Injection Of Vaccine Research Articles

Designing an optimization model for the vaccine supply chain during the COVID-19 pandemic

The COVID-19 pandemic has affected people's lives worldwide. Among various strategies being applied to addressing such a global crisis, public vaccination has been arguably the most appropriate approach to control a pandemic. However, vaccine supply chain and management have become a new challenge for governments. In this study, a solution for the vaccine supply chain is presented to address the hurdles in the public vaccination program according to the concerns of the government and the organizations involved. For this purpose, a robust bi-level optimization model is proposed. At the upper level, the risk of mortality due to the untimely supply of the vaccine and the risk of inequality in the distribution of the vaccine is considered. All costs related to the vaccine supply chain are considered at the lower level, including the vaccine supply, allocation of candidate centers for vaccine injection, cost of maintenance and injection, transportation cost, and penalty cost due to the vaccine shortage. In addition, the uncertainty of demand for vaccines is considered with multiple scenarios of different demand levels. Numerical experiments are conducted based on the vaccine supply chain in Kermanshah, Iran, and the results show that the proposed model significantly reduces the risk of mortality and inequality in the distribution of vaccines as well as the total cost, which leads to managerial insights for better coordination of the vaccination network during the COVID-19 pandemic.

A retrospective review of vaccine wastage and associated risk factors in the Littoral region of Cameroon during 2016–2017

BackgroundImmunization is an effective preventive health intervention. In Cameroon, the Expanded Program on Immunization (EPI) aims to vaccinate children under 5 years of age for free, but vaccination coverage has consistently remained below the national target. Vaccines are distributed based on the target population size, factoring in wastage norms. However, the vaccine wastage rate (VWR) may differ among various settings. Our study aimed to assess vaccine wastage for different site settings, seasonality, and vaccine types in comparison to vaccination coverage in order to provide comprehensive insights on vaccine wastage.MethodsA retrospective data collection and analysis were conducted on immunization and vaccine wastage data in the Littoral Region of Cameroon during 2016 and 2017. Health districts were classified as urban or rural, seasonality was categorized as rainy or dry season, and vaccine types were grouped into liquid, lyophilized, oral, and injectable vaccines. VWRs and vaccination coverage rates (VCRs) were calculated, and the vaccine waste factor was investigated.ResultsThe VWR of Bacillus Calmette-Guérin (BCG; 32.19%) was the highest, followed by measles and rubella (MR; 19.05%) and yellow fever (YF; 18.34%) among all EPI vaccines in the Littoral Region of Cameroon during 2016 and 2017. Single-dose vaccine vials exhibited lower VWRs than multi-dose vials. Dry season was associated with higher VWRs for most vaccines, although more lyophilized vaccines (BCG, MR, YF vaccines) were wasted in rainy season in 2016. The VWR was persistently higher in rural than urban health districts. The months of February and November saw a decrease in VCRs. The study found an overall negative correlation between VCR and VWR.ConclusionsMultiple factors may cause wastage of EPI vaccines in Cameroon. Vaccination area characteristics, seasonality, types of vaccines such as multi- or single-dose, lyophilized or injectable vaccines are related to VWRs in Littoral Region. Further research on vaccine wastage and vaccination coverage across Cameroon is needed to better understand the socio-behavioral aspect of vaccine in-take that may affect the level of vaccination and vaccine wastage. Public health system strengthening is warranted to adapt more real-time monitoring of the VWR and VCR for each vaccine in the government’s immunization programs.

Optimization of In Vivo Electroporation Conditions and Delivery of DNA Vaccine Encoding SARS-CoV-2 RBD Using the Determined Protocol.

