Comparison of 2 Different Regimens for Reactogenicity, Safety, and Immunogenicity of the Live Attenuated Oral Rotavirus Vaccine RIX4414 Coadministered with Oral Polio Vaccine in South African Infants

Steele, A. Duncan; Reynders, J.; Scholtz, F.; Bos, P.K.; Beer, M.; Tumbo, John; Merwe, C.F. van der; Delem, Andrée; Vos, B. De

doi:10.1086/653550

Cited by 42 publications

(31 citation statements)

References 21 publications

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“…This evidence has been confirmed in the other studies conducted in the same population. 15,16 Peak rotavirus vaccine shedding was seen on Day 7 after Dose 1 of RIX4414 vaccine, which is similar to that reported in a study conducted in healthy infants. 27 The duration of rotavirus antigen excretion in HIV-positive infants appeared to be similar to that observed in healthy infants with prolonged shedding observed in only 1 infant in the RIX4414 vaccine group (rotavirus shedding beyond Day 42 post-Dose 3).…”

Section: Discussionsupporting

confidence: 85%

“…6,10,15 Currently, 2 oral doses of RIX4414 vaccine are administered at 2 and 4 months of age; however, at the time of this study, the number of doses to be administered to infants from low socioeconomic background and of very low age was still under evaluation. 16,17 In addition, if safety was to be evaluated in a developing country setting, the assessment of the longest possible regimen (ie, 3-dose schedule) was critical to consider. Therefore, the present study was conducted in asymptomatic or mildly symptomatic (clinical stages I and II according to WHO classification) 18 HIV-infected infants from South Africa to evaluate the safety, reactogenicity, and immunogenicity of 3 doses of RIX4414 vaccine as compared with placebo, when administered concomitantly with routine vaccines including oral polio vaccine (OPV).…”

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confidence: 99%

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

Steele¹,

Madhi²,

Louw³

et al. 2011

Pediatric Infectious Disease Journal

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Section: Discussionsupporting

confidence: 85%

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confidence: 99%

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

Steele¹,

Madhi²,

Louw³

et al. 2011

Pediatric Infectious Disease Journal

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“…We used an exclusion/dropout rate of 30%, which was the exclusion/dropout rate in another trial (NCT00383903 [23]) conducted in South Africa around the same time period, to estimate the sample sizes of each group. Likewise, we were unable to determine the sample size for the immunogenicity cohort in Malawi from trial NCT00241644 [5, 18].…”

Section: Resultsmentioning

confidence: 99%

Rotavirus Vaccine Schedules and Vaccine Response Among Infants in Low- and Middle-Income Countries: A Systematic Review

Gruber¹,

Gruber

Weber

et al. 2017

Open Forum Infectious Diseases

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Background.Rotavirus vaccine schedules may impact vaccine response among children in low- and middle-income countries (LMICs). Our objective was to review the literature evaluating the effects of monovalent (RV1) or pentavalent rotavirus vaccines schedules on vaccine response.Methods.We searched PubMed, Web of Science, Embase, and ClinicalTrials.gov for eligible trials conducted in LMICs comparing ≥2 vaccine schedules and reporting immunologic response or efficacy. We calculated seroconversion proportion differences and geometric mean concentration (GMC) ratios with 95% confidence intervals.Results.We abstracted data from 8 eligible trials of RV1. The point estimates for seroconversion proportions difference ranged from −0.25 to −0.09 for the 6/10-week schedule compared with 10/14. The range for the 6/10/14- compared with 10/14-week schedule was −0.02 to 0.10. Patterns were similar for GMC ratios and efficacy estimates.Conclusions.The commonly used 6/10-week RV1 schedule in LMICs may not be optimal. Further research on the effect of rotavirus schedules using clinical endpoints is essential.

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“…Administering rotavirus vaccines at younger ages could lower the immunogenicity of the vaccines, because of the potential for greater interference of maternal antibody 20 and enhanced replication of the oral poliovirus vaccine. 22,31,32 It will be important to undertake studies to assess the effectiveness of two doses of rotavirus vaccine administered at earlier ages than those at which they were administered in this study. The WHO's Global Advisory Committee on Vaccine Safety (GACVS) has reviewed the safety of the currently licensed rotavirus vaccines 33,34 and has concluded that in clinical trials of these vaccines, no association was seen between receipt of the vaccines and an increased risk of intussusception.…”

Section: Immunogenicitymentioning

confidence: 99%

Effect of Human Rotavirus Vaccine on Severe Diarrhea in African Infants

et al. 2010

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BackgroundRotavirus is the most common cause of severe gastroenteritis among young children worldwide. Data are needed to assess the efficacy of the rotavirus vaccine in African children. MethodsWe conducted a randomized, placebo-controlled, multicenter trial in South Africa (3166 infants; 64.1% of the total) and Malawi (1773 infants; 35.9% of the total) to evaluate the efficacy of a live, oral rotavirus vaccine in preventing severe rotavirus gastroenteritis. Healthy infants were randomly assigned in a 1:1:1 ratio to receive two doses of vaccine (in addition to one dose of placebo) or three doses of vaccine -the pooled vaccine group -or three doses of placebo at 6, 10, and 14 weeks of age. Episodes of gastroenteritis caused by wild-type rotavirus during the first year of life were assessed through active follow-up surveillance and were graded with the use of the Vesikari scale. Results A total of 4939 infants were enrolled and randomly assigned to one of the three groups; 1647 infants received two doses of the vaccine, 1651 infants received three doses of the vaccine, and 1641 received placebo. Of the 4417 infants included in the per-protocol efficacy analysis, severe rotavirus gastroenteritis occurred in 4.9% of the infants in the placebo group and in 1.9% of those in the pooled vaccine group (vaccine efficacy, 61.2%; 95% confidence interval, 44.0 to 73.2). Vaccine efficacy was lower in Malawi than in South Africa (49.4% vs. 76.9%); however, the number of episodes of severe rotavirus gastroenteritis that were prevented was greater in Malawi than in South Africa (6.7 vs. 4.2 cases prevented per 100 infants vaccinated per year). Efficacy against all-cause severe gastroenteritis was 30.2%. At least one serious adverse event was reported in 9.7% of the infants in the pooled vaccine group and in 11.5% of the infants in the placebo group. Conclusions Human rotavirus vaccine significantly reduced the incidence of severe rotavirus gastroenteritis among African infants during the first year of life. (ClinicalTrials.gov number, NCT00241644.)

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Comparison of 2 Different Regimens for Reactogenicity, Safety, and Immunogenicity of the Live Attenuated Oral Rotavirus Vaccine RIX4414 Coadministered with Oral Polio Vaccine in South African Infants

Abstract: The immune seroconversion response to the RIX4414 vaccine with 3 doses was not superior to the 2-dose regimen. There was no interference by either regimen with antibody response to oral polio vaccine, and RIX4414 was well tolerated when given with routine vaccinations.

Cited by 42 publications

References 21 publications

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

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

Rotavirus Vaccine Schedules and Vaccine Response Among Infants in Low- and Middle-Income Countries: A Systematic Review

Effect of Human Rotavirus Vaccine on Severe Diarrhea in African Infants

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