Curevo Vaccine Reports Efficacious Phase 2 Results for Amezosvatein in Shingles Prevention

Curevo is dedicated to developing vaccines with improved accessibility and tolerability, aiming to address the $4+ billion shingles vaccine market.

Image credit: Curevo Vaccine

Curevo Vaccine announced zero cases of shingles after 18.8 months of follow-up in 619 patients receiving amezosvatein, an adjuvanted subunit vaccine. In a Phase 2 trial involving 876 participants aged 50 and older, 10 cases of shingles were expected without vaccination.¹

The trial (NCT05304351) compared amezosvatein to pre-existing, FDA-approved shingles vaccine, Shingrix on a two-dose schedule. It confirmed that amezosvatein had no shingles cases in the vaccinated group, while the Shingrix arm also reported zero cases. Additionally, amezosvatein demonstrated improved tolerability compared to Shingrix, with only 7.3% of participants reporting significant reactogenicity events versus 33.3% for Shingrix. Both vaccines exhibited comparable safety profiles.¹

“These data support our efforts to bring a new shingles vaccine to global markets,” stated George Simeon, Curevo’s Chief Executive Officer. “Though somewhat unsurprising, given amezosvatein also showed non-inferior immunogenicity to Shingrix at day 84 in this trial, these longer-term data represent additional de-risking for the program.”¹

Study Details

The study, titled “A Randomized, Observer-Blind, Phase 2 Study To Assess the Safety and Immunogenicity of CRV-101 Vaccine Head-To-Head With SHINGRIX for the Prevention of Herpes Zoster in Adults Aged 50 Years and Older,” aimed to evaluate the safety and effectiveness of CRV-101 (amezosvatein) compared to Shingrix for preventing shingles in adults aged 50 and older.²

The trial consisted of two parts. In the first part, participants were randomly assigned to receive either a high or low dose of amezosvatein, or Shingrix, in a 1:1:1 ratio. The second part involved participants receiving either high, middle, or low doses of amezosvatein versus Shingrix, following a 5:1 ratio.²

Both vaccines were administered through intramuscular injections at the start of the study and again two months later. Participants were monitored for safety and immune response for 14 months, with additional follow-up extending up to six years.²

The study focuses on herpes zoster (shingles) and involves interventions with amezosvatein in both high and low doses, as well as Shingrix. Amezosvatein targets the varicella zoster virus (VZV) using a glycoprotein E antigen, designed for improved safety and manufacturing advantages.²

Shingles Incidence Rates and Symptoms

Shingles is a reactivation of a latent varicella-zoster virus, the same virus that causes childhood chickenpox, with attacks leading to potential complications including chronic pain. So, for anyone who contracted chickenpox, they can get shingles.³

Shingles are not transmissible between people, but people who have shingles can spread the varicella-zoster virus to people who have never had chickenpox or the chickenpox vaccine, causing them to contract it. The virus is spread through direct contact with the rash or by breathing in virus particles that are in the air.³

According to the CDC, about 1 in 3 people in the US will develop shingles in their lifetime. People’s risk of having shingles increases as they age or if they have a weakened immune system. Most people who have shingles only have it one time. Although, you can have shingles more than once.³

The main virus symptom is characterized by a painful skin rash. This is known as postherpetic neuralgia. Approximately 10% to 18% of people with herpes zoster will get PHN. CDC reports 1% to 4% of people with shingles go to the hospital for complications. This subset of patients is typically older adults and people with weakened or suppressed immune systems.

In conclusion, Curevo’s Phase 2 trial of amezosvatein reports zero shingles cases and lower reactogenicity compared to Shingrix in adults 50 and older. These results support its potential as an alternative for shingles prevention. Ongoing long-term follow-up will be essential for assessing safety and efficacy, underscoring the need for effective vaccines in addressing this public health issue.

Reference

1. Curevo Presents Positive Shingles Vaccine Outcomes Data. GlobeNewswire. October 31, 2024. Accessed October 31, 2024. https://www.globenewswire.com/en/news-release/2024/10/31/2972262/0/en/Curevo-Presents-Positive-Shingles-Vaccine-Outcomes-Data.html

2. Safety and Immunogenicity of CRV-101 Vaccine for the Prevention of Herpes Zoster in Adults Aged 50 Years and Older. ClinicalTrials.gov. Last updated September 9, 2023. Accessed October 31, 2024. https://clinicaltrials.gov/study/NCT05304351#study-plan

3. Shingles (Herpes Zoster). CDC. April 12, 2024. Accessed October 31, 2024.
   https://www.cdc.gov/shingles/data-research/index.html