Vaccination against SARS-CoV-2 and other viral infections requires safe, effective, and inexpensive vaccines that can be rapidly developed. DNA vaccines are candidates that meet these criteria, but one of their drawbacks is their relatively weak immunogenicity. Electroporation (EP) is an effective way to enhance the immunogenicity of DNA vaccines, but because of the different configurations of the devices that are used for EP, it is necessary to carefully select the conditions of the procedure, including characteristics such as voltage, current strength, number of pulses, etc. In this study, we determined the optimal parameters for delivery DNA vaccine by electroporation using the BEX CO device. BALB/c mice were used as a model. Plasmid DNA phMGFP was intramuscular (I/M) injected into the quadriceps muscle of the left hind leg of animals using insulin syringes, followed by EP. As a result of the experiments, the following EP parameters were determined: direct and reverse polarity rectangular DC current in three pulses, 12 V voltage for 30 ms and 950 ms intervals, with a current limit of 45 mA. The selected protocol induced a low level of injury and provided a high level of GFP expression. The chosen protocol was used to evaluate the immunogenicity of the DNA vaccine encoding the receptor-binding domain (RBD) of the SARS-CoV-2 protein (pVAXrbd) injected by EP. It was shown that the delivery of pVAXrbd via EP significantly enhanced both specific humoral and cellular immune responses compared to the intramuscular injection of the DNA vaccine.

Influenza Vaccination in Perioperative Settings: A Teachable Moment.

Influenza Vaccination in Perioperative Settings: A Teachable Moment.

93 Mapping Mobile Health Clinics in Canada: Delivering Equitable Primary Care to Children and Vulnerable Populations

Abstract Background Low-income and racially diverse populations often have multiple barriers in accessing healthcare and are at increased risk of poor health outcomes. COVID-19 exacerbated these health inequities: decreased in-person appointments, difficult access to virtual care and deprioritization of elective clinical activity led to delays in well-child visits and vaccination. This public health emergency highlighted a need to develop alternative models to enable access to primary care for vulnerable children. While mobile clinics are well-established in the United States, little is known about them in Canada. Objectives This study aims to characterize Canadian mobile clinics providing primary care health services to vulnerable populations, including children, and seeks to inform the implementation of a pediatric mobile clinic under development. Design/Methods This environmental scan screened scientific databases and the grey literature using a combination of terms designating mobile health clinics and Canadian locations. Relevant Canadian primary care mobile clinic initiatives were subsequently included. We defined primary care mobile clinics as movable health care units providing primary healthcare services delivered by general medical practitioners (pediatricians and family physicians). Examples of excluded initiatives were mobile clinics focused on education/literacy, dental care, vision care, endocrinology, cancer screening, safe injection sites, vaccination, physical rehabilitation and urgent care. Descriptive statistics and qualitative analysis were performed. Results 29 clinics were identified, of which 26 are still active. Most clinics were located in Ontario (n=11), followed by British Columbia (n=8), Alberta (n=5), Quebec (n=2) and the Maritimes (n=2). The first mobile clinic in Canada was launched in 1996, with an increasing number of new clinics in 2021. While all clinics served vulnerable populations, some targeted specific groups, such as children, people experiencing homelessness, immigrants, LGBTQ+ individuals and Indigenous peoples. We identified three pediatric mobile clinics, two of which targeted teenagers. Onboard the clinics, physicians often worked with nurses, outreach workers and social workers. These professionals provided primary care services, as well as healthcare navigation, sexual education, mental health care, harm reduction supplies, vaccination and emergency care. All mobile clinics partnered with their local government, charities or businesses to fund their initiative. Conclusion Mobile health clinics are a growing model of primary care in Canada. They are the result of a multidisciplinary collaboration between healthcare providers, social workers and outreach workers. To this date, Canadian pediatric mobile clinics remain a handful and represent an interesting avenue to address health inequities in children, during the pandemic and beyond.

Plant-made poliovirus vaccines - Safe alternatives for global vaccination.

Human polioviruses are highly infectious viruses that are spread mainly through the fecal-oral route. Infection of the central nervous system frequently results in irreversible paralysis, a disease called poliomyelitis. Children under five years are mainly affected if they have not acquired immunity through natural infection or via vaccination. Current polio vaccines comprise the injectable inactivated polio vaccine (IPV, also called the Salk vaccine) and the live-attenuated oral polio vaccine (OPV, also called the Sabin vaccine). The main limitations of the IPV are the reduced protection at the intestinal mucosa, the site of virus replication, and the high costs for manufacturing due to use of live viruses. While the OPV is more effective and stimulates mucosal immunity, it is manufactured using live-attenuated strains that can revert into pathogenic viruses resulting in major safety concerns and vaccine-derived outbreaks. During the last fifteen years, plant-based poliovirus vaccines have been explored by several groups as a safe and low-cost alternative, and promising results in protection against challenges with viruses and induction of neutralizing antibodies have been obtained. However, low yields and a high frequency in dose administration highlight the need for improvements in polioviral antigen production. In this review, we provide insights into recent efforts to develop plant-made poliovirus candidates, with an emphasis on strategies to optimize the production of viral antigens.

