Reminders for Shingles Vaccination

Overseen By Amir Goren, PhD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Geisinger Clinic

Disqualifiers: No flu shot, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 3 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 1

50000 Participants Needed

Trial Summary

What is the purpose of this trial?

The purpose of this study is to test whether messages encouraging patients to ask about a Shingrix vaccine at an upcoming appointment will increase Shingrix vaccination rates. The study will also test which of several message versions is most effective.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications.

What data supports the effectiveness of the Shingrix vaccine for shingles prevention?

Research shows that the Shingrix vaccine is highly effective in preventing shingles (herpes zoster) and its complications, with over 90% efficacy in clinical trials for adults aged 50 and older. It also reduces the severity of pain and illness in those who do get shingles, and its effectiveness remains strong over several years. ^{1 2 3 4 5}

Is the Shingrix vaccine safe for humans?

The Shingrix vaccine is generally considered safe for humans. In clinical trials, most people experienced mild to moderate reactions like pain at the injection site, muscle pain, and fatigue, which were temporary. Serious side effects were rare and occurred at similar rates as in those who received a placebo. ^{1 2 4 6 7}

How does the Shingrix vaccine differ from other treatments for shingles?

Shingrix is unique because it is a recombinant subunit vaccine, meaning it uses a piece of the virus combined with an adjuvant (a substance that enhances the body's immune response) to prevent shingles, unlike older vaccines that used a weakened form of the virus. It is administered in two doses and is approved for use in both immunocompetent and immunocompromised individuals, offering a broader range of protection. ^{1 2 4 8 9}

Research Team

Christopher F Chabris, PhD

Principal Investigator

Geisinger Clinic

Eligibility Criteria

This trial is for individuals aged 50 or older who haven't had the Shingrix vaccine and have an upcoming non-urgent in-person appointment at a Geisinger primary care facility that has the vaccine available.

Inclusion Criteria

I am 50 years old or older.

I have a scheduled in-person appointment with my primary care doctor who can provide the Shingrix vaccine.

I have not received the Shingrix vaccine.

Exclusion Criteria

Patient does not have an approved insurance on file for Shingrix outreach for their appointment type or department

Appointment type or department not approved for outreach by Geisinger leadership at the time of outreach

Cannot be contacted via the communication modality being used in the study (e.g., patient portal, SMS), e.g., due to insufficient/missing contact information in the EHR or because they opted out

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2 weeks

1 visit (in-person)

Enrollment

Enrollment begins with a 2-week pilot period for each insurance group, followed by full rollout

1 year

Intervention

Participants receive messages encouraging them to ask about Shingrix at their upcoming appointment

14 months

Follow-up

Participants are monitored for vaccination completion and shingles diagnosis

14 months

Treatment Details

Interventions

• Shingrix Vaccine

Trial Overview The study is examining if different types of reminder messages can encourage patients to discuss and potentially receive the Shingrix shingles vaccine during their next doctor's visit.

Participant Groups

Group I: Multi-fact Experimental Treatment 1 Intervention

Patients in this arm will be sent messages with facts about shingles and Shingrix, and encouraging them to ask about Shingrix at their upcoming appointment.

Group II: High risk + multi-fact Experimental Treatment 1 Intervention

Patients in this arm will be sent messages informing them that they are at high risk for shingles because they are ages 50+, with additional facts about shingles and Shingrix, and encouraging them to ask about Shingrix at their upcoming appointment.

Group III: High risk Experimental Treatment 1 Intervention

Patients in this arm will be sent messages informing them that they are at high risk for shingles because they are ages 50+, and encouraging them to ask about Shingrix at their upcoming appointment.

Group IV: Passive control Active Control 1 Intervention

Patients in this arm will not be sent any messages.

Group V: Active control Active Control 1 Intervention

Patients in this arm will be sent messages encouraging them to ask about Shingrix at their upcoming appointment.

Who Is Running the Clinical Trial?

Geisinger Clinic

Lead Sponsor

Trials

159

Recruited

1,976,000+

National Bureau of Economic Research, Inc.

Collaborator

Trials

32

Recruited

926,000+

Massachusetts Institute of Technology

Collaborator

Trials

104

Recruited

12,810,000+

Findings from Research

Shingrix® is a highly effective recombinant zoster vaccine that significantly reduces the risk of herpes zoster (HZ) and postherpetic neuralgia (PHN) in adults aged 50 and older, with efficacy remaining strong even after 4 years.

While Shingrix® is associated with more side effects than a placebo, such as injection-site reactions and fatigue, these reactions are generally mild to moderate and transient, making it a well-tolerated option for preventing HZ and PHN.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Recombinant Zoster Vaccine (Shingrix®): A Review in Herpes Zoster. Syed, YY.[2022]

Shingrix is a new vaccine designed to prevent herpes zoster, commonly known as shingles, which can cause painful rashes and complications.

Clinical trials have shown that Shingrix is highly effective in reducing the incidence of shingles in adults, particularly in older populations, making it a significant advancement in herpes zoster prevention.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Shingrix: A New Herpes Zoster Vaccine. Maltz, F., Fidler, B.[2020]

In a study of Medicare beneficiaries aged over 65, Shingrix demonstrated a vaccine effectiveness of 70.1% for those receiving the full 2-dose regimen and 56.9% for those receiving only 1 dose, indicating that completing the 2-dose series is beneficial.

