In the trial, the vaccine demonstrated non-inferiority to Shingrix as measured by humoral immune response along with reduced rates of requested systemic and local adverse events
Curevo reports positive topline results from Phase 2 trial of Amezosvatein. (Credit: Mufid Majnun on Unsplash)
Curevo Vaccine, a biotechnology company focused on the development of varicella zoster virus vaccines, said that its shingles vaccine, Amezosvatein, has met all primary endpoints in the Phase 2 trial.
Also known as CRV-101, Amezosvatein is a next-generation non-mRNA, adjuvanted subunit vaccine.
The 876-patient randomised, controlled, observer-blind Phase 2 study assessed the vaccine head-to-head against Shingrix in participants aged 50 years and older.
In the trial, the vaccine demonstrated non-inferiority to Shingrix as measured by humoral immune response.
In addition, Amezosvatein showed reduced rates of requested systemic and local adverse events.
Based on these findings, Curevo plans to move the vaccine into Phase 3 trials around the world this year.
The co-primary outcome of the trial was humoral immune responses one month after the second vaccine dose.
Curevo said the primary immunogenicity endpoint was achieved as individuals’ immune responses to Amezosvatein were comparable to their immunological responses to Shingrix.
Furthermore, the vaccine response rate for Amezosvatein was 100.0%, whereas for Shingrix, it was noted at 97.9%.
Curevo CEO George Simeon said: “Fewer than 5% of eligible adults in most European countries and China have received both doses of Shingrix and two-thirds of adults in the USA still need to be immunised against shingles.
“The market opportunity in shingles is large and underserved with only a small fraction of the over $350bn global addressable market currently vaccinated.
“The entire Curevo team is dedicated to swiftly bringing Amezosvatein to global markets.”
The vaccine also showed decreased rates of requested local and systemic adverse events in this Phase 2 trial, meeting the co-primary safety goal.
This would be a major benefit for people who are thinking about getting vaccinated against shingles, the biotechnology firm claimed.
The Phase 2 study administered Amezosvatein or Shingrix on an identical two-dose, two-month apart schedule on participants from the US.