A Phase II, Observer-blinded, Randomized, Active-controlled Study to Examine the Immunogenicity and Safety of Rotarix® and RV3-BB When Co-administered/Boosted With Trivalent P2-VP8 Subunit Rotavirus Vaccine Candidate in Healthy Infants in South Africa

The study will evaluate safety and immunogenicity of LORV (Rotarix and RV3-BB) when TV P2-VP8, a parentally administered rotavirus vaccine is administered either concomitantly or as a prime/boost model. Participants would be newborn babies or infants approximately at 6 weeks of age ta the time of enrollment. The vaccines will be administered at birth (only for one cohort) and at 6, 10 and 14 weeks. Immune response will be assessed prior to first vaccination, 14 weeks and at 18 weeks of age. The study will also evaluate the shedding of Rotarix virus after a challenge dose administered 28 days after last investigational product administration. Safety assessments will be conducted throughout the study duration.

开始日期2021-02-22

申办/合作机构

Program for Appropriate Technology in Health

[+4]

NCT04185545

/ Completed临床3期

Efficacy, Safety and Immunogenicity of Rotavirus RV3 Vaccine (Bio Farma) in Neonates, Lot to Lot Consistency and Antigen Interference With Co-Administered EPI Vaccines (Phase III)

This phase III trial aims to assess the efficacy, safety and immunogenicity of Rotavirus RV3 Vaccine (Bio Farma) in neonates, lot-to-lot consistency, and antigen interference with co-administered EPI vaccines

开始日期2020-10-30

申办/合作机构

PT Bio Farma

NCT03483116

/ Completed临床2期

A Phase II Randomized, Double Blind, Parallel Group Dose-ranging Study of Oral RV3-BB Rotavirus Vaccine Administered at a High, Mid and Low Titre as a 3 Dose Neonate Schedule or Administered at a High Titre as a 3 Dose Infant Schedule.

The purpose of this study is to determine the serum IgA response of three dose levels of the oral RV3-BB vaccine when administered in a neonatal schedule or when administered as a high dose in an infant schedule.

开始日期2018-06-15

申办/合作机构

Murdoch Childrens Research Institute

100 项与 Rotavirus vaccine (Bio-Farma/Murdoch-Childrens-Research-Institute) 相关的临床结果

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项与 Rotavirus vaccine (Bio-Farma/Murdoch-Childrens-Research-Institute) 相关的文献（医药）

2024-04-12·The Journal of infectious diseases

Vaccine Take of RV3-BB Rotavirus Vaccine Observed in Indonesian Infants Regardless of HBGA Status

Article

作者: Satria, Cahya Dewi ; Ong, Darren S ; Donato, Celeste M ; At Thobari, Jarir ; Lyons, Eleanor A ; Nirwati, Hera ; Handley, Amanda ; Bogdanovic-Sakran, Nada ; Watts, Emma ; Bines, Julie E ; Soenarto, Yati ; Byars, Sean G ; Pavlic, Daniel

Abstract:

Background:

Histo-blood group antigen (HBGA) status may affect vaccine efficacy due to rotavirus strains binding to HBGAs in a P genotype–dependent manner. This study aimed to determine if HBGA status affected vaccine take of the G3P[6] neonatal vaccine RV3-BB.

Methods:

DNA was extracted from stool samples collected in a subset (n = 164) of the RV3-BB phase IIb trial in Indonesian infants. FUT2 and FUT3 genes were amplified and sequenced, with any single-nucleotide polymorphisms analyzed to infer Lewis and secretor status. Measures of positive cumulative vaccine take were defined as serum immune response (immunoglobulin A or serum-neutralizing antibody) and/or stool excretion of RV3-BB virus. Participants were stratified by HBGA status and measures of vaccine take.

Results:

In 147 of 164 participants, Lewis and secretor phenotype were determined. Positive vaccine take was recorded for 144 (97.9%) of 147 participants with the combined phenotype determined. Cumulative vaccine take was not significantly associated with secretor status (relative risk, 1.00 [95% CI, .94–1.06]; P = .97) or Lewis phenotype (relative risk, 1.03 [95% CI, .94–1.14]; P = .33), nor was a difference observed when analyzed by each component of vaccine take.

