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1. The duration of protection against clinical malaria provided by the combination of seasonal RTS,S/AS01E vaccination and seasonal malaria chemoprevention versus either intervention given alone

Author

Matthew Cairns, Amadou Barry, Issaka Zongo, Issaka Sagara, Serge R. Yerbanga, Modibo Diarra, Charles Zoungrana, Djibrilla Issiaka, Abdoul Aziz Sienou, Amadou Tapily, Koualy Sanogo, Mahamadou Kaya, Seydou Traore, Kalifa Diarra, Hama Yalcouye, Youssoufa Sidibe, Alassane Haro, Ismaila Thera, Paul Snell, Jane Grant, Halidou Tinto, Paul Milligan, Daniel Chandramohan, Brian Greenwood, Alassane Dicko, and Jean Bosco Ouedraogo

Subjects
Malaria, Plasmodium falciparum, Seasonal malaria chemoprevention, Malaria vaccination, RTS,S/AS01E, Medicine
Abstract

Abstract Background A recent trial of 5920 children in Burkina Faso and Mali showed that the combination of seasonal vaccination with the RTS,S/AS01E 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/AS01E when deployed seasonally, by comparing the group who received the combination of SMC and RTS,S/AS01E 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/AS01E alone. Three methods were used: Piecewise Cox regression, Flexible parametric survival models and Smoothed Schoenfeld residuals from Cox models, stratifying on the study area and using robust standard errors to control for within-child clustering of multiple episodes. Results The overall protective efficacy from RTS,S/AS01E over 6 months was at least 60% following the primary series and the two seasonal booster doses and remained at a high level over the full malaria transmission season. Beyond 6 months, protective efficacy appeared to wane more rapidly, but the uncertainty around the estimates increases due to the lower number of cases during this period (coinciding with the onset of the dry season). Protection from SMC exceeded 90% in the first 2–3 weeks post-administration after several cycles, but was not 100%, even immediately post-administration. Efficacy begins to decline from approximately day 21 and then declines more sharply after day 28, indicating the importance of preserving the delivery interval for SMC cycles at a maximum of four weeks. Conclusions The efficacy of both interventions was highest immediately post-administration. Understanding differences between these interventions in their peak efficacy and how rapidly efficacy declines over time will help to optimise the scheduling of SMC, malaria vaccination and the combination in areas of seasonal transmission with differing epidemiology, and using different vaccine delivery systems. Trial registration The RTS,S-SMC trial in which these data were collected was registered at clinicaltrials.gov: NCT03143218

Published
2022
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2. Impact of seasonal RTS,S/AS01E vaccination plus seasonal malaria chemoprevention on the nutritional status of children in Burkina Faso and Mali

Author

Jane Grant, Issaka Sagara, Issaka Zongo, Matthew Cairns, Rakiswendé Serge Yerbanga, Modibo Diarra, Charles Zoungrana, Djibrilla Issiaka, Frédéric Nikièma, Frédéric Sompougdou, Amadou Tapily, Mahamadou Kaya, Alassane Haro, Koualy Sanogo, Abdoul Aziz Sienou, Seydou Traore, Ismaila Thera, Hama Yalcouye, Irene Kuepfer, Paul Snell, Paul Milligan, Christian Ockenhouse, Opokua Ofori-Anyinam, Halidou Tinto, Abdoulaye Djimde, Daniel Chandramohan, Brian Greenwood, Alassane Dicko, and Jean-Bosco Ouédraogo

Subjects
Malaria, Nutrition, Seasonal malaria chemoprevention, RTS,S/AS01E, Mali, Burkina Faso, Arctic medicine. Tropical medicine, RC955-962, Infectious and parasitic diseases, RC109-216
Abstract

Abstract Background A recent trial in Burkina Faso and Mali showed that combining seasonal RTS,S/AS01E 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/AS01E alone, or SMC combined with RTS,S/AS01E for three malaria transmission seasons (2017–2019). After each transmission season, anthropometric measurements were collected from all study children at a cross-sectional survey and used to derive nutritional status indicators, including the binary variables wasted and stunted (weight-for-height and height-for-age z-scores below − 2, respectively). Binary and continuous outcomes between treatment groups were compared by Poisson and linear regression. Results In 2017, compared to SMC alone, the combined intervention reduced the prevalence of wasting by approximately 12% [prevalence ratio (PR) = 0.88 (95% CI 0.75, 1.03)], and approximately 21% in 2018 [PR = 0.79 (95% CI 0.62, 1.01)]. Point estimates were similar for comparisons with RTS,S/AS01E, but there was stronger evidence of a difference. There was at least a 30% reduction in the point estimates for the prevalence of severe wasting in the combined group compared to the other two groups in 2017 and 2018. There was no difference in the prevalence of moderate or severe wasting between the groups in 2019. The prevalence of stunting, low-MUAC-for-age or being underweight did not differ between groups for any of the three years. The prevalence of severe stunting was higher in the combined group compared to both other groups in 2018, and compared to RTS,S/AS01E alone in 2017; this observation does not have an obvious explanation and may be a chance finding. Overall, malnutrition was very common in this cohort, but declined over the study as the children became older. Conclusions Despite a high burden of malnutrition and malaria in the study populations, and a major reduction in the incidence of malaria in children receiving both interventions, this had only a modest impact on nutritional status. Therefore, other interventions are needed to reduce the high burden of malnutrition in these areas. Trial registration: https://www.clinicaltrials.gov/ct2/show/NCT03143218 , registered 8th May 2017.

