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1.
Beatriz P. Quiambao Cristina Ambas Sherylle Diego Valérie Bosch Castells Joanna Korejwo Céline Petit Guy Houillon 《Vaccine》2019,37(16):2268-2277
Background
Rabies post-exposure prophylaxis (PEP) via intradermal (ID) administration is standard practice in Asia. Accumulating evidence suggests that PEP shortened to 3 visits in one week does not adversely affect seroconversion rates or immune memory.Objective
To determine whether the seroconversion rate at Day14 with a 1-week, 4-site (4-4-4-0-0) ID vaccination regimen with or without rabies immunoglobulin (RIG) was non-inferior to the updated Thai Red Cross (TRC) 28-day, 2-site (2-2-2-0-2) ID regimen with RIG during rabies PEP. We also assessed one-year antibody persistence.Methods
This phase III, mono-center, open-label, randomized-controlled trial assigned participants aged ≤50?years (n?=?600) exposed to suspected rabid animals and sustaining WHO Category II injuries (automatic allocation to G1) or Category III injuries (randomized to G2 or G3) to the following groups (1:1:1 ratio): G1 (n?=?200), 1-week 4-site ID regimen with the purified Vero cell rabies vaccine (PVRV; Verorab®) without RIG; G2 (n?=?201), 1-week 4-site ID regimen with PVRV, and purified equine rabies immunoglobulin (pERIG); G3 (n?=?199), TRC 28-day, 2-site ID regimen with PVRV, and pERIG. Non-inferiority tests compared G1 vs. G3 and G2 vs. G3. Seroconversion rate was the proportion (%) of vaccinees with rabies virus neutralizing antibodies (RVNA) titers ≥0.5?IU/mL measured by rapid fluorescent focus inhibition test.Results
On Day14, after the third vaccine administration, seroconversion rates were non-inferior in both comparisons and were, respectively, 100%, 99.4%, 98.8% in G1, G2, G3 with a decrease to 97.6%, 89%, 79.8% at Year 1. At Day14, RVNA geometric mean titers were 11.3?IU/mL; 9.89?IU/mL; 6.15?IU/mL, respectively, decreasing to 2.96?IU/mL, 1.37?IU/mL, 0.97?IU/mL at Year1. Safety and tolerability were similar between the three groups.Conclusion
The seroconversion rate at Day 14 with the 1-week 4-site ID regimen, both with and without pERIG, was non-inferior to the reference TRC 28-day 2-site ID regimen with pERIG during rabies PEP with PVRV.ClinicalTrials.gov ID: NCT01622062. 相似文献2.
Ilaria Morra Cinzia Ferrara Gabriella Sglavo Anna Sansone Gabriele Saccone Lisa Perriera Costantino Di Carlo 《Contraception》2019,99(3):152-154
Objectives
To compare uterine rupture rates in women having a medical abortion receiving gemeprost alone to those receiving mifepristone plus gemeprost.Study design
We reviewed the records of women undergoing medical abortion at 13 0/7–23 6/7?weeks from January 2007 to December 2014 at a single center in Italy. Prior to January 2011, we used gemeprost 1?mg vaginally every 3?h up to a maximum of five doses. After January 2011, we added mifepristone 200 mg orally 24?h prior to the same gemeprost protocol. The primary outcome of the study was the incidence of uterine rupture. We compared the outcome between women receiving gemeprost alone with the combination of gemeprost and mifepristone.Results
One thousand and sixty-one (58.5%) and 753 (41.5%) women underwent medical abortion in the gemeprost-alone and the gemeprost/mifepristone groups, respectively. Five (0.47%) uterine ruptures occurred in the gemeprost and four uterine ruptures occurred in the gemeprost/mifepristone groups, respectively (0.53%) (p=.89). All uterine ruptures occurred in women with prior cesarean delivery.Conclusions
We rep orted no difference in the incidence of uterine rupture between the gemeprost-alone and gemeprost and mifepristone groups.Implications
Uterine rupture is a rare complication of second-trimester medical abortion with gemeprost. Use of mifepristone prior to gemeprost does not affect this risk. 相似文献3.
