HZ Vaccine for Shingles
Recruiting in Palo Alto (17 mi)
+2 other locations
Age: 18+
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Phase 1
Waitlist Available
Sponsor: Shenzhen Shenxin Biotechnology Co., Ltd
No Placebo Group
Approved in 2 Jurisdictions
Trial Summary
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
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.
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.
12345What 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.
15678Is 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.
135910Eligibility 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
Key
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.
+3 more
Participant Groups
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.
5Treatment groups
Experimental Treatment
Active Control
Group I: Arm 4: Dose DExperimental Treatment1 Intervention
Participants will receive IN001 by IM injection on Day 0 and Day 56.
Group II: Arm 3: Dose CExperimental Treatment1 Intervention
Participants will receive IN001 by IM injection on Day 0 and Day 56.
Group III: Arm 2: Dose BExperimental Treatment1 Intervention
Participants will receive IN001 by IM injection on Day 0 and Day 56.
Group IV: Arm 1: Dose AExperimental Treatment2 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: ShingrixActive Control1 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
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
CenExelHollywood, FL
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Who Is Running the Clinical Trial?
Shenzhen Shenxin Biotechnology Co., LtdLead Sponsor
References
Shingrix: The New Adjuvanted Recombinant Herpes Zoster Vaccine. [2019]To review the immunogenicity, efficacy, and safety of the herpes zoster subunit vaccine (HZ/su) for use in adult patients for the prevention of shingles.
A phase 1/2 study of an adjuvanted varicella-zoster virus subunit vaccine in autologous hematopoietic cell transplant recipients. [2021]Recombinant herpes zoster (HZ) vaccines may be an alternative to the live-attenuated HZ vaccine for immunocompromised individuals. This was a phase 1/2, randomized, observer-blind, placebo-controlled study in adults with multiple myeloma, non-Hodgkin lymphoma (B- or T-cell), Hodgkin lymphoma, or acute myeloid leukemia who had undergone autologous hematopoietic stem-cell transplant 50 to 70 days earlier. Subjects (N = 121) were randomized 1:1:1:1 to receive (at months 0, 1, 3) three doses of 50 μg varicella-zoster virus glycoprotein E (gE) adjuvanted with AS01B, 3 doses of gE adjuvanted with AS01E, 1 dose of saline followed by 2 doses of gE/AS01B, or 3 doses of saline. One month after the last dose (6 months after transplant), frequencies of CD4(+) T cells expressing ≥2 activation markers after induction with gE and anti-gE antibody concentrations were higher with all gE/AS01 regimens than with saline. Both responses persisted up to 1 year in subjects vaccinated with gE/AS01. Immune responses were higher in the gE/AS01B 3-dose group than in the gE/AS01B 2-dose group but not higher than in the gE/AS01E 3-dose group. One serious adverse event (pneumonia) was considered vaccine related. Both formulations and both schedules were immunogenic and well tolerated in this population. This study was registered at www.clinicaltrials.gov as #NCT00920218.
Vaccine profile of herpes zoster (HZ/su) subunit vaccine. [2018]Label="INTRODUCTION">Herpes zoster (HZ) causes an often severe and painful rash in older people and may be complicated by prolonged pain (postherpetic neuralgia; PHN) and by dissemination in immune-compromised patients. HZ results from reactivation of latent varicella-zoster virus (VZV) infection, often associated with age-related or other causes of decreased T cell immunity. A live attenuated vaccine boosts this immunity and provides partial protection against HZ, but this decreases with age and declines over 8 years. Areas covered: A new HZ subunit (HZ/su) vaccine combines a key surface VZV glycoprotein (E) with a T cell-boosting adjuvant system (AS01B) and is administered by two intramuscular injections two months apart. Expert commentary: HZ/su showed excellent efficacy of ~90% in immunocompetent adults ≥50 and ≥70 years of age, respectively, in the ZOE-50 and ZOE-70 phase III controlled trials. Efficacy was unaffected by advancing age and persisted for >3 years. Approximately 9.5% of subjects had severe, but transient (1-2 days) injection site pain, swelling or redness. Compliance with both vaccine doses was high (95%). The vaccine will have a major impact on HZ management. Phase I-II trials showed safety and immunogenicity in severely immunocompromised patients. Phase III trial results are expected soon.
