Islamabad:Amidst the surge in COVID-19 pandemic, Maroof International Hospital Clinical Trial Unit is conducting a clinical trial involving a covid-19 vaccine LVRNA021 (mRNA based) booster dose targeting the Delta BA.5 strain as well as Omicron variant B.1.1.529, says a press release.
Maroof International Hospital (MIH) is part of a multicenter phase III study for the COVID-19 booster vaccine LVRNA021. The trial has been approved by the National Bioethics Committee (NBC) Pakistan and the Drug Regulatory Authority of Pakistan (DRAP). LVRNA021 vaccine is co-developed by AIM Vaccine Co., Ltd., Ningbo Rongan Biological Pharmaceutical Co., Ltd LiveRNA Therapeutics Inc. It is an mRNA-based vaccine targeting different variants of COVID-19 encoding the SARS-CoV-2 S protein of the Delta and Omicron BA.5 strain (Delta:BA.5=1:3) as well.
The phase 1 and phase 2 Investigator Initiated Trials (IIT) of the SARS-CoV-2 bivalent mRNA vaccine (LVRNA021) have been completed and the study results demonstrated a favourable safety profile. The results have proved that the vaccine is well tolerated, safe and immunogenic, supporting the next stage of clinical trials.
These trials are also being conducted at 7 different sites in many cities including Islamabad, Lahore, Peshawar and Karachi for recruiting volunteers in Pakistan. The trial participants are selected after necessary blood tests and after meeting the eligibility criteria mentioned in the trial protocol and standard operating procedures as approved by DRAP, NBC and Maroof ethics committee.
Screening of volunteers for vaccine administration has been initiated at the Maroof clinical trial unit which is run by foreign qualified researchers. The trial is going on and will continue for 14 months to check the safety and effectiveness of this vaccine. Due to emerging new variants of COVID-19, researchers all over the world are developing new vaccines to cater and decrease transmission of new variants.
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