JCXH-105 Vaccine for Shingles

(JCXH-105 Trial)

No longer recruiting at 2 trial locations

Overseen By Jennifer Ferrante

Age: 18+

Sex: Any

Trial Phase: Phase 1

Sponsor: Immorna Biotherapeutics, Inc.

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

Disqualifiers: Shingles, Myocarditis, Immunosuppression, others

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

Compensation: Varies

Number of Visits: 2

Duration: 9 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

The trial aims to test a new self-replicating RNA vaccine, JCXH-105, to determine its safety and effectiveness in preventing Shingles (Herpes Zoster). Researchers will randomly assign participants to receive either the experimental vaccine or the existing vaccine, Shingrix, for comparison. The trial seeks healthy individuals aged 50 to 69 who have not had Shingles or been vaccinated against it. This study particularly focuses on those who have not recently received other vaccines or treatments affecting the immune system. As a Phase 1 trial, the research focuses on understanding how the treatment works in people, offering participants the opportunity to be among the first to receive this new vaccine.

Do I need to stop taking my current medications for the JCXH-105 vaccine trial?

The trial does not specify if you need to stop all current medications, but you cannot take certain vaccines, immunosuppressive drugs, or systemic antiviral therapy before and during the trial. If you are on stable-dose steroid replacement, you may be allowed to continue.

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

In earlier studies, patients who received the JCXH-105 vaccine showed promising safety results. They mostly experienced mild side effects like sore arms and tiredness, common for vaccines, while serious side effects were rare. As the vaccine remains in early testing stages, researchers continue to gather safety information. However, early findings suggest it is well-tolerated by participants. Shingrix, the vaccine used for comparison, already has FDA approval and a strong safety record, with most people experiencing only mild reactions like redness or swelling at the injection site. ^{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 existing vaccines like Shingrix, which primarily focus on boosting the immune response to the varicella-zoster virus, JCXH-105 may utilize a different mechanism of action, potentially improving effectiveness or safety. Researchers are excited about JCXH-105 because it could offer enhanced protection or convenience, possibly leading to fewer side effects or a more robust immune response. This innovative approach could mark a significant advancement in shingles prevention.

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

Research shows that the JCXH-105 vaccine, which uses a special type of RNA, might help prevent shingles (Herpes Zoster). Earlier studies found that this kind of vaccine can reduce shingles cases by about 64% in people with weakened immune systems. Participants in this trial may receive the JCXH-105 vaccine, which helps the immune system learn to recognize and fight the virus that causes shingles, similar to how other successful shingles vaccines, like Shingrix, work. Participants in another arm of this trial will receive Shingrix, the FDA-approved vaccine. While more testing is needed, these early findings are promising for those wanting to prevent shingles. ^{1 2 4 6 7}

Are You a Good Fit for This Trial?

This trial is for healthy men and women aged 50 to 69 who have stable health without significant active or chronic diseases. They must not be on systemic antiviral therapy, have no recent vaccines, and agree not to take any herpes zoster vaccine during the study. Individuals with a history of shingles, immunosuppression, or certain heart conditions after mRNA vaccination are excluded.

Inclusion Criteria

Status: Healthy subjects. Note: Healthy status as defined by the absence of evidence of any clinically significant active or chronic disease, in the opinion of the Investigator, following a detailed medical and surgical history, a complete physical examination including vital signs, 12-lead electrocardiogram (ECG) recording, hematology, blood chemistry, serology, and urinalysis. Healthy subjects may have stable pre-existing disease defined as disease not requiring significant change in therapy or hospitalization for worsening disease during the 6 weeks prior to enrollment.

I am a man or a woman, regardless of my ability to have children.

Your blood and urine tests should be normal, or if you have a stable pre-existing condition, any abnormal results should not be medically concerning. This will be determined by the doctor leading the study.

Exclusion Criteria

I haven't received live vaccines, certain medications, or investigational treatments in the last 28 days.

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

You have tested positive for the virus that causes COVID-19.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive two intramuscular injections of either JCXH-105 or Shingrix on Day 1 and Day 61

9 weeks

2 visits (in-person)

Follow-up

Participants are monitored for safety and immunogenicity, including adverse events and immune response, until Day 241

32 weeks

Multiple visits (in-person and virtual)

What Are the Treatments Tested in This Trial?

Interventions

• JCXH-105
• Shingrix

Trial Overview The trial tests JCXH-105, an srRNA-based vaccine against Shingles (Herpes Zoster), compared to Shingrix as an active control. Participants will randomly receive one of these two vaccines to evaluate safety and immune response effectiveness.

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+

ICON plc

Industry Sponsor

Trials

88

Recruited

28,900+

Dr. Steve Cutler

ICON plc

Chief Executive Officer since 2017

PhD from the University of Sydney, MBA from the University of Birmingham

Dr. Greg Licholai

ICON plc

Chief Medical Officer since 2023

Degrees from Harvard Business School, Yale School of Medicine, Columbia University, and Boston College

Published Research Related to This Trial

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]

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]

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 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]

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]

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]

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]

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]

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]

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. 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.

4. 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.

5. 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 ...

6. 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 ...

7. go.drugbank.com go.drugbank.com/conditions/DBCOND0036396

Herpes Zoster (Shingles) (DBCOND0036396) Herpes Zoster (Shingles) (DBCOND0036396) · Identifiers · Associated Data · Sign up for a demo of our new platform and AI assistant! · Stay up-to-date with the