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Putting the Baby's Cot together

By Eunice Menka - Ghana

Five  years  ago,  27-year  old Dinah Konadu offered her  little daughter, Rachael Asantewaa,  F as  a  participant  in  a  malaria  trial because the disease was taking a toll
on  the child's  life and her business. Before long, Dinah, a trader, said she b e g a n   t o   n o t i c e   a   ma r k e d   improvement  in  the  health  of Rachael. 

"I was always taking  my child to the hospital  but  since my  child  started receiving the vaccines,  I now have the peace  to  concentrate  on my work,” Dinah  said  in  an  interview  with Journalists  from  AMMREN  back  in 2007,  during  a  community  visit  to Kintampo and  the Kintampo Health Research Centre, (KHRC).

The Centre had then embarked on a Phase  2  trial  into  the  experimental RTS,S vaccine. 

Lot  Gyamfi,  Dinah's  husband,  said they felt they had to enrol Rachael as a participant in  the trial as their little contribution  towards  the  control of the disease  in  the area.

Kintampo,  a  forest  area  situated  in the middle  belt  of  Ghana,  has  high clinical  malaria  cases  averaging about  six  episodes  per  child  every year. And this was especially among children under-five years old.

It comes as no surprise therefore that parents  like  Dinah  and  Musah Haruna were willing  to  allow  their children  to  take  part  in  a  Phase  2,vaccine  trials  in  the Kintampo area.

Rachael,  Dorcas  Agyei  and  Hafisu Haruna,  then aged below  two, were among  the  270  children, who  took part in the Phase 2, which took place between  September  2006  and September 2007.

The Centre was one of the eight sites in Africa which  researched  into  the Phase  2  trials.  The  involvement  of these children  in  the Phase 2  trials, set  the stage  for  the  final  lap of  the RTS,S studies, the Phase 3, the  largest clinical trials in Africa, involving over15,000 children.

Parents like Dinah and Musah had no inkling  back  in 2007  that  the  steps they  were  taking  could  lead  to  a major  breakthrough. Recent  official announcements  in Seattle  in  the US have  proven  that  the RTS,S  vaccine has a future.The results of the Phase 3  breakthrough  were  published online in the New England Journal of Medicine,  and were  simultaneously announced  at  the  Malaria  Forum hosted  by  the  Bill & Melinda  Gates
Foundation in Seattle, Washington in October  this year.

The   Kint ampo  pa rent s   who contributed to the Phase 2, which set the  stage  for  the Phase 3, were not invited to the Seattle forum, but their contributions are no  less  important to  the success story so  far. The  journey  of  the  RTS,S  vaccine from  birth  to  date  has  been remarkable.  It  has  seen  different people mounting the stage one time or  the  other  to  contribute  to  the unfolding story of  the RTS,S.

Lead  actors,   l ike  the  vaccine producers,  scientists,  regulators, financiers  and minor  ones  like  the communities,  parents,  children  and the  media  have  all  come  together
with a single mission: find a malaria vaccine  for African children by 2015.

A Family Meeting
Perhaps,  it  was  in  recognition  that everyone  counts  in  the  successful birthing  and  roll-out  of  the  RTS,S vaccine,    that  the  two  research institutions  in  Ghana  where  the RTS,S  trials  are  taking  place organized a post-Seattle meeting and extended  an  invitation  to  people  it termed   stakeholders to see the way forward.

Following on the heels of the Seattle Malaria  Forum,  the  KHRC  and  the Malaria  Research  Centre  at  Agogo, organised  a  meeting  under  the auspices of WHO and MVI/PATH, and brought together RTS,S stakeholders to a family meeting in Miklin Hotel in
Kumasi  to consider  the  findings.

In  attendance  were  researchers, traditional  and  religious  leaders, regulators,   pol icymakers  and journalists among others.  

The  Agenda:  “to  put  the  baby  cot together” as a means of securing the safe  delivery  of  the  RTS,S  vaccine sometime  in 2015.

The meeting was  to ensure  that  the vaccine  smoothly  settles  in with  its other  “siblings”  in  the  Expanded Programme on  Immunization (EPI).

Simple and critical issues like which part  of  the  child's  body  should receive the vaccine, policy direction, operational  cost,  a monitoring  and evaluation system and arrangements
need to be put in place before Ghana and other African countries can roll out  the RTS,S vaccine within  the EPI.

The good news so far is that it takes only  three  doses  to  give  hope  to Africa's children aged 5 to 17 months suffering  from  malaria. The  initial results of  the Phase 3  trial  showed, t h r e e     d o s e s   o f   t h e   RTS , S experimental   malaria  vaccine,   reduces  the  risk  of   chi ldren experiencing  clinical  malaria  and severe  malaria  by  56%  and  47%, respectively.

