Safety and immunogenicity of RTS,S/AS01 malaria vaccine in infants and children with WHO stage 1 or 2 HIV disease: a randomised, double-blind, controlled trial

Otieno, Lucas; Oneko, Martina; Otieno, Walter; Abuodha, Joseph; Owino, Emmanuel; Odero, Chris; Mendoza, Yolanda Guerra; Andagalu, Ben; Awino, Norbert; Ivinson, Karen; Heerwegh, Dirk; Otsyula, Nekoye; Oziemkowska, Maria; Usuf, Effua; Otieno, Allan; Otieno, Kephas; Leboulleux, Didier; Leach, Amanda; Oyieko, Janet; Slutsker, Laurence; Lievens, Marc; Cowden, Jessica; Lapierre, Didier; Kariuki, Simon; Ogutu, Bernhards; Vekemans, Johan; Hamel, Mary J.

doi:10.1016/s1473-3099(16)30161-x

Cited by 31 publications

(38 citation statements)

References 21 publications

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“…This renewed confidence in future RTS,S/AS01 vaccine studies and programs involving children with HIV to be pursued. 13 While the RTS,S/AS01 vaccine was shown to confer limited efficacy in both children and infants and limited duration of immunity, 14 it is nevertheless expected to have a significant impact on the high disease burden of this deadly parasitic disease. 15 A malaria vaccine mathematical model showing the supply-and-demand forecast and the impact on public health and financial costs projected that 150 million uncomplicated malaria cases and 1.1 million mortalities would be averted through vaccination over a period of 10 years.…”

Section: Results Of the Pivotal Trialsmentioning

confidence: 99%

Vaccine Update: Recent Progress With Novel Vaccines, and New Approaches to Safety Monitoring and Vaccine Shortage

Ndaya-Oloo

Pitisuttithum

Tornieporth³

et al. 2018

The Journal of Clinical Pharma

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Vaccines are increasingly based on new constructs, new technologies, and new compounds. Novel immunization programs are rapidly implemented globally. In this article, we highlight selected hot topics of this highly dynamic and broad field of scientific and public health development. The first section focuses on novel vaccines including malaria, dengue, serogroup B meningococcal, and respiratory syncytial virus vaccines and antibodies. The second section is addressing emerging strategies and programmatic challenges including maternal immunization, integrated mother‐child safety monitoring, and finally coping strategies with vaccine shortages.

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Section: Results Of the Pivotal Trialsmentioning

confidence: 99%

Vaccine Update: Recent Progress With Novel Vaccines, and New Approaches to Safety Monitoring and Vaccine Shortage

Ndaya-Oloo

Pitisuttithum

Tornieporth³

et al. 2018

The Journal of Clinical Pharma

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“…These include more powerful influenza vaccines, a vaccine against human papilloma virus, a vaccine against malaria, a vaccine against herpes zoster that has shown remarkable efficacy in elderly people, and an improved vaccine against hepatitis B. Probably, the most notable example is the adjuvant AS01, recently licensed for a vaccine against malaria and for a novel herpes zoster vaccine (21,22). This adjuvant is composed of two immunostimulants, the saponin QS21 and monophosphoryl lipid A, targeting TLR4; both compounds are formulated in liposomes.…”

Section: Glycoconjugation a Second Technological Revolution Of The 1mentioning

confidence: 99%

Technologies to address antimicrobial resistance

Baker

Payne

Rappuoli

et al. 2018

Proc. Natl. Acad. Sci. U.S.A.

