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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests which reminder messages best encourage people to get the Shingrix vaccine, which protects against shingles. Different groups will receive various types of messages, and researchers will determine which messages prompt more people to inquire about the vaccine during doctor appointments. It suits individuals aged 50 and older who haven't received the Shingrix vaccine and have a scheduled doctor visit at a participating location.

As an unphased trial, this study provides a unique opportunity to contribute to research that could enhance public health messaging and vaccination rates.

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 prior data suggests that these messaging strategies are safe?

Research has shown that the Shingrix vaccine, which helps prevent shingles, is generally safe for people. Studies involving over 29,000 participants aged 50 and older have found that Shingrix is well tolerated. Most side effects are mild, such as soreness or redness at the injection site.

Some people have reported more serious issues, like a higher risk of Guillain-Barré syndrome, a condition that causes muscle weakness. However, these cases are rare. Most reactions occur within a day of vaccination. The vaccine is widely used, and its safety undergoes continuous monitoring to ensure it remains safe for the public. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about this trial because it explores new ways to boost shingles vaccination rates using targeted reminder messages. Unlike traditional approaches that rely solely on patient initiative, this method actively engages patients by sending tailored messages. Some messages emphasize the recipient's high risk for shingles, while others provide detailed facts about shingles and the benefits of the Shingrix vaccine. By personalizing communication, the trial aims to increase awareness and encourage proactive health actions, potentially improving vaccination rates among those over 50.

What evidence suggests that this trial's messages could effectively increase Shingrix vaccination rates?

Research has shown that the Shingrix vaccine effectively prevents shingles in people aged 50 and older. Studies have found that Shingrix provides more than 90% protection against shingles. Besides preventing shingles, the vaccine might also reduce the risk of other health problems, like dementia, according to some studies. The vaccine is given in two doses and has maintained its high effectiveness across different age groups. Overall, Shingrix is considered a dependable choice for protecting against shingles and its complications.

In this trial, researchers will divide participants into different arms to evaluate the effectiveness of various reminder messages about the Shingrix vaccine. Some participants will receive messages highlighting their high risk for shingles, while others will receive additional facts about shingles and the vaccine. A passive control arm will include participants who do not receive any messages. ^{6 7 8 9 10}

Who Is on the Research Team?

Christopher F Chabris, PhD

Principal Investigator

Geisinger Clinic

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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]

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]

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]

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]

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]

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]

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]

Citations

1. nature.com nature.com/articles/s41591-024-03201-5

The recombinant shingles vaccine is associated with lower ... We show that the recombinant vaccine is associated with a significantly lower risk of dementia in the 6 years post-vaccination.

2. escardio.org escardio.org/The-ESC/Press-Office/Press-releases/New-systematic-review-and-meta-analysis-shows-an-association-between-shingles-vaccination-and-lower-risk-of-heart-attack-and-stroke

New systematic review and meta-analysis shows an ... The research found that vaccination against shingles, with either RZV or ZVL, was associated with an 18% and 16% reduction in risk of ...

3. shingrixhcp.com shingrixhcp.com/efficacy-safety/efficacy-data/

SHINGRIX (Zoster Vaccine Recombinant, Adjuvanted) PROVEN OUTSTANDING EFFICACY. SHINGRIX delivered greater than 90 percent efficacy against shingles graphic. Data from ZOE-50 and pooled analysis from ZOE-50/-70.

4. acpjournals.org acpjournals.org/doi/10.7326/ANNALS-24-02409

Effectiveness of Recombinant Herpes Zoster Vaccine in the ... Vaccine effectiveness was 51.8% (CI, 44.7% to 57.9%) among individuals who had previously received ZVL vaccination, compared with 57.7% (CI, ...

5. shingrix.com shingrix.com/

SHINGRIX (Zoster Vaccine Recombinant, Adjuvanted) SHINGRIX is a vaccine given as a 2-dose series. In clinical trials, it was proven to be more than 90% effective in preventing shingles in adults 50 years and ...

6. cdc.gov cdc.gov/vaccine-safety/vaccines/shingles-herpes.html

Shingles (Herpes Zoster) Vaccine Safety Both Shingrix and Zostavax shingles vaccines have been shown to be safe and well tolerated. Common side effects, such as soreness and redness at the injection ...

7. fda.gov fda.gov/files/vaccines%2C%20blood%20%26%20biologics/published/Package-Insert-SHINGRIX.pdf

Package Insert - SHINGRIX The safety of SHINGRIX was evaluated by pooling data from 2 placebo-controlled clinical studies (Studies 1 and 2) involving 29,305 subjects aged 50 years and ...

8. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11788766/

Post-marketing safety surveillance for the recombinant zoster ... The median time-to-onset for adverse events of recombinant zoster vaccine was 1 day. •. Eighty-six deaths were reported following recombinant ...

9. shingrixhcp.com shingrixhcp.com/efficacy-safety/adverse-reactions/

Safety Profile & Adverse Reactions | SHINGRIX (Zoster ... Read about the safety profile of SHINGRIX (Zoster Vaccine Recombinant, Adjuvanted). Find details about solicited local and general adverse reactions.

10. shingrix.com shingrix.com/side-effects/

Side Effects | SHINGRIX (Zoster Vaccine Recombinant, ... An increased risk of Guillain-Barré syndrome (severe muscle weakness) was observed after vaccination with SHINGRIX · Fainting can happen after getting injectable ...