Wivine Burny Arnaud Marchant Caroline Hervé Andrea Callegaro Magalie Caubet Laurence Fissette Lien Gheyle Catherine Legrand Cheikh Ndour Fernanda Tavares Da Silva Robbert van der Most Fabienne Willems Arnaud M. Didierlaurent Juan Yarzabal 《Vaccine》2019,37(14):2004-2015
Background
Adjuvants like AS01B increase the immunogenicity of vaccines and generally cause increased transient reactogenicity compared with Alum. A phase II randomized trial was conducted to characterize the response to AS01B and Alum adjuvanted vaccines. A post-hoc analysis was performed to examine the associations between reactogenicity and innate immune parameters.Methods
The trial involved 60 hepatitis B-naïve adults aged 18–45?years randomized 1:1 to receive either two doses of HBsAg-AS01B on Day (D)0 and D30, or three doses of HBsAg-Alum on D0, D30, D180. Prior to vaccination, all subjects received placebo injection in order to differentiate the impact of injection process and the vaccination. Main outcomes included reactogenicity symptoms, vital signs, blood cytokines, biochemical and hematological parameters after vaccination. Associations were explored using linear regression.Findings
The vaccine with AS01B induced higher HBsAg-specific antibody levels than Alum. Local and systemic symptoms were more frequent in individuals who received HBsAg AS01B/Alum vaccine or placebo, but were mild and short-lived. Blood levels of C-reactive protein (CRP), bilirubin, leukocyte, monocyte and neutrophil counts increased rapidly and transiently after AS01B but not after Alum or placebo. Lymphocyte counts decreased in the AS01B group and lactate dehydrogenase levels decreased after Alum. Modelling revealed associations between systemic symptoms and increased levels of CRP and IL-6 after the first HBsAg-AS01B or HBsAg-Alum immunization. Following the second vaccine dose, CRP, IL-6, IP-10, IFN-γ, MIP-1β and MCP-2 were identified as key parameters associated with systemic symptoms. These observations were confirmed using an independent data set extracted from a previous study of the immune response to HBsAg-adjuvanted vaccines (NCT00805389).Conclusions
IL-6 and IFN-γ signals were associated with systemic reactogenicity following administration of AS01B-adjuvanted vaccine. These signals were similar to those previously associated with antibody and T-cell responses induced by HBsAg-adjuvanted vaccines, suggesting that similar innate immune signals may underlie adjuvant reactogenicity and immunogenicity.Trial registration: www.clinicaltrials.gov NCT01777295. 相似文献4.
Aderonke Odutola Martin O.C. Ota Martin Antonio Ezra O. Ogundare Yauba Saidu Patrick K. Owiafe Archibald Worwui Olubukola T. Idoko Olumuyiwa Owolabi Beate Kampmann Brian M. Greenwood Mark Alderson Magali Traskine Kristien Swinnen Vincent Verlant Kurt Dobbelaere Dorota Borys 《Vaccine》2019,37(19):2586-2599
Background
Two conserved pneumococcal proteins, pneumolysin toxoid (dPly) and pneumococcal histidine triad protein D (PhtD), combined with 10 polysaccharide conjugates from the pneumococcal non-typeable Haemophilus influenzae protein D-conjugate vaccine (PHiD-CV) in two investigational pneumococcal vaccine (PHiD-CV/dPly/PhtD) formulations were immunogenic and well-tolerated when administered to Gambian children. Here, we report immunogenicity of the polysaccharide conjugates, and immunogenicity and reactogenicity of co-administered routine vaccines.Methods
In this phase II, controlled, observer-blind, single-centre study, healthy infants aged 8–10?weeks were randomised (1:1:1:1:1:1) to six groups. Four groups received 3+0 schedule (2-3-4?months [M]) of PHiD-CV/dPly/PhtD (10 or 30?µg of each protein), PHiD-CV, or 13-valent pneumococcal conjugate vaccine; and two groups received 2+1 schedule (2-4-9?M) of PHiD-CV/dPly/PhtD (30?µg of each protein) or PHiD-CV. All infants received diphtheria-tetanus-whole cell pertussis-hepatitis B-Haemophilus influenzae type b (DTPw-HBV/Hib) and oral trivalent polio vaccines (OPV) at 2-3-4?M, and measles, yellow fever, and OPV vaccines at 9?M. We evaluated immune responses at 2-5-9-12?M; and reactogenicity 0–3?days post-vaccination.Results
1200 infants were enrolled between June 2011 and May 2012; 1152 completed the study. 1?M post-primary vaccination, for each PHiD-CV serotype except 6B and 23F, ≥97.4% (3+0 schedule) and ≥96.4% (2+1 schedule) of infants had antibody concentrations ≥0.2?μg/mL. Immune responses were comparable between groups within the same vaccination schedules. Observed antibody geometric mean concentrations (GMCs) increased by 1?M post-primary vaccination compared to pre-vaccination. In the following months, GMCs and opsonophagocytic activity titres waned, with an increase post-booster for the 2+1 schedule. Immune responses to protein D and, DTPw-HBV/Hib, OPV, measles, and yellow fever vaccines were not altered by co-administration with pneumococcal proteins. Reactogenicity of co-administered vaccines was comparable between groups and did not raise concerns.Conclusion
Immune responses to the 10 PHiD-CV polysaccharide conjugates and co-administered vaccines were not altered by addition of dPly and PhtD. ClinicalTrials.gov identifier NCT01262872. 相似文献5.
