Clara Ejembi

Community mobilization to reduce postpartum hemorrhage in home births in northern Nigeria

The purpose of this study is to demonstrate the importance of community mobilization in the uptake of a health intervention, namely, community-based distribution of misoprostol to prevent postpartum hemorrhage. Community mobilization to increase access to misoprostol for postpartum hemorrhage prevention was implemented in northwestern Nigeria in 2009. Theories of community participation and the current near-epidemic maternal mortality conditions underpin an approach using modest levels of community involvement. The study was undertaken in five communities around Zaria, Nigeria. Community leaders and selected community members participated in a series of dialogs. Additionally, community education, information and dramas sessions were held. Twenty nine community oriented resource persons (CORPs), 27 drug keepers and 41 traditional birth attendants (TBAs) were involved in the intervention. Postpartum interviews were used to assess the impact of community mobilization efforts and to track use of misoprostol. Multiple logistic regression was used to examine the association between correct use and receiving information regarding misoprostol from TBAs or CORPs. A total of 1875 women were enrolled in the study in 2009. Most women delivered at home (95%) and skilled attendance at delivery was low (7%). Community mobilization efforts reached most women with information about postpartum hemorrhage and misoprostol (88%), resulting in high comprehension of intervention messages. Women identified TBAs and CORPs as the single most important source of information about misoprostol 41% and 31% of the time, respectively. Availability of misoprostol at the community level gave 79% of enrolled women some protection against postpartum hemorrhage which they otherwise would not have had. Although high level community participation in health care interventions is the ideal, this study suggests that even in circumstances where only modest levels of participation can realistically be achieved, community mobilization can have a significant impact on the successful distribution and uptake of a potentially life-saving health intervention, in turn helping promote policy change.

Simplified antibiotic regimens compared with injectable procaine benzylpenicillin plus gentamicin for treatment of neonates and young infants with clinical signs of possible serious bacterial infection when referral is not possible: a randomised, open-label, equivalence trial

BACKGROUND WHO recommends hospital-based treatment for young infants aged 0-59 days with clinical signs of possible serious bacterial infection, but most families in resource-poor settings cannot accept referral. We aimed to assess whether use of simplified antibiotic regimens to treat young infants with clinical signs of severe infection was as efficacious as an injectable procaine benzylpenicillin-gentamicin combination for 7 days for situations in which hospital referral was not possible. METHODS In a multisite open-label equivalence trial in DR Congo, Kenya, and Nigeria, community health workers visited all newborn babies at home, identifying and referring unwell young infants to a study nurse. We stratified young infants with clinical signs of severe infection whose parents did not accept referral to hospital by age (0-6 days and 7-59 days), and randomly assigned each individual within these strata to receive one of the four treatment regimens. Randomisation was stratified by age group of infants. An age-stratified randomisation scheme with block size of eight was computer-generated off-site at WHO. The outcome assessor was masked. We randomly allocated infants to receive injectable procaine benzylpenicillin-gentamicin for 7 days (group A, reference group); injectable gentamicin and oral amoxicillin for 7 days (group B); injectable procaine benzylpenicillin-gentamicin for 2 days, then oral amoxicillin for 5 days (group C); or injectable gentamicin for 2 days and oral amoxicillin for 7 days (group D). Trained health professionals gave daily injections and the first dose of oral amoxicillin. Our primary outcome was treatment failure by day 8 after enrolment, defined as clinical deterioration, development of a serious adverse event (including death), no improvement by day 4, or not cured by day 8. Independent outcome assessors, who did not know the infants treatment regimen, assessed study outcomes on days 4, 8, 11, and 15. Primary analysis was per protocol. We used a prespecified similarity margin of 5% to assess equivalence between regimens. This study is registered with the Australian New Zealand Clinical Trials Registry, number ACTRN12610000286044. FINDINGS In Kenya and Nigeria, we started enrolment on April 4, 2011, and we enrolled the necessary number of young infants aged 7 days or older from Oct 17, 2011, to April 30, 2012. At these sites, we continued to enrol infants younger than 7 days until March 29, 2013. In DR Congo, we started enrolment on Sept 17, 2012, and continued until June 28, 2013. We randomly assigned 3564 young infants to either group A (n=894), group B (n=884), group C (n=896), or group D (n=890). We excluded 200 randomly assigned infants, who did not fulfil the predefined criteria of adherence to treatment and adequate follow-up. In the per-protocol analysis, 828 infants were included in group A, 826 in group B, 862 in group C, and 848 in group D. 67 (8%) infants failed treatment in group A compared with 51 (6%) infants in group B (risk difference -1·9%, 95% CI -4·4 to 0·1), 65 (8%) in group C (-0·6%, -3·1 to 2·0), and 46 (5%) in group D (-2·7%, -5·1 to 0·3). Treatment failure in groups B, C, and D was within the similarity margin compared with group A. During the 15 days after random allocation, 12 (1%) infants died in group A, compared with ten (1%) infants in group B, 20 (2%) infants in group C, and 11 (1%) infants in group D. An infant in group A had a serious adverse event other than death (injection abscess). INTERPRETATION The three simplified regimens were as effective as injectable procaine benzylpenicillin-gentamicin for 7 days on an outpatient basis in young infants with clinical signs of severe infection, without signs of critical illness, and whose caregivers did not accept referral for hospital admission. FUNDING Bill & Melinda Gates Foundation grant to WHO.