Vaccine Wastage and its Contributing Factors in Public Health Facilities of Oromia Special Zone, Ethiopia: Explanatory Sequential Mixed Method Design

Background: Although the availability of vaccines is crucial to achieve comprehensive and equitable immunization coverage. This study assessed vaccine wastage and its contributing factors in public health facilities in Ethiopia. Methods: A facility-based explanatory sequential mixed method was used. An institutional-based cross-sectional study design used to assess the vaccine wastage and vaccine cold chain management in all (27) health facilities offering consistence vaccination service and assessed the knowledge and attitude of 127 vaccinators and handlers. Finally, a phenomenological study design was employed among key informants and content analysis was performed using NVivo 11 plus. Results: The overall vaccine wastage rate was 22.9% while the wastage factor was 1.4. The vaccine wastage rate was found highest for Bacillus-Calmette-Guerin (55.2%), 20 dose vials (55.2%), lyophilized (44.7%) and injectable vaccine (26.0%). Only 13 (48.1%) facilities were having satisfactory cold chain infrastructure while 17 (63%) had good cold chain practices.. Distance from Woreda health office (p=0.03) and Ethiopian pharmaceutical supply agency (p=0.02), work experience (p=0.04), level of education (p=<0.001), profession (p=0.001), and attitude (p=0.04) of vaccinators and vaccine handlers were determinants of vaccine wastage. Key informants stated that factors related to logistics, immunization practices, health professional and vaccines were contributing to wastage. Conclusion: Vaccine wastage in health care facilities was above the standard. Large dose vials and opened vial policy were resulted higher wastage and hence, recommended to reduce vial size. Improving the availability of cold chain logistics, supportive supervisions and training were recommended to reduce wastage.

The effect of vaccination beliefs regarding vaccination benefits and COVID-19 fear on the number of vaccination injections.

The Coronavirus disease pandemic of 2019 is a vast worldwide public health hazard, impacting people of all ages and socioeconomic statuses. Vaccination is one of the most effective methods of controlling a pandemic like COVID-19. This study aims to investigate the relationship between the number of vaccination injections and fear of COVID-19 and test whether beliefs benefit from vaccination COVID-19 mediate the effect of fear of COVID-19 on the number of vaccination injections. A total of 649 Vietnamese adults were enrolled online to finish answering, including scales The Health Belief Model (HBM) and The Fear of COVID-19 (FCV-19S), consisting of 340 (52.4%) males and 309 (47.6%) females. The data were analyzed using variance, regression, and a simple mediation model. The total score of COVID-19 fear was M = 22.26, SD = 5.49. Vietnamese fear of COVID-19 was at a medium level. Our results suggest that 18- to 20-year-olds are more fearful of COVID-19 than others. People who received the first dosage exhibited a greater fear of COVID-19 than those who received the second dose and were not inoculated. Additionally, the beliefs benefit of vaccination COVID-19 has a role in the relationship between the number of vaccination injections and fear of COVID-19. During the pandemic, adults in Vietnam are more afraid of COVID-19 than during prior outbreaks. Besides, the Vietnamese populace demonstrated a considerable demand for and high acceptability of the COVID-19 vaccine. The current study indicates that psychological counselors and therapists should counsel clients on the value of vaccination and address the fear of COVID-19 as public understanding of the benefits of vaccines increases. To further clarify the effect of this issue on the correlation between fear of COVID-19 and the number of vaccinations, the results of this study indicate that the existing vaccine communication factor for COVID-19 vaccination should be modified to increase confidence in the benefits of immunization.

Oral vaccination of fish against vibriosis using spore-display technology.

