CRV-101 Vaccine for Shingles

Recruiting at 11 trial locations

Overseen By Tamra Madenwald

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

876 Participants Needed

Trial Summary

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.

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. ^{1 2 3 4 5}

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. ^{3 6 7 8 9}

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. ^{3 10 11 12 13}

Research Team

Guy De La Rosa, MD

Principal Investigator

Curevo Vaccine

Lisa Shelton, ARNP

Principal Investigator

Curevo Vaccine

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

Group I: Arm F Experimental Treatment 1 Intervention

Investigational Vaccine

Group II: Arm E Experimental Treatment 1 Intervention

Investigational Vaccine

Group III: Arm D Experimental Treatment 1 Intervention

Investigational Vaccine

Group IV: Arm B Experimental Treatment 1 Intervention

Investigational Vaccine

Group V: Arm A Experimental Treatment 1 Intervention

Investigational Vaccine

Group VI: Arm C & G 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

Findings from Research

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]

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]

References

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

Vaccine approved for shingles in older people. [2007]

2. Spain pubmed.ncbi.nlm.nih.gov

[Vaccines against varicella-zoster virus (VZV)]. [2017]

3. Switzerland pubmed.ncbi.nlm.nih.gov

Pre-Clinical Development of an Adenovirus Vector Based RSV and Shingles Vaccine Candidate. [2023]

4. Netherlands pubmed.ncbi.nlm.nih.gov

National and State-Specific Shingles Vaccination Among Adults Aged ≥60 Years. [2020]

5. Netherlands pubmed.ncbi.nlm.nih.gov

The effectiveness of shingles vaccine among Albertans aged 50 years or older: A retrospective cohort study. [2022]

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

Safety Surveillance of Varicella Vaccines in the Vaccine Adverse Event Reporting System, United States, 2006-2020. [2022]

7. United States 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. [2022]

8. England pubmed.ncbi.nlm.nih.gov

Partial third nerve palsy after Measles Mumps Rubella vaccination. [2021]

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

Aplastic anemia following varicella vaccine. [2009]

10. England pubmed.ncbi.nlm.nih.gov

Evaluation of glycoprotein E subunit and live attenuated varicella-zoster virus vaccines formulated with a single-strand RNA-based adjuvant. [2021]

11. Netherlands 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. [2021]

12. England pubmed.ncbi.nlm.nih.gov

Help to ease the pain. [2016]

13. Netherlands pubmed.ncbi.nlm.nih.gov

Assessing the effectiveness of zoster vaccine live: A retrospective cohort study using primary care data in the United Kingdom. [2019]