Recombinant Varicella Zoster Virus Glycoprotein E

This article examines several clinical trials investigating the use of a recombinant varicella zoster virus glycoprotein E vaccine, known as Shingrix, for preventing shingles (herpes zoster). The trials explore the vaccine’s safety, efficacy, and immune response in different patient populations, including kidney transplant recipients, people living with HIV, older adults, and those with psoriasis or psoriatic arthritis. These studies aim to better understand how the vaccine performs in various groups and its potential to prevent shingles and related complications.

What is Shingrix?
How Shingrix Works
Who Should Get the Shingrix Vaccine?
Effectiveness of Shingrix
Safety and Side Effects
How Shingrix is Administered
Use in Special Populations
Ongoing Research

What is Shingrix?

Shingrix is a vaccine used to prevent shingles (herpes zoster) in adults. Its active ingredient is a recombinant varicella zoster virus glycoprotein E, which is a protein found on the surface of the varicella zoster virus that causes shingles^[1]. Shingrix is manufactured by GlaxoSmithKline Biologicals and is approved for use in many countries, including the European Union and the United States.

How Shingrix Works

Shingrix works by stimulating the body’s immune system to produce antibodies and T-cells that can recognize and fight off the varicella zoster virus if you’re exposed to it. The vaccine contains a piece of the virus (the glycoprotein E) rather than the whole virus, which allows it to generate an immune response without causing infection^[1].

Who Should Get the Shingrix Vaccine?

Shingrix is recommended for adults aged 50 years and older. It’s particularly important for older adults because the risk of developing shingles increases with age. The vaccine is also recommended for people who have previously received the older shingles vaccine (Zostavax) or who have had shingles in the past^[2].

Effectiveness of Shingrix

Clinical trials have shown Shingrix to be highly effective in preventing shingles. Studies indicate that it reduces the risk of developing shingles by more than 90% in adults 50 years and older. The vaccine also helps prevent a painful complication of shingles called postherpetic neuralgia^[1].

Safety and Side Effects

Shingrix is generally considered safe, but like all vaccines, it can cause side effects. The most common side effects include:

Pain, redness, and swelling at the injection site
Fatigue
Muscle pain
Headache
Shivering
Fever
Upset stomach

These side effects are usually mild to moderate and resolve within a few days^[1].

How Shingrix is Administered

Shingrix is given as two doses, with the second dose administered 2 to 6 months after the first dose. It’s important to receive both doses to ensure maximum protection. The vaccine is injected into the muscle, usually in the upper arm^[1].

Use in Special Populations

Research is ongoing to evaluate the safety and effectiveness of Shingrix in various populations. For example, studies are being conducted to assess its use in people with weakened immune systems, such as those who have received organ transplants or are living with HIV^[2].

Ongoing Research

Several clinical trials are currently underway to further investigate Shingrix:

A study is examining the vaccine’s effectiveness in preventing shingles in kidney transplant patients^[1].
Another trial is looking at the immune response to Shingrix in people living with HIV who are over 50 years old^[2].
Researchers are also conducting a long-term follow-up study to assess the vaccine’s efficacy, safety, and persistence of immune response over time^[3].
A study is investigating the safety and immune response of Shingrix in patients with psoriasis or psoriatic arthritis^[4].

These ongoing studies will help provide more information about the vaccine’s long-term effectiveness and its use in different patient populations.

Trial Focus	Patient Population	Key Objectives	Main Outcomes Measured
Kidney Transplant Recipients	Kidney transplant patients on immunosuppressive therapy	Compare immune response with everolimus vs. MMF/MPA	Antibody titers, T-cell responses, safety
HIV Patients	People living with HIV over 50 years old	Assess antibody response compared to non-HIV controls	Antibody levels, T-cell responses, safety
Long-term Follow-up	Older adults from previous Shingrix trials	Evaluate long-term efficacy and immune persistence	Confirmed HZ cases, antibody levels, T-cell responses
Psoriasis/Psoriatic Arthritis	Patients with psoriasis or psoriatic arthritis	Investigate safety and impact on disease activity	Disease activity scores, immune response, adverse events

Trial Focus

Patient Population

Key Objectives

Main Outcomes Measured

Kidney Transplant Recipients

Kidney transplant patients on immunosuppressive therapy

Compare immune response with everolimus vs. MMF/MPA

Antibody titers, T-cell responses, safety

HIV Patients

People living with HIV over 50 years old

Assess antibody response compared to non-HIV controls

Antibody levels, T-cell responses, safety

Long-term Follow-up

Older adults from previous Shingrix trials

Evaluate long-term efficacy and immune persistence

Confirmed HZ cases, antibody levels, T-cell responses

Psoriasis/Psoriatic Arthritis

Patients with psoriasis or psoriatic arthritis

Investigate safety and impact on disease activity

Disease activity scores, immune response, adverse events

Ongoing Clinical Trials on Recombinant Varicella Zoster Virus Glycoprotein E

Glossary

Herpes Zoster (HZ): Also known as shingles, this is a painful rash caused by reactivation of the varicella zoster virus, which also causes chickenpox.
Recombinant Varicella Zoster Virus Glycoprotein E: A protein component of the varicella zoster virus that is produced through genetic engineering and used as the active ingredient in the Shingrix vaccine.
Immunogenicity: The ability of a substance, such as a vaccine, to provoke an immune response in the body.
cART: Combination Antiretroviral Therapy, a treatment approach for HIV that uses multiple antiretroviral drugs.
PLWH: People Living With HIV.
Vaccine Efficacy (VE): A measure of how well a vaccine prevents a specific condition in clinical trials, usually expressed as a percentage.
gE-specific antibodies: Antibodies that specifically target the glycoprotein E component of the varicella zoster virus.
T-cell response: A type of immune response involving T lymphocytes, which are crucial for cellular immunity against viruses.
Post-herpetic neuralgia: Persistent nerve pain that continues after a shingles rash has cleared.
Psoriasis: A chronic skin condition characterized by red, itchy, and scaly patches.
Psoriatic arthritis: A form of inflammatory arthritis that can affect some people with psoriasis.
PASI score: Psoriasis Area and Severity Index, a tool used to measure the severity and extent of psoriasis.
DAPSA score: Disease Activity in Psoriatic Arthritis score, used to assess the activity of psoriatic arthritis.

References

http://clinicaltrials.eu/trial/study-on-everolimus-and-mycophenolate-mofetil-for-improving-covid-19-vaccine-response-in-kidney-transplant-patients/
http://clinicaltrials.eu/trial-id/2023-504482-23-00
http://clinicaltrials.eu/trial-id/2023-505255-51-00
http://clinicaltrials.eu/trial/study-on-the-safety-and-immune-response-of-shingrix-vaccine-in-patients-with-psoriasis-or-psoriatic-arthritis/

#1 Clinical Trials Search in Europe