Safety and immunogenicity of a parenteral P2-VP8-P[8] subunit rotavirus vaccine in toddlers and infants in South Africa: a randomised, double-blind, placebo-controlled trial

Groome, Michelle; Koen, Anthonet; Fix, Alan; Page, Nicola; Jose, Lisa; Madhi, Shabir А.; McNeal, Monica; Dally, Len; Cho, Iksung; Power, Maureen; Flores, Jorge; Cryz, Stanley

doi:10.1016/s1473-3099(17)30242-6

Cited by 117 publications

(136 citation statements)

References 28 publications

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“…A combination of oral and parenteral vaccines (inactivated or recombinant non-live vaccines) or only parenteral vaccines might be useful in this regard 90 . Indeed, a parenterally administered recombinant VP8* vaccine is safe and immunogenic in children 131 .…”

Section: Diagnosis Screening and Preventionmentioning

confidence: 99%

Rotavirus infection

Crawford

Ramani

Tate

et al. 2017

Nat Rev Dis Primers

554

558

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Rotavirus infections are a leading cause of severe, dehydrating gastroenteritis in children <5 years of age. Despite the global introduction of vaccinations for rotavirus over a decade ago, rotavirus infections still result in >200,000 deaths annually, mostly in low-income countries. Rotavirus primarily infects enterocytes and induces diarrhoea through the destruction of absorptive enterocytes (leading to malabsorption), intestinal secretion stimulated by rotavirus non-structural protein 4 and activation of the enteric nervous system. In addition, rotavirus infections can lead to antigenaemia (which is associated with more severe manifestations of acute gastroenteritis) and viraemia, and rotavirus can replicate in systemic sites, although this is limited. Reinfections with rotavirus are common throughout life, although the disease severity is reduced with repeat infections. The immune correlates of protection against rotavirus reinfection and recovery from infection are poorly understood, although rotavirus-specific immunoglobulin A has a role in both aspects. The management of rotavirus infection focuses on the prevention and treatment of dehydration, although the use of antiviral and anti-emetic drugs can be indicated in some cases.

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Section: Diagnosis Screening and Preventionmentioning

confidence: 99%

Rotavirus infection

Crawford

Ramani

Tate

et al. 2017

Nat Rev Dis Primers

554

558

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show abstract

“…28 Results of four more phase I trials in the United States and Canada were reported simultaneously (Regules et al, NEJM 2016) or shortly thereafter. [29][30][31] To date, a total of 17 phase I-III clinical trials have been completed or are ongoing (summarized in Tables 1 and 2). 16,32 VSV-EBOV is furthermore the only vaccine that is being deployed during the 10 th EBOV outbreak in the Democratic Republic of the Congo (DRC).…”

Section: Ebola Virusmentioning

confidence: 99%

“…After the study halt, simultaneously running phase I studies of VSV-EBOV included arthralgia/arthritis as a solicited adverse event, but while transient arthralgia was likewise reported, the high frequency of arthritis cases was not observed to the same extent. [28][29][30][31]41 Finally, arthritis frequency was assessed in a large placebocontrolled phase III trial. Here, the incidence of arthritis or joint swelling was 4.9% in a study population of 1050 individuals.…”

Section: Safety Datamentioning

confidence: 99%

Recombinant vesicular stomatitis virus vector vaccines for WHO blueprint priority pathogens

Fathi

Dahlke

Addo

2019

Human Vaccines & Immunotherapeutics

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The devastating Ebola virus (EBOV) outbreak in West Africa in 2013-2016 has flagged the need for the timely development of vaccines for high-threat pathogens. To be better prepared for new epidemics, the WHO has compiled a list of priority pathogens that are likely to cause future outbreaks and for which R&D efforts are, therefore, paramount (R&D Blueprint: https://www.who.int/blueprint/priority-diseases/en/). To this end, the detailed characterization of vaccine platforms is needed. The vesicular stomatitis virus (VSV) has been established as a robust vaccine vector backbone for infectious diseases for well over a decade. The recent clinical trials testing the vaccine candidate VSV-EBOV against EBOV disease now have added a substantial amount of clinical data and suggest VSV to be an ideal vaccine vector candidate for outbreak pathogens. In this review, we discuss insights gained from the clinical VSV-EBOV vaccine trials as well as from animal studies investigating vaccine candidates for Blueprint pathogens. ARTICLE HISTORY

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“…Two candidates are being developed: a trivalent nonreplicating rotavirus vaccine expressed in E. coli, developed by PATH -SK Bioscience as partner-showed good safety and immunogenicity (e.g. neutralizing antibodies) in human clinical studies [13], clinical protection will be evaluated. The inactivated whole-virus particle Rotavirus vaccine developed by the U.S. CDC -SII as partner -showed protective immunity in animals.…”

Section: Future Vaccinesmentioning

confidence: 99%

The art of partnerships for vaccines

Pagliusi¹,

Che²,

Dong³

2019

Vaccine

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The Developing Countries Vaccine Manufacturers Network (DCVMN) convened vaccine manufacturing experts and leaders from local and global public health organizations for its 19th Annual General Meeting. Lectures and panel discussions centered on international cooperation for better access to vaccines, and partnerships in areas ranging from vaccine research and process development, to clinical studies, regulatory, supply chain and emergency preparedness and response.Global vaccine market trends and changes that will impact vaccine financing and procurement methods were discussed as well as capital sources, including funding, for the development of new or improved vaccines.DCVMN members presented their progress in developing novel Hexavalent, Meningitis, Pneumococcal Conjugate Vaccine, Shigella, Mumps, Rotavirus, Yellow Fever, Polio, Hepatitis E and Dengue vaccines, and a novel monoclonal antibody cocktail for post-bite prophylaxis against rabies infections.Access to and availability of vaccines is enhanced through sharing of best practices for vaccine quality control, reducing redundant testing and promoting development of harmonized common standards. Eligible stakeholders were encouraged to join the WHO-National Control Laboratory Network for Biologicals which serves as a platform for collaboration and technical exchange in this area.Increasing regulatory convergence at the regional and global levels through mechanisms such as joint dossier review and the WHO Collaborative Registration Procedure can help to accelerate vaccine access globally. Additionally, four proposals for streamlining procedures and alignment of dossiers were discussed.Successful partnerships between a broad range of stakeholders, including international organizations, manufacturers, academic research institutes and regulators have provided support for, and in some cases accelerated, vaccine innovation, clinical trials and registration, WHO prequalification, vaccine introduction and access. Strong partnerships, based on experience and trust, help leverage opportunities and are critically important to advancing the shared goal of providing quality vaccines for all people.

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Safety and immunogenicity of a parenteral P2-VP8-P[8] subunit rotavirus vaccine in toddlers and infants in South Africa: a randomised, double-blind, placebo-controlled trial

Abstract: Bill & Melinda Gates Foundation.

Cited by 117 publications

References 28 publications

Rotavirus infection

Rotavirus infection

Recombinant vesicular stomatitis virus vector vaccines for WHO blueprint priority pathogens

The art of partnerships for vaccines

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