Parallel Red And White Vaccine Booster Trial In Phase 3

Head of Red and White Vaccine Researcher at Airlangga University Surabaya Prof Fedik Abdul Rantam/ANTARA

JAKARTA - The Chief Researcher for the Red and White Vaccine at Airlangga University Surabaya, Prof. Fedik Abdul Rantam, said the phase 3 clinical trial of the Red and White Vaccine was running in parallel with booster testing or booster doses.

"We are planning parallels to cut time, so that phase three of the road and the booster test will also run because of the emergency situation," said Fedik Abdul Rantam, quoted by Antara, Wednesday, April 13.

The Red and White vaccine is currently entering phase 2 clinical trials, starting from the initial development of vaccine raw material development (upstream), vaccine formulation (downstream), to the process of filling into vials into finished products.

Phase 2 clinical trials will include 405 human subjects who will be divided into three groups who will receive vaccines at 3 mcg and 5 mcg doses and control vaccines which will be given two injections with an interval of 28 days.

Phase 3 clinical trials to determine the type of target age group are scheduled to start on May 28, 2022. "Since preclinical trials have been prepared for children, adolescents, pregnant women, parents," he said.

Fedik said that in normal situations, booster vaccine trials are carried out separately with phase 3 clinical trials.

"For example, vaccine A is used as a booster, that's my own research. But because it's an emergency, sometimes it's allowed," he said.

The booster trial for the Red and White Vaccine, said Fendik, will use the same homologous method or vaccine platform as the complete primary dose so that the results are more optimal.

"Boosters are in the same substance homologous. If the heterologous boosters (different platforms) will start over again. Because memory cells will recognize the virus from the beginning again. Unless the protein composition is the same, the result will be that there is memory and a faster reaction to the virus," he said. .

If the entire series of phase 2 and 3 clinical trials run smoothly, BPOM RI targets the Red and White Vaccine to obtain an Emergency Use Authorization (EUA) in August 2022 and be ready for public use.