JCXH-105 Vaccine for Shingles

Not currently recruiting at 12 trial locations

Overseen By Brittany Stine

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: Immorna Biotherapeutics, Inc.

Must not be taking: Immunosuppressants, Antivirals, Corticosteroids, others

Disqualifiers: Herpes zoster, Immunodeficiency, Myocarditis, others

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

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 2

Duration: 9 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new vaccine, JCXH-105, to determine if it can safely prevent shingles, a painful rash caused by the herpes zoster virus. Participants will receive either the new vaccine or the already approved Shingrix vaccine to compare effectiveness and safety. The study seeks healthy individuals aged 50 and older who have not had shingles in the past 10 years and have not been vaccinated for it.

As a Phase 2 trial, the research focuses on measuring the treatment's effectiveness in an initial, smaller group, offering participants a chance to contribute to important medical advancements.

Do I need to stop taking my current medications to join the trial?

The trial requires that you stop taking systemic antiviral therapy and certain immune-suppressive medications before joining. If you're on stable-dose steroid replacement of prednisone ≤10 mg/day or equivalent, you can continue. Please check with the trial team for specific guidance on your medications.

Will I have to stop taking my current medications?

The trial requires that you stop taking systemic antiviral therapy and certain immune-suppressive medications before participating. If you are on stable-dose steroid replacement of prednisone ≤10 mg/day or equivalent, you may continue. Please consult with the trial team for specific guidance on your medications.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research shows that JCXH-105, a new vaccine for shingles, is being tested for safety in people. This vaccine is in the middle stages of testing, providing some early information about its safety. Initial studies suggest that the vaccine is generally well-tolerated. Some participants have experienced mild side effects, such as soreness at the injection site and mild fever, which are common with vaccines. Serious side effects have not been widely reported. This suggests JCXH-105 might be safe, but ongoing studies will provide clearer answers.

For comparison, the trial also includes Shingrix, a shingles vaccine already approved by the FDA and known to be safe and effective. While researchers continue to study JCXH-105, Shingrix serves as a reliable standard for safety in this research. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

The JCXH-105 vaccine for shingles is unique because it introduces a novel approach to preventing the condition. Unlike the standard of care, such as the FDA-approved Shingrix, JCXH-105 is an investigational product that researchers believe may offer improved immune response. Additionally, while Shingrix provides robust protection, JCXH-105 might target the virus differently, potentially offering enhanced efficacy or a longer duration of protection. Researchers are excited about JCXH-105 because it could represent a significant step forward in how we prevent shingles, possibly providing better and longer-lasting immunity.

What evidence suggests that this trial's treatments could be effective for shingles?

Research shows that JCXH-105, a new vaccine, is designed to prevent shingles, also known as Herpes Zoster. This vaccine employs a novel approach to help the body defend against the virus causing shingles. Although detailed information from human studies remains limited, early research suggests that this vaccine can trigger strong immune responses. In this trial, participants will be randomized into different arms: one group will receive the investigational product JCXH-105, while another group will receive Shingrix, the current standard vaccine, which has already been proven to significantly reduce shingles cases. This study compares the effectiveness of JCXH-105 against Shingrix, aiming to provide more information on its efficacy. ^{3 4 6 7 8}

Are You a Good Fit for This Trial?

This trial is for healthy men and women over 50 who haven't received any Herpes Zoster vaccines or RNA-based vaccines like Spikevax or Comirnaty within a month before the study starts and won't get them during the study.

Inclusion Criteria

I am currently healthy without any ongoing illnesses.

I agree not to get any shingles vaccines during the study.

I agree not to get any RNA-based vaccines for 4 months around my treatment doses.

Exclusion Criteria

I haven't had a serious respiratory illness or been hospitalized for over 24 hours in the last month.

I have not had a fever of 100.4°F or higher in the last 72 hours.

I have a condition that affects my immune system, but it's under control.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive two doses of the study vaccine (JCXH-105 or Shingrix) approximately 2 months apart

9 weeks

2 visits (in-person)

Follow-up

Participants are monitored for safety and immunogenicity, including adverse events and immune response, after the second dose

25 weeks

Multiple visits (in-person and virtual)

What Are the Treatments Tested in This Trial?

Interventions

• JCXH-105

Trial Overview The trial is testing JCXH-105, an srRNA-based vaccine, against Shingrix to see which is better at preventing shingles. Participants will be randomly assigned to receive one of these two vaccines.

How Is the Trial Designed?

Group I: Investigational Product Experimental Treatment 1 Intervention

Participants randomized to this arm will be given the investigational product (JCXH-105).

Group II: Active Control Active Control 1 Intervention

Participants randomized to this arm will be given the FDA approved Shingrix.

Who Is Running the Clinical Trial?

Immorna Biotherapeutics, Inc.

Lead Sponsor

Trials

7

Recruited

920+

Tigermed Consulting Co., Ltd

Industry Sponsor

Trials

34

Recruited

58,000+

Published Research Related to This Trial

The implementation of a clinical decision support tool in community pharmacies led to a slight increase in the completion rate of the herpes zoster vaccine doses, from 71.9% to 75.2%.

More significantly, the time taken for patients to complete their second dose decreased dramatically from an average of 109.8 days to 93.3 days after the system was introduced, indicating improved efficiency in vaccine management.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Clinical Nudge Impact on Herpes Zoster Vaccine Series Completion in Pharmacies. Gatwood, J., Brookhart, A., Kinney, O., et al.[2022]

The new recombinant herpes zoster vaccine (Shingrix) has been shown to reduce the risk of herpes zoster and postherpetic neuralgia (PHN) by over 90% in large randomized trials, making it highly effective for preventing complications associated with shingles.

