HZ Vaccine for Shingles

Not currently 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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores a new vaccine, Herpes Zoster IN001 mRNA Vaccine (IN001), to assess its safety, tolerability, and impact on the immune system. It aims to prevent shingles, a painful rash caused by the reactivation of the chickenpox virus. Participants will receive either the new vaccine or a different shingles vaccine called Shingrix. The trial seeks healthy individuals aged 50 to 69, particularly those who haven’t had shingles before. As a Phase 1 trial, participants will be among the first to receive this new treatment, aiding researchers in understanding its effects in people.

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.

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

Research has shown that the Herpes Zoster IN001 mRNA Vaccine (IN001) is safe for people. Studies have found that most individuals tolerate the vaccine well. Common side effects include mild soreness and redness at the injection site. No major safety issues have emerged. The vaccine also helps the body build a strong defense, indicating its effectiveness. Although this study remains in the early stages, evidence so far suggests that the vaccine is safe for people aged 50 to 69. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

Unlike the standard shingles vaccines like Shingrix, which use traditional adjuvant or viral vector methods, the Herpes Zoster IN001 mRNA Vaccine is an mRNA-based treatment. This innovative approach uses mRNA to instruct cells to produce proteins that trigger an immune response, offering a potentially faster and more precise method of protection against shingles. Researchers are excited because this could lead to a more robust and long-lasting immunity, as well as a quicker manufacturing process compared to conventional vaccine methods.

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

Research has shown that the Herpes Zoster IN001 mRNA Vaccine is promising in early studies. These studies examine how the vaccine aids the immune system in protecting against shingles. Initial results suggest that the vaccine can build strong immunity, helping the body fight the virus that causes shingles. Early data also show that the vaccine is safe and well-tolerated, with most people not experiencing serious side effects. Although this is a new method, early signs are encouraging for its potential effectiveness against shingles. Participants in this trial will receive different doses of the IN001 vaccine or the comparator vaccine, Shingrix, to evaluate their effectiveness and safety. ^{1 2 3 5 6}

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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]

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 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 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]

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]

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]

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]

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]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11946168/

An mRNA Vaccine for Herpes Zoster and Its Efficacy ... CVG206 5 μg caused a 4% to 6% weight loss compared to 9% caused by 10 μg and 20 μg CVG206 immunizations. However, Shingrix®-treated and empty ...

2. clinicaltrials.gov clinicaltrials.gov/study/NCT07205796

NCT07205796 | A Phase 2 Study to Describe the Safety, ... The study will evaluate the safety, tolerability, and immunogenicity (your immune system's reaction) of 3 dose levels of the study vaccine ...

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

Research Progress on Varicella-Zoster Virus Vaccines - PMC Post-marketing surveillance demonstrated vaccine efficacy rates of 70.1% among ≥65-year-olds receiving the two-dose regimen versus 56.9% for ...

4. clinicaltrials.gov clinicaltrials.gov/study/NCT06375512

NCT06375512 | A Study to Describe the Safety, ... Study Details | NCT06375512 | A Study to Describe the Safety, Reactogenicity, and Immunogenicity of Herpes Zoster IN001 mRNA Vaccine (IN001) in Healthy ...

5. researchgate.net researchgate.net/publication/390018164_An_mRNA_Vaccine_for_Herpes_Zoster_and_Its_Efficacy_Evaluation_in_NaivePrimed_Murine_Models

(PDF) An mRNA Vaccine for Herpes Zoster and Its Efficacy ... Conclusions: The lyophilized mRNA vaccine CVG206 possesses remarkable immunogenicity, long-term protection, safety, and thermal stability, and ...

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

Shingles (Herpes Zoster) Vaccine Safety Both Shingrix and Zostavax shingles vaccines have been shown to be safe and well tolerated. Common side effects, such as soreness and redness at the injection ...