Halima Shaban is seated on a bench at the Bagamoyo District Hospital clinic to wait for her turn to see the doctor. She is cuddling a bouncing baby, Shaban Msafiri.

Several other women carrying their babies aged between three months and one year are also in the queue waiting for their turn.

Msafiri, six months old, is among 340 children participating in a malaria vaccine trial at the Bagamoyo Research and Training Unit (BRTU) in Tanzania. It is under the Ifakara Health Research and Development Centre (IHRDC).

According to Mr. Omar Juma, Field Co-ordinator for the malaria vaccine trials, (RTSS), code named Mal040, 300 children are already participating and 40 more are being recruited gradually.

He said the process of recruiting the candidates started in July 2006, while their mothers were pregnant and the first vaccine was injected in October, the same year.

“Some of the children have already received the required three malaria vaccinations while others are on second and first jab. Recruitment continues until we get all the 340 required candidates,” says Mr. Juma.

The recruitment starts with screening of pregnant women for HIV and Hepatitis B, after sensitization programmes on the importance of the vaccine for the number one killer disease, malaria, which takes the lives of people, particularly children below five years.

“The women and their spouses are also enlightened on the fact that the drug had no known effects since it has already been tested in animals and human beings. At first it was difficult to convince them especially because it had the concept of HIV screening, but after sensitization programmes they came in big numbers,” he says.

Infants of HIV positive women and those with Hepatitis B are excluded from the study, according to the director of the BRTU, Dr Salim Abdullah, to avoid obscuring the safety pattern associated with the vaccine trial.

However, women found with the two infectious diseases were not abandoned but linked to clinics where they get quality services including counseling and anti-retroviral drugs, he says.

Dr. Juma says about 700 women volunteered for the exercise but some did not qualify while others were dropped because of the large numbers.

The women had to enter into a contract with the research centre about their willingness to participate in the trials.

“We sensitize and then give them forms which they, together with their spouses, study for two weeks and if they agree, then they sign. We give them enough time to volunteer or refuse and we do not force anyone,” Dr. Juma says.

One of the conditions that the women volunteers are given is to deliver at the hospital to monitor them and their babies closely. The centre has ambulances that are at their disposal and are given telephone numbers to call in case they or their babies need any medical attention.

After delivery, the women have to sign another consent form for their child to be vaccinated, and their new born are subjected to screening involving liver function tests and the blood level (HB).

“This is crucial to make sure that the babies that are involved are healthy. If the blood level is eight and above then we enroll them, if it is below, we defer the child to a later dates,” he said.

The first malaria vaccine is administered when the baby is between eight and 10 weeks, and is observed for an hour for immediate reaction, and later allowed to go home. Field clinicians then follow up on the baby on daily basis for five days to check for possible side effects, such as swelling, fever and general physical wellbeing.

On the sixth day, the child is sent back to the hospital for check up. After a month, the child is sent for the second malaria jab and is subjected to the same check up before the injection.

The baby is again subjected to follow up by the field clinician for six days and sent back to hospital for the same check up. After this jab, the baby is given coartem anti-malarial drug, says Dr. Juma for parasite clearance.

“The vaccine we administer is double blind, meaning that there is real drug, (RTSS), and the control (placebo). No one knows which is which except for the manufacturers since they come in numbers and treatment number does not change,” he says.

The third and final jab is administered a month after the second one, and same procedures are followed before and after the vaccination.

After the third jab, the baby is subjected to what they call Active Detection of Infection (ADI) where blood samples are taken every two weeks for 11 times to check for malaria.

“Our major concern was the blood they take from our baby every two weeks but the experts educated us that it will not harm our son,” says Mosi Rashid from Magereza village, whose son, Samwel Edward, is participating in the exercise.

This concern was echoed by Sophia Abdallah from Yombo village and Hapiness Yohana from Kongo village whose children are also part of the vaccine trials.

Sophia says the neighbors who were reluctant to join the exercise are envying her because her daughter, Zuhura, is healthy and gets the attention of the medical practitioners whenever she falls sick.

“When Zuhura is having any illness, not necessarily malaria, what I do is just beep our field clinician and he calls back. In no time the ambulance comes to pick us,” she says.

The vaccine was tried in Gambia in 2000 and Mozambique in 2004. In Mozambique it showed it was effective by 50 percent. In Tanzania, the study focuses on safety, immunogenicity and its efficiency when incorporated into immunization programmes under the Expanded Programme on Immunization (EPI), says Dr. Salim.

Malaria is a life-threatening parasitic disease transmitted by mosquitoes. It is passed over from one person to another through the bite of a female Anopheles mosquito which requires blood to nurture eggs.

Over 300 million people in the tropical and sub-tropical areas suffer from malaria annually and Africa, south of Sahara bears 90 per cent of global malaria burden.

In Tanzania, 18 million people suffer from the disease every year, with 100,000 losing their lives to the disease. Malaria remains the number one killer disease in the country, and accounts for 30 per cent of hospital cases and 25 per cent of hospital child deaths.

It is estimated that the government loses 121bn/- (about 121 million US dollars) a year which is about 3.4per cent of the GDP, as a result of malaria.