Safety, Reactogenicity, and Immunogenicity of Human Rotavirus Vaccine RIX4414 in Human Immunodeficiency Virus-positive Infants in South Africa

Steele, A. Duncan; Madhi, Shabir А.; Louw, Cheryl; Bos, P.K.; Tumbo, John; Werner, Corne M.; Bicer, Ceyhun; Vos, B. De; Delem, Andrée; Han, Htay Htay

doi:10.1097/inf.0b013e3181f42db9

Cited by 60 publications

(45 citation statements)

References 20 publications

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“…In these studies, the HIV status of children did not affect their ability to mount an immune response to the vaccine, and no significant adverse reactions have been reported (77)(78)(79). A review by Filteau (80) also brings to light the fact that HIV is responsible for significant immune dysfunction, including a reduced ability of HIV-positive pregnant mothers to transfer transplacental antibodies to infants (81,82).…”

Section: Hiv Infection/exposure and Its Implications For Rotavirus Vamentioning

confidence: 99%

Contribution of Maternal Immunity to Decreased Rotavirus Vaccine Performance in Low- and Middle-Income Countries

Mwila

Chilengi

Simuyandi

et al. 2017

Clin Vaccine Immunol

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The role of maternal immunity, received by infants either transplacentally or orally from breast milk, in rotavirus vaccine (RV) performance is evaluated here. Breastfeeding withholding has no effect on vaccine responses, but higher levels of transplacental rotavirus-specific IgG antibody contribute to reduced vaccine seroconversion. The gaps in knowledge on the factors associated with low RV efficacy in low-and middle-income countries (LMIC) remain, and further research is needed to shed more light on these issues. KEYWORDS immunization, low-and middle-income countries, maternal, rotavirus D espite the progress seen with the global introduction of rotavirus vaccines (RV), diarrhea is still a leading cause of death in children under the age of 5 years, and a substantial proportion of disease cases are still attributable to rotavirus infection. The latest estimates show that approximately 215,000 children die each year from rotavirusassociated diarrhea, and approximately 56% of these deaths are in sub-Saharan Africa (1). The World Health Organization (WHO) recommended the introduction of oral RV into national immunization programs (2), and many countries have heeded this call. As of September 2016, the WHO lists 86 countries as having included RV in their national immunization programs, and 6 more are in the course of doing so in 2016 (www.who.int/immunization/monitoring_surveillance/VaccineIntroStatus.pptx). Approximately 50% of the countries in Africa and Asia, over 80% of those in North America, South America, and Australia, and approximately 40% of those in Europe have introduced RV. Following RV introduction, there was a notable reduction in the number of deaths due to diarrhea (1). However, there is consistent evidence from clinical trials that RV have lower efficacies in low-and middle-income countries (LMIC): vaccine efficacies are 80 to 90% in high-income countries (HIC) and 40 to 60% in LMIC (3-8). Indeed, there is growing evidence from vaccine effectiveness studies emerging from the field that in real-life use, vaccine effectiveness is also consistently lower in LMIC (9-12).In addition to the differences in observed vaccine efficacy and effectiveness, there are also marked differences in vaccine-elicited immunity as reported by various vaccine-elicited antibody titers following rotavirus immunization (13)(14)(15)(16)(17)(18). A number of hypotheses have been put forward to explain the differences in efficacy and vaccineelicited immunity between HIC and LMIC. The hypotheses include (i) maternal factors (such as interference from transplacental antibodies and antibody and nonantibody breast milk components [13,[19][20][21][22][23] [38,39]). A better understanding of these factors which decrease the efficacy of RV in LMIC may help to inform interventions to improve efficacy and to further reduce the number of child deaths due to rotavirus disease. This review examines the correlations between maternal immune factors and RV responses and their potential effect on vaccine efficacy. NATURAL ROTAVIRUS...

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Section: Hiv Infection/exposure and Its Implications For Rotavirus Vamentioning

confidence: 99%

Contribution of Maternal Immunity to Decreased Rotavirus Vaccine Performance in Low- and Middle-Income Countries

Mwila

Chilengi

Simuyandi

et al. 2017

Clin Vaccine Immunol

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“…[10] Although the efficacy study on RV was not specifically powered to evaluate for protection in HIV-infected children, the immunogenicity and safety of RV in this group had been established in a separate SA study. [11] Introduction of PCV and RV into the SA public immunisation programme SA was the first country in Africa to introduce PCV and RV into its routine Expanded Programme on Immunization (EPI). PCV-7 was introduced in April 2009, followed by RV in August of the same year.…”

Section: Rationale For Pneumococcal Conjugate Vaccine and Rotavirus Vmentioning

confidence: 99%

Effectiveness of pneumococcal conjugate vaccine and rotavirus vaccine introduction into the South African public immunisation programme

2014

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“…-Live-attenuated human rotavirus vaccine have been studied in HIV infected infants, in clinical stages I and II according to WHO classification, in a three dose schedule starting on 6 to 10 weeks of age. The vaccine was safe and a satisfactory immune response was mounted without aggravating their immunologic or HIV condition (Steele, 2011). Although the data are limited, this vaccine could be considered in HIV infected infants within the routine age range recommended in HIV healthy infants.…”

Section: Vaccinesmentioning

confidence: 99%

Clinical Manifestations of HIV-Infection in the Era of Highly Active Antiretroviral Therapy

Guillén¹,

Prieto²,

Jiménez³

et al. 2011

Microbes, Viruses and Parasites in AIDS Process

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Safety, Reactogenicity, and Immunogenicity of Human Rotavirus Vaccine RIX4414 in Human Immunodeficiency Virus-positive Infants in South Africa

Abstract: : Three doses of RIX4414 vaccine was tolerated well by the South African HIV-positive infants. A satisfactory immune response was mounted without aggravating their immunologic or HIV condition.

Cited by 60 publications

References 20 publications

Contribution of Maternal Immunity to Decreased Rotavirus Vaccine Performance in Low- and Middle-Income Countries

Contribution of Maternal Immunity to Decreased Rotavirus Vaccine Performance in Low- and Middle-Income Countries

Effectiveness of pneumococcal conjugate vaccine and rotavirus vaccine introduction into the South African public immunisation programme

Clinical Manifestations of HIV-Infection in the Era of Highly Active Antiretroviral Therapy

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