JCXH-105 Vaccine for Shingles

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

467 Participants Needed

Trial Summary

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.

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

Research on similar vaccines, like Shingrix, shows that vaccines targeting the varicella-zoster virus (which causes shingles) can be highly effective, with Shingrix reducing the risk of shingles by over 90% in clinical trials. This suggests that vaccines targeting the same virus, like JCXH-105, may also be effective. ^{1 2 3 4 5}

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

Research on similar vaccines, like Shingrix, shows that they can reduce the risk of shingles by more than 90%. This suggests that new vaccines, like JCXH-105, might also be effective in preventing shingles. ^{1 2 3 4 5}

Is the JCXH-105 vaccine for shingles safe for humans?

The safety data for the recombinant zoster vaccine (Shingrix), which may be similar to JCXH-105, shows that most people experience mild reactions like pain or redness at the injection site, and serious side effects are rare. Studies have not found unexpected safety issues, and the vaccine's safety profile is similar to that of a placebo. ^{6 7 8 9 10}

Is the JCXH-105 vaccine for shingles safe for humans?

The safety data for the recombinant zoster vaccine (Shingrix), which is similar to JCXH-105, shows that most people experience mild reactions like pain at the injection site or fever. Serious side effects are rare and occur at similar rates to those who received a placebo, providing reassurance about its overall safety. ^{6 7 8 9 10}

What is the purpose of this trial?

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). Subjects will be randomized to receive either JCXH-105 or Shingrix.

Eligibility Criteria

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

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)

Treatment Details

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.

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+

Tigermed Consulting Co., Ltd

Industry Sponsor

Trials

34

Recruited

58,000+

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]