Published
2022
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3. The Anti-Circumsporozoite Antibody Response of Children to Seasonal Vaccination With the RTS,S/AS01E Malaria Vaccine

Author

Issaka, Sagara, Issaka, Zongo, Matthew, Cairns, Rakiswendé Serge, Yerbanga, Almahamoudou, Mahamar, Frédéric, Nikièma, Amadou, Tapily, Frédéric, Sompougdou, Modibo, Diarra, Charles, Zoungrana, Djibrilla, Issiaka, Alassane, Haro, Koualy, Sanogo, Abdoul, Aziz Sienou, Mahamadou, Kaya, Seydou, Traore, Ismaila, Thera, Kalifa, Diarra, Amagana, Dolo, Irene, Kuepfer, Paul, Snell, Paul, Milligan, Christian, Ockenhouse, Opokua, Ofori-Anyinam, Halidou, Tinto, Abdoulaye, Djimde, Jean Bosco, Ouedraogo, Alassane, Dicko, Daniel, Chandramohan, and Brian, Greenwood

Subjects
Microbiology (medical), Infectious Diseases, Antibody Formation, Malaria Vaccines, Plasmodium falciparum, Vaccination, Humans, Infant, Seasons, Malaria, Falciparum, Child, Malaria
Abstract

Background A trial in African children showed that combining seasonal vaccination with the RTS,S/AS01E vaccine with seasonal malaria chemoprevention reduced the incidence of uncomplicated and severe malaria compared with either intervention given alone. Here, we report on the anti-circumsporozoite antibody response to seasonal RTS,S/AS01E vaccination in children in this trial. Methods Sera from a randomly selected subset of children collected before and 1 month after 3 priming doses of RTS,S/AS01E and before and 1 month after 2 seasonal booster doses were tested for anti-circumsporozoite antibodies using enzyme-linked immunosorbent assay. The association between post-vaccination antibody titer and incidence of malaria was explored. Results A strong anti-circumsporozoite antibody response to 3 priming doses of RTS,S/AS01E was seen (geometric mean titer, 368.9 enzyme-linked immunosorbent assay units/mL), but titers fell prior to the first booster dose. A strong antibody response to an annual, pre-malaria transmission season booster dose was observed, but this was lower than after the primary vaccination series and lower after the second than after the first booster dose (ratio of geometric mean rise, 0.66; 95% confidence interval [CI], .57–.77). Children whose antibody response was in the upper tercile post-vaccination had a lower incidence of malaria during the following year than children in the lowest tercile (hazard ratio, 0.43; 95% CI, .28–.66). Conclusions Seasonal vaccination with RTS,S/AS01E induced a strong booster antibody response that was lower after the second than after the first booster dose. The diminished antibody response to the second booster dose was not associated with diminished efficacy. Clinical Trials Registration NCT03143218.

Published
2021

4. Impact of seasonal RTS,S/AS01

Author

Jane, Grant, Issaka, Sagara, Issaka, Zongo, Matthew, Cairns, Rakiswendé Serge, Yerbanga, Modibo, Diarra, Charles, Zoungrana, Djibrilla, Issiaka, Frédéric, Nikièma, Frédéric, Sompougdou, Amadou, Tapily, Mahamadou, Kaya, Alassane, Haro, Koualy, Sanogo, Abdoul Aziz, Sienou, Seydou, Traore, Ismaila, Thera, Hama, Yalcouye, Irene, Kuepfer, Paul, Snell, Paul, Milligan, Christian, Ockenhouse, Opokua, Ofori-Anyinam, Halidou, Tinto, Abdoulaye, Djimde, Daniel, Chandramohan, Brian, Greenwood, Alassane, Dicko, and Jean-Bosco, Ouédraogo

Subjects
Antimalarials, Cross-Sectional Studies, Child, Preschool, Burkina Faso, Vaccination, Humans, Infant, Nutritional Status, Seasons, Child, Mali, Chemoprevention, Malaria
Abstract

A recent trial in Burkina Faso and Mali showed that combining seasonal RTS,S/AS01In Burkina Faso and Mali 5920 children were randomized to receive either SMC alone, RTS,S/AS01In 2017, compared to SMC alone, the combined intervention reduced the prevalence of wasting by approximately 12% [prevalence ratio (PR) = 0.88 (95% CI 0.75, 1.03)], and approximately 21% in 2018 [PR = 0.79 (95% CI 0.62, 1.01)]. Point estimates were similar for comparisons with RTS,S/AS01Despite a high burden of malnutrition and malaria in the study populations, and a major reduction in the incidence of malaria in children receiving both interventions, this had only a modest impact on nutritional status. Therefore, other interventions are needed to reduce the high burden of malnutrition in these areas.https://www.clinicaltrials.gov/ct2/show/NCT03143218 , registered 8th May 2017.

