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Background & objectives: Three doses of intermittent preventive treatment with sulphadoxine-pyrimethamine (IPTp-SP) has been adopted as the new recommendation for prevention of malaria in pregnancy. This study evaluated the effectiveness of two-dose versus three-dose of SP for IPTp-SP in the prevention of low birth weight (LBW) and malaria parasitaemia. Methods: An open, randomized, controlled, longitudinal trial was conducted in a secondary level hospital in Nsukka region of Enugu State, Nigeria. A sample of 210 pregnant women within gestational ages of 16-24 wk were recruited at antenatal clinics and equally randomized to either a two-dose SP or three-dose SP group. The primary endpoints were LBWs, peripheral, and placental parasitaemia, while the secondary endpoints were maternal anaemia, pre-term birth, clinical malaria and adverse effects of SP. Results: Among 207 cases followed till delivery, the prevalence of parasitaemia was lower in three-dose group than in two-dose group for both peripheral (9.3% versus 27.8%) and placental (10.6% versus 25.6%) parasitaemia. The adjusted odds ratios (aOR) were 0.15 [95% confidence interval (CI), 0.05 - 0.45] and 0.17 (95% CI, 0.06-0.51), respectively. The prevalence of LBW was also lower in three-dose (3.5%) than in two-dose (12.2%) group (aOR, 0.15; 95% CI, 0.04-0.63); however, the prevalence of maternal anaemia, pre-term births, clinical malaria and SP adverse effects were similar between the two arms of treatment. Interpretation & conclusion: Addition of a third SP dose to the standard two-dose SP for IPTp led to improved reductions in the risk of some adverse pregnancy outcomes.

•Adult HBV immunization.•Adherence with multi-dose vaccines.•Cost per person seroprotected.•Three-dose vs two-dose HBV vaccines. At least one-half of adults beginning an immunization series with a three-dose hepatitis B virus (HBV) vaccine (ENGERIX-B, RECOMBIVAX-B) have been reported not to receive the third dose. Use of a two-dose vaccine may improve adherence and lead to greater overall levels of seroprotection. To examine expected levels of adherence and overall seroprotection at one year among adults in routine clinical settings beginning an immunization series with either ENGERIX-B or the two-dose HBV vaccine, HEPLISAV-B. Decision-analytic model comparing expected levels of adherence and overall seroprotection at one year among a hypothetical cohort of one million previously unvaccinated adults aged ≥ 30 years receiving first doses of either ENGERIX-B or HEPLISAV-B in a routine clinical setting. We stratified the population by age (30–49 years vs ≥ 50 years) to allow for possible differences in adherence and seroprotection. We estimated our model using published adherence rates for HBV vaccines, and reported seroprotection rates by number of doses administered. We also compared total expected costs of HBV immunization with each vaccine. Use of a two-dose rather than three-dose HBV vaccine would increase the expected number of adults seroprotected at one year by 275,000 per one million persons beginning immunization series, largely reflecting a gain of 290,000 in the expected number of persons fully vaccinated. Results were similar for the two age groups. While the cost per dose of HEPLISAV-B exceeds that of ENGERIX-B, its estimated mean cost per person seroprotected at one year is $50-$70 (∼15%) lower. Use of a two-dose HBV vaccine would increase the number of adults fully seroprotected at one year compared with the number expected with a three-dose vaccine. Notwithstanding its higher unit cost, mean expected cost per person seroprotected is substantially lower for HEPLISAV-B than ENGERIX-B as a result of much higher levels of seroprotection.

