Equivalent immunogenicity across three RSVpreF vaccine lots in healthy adults 18-49 years of age: Results of a randomized phase 3 study.

BACKGROUND: Bivalent RSV prefusion F subunit vaccine (RSVpreF), comprised of equal quantities of stabilized prefusion F antigens from the major circulating subgroups (RSV A, RSV B), is licensed for prevention of RSV-associated lower respiratory tract illness (LRTI) in older adults and for maternal vaccination for prevention of RSV-associated LRTI in infants. To support licensure and large-scale manufacturing, this lot consistency study was conducted to demonstrate equivalence in immunogenicity across 3 RSVpreF lots. METHODS: This phase 3, multicenter, parallel-group, placebo-controlled, randomized (1:1:1:1), double-blind study evaluated immunogenicity, safety, and tolerability of RSVpreF in healthy 18-49-year-old adults. Participants received a single 120-µg injection of 1 of 3RSVpreF lots or placebo. Geometric mean ratio (GMR) of RSV serum 50 % neutralizing geometric mean titers obtained 1 month after vaccination were compared between each vaccine lot for RSV A and RSV B, separately. Equivalence between lots was defined using a 1.5-fold criterion (GMR 95 % CIs for every lot pair within the 0.667-1.5 interval). Safety and tolerability were assessed. RESULTS: Of 992participants vaccinated, 948 were included in the evaluable immunogenicity population. All 3 RSVpreF lots elicited strong immune responses, meeting the 1.5-fold equivalence criterion for all between-lot comparisons for both RSV A and RSV B. Across the 3 lots, RSV A and RSV B 50 % neutralizing geometric mean titers substantially increased from baseline (RSV A, 1671-1795; RSV B 1358-1429) to 1 month after RSVpreF vaccination (RSV A, 24,131-25,238; RSV B, 19,238-21,702), corresponding to ≥14-fold increases in 50 % neutralizing titers for both RSV A and RSV B from before to 1 month after vaccination. Single doses of RSVpreF were safe and well tolerated, with similar safety profiles across the 3 RSVpreF lots. CONCLUSIONS: These findings support the reproducibility of RSVpreF vaccine manufacturing with similar safety and reactogenicity profiles (NCT05096208).

Evaluation of Intussusception Following Pentavalent Rotavirus Vaccine (RotaTeq) Administration in 5 African Countries.

BACKGROUND: A low-level risk of intussusception following rotavirus vaccination has been observed in some settings and may vary by vaccine type. We examined the association between RotaTeq vaccination and intussusception in low-income settings in a pooled analysis from 5 African countries that introduced RotaTeq into their national immunization program. METHODS: Active surveillance was conducted at 20 hospitals to identify intussusception cases. A standard case report form was completed for each enrolled child, and vaccination status was determined by review of the child's vaccination card. The pseudo-likelihood adaptation of self-controlled case-series method was used to assess the association between RotaTeq administration and intussusception in the 1-7, 8-21, and 1-21 day periods after each vaccine dose in infants aged 28-245 days. RESULTS: Data from 318 infants with confirmed rotavirus vaccination status were analyzed. No clustering of cases occurred in any of the risk windows after any of the vaccine doses. Compared with the background risk of naturally occurring intussusception, no increased risk was observed after dose 1 in the 1-7 day (relative incidence = 2.71; 95% confidence interval [CI] = 0.47-8.03) or the 8-21 day window (relative incidence = 0.77; 95%CI = 0.0-2.69). Similarly, no increased risk of intussusception was observed in any risk window after dose 2 or 3. CONCLUSIONS: RotaTeq vaccination was not associated with increased risk of intussusception in this analysis from 5 African countries. This finding mirrors results from similar analyses with other rotavirus vaccines in low-income settings and highlights the need for vaccine-specific and setting-specific risk monitoring.

Impact of rotavirus vaccine introduction in Abidjan, Côte d'Ivoire.

