Stepping up to be a human clinical trial volunteer


GEORGE TOWN: I will be heading towards the Year of the Ox as a guinea pig.

Last week, I passed a pre-screening interview to volunteer in the Phase III human trial of an experimental Covid-19 vaccine.

The next step is to take a Covid-19 PCR test, HIV test, the final screening and then get the jab. All this should be done by next week.

There are small sacrifices to be made by pioneer volunteers like yours truly.

According to the guidelines, I must diligently fill the diary and contact cards and regularly take my temperature at home.

I am not allowed to father a child during my year as a guinea pig.

Just one or two alcoholic drinks are allowed every month or so.

I cannot donate blood or undergo elective surgery.

And even if I am qualified to receive a different approved vaccine during the year, I have to decline.

It was curiosity in the name of journalism that led to me submitting my name and number to Hospital Pulau Pinang on Jan 16.

It is an important step in Malaysia’s fight against Covid-19. How is it like? What will the experience be? These questions burned in me.

It was only after I became shortlisted, answered numerous written questions and read a long FAQ that the seriousness of my action dawned on me.

But I went ahead with it anyway.

I am 49 and physically active, though no matter how I diet, I remain slightly overweight (God bless Malaysian food).

My blood pressure is a little elevated, hovering at around 135/90 most of the day and sliding down only after I am relaxed and getting ready for bed.

How will a Malaysian like me react to the vaccine?

This must be known before the vaccine can be given to all and sundry.

Reporters in Sungai Petani yesterday saw that nearly all of the first batch of volunteers who got injected were in their 20s and 30s.

During the pre-screening phone interview, one of the major questions that I had to answer elaborately was the reason behind my willingness to volunteer.

I said I stepped forward because I sensed that not many middle-aged Malaysians would do so (middle-aged being understood as 45 to 65.)

For the trial to be comprehensive, Malaysians of diverse profiles need to be a part of it.

Each of the 3,000 Malaysians who volunteered has a 50-50 chance of getting either the experimental vaccine or a placebo.

This is a double-blinded study, in which volunteers injected with the placebo are in the control group.

Neither the volunteers nor the study doctors will know if a particular volunteer got injected with the real thing or a placebo. This is important to avoid bias.

The trial conforms with the Declaration of Helsinki and global medical ethics, and I was impressed with Hospital Pulau Pinang’s professionalism during the screening process.

According to the FAQ, should an emergency arise, the study doctor may open a code book and check the serial number of the vaccine vials to see if a particular volunteer got the experimental vaccine or the placebo.

Am I nervous? Yes.

But I am more terrified of Covid-19.

My ex-schoolmate died of the disease last year.

I personally know six people who caught the virus. Thankfully, they recovered.

An entire family living below my sister’s apartment was infected. They quarantined at home till they recovered.

If the little sacrifices of being a clinical trial volunteer will help Malaysians have normal lives again, so be it.

Arnold Loh is Assistant News Editor of The Star.

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