Oral vaccines are highly demanded by the aquaculture sector, to allow mass delivery of antigens without using the expensive and labor-intensive injectable vaccines. These later require individual handling of fish, provoking stress-related mortalities.One possible strategy to create injection-free vaccine delivery vehicles is the use of bacterial spores, extremely resistant structures with wide biotechnological applications, including as probiotics, display systems, or adjuvants. Bacterial spores, in particular those of Bacillus subtilis, have been shown to behave as mucosal vaccine adjuvants in mice models. However, such technology has not been extensively explored against fish bacterial disease.In this study, we used a laboratory strain of B. subtilis, for which a variety of genetic manipulation tools are available, to display at its spores surface either a Vibrio antigenic protein, OmpK, or the green fluorescence protein, GFP. When previously vaccinated by immersion with the OmpK- carrying spores, zebrafish survival upon a bacterial challenge with V. anguillarum and V. parahaemolyticus, increased up to 50 - 90% depending on the pathogen targeted. Further, we were able to detect anti-GFP-antibodies in the serum of European seabass juveniles fed diets containing the GFP-carrying spores and anti-V. anguillarum antibodies in the serum of European seabass juveniles fed the OmpK-carrying spores containing diet. More important, seabass survival was increased from 60 to 86% when previously orally vaccinated with in-feed OmpK- carrying spores. Our results indicate that B. subtilis spores can effectively be used as antigen-carriers for oral vaccine delivery in fish.

Does an Intradermal Vaccination for Monkeypox Make Sense?

Mankind has recently had to deal a series of virus-mediated pandemics, resulting in extensive morbidity and mortality rates that have severely strained healthcare systems. While dealing with viral infections as a healthcare concern is not new, our exceptionally mobile society has added to the critical challenge of limiting pathogen spread of a highly transmissible virus prior to the generation, testing, and distribution of safe and effective vaccines. The tremendous global effort put forth to address the recent pandemic induced by SARS-CoV-2 infection has highlighted many of the strengths and weaknesses of how vaccines are identified, tested, and used to provide protection. These uncertainties are exacerbated by the lack of clear and consistent messaging that can occur when the processes of research, development, and clinical testing that normally requires years of study and consideration are compressed into a few months. In this commentary, I will provide some background on the intramuscular (IM), subcutaneous (SC), and intradermal (ID) administration routes used for injectable vaccines and some information on potential immunological outcomes. With this background, I will address the recent FDA decision to allow an approved vaccine against monkeypox virus to be administered by ID, as well as its initial approval route via SC, injection as a dose-sparing strategy to maximize immunization numbers using current stockpiles.

Evaluating the toxicity of the antiPCSK9 vaccine in the animal model

Abstract Background Proprotein convertase subtilisin/kexin type 9 (PCSK9) inhibition is a novel cholesterol-lowering treatment for decreasing the risk of atherosclerosis. We have previously shown that active immunization using the antiPCSK9 vaccine could decrease hypercholesterolemia and impede the development of atherosclerotic lesions in the experimental model of atherosclerosis. Purpose Here, we intended to evaluate the toxicity of the vaccine in healthy mice. Methods Forty male and female mice were divided into 4 experimental groups, including vaccine female (10 mice) and male (10 mice) groups receiving the antiPCSK9 vaccine as well as corresponding control female (10 mice) and male (10 mice) groups receiving the phosphate buffer. Vaccination was planned based on 4 subcutaneous injections of the vaccine formulation (10 μg/mouse) in bi-weekly intervals. The toxicity study was performed by the sub-acute protocol, 28 days after the last vaccine injection. To this end, the plasma levels of lipid indexes, urea, creatinine, AST, ALT, ALP, and fasting plasma glucose (FPG), as well as the CBC test were measured using commercial kits. To evaluate histopathological alterations, various tissues including the heart, liver, kidneys, spleen, and brain were studied using hematoxylin & eosin (H&E) staining by an expert pathologist. The severity of damage to the tissue was considered based on the standard classification; grade 1 as light damage, grade 2 as moderate damage, grade 3 as the bit-intense damage, and grade 4 as the intense damage. Results The results showed the non-significant changes of total cholesterol, triglyceride, HDL-C, FBS, creatinine, urea, AST, ALP, ALT, and PAB in the vaccinated mice when compared with control mice. However, plasma levels of LDL-C were significantly decreased in vaccinated male (by16.93±2.5 mg/dL, p=0.001) and female mice (by 22±2.7 mg/dL, p=0.001) when compared with corresponding control mice. CBS test indicated that there were no significant changes in the levels of WBC, RBC, HGB, HCT, MCH, MCHC, PLT, LYM, NEUT, PDW, and MPV in the vaccinated mice when compared with control mice. However, the levels of MCV, RDW-SD, and P-LCR were significantly decreased by (4.6±1.2 fL, p=0.02), (4±0.6 fL, p=0.001), and (0.13±0.01%, p=0.001), respectively, in vaccinated male mice when compared with control male mice. Evaluating histopathological alterations in various tissues indicated no significant adverse effects in vaccinated mice when compared to control mice. Conclusions The findings of the present study indicate that the antiPCSK9 is safe and exerts no adverse effects on the function of different organs and blood levels of the cellular and biochemical biomarkers in healthy mice. Funding Acknowledgement Type of funding sources: None.

