Seasonal vaccination with RTS,S/AS01 vaccine with or without seasonal malaria chemoprevention in children up to the age of 5 years in Burkina Faso and Mali: a double-blind, randomised, controlled, phase 3 trial.

Background: Seasonal vaccination with the RTS,S/AS01 vaccine combined with seasonal malaria chemoprevention (SMC) prevented malaria in young children more effectively than either intervention given alone over a 3 year period. The objective of this study was to establish whether the added protection provided by the combination could be sustained for a further 2 years.

Methods: This was a double-blind, individually randomised, controlled, non-inferiority and superiority, phase 3 trial done at two sites: the Bougouni district and neighbouring areas in Mali and Houndé district, Burkina Faso.

The duration of protection against clinical malaria provided by the combination of seasonal RTS,S/AS01 vaccination and seasonal malaria chemoprevention versus either intervention given alone.

Background: A recent trial of 5920 children in Burkina Faso and Mali showed that the combination of seasonal vaccination with the RTS,S/AS01 malaria vaccine (primary series and two seasonal boosters) and seasonal malaria chemoprevention (four monthly cycles per year) was markedly more effective than either intervention given alone in preventing clinical malaria, severe malaria, and deaths from malaria.

Methods: In order to help optimise the timing of these two interventions, trial data were reanalysed to estimate the duration of protection against clinical malaria provided by RTS,S/AS01 when deployed seasonally, by comparing the group who received the combination of SMC and RTS,S/AS01 with the group who received SMC alone. The duration of protection from SMC was also estimated comparing the combined intervention group with the group who received RTS,S/AS01 alone.

Impact of seasonal RTS,S/AS01 vaccination plus seasonal malaria chemoprevention on the nutritional status of children in Burkina Faso and Mali.

Background: A recent trial in Burkina Faso and Mali showed that combining seasonal RTS,S/AS01 malaria vaccination with seasonal malaria chemoprevention (SMC) substantially reduced the incidence of uncomplicated and severe malaria in young children compared to either intervention alone. Given the possible negative effect of malaria on nutrition, the study investigated whether these children also experienced lower prevalence of acute and chronic malnutrition.

Methods: In Burkina Faso and Mali 5920 children were randomized to receive either SMC alone, RTS,S/AS01 alone, or SMC combined with RTS,S/AS01 for three malaria transmission seasons (2017-2019).