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]The newly registered adjuvanted herpes zoster subunit vaccine (HZ/su) has a higher efficacy than the available live-attenuated vaccine (ZVL). National decision-makers soon need to decide whether to introduce HZ/su or to prefer HZ/su above ZVL.
Herpes zoster subunit vaccine for the prevention of herpes zoster. [2019]Published literature on the efficacy and safety of the herpes zoster (HZ) subunit vaccine (HZ/su vaccine) in reducing the risks of HZ and postherpetic neuralgia (PHN) in adults 50 years of age and older, as well as the vaccine's properties and efficacy relative to live attenuated vaccine, is reviewed.
Safety, tolerability, and immunogenicity of zoster vaccine in subjects with a history of herpes zoster. [2010]Prior clinical studies of zoster vaccine enrolled subjects without a history of herpes zoster (HZ), so there are limited data on safety and immunogenicity in vaccinees with a prior history of HZ. This study was conducted to evaluate the safety and immunogenicity of zoster vaccine recipients who had a prior episode of HZ.
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]An adjuvanted recombinant subunit candidate vaccine (HZ/su) containing varicella zoster virus envelope glycoprotein E was developed for the prevention of herpes zoster and its complications. This study evaluated safety and reactogenicity of HZ/su in an ethnic Japanese population. This was a phase I, open-label and single-center study conducted between March and November of 2010 in Australia. Twenty healthy ethnic Japanese subjects, aged 18-30 y and 50-69 y (1:1) were enrolled. Subjects were administered two doses of HZ/su vaccine according to a 0, 2-mo schedule. Local and general solicited symptoms were recorded for 7 d post-vaccination. Unsolicited symptoms were recorded for 30 d post-vaccination. Serious adverse events (SAEs), new onset of autoimmune disease (NOAD), other potential immune mediated disorders and HZ cases were recorded throughout the study period. All 20 subjects were included in the according-to-protocol cohort for safety. A total of 18 subjects were included in the according-to-protocol cohort for immunogenicity: 10 in the 18-30 y age group and 8 in the 50-69 y age group. The most commonly reported local and general solicited symptoms were pain and fatigue in both groups. Back pain (in the 18-30 y age group) and chills (in the 50-69 y age group) were the most frequently reported unsolicited symptoms. There were no reports of death, SAEs, NOADs, other autoimmune mediated inflammatory disorder or suspected HZ cases. This study indicated that the two-dose regimen of HZ/su exhibited a clinically acceptable safety profile in healthy young and older ethnic Japanese adults.
Strategies for herpes zoster vaccination of immunocompromised patients. [2021]A vaccine to prevent herpes zoster (HZ) in adults > or =60 years of age with healthy immune systems was recently approved by the US Food and Drug Administration. This vaccine is contraindicated in persons with certain immunodeficiency states or who are receiving immunosuppressive therapy. On the basis of studies of the varicella vaccine in healthy and immunosuppressed children and studies of HZ vaccine in healthy adults before its licensure, a series of strategies are proposed for evaluating the live HZ vaccine in immunosuppressed persons. In addition, the use of other vaccines, including heat-inactivated or replication-defective varicella-zoster virus to prevent HZ in immunocompromised persons, is also discussed.
Post-licensure safety surveillance of zoster vaccine live (Zostavax®) in the United States, Vaccine Adverse Event Reporting System (VAERS), 2006-2015. [2019]Herpes zoster (HZ), or shingles, is caused by reactivation of varicella-zoster virus in latently infected individuals. Live-attenuated HZ vaccine (zoster vaccine live, ZVL) is approved in the United States for persons aged ≥50 years and recommended by the CDC for persons ≥60 years.
Immune Responses to a Recombinant Glycoprotein E Herpes Zoster Vaccine in Adults Aged 50 Years or Older. [2019]The herpes zoster subunit vaccine (HZ/su), consisting of varicella-zoster virus glycoprotein E (gE) and AS01B Adjuvant System, was highly efficacious in preventing herpes zoster in the ZOE-50 and ZOE-70 trials. We present immunogenicity results from those trials.