In contrast, the live-attenuated vaccine (Zostavax) has been available for over a decade but offers less protection compared to the newer Shingrix vaccine, highlighting the advancements in vaccine efficacy for older adults.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Herpes Zoster Vaccine]. Watanabe, D.[2019]

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 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]

Between 1995 and 2005, nearly 48 million doses of the varicella vaccine were distributed, with 25,306 adverse events reported, indicating a low incidence of serious adverse events at 2.6 per 100,000 doses.

While some adverse events, such as meningitis, were linked to the vaccine strain of varicella-zoster virus, serious complications remain rare and are outweighed by the significant benefits of vaccination, highlighting the importance of ongoing safety monitoring.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Safety of varicella vaccine after licensure in the United States: experience from reports to the vaccine adverse event reporting system, 1995-2005. Chaves, SS., Haber, P., Walton, K., 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 varicella zoster vaccine is generally safe and rarely causes serious complications, but there is a potential risk of severe aplastic anemia, as demonstrated in a case involving an immunocompetent child who developed this condition three weeks after vaccination.

Pediatricians should be aware of this rare but serious adverse event, highlighting the importance of monitoring for unusual reactions following vaccination.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Aplastic anemia following varicella vaccine. Angelini, P., Kavadas, F., Sharma, N., et al.[2009]

In a study of 647,833 adults aged 50 and older who received the recombinant zoster vaccine (RZV), no sustained increased risk of serious health outcomes like stroke or Guillain-Barré syndrome was found compared to historical and contemporary vaccine recipients.

The study confirmed that while RZV may cause more systemic and local reactions than previous vaccines, it provides reassurance about its overall safety profile in preventing shingles and its complications.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Active Postlicensure Safety Surveillance for Recombinant Zoster Vaccine Using Electronic Health Record Data. Nelson, JC., Ulloa-Pérez, E., Yu, O., et al.[2023]

A new mRNA vaccine platform (VZV gE mRNA/LNP) shows promise in eliciting a strong immune response against shingles, comparable to established vaccines like Shingrix™, while outperforming the live attenuated vaccine ZOSTAVAX® in terms of immune response magnitude.

The study utilized non-human primates to demonstrate that the immune responses generated by the mRNA vaccine and protein/adjuvant vaccine were similar to those observed in human clinical trials, supporting the use of NHP as a reliable model for future vaccine evaluations.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Immunogenicity generated by mRNA vaccine encoding VZV gE antigen is comparable to adjuvanted subunit vaccine and better than live attenuated vaccine in nonhuman primates. Monslow, MA., Elbashir, S., Sullivan, NL., et al.[2021]

The high-titer live attenuated herpes zoster vaccine significantly reduced the incidence of herpes zoster by 51.3% and the burden of illness by 61.1% in adults aged 60 and older, as shown in the Shingles Prevention Study.

The vaccine also decreased the incidence of postherpetic neuralgia (PHN) by 66.5% and was found to be safe, with adverse events similar to those of the placebo group, except for a higher risk of injection site reactions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Herpes zoster vaccine: clinical trial evidence and implications for medical practice. Burke, MS.[2007]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT06581575

NCT06581575 | A Phase 2 Study to Evaluate JCXH-105, ... The goal of this clinical trial is to assess the safety and immunogenicity of an srRNA-based vaccine, JCXH-105, in the prevention of Herpes Zoster (Shingles).

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12299449/

Research Progress on Varicella-Zoster Virus Vaccines - PMC ... herpes-zoster-cases-by-an-estimated-64-percent-in-immunocom/; 37. Immorna JCXH-105, the World's First RNA Shingles Vaccine, Has Been Approved ...

3. app.trialscreen.org app.trialscreen.org/trials/phase-2-to-evaluate-jcxh-105-srrna-based-herpes-zoster-vaccine-trial-nct06581575

A Phase 2 study of JCXH-105 vs Shingrix in Herpes Zoster A Phase 2 study of JCXH-105 vs Shingrix in Herpes Zoster · A Study Evaluating a New Herpes Zoster (Shingles) Vaccine Compared to an Approved Vaccine · Study Goals.

4. vax-before-travel.com vax-before-travel.com/vaccines/shingles-vaccines

Shingles Vaccines Recombinant Herpes Zoster Vaccine Is Effective at Reducing Shingles · Shingles episodes reduced by vaccination ; herpes vaccine · Herpes Zoster Vaccination Delays ...

5. centerwatch.com centerwatch.com/clinical-trials/listings/NCT06581575/a-phase-2-study-to-evaluate-jcxh-105-an-srrna-based-herpes-zoster-vaccine

A Phase 2 Study to Evaluate JCXH-105, an srRNA-based ... A Phase 2 Study to Evaluate JCXH-105, an srRNA-based Herpes Zoster Vaccine ; Condition. Shingles. Herpes Simplex Infections. Chickenpox ( ...

6. clinicaltrials.gov clinicaltrials.gov/study/NCT05871541

A First-in-Human Study to Evaluate JCXH-105, an SrRNA- ... ... vaccine, JCXH-105, in the prevention of Shingles (Herpes Zoster). Participant will be randomized to receive either JCXH-105 or Shingrix. Detailed Description.

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

Shingles (Herpes Zoster) Vaccine Safety Shingles (Herpes Zoster) Vaccine Safety. Safety Information by Vaccine | Page ... Active Post-Licensure Safety Surveillance for Recombinant Zoster Vaccine Using ...

8. ctv.veeva.com ctv.veeva.com/study/a-phase-2-study-to-evaluate-jcxh-105-an-srrna-based-herpes-zoster-vaccine

A Phase 2 Study to Evaluate JCXH-105, an srRNA-based ... ... vaccine, JCXH-105, in the prevention of Herpes Zoster (Shingles). Subjects will be randomized to receive either JCXH-105 or Shingrix.