Safety and immunogenicity of pentavalent rotavirus vaccine in a randomized, double-blind, placebo-controlled study in healthy elderly subjects

Lawrence, Jody; He, Shuangba; Martin, Jason; Schödel, Florian; Ciarlet, Max; Murray, Alexander V.

doi:10.4161/hv.29107

Cited by 16 publications

(14 citation statements)

References 27 publications

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“…Recently, a pentavalent bovine-human reassortant RV vaccine (PRV; RotaTeq, Merck, Whitehouse Station, NJ, USA) and a human attenuated monovalent RV vaccine (HRV; Rotarix, GlaxoSmithKline, Brentford, UK) have been licensed in many countries. Studies reported that these three vaccines caused viral shedding in stool samples within a relatively short period (i.e., 30 days) post-vaccination and also confirmed the risk of vaccine strain transmission 5 , 6 . Vaccine strain transmission from vaccinated children to unvaccinated contacts may lead to herd immunity.…”

Section: Introductionmentioning

confidence: 65%

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Faecal shedding of rotavirus vaccine in Chinese children after vaccination with Lanzhou lamb rotavirus vaccine

Cao

Gao

et al. 2018

Sci Rep

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Lanzhou lamb rotavirus vaccine (LLR) is an oral live attenuated vaccine first licensed in China in 2000. To date, > 60 million doses of LLR have been distributed to children. However, very little is known about faecal shedding of LLR in children. Therefore, faecal samples (n = 1,184) were collected from 114 children for 15 days post-vaccination in September–November 2011/2012. Faecal shedding and viral loads were determined by an enzyme immunoassay kit (EIA) and real-time RT-PCR. The complete genome was sequenced and the vaccine strain was isolated by culture in MA104 cells. Approximately 14.0% (16/114) of children had rotavirus-positive samples by EIA for at least 1 day post-vaccination. Viral loads in EIA-positive samples ranged from < 1.0 × 103 to 1.9 × 108 copies/g. Faecal shedding occurred as early as post-vaccination day 2 and as late as post-vaccination day 13 and peaked on post-vaccination day 5–10. One LLR strain was isolated by culture in MA104 cells. Sequence analysis showed 99% identity with LLR prototype strain. Faecal shedding of LLR in stool is common within 15 days of LLR vaccination, indicating vaccine strains can replicate in human enteric tissues.

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Section: Introductionmentioning

confidence: 65%

“…Approximately 12.7–14.9% of HRV vaccinated individuals and 27% of PRV vaccinated individuals experienced a vaccine-related adverse event of mild or moderate intensity within 30 days 5 , 6 . In this study, 15.8% (19/120) of vaccinated individuals reported adverse events, such as fever, nausea, vomiting, and diarrhoea.…”

Section: Discussionmentioning

confidence: 99%

Faecal shedding of rotavirus vaccine in Chinese children after vaccination with Lanzhou lamb rotavirus vaccine

Cao

Gao

et al. 2018

Sci Rep

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“…This was a proof-of-concept study where effects of microbiome modulation could not safely be estimated. To gain an indication for sample size we used a previous published study evaluating the effect of rotavirus (Rotateq) vaccination in elderly adults to estimate a mean 28 day post-vaccination IgA geometric mean titers (GMT) response of 1026 dilution units in controls and estimate a projected standard deviation of approximately 400 dilution units (Lawrence et al, 2014). We calculated an enrollment of 21 volunteers per treatment group would provide 80% power with a = 0$05 to detect a difference in mean anti-RV IgA titer of 35% between control and treatment groups.…”

Section: Discussionmentioning

confidence: 99%

Effect of Antibiotic-Mediated Microbiome Modulation on Rotavirus Vaccine Immunogenicity: A Human, Randomized-Control Proof-of-Concept Trial

Harris

Haak

Handley

et al. 2018

Cell Host & Microbe

100

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Rotavirus vaccines (RVV) protect against childhood gastroenteritis caused by rotavirus (RV) but have decreased effectiveness in low- and middle-income settings. This proof-of-concept, randomized-controlled, open-label trial tested if microbiome modulation can improve RVV immunogenicity. Healthy adults were randomized and administered broad-spectrum (oral vancomycin, ciprofloxacin, metronidazole), narrow-spectrum (vancomycin), or no antibiotics and then vaccinated with RVV, 21 per group per protocol. Baseline anti-RV IgA was high in all subjects. Although antibiotics did not alter absolute anti-RV IgA titers, RVV immunogenicity was boosted at 7 days in the narrow-spectrum group. Further, antibiotics increased fecal shedding of RV while also rapidly altering gut bacterial beta diversity. Beta diversity associated with RVV immunogenicity boosting at day 7 and specific bacterial taxa that distinguish RVV boosters and RV shedders were identified. Despite the negative primary endpoint, this study demonstrates that microbiota modification alters the immune response to RVV and supports further exploration of microbiome manipulation to improve RVV immunogenicity.

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“…These studies indicate the possible horizontal transmission of a live attenuated vaccine and the potential environmental spread of new reassortant strains leading to development of new infections [ 68 ]. Other studies have similarly demonstrated viral elimination in stool samples at relatively short intervals after Rotarix [ 69 ] and RotaTeq [ 70 ] vaccination, which involves risk of vaccine strain transmission. In general, transmission of the attenuated vaccine strain from vaccinated to non-immunized children can lead to herd immunity, contributing greatly to the protection of a population.…”

Section: Rv Vaccine Pipelinementioning

confidence: 96%

The Rotavirus Vaccine Landscape, an Update

et al. 2021

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Rotavirus is the leading cause of severe acute childhood gastroenteritis, responsible for more than 128,500 deaths per year, mainly in low-income countries. Although the mortality rate has dropped significantly since the introduction of the first vaccines around 2006, an estimated 83,158 deaths are still preventable. The two main vaccines currently deployed, Rotarix and RotaTeq, both live oral vaccines, have been shown to be less effective in developing countries. In addition, they have been associated with a slight risk of intussusception, and the need for cold chain maintenance limits the accessibility of these vaccines to certain areas, leaving 65% of children worldwide unvaccinated and therefore unprotected. Against this backdrop, here we review the main vaccines under development and the state of the art on potential alternatives.

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Safety and immunogenicity of pentavalent rotavirus vaccine in a randomized, double-blind, placebo-controlled study in healthy elderly subjects

Cited by 16 publications

References 27 publications

Faecal shedding of rotavirus vaccine in Chinese children after vaccination with Lanzhou lamb rotavirus vaccine

Faecal shedding of rotavirus vaccine in Chinese children after vaccination with Lanzhou lamb rotavirus vaccine

Effect of Antibiotic-Mediated Microbiome Modulation on Rotavirus Vaccine Immunogenicity: A Human, Randomized-Control Proof-of-Concept Trial

The Rotavirus Vaccine Landscape, an Update

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