM, Ramadan HK. High Incidence of Acute Liver Failure among Patients in Egypt Coinfected with Hepatitis A and Hepatitis E Viruses. Microorganisms. 2023 Nov 30;11(12):2898. doi: 10.3390/microorganisms11122898.
PubMed 38138042Elbahrawy A, Ibrahim MK, Eliwa A, Alboraie M, Madian A, Aly HH. Current situation of viral hepatitis in Egypt. Microbiol Immunol. 2021 Sep;65(9):352-372. doi: 10.1111/1348-0421.12916. Epub 2021 Aug 21.
PubMed 33990999Doss W, Hermez J, Atta H, Jabbour J. Towards a hepatitis-free Egypt: is this achievable? (Editorial). East Mediterr Health J. 2018 Sep 6;24(7):609-610. doi: 10.26719/2018.24.7.609.
PubMed 30370918Abosheaishaa H, Abdelghany A, Abdelhalim O, Mohamed I, Morsi S, Youssef M, Salem A, Bahbah AA, Shady A, Naguib MS, Nassar M, El-Kassas M. The Egyptian journey from having the highest prevalence of hepatitis C virus to being the first to achieve "gold tier" in conquering the disease. Proc (Bayl Univ Med Cent). 2024 Jul 22;37(5):877-883. doi: 10.1080/08998280.2024.2379185. eCollection 2024.
PubMed 39165801
Study at a glance
From the registry record, last updated by the sponsor on 24 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of Lymphocyte Subset Functions in Children Admitted to Assiut University Children Hospital With Acute Hepatitis A Infection
- ClinicalTrials.gov ID
- NCT06942962
- Acronym / sponsor ID
- Hepatitis A / Lymphocyte subset functions
- Conditions
- Hepatitis A, Hepatitis A Virus
- Keywords
- Immunity with hepatitis A in children, Lymphocyte subset function in hepatitis A
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 1 Oct 2025 (estimated)
- Primary completion
- 1 Oct 2026 (estimated)
- Study completion
- 1 Nov 2026 (estimated)
- First posted
- 24 Apr 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Hepatitis A Virus (HAV) is a public health concern in Egypt, especially among children. Historically highly endemic, recent studies suggest a changing epidemiology. While improved socioeconomic conditions have reduced its spread, HAV remains prevalent, with over 50% of Egyptians exposed by age 15. Infection is often asymptomatic or mild in children but can be more severe with age. Prevention relies on improved sanitation and hygiene, with vaccin and recov
Detailed description
Introduction
Hepatitis A virus (HAV) infection remains a significant public health concern in Egypt, particularly among children. Egypt has historically been considered an area of high endemicity for HAV infection, with the highest prevalence occurring in early childhood. Recent studies, however, suggest a shifting epidemiological pattern. An estimated 8-10 million people suffer from viral hepatitis in Egypt, with HAV being one of the major causative agents.
The seroprevalence of HAV antibodies among Egyptian children has shown significant variability in recent years, reflecting changes in socioeconomic conditions and public health measures.
A study conducted in 2008 found that 61.4% of Egyptian children aged 2.5-18 years were seropositive for HAV antibodies. This study revealed a significant increase in HAV seroprevalence with higher age and lower social class. (WHO EMRO | Seroprevalence of Hepatitis A Virus, n.d.)Notably, among children under 6 years old, 72.7% from high social classes were seronegative for HAV antibodies, compared to only 19.0% from low social classes. These findings suggest that improvements in socioeconomic conditions may be altering the epidemiological landscape of HAV in Egypt.
More recent data indicate that HAV infection remains prevalent in Egypt, with 50% or more of the Egyptian population exposed to HAV by the age of 15. This high rate of early childhood exposure has important implications for public health strategies and vaccination policies.
Hepatitis A in children is often asymptomatic or presents with mild, non-specific symptoms. However, the severity of the disease tends to increase with age. In symptomatic cases, children may experience fever, fatigue, nausea, abdominal pain, and jaundice. While most cases resolve spontaneously without complications, severe manifestations such as fulminant hepatitis and liver failure have been reported in Egypt.
The risk of complications appears to be influenced by various factors, including age, nutritional status, and pre-existing liver conditions. In Egypt, where chronic liver diseases due to hepatitis B and C are prevalent, superinfection with HAV can lead to more severe outcomes.
Given the high prevalence of HAV in Egypt, prevention strategies are crucial. Improved sanitation and hygiene practices have contributed to reducing HAV transmission. However, vaccination remains the most effective preventive measure.
Currently, hepatitis A vaccination is not part of the standard immunization program in Egypt. The decision to implement universal vaccination should be based on cost-effectiveness analyses and the changing epidemiology of HAV in the country. Some experts recommend vaccination for high social class children at the preschool period without prior testing for HAV antibodies, while for middle social class children, vaccination after testing for HAV antibodies is suggested The immune response to HAV infection plays a crucial role in disease progression and resolution. In acute HAV infection, both innate and adaptive immune responses are activated. Natural Killer (NK) cells, part of the innate immune system, show a significant increase in the initial phase of acute hepatitis A, suggesting an important role in the first line of defense.
The adaptive immune response, particularly T cell-mediated immunity, is critical for viral clearance and long-term protection. Recent studies have highlighted the dominance of CD4+ T helper cell responses during acute resolving HAV infection.
CD4+ T cells produce multiple cytokines when viremia first declines and play a crucial role in the termination of HAV infection. In contrast, HAV-specific CD8+ T cells often fail to display effector functions until after viremia and hepatitis begin to subside.