Dr Odei Antwi-Agyei, Coordinator of the National EPI, who spoke on  the country's  plans  to  roll  out  a succes s ful   vaccine,   said  the expansion  of  cold  chain  storage facilities  for vaccines are taking place in Ghana  in preparation  to  add  the Rota  virus  and  the  Pneumococcal vaccines  to  the  EPI  in  2012  and  to also prepare  the way  for  the RTS,S. He  said  the  EPI  has  been  involved from  the  beginning  of  the  malaria
trials to ensure that the vaccine will be safe  for children when  licensed  for u s e   b y   t h e   Wo r l d   H e a l t h   Organization and  the Food and Drugs Board.

“A  strong  case has been made  for a malaria  vaccine  in  Ghana  but  the vaccine  should  not   be  more dangerous  than  the  disease  and therefore  the  concern  for  a  good vaccine.”
 
He said a walking cold chain is being put together for all the 10 regions in Ghana   to  a c commoda te   the   introduction  of more  vaccines  into the EPI  list.

Dr  Felicia  Owusu-Antwi,  the  WHO Programme  Manager  on  Malaria, said public health impact can only be realized  when  there  is  a  high c o u n t r y -wi d e   c o v e r a g e  in immunization,  preferably  80  per cent.

According  her,  because  Ghana  has experienced  political  stability  over the years, its national programme on immunization  has  been  smooth sailing.   

She  said  arrangements  such  as operational  costs  of  immunizing children country-wide, a monitoring and  evaluation  system  to  check  on adve r s e   re a c t ions   from  the  vaccination and policy decisions are some  of  the  important  elements  in
the determination of adding vaccines to  the EPI.

Prof  Tsiri  Agbenyega,  a  Principal Investigator  on  the  RTS,S  at  Agogo and  Chairperson  on  the  Clinical Trials  Partnership  Committee,  also told the meeting that “ we don't have a finished product yet but we need to plan for the vaccine because there is a  lot  of  bargaining  to  be  done  and infrastructure  to roll  it out.”

Managing the Birth Pangs
At the moment, lots of activities are taking  place  and  whi le  the implementing and regulatory bodies deliberate  on  the  way  forward, diligent work by scientists are taking place to ensure that the vaccine  lands safely and without  incidence.

Meanwhile,  the  safety  of  children participating  remains  paramount and scientists like Dr Kingsley Osei- Kwakye,  Lead  Clinician, monitoring participants in Kintampo will have to lose more sleep until 2015.

The 24-hour vigil is not easy for the clinicians  across  the  11  sites  and seven  countries  working  with  the children  in  the study.

“Well,  some  of  the  challenges  are waking up at odd hours to respond to a call that a child has been admitted or  is  having  convulsion,”  Dr  Osei- Kwakye said  in Kumasi.

“They  need  special  attention  forstudy purposes and to collect data. In research you need a lot of data. Once a child is given the vaccine you have to monitor them until the end of the trials.”

Even  a  rash  or  any  infection  is  an issue  because  the  study  needs  to know  if  it  is related  to  the vaccine.

Other activities to ensure that all play their  assigned  roles  effectively include  ensuring  that  good  clinical practices  are  maintained  to  meet international standards.

According to Mr Owusu Boahen, the Study Site Coordinator at the KHRC, who  is  in  touch  with  all  the  key actors, he has to make sure logistics are in place and everyone is playing by  the  rules  of  engagement  with international monitors, Quintiles  in South Africa  on  stand-by  to  ensure that protocols and good practices are kept.

In  2010,   for  instance,   clinical monitoring  and  assessment  visits were  conducted  at  Kintampo  to review the study source documents, check  on  adverse  events,  handling  and  storage  of  investigational products  and  to  also  assist  in  data cleaning.

The  trial  centres  have  had  to regularly  organize  good  clinical practice  training  and  refreshercourses  for staff.

There  are  also  visits  by  laboratory service  groups  to  find  out whether l a b o r a t o r y   s t a f f   a n d   X - r a y  departments are working according to  the  protocol  and  standard operating procedures.

All  these  activities  are  aimed  at managing  birth-related  pangs associated  with  the  vaccine,  to ensure  that  come  2015,  the  world will  be  ready  for  its  first  malaria vaccine,  with  the  hope  that  it  will drive  the  process  to  find  a  second generation  vaccine  with  a  higher potency to check malaria in the not- too- distant  future.

 

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