Human papillomavirus (HPV) vaccination is a major strategy for preventing cervical and other ano-genital cancers. Worldwide HPV vaccination introduction and coverage will be facilitated if a single dose of vaccine is as effective as two or three doses or demonstrates significant protective effect compared to ‘no vaccination’. In a multi-centre cluster randomized trial of two vs three doses of quadrivalent HPV vaccination (Gardasil™) in India, suspension of the vaccination due to events unrelated to the study led to per protocol and partial vaccination of unmarried 10–18 year old girls leading to four study groups, two by design and two by default. They were followed up for the primary outcomes of immunogenicity in terms of L1 genotype-specific binding antibody titres, neutralising antibody titres, and antibody avidity for the vaccine-targeted HPV types and HPV infections. Analysis was per actual number of vaccine doses received. This study is registered with ISRCTN, number ISRCTN98283094; and with ClinicalTrials.gov, number NCT00923702. Of the 17,729 vaccinated girls, 4348 (25%) received three doses on days 1, 60, 180 or later, 4979 (28%) received two doses on days 1 and 180 or later, 3452 (19%) received two doses on days 1 and 60, and 4950 (28%) received one dose. One dose recipients demonstrated a robust and sustained immune response against HPV 16 and 18, albeit inferior to that of 3- or 2-doses and the antibody levels were stable over a 4 year period. The frequencies of cumulative incident and persistent HPV 16 and 18 infections up to 7 years of follow-up were similar and uniformly low in all the vaccinated study groups; the frequency of HPV 16 and 18 infections were significantly higher in unvaccinated age-matched control women than among vaccine recipients. The frequency of vaccine non-targeted HPV types was similar in the vaccinated groups but higher in the unvaccinated control women. Our results indicate that a single dose of quadrivalent HPV vaccine is immunogenic and provides lasting protection against HPV 16 and 18 infections similar to the three- and two-dose vaccine schedules, although the study suffer from some limitations. Data on long term protection beyond 7 years against HPV infection and cervical precancerous lesions are needed before policy guidelines regarding a single dose can be formulated and implemented. Significant and long-lasting protective effect of a single dose can be a strong argument to introduce one dose of the HPV vaccine in many low income countries where the current standard of care for cervical cancer prevention is ‘no intervention’.

BackgroundThe efficacy of the two-dose hepatitis B virus (HBV) vaccine (Heplisav-B®) in patients with chronic liver disease (CLD) is unknown.AimsTo compare the immunogenicity achieved with Heplisav-B and the conventional three-dose vaccine (Engerix-B®) in patients with CLD, and to identify factors that predict seroconversion.MethodsWe retrospectively identified all adults who completed Heplisav-B or Engerix-B regimens from August 1, 2015, to January 31, 2019. Post-vaccination immunity was assessed by quantitative HBV surface antibody (HBsAb) measurement.ResultsWe identified 166 patients (106 Engerix-B and 60 Heplisav-B) with chronic liver disease (mean age 59.0 ± 11.3 years, 52% male, 34% cirrhosis, mean MELD score of those with cirrhosis 10.1 ± 5.4) who had completed the vaccinations and had data available on post-vaccination HBsAb levels at least 2 months after completion of the vaccine regimen. Seroprotective HBsAb levels (> 10 mIU/ml) were achieved in 63% with Heplisav-B and in 45% with Engerix-B (p = 0.03). Univariable analysis showed that age (p = 0.01), insurance (p = 0.02), renal failure (p = 0.02), COPD (p = 0.05), and cirrhosis (p < 0.01) had a significant effect on achieving immunogenicity. On multivariable analysis, patients with cirrhosis (adjusted odds ratio [aOR]: 0.27, 95% CI 0.13–0.55), COPD (aOR: 0.06, 95% CI 0.01–0.56), or renal failure (aOR 0.36, 95% CI 0.14–0.93) had a lower likelihood of achieving immunity, and patients who received Heplisav-B® had a 2.7-fold greater likelihood of achieving immunity than those who received Engerix-B® (aOR: 2.74, 95% CI 1.31–5.71).ConclusionThe two-dose recombinant hepatitis B vaccine resulted in better seroconversion than the three-dose vaccine. Cirrhosis, COPD, and renal failure were associated with a lower likelihood of achieving immunogenicity.

Purpose Neurokinin 1 receptor antagonists included prophylactic treatment was recommended for patients who receive one-day cisplatin chemotherapy. It is unclear whether the prolonged administration of fosaprepitant is effective for three-day cisplatin-based chemotherapy induced nausea and vomiting (CINV). We aim to explore the prophylactic antiemetic efficacy and safety of two doses of fosaprepitant included regimen in the patients receiving multiple-day cisplatin chemotherapy. Methods This randomized, parallel-group, open-labelled study was conducted in nine hospitals between February 2021 and February 2023. Patients diagnosed as lung cancer and chemotherapy naive were screened. Eligible participants were scheduled to be treated with highly emetogenic chemotherapy regimen which including three days of cisplatin. Then they were randomly divided into the experimental group (two doses of fosaprepitant, Group 2DF) and the control group (one dose of fosaprepitant, Group C). The primary endpoints included the safety and the average none CINV days (NCDs). This study was registered on the website of chictr.org.cn, number ChiCTR2100042665. Results Overall, 204 participants were randomly assigned, and 198 patients were analyzed. No statistical difference in adverse events was found between the two groups. All treatment-related adverse effects for fosaprepitant observed were of grade 1–2. The average NCDs of Group 2DF was significantly more than Group C (18.21 ± 3.40 days vs 16.14 ± 5.20 days, P  = 0.001). Furthermore, the better life function score was achieved in Group 2DF according to FLIE questionnaire. Conclusion The administration of two-dose fosaprepitant was safe and more effective than one dose in protecting patients from CINV induced by three-day cisplatin included chemotherapy.