Côte d'Ivoire introduced rotavirus vaccine in March 2017. Rotavirus surveillance is conducted at Centre Hospitalier Universitaire de Yopougon in Abidjan, the capital city. Children <5 years of age are enrolled in rotavirus surveillance if admitted to the hospital with acute gastroenteritis. We used sentinel surveillance data from 2014 through mid-2019 to compare trends in rotavirus pediatric gastroenteritis hospitalizations before and after rotavirus vaccine introduction. We used Poisson regression to analyze changes in rotavirus prevalence, adjusting for calendar month and accounting for total monthly admissions; January 2014 - December 2016 was considered "pre-vaccine," and January 2017 - June 2019 was considered "post-vaccine." Age distribution and severity were compared between periods using the Mann-Whitney U test. Rotavirus-positive admissions declined 51% (95% CI: 28%-67%), from 31.5% pre-vaccine to 14.9% afterward. The median age of rotavirus-positive children increased from 7 months (interquartile range [IQR]: 5-11) in the pre-vaccine period to 11 months (IQR: 7-18, p = .005) in the post-vaccine period. The median severity score decreased from 11 to 9 (p = .008) among all children, and from 12 pre- to 10.5 post-vaccine (p = .35) among rotavirus-positive children. Our findings suggest that rotavirus vaccine introduction contributed to reduced rotavirus hospitalization in Abidjan and possibly more broadly.

Diversity of rotavirus strains circulating in Haiti before and after introduction of monovalent vaccine.

Background: Haiti introduced a monovalent human group A rotavirus (RVA) vaccine (Rotarix) into its routine infant immunization program in April 2014. The goal of the surveillance program was to characterize RVA strains circulating in Haiti before and after RVA vaccine introduction. Methods: Stool samples were collected from children <5 years old presenting with acute gastroenteritis at 16 hospitals in Haiti. RVA antigen enzyme immunoassay (EIA) testing was performed, and G and P genotypes were determined for positive specimens. In this study, genotype data for samples collected from May 2012 through April 2014 (the pre-vaccine introduction era) and May 2014 through July 2019 (post-vaccine introduction era) were analyzed. Results: A total of 809 specimens were tested by the Centers for Disease Control and Prevention. During the pre-vaccine introduction era (May 2012 through April 2014), G12P[8] was the predominant genotype, detected in 88-94% of specimens. There was a high prevalence of the equine-like G3P[8] genotype among Haitian children with RVA after vaccine introduction. Conclusions: The predominance of equine-like G3P[8] in three of five RVA seasons post-vaccine introduction suggests possible vaccine-specific selection pressure in Haiti. These temporal variations in RVA genotype predominance will require continued monitoring in Haiti as the vaccination program continues.

Acute intestinal intussusception among children under five years of age admitted in an Ouagadougou hospital, Burkina Faso, 2008-2013: epidemiological, clinical and therapeutic aspects.

INTRODUCTION: acute intestinal intussusception is a life-threatening surgical condition. In some settings, rotavirus vaccines have been associated with a low-level increased risk of intussusception. We describe the epidemiology, clinical manifestations and management of intussusception in a tertiary referral hospital in Burkina Faso prior to the introduction of rotavirus vaccine in October 2013. METHODS: we retrospectively reviewed medical records of all children under 5 years of age treated at the Charles de Gaulle Pediatric Hospital for intussusception meeting the Brighton level 1 diagnostic criteria, from October 31st, 2008 to October 30th, 2013. We report the incidence of intussusception as well as descriptive characteristics of these cases. RESULTS: a total of 107 Brighton level 1 intussusception cases were identified, representing a hospital incidence of 21.4 cases / year. There were 69 males and 38 females (sex ratio of 1.8), with a median age of 8 months (range 2 months to 4 years). Sixty-two percent of intussusception cases occurred among infants (n = 67 cases). The average time from symptom onset to seeking medical consultation was 3.8 days +/- 2.7 (range 0 to 14 days). Treatment was mainly surgical (105 patients, 98.1%) with 35 patients (32.7%) undergoing intestinal resection. Thirty-seven patients (35.5%) experienced post-operative complications. The mortality rate was 9.3%. Intestinal resection was a risk factor for death from intussusception. CONCLUSION: in this review of intussusception hospitalizations prior to rotavirus vaccine introduction in Burkina Faso, delays in seeking care were common and were associated with mortality.

