HZ Vaccine for Shingles

Recruiting at 2 trial locations

Overseen By Clinical Development Innorna

Age: 18+

Sex: Any

Trial Phase: Phase 1

Sponsor: Shenzhen Shenxin Biotechnology Co., Ltd

Must not be taking: Immunosuppressants, Corticosteroids, others

Disqualifiers: Heart disease, Immunodeficiency, Chronic infection, others

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

Approved in 2 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 2

Duration: 8 weeks

150 Participants Needed

Trial Summary

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

The trial protocol does not specify if you need to stop taking your current medications. However, you cannot participate if you are on certain treatments like immunosuppressive drugs, systemic corticosteroids above a certain dose, or if you plan to receive other vaccines close to the study vaccinations. It's best to discuss your specific medications with the trial investigator.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications. However, if you are on immunosuppressive drugs, systemic corticosteroids, or have received certain vaccines recently, you may need to adjust your medication schedule. It's best to discuss your specific medications with the trial team.

What data supports the idea that HZ Vaccine for Shingles is an effective treatment?

The available research shows that the HZ Vaccine for Shingles is highly effective in preventing shingles in adults. Studies indicate that the vaccine has an efficacy of about 90% in adults aged 50 and older, and this effectiveness does not decrease with age. Additionally, the vaccine's protection lasts for more than three years. Compared to the older live-attenuated vaccine, the HZ Vaccine for Shingles has a higher efficacy, making it a better option for preventing shingles. The vaccine is also well-tolerated, with most side effects being mild and temporary, such as pain or swelling at the injection site. ^{1 2 3 4 5}

What data supports the effectiveness of the HZ Vaccine for Shingles treatment?

Research shows that a similar herpes zoster subunit vaccine (HZ/su) has about 90% effectiveness in preventing shingles in adults over 50, and this effectiveness remains high even as people age. This suggests that the HZ Vaccine for Shingles could also be highly effective. ^{1 2 3 4 5}

What safety data exists for the HZ Vaccine for Shingles?

The safety data for the HZ Vaccine, also known as the herpes zoster subunit vaccine (HZ/su), indicates a clinically acceptable safety profile. Studies have shown that the most common symptoms are pain and fatigue, with no reports of serious adverse events, new onset autoimmune diseases, or herpes zoster cases. The vaccine has been evaluated in both healthy young and older adults, including those with a history of herpes zoster, and has been found to be safe and well-tolerated. ^{1 5 6 7 8}

Is the Herpes Zoster IN001 mRNA Vaccine safe for humans?

The Herpes Zoster subunit vaccine (HZ/su) has been studied for safety in various groups, including healthy young and older adults, showing a clinically acceptable safety profile with common mild symptoms like pain and fatigue. No serious adverse events or autoimmune disorders were reported in these studies. ^{1 5 6 7 8}

Is the Herpes Zoster IN001 mRNA Vaccine a promising drug for shingles?

The Herpes Zoster IN001 mRNA Vaccine is a promising drug for shingles because it aims to prevent the painful rash and complications associated with the disease. Similar vaccines have shown high effectiveness in preventing shingles in adults, especially those over 50, and have been well-received in trials. This suggests that the IN001 vaccine could also be highly effective in managing shingles. ^{1 3 5 9 10}

How is the Herpes Zoster IN001 mRNA Vaccine different from other shingles treatments?

The Herpes Zoster IN001 mRNA Vaccine is unique because it uses mRNA technology, which is a newer approach compared to traditional vaccines like the live-attenuated or subunit vaccines. This method instructs cells to produce a protein that triggers an immune response, potentially offering a different mechanism of protection against shingles. ^{1 3 5 9 11}

What is the purpose of this trial?

The study will evaluate the safety, tolerability, and immunogenicity (your immune system's reaction) of the study vaccine called Herpes Zoster IN001 mRNA Vaccine (IN001) in healthy participants who are between 50 and 69 years of age

Eligibility Criteria

Healthy adults aged 50-69, who are not pregnant or breastfeeding and agree to use effective contraception. Participants can have stable, treated conditions like hypertension but must not be on treatments that would exclude them from the study as per the investigator's judgment.

Inclusion Criteria

I am between 50 and 69 years old and in good health.

I weigh at least 50 kg if male, 45 kg if female, and my BMI is between 18.5 and 35.

