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The RTS, S malaria vaccine provides long-lasting protection against severe malaria 7 years after vaccination, according to the prolonged results of a phase 3 trial published in Infectious diseases of the lancet.
The first results of the phase 3 study demonstrated the effectiveness of RTS, S (GlaxoSmithKline) against severe and clinical malaria in children over a follow-up period of 3 to 4 years. In July 2015, the vaccine received a "positive regulatory badessment" from the European Medicines Agency, noted the researchers. In April of this year, WHO launched a pilot malaria vaccine program using RTS, S in three African countries.
However, a previous single-phase, Phase 2 study showed a 7-year decrease in protection – from 35.9% to 4.4% – in children aged 5 to 17 months who received three doses, noted Researchers.
In this study, researchers studied the incidence of malaria up to 7 years after vaccination as part of an open-label extension study of the initial trial. phase 3, including infants aged 6 to 12 weeks and children aged 5 to 17 months. They were randomized to receive four doses of vaccine (four-dose group), three doses of vaccine and one comparator dose (three-dose group) or four comparator doses (control group).
The extension study evaluated the incidence of severe malaria for an additional three years, from January 2014 to December 2016, following vaccination at three study sites in Tanzania, Kenya, and Burkina Faso. The researchers also evaluated the incidence of malaria up to age 6 in young children aged 3 to 5 years (n = 1345) and up to 7 years old in older children 5-7 years (n = 1739).
During the three years of follow-up, the researchers reported 66 cases of malaria. Among older children in the four-dose group, the incidence of severe malaria was 0.004 per person-years at risk (PPY) (95% CI, 0-0.033). In the group of three doses and the control group, the incidence of severe malaria was 0.007 PPY case (95% CI, 0.001-0.52) and 0.009 PPY case (95% CI, 0.001-0.066), respectively .
In younger children in the four-dose group, the incidence of severe malaria was 0.007 PPY (95% CI, 0.001-0.058). In the group of three doses and the control group, the incidence of severe malaria was respectively 0.007 PPY (95% CI, 0.001-0.054) and 0.011 PPY (95% CI, 0.001-0.083).
According to the study, in both age groups, the effectiveness of the vaccine against severe malaria did not contribute significantly to the overall efficacy.
The researchers noted the continued transmission of malaria. They reported that the incidence of clinical malaria ranged from 0.165 PPY to 3.124 PPY in all groups and study sites. When disaggregated by group, the clinical incidence of malaria in older children was 1.079 PPJ (95% CI, 0.152 to 76.62) in the four-dose group, 1.108 PPY (95% CI, 0.156 to 7.868). ) in the three dose group and 1.016. PPY (95% CI, 0.14-7.213) in the control group. The incidence of clinical malaria in younger children was 1.632 PPY (95% CI, 0.23 to 11.59) in the four-dose group, 1.563 PPY (95% CI, 0.22 to 11.104) in the three dose group and 1.686 PPY (95%). CI, 0.237-11.974) in the control group.
Overall, the results showed that the incidence of severe malaria was low in all groups and that there was no evidence of rebound in vaccine recipients.
In a related editorial, Albadane Dicko, MD, PhD, professor at the Malaria Research and Training Center at the University of Bamako in Mali, and Brian Greenwood, CBE, FRCP, FRS, Professor of Tropical Clinical Medicine at the London School of Hygiene & Tropical Medicine, noted that among children who received a booster dose of RTS, S, the vaccine was effective at 36.7% in older children and at 31% in the youngest age 7-year post-vaccination period, demonstrating sustained efficacy.
"This study provides strong evidence that RTS, S / AS01 can provide lasting protection against severe malaria and rebadure its safety," they wrote. – by Marley Ghizzone
Disclosures: Tinto does not report any relevant financial information. Please consult the study for the relevant financial information of all other authors. Dicko says he received a grant from the Malaria Research and Training Center (Bamako, Mali) as part of the Global Health Essay program. Greenwood reports receiving a grant from the London Global Health Health Trial outside the submitted work at the London School of Hygiene.
