What side effects are associated with this type of intervention?

The most common treatments for Shingles, such as the Shingrix vaccine, are generally well-tolerated but can cause side effects. The most frequently reported side effects include chills, fatigue, fever, back pain, nausea, joint ache, and headache. These side effects are typically mild and transient, resolving within one to two days. Serious adverse events are rare but can include infusion reactions and cerebrovascular events, such as transient ischemic attacks. Overall, the benefits of vaccination in preventing Shingles outweigh the risks of these side effects.

What prior FDA approvals exist?

The FDA has approved several treatments for shingles, including antiviral medications like acyclovir, valacyclovir, and famciclovir, which help reduce the severity and duration of the illness. For prevention, the FDA has approved vaccines such as Zostavax, a live attenuated vaccine, and Shingrix, a recombinant subunit vaccine that stimulates the immune response against the varicella-zoster virus. Shingrix is particularly noted for its efficacy in preventing shingles in both healthy adults over 50 and immunocompromised adults over 18.

What other types of research exist?

As of now, Shingrix remains the primary vaccine for preventing shingles. There are no specific novel vaccines mentioned as alternatives to Shingrix in the provided context. However, ongoing research in antiviral therapies and immunotherapy may offer new treatment options in the future. Patients should consult with their healthcare provider for the most current and personalized treatment recommendations.

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Virus Vaccine

Shingrix Vaccine Safety and Immunogenicity in People With HIV

Phase 1 & 2

Recruiting

Led By Maura M Manion, M.D.

Research Sponsored by National Institute of Allergy and Infectious Diseases (NIAID)

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up months 3 and 12

Awards & highlights

No Placebo-Only Group

Summary

This trial studies how the Shingrix vaccine affects people with HIV and healthy older adults. Shingrix helps prevent shingles by boosting the body's immunity against the virus. Participants will receive two shots and be monitored over time. Shingrix has shown promising results and is recommended for adults aged 50 and over.

Who is the study for?

This trial is for adults over 18 with HIV who have a viral load under control and are on stable antiretroviral therapy, or elite controllers. Healthy volunteers over 50 can also join. Participants must agree to use contraception if they can become pregnant. Exclusions include pregnancy, breastfeeding, recent shingles or chickenpox vaccines, certain acute illnesses, immunoglobulin treatments within the past 90 days, and severe allergies to Shingrix components.

What is being tested?

The study tests how well the Shingrix vaccine boosts immune response in people with HIV compared to healthy older adults. It involves at least four clinic visits over a year where participants receive two shots of Shingrix and provide blood samples through regular draws and possibly apheresis (a process that separates white blood cells from drawn blood).

What are the potential side effects?

Possible side effects of the Shingrix vaccine may include pain at the injection site, muscle pain, tiredness, headache, shivering, fever, stomach issues like nausea or vomiting. Side effects will be tracked using a memory tool between visits and discussed during follow-up phone calls.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ months 3 and 12

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~months 3 and 12

This trial's timeline: 3 weeks for screening, Varies for treatment, and months 3 and 12 for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Fold change of anti-gE antibody concentrations evaluated regularly through the end of study (months 3 and 12) by CD4 count (< 300 and >= 300)

Secondary study objectives

Antibodies

Grade 3 and/or Grade 4 Shingrix ARs (solicited and unsolicited local and systemic).

Side effects data

From 2024 Phase 4 trial • 105 Patients • NCT04169009

nausea and vomiting

100%

80%

60%

40%

20%

Study treatment Arm

SRX >5 Years Previously (Cohort 2)

ZVL 6-12 Months Previously (Cohort 3)

ZVL >5 Years Previously (Cohort 1)

No Previous ZVL (Cohort 4)

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups

Experimental Treatment

Group I: ShingrixExperimental Treatment1 Intervention

Shingrix will be administered in two 0.5-mL doses approximately 2 months apart.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Shingrix

2019

Completed Phase 4

~530

Do I qualify?Apply below to find out

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

The most common treatments for Shingles include antiviral medications and vaccines like Shingrix. Antiviral medications, such as acyclovir, work by inhibiting the replication of the varicella-zoster virus, thereby reducing the severity and duration of the infection. Shingrix, a recombinant zoster vaccine, stimulates the immune system to produce a robust response against the varicella-zoster virus, which helps prevent the reactivation of the virus that causes Shingles. These treatments are crucial for Shingles patients as they not only alleviate acute symptoms but also reduce the risk of complications such as postherpetic neuralgia, a condition where pain persists long after the rash has healed.

Assessment of pain in herpes zoster: lessons learned from antiviral trials.