TY - JOUR
T1 - Evaluation of the safety and immunogenicity of the RTS,S/AS01E malaria candidate vaccine when integrated in the expanded program of immunization
AU - Agnandji, Selidji T.
AU - Asante, Kwaku Poku
AU - Lyimo, John
AU - Vekemans, Johan
AU - Soulanoudjingar, Solange S.
AU - Owusu, Ruth
AU - Shomari, Mwanajaa
AU - Leach, Amanda
AU - Fernandes, Jose
AU - Dosoo, David
AU - Chikawe, Maria
AU - Issifou, Saadou
AU - Osei-Kwakye, Kingsley
AU - Lievens, Marc
AU - Paricek, Maria
AU - Apanga, Stephen
AU - Mwangoka, Grace
AU - Okissi, Blaise
AU - Kwara, Evans
AU - Minja, Rose
AU - Lange, Jorn
AU - Boahen, Owusu
AU - Kayan, Kingsley
AU - Adjei, George
AU - Chandramohan, Daniel
AU - Jongert, Erik
AU - Demoitié, Marie Ange
AU - Dubois, Marie Claude
AU - Carter, Terrel
AU - Vansadia, Preeti
AU - Villafana, Tonya
AU - Sillman, Marla
AU - Savarese, Barbara
AU - Lapierre, Didier
AU - Ballou, William Ripley
AU - Greenwood, Brian
AU - Tanner, Marcel
AU - Cohen, Joe
AU - Kremsner, Peter G.
AU - Lell, Bertrand
AU - Owusu-Agyei, Seth
AU - Abdulla, Salim
PY - 2010/10/1
Y1 - 2010/10/1
N2 - Background: The RTS,S/AS01E malaria candidate vaccine is being developed for immunization of African infants through the Expanded Program of Immunization (EPI). Methods: This phase 2, randomized, open, controlled trial conducted in Ghana, Tanzania, and Gabon evaluated the safety and immunogenicity of RTS,S/AS01E when coadministered with EPI vaccines. Five hundred eleven infants were randomized to receive RTS,S/AS01E at 0, 1, and 2 months (in 3 doses with diphtheria, tetanus, and whole-cell pertussis conjugate [DTPw]; hepatitis B [HepB]; Haemophilus influenzae type b [Hib]; and oral polio vaccine [OPV]), RTS,S/AS01E at 0, 1, and 7 months (2 doses with DTPwHepB/Hib+OPV and 1 dose with measles and yellow fever), or EPI vaccines only. Results: The occurrences of serious adverse events were balanced across groups; none were vaccine-related. One child from the control group died. Mild to moderate fever and diaper dermatitis occurred more frequently in the RTS,S/AS01E coadministration groups. RTS,S/AS01E generated high anti-circumsporozoite protein and anti-hepatitis B surface antigen antibody levels. Regarding EPI vaccine responses upon coadministration when considering both immunization schedules, despite a tendency toward lower geometric mean titers to some EPI antigens, predefined noninferiority criteria were met for all EPI antigens except for polio 3 when EPI vaccines were given with RTS,S/AS01E at 0, 1, and 2 months. However, when antibody levels at screening were taken into account, the rates of response to polio 3 antigens were comparable between groups. Conclusion: RTS,S/AS01E integrated in the EPI showed a favorable safety and immunogenicity evaluation. Trial registration: ClinicalTrials.gov identifier: NCT00436007. GlaxoSmithKline study ID number: 106369 (Malaria-050).
AB - Background: The RTS,S/AS01E malaria candidate vaccine is being developed for immunization of African infants through the Expanded Program of Immunization (EPI). Methods: This phase 2, randomized, open, controlled trial conducted in Ghana, Tanzania, and Gabon evaluated the safety and immunogenicity of RTS,S/AS01E when coadministered with EPI vaccines. Five hundred eleven infants were randomized to receive RTS,S/AS01E at 0, 1, and 2 months (in 3 doses with diphtheria, tetanus, and whole-cell pertussis conjugate [DTPw]; hepatitis B [HepB]; Haemophilus influenzae type b [Hib]; and oral polio vaccine [OPV]), RTS,S/AS01E at 0, 1, and 7 months (2 doses with DTPwHepB/Hib+OPV and 1 dose with measles and yellow fever), or EPI vaccines only. Results: The occurrences of serious adverse events were balanced across groups; none were vaccine-related. One child from the control group died. Mild to moderate fever and diaper dermatitis occurred more frequently in the RTS,S/AS01E coadministration groups. RTS,S/AS01E generated high anti-circumsporozoite protein and anti-hepatitis B surface antigen antibody levels. Regarding EPI vaccine responses upon coadministration when considering both immunization schedules, despite a tendency toward lower geometric mean titers to some EPI antigens, predefined noninferiority criteria were met for all EPI antigens except for polio 3 when EPI vaccines were given with RTS,S/AS01E at 0, 1, and 2 months. However, when antibody levels at screening were taken into account, the rates of response to polio 3 antigens were comparable between groups. Conclusion: RTS,S/AS01E integrated in the EPI showed a favorable safety and immunogenicity evaluation. Trial registration: ClinicalTrials.gov identifier: NCT00436007. GlaxoSmithKline study ID number: 106369 (Malaria-050).
UR - http://www.scopus.com/inward/record.url?scp=77956936556&partnerID=8YFLogxK
U2 - 10.1086/656190
DO - 10.1086/656190
M3 - Article
C2 - 20735271
SN - 0022-1899
VL - 202
SP - 1076
EP - 1087
JO - Journal of Infectious Diseases
JF - Journal of Infectious Diseases
IS - 7
ER -