Muriel Feyssaguet Aurélie Bellanger Florence Nozay Damien Friel Estelle Merck Vincent Verlant Michel Malevé Stéphane Lallemand Abdelkarim El Moussaoui Polly De Gorguette D&#x;Argoeuves Tessa Jones David Goldblatt Sonia Schoonbroodt 《Vaccine》2019,37(16):2208-2215
Background
Two electrochemiluminescence (ECL) assays were developed which, together, can simultaneously measure serum antibodies against pneumococcal capsular polysaccharides (PnPS) for 17 serotypes. The assays were validated for the 13 PnPS included in the 13-valent pneumococcal conjugate vaccine (PCV13). As recommended by the World Health Organization (WHO), we compared the ECL assays with the WHO reference enzyme-linked immunosorbent assay (ELISA) and derived a threshold corresponding to the 0.35?µg/mL threshold established for the WHO reference ELISA for the non-inferiority comparison and licensure of new PCVs against invasive pneumococcal disease.Methods
A panel of 452 serum samples from children vaccinated with one of the three licensed PCVs was assessed with the ECL assays and the WHO reference ELISA. The ECL assay threshold for the aggregated seven PnPS included in the 7-valent PCV (PCV7) and serotype-specific thresholds were determined using a receiver operating characteristics (ROC) curve-based approach and Deming regression. To evaluate concordance between the ECL assays and the WHO reference ELISA, serostatus agreement rates between both assays and geometric means of the ratios (GMRs) of concentrations obtained with both assays were calculated.Results
The thresholds for the seven aggregated PCV7 serotypes obtained with the ROC curve-based approach and Deming regression approximated 0.35?µg/mL (0.38 and 0.34?µg/mL, respectively). Individual thresholds for the PCV13 serotypes ranged between 0.24 and 0.51?µg/mL across both approaches. Serostatus agreement rates using a 0.35?µg/mL threshold for both assays were ≥86.9% for all PCV13 serotypes. GMRs ranged between 0.85 and 1.25 for 11/13 serotypes and were <1.29 for the two remaining serotypes.Conclusion
The ECL assays were comparable to the WHO reference ELISA and offer a sensitive, time- and serum volume-saving method to quantify serotype-specific anti-PnPS antibodies in pediatric sera. A 0.35?µg/mL threshold will be used for each PCV13 serotype to assess PCV immunogenicity in clinical trials. 相似文献6.
Stephanie Pepin Martin Dupuy Charissa Fay Corazon Borja-Tabora May Montellano Lulu Bravo Jaime Santos Jo-Anne de Castro Doris Maribel Rivera-Medina Clare Cutland Miguel Ariza Javier Diez-Domingo Celia Diaz Gonzalez Federico Martinón-Torres Efimia Papadopoulou-Alataki Maria Theodoriadou Marie Pierre Kazek-Duret Sanjay Gurunathan Iris De Bruijn 《Vaccine》2019,37(13):1876-1884
Background
A quadrivalent split-virion inactivated influenza vaccine (VaxigripTetra?, Sanofi Pasteur; IIV4) containing two A strains (H1N1 and H3N2) and B strains from both lineages (Victoria and Yamagata) was approved in Europe in 2016 for individuals aged?≥?3?years. This study examined the efficacy and safety of IIV4 in children aged 6–35?months.Methods
This was a phase III randomised controlled trial conducted in Latin America, Asia, Africa, and Europe during the Northern Hemisphere 2014/2015 and 2015/2016 and Southern Hemisphere 2014 and 2015 influenza seasons. Healthy children aged 6–35?months not previously vaccinated against influenza were randomised to receive two full doses 28?days apart of IIV4, placebo, the licensed trivalent split-virion inactivated vaccine (IIV3), an investigational IIV3 containing a B strain from the alternate lineage. The primary objective was to demonstrate efficacy against influenza illness caused by any strain or vaccine-similar strains.Results
The study enrolled 5806 participants. Efficacy, assessed in 4980 participants completing the study according to protocol, was demonstrated for IIV4. Vaccine efficacy was 50.98% (97% CI, 37.36–61.86%) against influenza caused by any A or B type and 68.40% (97% CI, 47.07–81.92%) against influenza caused by vaccine-like strains. Safety profiles were similar for IIV4, placebo, and the IIV3s, although injection-site reactions were slightly more frequent for IIV4 than placebo.Conclusions
IIV4 was safe and effective for protecting children aged 6–35?months against influenza illness caused by vaccine-similar or any circulating strains.Clinical trial registration
EudraCT no. 2013-001231-51. 相似文献7.
