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Dose-finding Trial Paves Way For New Rotavirus Vaccine To Prevent A ...

A phase 2 clinical trial has found that the Australian-developed neonatal rotavirus vaccine RV3-BB was safe and produced a robust immune response in African babies. The immune response generated was similar in the group given a reduced dose of the vaccine compared to the high dose, providing an opportunity to reduce vaccine manufacturing costs.

Rotavirus vaccines reduce rotavirus-related deaths and hospitalisations but are less effective in high child mortality countries. The unique characteristics of RV3-BB, with the first dose given soon after birth, has the potential to make a significant impact on rotavirus diarrhea disease burden in children in Africa and Asia.

Researchers from the Murdoch Children's Research Institute (MCRI), the Malawi Liverpool Wellcome Clinical Research Programme and University of Liverpool have found a reduced dose of an Australian-developed rotavirus vaccine produced a robust immune response in children at risk from deadly diarrheal disease in Africa.

Rotavirus vaccines reduce rotavirus-related deaths and hospitalisations but are less effective in high child mortality countries. Although 114 countries have now introduced a rotavirus vaccine, there are still over 80 million or 45% of children less than 5 years of age that do not receive a rotavirus vaccine.

Developed from a unique neonatal rotavirus strain in Melbourne, the RV3-BB vaccine is given to babies from birth with the potential to improve the level of protection, limit barriers to timely administration and improve the safety of rotavirus vaccines.

The phase 2 clinical trial, published in Lancet Infectious Diseases, was co-led by the Murdoch Institute's Professor Julie Bines and Professor Nigel Cunliffe from the University of Liverpool. It assessed the safety and immune reaction to three different amounts of the RV3-BB vaccine in 711 Malawian infants at birth or in the first weeks of life.

Three doses of the mid-level amount of vaccine produced an equivalent immune response in the babies, as measured in their blood and stool, as the highest dose schedule.

Professor Bines said, "This level of immune response was similar to our Indonesian phase 2b trial, which used the higher dose. In that trial we found 94 per cent of babies that received RV3- BB soon after birth were protected from severe rotavirus diarrhea in the first year of life.

"Our results are hugely encouraging when compared to current World Health Organization prequalified and globally available vaccines. The WHO recommends all children receive a rotavirus vaccine."

Professor Cunliffe said, "While currently used rotavirus vaccines have significantly reduced illness and death from rotavirus disease in Malawi and other African countries with high child mortality, rotavirus is still the leading cause of diarrheal deaths in these settings. Our data from Malawi offer new hope that the RV3-BB neonatal rotavirus vaccine can further reduce the high burden of disease still attributed to this diarrheal pathogen."

Head of Virology at the Malawi Liverpool Wellcome Clinical Research Programme Dr Khuzwayo Jere said, 'It is exciting that the neonatal RV3-BB vaccine was well tolerated in Malawian children in both neonatal and infant schedule when co-administered with Expanded Programme on Immunisation vaccines.

Deputy Director of Global Health at the Bill & Melinda Gates Foundation Dr Duncan Steele said, "Despite being preventable with safe and effective vaccines, rotavirus remains a leading infectious killer of young children worldwide," said Duncan Stelle, Deputy Director of the Enteric Diarrheal Diseases team at the Bill & Melinda Gates Foundation. "It is gratifying to see this neonatal rotavirus vaccine, which was initially developed by Professors Ruth Bishop and Graeme Barnes at Murdoch Children's Research Institute, perform well in an African population with high rotavirus disease burden. These results support those observed in Indonesia and New Zealand showing great promise to reduce the high burden of rotavirus that we still see in Africa and Asia. We are pleased to support the Murdoch Children's Research Institute and the University of Liverpool on this important work."

To make rotavirus vaccine more readily accessible, Murdoch Children's has made RV3-BB available to manufacturers for license to produce vaccines at large scale for an accessible price.

Current licensee, Indonesian vaccine manufacturer PT BioFarma, is conducting a phase 3 clinical trial of RV3-BB in Indonesia with results due to be announced in 2023.

In 2021, Professor Bines was awarded an Australian Museum Eureka Prize, one of the most prestigious awards given to Australian researchers, for her work in developing RV3-BB.

RV3-BB represents a significant scientific and global health achievement. It began four decades ago, when Professor Ruth Bishop discovered rotavirus and led critical work at the Murdoch Children's to understand more about this important virus.

"In 1973, Professor Ruth Bishop led a team of researchers to make one of the most important Australian contributions to global child health," Professor Bines said. "Our aim is to build on this legacy by developing an effective rotavirus vaccine that prevents rotavirus disease from birth for the world's children."

Rotavirus Vaccine - Indications, Dosage, Side Effects And Precautions

Rotavirus Vaccine Medication Information

Discover comprehensive details about Rotavirus Vaccine, including its pronunciation, uses, dosage instructions, indications, and guidelines on how and when to take it or avoid it.

The updated prescription information covers potential side effects, precautions, warnings, and storage recommendations.

Additionally, explore the Rotavirus Vaccine brands available in India and internationally, along with pricing information. For personalized advice, consult your healthcare provider.

