1516 Participants Needed

CRV-101 Vaccine for Shingles

Recruiting at 19 trial locations
CO
CT
TM
CI
Overseen ByCurevo Inc
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Prior Safety DataThis treatment has passed at least one previous human trial

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new shingles vaccine called CRV-101 in adults aged 50 and older. The vaccine aims to boost the immune system to prevent shingles. Participants receive two injections and are monitored for safety and effectiveness.

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 medications that might interfere with the vaccine's safety or effectiveness, the study doctor might ask you to stop them. It's best to discuss your specific medications with the study team.

Is the CRV-101 Vaccine for Shingles safe for humans?

There is no specific safety data available for the CRV-101 Vaccine for Shingles, but similar vaccines for varicella (chickenpox) have been used widely with rare serious adverse events. Ongoing safety surveillance suggests that serious side effects are uncommon and should be weighed against the benefits of vaccination.12345

How is the CRV-101 Vaccine for Shingles different from other treatments?

The CRV-101 Vaccine for Shingles is unique because it may utilize a novel adjuvant based on single-strand RNA (ssRNA) to enhance the immune response, which is different from the traditional live attenuated or protein-based vaccines currently available.26789

What data supports the effectiveness of the CRV-101 Vaccine for Shingles treatment?

Research shows that vaccines for shingles, like Zostavax and others, have been effective in reducing the risk of shingles and its complications in older adults. For example, a study found that a shingles vaccine reduced the incidence of the disease by over 50% in people aged 60 and older, and another vaccine showed high effectiveness in people aged 50 and above.210111213

Who Is on the Research Team?

GD

Guy De La Rosa, MD

Principal Investigator

Curevo Inc

LS

Lisa Shelton, ARNP

Principal Investigator

Curevo Inc

Are You a Good Fit for This Trial?

Adults aged 50 and older who are healthy, have completed a COVID-19 vaccine series at least 30 days prior to enrollment, and can give informed consent. They must not have had shingles vaccines before, no recent vaccinations or blood donations, no immune system issues or certain medications that affect immunity.

Inclusion Criteria

Your blood test results must be normal or not concerning to the doctor.
I am following the required birth control guidelines.
I understand the study and can sign the consent form.
See 14 more

Exclusion Criteria

I am not on long-term immune system medications.
I am not on medication that affects vaccine testing.
I haven't had any vaccines in the last 30 days or any non-study vaccines while in the study.
See 16 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive either CRV-101 Vaccine or Shingrix administered by intramuscular injection on Month 0 and Month 2

2 months
2 visits (in-person)

Follow-up

Participants are monitored for safety, immunogenicity, and herpes zoster cases from Day 0 to the main study end

12 months

Long-term Follow-up

Participants are followed for safety, immunogenicity, and herpes zoster cases during the long-term follow-up extension period

up to 6 years

What Are the Treatments Tested in This Trial?

Interventions

  • CRV-101 Vaccine
Trial Overview The trial is testing the safety and effectiveness of different doses of CRV-101 vaccine with adjuvants against Shingrix for preventing herpes zoster (shingles). Participants will receive one of several dose combinations to compare responses.
How Is the Trial Designed?
13Treatment groups
Experimental Treatment
Active Control
Group I: Arm LExperimental Treatment1 Intervention
Group II: Arm JExperimental Treatment1 Intervention
Group III: Arm HExperimental Treatment1 Intervention
Group IV: Arm FExperimental Treatment1 Intervention
Group V: Arm DExperimental Treatment1 Intervention
Group VI: Arm BExperimental Treatment1 Intervention
Group VII: Arm AExperimental Treatment1 Intervention
Group VIII: Arm CActive Control1 Intervention
Group IX: Arm GActive Control1 Intervention
Group X: IActive Control1 Intervention
Group XI: Arm KActive Control1 Intervention
Group XII: Arm MActive Control1 Intervention
Group XIII: Arm EActive Control1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Curevo Inc

Lead Sponsor

Trials
2
Recruited
970+

Mogam Biotechnology Research Institute

Collaborator

Trials
2
Recruited
970+

Green Cross Corporation

Industry Sponsor

Trials
82
Recruited
24,000+

Il-Sub Huh

Green Cross Corporation

Chief Executive Officer since 2023

MBA from Seoul National University

Heo Yong-jun

Green Cross Corporation

Chief Medical Officer since 2023

MD from Yonsei University

Published Research Related to This Trial

From 2006 to 2020, the single-antigen varicella vaccine (VAR) and the combination measles, mumps, rubella, and varicella vaccine (MMRV) showed favorable safety profiles, with serious adverse events reported at rates of 1.3 per 100,000 doses for both vaccines.
The most common adverse events were mild, such as injection site reactions and fever, and no new or unexpected safety issues were identified, reinforcing the vaccines' safety when administered as recommended.
Safety Surveillance of Varicella Vaccines in the Vaccine Adverse Event Reporting System, United States, 2006-2020.Moro, PL., Leung, J., Marquez, P., et al.[2022]
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.
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]
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.
Aplastic anemia following varicella vaccine.Angelini, P., Kavadas, F., Sharma, N., et al.[2009]

Citations

Vaccine approved for shingles in older people. [2007]
[Vaccines against varicella-zoster virus (VZV)]. [2017]
Pre-Clinical Development of an Adenovirus Vector Based RSV and Shingles Vaccine Candidate. [2023]
National and State-Specific Shingles Vaccination Among Adults Aged ≥60 Years. [2020]
The effectiveness of shingles vaccine among Albertans aged 50 years or older: A retrospective cohort study. [2022]
Safety Surveillance of Varicella Vaccines in the Vaccine Adverse Event Reporting System, United States, 2006-2020. [2022]
Safety of varicella vaccine after licensure in the United States: experience from reports to the vaccine adverse event reporting system, 1995-2005. [2022]
Partial third nerve palsy after Measles Mumps Rubella vaccination. [2021]
Aplastic anemia following varicella vaccine. [2009]
Evaluation of glycoprotein E subunit and live attenuated varicella-zoster virus vaccines formulated with a single-strand RNA-based adjuvant. [2021]
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]
Help to ease the pain. [2016]
Assessing the effectiveness of zoster vaccine live: A retrospective cohort study using primary care data in the United Kingdom. [2019]
Unbiased ResultsWe believe in providing patients with all the options.
Your Data Stays Your DataWe only share your information with the clinical trials you're trying to access.
Verified Trials OnlyAll of our trials are run by licensed doctors, researchers, and healthcare companies.
Back to top
Terms of Service·Privacy Policy·Cookies·Security