Oral amoxicillin compared with injectable procaine benzylpenicillin plus gentamicin for treatment of neonates and young infants with fast breathing when referral is not possible: a randomised, open-label, equivalence trial

BACKGROUND WHO recommends referral to hospital for possible serious bacterial infection in young infants aged 0-59 days. We aimed to assess whether oral amoxicillin treatment for fast breathing, in the absence of other signs, is as efficacious as the combination of injectable procaine benzylpenicillin-gentamicin. METHODS In a randomised, open-label, equivalence trial at five sites in DR Congo, Kenya, and Nigeria, community health workers followed up all births in the community, identified unwell young infants, and referred them to study nurses. We randomly assigned infants with fast breathing as a single sign of illness or possible serious bacterial infection, whose parents did not accept referral to hospital, to receive either injectable procaine benzylpenicillin-gentamicin once per day or oral amoxicillin treatment twice per day for 7 days. A person who was off-site generated randomisation lists using computer software. Trained health professionals gave injections, but outcome assessors were masked to group allocations. The primary outcome was treatment failure by day 8 after enrolment, defined as clinical deterioration, development of a serious adverse event including death, persistence of fast breathing on day 4, or recurrence up to day 8. The primary analysis was per protocol and we used a prespecified similarity margin of 5% to assess equivalence between regimens. This study is registered with the Australian New Zealand Clinical Trials Registry, number ACTRN12610000286044. FINDINGS From April 4, 2011, to March 29, 2013, we enrolled 2333 infants aged 0-59 days with fast breathing as the only sign of possible serious bacterial infection at the five study sites. We assigned 1170 infants to receive injectable procaine benzylpenicillin-gentamicin and 1163 infants to receive oral amoxicillin. In the per-protocol analysis, from which 137 infants were excluded, we included 1061 (91%) infants who fulfilled predefined criteria of adherence to treatment and adequate follow-up in the injectable procaine benzylpenicillin-gentamicin group and 1145 (98%) infants in the oral amoxicillin group. In the procaine benzylpenicillin-gentamicin group, 234 infants (22%) failed treatment, compared with 221 (19%) infants in the oral amoxicillin group (risk difference -2·6%, 95% CI -6·0 to 0·8). Four infants died within 15 days of follow-up in each group. We detected no drug-related serious adverse events. INTERPRETATION Young infants with fast breathing alone can be effectively treated with oral amoxicillin on an outpatient basis when referral to a hospital is not possible. FUNDING Bill & Melinda Gates Foundation grant to WHO.

Molecular characterizations of Cryptosporidium, Giardia, and Enterocytozoon in humans in Kaduna State, Nigeria.

The use of molecular diagnostic tools in epidemiological investigations of Cryptosporidium, Giardia, and Enterocytozoon has provided new insights into their diversity and transmission pathways. In this study, 157 stool specimens from 2-month to 70-year-old patients were collected, a polymerase chain reaction (PCR)-restriction fragment length polymorphism (RFLP) analysis of the small subunit (SSU) rRNA gene was used to detect and differentiate Cryptosporidium species, and DNA sequence analysis of the 60 kDa glycoprotein (gp60) gene was used to subtype Cryptosporidium hominis and Cryptosporidium parvum. Giardia duodenalis, and Enterocytozoon bieneusi in the specimens were detected using PCR and sequence analysis of the triosephosphate isomerase (tpi) gene and internal transcribed spacer (ITS), respectively. C. hominis and C. parvum were found in two (1.3%) and one (0.6%) specimen respectively, comprising of Ia and IIe (with 8 nucleotide substitutions) subtype families. The G. duodenalis A2 subtype was detected in five (3.2%) specimens, while four genotypes of E. bieneusi, namely A, type IV, D and WL7 were found in 10 (6.4%) specimens. Children aged two years or younger had the highest occurrence of Cryptosporidium (4.4%) and Enterocytozoon (13.0%) while children of 6 to 17 years had the highest Giardia infection rate (40.0%). No Cryptosporidium, Giardia, and Enterocytozoon were detected in patients older than 60 years. Enterocytozoon had high infection rates in both HIV-positive (3.3%) and HIV-negative (8.3%) patients. Results of the study suggest that anthroponotic transmission may be important in the transmission of Cryptosporidium spp. and G. duodenalis while zoonotic transmissions may also play a role in the transmission of E. bieneusi in humans in Kaduna State, Nigeria.

