CRV-101 Vaccine for Shingles

Not currently recruiting at 20 trial locations

Overseen By Curevo Inc

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: Curevo Inc

Must not be taking: Immunosuppressants, Cytotoxic therapies

Disqualifiers: Herpes zoster, Autoimmune disease, 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: 2 months

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new vaccine, CRV-101, to determine its safety and effectiveness in preventing shingles (herpes zoster) in adults. It compares CRV-101 to the already approved vaccine, Shingrix®. Individuals aged 50 or older, who are healthy and have not previously had shingles, may qualify. Participants should also have completed their initial COVID-19 vaccine series at least 30 days before joining the trial. As a Phase 2 trial, the research focuses on assessing the treatment's effectiveness in an initial, smaller group of people.

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

Research has shown that the CRV-101 vaccine, also known as amezosvatein, demonstrated promising safety results in earlier studies. The vaccine was safe and well-tolerated at all doses tested, with no severe local reactions (Grade 3 or 4) reported. However, one study did report a more serious overall reaction (Grade 3).

Additionally, participants who received the highest dose of the vaccine did not develop shingles, suggesting a positive safety profile for CRV-101. While specific safety data for CRV-101 alone is not available, similar vaccines for chickenpox have been used widely and safely. The current trial is in an early stage, so the treatment has not been tested on a large number of people yet, but initial findings are encouraging. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

The CRV-101 Vaccine for shingles is unique because it uses a novel approach to stimulate the immune system more effectively than existing vaccines. Most current shingles vaccines, like Shingrix, use a single protein from the varicella-zoster virus to trigger immunity. However, CRV-101 incorporates multiple antigens from the virus, potentially leading to a broader and more robust immune response. Researchers are excited because this could not only enhance efficacy but also improve protection duration, reducing the frequency of shingles outbreaks and associated complications.

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

Research has shown that the CRV-101 vaccine, which participants in this trial may receive, is promising in preventing shingles. In a study with 619 participants, none developed shingles after 18.8 months of follow-up. The immune response from this vaccine matched that of Shingrix, a well-known shingles vaccine, one year after the second dose. These findings suggest that CRV-101 could effectively prevent shingles in older adults. ^{1 3 6 7 8}

Who Is on the Research Team?

Guy De La Rosa, MD

Principal Investigator

Curevo Inc

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.

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.

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?

Group I: Arm L Experimental Treatment 1 Intervention

Investigational Vaccine

Group II: Arm J Experimental Treatment 1 Intervention

Investigational Vaccine

Group III: Arm H Experimental Treatment 1 Intervention

Investigational Vaccine

Group IV: Arm F Experimental Treatment 1 Intervention

Investigational Vaccine

Group V: Arm D Experimental Treatment 1 Intervention

Investigational Vaccine

Group VI: Arm B Experimental Treatment 1 Intervention

Investigational Vaccine

Group VII: Arm A Experimental Treatment 1 Intervention

Investigational Vaccine

Group VIII: Arm C Active Control 1 Intervention

Active comparator

Group IX: Arm G Active Control 1 Intervention

Active Comparator

Group X: I Active Control 1 Intervention

Active Comparator

Group XI: Arm K Active Control 1 Intervention

Active Comparator

Group XII: Arm M Active Control 1 Intervention

Active Comparator

Group XIII: Arm E Active Control 1 Intervention

Active Comparator

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

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]

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]

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]

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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]

Citations

1. curevovaccine.com curevovaccine.com/uncategorized/curevo-presents-positive-shingles-vaccine-outcomes-data/

Curevo Presents Positive Shingles Vaccine Outcomes Data Zero shingles cases after 18.8 months follow-up in 619 patients receiving any dose of amezosvatein, a development-stage adjuvanted subunit ...

2. curevovaccine.com curevovaccine.com/uncategorized/curevo-announces-positive-updated-phase-2-data-for-amezosvatein-shingles-vaccine/

Curevo Announces Positive Updated Phase 2 Data for ... One year after the second vaccine dose, the anti-gE antibody immune response to amezosvatein continues to be non-inferior to Shingrix.

3. contagionlive.com contagionlive.com/view/curevo-vaccine-reports-efficacious-phase-2-results-for-amezosvatein-in-shingles-prevention

Curevo Vaccine Reports Efficacious Phase 2 Results for ... Curevo Vaccine announced zero cases of shingles after 18.8 months of follow-up in 619 patients receiving amezosvatein, an adjuvanted subunit ...

4. withpower.com withpower.com/trial/phase-2-herpes-zoster-1-2022-c80e8

CRV-101 Vaccine for Shingles · Info for Participants 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.

5. app.trialscreen.org app.trialscreen.org/resources/the-future-of-shingles-vaccine-innovations-on-the-horizon

The Future of Shingles Vaccine: Innovations on the Horizon Recent large-scale studies have found that people who received shingles vaccines had a 23% lower risk of cardiovascular events, with protection ...

6. clinicaltrials.gov clinicaltrials.gov/study/NCT05304351

NCT05304351 | Safety and Immunogenicity of CRV-101 ... Safety and Immunogenicity of CRV-101 Vaccine for the Prevention of Herpes Zoster in Adults Aged 50 Years and Older. ClinicalTrials.gov ID NCT05304351. Sponsor ...

7. curevovaccine.com curevovaccine.com/uncategorized/curevo-vaccine-presents-amezosvatein-shingles-vaccine-data-at-id-week/

Curevo Vaccine Presents Amezosvatein Shingles ... Vaccines are studied for both safety and reactogenicity/tolerability. Data on the reactogenicity/tolerability of amezosvatein and Shingrix were ...

8. vax-before-travel.com vax-before-travel.com/curevo-shingles-vaccine-candidate-crv101-reported-initial-safety-and-tolerance-results

Shingles Vaccine Candidate Presented Preliminary ... The vaccine was found safe and well-tolerated at all doses, · No Grade 3 or Grade 4 local reactogenicity, · One Grade 3 systemic adverse event ( ...