Shingles Vaccine Candidate Presented Preliminary Positive Phase 1 Results
Curevo shingles vaccine candidate CRV101 reported initial safety and tolerance results
A Seattle-based biotechnology company announced encouraging preliminary Phase I study results of their Shingles vaccine candidate, CRV-101.
The interim trial results presented by leaders from Curevo, Inc., at the 44th annual International Herpesvirus Workshop on September 26, 2019, demonstrate a promising safety and tolerability profile of the CRV-101 vaccine in 90 healthy adults.
Key Findings of the Phase I Trial are as follows:
- 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 (fever) in the highest dose cohort.
- The proportion of participants experiencing soreness at the injection site was <10%.
Dr. Corey Casper, who led the study and serves as the President and Chief Executive Officer for Infectious Disease Research Institute, said in a related press release, “Immunologic analyses are ongoing, but we believe that CRV-101 may be an important addition to current vaccines for Shingles as the manufacturing process should allow it to be widely available and the components of the vaccine appear minimally toxic.”
This data was last updated on August 12, 2019, from the Phase 1, Randomized, Placebo-Controlled, Observer-Blind, Antigen Dose-Escalation, and Adjuvant Dose-Ranging Clinical Trial to Evaluate the Safety, Tolerability, and Immunogenicity of CRV-101 in (90) Healthy Adult Subjects.
This phase 1 study is located in Kansas City, Missouri, with the Principal Investigator John E. Ervin, M.D.
Recent shingles vaccine news
According to the Centers for Disease Control and Prevention (CDC), shingles vaccination has been available in the United States since 2006 with the approval of the Zostavax a live zoster vaccine. Since then, this vaccine has been recommended for routine use in all adults aged 60 years or older and is now approved for use in adults aged 50 years or older.
In October 2017, the Advisory Committee on Immunization Practices (ACIP) of the CDC issued a recommendation for use of a new shingles vaccine called Shingrix a recombinant zoster vaccine.
Shingles is a painful rash that develops on one side of the face or body. The rash consists of blisters that typically scab over in 7 to 10 days and fully clear up within 2 to 4 weeks, says the CDC.
Most commonly, the rash occurs in a single stripe around either the left or the right side of the body. In other cases, the rash occurs on one side of the face. Shingles on the face can affect the eye and cause vision loss. In rare cases (usually in people with weakened immune systems), the rash may be more widespread on the body and look similar to a chickenpox rash.
This long-lasting pain is called postherpetic neuralgia (PHN), and it is the most common complication of shingles.
The risk of getting shingles and PHN increases as people age.
Curevo’s clinical development plans include a Phase II study of CRV-101 in adults to optimize dose selection and assess preliminary efficacy.
Curevo Inc. has a goal to rapidly advance innovative new vaccine candidates from the research laboratory to the clinic by joining forces with South Korean Mogam Institute for Biomedical Research, GC Pharma, and the Infectious Disease Research Institute based in Seattle, Washington.
Shingles news is published by Precision Vaccinations
- GC Pharma to Establish Curevo - a Seattle-based New Company Dedicated to Development of New Vaccines
- Safety, Tolerability, and Immunogenicity of CRV-101 in Healthy Adult Subjects
- Curevo Announces FDA Advancement of IND Application for CRV-101, New Shingles Vaccine Candidate
- Curevo Vaccine Announces Interim Results of Phase I Clinical Trial of CRV-101