Immunogenic properties of B. suis 245 strain brucellle culture

The article presents materials of study of antigenic, virulent and immunogenic properties of B. suis 245 strain brucelle culture in a comparative aspect with other vaccine strains in the body of laboratory animals. Transfers were made from the strains B. suis 245, B. abortus 19, 82, B. melitensis Rev-1 on dense nutrient medium after growth of lyophilized cultures of brucellas. A bacteriological study was conducted on meat-pepton glucose-glycerin broth (one test tube per object) and meat-pepton hepatic-glucose-glycerin agar (two test tubes per object) of pathological material (ten objects from each of the test animals). The identification of the isolated cultures of microorganisms was carried out by establishing an agglutination reaction on the glass with S- and R-anti-brucellosis serums. Regardless of the vaccine injection method, all animals that have been vaccinated with the B. suis 245 vaccine have shown resistance to artificial infection with virulent brucellosis. It was noted that in the group of guinea pigs vaccinated with a drug from the B. melitensis Rev-1 strain, resistance to infection was quite high. The protective properties of brucellosis vaccines are monitored in mice 10 days after vaccination. The test animals follow the observation for 7-10 days.

Shoulder injury related to rabies vaccine administration: a case report

Reactions at the vaccine injection site are usually mild and transient. Musculoskeletal symptoms, such as myalgia and arthralgia, are commonly seen following vaccination. Shoulder injury related to vaccine administration (SIRVA), defined as shoulder pain and limited range of motion in the shoulder after intramuscular vaccine administration into the upper arm, may occur due to incorrect vaccine administration. Using the appropriate injection technique in the intramuscular administration of vaccines will reduce the risk of SIRVA. In this paper, we report the clinical and magnetic resonance imaging findings of a 26-year-old female patient presenting with SIRVA after rabies vaccination and discuss this case in light of the current literature.

Clinical status and endoscopy of the upper respiratory tract of dairy calves infected with Bovine viral diarrhea virus 2 and Bovine herpes virus 1 after vaccination and trace minerals injection

The objective was to compare clinical protection [evaluated through health scoring, endoscopy score of the upper respiratory tract (URT-ES), leukocyte count, viremia, and virus shedding in nasal secretions] following Bovine viral diarrhea virus 2 (BVDV2) and Bovine herpes virus 1 (BHV1) challenge among calves submitted to modified-live virus (MLV) booster vaccination (either intranasal or subcutaneous) concurrent with injectable trace minerals (ITM) or saline. Forty-eight dairy calves received an MLV intranasal (IN) vaccine containing BHV1, BRSV, and BPI3V and subcutaneous (SC) ITM (Se, Cu, Zn & Mn; ITM, n = 24) or saline (SAL, n = 24). Ten weeks later, calves received a second dose of ITM, or saline, according to previous groups and were randomly assigned to receive the same IN vaccine [ITM-IN (n = 12), SAL-IN (n = 12)] or a SC MLV vaccine containing BHV1, BRSV, BPI3V, BVDV1 & 2 [ITM-SC (n = 12), SAL-SC (n = 12)]. Additionally, 12 calves did not receive vaccine or treatment and served as a control group (UNVAC, n = 12). Forty-nine days after booster, calves were challenged with BVDV2; and seven days later with BHV1. Health scores indicated disease in UNVAC on days 6, 10 and 12 compared to the vaccinated groups. Unvaccinated calves had the highest URT-ES after BHV1 challenge. Calves that received SC booster had lower URT-ES after BHV1 challenge than UNVAC calves. Calves in ITM-IN had significantly lower URT-ES after BHV1 infection than SAL-IN and UNVAC calves. In conclusion, IN or SC MLV vaccination was similarly effective in protecting calves from BVDV2 + BHV1 challenges (reducing clinical and endoscopy scores, preventing leukopenia, and viremia), compared to unvaccinated calves. Endoscopic evaluation of the URT allowed visualization of the inflammation and damage at multiple depths in the URT caused by a serial BVDV2 + BHV1 challenge. Calves that received SC vaccination had significantly lower URT-ES after BHV1 challenge than the UNVAC calves. Administration of ITM concurrent with IN vaccination was associated with reduced URT inflammation after BVDV2 + BHV1 challenge.