Anand Kawade Sudhir Babji Veena Kamath Abhishek Raut Chandra Mohan Kumar Ritabrata Kundu Padmasani Venkatramanan Sanjay K. Lalwani Ashish Bavdekar Sanjay Juvekar Girish Dayma Rakesh Patil Muralidhar Kulkarni Asha Hegde Dinesh Nayak B.S. Garg Subodh Gupta Smita Jategaonkar Prasad S. Kulkarni 《Vaccine》2019,37(19):2554-2560
Background
A lyophilized bovine-human rotavirus reassortant pentavalent vaccine (BRV-PV, Rotasiil®) was licensed in 2016. A liquid formulation of this vaccine (LBRV-PV, Rotasiil - Liquid) was subsequently developed and was tested for non-inferiority to Rotasiil® and for lot-to-lot consistency.Methods
This Phase II/III, open label, randomized study was conducted at seven sites across India from November 2017 to June 2018. Participants were randomized into four arms; Lots A, B, and C of LBRV-PV and Rotasiil® in 1:1:1:1 ratio. Three doses of study vaccines were given at 6, 10, and 14?weeks of age. Blood samples were collected four weeks after the third dose to assess rotavirus IgA antibody levels. Non-inferiority of LBRV-PV to Rotasiil was proven if the lower limit two-sided 95% confidence interval (CI) of geometric mean concentration (GMC) ratio was at least 0.5. Lot-to-lot consistency was proven if 95% CI of the GMC ratios of three lots were between 0.5 and 2. Solicited reactions were collected by using diary cards.Results
Of the 1500 randomized infants, 1436 infants completed the study. The IgA GMC ratio of LBRV-PV to Rotasiil® was 1.19 (95% CI 0.96, 1.48). The corresponding IgA seropositivity rates were 60.41% (57.41, 63.35) and 52.75% (47.48, 57.97). The IgA GMC ratios among the three LBRV-PV lots were: Lot A versus Lot B: 1.34 (1.03, 1.75); Lot A versus Lot C: 1.22 (0.93, 1.60); and Lot B versus Lot C: 0.91 (0.69, 1.19). The 95% CIs for the GMC ratios were between 0.69 and 1.75. The incidence of solicited reactions was comparable across the four arms. Only one serious adverse event of gastroenteritis event in the Rotasiil® group was causally related.Conclusion
The immunological non-inferiority of LBRV-PV against Rotasiil® as well as lot-to-lot consistency of LBRV-PV was demonstrated. LBRV-PV had safety profile similar to Rotasiil®.Trial registration number: Clinical Trials.Gov [NCT03474055] and Clinical Trial Registry of India [CTRI/2017/10/010104]. 相似文献8.
Gillian B. Schivone Klaira Lerma Corinne Montgomery Paul Wright Jennifer A. Conti Paul D. Blumenthal Kate A. Shaw 《Contraception》2019,99(3):148-151
Objective(s)
To compare pain scores during cervical dilator placement prior to dilation and evacuation (D&E) with patient-administered vaginal lidocaine gel versus lidocaine paracervical block (PCB).Study design
We conducted an unblinded randomized trial of women ≥18?years of age undergoing surgical abortion at ≥16?weeks’ gestation in two outpatient clinics. We randomized participants to receive self-administered lidocaine gel 2% 20?mL intravaginally 15–30?min before procedure initiation or lidocaine 1% 12?mL PCB immediately prior to dilator placement. Participants rated their pain at various time points using a visual analog scale (VAS), including anticipated and baseline pain, speculum insertion, tenaculum placement, cervical dilator placement (primary outcome) and speculum removal.Results
We enrolled 72 women and analyzed data for 69 participants. Sociodemographic characteristics and VAS scores at all time points, except for anticipated pain, were similar between groups. The median pain score with dilator placement was 48?mm in the gel group and 61?mm in the PCB group (p=.23). Procedure times for the gel group and PCB group were 3.7?min and 5.2?min, respectively (p<.01). Lidocaine gel was noninferior to PCB for reported pain scores (VAS) with dilator placement, with a difference in means of ?8?mm (95% CI ?21, 5) favoring the gel.Conclusions
Self-administration of lidocaine gel prior to placement of cervical dilators for D&E is noninferior to paracervical lidocaine block for local anesthesia and is a potential alternative to PCB for pain management with osmotic dilator placement.Implications
Lidocaine gel and similar products represent noninvasive, nonpainful methods of local anesthesia for a variety of outpatient gynecologic procedures. Given our noninferiority findings, if gel anesthetics are available, they should be considered as an alternative to paracervical block. 相似文献9.
