CUREVO VACCINE ANNOUNCES THE APPROVAL TO CONDUCT A PHASE 1B CLINICAL TRIAL IN SOUTH AFRICA TO EVALUATE SAFETY AND IMMUNOGENICITY OF ITS ADJUVANTED SUBUNIT INVESTIGATIONAL VACCINE, CRV-101, AGAINST VARICELLA (CHICKENPOX) IN HIV-POSITIVE CHILDREN.
Curevo Vaccine, a clinical-stage biopharmaceutical company combining excellence in protein and adjuvant biology to develop new generation sub-unit vaccines of global importance, announced today that approval was granted to move forward with a Phase 1b pediatric clinical trial in South Africa to evaluate the safety, efficacy, and immunogenicity of its non-live investigational vaccine, CRV-101, against varicella (chickenpox) in immunocompromised (IC) pediatric HIV-infected populations.
Curevo Vaccine submitted its clinical trial application to the South African Health Products Regulatory Authority (SAHPRA), an entity of the South African Government’s National Health Department, on the 6th of November 2020. Just shy of four months later, on the 3rd of March 2021, Curevo Vaccine’s submission was approved. This is a significant milestone for Curevo Vaccine, which has the exclusive worldwide license to CRV-101, a Varicella Zoster Virus (VZV) sub-unit adjuvant vaccine candidate.
“Thanks to the support of South African infectious disease community and our Scientific Advisors, we will be able to progress in our efforts to address the needs of vulnerable populations. We are hopeful that this vaccine will provide immune compromised children with a safe and effective alternative to Live Attenuated Varicella Vaccines and provide countries around the world with a valuable addition to their public health programs,” said George Simeon, the Chief Executive Officer of Curevo Vaccine.
Curevo Vaccine is committed to investing in and improving global public health by developing scalable, cost effective, and easily produced novel vaccines. SAHPRA’s authorization to investigate CRV -101 in IC pediatric populations is a positive step towards addressing international healthcare inequities, socioeconomic barriers, and disparities in access to lifesaving vaccines worldwide.
Curevo Vaccine Scientific Advisory Board member, Myron Levin, MD, said, “This investigational vaccine against chickenpox has several potential advantages over the current licensed vaccine. It is likely to have less reactogenicity for children who have a compromised immune system and has potential for easier storage and transport than the current live vaccine.”
The Phase 1b clinical trial will be conducted at the Family Center for Research with Ubuntu (FAMCRU), at Tygerberg Academic Hospital, a research center within Stellenbosch University in Cape Town, South Africa, Q4 2021.
Principal Investigator, Dr. Mark Cotton, PhD, FAMCRU Director, Head of Infectious Diseases, Department of Pediatrics and Child Health, Tygerberg Hospital, says “We are delighted to be involved in this trial. Chickenpox, although common and often quite serious, has received little attention in South Africa to date. Children living with HIV are vulnerable. We think that this vaccine has great potential for the HIV population and beyond.”
Phase 1b study objectives include evaluating the safety, tolerability, and immunogenicity of two intramuscular vaccinations approximately 2 months apart in HIV-infected children.
Lisa Shelton, Curevo Vaccine’s Associate Director of Clinical Operations stated, “HIV- infected and other immune compromised children bear a greater burden than healthy children when infected with varicella. They have more extensive illness, longer duration, and higher rates of complications and death caused by VZV. With only live attenuated virus vaccines available, and being immunocompromised, they also risk developing severe and/or disseminated infection with the vaccine strain of the virus. CRV-101 has no live virus, but still elicits a robust antibody response against gE in adults, which is the most abundant glycoprotein that is expressed on VZV infected cells. We are thrilled to partner with Dr. Cotton and the FAMCRU to bring CRV-101 into pediatric trials.”
CRV-101 is currently being investigated for its safety, tolerability, immunogenicity, and effectiveness to prevent shingles in adults. Following a successful Phase 1 study, which showed low reactogenicity safety profile and a strong humoral and cellular immune response in healthy adults aged 18 to <50, a Phase 2 shingles clinical trial is scheduled to start in Q3 2021.
About Curevo Vaccine:
Curevo, Inc., Dba Curevo Vaccine, is a Seattle, Washington, based clinical-stage company dedicated to bringing next generation vaccines that offer effectiveness, safety, tolerability, and production advantages to the market, quickly and efficiently. Curevo Vaccine’s partners include South Korea’s Mogam Institute for Biomedical Research and GC Pharma. For more information, please visit www.curevovaccine.com