Randomized Controlled Clinical Trial of Bivalent Oral Poliovirus Vaccine and Inactivated Poliovirus Vaccine in Nigerian Children.

BACKGROUND: We conducted a trial in Nigeria to assess the immunogenicity of the new bivalent oral poliovirus vaccine + inactivated poliovirus vaccine (bOPV+IPV) immunization schedule and gains in type 2 immunity with addition of second dose of IPV. The trial was conducted in August 2016-March 2017, well past the trivalent OPV-bOPV switch in April 2016. METHODS: This was an open-label, 2-arm, noninferiority, multicenter, randomized, controlled trial. We enrolled 572 infants aged ≤14 days and randomized them into 2 arms. Arm A received bOPV at birth, 6, and 10 weeks, bOPV+IPV at week 14, and IPV at week 18. Arm B received IPV each at 6, 10, and 14 weeks and bOPV at 18 weeks of age. RESULTS: Seroconversion rates for poliovirus types 1 and 3, respectively, were 98.9% (95% confidence interval [CI], 96.7-99.8) and 98.1% (95% CI, 88.2-94.8) in Arm A and 89.6% (95% CI, 85.4-93.0) and 98.5% (95% CI, 96.3-99.6) in Arm B. Type 2 seroconversion with 1 dose IPV in Arm A was 72.0% (95% CI, 66.2-77.3), which increased significantly with addition of second dose to 95.9% (95% CI, 92.8-97.9). CONCLUSIONS: This first trial on the new Expanded Program on Immunization (EPI) schedule in a sub-Saharan African country demonstrated excellent immunogenicity against poliovirus types 1 and 3 and substantial/enhanced immunogenicity against poliovirus type 2 after 1 to 2 doses of IPV, respectively.

Improving the timeliness and completeness of childhood vaccination through color-coded bracelets: a pilot study among Fulani tribe populations in Nigeria.

Background: Childhood immunization remains one of the most cost-effective public health interventions. Globally, millions of children are not being reached with safe and effective vaccines and Nigeria has the highest number of unprotected children. Objective: The effects of locally adapted interventions on vaccination timeliness and completeness were studied amongst Fulani populations across 6 health facilities in 2 districts of Bauchi State, Nigeria. Methods: The intervention group consisted of newborns who received 5-color-coded bracelets representing different immunization contacts, while the control group had no bracelets. Vaccination rates across contacts were followed for 11 months. In addition, mothers of children in the intervention group were voluntarily recruited as peer-to-peer mobilizers (PPM). Results: In this study, 435 children were studied. Vaccination completeness was higher in the intervention group compared to the control group at all contacts during follow-up. The difference was most noticeable at the fifth contact, with 158/256 (62%) children in the intervention group completing, compared to 73/179 (41%) in the control group (P<0.0001). Vaccination timeliness was better in the intervention group compared to the control one, which reached statistical significance at the second and third vaccination contacts (P<0.05). 68% of women volunteered as PPM and recruited 82 additional children for vaccination. Conclusion: This study demonstrated the feasibility of a composite intervention (bracelets and PPM) to increase the completeness and timeliness of childhood immunization and provided preliminary evidence for its efficacy among Fulani populations in Nigeria. Findings from this pilot study should be confirmed through a larger cluster randomized controlled trial.

Combining cluster surveys to estimate vaccination coverage: Experiences from Nigeria's multiple indicator cluster survey / national immunization coverage survey (MICS/NICS), 2016-17.

In 2015 immunization stakeholders in Nigeria were proceeding with plans that would have fielded two nationally representative surveys to estimate vaccination coverage at the same time. Rather than duplicate efforts and generate either conflicting or redundant results, the stakeholders collaborated to conduct a combined Multiple Indicator Cluster Survey (MICS) / National Immunization Coverage Survey (NICS) with MICS focusing on core sampling clusters and NICS adding supplementary clusters in 20 states, to improve precision of outcomes there. This paper describes the organizational and technical aspects of that collaboration, including details on design of the sample supplement and analysis of the pooled dataset. While complicated, the collaboration was successful; it yielded a unified set of relevant coverage estimates and fostered some novel sub-national results dissemination work.

Vaccine wastage in Nigeria: An assessment of wastage rates and related vaccinator knowledge, attitudes and practices.

