The country’s P240-million “Mix and Match” (MnM) study seeking to evaluate the safety and immunogenicity of mixing different coronavirus disease (COVID-19) vaccines and vaccine platforms in Filipino adults is expected to be rolled out in in Muntinlupa City next week, the Department of Science and Technology (DOST) said Saturday, Nov. 20.
DOST Undersecretary for Research and Development Dr. Rowena Cristina L. Guevara said the multi-site, convenience sampling, unblinded trial will be conducted in Muntinlupa City on Nov. 22, four days after the actual vaccination of the three volunteer participants in Marikina City.
“Muntinlupa City is targeted to start implementation Monday of next week, November 22, 2021, while Manila City will be conducting its dry run on the same week,” she told the Manila Bulletin on Saturday.
Led by Dr. Michelle De Vera of the Philippine Society for Allergy, Asthma, and Immunology (PSAAI), the 18 month-long trial has been given a total budget of P204.19 million under the DOST-Grants-in-Aid (GIA) program, the DOST official said.
Guevara noted that the study secured the approval from the Philippine Food and Drug Administration (FDA) on Nov. 16.
“Accordingly, the project team has started screening in Marikina City the next day after (November 17, 2021) and the first three successfully screened participants were vaccinated on November 19, 2021 with their Sinovac first dose.”
The DOST official said aside from cities of Marikina, Muntinlupa, and Manila, Davao City, and Dasmariñas City, Cavite are included as study sites.
The MnM study is expected to enroll 3,000 adult volunteers aged 18 and above.
“As per the protocol, there will be two interim analyses planned for the study to evaluate the immune responses of the participants to the vaccine combinations and what would be the side effects, if any. The first interim analysis will be performed once 1,000 participants or one-third of the total 3,000 sample size have been enrolled and evaluated,” Guevara said.
“The second interim analysis will be done when two-thirds of the total sample or 2,000 participants have been enrolled and evaluated.”
The study aims to determine the safety and immunogenicity of completing the vaccination series with available COVID-19 vaccines in the Philippines in those given Sinovac as the first dose.
The trial will also analyze whether those who already completed the dosing regimen for Sinovac will have a better immune response after the immunization of a booster dose from a different vaccine platform or brand.
Locally available vaccines under the National Immunization Program are expected to be used in the trial. These include Sinovac, Sputnik V, AstraZeneca, Pfizer and Moderna.
“These vaccines will be mixed-and-matched to determine the safety and immunogenicity of mixing different COVID-19 vaccine brands/platforms. The main vaccine that will be utilized is Sinovac as this is the most available and stable vaccine supply in the Philippines,” Guevara said.