David Poland of PATH offers this amazing account of the Phase 3 trial of the RTS,S malaria vaccine candidate.

Photo: MVI/David Poland
Trial participants and their mothers (on bench) with Dr. Salim Abdulla (standing left) and vaccination staff at the Bagamoyo Research and Training Centre of the Ifakara Health Institute (IHI) in Tanzania.

The initial vaccination of the Phase 3 trial of the RTS,S malaria vaccine candidate was at hand. Pulling through the gate of the district hospital and up to research facility, I saw Dr. Salim Abdulla, Director of the Ifakara Health Institute, Dr. Omary Juma, and Dr. Kafuruki Shubis talking out front.

“The day is here my friend,” Salim remarked, with the entire group sporting broad grins.

Salim convened the larger team for a last review of roles and instructions. I then made my way to the vaccination area and saw the five mothers and their rambunctious children who had already been screened for the trial. Staffer Richard Kamata was methodically explaining the consent form to the mothers and responding to their questions. A few exchanges provoked some laughter and ribbing and the mood was relaxed and casual.

The mothers then had individual sessions before giving their written consent. Shortly after, the toddlers were given their medical exams. For Salim, this was a time of wait and see; if a child showed signs of illness, they could not participate in the trial that day.

An hour later, the screening results came in. All the children were fit to be vaccinated…and Salim breathed a sigh of relief. “We’re still moving,” he affirmed.

The insulated box with the vaccines, hoisted on the shoulder of a team member, was brought down to the vaccination area. A file of research staff followed the box in a cheerful informal procession.

Finally the moment arrived. The mom was smiling and conversing with the nurses, while her daughter looked about curiously. Salim and the researchers left the vaccination room, as dictated by strict protocol of the double-blind study, and stood outside. The nurse confidently positioned the young girl and administered the injection. With that first piercing cry, I could swear I heard someone outside exclaim “All right.” A minute later, the girl was back to her normal inquisitive self. Mother and child made their way to the monitoring area and the other participants soon followed.

I went out in the courtyard and Salim declared “Well, we’ve started,” and there were handshakes all around. “Now the real work begins,” he added.

The monitoring period proceeded, and the children were regularly checked by the attending doctors. The children were given a final check and found to be fine—which seemed evident by the way they were back to playing.

The mothers and kids strolled out of the vaccination courtyard—off to attend to their daily activities. Salim and his extended team met to debrief about the day. Afterwards, the team went out on the veranda and enjoyed a modest celebratory lunch as the breeze blew through from the Indian Ocean.

A good day indeed for all involved.

Download more information on RTS,S and the Phase 3 trial:

• Fact sheet: Phase 3 trial of RTS,S (49 KB PDF)
• Fact sheet: RTS,S malaria vaccine candidate (83KB PDF)
• RTS,S frequently asked questions (47KB PDF)

-David Poland, Communications Officer, PATH Malaria Vaccine Initiative