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Randomized controlled trial of RTS,S/AS02D and RTS,S/AS01E malaria candidate vaccines given according to different schedules in Ghanaian children

Owusu-Agyei, Seth, Ansong, Daniel, Asante, Kwaku, Owusu, Sandra K., Owusu, Ruth, Brobby, Naana A. W., Dosoo, David, Akoto, Alex O., Osei-Kwakye, Kingsley, Adjei, Emmanuel A., Boahen, Kwadwo O., Sylverken, Justice, Adjei, George, Sambian, David, Apanga, Stephen, Kayan, Kingsley, Vekemans, Johan, Ofori-Anyinam, Opokua, Leach, Amanda J., Evans, Jennifer C. and et al. (2009). Randomized controlled trial of RTS,S/AS02D and RTS,S/AS01E malaria candidate vaccines given according to different schedules in Ghanaian children. PLoS One,4(10):e7302-1-e7302-11.

Document type: Journal Article
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IRMA ID 75039815xPUB513
Title Randomized controlled trial of RTS,S/AS02D and RTS,S/AS01E malaria candidate vaccines given according to different schedules in Ghanaian children
Author Owusu-Agyei, Seth
Ansong, Daniel
Asante, Kwaku
Owusu, Sandra K.
Owusu, Ruth
Brobby, Naana A. W.
Dosoo, David
Akoto, Alex O.
Osei-Kwakye, Kingsley
Adjei, Emmanuel A.
Boahen, Kwadwo O.
Sylverken, Justice
Adjei, George
Sambian, David
Apanga, Stephen
Kayan, Kingsley
Vekemans, Johan
Ofori-Anyinam, Opokua
Leach, Amanda J.
Evans, Jennifer C.
et al.
Journal Name PLoS One
Publication Date 2009
Volume Number 4
Issue Number 10
ISSN 1932-6203   (check CDU catalogue  open catalogue search in new window)
Scopus ID 2-s2.0-70350002150
Start Page e7302-1
End Page e7302-11
Total Pages 11
Place of Publication United States
Publisher Public Library of Science
HERDC Category C1 - Journal Article (DIISR)
Abstract Background:
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.
DOI http://dx.doi.org/DOI: 10.1371/journal.pone.0007302   (check subscription with CDU E-Gateway service for CDU Staff and Students  check subscription with CDU E-Gateway in new window)


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