Impact of Monovalent Rotavirus Vaccine on Rotavirus Hospitalizations among Children Younger Than 5 Years of Age in the Ouest and Artibonite Departments, Haiti, 2013 to 2019.

Rotavirus is responsible for 26% of diarrheal deaths in Latin America and the Caribbean. Haiti introduced the monovalent rotavirus vaccine in April 2014. The objective of this analysis is to describe the impact of the rotavirus vaccine on hospitalizations among Haitian children younger than 5 years old during the first 5 years after introduction. This analysis includes all children with diarrhea who were enrolled as part of a sentinel surveillance system at two hospitals from May 2013 to April 2019. We compare the proportion of rotavirus-positive specimens in each post-vaccine introduction year to the pre-vaccine period. To account for the potential dilution of the proportion of rotavirus-positive specimens from a waning cholera outbreak, we also analyzed annual trends in the absolute number of positive stools, fit a two-component finite-mixture model to the negative specimens, and fit a negative binomial time series model to the pre-vaccine rotavirus-positive specimens to predict the number of rotavirus diarrhea hospital admissions in the absence of rotavirus vaccination. The overall percentage of rotavirus-positive specimens declined by 22% the first year after introduction, increased by 17% the second year, and declined by 33% to 50% the subsequent 3 years. All sensitivity analyses confirmed an overall decline. We observed a clear annual rotavirus seasonality before and after vaccine introduction, with the greatest activity in December through April, and a biennial pattern, with high sharp peaks and flatter longer periods of increased rotavirus activity in alternating years, consistent with suboptimal vaccination coverage. Overall, our study shows evidence that the introduction of the rotavirus vaccine reduced the burden of severe rotavirus diarrhea.

Effectiveness of monovalent rotavirus vaccine against hospitalizations due to all rotavirus and equine-like G3P[8] genotypes in Haiti 2014-2019.

BACKGROUND: Rotavirus vaccines are effective in preventing severe rotavirus. Haiti introduced 2-dose monovalent (G1P[8]) rotavirus vaccine recommended for infants at 6 and 10 weeks of age in 2014. We calculated the effectiveness of rotavirus vaccine against hospitalization for acute gastroenteritis in Haiti. METHODS: We enrolled children 6-59 months old admitted May 2014-September 2019 for acute watery diarrhea at any sentinel surveillance hospital. Stool was tested for rotavirus using enzyme immunoassay (EIA) and genotyped with multiplex one-step RT-PCR assay and Sanger sequencing for stratification by genotype. We used a case-negative design where cases were children positive for rotavirus and controls were negative for rotavirus. Only children eligible for vaccination were included and a child was considered vaccinated if vaccine was given ≥ 14 days before enrollment. We used unconditional logistic regression to calculate odds ratios and calculated 2-dose and 1-dose vaccine effectiveness (VE) as (1 - odds ratio) * 100. RESULTS: We included 129 (19%) positive cases and 543 (81%) negative controls. Among cases, 77 (60%) were positive for equine-like G3P[8]. Two doses of rotavirus vaccine were 66% (95% CI: 44, 80) effective against hospitalizations due to any strain of rotavirus and 64% (95% CI: 33, 81) effective against hospitalizations due to the equine-like G3P[8] genotype. CONCLUSIONS: These findings are comparable to other countries in the Americas region. To the best of our knowledge, this is the first VE estimate both against the equine-like G3P[8] genotype and from a Caribbean country. Overall, these results support rotavirus vaccine use and demonstrate the importance of complete vaccination.

Cost of pediatric hospitalizations in Burkina Faso: A cross-sectional study of children aged <5 years enrolled through an acute gastroenteritis surveillance program.