Generic Name : Rotavirus Vaccine Pronunciation : ROE-ta-vye-rus VAX-een, lyve ICD Code : Y59.0 Therapeutic Classification : Immunizing Agents Brand Names or Trade Names of Rotavirus Vaccine International : Rotarix, RotaTeq Why is Rotavirus Vaccine Prescribed? (Indications) This medication is a vaccine, prescribed for the prevention of rotavirus gastroenteritis caused by G1 and non-G1 types in infants and children. It helps the immune system to protect against rotavirus. When should Rotavirus Vaccine not be taken? (Contraindications) Contraindicated in patients with uncorrected congenital malformation of the gastrointestinal tract. What is the dosage of Rotavirus Vaccine? The vaccination series consists of two 1-mL doses administered orally. The first dose should be administered to infants beginning at 6 weeks of age. There should be an interval of at least 4 weeks between the first and second dose. The 2-dose series should be completed by 24 weeks of age. How should Rotavirus Vaccine be taken? It comes as a solution to take by mouth. What are the warnings and precautions for Rotavirus Vaccine? • Caution should be exercised in patients with history of gastrointestinal disorders, poor immunity and any allergy.• The healthcare provider should inform the parents or guardians about the possible adverse reactions. What are the side effects of Rotavirus Vaccine? Most Common- Fussiness, irritability, cough, runny nose, fever, vomiting and diarrhea.Serious- Death and intestinal blockage.Blood and Lymphatic- Decrease in platelets and bruising.♦ Gastrointestinal- Blood in the stools and intussusception.General- Maladministration. What are the other precautions for Rotavirus Vaccine? Avoid excess dosage. What are the storage conditions for Rotavirus Vaccine? Vial- Store it in refrigerator (2° to 8°C).Diluent- The diluent may be stored at a controlled room temperature 20° to 25°C. Do not freeze. Discard if the diluent has been frozen.

Rotavirus Vaccine Coverage Remains Lower Than DTaP Vaccine

In addition to sociodemographic factors, preterm birth and older age were associated with lower rotavirus vaccine coverage in infants when compared with the diphtheria-tetanus-acellular pertussis (DTaP) vaccine, according to a study recently published in Pediatrics.

Researchers analyzed data from a large active acute gastroenteritis surveillance system at 7 medical institutions in the United States with large catchment areas to better understand why rotavirus vaccine coverage continues to be lower than that for the DTaP vaccine despite the recommendation to administer both vaccines at the same age-defined healthcare visits.

Data for 10,603 children born after January 1, 2007, were analyzed between December 2014 and June 2016. In 2015, 91% of enrollees in the coverage cohort who were rotavirus-negative initiated rotavirus vaccine, and 97% initiated DTaP vaccine. Roughly 4% of children (341 of 8798) received the first rotavirus vaccine dose at age ≥15 weeks compared with 7.2% (695 of 9641) for the DTaP vaccine (P ≤.001).

Unconditional multivariable logistic regression models revealed that children born between 2013 and 2016 had 5.72 higher odds of rotavirus vaccine initiation and 1.57 higher odds of rotavirus vaccine completion compared with those born between 2007 and 2009 (95% CI, 4.43-7.39 and 1.32-1.88, respectively). Higher maternal education was also associated with higher odds of rotavirus vaccine completion (odds ratio [OR], 1.31; 95% CI, 1.07-1.60).

Researchers found 15% lower odds of rotavirus vaccine initiation with each 1-week increase in infant age at DTaP vaccine initiation (OR, 0.85; 95% CI, 0.80-0.91).

Other factors associated with lower odds of rotavirus vaccine initiation included preterm birth (OR, 0.32; 95% CI, 0.24-0.41), household income between $50,000 and $100,000 (OR, 0.56; 95% CI, 0.40-0.78), and higher maternal education (OR, 0.52; 95% CI, 0.36-0.74).

Factors associated with lower odds of rotavirus vaccine completion included preterm birth (OR, 0.76; 95% CI, 0.62-0.94), African American race (OR, 0.82; 95% CI, 0.70-0.97), and public or no insurance (OR, 0.75; 95% CI, 0.60-0.93).

Findings showed that the rotavirus vaccine age restrictions, which were developed as a result of safety concerns related to intussusception, and vaccination practices in the neonatal intensive care unit contributed to the lower odds of uptake for rotavirus vaccine compared with the DTaP vaccine.

"Whether decreased [rotavirus vaccine] initiation among wealthier parents with higher education is due to vaccine hesitancy, and whether some wealthier families with greater educational attainment (if they do initiate [rotavirus vaccine]) are more likely to complete the series because of greater access to medical care, requires further study," noted the researchers.

Because rotavirus vaccine coverage remains lower than DTaP vaccine, timely DTaP administration may help improve coverage. Moreover, "further exploration of preterm children and socioeconomic factors may aid in developing public health efforts to improve [rotavirus vaccine] coverage in the United States," concluded the authors.

Disclosure: Natasha B. Halasa, MD; Janet A. Englund, MD; David I. Bernstein, MD; and Christopher J. Harrison, MD, disclosed affiliations with pharmaceutical companies. See the reference for complete disclosure information.

Reference

Aliabadi N, Wikswo ME, Tate JE, et al. Factors associated with rotavirus vaccine coverage. Pediatrics. 2019;143(2):e20181824.

This article originally appeared on Infectious Disease Advisor

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