I have stable health conditions like high blood pressure or cholesterol, without any damage to organs.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive the study vaccine or comparator by intramuscular injection on Day 0 and Day 56

8 weeks

2 visits (in-person)

Follow-up

Participants are monitored for safety and immunogenicity after receiving the vaccine

4 weeks

Treatment Details

Interventions

• Herpes Zoster IN001 mRNA Vaccine (IN001)

Trial Overview The trial is testing a new Herpes Zoster mRNA vaccine (IN001) against Shingrix and a placebo. It aims to assess how safe IN001 is, how well it's tolerated by participants, and its ability to provoke an immune response in healthy individuals within the specified age range.

Participant Groups

Group I: Arm 4: Dose D Experimental Treatment 1 Intervention

Participants will receive IN001 by IM injection on Day 0 and Day 56.

Group II: Arm 3: Dose C Experimental Treatment 1 Intervention

Participants will receive IN001 by IM injection on Day 0 and Day 56.

Group III: Arm 2: Dose B Experimental Treatment 1 Intervention

Participants will receive IN001 by IM injection on Day 0 and Day 56.

Group IV: Arm 1: Dose A Experimental Treatment 2 Interventions

Participants will receive placebo by intramuscular (IM) injection on Day 0 followed with IN001 by IM injection on Day 56.

Group V: Arm 5: Shingrix Active Control 1 Intervention

Participants will receive Shingrix by IM injection on Day 0 and Day 56.

Herpes Zoster IN001 mRNA Vaccine (IN001) is already approved in United States, China for the following indications:

Approved in United States as IN001 for:

• Prevention of herpes zoster in healthy participants aged 50-69 years

Approved in China as IN001 for:

• Prevention of herpes zoster

Who Is Running the Clinical Trial?

Shenzhen Shenxin Biotechnology Co., Ltd

Lead Sponsor

Trials

3

Recruited

590+

Findings from Research

The herpes zoster subunit vaccine (HZ/su) is highly effective, reducing the risk of developing shingles by over 90% compared to a placebo, making it a strong preventive measure for adults aged 50 and older.

The vaccine has a comparable safety profile to other vaccines, with common side effects including injection site pain and mild systemic reactions like fatigue and headache, supporting its routine use as recommended by the Advisory Committee on Immunization Practices (ACIP).

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Shingrix: The New Adjuvanted Recombinant Herpes Zoster Vaccine. James, SF., Chahine, EB., Sucher, AJ., et al.[2019]

In a phase 1/2 study involving 121 adults with various blood cancers who had undergone stem-cell transplants, recombinant herpes zoster vaccines showed significantly higher immune responses compared to a saline placebo, indicating their potential efficacy in immunocompromised individuals.

Both vaccine formulations (gE/AS01B and gE/AS01E) were well tolerated, with only one serious adverse event reported, suggesting a favorable safety profile for these vaccines in this vulnerable population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A phase 1/2 study of an adjuvanted varicella-zoster virus subunit vaccine in autologous hematopoietic cell transplant recipients. Stadtmauer, EA., Sullivan, KM., Marty, FM., et al.[2021]

The new herpes zoster (HZ) subunit vaccine (HZ/su) demonstrated about 90% efficacy in preventing HZ in adults aged 50 and older, with protection lasting over 3 years, regardless of age.

While approximately 9.5% of participants experienced temporary injection site pain, the vaccine was generally well-tolerated, and compliance with the two-dose regimen was high at 95%.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Vaccine profile of herpes zoster (HZ/su) subunit vaccine. Cunningham, AL., Heineman, T.[2018]

The newly registered adjuvanted herpes zoster subunit vaccine (HZ/su) is significantly more effective than the live-attenuated vaccine (ZVL) in preventing herpes zoster (HZ), with estimates showing HZ/su could prevent 4,335 to 10,896 cases compared to 400-4,877 cases for ZVL.

Cost-effectiveness analysis indicates that while both vaccines could be cost-effective, the choice between HZ/su and ZVL largely depends on the cost of the vaccines, with HZ/su requiring a maximum cost per series of €109.09 for 70-year-olds to remain cost-effective.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Cost-effectiveness of vaccination of immunocompetent older adults against herpes zoster in the Netherlands: a comparison between the adjuvanted subunit and live-attenuated vaccines. de Boer, PT., van Lier, A., de Melker, H., et al.[2019]

The HZ/su vaccine (Shingrix) is highly effective in preventing herpes zoster (HZ), with efficacy rates between 89.8% and 97.2% in Phase III trials, making it a preferred option for adults aged 50 and older.

While the HZ/su vaccine is associated with higher rates of transient local and systemic adverse events compared to placebo, it has similar rates of serious adverse events, indicating it is generally safe for use in various populations, including those with prior HZ or HIV.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Herpes zoster subunit vaccine for the prevention of herpes zoster. Symoniak, MR., Farrokh, P., Gandhi, MA., et al.[2019]

The zoster vaccine was found to be safe and well-tolerated in adults aged 50 and older with a prior history of herpes zoster, with no serious adverse events reported after vaccination.

