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|Title: ||Randomized Controlled Trial of RTS,S/AS02D and RTS,S/AS01E Malaria Candidate Vaccines Given According to Different Schedules in Ghanaian Children|
|Authors: ||Owusu-Agyei, Seth|
Kwarteng Owusu, Sandra
Wireko Brobby, Naana Ayiwa
Osei-Akoto, Alex ..et..al
|Issue Date: ||2009|
|Publisher: ||PLoS ONE|
|Citation: ||PLoS ONE|
|Abstract: ||The target delivery channel of RTS,S candidate malaria vaccines in malaria-endemic countries in Africa is the
World Health Organisation Expanded Program on Immunization. As an Adjuvant System, age de-escalation and schedule
selection step, this study assessed 3 schedules of RTS,S/AS01E and RTS,S/AS02D in infants and young children 5–17 months
of age in Ghana.
Methodology: A Phase II, partially-blind randomized controlled study (blind to vaccine, not to schedule), of 19 months
duration was conducted in two (2) centres in Ghana between August 2006 and May 2008. Subjects were allocated randomly
(1:1:1:1:1:1) to one of six study groups at each study site, each defining which vaccine should be given and by which schedule
(0,1-, 0,1,2- or 0,1,7-months). For the 0,1,2-month schedule participants received RTS,S/AS01E or rabies vaccine at one center
and RTS,S/AS01E or RTS,S/AS02D at the other. For the other schedules at both study sites, they received RTS,S/AS01E or RTS,S/
AS02D. The primary outcome measure was the occurrence of serious adverse events until 10 months post dose 1.
Results: The number of serious adverse events reported across groups was balanced. One child had a simple febrile
convulsion, which evolved favourably without sequelae, considered to be related to RTS,S/AS01E vaccination. Low grade
reactions occurred slightly more frequently in recipients of RTS,S/AS than rabies vaccines; grade 3 reactions were infrequent.
Less local reactogenicity occurred with RTS,S/AS01E than RTS,S/AS02D. Both candidate vaccines were highly immunogenic
for anti-circumsporozoite and anti-Hepatitis B Virus surface antigen antibodies. Recipients of RTS,S/AS01E compared to
RTS,S/AS02D had higher peak anti-circumsporozoite antibody responses for all 3 schedules. Three dose schedules were
more immunogenic than 2 dose schedules. Area under the curve analyses for anti-circumsporozoite antibodies were
comparable between the 0,1,2- and 0,1,7-month RTS,S/AS01E schedules.
Conclusions: Both candidate malaria vaccines were well tolerated. Anti-circumsporozoite responses were greater with
RTS,S/AS01E than RTS,S/AS02D and when 3 rather than 2 doses were given. This study supports the selection of RTS,S/AS01E
and a 3 dose schedule for further development in children and infants.|
|Description: ||This article is published in PLoS ONE and also available at doi:10.1371/journal.pone.0007302|
|Appears in Collections:||College of Agric and Natural Resources|
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