The RTS,S/AS01 malaria vaccine in children 5 to 17 months of age at first vaccination

Vandoolaeghe, Pascale; Schuerman, Lode

doi:10.1080/14760584.2016.1236689

Cited by 47 publications

(52 citation statements)

References 50 publications

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“…We have previously reported that a 4-dose regimen of RTS,S/ AS01 was efficacious and provided the strongest benefit in terms of impact against clinical and severe malaria in children aged 5-17 months at the time of the first vaccination. 16 Additionally, reductions in overall hospital admissions, admissions because of malaria, severe anemia, and the need for blood transfusion in children were observed. We also previously reported an increased risk of febrile convulsions in children vaccinated with RTS,S/AS01 in our large doubleblind, randomized, phase III trial in SSA.…”

Section: Discussionmentioning

confidence: 99%

Safety profile of the RTS,S/AS01 malaria vaccine in infants and children: additional data from a phase III randomized controlled trial in sub-Saharan Africa

Mendoza

Garric

Leach

et al. 2019

Human Vaccines & Immunotherapeutics

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A phase III, double-blind, randomized, controlled trial (NCT00866619) in sub-Saharan Africa showed RTS,S/AS01 vaccine efficacy against malaria. We now present in-depth safety results from this study. 8922 children (enrolled at 5–17 months) and 6537 infants (enrolled at 6–12 weeks) were 1:1:1-randomized to receive 4 doses of RTS,S/AS01 (R3R) or non-malaria control vaccine (C3C), or 3 RTS,S/AS01 doses plus control (R3C). Aggregate safety data were reviewed by a multi-functional team. Severe malaria with Blantyre Coma Score ≤2 (cerebral malaria [CM]) and gender-specific mortality were assessed post-hoc. Serious adverse event (SAE) and fatal SAE incidences throughout the study were 24.2%–28.4% and 1.5%–2.5%, respectively across groups; 0.0%–0.3% of participants reported vaccination-related SAEs. The incidence of febrile convulsions in children was higher during the first 2–3 days post-vaccination with RTS,S/AS01 than with control vaccine, consistent with the time window of post-vaccination febrile reactions in this study (mostly the day after vaccination). A statistically significant numerical imbalance was observed for meningitis cases in children (R3R: 11, R3C: 10, C3C: 1) but not in infants. CM cases were more frequent in RTS,S/AS01-vaccinated children (R3R: 19, R3C: 24, C3C: 10) but not in infants. All-cause mortality was higher in RTS,S/AS01-vaccinated versus control girls (2.4% vs 1.3%, all ages) in our setting with low overall mortality. The observed meningitis and CM signals are considered likely chance findings, that – given their severity – warrant further evaluation in phase IV studies and WHO-led pilot implementation programs to establish the RTS,S/AS01 benefit-risk profile in real-life settings.

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Section: Discussionmentioning

confidence: 99%

Safety profile of the RTS,S/AS01 malaria vaccine in infants and children: additional data from a phase III randomized controlled trial in sub-Saharan Africa

Mendoza

Garric

Leach

et al. 2019

Human Vaccines & Immunotherapeutics

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“…The vaccine induces antibodies against parasites that have reached or are in transit to the liver (where they mature and multiply), thereby limiting the ability of the parasites to cause clinical disease. Due to the high frequency of malaria in children in some parts of the world, this vaccine has the potential to prevent a large number of malaria cases [37,38].…”

Section: Protein Vaccinesmentioning

confidence: 99%

Understanding modern-day vaccines: what you need to know

et al. 2017

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Vaccines are considered to be one of the greatest public health achievements of the last century. Depending on the biology of the infection, the disease to be prevented, and the targeted population, a vaccine may require the induction of different adaptive immune mechanisms to be effective. Understanding the basic concepts of different vaccines is therefore crucial to understand their mode of action, benefits, risks, and their potential real-life impact on protection. This review aims to provide healthcare professionals with background information about the main vaccine designs and concepts of protection in a simplified way to improve their knowledge and understanding, and increase their confidence in the science of vaccination ( Supplementary Material ). KEY MESSAGE Different vaccine designs, each with different advantages and limitations, can be applied for protection against a particular disease. Vaccines may contain live-attenuated pathogens, inactivated pathogens, or only parts of pathogens and may also contain adjuvants to stimulate the immune responses. This review explains the mode of action, benefits, risks and real-life impact of vaccines by highlighting key vaccine concepts. An improved knowledge and understanding of the main vaccine designs and concepts of protection will help support the appropriate use and expectations of vaccines, increase confidence in the science of vaccination, and help reduce vaccine hesitancy.

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“…The anti-malaria vaccine Malaria RTS has been certified, which represents the C-terminal part of the CS protein of Plasmodium falciparum attached to the surface antigen of the hepatitis B virus (HBsAg), which is also used in the certified vaccines against hepatitis B. To stabilize recombinant VLPs, the fused protein is expressed together with the HBsAg protein in Saccharomyces cerevisease [89]. A vaccine against the porcine circovirus representing VLPs assembled from the VP2PCV2 capsid protein synthesized in a heterologous system has also been commercialized [41].…”

Section: Commercial Vaccines Based On Vlp and Prospects Of Broadeningmentioning

confidence: 99%

Virus-Like Particles as an Instrument of Vaccine Production

Syomin

Ilyin

2019

Mol Biol

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The paper discusses the techniques which are currently implemented for vaccine production based on virus-like particles (VLPs). The factors which determine the characteristics of VLP monomers assembly are provided in detail. Analysis of the literature demonstrates that the development of the techniques of VLP production and immobilization of target antigens on their surface have led to the development of universal platforms which make it possible for virtually any known antigen to be exposed on the particle surface in a highly concentrated form. As a result, the focus of attention has shifted from the approaches to VLP production to the development of a precise interface between the organism's immune system and the peptides inducing a strong immune response to pathogens or the organism's own pathological cells. Immunome-specified methods for vaccine design and the prospects of immunoprophylaxis are discussed. Certain examples of vaccines against viral diseases and cancers are considered.

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The RTS,S/AS01 malaria vaccine in children 5 to 17 months of age at first vaccination

Cited by 47 publications

References 50 publications

Safety profile of the RTS,S/AS01 malaria vaccine in infants and children: additional data from a phase III randomized controlled trial in sub-Saharan Africa

Safety profile of the RTS,S/AS01 malaria vaccine in infants and children: additional data from a phase III randomized controlled trial in sub-Saharan Africa

Understanding modern-day vaccines: what you need to know

Virus-Like Particles as an Instrument of Vaccine Production

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