Conclusions:

The RV3-BB vaccine produced positive cumulative vaccine take, irrespective of HBGA status in Indonesian infants.

2022-11-30·Human vaccines & immunotherapeutics

Model-based estimation of the impact on rotavirus disease of RV3-BB vaccine administered in a neonatal or infant schedule

Article

作者: Tellioglu, Nefel ; Bines, Julie E. ; McVernon, Jodie ; Bradhurst, Richard ; Handley, Amanda ; Geard, Nicholas ; Oktaria, Vicka

Rotavirus infection is a common cause of severe diarrheal disease and a major cause of deaths and hospitalizations among young children. Incidence of rotavirus has declined globally with increasing vaccine coverage. However, it remains a significant cause of morbidity and mortality in low-income countries where vaccine access is limited and efficacy is lower. The oral human neonatal vaccine RV3-BB can be safely administered earlier than other vaccines, and recent trials in Indonesia have demonstrated high efficacy. In this study, we use a stochastic individual-based model of rotavirus transmission and disease to estimate the anticipated population-level impact of RV3-BB following delivery according to either an infant (2, 4, 6 months) and neonatal (0, 2, 4 months) schedule. Using our model, which incorporated an age- and household-structured population and estimates of vaccine efficacy derived from trial data, we found both delivery schedules to be effective at reducing infection and disease. We estimated 95-96% reductions in infection and disease in children under 12 months of age when vaccine coverage is 85%. We also estimate high levels of indirect protection from vaccination, including 78% reductions in infection in adults over 17 years of age. Even for lower vaccine coverage of 55%, we estimate reductions of 84% in infection and disease in children under 12 months of age. While open questions remain about the drivers of observed lower efficacy in low-income settings, our model suggests RV3-BB could be effective at reducing infection and preventing disease in young infants at the population level.

2022-05-01·The Lancet. Infectious diseases1区 · 医学

Neonatal rotavirus vaccine (RV3-BB) immunogenicity and safety in a neonatal and infant administration schedule in Malawi: a randomised, double-blind, four-arm parallel group dose-ranging study

1区 · 医学

Article

作者: Ong, Darren Suryawijaya ; Justice, Frances ; Mandolo, Jonathan ; Jere, Khuzwayo C ; Iturriza-Gomara, Miren ; Cowley, Daniel ; Boniface, Karen ; Bonnici, Rhian ; Turner, Ann ; Ackland, Jim ; Donato, Celeste M ; Witte, Desiree ; Mpakiza, Ashley ; Bines, Julie E ; Handley, Amanda ; Pavlic, Daniel ; Bogandovic-Sakran, Nada ; Barnes, Graeme ; Bar-Zeev, Naor ; Cunliffe, Nigel A

BACKGROUND:

Rotavirus vaccines reduce rotavirus-related deaths and hospitalisations but are less effective in high child mortality countries. The human RV3-BB neonatal G3P[6] rotavirus vaccine administered in a neonatal schedule was efficacious in reducing severe rotavirus gastroenteritis in Indonesia but had not yet been evaluated in African infants.

METHODS:

We did a phase 2, randomised, double-blind, parallel group dose-ranging study of three doses of oral RV3-BB rotavirus vaccine in infants in three primary health centres in Blantyre, Malawi. Healthy infants less than 6 days of age with a birthweight 2·5 to 4·0 kg were randomly assigned (1:1:1:1) into one of four treatment groups: neonatal vaccine group, which included high-titre (1·0 × 10⁷ focus-forming unit [FFU] per mL), mid-titre (3·0 × 10⁶ FFU per mL), or low-titre (1·0 × 10⁶ FFU per mL); and infant vaccine group, which included high-titre (1·0 × 10⁷ FFU per mL) using a computer generated code (block size of four), stratified by birth (singleton vs multiple). Neonates received their three doses at 0-5 days to 10 weeks and infants at 6-14 weeks. Investigators, participant families, and laboratory staff were masked to group allocation. Anti-rotavirus IgA seroconversion and vaccine take (IgA seroconversion and stool shedding) were evaluated. Safety was assessed in all participants who received at least one dose of vaccine or placebo. The primary outcome was the cumulative IgA seroconversion 4 weeks after three doses of RV3-BB in the neonatal schedule in the high-titre, mid-titre, and low-titre groups in the per protocol population, with its 95% CI. With the high-titre group as the active control group, we did a non-inferiority analysis of the proportion of participants with IgA seroconversion in the mid-titre and low-titre groups, using a non-inferiority margin of less than 20%. This trial is registered at ClinicalTrials.gov (NCT03483116).

