JCXH-105 Vaccine for Shingles

(JCXH-105 Trial)

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

75 Participants Needed

Trial Summary

What is the purpose of this trial?

This trial is testing a new vaccine called JCXH-105, which uses self-replicating RNA to help the body fight Shingles. It targets people who are at risk of Shingles and aims to see if this new approach is safe and effective.

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.

What data supports the effectiveness of the JCXH-105 treatment for shingles?

Research shows that Shingrix, a similar vaccine to JCXH-105, has been highly effective in preventing shingles, with studies indicating over 90% efficacy. This suggests that JCXH-105, which involves similar components, may also be effective in preventing shingles. ^{1 2 3 4 5}

Is the JCXH-105 (Shingrix) vaccine safe for humans?

The JCXH-105 vaccine, also known as Shingrix, has been shown to be generally safe in humans. Most people experience mild reactions like pain or redness at the injection site, and serious side effects are rare and similar to those seen with a placebo. ^{6 7 8 9 10}

Eligibility Criteria

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

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)

Treatment Details

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.

Participant Groups

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

Findings from Research

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]

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 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]

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 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 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]

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]

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]

References

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

Shingrix: A New Herpes Zoster Vaccine. [2020]

2. Netherlands 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. [2021]

3. Japan pubmed.ncbi.nlm.nih.gov

[Herpes Zoster Vaccine]. [2019]

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

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

5. Netherlands pubmed.ncbi.nlm.nih.gov

Clinical Nudge Impact on Herpes Zoster Vaccine Series Completion in Pharmacies. [2022]

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

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

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

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

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

Aplastic anemia following varicella vaccine. [2009]

9. United States 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. [2022]

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

Active Postlicensure Safety Surveillance for Recombinant Zoster Vaccine Using Electronic Health Record Data. [2023]