INTRODUCTION: Diarrheal illness is a leading cause of hospitalizations among children <5 years. We estimated the costs of inpatient care for rotavirus and all-cause acute gastroenteritis (AGE) in two Burkina Faso hospitals. METHODS: We conducted a cross-sectional study among children <5 years from December 2017 to June 2018 in one urban and one rural pediatric hospital. Costs were ascertained through caregiver interview and chart abstraction. Direct medical, non-medical, and indirect costs per child incurred are reported. Costs were stratified by rotavirus results. RESULTS: 211 children <5 years were included. AGE hospitalizations cost 161USD (IQR 117-239); 180USD (IQR 121-242) at the urban and 154USD (IQR 116-235) at the rural site. Direct medical costs were higher in the urban compared to the rural site (140USD (IQR 102-182) vs. 90USD (IQR 71-108), respectively). Direct non-medical costs were higher at the rural versus urban site (15USD (IQR 10, 15) vs. 11USD (IQR 5-20), respectively). Indirect costs were higher at the rural versus urban site (35USD (IQR 8-91) vs. 0USD (IQR 0-26), respectively). Rotavirus hospitalizations incurred less direct medical costs as compared to non-rotavirus hospitalizations at the rural site (79USD (IQR 64-103) vs. 95USD (IQR 80-118)). No other differences by rotavirus testing status were observed. The total median cost of a hospitalization incurred by households was 24USD (IQR 12-49) compared to 75USD for government (IQR 59-97). Direct medical costs for households were higher in the urban site (median 49USD (IQR 31-81) versus rural (median 14USD (IQR 8-25)). Households in the lowest wealth quintiles at the urban site expended 149% of their monthly income on the child's hospitalization, compared to 96% at the rural site. CONCLUSIONS: AGE hospitalization costs differed between the urban and rural hospitals and were most burdensome to the lowest income households. Rotavirus positivity was not associated with greater household costs.

Does Rotavirus Vaccination Affect Longer-Term Intussusception Risk in US Infants?

Rotavirus vaccination has been associated with a short-term increased risk of intussusception. Our analysis of insurance claims for 1 858 827 US children with 544 recorded cases of intussusception found a nonsignificant decrease in intussusception (hazard ratio, 0.79 [95% confidence interval, 0.57-1.09]) in fully rotavirus-vaccinated children followed up to the age of 2 years.

Multicountry Analysis of Spectrum of Clinical Manifestations of Children <5 Years of Age Hospitalized with Diarrhea.

After introduction of rotavirus vaccine, other pathogens might become leading causes of hospitalizations for severe diarrhea among children <5 years of age. Our study in 33 hospitals in 7 countries found acute gastroenteritis accounted for most (84%) reported hospitalizations of children with diarrhea. Bloody and persistent diarrhea each accounted for <1%.

Global impact of rotavirus vaccine introduction on rotavirus hospitalisations among children under 5 years of age, 2008-16: findings from the Global Rotavirus Surveillance Network.