FINDINGS:

Between Sept 17, 2018, and Jan 27, 2020, 711 participants recruited were randomly assigned into four treatment groups (neonatal schedule high titre n=178, mid titre n=179, low titre n=175, or infant schedule high titre n=179). In the neonatal schedule, cumulative IgA seroconversion 4 weeks after three doses of RV3-BB was observed in 79 (57%) of 139 participants in the high-titre group, 80 (57%) of 141 participants in the mid-titre group, and 57 (41%) of 138 participants in the low-titre group and at 18 weeks in 100 (72%) of 139 participants in the high-titre group, 96 (67%) of 143 participants in the mid-titre group, and 86 (62%) of 138 of participants in the low-titre. No difference in cumulative IgA seroconversion 4 weeks after three doses of RV3-BB was observed between high-titre and mid-titre groups in the neonatal schedule (difference in response rate 0·001 [95%CI -0·115 to 0·117]), fulfilling the criteria for non-inferiority. In the infant schedule group 82 (59%) of 139 participants had a cumulative IgA seroconversion 4 weeks after three doses of RV3-BB at 18 weeks. Cumulative vaccine take was detected in 483 (85%) of 565 participants at 18 weeks. Three doses of RV3-BB were well tolerated with no difference in adverse events among treatment groups: 67 (39%) of 170 participants had at least one adverse event in the high titre group, 68 (40%) of 172 participants had at least one adverse event in the mid titre group, and 69 (41%) of 169 participants had at least one adverse event in the low titre group.

INTERPRETATION:

RV3-BB was well tolerated and immunogenic when co-administered with Expanded Programme on Immunisation vaccines in a neonatal or infant schedule. A lower titre (mid-titre) vaccine generated similar IgA seroconversion to the high-titre vaccine presenting an opportunity to enhance manufacturing capacity and reduce costs. Neonatal administration of the RV3-BB vaccine has the potential to improve protection against rotavirus disease in children in a high-child mortality country in Africa.

FUNDING:

Bill & Melinda Gates Foundation, Australian Tropical Medicine Commercialisation Grant.

