Clinical Trial Of Covid-19 Vaccine Phase 3 Approved By Unpad Ethics Committee

Lab illustration at Prof. Infectious Disease Hospital. Dr. Sulianti Saroso (Irfan Meidianto / VOI)

BANDUNG - The third phase of the Covid-19 vaccine clinical trial can be carried out in the near future. Approval from the University Research Ethics Committee has given the green light. Now the Unpad Covid-19 vaccine clinical trial research team has started to open registration for participants starting Monday, July 27 yesterday.

"That's right, (the Ethics Committee) has (approved)," said the head of the Unpad Covid-19 vaccine clinical trial research team, Prof. Dr. Kusnandi Rusmil.

Reporting from the official Unpad page in the news written by Arif Maulana explained the criteria that must be mandatory for prospective clinical trial participants. First, prospective participants are adults aged 18-59 years who are declared healthy, and always comply with health protocols and carry out physical and social restrictions during the Covid-19 pandemic outbreak. Prospective participants are also declared to have no history of being infected with Corona.

"Prospective participants will have a swab test and a rapid test to find out if there is a possibility that they are currently or have been infected with Covid-19," continued Prof. Kusnandi.

Participants will get a swab test and rapid test for free. Whether or not the prospective participant's condition is proven by not having mild, moderate, or severe disease, no history of asthma and allergies to vaccines, so that they do not have disorders or chronic diseases such as heart problems, uncontrolled high blood pressure, diabetes, kidney disease and liver, tumor, epilepsy or other neurological disorders.

Furthermore, Prof. Kusnandi explained, prospective participants do not have blood disorders or a history of blood clots, do not have other infectious diseases and fever, and do not have a history of immune system disorders. The applicant's body temperature should not exceed 37.5 degrees Celsius.

Furthermore, prospective participants were not pregnant women or planning to become pregnant during the study period, and were not breastfeeding. Prospective participants are also not currently participating or will be included in other clinical trials.

"Participants have not received any immunizations within the past 1 month or will receive other vaccines within the next 1 month," said Prof. Kusnandi.

Prospective participants must also be domiciled in the city of Bandung and do not plan to move from the research location before the research is completed. 14 days before the start of the study, participants had no history of contact with patients infected with Coronavirus, had no history of contact with patients who showed fever or symptoms of respiratory tract pain who are domiciled in areas or communities affected by Covid-19, and did not have two or more cases of fever and / or respiratory symptoms in areas of a small scope, such as homes, offices, and schools.

A total of 1,620 volunteers are needed in the process of vaccinating clinical trials. However, not all participants will be injected with the vaccine. A total of 540 people will be injected with the vaccine, while the rest will receive a placebo solution. The determination of the vaccine or placebo will be done randomly.

"Those who receive a placebo will get the Covid-19 vaccine after the vaccine is registered," explained Prof. Kusnandi.

It was ensured that participants' health was monitored regularly by research officers during the course of the study, or about 6 months after the last vaccine administration. Prof. Kusnandi ensured that all participants were covered by health insurance.

For those who want to participate, registration is open until August 31, 2020. Or please contact the Clinical Research Unit of the Children's Health Department, 1st Floor of Hasan Sadikin Hospital in Bandung on telephone 022 - 2034471 or WhatsApp [phone].