New global guidance supports community and lay health workers in postpartum hemorrhage prevention

New global guidance has emerged to support countries as they consider introducing or scaling‐up misoprostol for postpartum hemorrhage (PPH). The World Health Organization (WHO) and the International Federation of Gynecology and Obstetrics (FIGO) recognize the critical role that community and lay health workers play in preventing PPH and increasing access to misoprostol where skilled birth attendants are not available. As case examples from Nigeria and Nepal illustrate, community engagement and empowerment are critical strategies in successful misoprostol for PPH programs, and must increasingly be viewed as part of efforts to improve maternal health and achieve Millennium Development Goal 5.

A comparative study of quality of care before and after introduction of National Health Insurance Scheme in health facilities in Zaria, Kaduna State, Northwestern Nigeria

Background: The National Health Insurance Scheme (NHIS) in Nigeria was introduced in 2005 to remove financial barriers to access of care and to improve quality of care. However, since introduction of the scheme, there has not been any documented study to assess whether there has any improvement in quality of care in the participating facilities as a result of its introduction. Objectives: This study was undertaken to determine and compare the quality of care before and after introduction of NHIS in health facilities in Zaria, Kaduna State, Northwestern Nigeria. Materials and Methods: The study was cross-sectional, descriptive, and comparative in design. Using stratified sampling one public and two private NHIS accredited secondary health facilities were selected. Adherence to Federal Ministry of Health performance standards for emergency obstetric care was used as proxy for quality. A retrospective analysis of a total of 320 case notes of female patients that were managed in these facilities for five maternal complications was undertaken, 160 before and 160 after introduction of NHIS. Results: Results showed that quality of care, represented by levels of adherence to standard treatment guidelines, was generally poor (42%). The mean adherence to standards of care levels at facility level of 37.9% before and 46.3% after introduction of NHIS was observed; this difference was statistically significant (P = 0.005), with the public facility performing significantly better, with an adherence level of 59% compared to 30% for private facilities (P = 0.001). Conclusion: The study demonstrated improvement in quality of care following introduction of NHIS in the facilities. Integrating supportive supervision and rapid expansion of the scheme are recommended to widely spread its quality-related benefits.

The role of National Health Insurance Scheme on structural development of health facilities in Zaria, Kaduna State, North Western Nigeria

Background: The National Health Insurance Scheme (NHIS) in Nigeria was introduced in 2005 to ensure universal access to good health care services, by protecting families from financial barriers to health care, and ensuring availability of funds to the health sector for improved services. Since introduction of the scheme, however, there has been no documented study carried out to assess whether there has been any improvement in human resource available for provision of health services and for other basic infrastructure in the participating facilities. Aim: This study was undertaken to assess and compare the funding patterns, and infrastructural and manpower development in health facilities in Zaria, Kaduna State, following the introduction of the NHIS. Materials and Methods: This study was comparative cross-sectional in design. Using stratified sampling technique one public and two private health facilities were selected from 16 secondary health facilities (5 public, 11 private) accredited by the NHIS. Retrospective analysis of data collected from their records on the pattern of funding, the levels of hospital infrastructure, and manpower in the facilities was carried out before and after the introduction of the NHIS. Results: The study demonstrated an almost three-fold increase in financial resources availability to the health facilities following enrolment into the NHIS, with the private facilities having a higher increase (300%) than the publicly owned facility (261%). Funds from the scheme, now constituting up to 36% of the total revenue, accounted for almost half (47%) of the increase. The facilities also witnessed improvement in physical infrastructure, staff strength, and diagnostic capability with variable statistical significance. Conclusion: The study demonstrates that the relationship between financial resource availability and facilities′ staffing, laboratory diagnostic capability, and physical infrastructure is not always linear.