项与 Rotavirus vaccine (Bio-Farma/Murdoch-Childrens-Research-Institute) 相关的新闻（医药）

2024-03-15

·Science Daily

Common viruses trigger most cases of intussusception in children

Viral infections trigger more cases of intussusception, the common cause of bowel blockages in young children, than previously thought, according to a new study. Viral infections trigger more cases of intussusception, the common cause of bowel blockages in young children, than previously thought, according to a new study. The research, led by Murdoch Children's Research Institute (MCRI) and published in Clinical Infectious Diseases, found during the COVID-19 lockdowns hospital admissions for intussusception, a medical emergency involving obstruction of the intestine, among young children significantly decreased. For the study, 12 years of data was analysed across Victoria, NSW and Queensland. A total of 5,589 intussusception cases were recorded between January, 2010 and April, 2022. Of those, 3,179 were children under the age of two. During the lockdown periods, Victoria and NSW experienced a decline in hospital admissions for intussusception among children under two by 62.7 per cent and 40.1 per cent, respectively. The rate of intussusception cases has now returned to normal levels. MCRI and Monash University researcher Dr Ben Townley said the magnitude of the decline supported that common respiratory diseases such as colds, the flu and respiratory syncytial virus (RSV), were behind a significant proportion of intussusception cases. "Reductions in intussusception hospital admissions were seen in all age groups, however most occurred in children less than two years of age," he said. "Intussusception is the leading cause of acute bowel obstruction in infants and young children and without prompt diagnosis and management, can be fatal. "Countries with prolonged COVID-19 lockdowns and suppression strategies saw reductions in common respiratory viruses, which influenced the drop in intussusception admissions." Victoria experienced the greatest lockdown duration, with Melbourne having six lockdown periods, for a total of 263 days. Greater Sydney had 159 days and Brisbane had 18 days in lockdown. MCRI Professor Jim Buttery said the decrease in intussusception cases was greater than expected given previous research into the causes of the condition. "Our analysis found commons viruses play a larger role than previously recognised in triggering intussusception," he said. Infectious triggers were thought to comprise only a minority, about 30 per cent, of cases." Professor Buttery said the findings raised the possibility that emerging vaccines like the new RSV vaccines may help prevent intussusception. "When a new vaccine against common childhood respiratory viruses is introduced, we may find there are some unexpected benefits, like protecting more children from intussusception," he said. We last saw this in 2007, when introducing the rotavirus vaccine against gastroenteritis, also reduced febrile convulsions in young children." Researchers fromSydney Children's Hospital Network, University of Melbourne and Queensland Health also contributed to the findings.

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适应症	最高研发状态	国家/地区	公司	日期
轮状病毒感染	临床3期	印尼	PT Bio Farma	2020-10-22

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研究	分期	人群特征	评价人数	分组	结果	评价	发布日期


NCT03483116 (CTgov)	临床2期	轮状病毒感染	711	Placebo+RV3-BB (High Dose RV3-BB Neonatal Schedule)	遞鑰襯淵膚構簾簾願糧 = 醖網餘艱範構膚簾製構鹽壓衊窪齋窪鏇鹽構築 (鬱齋鏇簾顧壓簾願夢獵, 夢膚齋簾蓋淵網繭夢醖 ~ 壓簾選鹹顧繭築夢夢鹹) 更多	-	2023-07-10
				Placebo+RV3-BB (Mid Dose RV3-BB Neonatal Schedule)	遞鑰襯淵膚構簾簾願糧 = 鏇選築遞蓋夢廠艱淵膚鹽壓衊窪齋窪鏇鹽構築 (鬱齋鏇簾顧壓簾願夢獵, 餘廠願繭網願壓鹽膚鑰 ~ 鹽繭夢艱憲窪觸積鹹積) 更多
NCT03483116 (Pubmed \| Lancet Infect Dis)	临床2期	轮状病毒引起的病毒性胃肠炎	711	Neonatal schedule high-titre RV3-BB vaccine	齋簾構簾網顧鬱襯製蓋(繭糧遞鬱壓憲構願鏇選) = 襯築範鹹築鬱壓選積遞鑰蓋遞鏇構觸積餘網獵 (築蓋鑰壓淵蓋構衊構選 ) 更多	积极	2022-01-20
				Neonatal schedule mid-titre RV3-BB vaccine	齋簾構簾網顧鬱襯製蓋(繭糧遞鬱壓憲構願鏇選) = 遞餘壓衊壓觸膚醖簾鬱鑰蓋遞鏇構觸積餘網獵 (築蓋鑰壓淵蓋構衊構選 ) 更多
ACTRN12612001282875 (Pubmed \| N Engl J Med)	临床2期	轮状病毒感染	1,513	Human Neonatal Rotavirus Vaccine (RV3-BB)RV3-BBNeonatal Rotavirus Vaccine (RV3-BB) (RV3-BB neonatal schedule)	鹽鏇鬱衊蓋齋襯積築齋(膚壓壓夢願製鬱鏇壓糧) = The incidence of adverse events was similar across the groups 鬱鬱願觸餘鹽簾餘鬱選 (鏇膚艱醖鹹積齋築繭願 )	积极	2018-02-22
				Human Neonatal Rotavirus Vaccine (RV3-BB)RV3-BBNeonatal Rotavirus Vaccine (RV3-BB) (RV3-BB infant schedule)