BACKGROUND: Rotavirus vaccine use in national immunisation programmes has led to declines in hospital admissions for rotavirus gastroenteritis among children; however, the global impact of rotavirus vaccine introduction has not been described using primary data. We describe the impact of rotavirus vaccine introduction on admissions for acute rotavirus gastroenteritis in primarily low-income and middle-income countries, using 9 years of data from the WHO-coordinated Global Rotavirus Surveillance Network (GRSN). METHODS: Between Jan 1, 2008, and Dec 31, 2016, children younger than 5 years of age who were admitted to hospital with acute gastroenteritis were prospectively enrolled in GRSN sites. We included sites that enrolled children and collected stool specimens monthly and tested at least 100 specimens annually in the impact analysis, with a separate analysis taking into account site continuity. We compared proportions of acute gastroenteritis cases positive for rotavirus in the pre-vaccine and post-vaccine periods and calculated mean proportion changes for WHO regions, with 95% CIs; these findings were then compared with interrupted time series analyses. We did further sensitivity analyses to account for rotavirus vaccination coverage levels and sites that collected specimens for at least 11 months per year and tested at least 80 specimens per year. We also analysed the age distribution of rotavirus-positive cases before and after vaccine introduction. FINDINGS: 403 140 children younger than 5 years of age admitted to hospital with acute gastroenteritis from 349 sites in 82 countries were enrolled over the study period, of whom 132 736 (32·9%) were positive for rotavirus. We included 305 789 children from 198 sites in 69 countries in the impact analysis. In countries that had not introduced rotavirus vaccine in their national immunisation programmes, rotavirus was detected in 38·0% (95% CI 4·8-73·4) of admissions for acute gastroenteritis annually whereas in those that have introduced the vaccine, rotavirus was detected in 23·0% (0·7-57·7) of admissions for acute gastroenteritis, showing a 39·6% (35·4-43·8) relative decline following introduction. Interrupted time series analyses confirmed these findings. Reductions by WHO regions ranged from 26·4% (15·0-37·8) in the Eastern Mediterranean Region to 55·2% (43·0-67·4) in the European Region and were sustained in nine countries (contributing up to 31 sites) for 6-10 years. The age distribution of children with rotavirus gastroenteritis shifted towards older children after rotavirus vaccine introduction. INTERPRETATION: A significant and sustained reduction in the proportion of hospital admissions for acute gastroenteritis due to rotavirus was seen among children younger than 5 years in GRSN sites following rotavirus vaccine introduction. These findings highlight the need to incorporate rotavirus vaccines into immunisation programmes in countries that have not yet introduced them and underline the importance of high-quality surveillance. FUNDING: The GRSN receives funding from Gavi, the Vaccine Alliance and the US Centers for Disease Control and Prevention. No specific funding was provided for this Article.

Bilateral choroidal osteoma associated with langerhans cell histiocytosis, a coincidence?

PURPOSE: To describe a case of bilateral choroidal osteoma (CO) in a patient with a history of langerhans cell histiocytosis (LCH). METHODS: A 24-year-old man complaining of gradually decreasing visual acuity in both eyes is presented. He had a history of lymphadenopathy, respiratory symptoms, and pathology-proven diagnosis of LCH. RESULTS: Ophthalmic clinical and imaging studies revealed bilateral CO. CONCLUSION: In this patient, we suggest a possible relationship between LCH and CO.

Factors Associated With Rotavirus Vaccine Coverage.

BACKGROUND: Rotavirus vaccines (RVVs) were included in the US immunization program in 2006 and are coadministered with the diphtheria-tetanus-acellular pertussis (DTaP) vaccine, yet their coverage lags behind DTaP. We assessed timing, initiation, and completion of the RVV series among children enrolled in active gastroenteritis surveillance at 7 US medical institutions during 2014-2016. METHODS: We compared coverage and timing of each vaccine series and analyzed characteristics associated with RVV initiation and completion. We report odds ratios (ORs) and 95% confidence intervals (CIs) from multivariable logistic regression models. RESULTS: We enrolled 10 603 children. In 2015, ≥1 dose coverage was 91% for RVV and 97% for DTaP. Seven percent of children received their first DTaP vaccine at age ≥15 weeks versus 4% for RVV (P ≤ .001). Recent birth years (2013-2016) were associated with higher odds of RVV initiation (OR = 5.72; 95% CI 4.43-7.39), whereas preterm birth (OR = 0.32; 95% CI 0.24-0.41), older age at DTaP initiation (OR 0.85; 95% CI 0.80-0.91), 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) were associated with lower odds. Once RVV was initiated, recent birth years (2013-2016; OR = 1.57 [95% CI 1.32-1.88]) and higher maternal education (OR = 1.31; 95% CI 1.07-1.60) were associated with higher odds of RVV completion, whereas 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) were associated with lower odds. Regional differences existed. CONCLUSIONS: RVV coverage remains lower than that for the DTaP vaccine. Timely DTaP administration may help improve RVV coverage.

Diarrhea-Associated Mortality in Children Less Than 5 Years of Age in the United States, 2005-2016.

Diarrheal disease morbidity decreased after the 2006 US introduction of rotavirus vaccine. We calculated diarrheal death rates for children who were <5 years of age during 2005-2016. Death rates declined from 2.3/100,000 (2005-2006) to 1.7/100,000 (2014-2016). Declines were seen among 1- to 23-month olds, white and black children. Further exploration of the role of rotavirus vaccine in decreasing deaths among children is warranted.