ARTICLE TOPIC SOCIOECONOMIC STATUS OF WOMEN AND IMMUNIZATION STATUS OF UNDER FIVE CHILDREN IN NORTHERN NIGERIA- A CASE STUDY OF POLIOMYELITIS IN KADUNA STATE

E of broadly neutralizing antibodies is a major goal of vaccine development. Antibody identification and immunogen design are two critical components of a rational vaccine design strategy and have become the focus of recent technology development. We demonstrated that next-generation sequencing could capture 106-107 diverse antibody sequences from peripheral blood sample of HIV-1 infected donors, thus enabling an in-depth analysis of somatic population, maturation pathway and lineage intermediates. We further extended the application of this technology, now termed antibodyomics, to the de novo antibody identification. Using a novel evolution-based method, we identified over a dozen of broadly neutralizing VRC01-like antibodies from a HIV-infected individual, C38. Despite their low representation in the sequenced repertoire and low homology to the known VRC-1 like antibodies, these antibodies could potently neutralize ~80% of the HIV-1 isolates. In terms of immunogen design, the concept of “epitope-scaffolds” has been recently advanced as a possible solution and showed some success in the design of epitope-specific antigens. Using a novel protein design technique of transplanting epitope onto heterologous protein scaffolds, we designed over 100 epitope-scaffold immunogens for three major epitopes on the HIV-1 viral spike V1/V2, V3 and MPER. A subset of these designed proteins have been validated experimentally and some showed nanomolar binding affinity for the target broadly neutralizing antibodies, making these promising vaccine candidates. It is foreseeable that the combined use of antibodyomics and protein design will provide a powerful tool for vaccine development for HIV, as well as for other infectious diseases.Jayaprakash Babu and D.N. Rao Dept. of Biochemistry, AIIMS, India Yersin pestis is the causative agent of the most deadly disease plague. F1 & V antigens are the vaccine candidates. We were the fi rst to map the B and T cell epitopes on F1 and V antigen and when we linked B-T and studied humoral, cellular and mucosal immune responses and in vivo protective study during challenge experiments, few B-T constructs showed complete protection as compared to native antigens. In this study, we followed multiple antigen peptide (MAP) approach towards development of sub-unit vaccine in which protective epitopes were assembled on a lysine backbone. MAP was synthesized containing seven peptides of length varying from 15-25 aa on the lysine backbone. Th e authenticity of MAP was verifi ed by amino acid analysis, SDS-PAGE and immunoblot. Palmitate was coupled at the end of amino terminus. MAP was encapsulated in microspheres (polylactide/glycolide beads) and immunized via intranasal with two immunoadjuvants murabutide (MB) and CpG ODN 1826 (CpG), in two strains of mice while humoral and mucosal immune responses were studied till days 120 and memory response was checked by immunizing with native V antigen.Background There is a decrease in vaccine-specific antibody to certain vaccine-preventable diseases in children after chemotherapy, but the frequency of non-immune patients is not clear. In the present case-control study, was taken under investigation protection level to Hepatitis B infection in children 6 months after completing chemotherapy. Materials and Methods In this study 68 patients with cancer and 68 healthy children were enrolled. Patients were 1.5 -12 years old with completed standard chemotherapy at least for 6 months. All the patients and healthy children were negative for HBsAg and HBeAg and had received Hepatitis B vaccination. IgG antibody concentrations against Hepatitis B Virus (HBV) were determined in the patients receiving chemotrapy and healthy subjects serum by ELISA method. IgG antibody titer > 10 mIU/ml was considered as baseline protective titer for preventing HBV infection. Results Anti-HBs antibody titer in 19.12% of patients was less than 10 mIU/ml and 11.76% of the patients had borderline antibody titer (10-20 mIU/ml). In healthy subjects, 2.94% and 5.88% had antibody titer < 10 mIU/ml and 10-20 mIU/ml, respectively. According to statistical analysis, frequency of non immune subjects in children with cancer was significantly higher than those in healthy children (P-value=0.024). Conclusion HBV vaccination post-intensive chemotherapy in the children with cancer is strongly recommended.B dysentery caused by Shigella species, is a major cause of infant morbidity and mortality in developed as well as in developing countries. Now-a-days, we are approaching towards untreatable Shigellosis due to the global emergence of multidrug resistance which is increasing the importance of an anti-dysentery vaccine. Till date no suitable Shigella vaccine is available for public health use. The immune responses against Shigella species are serotype-specific and there are different serotypes of Shigella species which demands an immunization strategy that will include multiple vaccine strains to provide protection