|A volunteer receives Việt Nam’s domestically developed COVID-19 vaccine Nano Covax during a clinical trial. — VNA/VNS Photo Minh Quyết|
The third and final phase of human trials of Việt Nam’s domestically developed COVID-19 vaccine Nano Covax, developed by HCM City-based biopharmaceutical company Nanogen, is scheduled to begin this month.
In a recent interview with Vietnam News Agency, Prof. Dr. Trương Việt Dũng, Chairman of the National Ethics Committee in Biomedical Research under the Ministry of Health, talks about Phase 3 of clinical trials as well as benefits and responsibilities of participants.
The committee is set to approve Phase 3 of clinical trials of Nano Covax. Could you share more about this phase of the study?
The committee recently announced the mid-term results of Phase 2. As main results of this phase have been made available, we want to go ahead with Phase 3.
The vaccine will be adjusted in each phase depending on results. The committee considered the study of Phase 3 even though we are still in Phase 2 of the trial.
Study of Phase 3 will be similar to that of Phase 2 in terms of technical issues and evaluation method. However, in Phase 3 the trial will be conducted in more areas. In Phase 3, we also use less placebos to ensure benefits for volunteers.
In Phase 2, there were four study groups. Participants in the three groups were administered with different doses and those in the other group were injected with a placebo. In Phase 3, we will study the use of single dose with the smallest dose being 25mcg, which is still enough to develop antibodies and immunity.
Is there any difference in study groups in Phase 3 compared to the previous phases?
The study groups will be expanded, they will be people from different areas, for example, we may have workers in industrial zones. Regarding this issue, the committee’s experts will have recommendations for specific groups based on the suggestions of Việt Nam Military Medical University, Ministry of Defense and The Pasteur Institute in HCM City, which are in charge of the trial.
However, the areas that are being hit hard by the pandemic, like the industrial zones, will not be selected.
Using these areas is violating regulations. The public may think that we are taking advantage of the pressure and concerns of local people about the pandemic to encourage them to participate in the trial.
Therefore, trials will not be conducted in areas already being hit by the pandemic. Doing COVID-19 testing for participants to confirm there is no antibodies in their body is a mandatory requirement.
What are the benefits and responsibilities for participants and how do we ensure their health safety?
Protecting privacy of and ensuring benefits and safety for participants is the first task in clinical trials.
Prior to the trial, they are informed about benefits, responsibilities, risks and whether they are vaccinated or given a placebo. They will decide to join only after being well informed about this. They are also covered with insurance in accordance with international law.
I would like to express my appreciation to everyone who has taken part and will participate in future trials. They did this with the hope of making some contributions to the COVID-19 prevention and control work of the country so domestically developed vaccines will be made. They don’t participate for their own personal benefits. — VNS