Using surveillance and economic data to make informed decisions about rotavirus vaccine introduction.

While rotavirus vaccines are available, safe, and effective, many countries are not yet widely using these vaccines. Surveillance for rotavirus disease and potential vaccine adverse events is critical for country decision making about rotavirus vaccine. This special issue shares rotavirus and intussusception disease surveillance data and rotavirus vaccine cost-effectiveness analyses from countries that have yet to introduce rotavirus vaccines into their routine infant immunization programs. The studies highlight the substantial burden of rotavirus disease and the cost-effectiveness of rotavirus vaccine in a broad set of countries without rotavirus vaccine in their routine immunization programs.

Rotavirus Vaccination Is Associated With Reduced Seizure Hospitalization Risk Among Commercially Insured US Children.

Rotavirus commonly causes diarrhea but can also cause seizures. Analysis of insurance claims for 1773295 US children with 2950 recorded seizures found that, compared to rotavirus-unvaccinated children, seizure hospitalization risk was reduced by 24% (95% confidence interval [CI], 13%-33%) and 14% (95% CI, 0%-26%) among fully and partially rotavirus-vaccinated children, respectively.

An update from hospital-based surveillance for rotavirus gastroenteritis among young children in Bangladesh, July 2012 to June 2017.

INTRODUCTION: In preparation for the introduction of a rotavirus vaccine into the routine immunization program of Bangladesh in 2018, we report data and highlight evolving genotypes from five years of active hospital-based rotavirus surveillance which began in July 2012. METHODS: We enrolled and collected fresh stool from every fourth child < 5 years admitted with acute gastroenteritis (AGE) at 8 participating surveillance hospitals. Rotavirus infections were detected by enzyme immune assay. Twenty-five percent of rotavirus isolates were genotyped using reverse transcription polymerase chain reaction. RESULTS: We found that 64% (4832/7562) of children < 5 years of age admitted with AGE had evidence of rotavirus infection. The majority (57%) of patients with rotavirus infection were <12 months of age. The most common strains were G1P[8] (43%), G12P[8] (15%) and G9P[8] (9%); 11% of children had mixed infection.G3P[8], which has not been reported in Bangladesh since 2001, was documented for the first time in our surveillance system. CONCLUSIONS: The high burden of rotavirus-associated hospitalizations highlights the potential value of rotavirus vaccination in Bangladesh. Continued surveillance is important for monitoring the impact of vaccination as well as monitoring evolving genotypes.

Rotavirus gastroenteritis surveillance in Azerbaijan, 2011-2016.

INTRODUCTION: Rotavirus is a leading cause of acute gastroenteritis and mortality among children worldwide but data describing rotavirus disease in Azerbaijan are lacking. This analysis describes the rotavirus disease burden in Baku, the largest city in Azerbaijan. METHODS: We conducted active, prospective, sentinel hospital surveillance with laboratory confirmation for rotavirus among children under 5 years of age hospitalized at a large pediatric hospital in Baku during 2011-2016. Children with bloody diarrhea, or prior use of antibiotics or intravenous fluids were excluded. The guardians of enrolled children completed a questionnaire documenting clinical and demographic information. A stool specimen was collected from each enrolled child. We report the number and proportion of rotavirus positive hospitalizations during the surveillance period and a clinical description of rotavirus-positive and rotavirus-negative children. RESULTS: From July 2011 through June 2016, 3139 children <5 years of age were enrolled into the surveillance system. Of these, 523 (17%) were positive for rotavirus, varying from 13% to 21% by surveillance year, with a median of 16% over the surveillance period. Increase in rotavirus detections occurred during December-May. Most rotavirus infections (303/523; 58%) occurred in children aged 6-23 months. CONCLUSION: Rotavirus is responsible for approximately 16% of annual hospital admissions for acute gastroenteritis in children <5 years of age in Baku. This is lower than regional estimates. Exclusion of children with a history of antibiotic use or intravenous fluids may be accounting for this lower prevalence, and expansion of surveillance to include these groups could provide a more comprehensive picture of acute rotavirus gastroenteritis in Baku.