against multiple serotypes. In our study, we evaluated the protective efficacy and immune response of heat-killed cocktail form (HKMS) of six Shigella strains (S. dysenteriae 1, S. flexneri 2a, S. flexneri 3a, S. flexneri 6, S. boydii and S. sonnei) in rabbit model. Rabbits were immunized with 107 heat-killed Shigella strains four times with one week interval on 0, 7th, 14th & 21st day and were challenged on the 28th day with 109 organisms of wild type virulent Shigella strains. Immunized rabbits did not develop shigellosis compare to the non-immunized rabbits. Serum IgG and IgA titers showed exponential rise during oral immunization. Antibody in Lymphocyte Supernatant (ALS) assay, Cytokine assay and Immunoblotting against both whole cell lysates and lypopolysaccharide have demonstrated a strong protective immune response following the oral immunization of HKMS; thus justifying the potential of HKMS to become a “non-living” vaccine candidate against shigellosis in our future. Dhrubajyoti Nag, J Vaccines Vaccin 2013, 4:5 http://dx.doi.org/10.4172/2157-7560.S1.018Introduction: Toxoplasma gondii is an obligatory intracellular parasite in different cells of human beings and animals. The aim of this study was to evaluate presence and movement trend of T. gondii tachyzoites in different tissues of Balb/c, after immunization with Excretory Secretory Antigens (ESA). Material and Methods: This experimental survey has been performed on 24 Balb/c mice in case and control groups. For immunization of mice, two times, in intervals of two weeks, case group (n=12) received 40 μL ESA+40 μL Adjuvant and control group got 40 μL PBS+40 μL Adjuvant. Two weeks after the second immunization, mice were challenged with 1×104 alive and the active tachyzoites of T. gondii RH strain and on days 1, 2, 3 and the last day (before death) after challenge, different tissues (eye, muscle, kidney, heart, brain, spleen, blood and liver) of 3 mice from each group were prepared and DNA extraction, parasite load of tissues has been evaluated by real time Q-PCR. Results: Toxoplasma after intraperitoneal injection, in both case and control groups were able to move to various tissues. In the case group receiving Excretory Secretory Antigens (ESA), parasite load in eye, kidney, brain, blood and liver was less than control group. Conclusion: Hence, ESA reduced the parasite load, but could not inhibit the distribution and presence of Toxoplasma in different tissues.D of a potential anticancer therapy is still a challenge to the scientists. Though many different kinds of therapies are developed none of them has lived up to the task to cure cancer completely. Cancer vaccines are found to be the latest discovery in the field of cancer. Although till date only one cancer vaccine is approved by FDA, there are number of vaccines undergoing preclinical & clinical trials which are promising to be an effective anticancer therapy. This article reviews some of the basic aspects of different types of cancer vaccines along with their drawbacks & future development. Novel vaccines produce specific immune responses and objective clinical responses with minimal toxicity in phase I/II trials. Advances in gene transfer technology, tumor immunology and better methods of monitoring specific anti tumor immune responses allow the hope that tumor vaccines will be introduced into the clinic, at least in some malignancies resistant to systemic therapy so far such as melanoma and renal cell carcinoma. The first generation of human cancer vaccines has been tested in phase III clinical trials, but only a few of these have demonstrated sufficient efficacy to be licensed for clinical use. This article reviews some of the mechanisms that could contribute to these limited clinical responses, and highlights the challenges faced for development of future vaccines. Parth B. Patel, J Vaccines Vaccin 2013, 4:5 http://dx.doi.org/10.4172/2157-7560.S1.018I with swine influenza virus (SIV) cause significant economic loss in the pork industry and presents continuous public health concern. Currently used vaccines against SIV are killed and their protection efficiency in the field is limited. Considering a pandemic potential of a novel influenza viruses emerging through the process of genetic reassortment in pigs, the importance of a vaccination is highlighted as the most effective countermeasure. Live attenuated influenza vaccines (LAIV) provide strong, longlived, cell mediated and humoral immunity against different influenza subtypes without the need for perfect antigen matching. Here we report a generation of potential LAIV, an eight segment SIV harbouring two different SIV hemagglutinins (H1 and H3). The chimeric H1H3 HA segment is constructed by fusing the H3 HA ectodomain with the non-coding region, cytoplasmic tail, transmembrane domain and stalk region of NA segment from H1N1 SIV. This H1H3 mutant SIV showed similar kinetics and growth properties to parental wild type virus in vitro when exogenous neuraminidase is provided. However the H1H3 mutant SIV was highly attenuated in pigs, demonstrating the great potential to serve as LAIV with broad protection.