Carlos Fritzsche Lisa Bergmann Micha Loebermann Aenne Glass Emil C. Reisinger 《Vaccine》2019,37(16):2278-2283
Objectives
The aim of this study was to evaluate the impact of various factors that may influence the immunologic response to hepatitis A mono-vaccine or hepatitis A/B co-vaccine (Twinrix®) in HIV-infected patients.Design
Retrospective cross-sectional study.Methods
HIV positive patients with a full course of hepatitis A vaccine were tested for HAV antibodies. The seroconversion rates were determined, and the influence of several factors including CD4 cell counts, CD4/CD8 ratio, plasma viral load, type of vaccine, and antiretroviral therapy at the time of vaccine, was evaluated.Results
After vaccination, 80.2% of the patients developed anti-HAV antibodies, 81.5% in the mono-vaccine group and 79.2% in the hepatitis A/B co-vaccine group. In the mono-vaccine group, factors significantly associated with a better response to the vaccine were higher CD4 cell count, higher CD4/CD8 ratio, and shorter time interval from vaccine to serological control. In patients who received the hepatitis A/B co-vaccine, younger age and female sex were significantly associated with better vaccine response. Multivariable logistic regression analysis revealed time interval from vaccine to serological control of more than 5?years vs. less than 1?year to be significantly associated with decrease of seroconversion after HAV vaccine.Conclusions
The response to hepatitis A vaccine is impaired in HIV positive patients. HIV patients, at least those older than 30, should be tested for seroconversion after receiving the hepatitis A vaccine. As hepatitis A titers may rapidly decline, control serology during follow-up should be proposed, possibly within two years. However, vaccine type does not play a role in vaccine response. 相似文献10.
Chioma Ndubisi Antoinette Danvers Melanie A. Gold Lisa Morrow Carolyn L. Westhoff 《Contraception》2019,99(3):143-147
Objectives
To assess pain-management using auricular acupuncture as an adjunct to ibuprofen and paracervical block during first trimester uterine aspiration, and to assess auricular acupuncture's effect on anxiety.Study design
This randomized, double-blinded, three-arm trial enrolled women undergoing uterine aspiration for spontaneous or induced abortion. Study participants were randomized 1:1:1 to receive auricular acupuncture, placebo, or usual care alone. Participants in all groups received ibuprofen and paracervical block (usual care). The main outcome was maximum pain reported at the end of the procedure measured using a Visual Analog Scale; we compared those receiving auricular acupuncture to those receiving usual care alone. We also compared auricular acupuncture to placebo and placebo to usual care alone. Finally, we compared the maximum anxiety scores between participants randomized to auricular acupuncture, placebo, and usual care alone.Results
We randomized 153 women over 9 months, and analyzed 52 participants in the auricular acupuncture group, 49 in the placebo group, and 49 in the usual care group. The groups had similar baseline characteristics. After uterine aspiration, participants reported median maximum pain scores as follows: auricular acupuncture 39.5 (interquartile range (IQR) 11, 64.5), placebo 70.0 (IQR 40.5, 84), and usual care alone 71.0 (IQR 32, 91.5) (p<0.01). In pairwise comparisons, the median maximum pain score after auricular acupuncture was lower than placebo and usual-care groups (p<0.01 for both). Post-procedure median anxiety scores were 11.5, 31.0 and 44.0, respectively (p=.01).Conclusions
Women undergoing first trimester uterine aspiration assigned to auricular acupuncture reported substantially less pain and anxiety than women assigned to placebo or usual care.Implications
Auricular acupuncture may be a useful adjunct to ibuprofen and paracervical block during first trimester uterine aspiration. This approach to managing pain and anxiety could avoid the operational complexities and expenses of sedation and opioid use. 相似文献11.
Somesh Kumar Ashish Srivastava Surendra Sharma Vivek Yadav Atul Mittal Young–Mi Kim Angela Nash-Mercado Sijmen A. Reijneveld Bulbul Sood 《Contraception》2019,99(4):212-216
Objective
To evaluate outcomes of a national postpartum (within 48?h of delivery) copper intrauterine device placement (PPCuIUD) program in six “high-focus states” with high unmet family planning need in India.Study design
We identified high-volume district hospitals that provided PPCuIUD in six (Bihar, Jharkhand, Uttar Pradesh, Uttarakhand, Madhya Pradesh and Chhattisgarh) Indian states (two per state). Each selected hospital maintained a list of PPCuIUD acceptors with contact phone numbers. We randomly selected 100 women at each site for inclusion in a telephone survey of IUD outcomes at 1 year. Questions regarded IUD expulsion, discontinuation because of symptoms (e.g., pain, bleeding, discharge), discontinuation for other reasons and use of alternative contraception if discontinuation reported.Results
We could contact 844 of the 1200 randomly selected women, of whom 673 (79.7%) had postplacental insertion (within 10?min of delivery), while 171 (20.3%) had an early postpartum insertion (between 10?min to 48?h after delivery). Of those contacted, 530 women (62.8%) reported continuing with the method beyond 1 year, 63 (7.5%) reported having an expulsion, 163 (19.3%) reported having removals for associated side effects (bleeding, pain and discharge), and 88 (10.4%) reported having removals for other reasons. After removal or expulsion, almost half of the women (46.5%) did not switch to any other modern contraceptive method.Conclusion
PPCuIUD continuation rate at 1?year was 62.8%. Most removals within 1 year were due to associated side effects. Almost half of the women discontinuing PPCuIUD did not switch to an alternative modern contraceptive method.Implications
The 1-year continuation rate of PPCuIUD achieved through a large-scale national program in India is satisfactory. The program though needs to address the low uptake of other modern contraceptive methods after discontinuation. 相似文献12.