The vaccine significantly increased varicella-zoster virus (VZV) antibody levels, demonstrating an effective immune response, which supports routine zoster vaccination for all immunocompetent individuals aged 60 and above, regardless of their herpes zoster history.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Safety, tolerability, and immunogenicity of zoster vaccine in subjects with a history of herpes zoster. Mills, R., Tyring, SK., Levin, MJ., et al.[2010]

The HZ/su vaccine, designed to prevent herpes zoster, demonstrated a clinically acceptable safety profile in a study involving 20 healthy ethnic Japanese adults aged 18-30 and 50-69, with no serious adverse events reported.

Common side effects included pain and fatigue, with no serious health issues or new autoimmune diseases observed, indicating that the vaccine is well-tolerated in both younger and older participants.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Safety and immunogenicity of an AS01-adjuvanted varicella zoster virus subunit candidate vaccine (HZ/su): a phase-I, open-label study in Japanese adults. Lal, H., Zahaf, T., Heineman, TC.[2021]

A new vaccine to prevent herpes zoster (shingles) has been approved for adults aged 60 and older with healthy immune systems, but it is not safe for those with certain immunodeficiencies or on immunosuppressive therapy.

The paper suggests strategies for evaluating the live herpes zoster vaccine in immunosuppressed individuals and discusses alternative vaccine options, such as heat-inactivated or replication-defective varicella-zoster virus, for preventing shingles in these patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Strategies for herpes zoster vaccination of immunocompromised patients. Cohen, JI.[2021]

A safety review of the live-attenuated herpes zoster vaccine (ZVL) involving 23,092 reports found that 96% of adverse events were classified as non-serious, with the most common reactions being injection site erythema, shingles, and rash.

The analysis showed no new or unexpected safety concerns, confirming that the safety profile of ZVL is consistent with previous clinical trials, making it a reassuring option for individuals aged 50 and older.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Post-licensure safety surveillance of zoster vaccine live (Zostavax®) in the United States, Vaccine Adverse Event Reporting System (VAERS), 2006-2015. Miller, ER., Lewis, P., Shimabukuro, TT., et al.[2019]

The herpes zoster subunit vaccine (HZ/su) demonstrated a strong immune response, with 97.8% of recipients showing a humoral response and significant increases in anti-gE antibody levels, indicating its efficacy in generating immunity against herpes zoster.

The vaccine also induced a robust CD4 T-cell response, with 93.3% of recipients showing activation, and these immune responses persisted for at least 3 years, suggesting long-term protection.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Immune Responses to a Recombinant Glycoprotein E Herpes Zoster Vaccine in Adults Aged 50 Years or Older. Cunningham, AL., Heineman, TC., Lal, H., et al.[2019]

References

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

Shingrix: The New Adjuvanted Recombinant Herpes Zoster Vaccine. [2019]

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

A phase 1/2 study of an adjuvanted varicella-zoster virus subunit vaccine in autologous hematopoietic cell transplant recipients. [2021]

3. England pubmed.ncbi.nlm.nih.gov

Vaccine profile of herpes zoster (HZ/su) subunit vaccine. [2018]

4. England pubmed.ncbi.nlm.nih.gov

Cost-effectiveness of vaccination of immunocompetent older adults against herpes zoster in the Netherlands: a comparison between the adjuvanted subunit and live-attenuated vaccines. [2019]

5. England pubmed.ncbi.nlm.nih.gov

Herpes zoster subunit vaccine for the prevention of herpes zoster. [2019]

6. Netherlands pubmed.ncbi.nlm.nih.gov

Safety, tolerability, and immunogenicity of zoster vaccine in subjects with a history of herpes zoster. [2010]

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

Safety and immunogenicity of an AS01-adjuvanted varicella zoster virus subunit candidate vaccine (HZ/su): a phase-I, open-label study in Japanese adults. [2021]

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

Strategies for herpes zoster vaccination of immunocompromised patients. [2021]

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

Post-licensure safety surveillance of zoster vaccine live (Zostavax®) in the United States, Vaccine Adverse Event Reporting System (VAERS), 2006-2015. [2019]

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

Immune Responses to a Recombinant Glycoprotein E Herpes Zoster Vaccine in Adults Aged 50 Years or Older. [2019]

11. Netherlands pubmed.ncbi.nlm.nih.gov

Safety and efficacy of recombinant and live herpes zoster vaccines for prevention in at-risk adults with chronic diseases and immunocompromising conditions. [2023]