•Real-world evidence of MMRV clinical protection against varicella is essential.•Data showed effectiveness of two doses MMRV against varicella of any severity of 93%.•Two-dose schedule should be recommended to optimise immunisation programmes worldwide. Priorix-Tetra™ (MMRV GlaxoSmithKline Biologicals’ vaccine) was developed based on the existing measles-mumps-rubella and varicella vaccines. In this study, we aimed to estimate the effectiveness of the combined measles-mumps-rubella-varicella Priorix-Tetra™ vaccine against varicella in real-world conditions. We conducted a post-marketing retrospective case-control study in the Apulia region of Italy in children aged 1–9 years born between January 1, 2008 and December 31, 2016. We assessed the effectiveness against varicella of all grades of severity (including hospitalisation) and against hospitalisation for varicella of a single and two doses of Priorix-Tetra™. Moreover, we also assessed effectiveness of monovalent varicella (monovalent-V) vaccine and any varicella vaccines. Vaccine effectiveness was calculated as (1–OR) x 100. We introduced demographic variables in the model to adjust Vaccine effectiveness (aVE) by potential confounders (sex and year of birth). We recorded 625 varicella cases and matched them with 1,875 controls. Among 625 cases, 198 had received a single MMRV dose, 10 two MMRV doses, 46 a single monovalent-V dose, none two monovalent-V doses; four a monovalent-V as first dose and MMRV as second dose, and one a MMRV as first dose and monovalent-V as second dose; 366 cases were not vaccinated. The aVE against varicella of all grades of severity was 77.0% and 93.0% after a single dose and after two doses of MMRV, respectively. The aVE against varicella of all grades was 72.0% after a single dose of monovalent-V vaccine. The aVE against varicella of all grades of severity was 76.0% after a single dose and 94.0% after two doses of any varicella vaccine. The aVE against varicella hospitalisation was 96% after a single dose of any varicella vaccine. Priorix-Tetra™ showed to be an effective vaccine and the two-dose schedule should be recommended to optimise immunisation programmes. A single dose was able to provide protection against varicella hospitalisation.

Objectives: The objectives of this study were as follows: to determine mean percentages of measles vaccination coverage with zero, one and two doses of vaccine and anti-measles herd immunity levels in World Health Organization (WHO) regions in 2023; to assess variations in measles vaccination coverage and anti-measles herd immunity-related indicators from 2019 to 2023; and to assess whether zero-dose measles vaccination coverage indicators were on track to achieve the Immunization Agenda 2030 objective. Methods: Mean percentages of vaccination coverage with two, one and zero doses of measles vaccine in WHO regions in 2023 were calculated using data from the WHO/UNICEF global and regional immunization information system. Results: In 2023, the global mean two-dose measles vaccination coverage was 65.3%, and mean two-dose vaccination coverage was lower than 95% in all WHO regions; the mean prevalence of measles-protected individuals in the target vaccination population was 87.6%, and anti-measles herd immunity levels in the target vaccination population were sufficient to block the transmission of measles viruses with greater transmissibility (Ro ≥ 15) only in the Western Pacific and European WHO regions. The global mean two-dose measles vaccination coverage decreased by 3.7% from 2019 to 2023. In 2023, the mean zero-dose measles coverage and number of zero-dose measles children were, respectively, 36.7% and 40.6% greater than the values required to be on track to achieve the 2030 objective. Conclusion: This study found that all measles-vaccination-coverage-related indicators worsened from 2019 to 2023, and the zero-dose measles vaccination coverage and number of zero-dose measles children in 2023 were not on track to achieve the AI2030 objective. Interventions to increase routine two-dose measles vaccination coverage should be developed in all WHO regions.

