The clinical trial includes evaluating tolerability, immunogenicity, and safety of two intramuscular vaccinations for HIV-infected children
U.S. headquartered clinical-stage biopharmaceutical company, Curevo Vaccine has attained an approval for initiating a Phase 1b clinical trial of its investigational vaccine, CRV-101, against chickenpox (varicella) in IC (immunocompromised) HIV-infected pediatric patients in South Africa. The trial would help the company to determine the safety, efficacy, and immunogenicity of the investigational vaccine.
Reports claim that Curevo Vaccine had submitted its clinical trial application to the South African Health Products Regulatory Authority (SAHPRA) on November 2020, which recently got approved by the government entity.
Commenting on the clinical trial, George Simeon, CEO of Curevo Vaccine, said that support from the South African infectious disease community and its Scientific Advisors has helped their firm to progress its efforts on addressing the needs of vulnerable populations.
Curevo believes that this vaccine will offer immune compromised children with an effective and safe alternative to Live Attenuated Varicella Vaccines and offer countries worldwide with a valuable addition to their public health programs.
Myron Levin, Curevo Vaccine Scientific Advisory Board member, explained that the investigational vaccine formulated against chickenpox has wide range of possible advantages over existing licensed vaccines. CRV-101 is likely to have less reactogenicity for children with compromised immune system and could easily be stored and transported in comparison to currently available live vaccine.
As of now, CRV-101 is being investigated for its tolerability, safety, immunogenicity, and effectiveness to prevent shingles in adults. Following a successful Phase 1 trial which displayed low reactogenicity safety profile and a robust humoral and cellular immune response in adults aged 18 to 50, a Phase 2 shingles clinical trial is slated to commence in Q3 2021.
Source Credit: https://www.businesswire.com/news/home/20210330005378/en/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