Published
2021

5. Seasonal Malaria Vaccination with or without Seasonal Malaria Chemoprevention

Author

Kalifa Diarra, Frederic Nikiema, Paul Snell, Matthew Cairns, Irene Kuepfer, Amadou Tapily, Djibrilla Issiaka, Issaka Zongo, Daniel Chandramohan, Rakiswendé-Serge Yerbanga, Opokua Ofori-Anyinam, Paul Milligan, Modibo Diarra, Charles Zoungrana, Alassane Dicko, Ismaila Thera, Halidou Tinto, Christian F. Ockenhouse, Frederic Sompougdou, Brian Greenwood, Issaka Sagara, Abdoul-Aziz Sienou, Alassane Haro, Mahamadou Kaya, Abdoulaye Djimde, Koualy Sanogo, Seydou Traore, Jean-Bosco Ouédraogo, Almahamoudou Mahamar, Amagana Dolo, London School of Hygiene and Tropical Medicine (LSHTM), Institut de Recherche en Sciences de la Santé Bobo Dioulasso (INSSA), Université Polytechnique Nazi Boni Bobo-Dioulasso (UNB), Université des Sciences, des Techniques et des Technologies de Bamako (USTTB), PATH [Seattle], GlaxoSmithKline Pharmaceuticals [Rixensart] (GSK), and Malbec, Odile

Subjects
Male, medicine.medical_specialty, Amodiaquine, Mali, Chemoprevention, Seizures, Febrile, law.invention, Antimalarials, Pharmacotherapy, Randomized controlled trial, Double-Blind Method, law, Internal medicine, Febrile seizure, parasitic diseases, Burkina Faso, Malaria Vaccines, Sulfadoxine, medicine, Humans, Malaria, Falciparum, business.industry, Hazard ratio, Infant, General Medicine, medicine.disease, Combined Modality Therapy, Confidence interval, Vaccination, Hospitalization, Drug Combinations, Pyrimethamine, [SDV.SPEE] Life Sciences [q-bio]/Santé publique et épidémiologie, [SDV.SPEE]Life Sciences [q-bio]/Santé publique et épidémiologie, Drug Therapy, Combination, Female, Seasons, business, Malaria, medicine.drug
Abstract

International audience; Background: Malaria control remains a challenge in many parts of the Sahel and sub-Sahel regions of Africa.Methods: We conducted an individually randomized, controlled trial to assess whether seasonal vaccination with RTS,S/AS01E was noninferior to chemoprevention in preventing uncomplicated malaria and whether the two interventions combined were superior to either one alone in preventing uncomplicated malaria and severe malaria-related outcomes.Results: We randomly assigned 6861 children 5 to 17 months of age to receive sulfadoxine-pyrimethamine and amodiaquine (2287 children [chemoprevention-alone group]), RTS,S/AS01E (2288 children [vaccine-alone group]), or chemoprevention and RTS,S/AS01E (2286 children [combination group]). Of these, 1965, 1988, and 1967 children in the three groups, respectively, received the first dose of the assigned intervention and were followed for 3 years. Febrile seizure developed in 5 children the day after receipt of the vaccine, but the children recovered and had no sequelae. There were 305 events of uncomplicated clinical malaria per 1000 person-years at risk in the chemoprevention-alone group, 278 events per 1000 person-years in the vaccine-alone group, and 113 events per 1000 person-years in the combination group. The hazard ratio for the protective efficacy of RTS,S/AS01E as compared with chemoprevention was 0.92 (95% confidence interval [CI], 0.84 to 1.01), which excluded the prespecified noninferiority margin of 1.20. The protective efficacy of the combination as compared with chemoprevention alone was 62.8% (95% CI, 58.4 to 66.8) against clinical malaria, 70.5% (95% CI, 41.9 to 85.0) against hospital admission with severe malaria according to the World Health Organization definition, and 72.9% (95% CI, 2.9 to 92.4) against death from malaria. The protective efficacy of the combination as compared with the vaccine alone against these outcomes was 59.6% (95% CI, 54.7 to 64.0), 70.6% (95% CI, 42.3 to 85.0), and 75.3% (95% CI, 12.5 to 93.0), respectively.Conclusions: Administration of RTS,S/AS01E was noninferior to chemoprevention in preventing uncomplicated malaria. The combination of these interventions resulted in a substantially lower incidence of uncomplicated malaria, severe malaria, and death from malaria than either intervention alone. (Funded by the Joint Global Health Trials and PATH; ClinicalTrials.gov number, NCT03143218.).

Published
2021

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