Strong SARS-CoV-2 T-Cell Responses after One or Two COVID-19 Vaccine Boosters in Allogeneic Hematopoietic Stem Cell Recipients.

A full exploration of immune responses is deserved after anti-SARS-CoV-2 vaccination and boosters, especially in the context of allogeneic hematopoietic stem cell transplantation (allo-HSCT). Although several reports indicate successful humoral responses in such patients, the literature is scarce on cellular specific immunity. Here, both B- (antibodies) and T-cell responses were explored after one (V3 n = 40) or two (V4 n = 12) BNT162b2 mRNA vaccine boosters in 52 allo-HSCT recipients at a median of 755 days post-transplant (<1 year n = 9). Results were compared with those of 12 controls who had received only one booster (BNT162b2 n = 6; mRNA-1273 n = 6). All controls developed protective antibody levels (>250 BAU/mL) and anti-spike T-cell responses. Similarly, 81% of the patients developed protective antibody levels, without difference between V3 and V4 (82.5% vs. 75%, p = 0.63), and 85% displayed T-cell responses. The median frequency of anti-spike T cells did not differ either between controls or the whole cohort of patients, although it was significantly lower for V3 (but not V4) patients. COVID-19 infections were solely observed in individuals having received only one booster. These results indicate that four vaccine injections help to achieve a satisfactory level of both humoral and cellular immune protection in allo-HSCT patients.

Myopericarditis in a Male Adolescent Following the Second Shot of COVID-19 Pfizer m-RNA Vaccine: Typical Example and Analysis of 110 Single Case Reports.

One of the most powerful weapons against COVID-19 is vaccines. After the worldwide spread of the disease, m-RNA vaccines were authorized not only in adult patients, but also in children and adolescents aged 12–18. Since then, alarming reports of cases of myocarditis and/or pericarditis have been noted, primarily involving males after the second vaccine shot. A typical example of myopericarditis occurring in an adolescent a few days after the second shot of an m-RNA vaccine is described here. An in-depth review of all 110 single case reports published up to July 2022 with related features and outcomes is also presented. This is the first extensive analysis focused solely on a significant number of single case reports, which have usually been excluded from systematic reviews and meta-analyses carried out in the field. The analysis presented here confirms that most cases occurred in males after the second injection of an m-RNA vaccine. Cases were mild and responsive to the usual medical treatment. What is newly reported is that not only adolescents, but also older people, especially females, were affected by this adverse event.

Effectiveness of parental education about pain in the neonatal period on knowledge, attitudes, and practices: A systematic review and meta-analysis.

