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Hepatitis B Surface Antigen (Rdna)

This article examines clinical trials investigating vaccines containing Hepatitis B Surface Antigen (rDNA) for various purposes, including prevention of hepatitis B in infants, treatment of chronic hepatitis B in adults, and as part of combination vaccines. The trials assess safety, tolerability, immunogenicity, and efficacy of these vaccines in different populations.

Table of Contents

What is HEPATITIS B SURFACE ANTIGEN (rDNA)?

HEPATITIS B SURFACE ANTIGEN (rDNA) is a key component in vaccines used to prevent hepatitis B virus (HBV) infection. It is a protein found on the surface of the hepatitis B virus, produced using recombinant DNA technology[1]. This means that instead of using the actual virus, scientists use genetic engineering techniques to create the antigen in a laboratory setting, typically using yeast cells.

How Does It Work?

When introduced into the body through vaccination, HEPATITIS B SURFACE ANTIGEN (rDNA) stimulates the immune system to produce antibodies against the hepatitis B virus. These antibodies provide protection against future HBV infections by recognizing and attacking the virus if it enters the body[2].

What Is It Used For?

The primary use of HEPATITIS B SURFACE ANTIGEN (rDNA) is in vaccines to prevent hepatitis B infection. It is a crucial component in various vaccine formulations, including:

  • Single-antigen hepatitis B vaccines
  • Combination vaccines that protect against multiple diseases, such as:
    • Diphtheria, tetanus, pertussis, hepatitis B, polio, and Haemophilus influenzae type b (Hib)[3]

Additionally, ongoing research is exploring its potential use in therapeutic vaccines for chronic hepatitis B patients[2].

How Is It Administered?

Vaccines containing HEPATITIS B SURFACE ANTIGEN (rDNA) are typically administered through intramuscular injection. The vaccination schedule can vary depending on the specific vaccine and the patient’s age and health status. For infants, it’s often given as part of a combination vaccine at 2, 4, and 12 months of age[3].

Current Clinical Trials

Several clinical trials are currently underway to further investigate the use of HEPATITIS B SURFACE ANTIGEN (rDNA) in various contexts:

  1. A Phase II trial is assessing the safety and efficacy of a therapeutic hepatitis B vaccine in adults with chronic hepatitis B. This vaccine combines HEPATITIS B SURFACE ANTIGEN (rDNA) with other components to potentially treat existing infections[2].
  2. Another study is investigating the immune response to hepatitis B vaccination in infants born to mothers who received the vaccine during pregnancy. This research aims to understand how maternal vaccination affects infant immunity to hepatitis B[3].

Safety and Side Effects

Vaccines containing HEPATITIS B SURFACE ANTIGEN (rDNA) have been extensively studied and are generally considered safe. However, like all medical interventions, they can have side effects. Common side effects may include:

  • Pain, redness, or swelling at the injection site
  • Mild fever
  • Fatigue
  • Headache

Severe allergic reactions are rare but possible. It’s important to discuss any concerns or pre-existing conditions with your healthcare provider before receiving the vaccine[1][3].

Conclusion

HEPATITIS B SURFACE ANTIGEN (rDNA) is a crucial component in the fight against hepatitis B infection. As a key ingredient in both preventive and potentially therapeutic vaccines, it plays a vital role in public health efforts to reduce the global burden of hepatitis B. Ongoing research continues to explore its applications and optimize its use in various patient populations.

Trial Aspect Details
Vaccine Types Hepatitis B Surface Antigen (rDNA) alone and in combination vaccines
Study Populations Healthy infants, adults with chronic hepatitis B, pregnant women
Main Objectives Safety, tolerability, immunogenicity, efficacy assessment
Safety Measures Adverse events monitoring, liver toxicity assessment
Immune Response Measurements Antibody production, T-cell responses, detailed antibody function analysis
Key Endpoints HBsAg reduction, anti-HBs antibody development, functional antibody profiling
Additional Vaccines Studied Meningococcal, pertussis, diphtheria, tetanus, polio, Haemophilus influenzae type b

FAQ

  • What is Hepatitis B Surface Antigen (rDNA)? Hepatitis B Surface Antigen (rDNA) is a vaccine component produced using recombinant DNA technology. It mimics a part of the hepatitis B virus to stimulate an immune response without causing infection.
  • Who are the target populations for these clinical trials? The trials target various populations, including healthy infants, adults with chronic hepatitis B, and pregnant women. Each trial has specific inclusion and exclusion criteria based on age, health status, and other factors.
  • What are the main objectives of these clinical trials? The main objectives include assessing the safety and tolerability of the vaccines, evaluating their immunogenicity (ability to provoke an immune response), and in some cases, measuring their efficacy in preventing or treating hepatitis B infection.
  • How is the safety of the vaccines being evaluated? Safety is evaluated by monitoring for adverse events, including local reactions at the injection site, systemic reactions, and any serious adverse events. Some trials also specifically monitor for liver toxicity in patients with chronic hepatitis B.
  • What types of immune responses are being measured in these trials? The trials measure various aspects of the immune response, including antibody production (anti-HBs antibodies), T-cell responses, and in some cases, more detailed analyses of antibody functions and B-cell repertoires.

Ongoing Clinical Trials on Hepatitis B Surface Antigen (Rdna)

  • Study on the Safety and Efficacy of a Hepatitis B Vaccine with Hepatitis B Surface Antigen (rDNA), MVA-HBVAC, and Mosaic HBcoreAg for Adults with Chronic Hepatitis B

    Recruiting

    1 1 1
    Investigated drugs:
    Germany Spain

  • Safety and immunogenicity study of Pentavalent Meningococcal ABCYW vaccine (MenPenta SD and MenPenta fHD) compared to licensed meningococcal vaccines in infants, toddlers and children

    Not recruiting

    2 1 1 1
    Investigated drugs:
    Czechia Denmark Finland Germany Poland Spain

Glossary

  • Hepatitis B Surface Antigen (rDNA): A vaccine component produced using recombinant DNA technology that mimics a part of the hepatitis B virus to stimulate an immune response without causing infection.
  • Immunogenicity: The ability of a substance, such as a vaccine, to provoke an immune response in the body.
  • Chronic hepatitis B: A long-lasting liver infection caused by the hepatitis B virus, typically defined as the presence of the virus for more than six months.
  • HBsAg: Hepatitis B surface antigen, a protein on the surface of the hepatitis B virus that can be detected in high levels in the blood of people with acute or chronic hepatitis B infection.
  • Anti-HBs: Antibodies produced by the immune system in response to the hepatitis B surface antigen, indicating immunity to hepatitis B.
  • Tdap vaccine: A combination vaccine that protects against tetanus, diphtheria, and pertussis (whooping cough).
  • Adverse event: Any unfavorable and unintended sign, symptom, or disease temporarily associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure.
  • Serogroup: A group of bacteria that share common antigens on their cell surface, often used in the context of classifying meningococcal bacteria.
  • hSBA: Human serum bactericidal assay, a laboratory test used to measure the functional ability of antibodies to kill bacteria with the help of human complement.
  • Geometric mean titer (GMT): A way of averaging antibody levels that takes into account the typically skewed distribution of titer results.

References

  1. http://clinicaltrials.eu/trial-id/2023-506449-40-00
  2. http://clinicaltrials.eu/trial/study-on-the-safety-and-efficacy-of-a-hepatitis-b-vaccine-with-hepatitis-b-surface-antigen-rdna-mva-hbvac-and-mosaic-hbcoreag-for-adults-with-chronic-hepatitis-b/
  3. http://clinicaltrials.eu/trial-id/2024-517893-73-00