The vaccine remained effective even for individuals over 80 years old and those with autoimmune or immunosuppressive conditions, with a notable 76.0% effectiveness against postherpetic neuralgia, suggesting its broad applicability in older and at-risk populations.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Recombinant Zoster Vaccine (Shingrix): Real-World Effectiveness in the First 2 Years Post-Licensure. Izurieta, HS., Wu, X., Forshee, R., et al.[2022]

Shingrix is an approved vaccine in Germany for preventing shingles (zoster) and its complications, specifically for adults aged 60 and older.

If patients experience bullous skin lesions after receiving Shingrix, it is important to consider the possibility of zoster disease and report any unexpected side effects to the appropriate medical authorities.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Zoster disease after Shingrix vaccination]. Kohn, D., Wetzig, T.[2021]

In a phase 3 study involving 569 adults with haematological malignancies, the adjuvanted recombinant zoster vaccine (Shingrix) demonstrated a strong immunogenic response, with 80.4% of participants showing a humoral vaccine response compared to only 0.8% in the placebo group, indicating its efficacy in this high-risk population.

While the vaccine was more reactogenic than placebo, with higher reports of pain and fatigue, the overall safety profile was similar between the vaccine and placebo groups, suggesting that the benefits of vaccination outweigh the risks for immunocompromised individuals.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Immunogenicity and safety of the adjuvanted recombinant zoster vaccine in adults with haematological malignancies: a phase 3, randomised, clinical trial and post-hoc efficacy analysis. Dagnew, AF., Ilhan, O., Lee, WS., et al.[2020]

A review of 2.5 years of post-marketing data from over 32 million doses of the adjuvanted recombinant zoster vaccine (RZV) found no significant safety concerns related to vesicular and bullous skin eruptions following vaccination.

The analysis showed that the number of herpes zoster (HZ) cases reported was lower than expected in the general population, suggesting that RZV vaccination does not increase the risk of HZ reactivation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

An Analysis of Spontaneously Reported Data of Vesicular and Bullous Cutaneous Eruptions Occurring Following Vaccination with the Adjuvanted Recombinant Zoster Vaccine. Pirrotta, P., Tavares-Da-Silva, F., Co, M., et al.[2022]

The recombinant zoster vaccine (RZV; Shingrix) is effective and recommended for adults aged 50 and older, showing a safety profile consistent with prelicensure trials, where serious adverse events were similar to placebo rates.

In the first 8 months post-licensure, out of 3.2 million doses distributed, 4,381 adverse event reports were received, with common reactions being fever and injection site pain, but no unexpected safety concerns were identified.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Postlicensure Safety Surveillance of Recombinant Zoster Vaccine (Shingrix) - United States, October 2017-June 2018. Hesse, EM., Shimabukuro, TT., Su, JR., et al.[2020]

The Zoster Vaccine Recombinant, Adjuvanted (Shingrix) is effective in preventing herpes zoster in adults aged 50 and older, and its use has been expanded to include adults aged 18 and older who are immunocompromised, making it the first vaccine approved for this group.

With moderate to high efficacy and a good safety profile, Shingrix has the potential to significantly reduce the incidence of herpes zoster and its complications, as recommended by health authorities like the FDA and ACIP.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Use of Recombinant Zoster Vaccine in Immunocompromised Adults Aged ≥19 Years: Recommendations of the Advisory Committee on Immunization Practices - United States, 2022. Anderson, TC., Masters, NB., Guo, A., et al.[2022]

Shingrix, a recombinant zoster vaccine approved by the FDA on October 20, 2017, is designed to prevent herpes zoster (shingles) in adults aged 50 and older, requiring two doses administered 2-6 months apart.

The vaccine contains a novel adjuvant (AS01B) that enhances the immune response, making it a recommended option by the Advisory Committee on Immunization Practices for immunocompetent adults in the same age group.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Recommendations of the Advisory Committee on Immunization Practices for Use of Herpes Zoster Vaccines. Dooling, KL., Guo, A., Patel, M., et al.[2022]

References

1. New Zealand pubmed.ncbi.nlm.nih.gov

Recombinant Zoster Vaccine (Shingrix®): A Review in Herpes Zoster. [2022]

2. United States pubmed.ncbi.nlm.nih.gov

Shingrix: A New Herpes Zoster Vaccine. [2020]

3. United States pubmed.ncbi.nlm.nih.gov

Recombinant Zoster Vaccine (Shingrix): Real-World Effectiveness in the First 2 Years Post-Licensure. [2022]

4. Germany pubmed.ncbi.nlm.nih.gov

[Zoster disease after Shingrix vaccination]. [2021]

5. United States pubmed.ncbi.nlm.nih.gov

Immunogenicity and safety of the adjuvanted recombinant zoster vaccine in adults with haematological malignancies: a phase 3, randomised, clinical trial and post-hoc efficacy analysis. [2020]

6. New Zealand pubmed.ncbi.nlm.nih.gov

An Analysis of Spontaneously Reported Data of Vesicular and Bullous Cutaneous Eruptions Occurring Following Vaccination with the Adjuvanted Recombinant Zoster Vaccine. [2022]

7. United States pubmed.ncbi.nlm.nih.gov

Postlicensure Safety Surveillance of Recombinant Zoster Vaccine (Shingrix) - United States, October 2017-June 2018. [2020]

8. United States pubmed.ncbi.nlm.nih.gov

Use of Recombinant Zoster Vaccine in Immunocompromised Adults Aged ≥19 Years: Recommendations of the Advisory Committee on Immunization Practices - United States, 2022. [2022]

9. United States pubmed.ncbi.nlm.nih.gov

Recommendations of the Advisory Committee on Immunization Practices for Use of Herpes Zoster Vaccines. [2022]