INTRODUCTION: The introduction of new vaccines highlights concerns about high vaccine wastage, knowledge of wastage policies and quality of stock management. However, an emphasis on minimizing wastage rates may cause confusion when recommendations are also being made to reduce missed opportunities to routinely vaccinate children. This concern is most relevant for lyophilized vaccines without preservatives [e.g. measles-containing vaccine (MCV)], which can be used for a limited time once reconstituted. METHODS: We sampled 54 health facilities within 11 local government areas (LGAs) in Nigeria and surveyed health sector personnel regarding routine vaccine usage and wastage-related knowledge and practices, conducted facility exit interviews with caregivers of children about missed opportunities for routine vaccination, and abstracted vaccine stock records and vaccination session data over a 6-month period to calculate wastage rates and vaccine vial usage patterns. RESULTS: Nearly half of facilities had incomplete vaccine stock data for calculating wastage rates. Among facilities with sufficient data, mean monthly facility-level wastage rates were between 18 and 35% across all reviewed vaccines, with little difference between lyophilized and liquid vaccines. Most (98%) vaccinators believed high wastage led to recent vaccine stockouts, yet only 55% were familiar with the multi-dose vial policy for minimizing wastage. On average, vaccinators reported that a minimum of six children must be present prior to opening a 10-dose MCV vial. Third dose of diphtheria-tetanus-pertussis vaccine (DTP3) was administered in 84% of sessions and MCV in 63%; however, the number of MCV and DTP3 doses administered were similar indicating the number of children vaccinated with DTP3 and MCV were similar despite less frequent MCV vaccination opportunities. Among caregivers, 30% reported being turned away for vaccination at least once; 53% of these children had not yet received the missed dose. DISCUSSION: Our findings show inadequate implementation of vaccine management guidelines, missed opportunities to vaccinate, and lyophilized vaccine wastage rates below expected rates. Missed opportunities for vaccination may occur due to how the health system's contradicting policies may force health workers to prioritize reduced wastage rates over vaccine administration, particularly for multi-dose vials.

Poliovirus seroprevalence before and after interruption of poliovirus transmission in Kano State, Nigeria.

INTRODUCTION: In September 2015, Nigeria was removed from the list of polio-endemic countries after more than 12months had passed since the detection of last wild poliovirus case in the country on 24 July 2014. We are presenting here a report of two polio seroprevalence surveys conducted in September 2013 and October 2014, respectively, in the Kano state of northern Nigeria. METHODS: Health facility based seroprevalence surveys were undertaken at Murtala Mohammad Specialist Hospital, Kano. Parents or guardians of children aged 6-9months, 36-47months, 5-9years and 10-14years in 2013 and 6-9months and 19-22months (corresponding to 6-9months range at the time of 2013 survey) in 2014 presenting to the outpatient department, were approached for participation, screened for eligibility and asked to provide informed consent. A questionnaire was administered and a blood sample collected for polio neutralization assay. RESULTS: Among subjects aged 6-9months in the 2013 survey, seroprevalence was 58% (95% confidence interval [CI] 51-66%) to poliovirus type 1, 42% (95% CI 34-50%) to poliovirus type 2, and 52% (95% CI 44-60%) to poliovirus type 3. Among children 36-47months and older, seroprevalence was 85% or higher for all three serotypes. In 2014, seroprevalence in 6-9month infants was 72% (95% CI 65-79%) for type 1, 59% (95% CI 52-66%) for type 2, and 65% (95% CI 57-72%) for type 3 and in 19-22months, 80% (95% CI 74-85%), 57% (49-63%) and 78% (71-83%) respectively. Seroprevalence was positively associated with history of increasing oral poliovirus vaccine doses. CONCLUSIONS: There was significant improvement in seroprevalence in 2014 over the 2013 levels indicating a positive impact of recent programmatic interventions. However the continued low seroprevalence in 6-9month age is a concern and calls for improved immunization efforts to sustain the polio-free Nigeria.

Survey of poliovirus antibodies in Kano, Northern Nigeria.

INTRODUCTION: In 1988, the World Health Assembly resolved to eradicate poliomyelitis. Since then, much progress towards this goal has been made, but three countries including Nigeria remain polio-endemic as of end 2012. To assess the immunity level against poliomyelitis in young children in Northern Nigeria, we conducted a seroprevalence survey in the Kano Metropolitan Area (KMA) in May 2011. METHODS: Parents or guardians of infants aged 6-9months or children aged 36-47months presenting to the outpatient department of Murtala Mohammad Specialist Hospital were approached for participation, screened for eligibility and were asked to provide informed consent. After that, a questionnaire was administered and blood was collected for neutralization assay. RESULTS: A total of 327 subjects were enrolled. Of these, 313 (96%) met the study requirements and were analyzed (161 [51%] aged 6-9months and 152 [49%] aged 36-47months). Among subjects aged 6-9months, seroprevalence was 81% (95% confidence interval [CI] 75-87%) to poliovirus type 1, 76% (95% CI 68-81%) to poliovirus type 2, and 73% (95% CI 67-80%) to poliovirus type 3. Among subjects aged 36-47months, the seroprevalence was 91% (95% CI 86-95%) to poliovirus type 1, 87% (95% CI 82-92%) for poliovirus type 2, and 86% (95% CI 80-91%) to poliovirus type 3. Seroprevalence was associated with history of oral poliovirus vaccine (OPV) doses, maternal education and gender. CONCLUSIONS: Seroprevalence is lower than required levels for poliovirus interruption in the KMA. Persistence of immunity gaps in the 36-47months group is a big concern. Since higher number of vaccine doses is associated with higher seroprevalence, it implies that failure-to-vaccinate and not vaccine failure accounts for the suboptimal seroprevalence. Intensified efforts are necessary to administer polio vaccines to all target children and surpass the threshold levels for herd immunity.