By Mbarwa Kivuyo - Tanzania

The  family  of  Balala  lost  their  first  child mysteriously.  Two-month-old  Mwema  had Tsuddenly  refused  to breastfeed one evening.

By mid-night  the baby was continuously vomiting. Her parents thought that a neighbour  with a “bad eye”  had  looked  at  the  baby  the  day  before. They believed that the instant cure for this kind of illness was  to  say  some words  to  the  spirits while bathing  the  baby  wi th  sal ted  water . Unfortunately, these rituals did not save Mwema's life.

Like Mwema, many children, especially in Africa have over the years, lost their lives, and  only the lucky  ones  survive  after  undergoing  the  right diagnosis and medication. It is not uncommon to find out that  in many parts of Africa, people still believe in the casting of spells, witchcraft and the spirit world.

The  devastating  impact  of   malar ia  on communities  caused  Tanzanian  and  other African  researchers  to  join  in  the  search  for  an effective and affordable malaria vaccine to help save  the  lives of African children.

The  first malaria  vaccine  to have  shown partial protection  in  a  Phase  3  trial  carried  out  in Colombia was called  the SPf66.

In 1991, the Ifakara Health Institute (IHI) accepted the challenge of conducting further trials  on this vaccine. A  paper  authored  by  Professor  Pedro Alonzo and his colleagues in 1994 said the SPf66 vaccine “was the  first to be conducted  in an area of high perennial  transmission.”

Therefore, in 1991, the IHI engaged in the trial of SPf66 Phase 3. The Institute recruited  586 children aged  between  one  and  five  years.  The  trial participants received three doses of the vaccine and their status monitored. Lead physician at the Bagamoyo  branch  of  IHI,  Dr  Nahya  Salim says,“the vaccine was found to be very safe with less  than 6% adverse events.

“However, the efficacy level was 31% on clinical malaria.  IHI  ran  the  second  round of   the  trial of SPf66 in 1995. During this round, 1,270 infants got three doses of the vaccine. This time, the efficacy of  the vaccine was 2% on clinical malaria. With  this poor performance  in  infants,  “the  vaccine was terminated,” says Dr. Kefas Mugittu who is the Site Leader of  the  IHI Bagamoyo branch.

The demoralizing results of the SPf66 vaccine did not stop IHI from further involvement in the search for a vaccine for malaria.  In 2006, a Phase 2 trial of a  new  vaccine  called  RTS'S/AS02  started  in Bagamoyo.    With  this  trial,  340  infants  were recruited  and  were  given  three  doses  of  the vaccine co-administered within the World Health Organization's  Expanded  Programme  on Immunization  (EPI).  The  aim  was  to  assess  the safety,  immunogenicity and efficacy on  infection. Other  RTS'S/AS01  Phase  2  studies  continued  in 2007 and were concluded with promising results.

The  promising  results  of  the  RTS,S  phase  2 encouraged  the  initiation  of  a  hospital-based surveillance  system  for  the  detection  of  severe malaria  disease  and  other  serious  morbidity  in children aged  two months  to  four years.

The  information  generated  from  this  pilot surveillance  then  supported  the  implementation of  a  Phase  3  multi-center  efficacy  trial  of  GSK Biologicals  candidate  malar ia  vaccine,   RTS,S/AS01E.

Phase  3  started  in  2009  in  Bagamoyo  and Korogwe sites. The two sites—one private  and the other   publ ic—suppor ted  each  other   to spearhead  the  match  towards  finding  the  first generation  malaria  vaccine.  The  initial  results announced in Seattle in October, 2011 by Bill and Melinda  Gates  were  celebrated  not  only  by research  scientists, but also by  the communities that participated  in  the  studies.

At  a media  briefing  in  Dar  es  Salaam  held  on October 19, 2011, the Principal Investigator at the Bagamoyo  sites  Dr  Salim  Abdulla  said  “as  a Tanzanian it is very gratifying to be working on this disease  that  inflicts  so  much  suffering  on  our communities,  the nation, and  the continent.”

Apart from clarifying critical issues about how the trials were conducted in the two sites, Dr  abdulla also  recognized  the  support  of  the  Ministry  of Health and  Social Welfare, district and  regional authorities  in Bagamoyo and Korogwe Sites,  the dedicated teams in the two sites, and most of all the communities and trial participants for bringing us  to “where we are  today.”

“We  came  a  long way  together,  from  SPf66  to RTS,S. We will continue to pursue  researches that give hopes  to our people,”  says Dr Abdulla. He noted that the vaccine, if finally deployed, would bring  to  an  end  the  deaths  of  children  like Mwema.