Despite the availability of effective, safe, and feasible pain management strategies, infant pain remains undertreated. Parents can play a key role in advocating for or delivering pain management strategies if they are educated. To date, a quantitative synthesis of the effectiveness of parental education about pain management in the neonatal period has not been performed. To systematically review the effectiveness of parental education during the neonatal period on pain management in infancy. MEDLINE, EMBASE, PsycInfo, CINAHL, and the Cochrane Library were searched for relevant randomized controlled trials (RCTs) and non-randomized trials (NRTs) that evaluated parental education with respect to pain management during the neonatal period in any setting from inception to February 2021. Screening of article titles and abstracts and data extraction were performed in duplicate. The risk of bias was assessed using the Cochrane Risk Bias Tool 2.0 and the Risk of Bias in Non-randomized Studies of Interventions for RCTs and NRTs, respectively. As per the GRADE methodology, critically important and important outcomes were identified. Critically important outcomes included utilization of pain management strategies and infant pain. Important outcomes included parental knowledge about pain mitigation strategies, parental attitudes, compliance with painful procedures, procedure outcomes, and safety. Data were combined and presented as relative risk (RR) or mean or standardized mean difference (MD or SMD) with 95% confidence interval (CI). Of the six studies eligible for inclusion, four studies were RCTs and two studies were NRTs. Written information and/or video were used to deliver parental education during the neonatal period in hospital settings in all studies. Four studies (two RCTs and two NRTs) reported on critically important outcomes. The risk of bias was low for the two RCTs and moderate to serious for the two NRTs. Utilization of pain management strategies was assessed for heel lance in the first 48 hours of life in two studies and for vaccine injection at 2 to 6 months of life in two studies. Higher utilization rate for pain management strategies was reported in the pain education group in three studies (RR 1.15, 95% CI 1.04, 1.26; N=2712). There was no difference in the mean number of pain management strategies used in one NRT tracking utilization tracking utilization as continuous data (MD 0.20, 95% CI -0.01, 0.41; N=178). Parent-reported infant pain scores were lower in the pain education group in one RCT (MD -0.16, 95% CI -0.27, -0.06; N=1615). The quality of evidence for the outcome of utilization of pain management strategies was very low while for the outcome of infant pain the quality of evidence was moderate. Five studies (3 RCTs and 2 NRTs) reported on important outcomes. The risk of bias was low for two RCTs and high for one RCT and moderate to serious for the two NRTs. Parental knowledge about pain management strategies (SMD 0.54, 95% CI 0.26, 0.82), parental confidence in their ability to manage pain (SMD 0.24, 95% CI 0.14, 0.34), parental satisfaction with education (MD 1.18, 95% CI 0.84, 1.52) and parental satisfaction with pain management (RR 1.05. 95% CI 1.01, 1.08) were increased in the pain education group. None of the included studies reported on procedural outcomes. No adverse events with the pain education nor the use of pain management interventions were reported in one study. Parental education in the neonatal period was effective in increasing utilization of pain management strategies during painful procedures. Reduction of pain in infants is based on one study of moderate quality. Furthermore, parental education increased parental knowledge about pain management strategies, confidence in their ability to manage infant pain, and satisfaction with the education and pain management. Parental pain education should be incorporated into postnatal care.

Innate cell markers that predict anti-HIV neutralizing antibody titers in vaccinated macaques

SummaryGiven the time and resources invested in clinical trials, innovative prediction methods are needed to decrease late-stage failure in vaccine development. We identify combinations of early innate responses that predict neutralizing antibody (nAb) responses induced in HIV-Env SOSIP immunized cynomolgus macaques using various routes of vaccine injection and adjuvants. We analyze blood myeloid cells before and 24 h after each immunization by mass cytometry using a three-step clustering, and we discriminate unique vaccine signatures based on HLA-DR, CD39, CD86, CD11b, CD45, CD64, CD14, CD32, CD11c, CD123, CD4, CD16, and CADM1 surface expression. Various combinations of these markers characterize cell families positively associated with nAb production, whereas CADM1-expressing cells are negatively associated (p < 0.05). Our results demonstrate that monitoring immune signatures during early vaccine development could assist in identifying biomarkers that predict vaccine immunogenicity.

Mobile for Mothers mHealth Intervention to Augment Maternal Health Awareness and Behavior of Pregnant Women in Tribal Societies: Randomized Quasi-Controlled Study.

