Skip to main content
OpenTrials
Not Yet Recruiting

NCT Number: NCT06942962

Immunity With Acute Hepatits A

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

Not Yet Recruiting

Trial opening soon.

Get Notified

Key information

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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)

Treatment and study plan

Primary outcomes

  1. Correlation between lymphocyte subset levels and development of hepatic encephalopathy or fulminant hepatic failure

    Time frame: One year

Sponsors and collaborators

Lead sponsor

Assiut University

Other

Registry information

Official study title

Assessment of Lymphocyte Subset Functions in Children Admitted to Assiut University Children Hospital With Acute Hepatitis A Infection

Acronym: Hepatitis A

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Apr 24, 2025
Registry last updated
Apr 24, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.