Leroux-Roels, Geert, Isabel Leroux-Roels, Frédéric Clement, et al. “Evaluation of the Immune Response to RTS,S/AS01 and RTS,S/AS02 Adjuvanted Vaccines : Randomized, Double-blind Study in Malaria-naïve Adults.” HUMAN VACCINES & IMMUNOTHERAPEUTICS 10.8 (2014): 2211–2219. Print.
Leroux-Roels, G., Leroux-Roels, I., Clement, F., Ofori-Anyinam, O., Lievens, M., Jongert, E., Moris, P., et al. (2014). Evaluation of the immune response to RTS,S/AS01 and RTS,S/AS02 adjuvanted vaccines : randomized, double-blind study in malaria-naïve adults. HUMAN VACCINES & IMMUNOTHERAPEUTICS, 10(8), 2211–2219.
Leroux-Roels, Geert, Isabel Leroux-Roels, Frédéric Clement, Opokua Ofori-Anyinam, Marc Lievens, Erik Jongert, Philippe Moris, W Ripley Ballou, and Joe Cohen. 2014. “Evaluation of the Immune Response to RTS,S/AS01 and RTS,S/AS02 Adjuvanted Vaccines : Randomized, Double-blind Study in Malaria-naïve Adults.” Human Vaccines & Immunotherapeutics 10 (8): 2211–2219.
Leroux-Roels G, Leroux-Roels I, Clement F, Ofori-Anyinam O, Lievens M, Jongert E, et al. Evaluation of the immune response to RTS,S/AS01 and RTS,S/AS02 adjuvanted vaccines : randomized, double-blind study in malaria-naïve adults. HUMAN VACCINES & IMMUNOTHERAPEUTICS. 2014;10(8):2211–9.
TY - JOUR
UR - http://lib.ugent.be/catalog/pug01:6839412
ID - pug01:6839412
LA - eng
TI - Evaluation of the immune response to RTS,S/AS01 and RTS,S/AS02 adjuvanted vaccines : randomized, double-blind study in malaria-naïve adults
PY - 2014
JO - (2014) HUMAN VACCINES & IMMUNOTHERAPEUTICS
SN - 2164-5515
PB - 2014
AU - Leroux-Roels, Geert
AU - Leroux-Roels, Isabel GE32 UZGent 001995243924
AU - Clement, Frédéric GE32 801001012493 0000-0002-2720-3655
AU - Ofori-Anyinam, Opokua
AU - Lievens, Marc
AU - Jongert, Erik
AU - Moris, Philippe
AU - Ballou, W Ripley
AU - Cohen, Joe
AB - This phase II, randomized, double-blind study evaluated the immunogenicity of RTS, S vaccines containing Adjuvant System AS 01 or AS 02 as compared with non-adjuvanted RTS, S in healthy, malaria-naive adults (NCT00443131). Thirty-six subjects were randomized (1:1:1) to receive RTS, S/AS 01, RTS, S/AS 02, or RTS, S/saline at months 0, 1, and 2. Antibody responses to Plasmodium falciparum circumsporozoite (CS) and hepatitis B surface (HBs) antigens were assessed and cell-mediated immune responses evaluated by flow cytometry using intracellular cytokine staining on peripheral blood mononuclear cells. Anti-CS antibody avidity was also characterized. Safety and reactogenicity after each vaccine dose were monitored. One month after the third vaccine dose, RTS, S/AS 01 (160.3 EU/mL [95%CI: 114.1-225.4]) and RTS, S/AS 02 (77.4 EU/mL (95%CI: 47.3-126.7)) recipients had significantly higher anti-CS antibody geometric mean titers (GMTs) than recipients of RTS, S/saline (12.2 EU/mL (95%CI: 4.8-30.7); P < 0.0001 and P = 0.0011, respectively). The anti-CS antibody GMT was significantly higher with RTS, S/AS 01 than with RTS, S/AS 02 (P = 0.0135). Anti-CS antibody avidity was in the same range in all groups. CS- and HBs-specific CD4(+) T cell responses were greater for both RTS, S/AS groups than for the RTS, S/saline group. Reactogenicity was in general higher for RTS, S/AS compared with RTS, S/saline. Most grade 3 solicited adverse events (AEs) were of short duration and grade 3 solicited general AEs were infrequent in the 3 groups. No serious adverse events were reported. In conclusion, in comparison with non-adjuvanted RTS, S, both RTS, S/AS vaccines exhibited better CS-specific immune responses. The anti-CS antibody response was significantly higher with RTS, S/AS 01 than with RTS, S/AS 02. The adjuvanted vaccines had acceptable safety profiles.
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