Clayton Harro A. Louis Bourgeois David Sack Richard Walker Barbara DeNearing Jessica Brubaker Nicole Maier Alan Fix Len Dally Subhra Chakraborty John D. Clements Ingelise Saunders Michael J. Darsley 《Vaccine》2019,37(14):1978-1986
Background
There is no licensed vaccine against enterotoxigenic Escherichia coli (ETEC), a major cause of diarrhea-associated morbidity and mortality among infants and children in low-income countries and travelers. The results of this vaccination/challenge study demonstrate strong protection by an attenuated ETEC vaccine candidate, ACE527, when co-administered with a mucosal adjuvant, the double-mutant heat-labile toxin (dmLT) of ETEC.Methods
Sixty healthy adults participated in a randomized, placebo-controlled, double-blind study with three doses of lyophilized ACE527 (～3?×?109 of each strain per dose) administered orally with or without dmLT adjuvant (25?µg/dose). Six months later, 36 of these volunteers and a control group of 21 unvaccinated volunteers were challenged with virulent ETEC strain H10407. The primary outcome was severe diarrhea, defined as passing >800?g of unformed stools during the inpatient period following challenge.Findings
The vaccine was well tolerated and induced robust immune responses to key antigens. The protective efficacy (PE) against the primary outcome of severe diarrhea was 65.9% (95% confidence interval [CI] 5.4–87.7, p?=?0.003). Among subjects receiving the adjuvanted vaccine, the attack rate of severe diarrhea was 23.1, while in unimmunized controls it was 67.7%. The PE against diarrhea of any severity was 58.5% (95% CI 3.8– 82.1, p?=?0.016). There was a strong inverse correlation between shedding of the vaccine strain after either of the first two doses and absence of severe diarrhea upon challenge (RR?=?0.29, 95% CI 0.08–1.05, p?=?0.041). Challenge strain shedding was 10-fold lower in those receiving the adjuvant than in those receiving vaccine alone. The unadjuvanted vaccine was not protective (PE?=?23.1%).Interpretation
The results of this study support further development of ACE527?+?dmLT as a vaccine for children in endemic countries and travelers. This is the first clinical demonstration that dmLT can contribute significantly to vaccine efficacy and may warrant testing with other oral vaccines.(ClinicalTrials.gov registration: NCT01739231). 相似文献13.
Objective
To evaluate which characteristics collected at the point of abortion are associated with contraceptive use over the extended postabortion period for women in Cambodia.Methods
The study includes a cohort of 500 women who attended a Marie Stopes International Cambodia clinic for an induced abortion. The primary outcomes are use of effective contraception ≥80% of the time over the 4- and 12-month period postabortion. We conducted a bivariate analysis to assess the association between each characteristic and the outcome, followed by multivariable modeling to identify the strongest predictors of the outcomes.Results
Nearly 44% of the women used contraception for more than 80% of the time during both follow-up periods. Several sociodemographic and reproductive factors were crudely associated with the outcomes. In the multivariable model, prior use of contraception, intention to use postabortion contraception, increased number of children and medical abortion were associated with increased contraceptive use over the year postabortion. Occupation was a predictor at 4 months only, and abortion method was a predictor at 12?months only.Conclusions
The models were satisfactory in predicting the outcome of contraceptive continuation both at 4 and 12?months. The paper sets out a methodology for modeling these predictors that can help inform more client-centered counseling and services for women.Implications
Factors known when attending a clinic for induced abortion can help inform more targeted and client-centered postabortion family planning counseling and services for women in Cambodia. 相似文献14.