Evidence of the impact of monovalent rotavirus vaccine on childhood acute gastroenteritis hospitalization in Togo.

BACKGROUND: Monovalent rotavirus vaccine (RV1) was introduced in the immunization schedule of Togo in June 2014. We evaluated the impact of rotavirus vaccines on acute gastroenteritis (AGE) and rotavirus-associated hospitalizations in Togolese children. METHODS: Sentinel surveillance for AGE (defined as ≥3 liquid or semi-liquid stools/24 h lasting <7 days) hospitalizations among children <5 years of age was conducted in two sites in the capital city, Lome. ELISA was used for diagnosis of rotavirus infection in children with AGE. Additionally, review of hospitalization registers was performed at five hospitals to assess trends in AGE hospitalizations among children aged <5 years. For the vaccine impact assessment, pre-rotavirus vaccine introduction (July 2010-June 2014) and post-rotavirus vaccine introduction (July 2014-June 2016) periods were compared for annual changes in proportions of hospitalizations associated with AGE and rotavirus. RESULTS: During the pre-vaccine period, sentinel surveillance showed that 1017 patients were enrolled and 57% (range, 53-62%) tested positive for rotavirus, declining to 42% (23% reduction) in the first post-vaccine year and to 26% (53% reduction) in the second post-vaccine year; declines were most marked among infants. The patient register review showed that, compared with pre-vaccine rotavirus seasons, declines in hospitalizations due to all-cause AGE during post-vaccine rotavirus seasons were 48% among <1 year age-group in both first and second years following vaccine introduction. Among 1-4 year olds no reduction was noted in the first year and a 19% decline occurred in the second year. CONCLUSIONS: We report rapid and marked reduction in the number of AGE hospitalizations and the proportion of AGE hospitalizations attributable to rotavirus in the first two years post- RV1 implementation in Togo. It is necessary to monitor long-term vaccine impact on rotavirus disease burden through continued surveillance.

Impact and effectiveness of pentavalent rotavirus vaccine in children <5 years of age in Burkina Faso.

BACKGROUND: Burkina Faso was one of the first African nations to introduce pentavalent rotavirus vaccine (RV5, RotaTeq) into its national immunization program in October 2013. We describe the impact and effectiveness of rotavirus vaccine on acute gastroenteritis (AGE) hospitalizations among Burkinabe children. METHODS: Sentinel hospital-based surveillance for AGE was conducted at four hospitals during December 2013 - February 2017. Demographic, clinical, and vaccination information was collected and stool specimens were tested by EIA. Trends in rotavirus AGE hospitalizations and changes in the proportion of AGE hospitalizations due to rotavirus were examined at two sentinel sites from January 2014 - December 2016. Unconditional logistic regression models using data from all 4 surveillance sites were used to calculate vaccine effectiveness (VE, defined as 1-odds ratio) by comparing the odds of vaccination among rotavirus AGE (cases) and non-rotavirus AGE (controls) patients, controlling for age, season, hospital site and socioeconomic factors. RESULTS: The proportion of AGE hospitalizations that tested positive for rotavirus declined significantly among children <5 years of age, from 36% (154/422) in 2014 to 22% (71/323, 40% reduction, p < .01) in 2015 and 20% (61/298, 44% reduction, p < .01) in 2016. Among infants, the percentage of AGE admissions due to rotavirus fell significantly from 38% (94/250) in 2014 to 21% (32/153, 44% reduction, p < .01) in 2015 and 17% (26/149, 54% reduction, p < .01) in 2016. The adjusted VE for full 3-dose series of RV5 against rotavirus hospitalization was 58% (95% [CI], 10%, 81%) in children 6-11 months of age and 19% (-78%, 63%) in children ≥12 months. CONCLUSION: Rotavirus hospitalizations declined after introduction of pentavalent rotavirus vaccine in children, particularly among infants. RV5 significantly protected against severe rotavirus gastroenteritis in infants, but effectiveness decreased in older children.