BackgroundDespite several initiatives taken by government bodies, disparities in maternal health have been noticeable across India’s socioeconomic gradient due to poor health awareness.ObjectiveThe aim of this study was to implement an easy-to-use mobile health (mHealth) app—Mobile for Mothers (MfM)—as a supporting tool to improve (1) maternal health awareness and (2) maternal health–related behavioral changes among tribal and rural communities in India.MethodsPregnant women, aged 18 to 45 years, were selected from two rural villages of Jharkhand, India: (1) the intervention group received government-mandated maternal care through an mHealth app and (2) the control group received the same government-mandated care via traditional means (ie, verbally). A total of 800 accredited social health activists (ASHAs) were involved, of which 400 were allocated to the intervention group. ASHAs used the MfM app to engage with pregnant women during each home visit in the intervention group. The mHealth intervention commenced soon after the baseline survey was completed in February 2014. The end-line data were collected between November 2015 and January 2016. We calculated descriptive statistics related to demographics and the percentage changes for each variable between baseline and end line per group. The baseline preintervention groups were compared to the end-line postintervention groups using Pearson chi-square analyses. Mantel-Haenszel tests for conditional independence were conducted to determine if the pre- to postintervention differences in the intervention group were significantly different from those in the control group.ResultsAwareness regarding the five cleans (5Cs) in the intervention group increased (P<.001) from 143 (baseline) to 555 (end line) out of 740 participants. Awareness about tetanus vaccine injections and the fact that pregnant women should receive two shots of tetanus vaccine in the intervention group significantly increased (P<.001) from 73 out of 740 participants (baseline) to 372 out of 555 participants (end line). In the intervention group, awareness regarding the fact that problems like painful or burning urination and itchy genitals during pregnancy are indicative of a reproductive tract infection increased (P<.001) from 15 (baseline) to 608 (end line) out of 740 participants. Similarly, knowledge about HIV testing increased (P<.001) from 39 (baseline) to 572 (end line) out of 740 participants. We also noted that the number of pregnant women in the intervention group who consumed the prescribed dosage of iron tablets increased (P<.001) from 193 (baseline) out of 288 participants to 612 (end line) out of 663 participants.ConclusionsmHealth interventions can augment awareness of, and persistence in, recommended maternal health behaviors among tribal communities in Jharkhand, India. In addition, mHealth could act as an educational tool to help tribal societies break away from their traditional beliefs about maternal health and take up modern health care recommendations.Trial RegistrationOSF Registries 9U8D5; https://doi.org/10.17605/OSF.IO/9U8D5

Safety and immunogenicity of the Na-APR-1 hookworm vaccine in infection-naïve adults

BackgroundThe Necator americanus hemoglobinase, aspartic protease-1 (Na-APR-1), facilitates the ability of adult hookworms to parasitize the intestine of their human hosts. A recombinant version of APR-1 protected laboratory animals against hookworm infection by inducing neutralizing antibodies that block the protein’s enzymatic activity and thereby impair blood feeding. A catalytically inactive version of the wild-type hemoglobinase (Na-APR-1(M74)) was expressed by infiltrating Nicotiana benthamiana tobacco plants with an Agrobacterium tumefaciens strain engineered to express the vaccine antigen, which was adjuvanted with aluminum hydroxide adjuvant (Alhydrogel). MethodsAn open-label dose-escalation Phase 1 clinical trial was conducted in 40 healthy, hookworm-naïve adult volunteers in the United States. Participants received 30 or 100 µg of recombinant Na-APR-1(M74) with Alhydrogel or with Alhydrogel co-administered with one of two doses (2.5 or 5.0 µg) of an aqueous formulation of Glucopyranosyl Lipid A (GLA-AF). Intramuscular injections of study vaccine were administered on days 0, 56, and 112. ResultsNa-APR-1(M74)/Alhydrogel was well-tolerated; the most frequent adverse events were mild or moderate injection site tenderness and pain, and mild or moderate nausea and headache. No serious adverse events or adverse events of special interest related to vaccination were observed. Significantly higher levels of antigen-specific IgG antibodies were induced in those who received 100 µg Na-APR-1(M74) than those who received 30 µg of antigen. Adding GLA-AF to Na-APR-1(M74)/Alhydrogel resulted in higher levels of IgG against Na-APR-1(M74) in both the 30 and 100 µg Na-APR-1(M74) groups in comparison to the non-GLA formulations at the same antigen dose. ConclusionsVaccination of hookworm-naïve adults with recombinant Na-APR-1(M74) was well-tolerated, safe, and induced significant IgG responses against the vaccine antigen Na-APR-1(M74). Given these favorable results, clinical trials of this product were initiated in hookworm-endemic areas of Gabon and Brazil.