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.

A Randomized Trial to Compare the Safety, Tolerability, and Effectiveness of 3 Antimalarial Regimens for the Prevention of Malaria in Nigerian Patients With Sickle Cell Disease.

BACKGROUND: Malaria prophylaxis is recommended for persons with sickle cell disease (SCD), but the value of this has been questioned. The aim of this study was to find out whether intermittent preventive treatment (IPT) with a fixed-dose combination of mefloquine-artesunate (MQAS) or sulfadoxine-pyrimethamine plus amodiaquine (SPAQ) was more effective than daily proguanil for malaria prevention in subjects with SCD. METHODS: Patients with SCD were randomized to receive daily treatment with proguanil or IPT with either MQAS or SPAQ once every 2 months at routine clinic visits. Patients were followed up for 14 months. FINDINGS: A total of 270 patients with SCD were studied, with 90 in each group. Adherence to the IPT regimens was excellent, but 57% of patients took <75% of their daily doses of proguanil. IPT was well tolerated; the most common side effects were vomiting and abdominal pain. Protective efficacy against malaria, compared with daily proguanil, was 61% (95% confidence interval, 3%-84%) for MQAS and 36% (40%-70%) for SPAQ. There were fewer outpatient illness episodes in children who received IPT than those who received proguanil. CONCLUSIONS: IPT with MQAS administered to patients with SCD during routine clinic visits was well tolerated and more effective in preventing malaria than daily prophylaxis with proguanil. CLINICAL TRIALS REGISTRATION: NCT01319448 and ISRCTN46158146.

Otological findings among Nigerian children with sickle cell anaemia.

BACKGROUND/AIM: Various degrees of hearing loss have been associated with sickle cell anaemia, especially of the sensorineural type (SNHL). However, there is little information on hearing pattern among sickle cell children in Nigeria. This study is to determine the prevalence of sensorineural hearing loss (SNHL) among children with sickle cell anaemia (SCA). PATIENTS AND METHODS: Eighty (80) stable children aged 4-15 with Hbss attending the pediatric sickle cell clinic and also 60 control patients with HbAA, matched for age, sex at the pediatric general medical clinic of the University of Ilorin teaching hospital, Ilorin, Nigeria, all had prospective study of their pure tone audiological assessment (PTA) and tympanometric evaluations done over a year period. RESULTS: Their age range was 4-15 years with a mean of 9.4 for the Hbss and 9.7 for the control group. The male/female ratio was 1.3:1 and 1.5:1 for SCA and control subjects respectively. 25 subjects (50 ears) had abnormal audiograms among the SCA subjects and OME was the cause in 22 subjects and only three (3) had mild SNHL which was bilateral. However, in the control group 15 had abnormal audiograms and all were due to OME and none had SNHL. OME was bilateral in 19 subjects with SCA, two on the left and only one on the right. In the control group, 11 of the OME was bilateral and only four were on the left side. The prevalence of SNHL was 3.8% and OME was 27.5%. CONCLUSION: We have found a prevalence rate for SNHL of 3.8% for 80 subjects with HbSS, and all cases have been a mild bilateral high frequency SNHL. Our findings suggested that SNHL is uncommon in early childhood, specifically during the years of language acquisition and early schooling. This could mean an age dependant prevalence rate of SNHL among SCA patients. However, no difference in the incidence of OME among both groups which can lead to educational difficulties from the resultant speech and language defects.