Humoral immunity also plays a significant role in HAV infection. IgM anti-HAV antibodies appear within a few days of symptom onset and generally become undetectable within 4 months. Anti-HAV IgG antibodies, on the other hand, persist for life, providing long-term protection against reinfection.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 1 year to 15 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- Children aged 1-15 years
Key inclusion criteria (4 listed)
- Children aged 1-15 years
- Confirmed diagnosis of acute hepatitis A infection (positive anti-HAV IgM)
- Admitted to the hospital for management of acute hepatitis A
- Parental/guardian consent and child assent (where appropriate) obtained
Key exclusion criteria (5 listed)
- Known pre-existing liver disease or chronic hepatitis
- Immunodeficiency disorders or current immunosuppressive therapy
- Coinfection with other hepatotropic viruses (HBV, HCV, HEV)
- Severe malnutrition
- Recent blood transfusion (within 3 months)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Correlation between lymphocyte subset levels and development of hepatic encephalopathy or fulminant hepatic failure
Time frame: One year
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Apr 2025.
- Results publication: PubMed 39810097Yigit M, Kalayci F. Vaccination status and hepatitis A immunity in children: insights from a large-scale study in Turkey. BMC Infect Dis. 2025 Jan 14;25(1):61. doi: 10.1186/s12879-025-10458-9.
- Results publication: PubMed 37252544Malik H, Malik H, Uderani M, Berhanu M, Soto CJ, Saleem F. Fulminant Hepatitis A and E Co-infection Leading to Acute Liver Failure: A Case Report. Cureus. 2023 Apr 25;15(4):e38101. doi: 10.7759/cureus.38101. eCollection 2023 Apr.
- Results publication: PubMed 37243166Gabrielli F, Alberti F, Russo C, Cursaro C, Seferi H, Margotti M, Andreone P. Treatment Options for Hepatitis A and E: A Non-Systematic Review. Viruses. 2023 Apr 28;15(5):1080. doi: 10.3390/v15051080.
- Results publication: PubMed 30030693Fouad HM, Reyad EM, El-Din AG. Acute hepatitis A is the chief etiology of acute hepatitis in Egyptian children: a single-center study. Eur J Clin Microbiol Infect Dis. 2018 Oct;37(10):1941-1947. doi: 10.1007/s10096-018-3329-0. Epub 2018 Jul 20.
- Results publication: PubMed 38138042El-Mokhtar MA, Elkhawaga AA, Ahmed MSH, El-Sabaa EMW, Mosa AA, Abdelmohsen AS, Moussa AM, Salama EH, Aboulfotuh S, Ashmawy AM, Seddik AI, Sayed IM, Ramadan HK. High Incidence of Acute Liver Failure among Patients in Egypt Coinfected with Hepatitis A and Hepatitis E Viruses. Microorganisms. 2023 Nov 30;11(12):2898. doi: 10.3390/microorganisms11122898.
- Results publication: PubMed 33990999Elbahrawy A, Ibrahim MK, Eliwa A, Alboraie M, Madian A, Aly HH. Current situation of viral hepatitis in Egypt. Microbiol Immunol. 2021 Sep;65(9):352-372. doi: 10.1111/1348-0421.12916. Epub 2021 Aug 21.
- Results publication: PubMed 30370918Doss W, Hermez J, Atta H, Jabbour J. Towards a hepatitis-free Egypt: is this achievable? (Editorial). East Mediterr Health J. 2018 Sep 6;24(7):609-610. doi: 10.26719/2018.24.7.609.
- Results publication: PubMed 39165801Abosheaishaa H, Abdelghany A, Abdelhalim O, Mohamed I, Morsi S, Youssef M, Salem A, Bahbah AA, Shady A, Naguib MS, Nassar M, El-Kassas M. The Egyptian journey from having the highest prevalence of hepatitis C virus to being the first to achieve "gold tier" in conquering the disease. Proc (Bayl Univ Med Cent). 2024 Jul 22;37(5):877-883. doi: 10.1080/08998280.2024.2379185. eCollection 2024.
- Related InfoLink provided by the sponsor.
- Related InfoLink provided by the sponsor.
- Related InfoLink provided by the sponsor.
Related trials for Hepatitis A
Active, not recruitingPhase 4
Understanding Poor Vaccine Responses to Hepatitis B Vaccination
Vaccine Reaction
Enrolling by invitationPhase 2/3
A Multicenter, Randomized, Controlled Trial of Prednisone Combined With Ursodeoxycholic Acid in the Treatment of Primary Biliary Cholangitis With Moderate to Severe Interface Hepatitis Characteristics
Primary Biliary Cholangitis (PBC)
Not yet recruiting
Study to Evaluate the Performance of the INSTI® HCV Antibody Test for Point-of-Care Use in Individuals at Risk for HCV Infection or Presenting With Signs or Symptoms of HCV Infection
HCV Infection
RecruitingPhase 2
Study of AHB-137 in Chronic Hepatitis B (CHB) Participants in North America and Europe Regions
Hepatitis B, Chronic
Active, not recruitingPhase 1/2
A Clinical Study of HT-101 and/or HT-102 in Patients With Chronic Hepatitis B Virus Infection
Chronic Hepatitis B
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Hepatitis A and Hepatitis A Virus, run by Assiut University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 24 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Correlation between lymphocyte subset levels and development of hepatic encephalopathy or fulminant hepatic failure (time frame: One year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06942962, which also lists 8 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Apr 2025.