Duty and pride: A vaccine clinical trial through the eyes of a volunteer

In a small town in Vietnam’s Khanh Hoa Province, dozens of people helped to change the course of influenza in their country. They held out their arms and clenched their teeth as a small needle pricked their skin and pierced their muscle: an influenza vaccine. They were volunteers in a clinical study to test the vaccine’s safety and effectiveness, a crucial step on the pathway toward licensure and market availability. No one had participated in a clinical study before; many had never even received an influenza vaccine.

But they were familiar with how dangerous certain types of influenza viruses can be—Vietnam had been ravaged by A/H1N1 and A/H5N1, after all; everyone knew someone who had been infected. So when they were asked to help make sure it wouldn’t happen again, volunteers eagerly lined up.

And perhaps, eventually, their contribution will stretch beyond borders and protect not just their neighbors in Vietnam, but people around the world.

To imagine a clinical trial operating here is a striking example of rural tradition colliding with modern life. The town is quiet, pastoral, yet bustling with activity; cows fight for road space with motorbikes, while street vendors sell fruit to men and women rushing to work. Buildings are sun- and time-worn and laundry is out to dry on iron fences.

But in the health center, an open-air building with modern equipment and facilities, clinical advancement reigned. Clinical trial staff met with interested parties; explained the seriousness of the disease and the significance of the trial; enrolled fully informed, consenting volunteers; and administered the vaccine. Volunteers returned to the health center periodically over the next three months for blood draws and clinical evaluations, and they kept a detailed diary of any side effects they might have experienced following vaccination.

They took their participation seriously. One clinical trial volunteer described the decision to enroll in the study as a “responsibility—to my neighbors, to society, to the country in general.”

That same volunteer also looked at the study as an opportunity to learn more about influenza. Given the threat of avian influenza—visible more so in this town where chickens roam freely than in Vietnam’s cities—infection is never far from the mind. But, protection from seasonal influenza had never been a priority, and the interplay between seasonal production and pandemic preparedness had never been explained.

“There are different ideas about influenza in the community, but overall many people don’t care about it very much,” said the study volunteer. “Now, thanks to the study, I am able to understand more about influenza and correct misinformation. I am ready to tell others about the danger of flu, and the importance of getting vaccinated.”

Because of the lack of disease awareness—and unfamiliarity with clinical trials—there were some nerves on vaccination day. Participants worried the vaccine might not work, or it could make them sick, or simply that the injection would hurt.

The clinical trial volunteer, who wasn’t worried at first, picked up on this collective nervousness as the day wore on and the wait grew a bit longer than anticipated. But confidence returned as soon as the vaccination was over and a cotton ball was pressed against the skin.

“There were so many others who were nervous, it made me a little nervous too,” the volunteer said. “But later on I saw that I had no problems, and I became a person who could calm others down if they were nervous.”

Though participation was an individual undertaking, it fostered a sense of community and duty to something larger than oneself. It helped volunteers claim a sense of ownership over their own health.

The clinical study is long over now, but its effects linger in this town: in the heightened awareness of influenza as a serious disease, in the community’s interest in vaccination; and in their openness to clinical studies. They now look forward to seeing their contribution fulfill its potential, and to knowing that a small, quiet town in rural Vietnam has the power to improve the health of its people.

“To have a vaccine that we make here at home, that would be a pride for the Vietnamese,” said the volunteer. “I dream that Vietnamese manufacturers can produce enough vaccine locally, and that we will be protected when we need it.”

PATH and its partners have the same dream. And while we wait for it to become a reality, we are comforted in knowing that participants received something just as valuable as the vaccine itself: hope.

• Defending the world from influenza: As a nine-year project to build vaccine development capacity worldwide comes to an end, PATH and partners reflect on how far we’ve come
• From Vietnam to the world: How PATH helped ready locally-made influenza vaccine for global use
• A decade of development: What does it take to build an influenza vaccine from scratch?
• Vietnam’s vaccine champion: Why Dr. Le Van Be fights influenza
• Building a new influenza vaccine: A longtime vaccine manufacturer conducts its first clinical trial
• The power of local: Can a domestically produced vaccine increase uptake?

• Vietnam welcomes two locally produced vaccines for seasonal and pandemic influenza press release
• Enhancing Influenza Vaccine Development in Low-resource Countries: Pandemic Preparedness Through Seasonal Sustainability report
• Supporting Influenza Vaccine Production in Vietnam fact sheet
• Moving the Needle e-newsletter
• Immunization Matters e-newsletter