Natasha S. Crowcroft Kevin L. Schwartz Cynthia Chen Caitlin Johnson Ye Li Alex Marchand-Austin Shelly Bolotin Frances B. Jamieson Steven J. Drews Margaret L. Russell Lawrence W. Svenson Kimberley Simmonds Salaheddin M Mahmud Jeffrey C. Kwong 《Vaccine》2019,37(19):2617-2623
Background
Resurgences of pertussis have occurred in several high-income countries, often linked to waning of immunity from acellular pertussis vaccines. The degree of waning observed has varied by study design and setting. In Ontario, pertussis has not shown a substantial resurgence in the past decade. The routine immunization schedule comprises three priming doses in infancy, toddler and pre-school doses, and an adolescent dose at 14–16?years of age.Methods
We estimated pertussis vaccine effectiveness (VE) through a case-control study of 1335 cases statutorily reported to public health in Ontario and occurring between January 1, 2009 and March 31, 2015, compared with 5340 randomly selected population controls, frequency-matched by age, primary-care provider and year of diagnosis. Pertussis cases met provincial confirmed or probable case definitions. We used multivariable logistic regression to estimate crude and adjusted odds ratios (aOR).Results
VE against pertussis was sustained between 92% (95% confidence interval (95%CI) 88–95%) in 2–3?year olds and 90% (95%CI: 80–95%) in 8–9?year olds, but fell rapidly to 49% (95%CI: 2–73%) in children 12–13?years of age. VE following the teenage booster given at 14–16?years in Ontario reached 76% (95%CI: 52–88%) in 14–16?year olds and 78% (95%CI: ?31 to 96%) in those 16–22?years old. For children who were up-to-date with the immunization schedule, VE declined from 87% (95%CI: 84–90%) during the first year to 74% (95%CI: 63–82%) after 8 or more years following their last dose of immunization.Conclusions
VE is high during the first decade of life but then falls rapidly. Protection is not fully restored by the teenage booster. Our findings are consistent with the localized outbreaks we observe in high school children and underline the importance of additional policies to protect infants. 相似文献15.
Sung-Ching Pan Szu-Min Hsieh Chih-Feng Lin Yu-Shen Hsu Mingi Chang Shan-Chwen Chang 《Vaccine》2019,37(14):1994-2003
Background
A nasal influenza vaccine has been available only in a live attenuated form, which limits the range of recipients to immune-competent individuals. The present study evaluated a newly developed intranasal inactivated influenza vaccine with a novel adjuvant, heat-labile enterotoxin (LT) derived from E. coli (LTh(αK)).Methods
The study was a randomized, double-blind, controlled phase I trial to evaluate the safety and immunogenicity of an intranasal vaccine containing the trivalent influenza HA antigen (7.5?µg each of A/California/7/09 (H1N1)-like virus, A/Victoria/210/2009 (H3N2) virus, and B/Brisbane/60/2008-like virus) in combination with 4 different doses of adjuvant LTh(αK) (7.5, 15, 30 or 45?μg) and 22.5?μg of influenza HA antigen alone (control vaccine). The vaccine was intranasally administered on Days 0 and 7. A safety evaluation commenced for 180?days, and hemagglutination inhibition (HI) antibody titers and nasal HA-specific IgA titers on Day 0 and Day 28 were assessed to determine whether an immunogenic response was elicited.Results
From November 2012 to September 2013, a total of 36 subjects were enrolled. Twenty-four subjects received an adjuvanted vaccine, and 12 subjects received a control vaccine. The most common adverse event (AE) was mild nasal discomfort, and systemic AEs were mild fatigue and headache. Only two subjects discontinued the study because of an AE (one had grade 3 fever, and one had nodal arrhythmia). In the group with 45?μg of LTh(αK), the seroprotection rates were 100%, 100% and 80%, and the nasal IgA conversion factors were 7.90, 7.46 and 12.27 for the A/H3N2, A/H1N1 and split B strains, respectively. Adjuvant LTh(αK) vaccine showed a significant enhancement in mucosal immunity in split B -specific IgA.Conclusion
The intranasal inactivated influenza vaccine is generally safe, and the LTh(αK)-adjuvanted vaccine is more immunogenic than non-adjuvanted control vaccine.ClinicalTrials.gov Identifier: NCT03293732. 相似文献16.