The RTS, S malaria vaccine provides long-lasting protection against severe malaria 7 years after vaccination, according to the prolonged results of a phase 3 trial published in Infectious diseases of the lancet.
The first results of the phase 3 study demonstrated the effectiveness of RTS, S (GlaxoSmithKline) against severe and clinical malaria in children over a follow-up period of 3 to 4 years. In July 2015, the vaccine received a "positive regulatory badessment" from the European Medicines Agency, noted the researchers. In April of this year, WHO launched a pilot malaria vaccine program using RTS, S in three African countries.
However, a previous single-phase, Phase 2 study showed a 7-year decrease in protection – from 35.9% to 4.4% – in children aged 5 to 17 months who received three doses, noted Researchers.
In this study, researchers studied the incidence of malaria up to 7 years after vaccination as part of an open-label extension study of the initial trial. phase 3, including infants aged 6 to 12 weeks and children aged 5 to 17 months. They were randomized to receive four doses of vaccine (four-dose group), three doses of vaccine and one comparator dose (three-dose group) or four comparator doses (control group).
The extension study evaluated the incidence of severe malaria for an additional three years, from January 2014 to December 2016, following vaccination at three study sites in Tanzania, Kenya, and Burkina Faso. The researchers also evaluated the incidence of malaria up to age 6 in young children aged 3 to 5 years (n = 1345) and up to 7 years old in older children 5-7 years (n = 1739).
During the three years of follow-up, the researchers reported 66 cases of malaria. Among older children in the four-dose group, the incidence of severe malaria was 0.004 per person-years at risk (PPY) (95% CI, 0-0.033). In the group of three doses and the control group, the incidence of severe malaria was 0.007 PPY case (95% CI, 0.001-0.52) and 0.009 PPY case (95% CI, 0.001-0.066), respectively .
In younger children in the four-dose group, the incidence of severe malaria was 0.007 PPY (95% CI, 0.001-0.058). In the group of three doses and the control group, the incidence of severe malaria was respectively 0.007 PPY (95% CI, 0.001-0.054) and 0.011 PPY (95% CI, 0.001-0.083).
According to the study, in both age groups, the effectiveness of the vaccine against severe malaria did not contribute significantly to the overall efficacy.
The researchers noted the continued transmission of malaria. They reported that the incidence of clinical malaria ranged from 0.165 PPY to 3.124 PPY in all groups and study sites. When disaggregated by group, the clinical incidence of malaria in older children was 1.079 PPJ (95% CI, 0.152 to 76.62) in the four-dose group, 1.108 PPY (95% CI, 0.156 to 7.868). ) in the three dose group and 1.016. PPY (95% CI, 0.14-7.213) in the control group. The incidence of clinical malaria in younger children was 1.632 PPY (95% CI, 0.23 to 11.59) in the four-dose group, 1.563 PPY (95% CI, 0.22 to 11.104) in the three dose group and 1.686 PPY (95%). CI, 0.237-11.974) in the control group.
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Overall, the results showed that the incidence of severe malaria was low in all groups and that there was no evidence of rebound in vaccine recipients.
In a related editorial, Albadane Dicko, MD, PhD, professor at the Malaria Research and Training Center at the University of Bamako in Mali, and Brian Greenwood, CBE, FRCP, FRS, Professor of Tropical Clinical Medicine at the London School of Hygiene & Tropical Medicine, reported that among children who received a booster dose of RTS, S, the vaccine was effective at 36.7% in older children and at 31% at the youngest ones. Post-vaccination period of 7 years, demonstrating sustained efficacy.
"This study provides strong evidence that RTS, S / AS01 can provide lasting protection against severe malaria and rebadure its safety," they wrote. – by Marley Ghizzone
Disclosures: Tinto does not report any relevant financial information. Please consult the study for the relevant financial information of all other authors. Dicko says he received a grant from the Malaria Research and Training Center (Bamako, Mali) as part of the Global Health Essay program. Greenwood reports receiving a grant from the London Global Health Health Trial outside the submitted work at the London School of Hygiene.
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