159

112

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Bacterial infections have been traditionally controlled by antibiotics and vaccines, and these approaches have greatly improved health and longevity. However, multiple stakeholders are declaring that the lack of new interventions is putting our ability to prevent and treat bacterial infections at risk. Vaccine and antibiotic approaches still have the potential to address this threat. Innovative vaccine technologies, such as reverse vaccinology, novel adjuvants, and rationally designed bacterial outer membrane vesicles, together with progress in polysaccharide conjugation and antigen design, have the potential to boost the development of vaccines targeting several classes of multidrug-resistant bacteria. Furthermore, new approaches to deliver small-molecule antibacterials into bacteria, such as hijacking active uptake pathways and potentiator approaches, along with a focus on alternative modalities, such as targeting host factors, blocking bacterial virulence factors, monoclonal antibodies, and microbiome interventions, all have potential. Both vaccines and antibacterial approaches are needed to tackle the global challenge of antimicrobial resistance (AMR), and both areas have the underpinning science to address this need. However, a concerted research agenda and rethinking of the value society puts on interventions that save lives, by preventing or treating life-threatening bacterial infections, are needed to bring these ideas to fruition. vaccines | AMR | antibiotics | bacterial infections

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“…Phase IIa/IIb clinical trials of the RTS,S vaccine conducted in Africa showed that it conferred partial protection in adults, children and infants . The phase III clinical trials in seven African countries confirmed that 51% and 33% protection against clinical malaria was achieved 12 months after vaccination in children and infants, respectively . Although the mechanism of the RTS,S/AS01‐induced protective immune response has not been clarified in detail, the anti‐CSP antibodies and CD4 + T‐cell responses induced by vaccination have been correlated with the protection .…”

Section: Introductionmentioning

confidence: 99%

“…8 The phase III clinical trials in seven African countries confirmed that 51% and 33% protection against clinical malaria was achieved 12 months after vaccination in children and infants, respectively. 9,10 Although the mechanism of the RTS,S/AS01-induced protective immune response has not been clarified in detail, the anti-CSP antibodies and CD4 + T-cell responses induced by vaccination have been correlated with the protection. 11 It has been reported that the high-titre antibodies induced by RTS,S/AS01 against the NANP repeat were correlated with the clinical protection.…”

mentioning

confidence: 99%

Down‐selecting circumsporozoite protein‐based malaria vaccine: A comparison of malaria sporozoite challenge model

Amelia

Iyori

Emran

et al. 2019

Parasite Immunology

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Summary Plasmodium falciparum circumsporozoite protein (PfCSP) is the main target antigen in development of pre‐erythrocytic malaria vaccines. To evaluate PfCSP vaccines in animal models, challenge by intravenous sporozoite injection is preferentially used. However, in clinical trials, vaccinated human volunteers are exposed to the bites of malaria‐infected mosquitoes. In this study, we down‐selected Escherichia coli‐produced full‐length PfCSP (PfCSP‐F) and its three truncated PfCSPs based on their abilities to elicit immune response and protection in mice against two challenge models. We showed that immunization with three doses of PfCSP‐F elicited high anti‐PfCSP antibody titres and 100% protection against the bites of infected mosquitoes. Meanwhile, three‐dose truncated PfCSP induced 60%‐70% protection after immunization with each truncated PfCSP. Heterologous prime‐boost immunization regimen with adenovirus‐PfCSP‐F and R32LR greatly induced complete protection against intravenous sporozoite injection. Our results suggest that Abs to both anti‐repeat and anti‐nonrepeat regions induced by PfCSP‐F are required to confer complete protection against challenge by the bites of infected mosquitoes, whereas anti‐repeat Abs play an important role in protection against intravenous sporozoite injection. Our findings provide a potential clinical application that PfCSP‐F vaccine induces potent Abs capable of neutralizing sporozoites in the dermis inoculated by infected mosquitoes and subsequently sporozoites in the blood circulation.

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Safety and immunogenicity of RTS,S/AS01 malaria vaccine in infants and children with WHO stage 1 or 2 HIV disease: a randomised, double-blind, controlled trial

Abstract: GlaxoSmithKline Biologicals SA and PATH Malaria Vaccine Initiative.

Cited by 31 publications

References 21 publications

Vaccine Update: Recent Progress With Novel Vaccines, and New Approaches to Safety Monitoring and Vaccine Shortage

Vaccine Update: Recent Progress With Novel Vaccines, and New Approaches to Safety Monitoring and Vaccine Shortage

Technologies to address antimicrobial resistance

Down‐selecting circumsporozoite protein‐based malaria vaccine: A comparison of malaria sporozoite challenge model

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