DOST: PH COVID-19 vaccine 'mix and match' trial may start soon
The Philippines’ study on the safety and immunogenicity of mixing different coronavirus disease (COVID-19) vaccines and vaccine platforms in Filipino adults may start soon.
During his weekly report on Friday, Oct. 22, Department of Science and Technology (DOST) Secretary Fortunato “Boy” T. de la Peña said the Vaccine Mix and Match study is ready to start once the Food and Drug Administration (FDA) approves it.
He said to date, around 400 doses of Sinovac vaccines have already been delivered to the Marikina City site for the dry run.
“This study is a multi-site, convenience sampling, unblinded trial which will determine the safety and immunogenicity of completing the vaccination series with available COVID-19 vaccines in the Philippines to those given Sinovac as the first dose,” he said.
The 18 month-long Philippine Society for Allergy, Asthma, and Immunology’s (PSAAI) study which was initially targeted to start by June this year is led by Dr. Michelle De Vera.
DOST Undersecretary for Research and Development (R&D) Dr. Rowena Cristina L. Guevara, who heads the Task Group on Vaccine Evaluation and Selection (TG-VES), said the “Mix and Match" or MnM study has already secured approvals of the DOST-Vaccine Expert Panel (VEP), Single Joint Research Ethics Board (SJREB), and site institutional review boards.
"In addition, regulatory requirements have already been submitted and are being reviewed by the FDA for final clinical trial approval. Once the FDA approves the said study, clinical trial proper may now commence,” she told the Manila Bulletin in a Viber message on Friday.
She said the study team is considering pilot implementation in Marikina City, Muntinlupa City, and Davao City where the vaccination sites have been identified.
“The team has already conducted their dry run in Marikina City last October 18, 2021 and they are now preparing for a dry run on the week of October 25 to 29, 2021 for their Muntinlupa and Davao City sites,” Guevara said.
She said the DOST, PSAAI, and Department of Health (DOH) were also closely working together regarding the requested vaccine doses for delivery to the sites.
The project is entitled, “A study evaluating the safety and immunogenicity of mixing different COVID-19 vaccines and vaccine platforms in Filipino adults”.
De la Peña said the study is expected to enroll 3,000 participants aged 18 years old and above in eight sites in Metro Manila, Cebu and Davao.
"The study will have three groups with a total of 12 study arms. Group A will study the same vaccines under the same platform. Group B will study the vaccines to be interchanged, and Group C will study the special high-risk group to be given a booster dose,” he said.
Five vaccine brands such as Sinovac, Sputnik V, AstraZeneca, Pfizer and Moderna will be used for the study.
READ MORE: https://mb.com.ph/2021/08/12/preparations-underway-for-ph-covid-19-vaccine-mix-and-match-trial/
Apart from determining the safety and immunogenicity of interchanging vaccine brands to complete COVID-19 vaccine series, the PISAAI study also seeks to determine the efficacy of the booster doses.
It aims to determine if the high-risk population who already completed the dosing regimen of the Sinovac vaccine would elicit a better immune response after the immunization of a booster dose from a different vaccine platform or brand.