Introduction
Few studies have reported on the epidemiological characteristics of pediatric primary intussusception in the pre-rotavirus vaccine era of China. It is important to complementary baseline data before rotavirus vaccine introduction in China. This study conduct a retrospective investigation and evaluated the incidence rate, described the epidemiology of pediatric primary intussusception aged ≤24?months.Methods
We conducted a retrospective investigation in all secondary- and tertiary-hospitals in Jinan. Pediatric primary intussusception inpatients aged ≤24?months were identified depending on ICD-10 discharge code from a total of 63 hospitals from 2011 to 2015. Demographic and clinical information were extracting from the electronic clinical record systems.Results
A total of 575 pediatric primary intussusception inpatients were identified with average annual incidence of 86.5 per 100,000. A significantly higher incidence was observed in males (χ2?=?13.8, P?<?0.01), in the ≤12?months old age group (χ2?=?19.5, P?<?0.01) and from the urban areas (χ2?=?63.31, P?<?0.001). No clear seasonality found. Abdominal pain (80.9%) and vomiting (63.3%) were the most frequently reported. Most intussusception cases occurred in ileo-cecum. Over 92% of intussusception cases were diagnosed by ultrasound alone and 77.4% was successfully treated by air enema. 99.7% were cured. The median time of hospitalization was 2?days (range: 0–35?days).Conclusion
This retrospective study provides baseline information of incidence, epidemiologyand clinical characteristics of pediatric primary intussusception in Jinan City during 2011–2016 before the introduction of rotavirus vaccine. It will be important for evaluating safety of rotavirus vaccine if it will be introduced to the routine immunization program in China. 相似文献17.
Fangjun Zhou Jing Xu Carla L. Black Helen Ding Bo-Hyun Cho Peng-Jun Lu Megan C. Lindley 《Vaccine》2019,37(14):1972-1977
Background
Infants younger than 6?months are at increased risk of complications and mortality from pertussis infection. In October 2012, the Advisory Committee on Immunization Practices revised its recommendation to include a Tdap dose during each pregnancy, ideally between 27 and 36?weeks gestation.Objective
Assess trends in Tdap vaccination coverage among privately insured pregnant women from 2009 to 2016 including timing of Tdap vaccination (before, during, or after pregnancy), trimester of vaccination for women vaccinated during pregnancy, and missed vaccination opportunities for unvaccinated women. Identify factors associated with vaccination during the optimal period of 27–36?weeks gestation.Study design
Retrospective analysis of privately insured women 15–49?years who delivered live births during 2009–2016 conducted using 2009–2016 MarketScan data. Tdap vaccination coverage and the timing of Tdap vaccine administration were assessed for women continuously enrolled from 6?months before pregnancy to 1?month after delivery. Multivariable logistic regression was performed to identify factors independently associated with receipt of Tdap vaccine at 27–36?weeks gestation.Results
Tdap vaccination coverage during pregnancy increased from 0.4% in 2009 to 6.2% in 2012 and to 53.2% in 2016. The proportion of vaccinated women receiving Tdap at 27–36?weeks gestation increased from <10% in 2009 to nearly 90% in 2016, with most vaccination occurring at 27–32?weeks gestation. Women of older age, residing in a metropolitan statistical area, residing outside the South, and having a capitated health insurance plan were more likely to receive Tdap at 27–36?weeks gestation than their counterparts. Among women not vaccinated during pregnancy, 77.7% had a pregnancy-related medical claim between 27 and 36?weeks gestation.Conclusion
Tdap vaccination coverage during pregnancy increased significantly from 2009 to 2016, with the greatest increase occurring after the revised Advisory Committee on Immunization Practices recommendation. Most women who did not receive Tdap vaccine had a missed vaccination opportunity during pregnancy, indicating potential for much higher vaccination coverage and consequent infant protection against pertussis. 相似文献18.
Emma J. Walker Noni E. MacDonald Nehal Islam Nicole Le Saux Karina A. Top Deshayne B. Fell 《Vaccine》2019,37(13):1725-1735
Objective
To systematically review literature on uptake and timeliness of diphtheria-tetanus-pertussis, measles-mumps-rubella, and/or polio-containing vaccines in infants who were born preterm, with a low birth weight, and/or with chronic health conditions that were diagnosed within the first 6?months of life.Methods
Using a standardized search strategy developed by a medical librarian, records were extracted from MEDLINE, Embase, Database of Abstracts of Reviews of Effects, and CINAHL up to May 8, 2018.Results
Out of the 1997 records that were screened, we identified 21 studies that met inclusion criteria. Eleven studies assessed vaccine coverage and/or timeliness in preterm infants, 6 in low birth weight infants, and 7 in children with chronic health conditions. Estimates of coverage in these populations were highly variable, ranging from 40% to 100% across the vaccines and population groups.Conclusions
There is a lack of studies reporting coverage and timeliness of routine immunizations in special populations of children.Policy implications
Our review suggests a need for improved surveillance of immunization status in special populations of infants, as well as a need for standardization of reporting practices. 相似文献19.
20.
Bruce Y. Lee Shawn T. Brown Leila A. Haidari Samantha Clark Taiwo Abimbola Sarah E. Pallas Aaron S. Wallace Elizabeth A. Mitgang Jim Leonard Sarah M. Bartsch Tatenda T. Yemeke Eli Zenkov Sachiko Ozawa 《Vaccine》2019,37(17):2377-2386