•VarV reached non-inferior criteria of immunogenicity in population ≥ 13 years.•VarV offered a more flexible immunization schedule, with an interval of 4–10 weeks between the two doses.•VarV could induce good immune response in both adolescents and adults.•Vaccination with VarV did not increase additional safety risk. Vaccines for prevention against varicella are important for adolescents and adults, who have an increased risk of severe varicella. This study aimed to evaluate the immunogenicity and safety of a two-dose immunization schedule of a live-attenuated varicella vaccine (VarV) manufactured by Sinovac (Dalian) in healthy adolescents and adults. A randomized, double-blind, controlled clinical trial was conducted in healthy population aged ≥ 13 years old in China. Participants in block 1 were randomly assigned (1:1) to receive two doses of either the test vaccine or an active control vaccine, administered 4, 6 or 8 weeks apart. Participants in block 2 were randomly assigned (2:1) to receive two doses of test vaccine or placebo, administered 10 weeks apart. The primary immunogenicity endpoint was the seroconversion rates and GMTs of varicella zoster virus (VZV) antibodies measured by fluorescent-antibody-to-membrane-antigen (FAMA) 4 weeks post-immunization. The primary safety endpoint was the incidence of adverse reactions within 4 weeks after each dose. A total of 2398 participants were enrolled. The seroconversion rates of VZV antibodies were 79.55 % in the test group and 76.41 % in the active control group respectively 4 weeks after two doses of pooled schedule, with the difference of 3.14 % (95 %CI: −0.69 %, 6.97 %). The GMTs were 1:162.07 and 1:160.04 respectively, with the ratio of 1.013 (95 %CI: 0.910, 1.127). Both the seroconversion rates and GMTs reached the prespecified non-inferiority criteria. Two-dose schedule with an interval of 10 weeks could also induce high immune responses, with a seroconversion rate of 83.22 % and a GMT of 1:160.38 in the test group. Safety profiles were similar among the test group, active control group and placebo group. VarV, manufactured by Sinovac (Dalian), demonstrated higher immune response and better flexibility in the immunization schedule among heathy population aged 13 years and older, without increased safety risk.

•About 40% of two-dose vaccinated nursery school children became ill with varicella.•Outbreaks at nursery schools might be transmitted from older students, perhaps siblings.•Vaccine effectiveness in the nursery school for more than one dose was not confirmed.•Vaccination using one dose or more can reduce severity significantly. In Japan, routine administration to one-year-old children of two-dose immunization for varicella was introduced in October 2014. Object The object of this study was to report outbreaks of varicella under routine immunization at a nursery school and in its surrounding area using data of surrounding areas from the (Nursery) School Absenteeism Surveillance System. Then, we measured the effectiveness of routine two-dose immunization for varicella to onset. We tentatively assessed its severity in a nursery school. The study period extended from April 2017 through March 2018. The study area comprised Nursery school B and other nursery schools, and elementary and junior high schools in City A. Subjects in Nursery school B were 120 children. We analyzed vaccine effectiveness (VE) as an observational study and assessed severity using Fisher’s exact test. We also assessed VE for severity using linear regression. Severity was defined as the length of nursery school absence attributable to varicella infection. During the one month preceding a period of two weeks before the initial case at Nursery school B, there were 16 cases of varicella infection in nursery schools, 45 cases in elementary schools, and one case in junior high schools in City A. For children who had received one vaccine dose or more, VE was 48.1% for all ages and 49.2% among children three years old and older. No significant VE against infection was found. Vaccination using one dose or more can reduce severity significantly. Discussion and conclusion: Because many nursery school children who had received two doses of vaccine were infected, VE was estimated as low in the nursery school and not significant. Although VE for severity with more than one dose was confirmed, a second dose might not reduce severity compared to one dose.

We aimed to examine changes in anti-varicella-zoster virus (VZV) antibody titers and seroprotection status from before the first dose of vaccination to before 7 years old entering elementary school in children who received the routine two-dose varicella vaccination. Participants were 37 healthy children who received the routine two-dose varicella vaccination at our hospital. A total of five serum samples per child were collected immediately before and 4–6 weeks after each dose of the vaccination and in the year before entry to elementary school. We measured anti-VZV antibody titers by immune adherence hemagglutination (IAHA) method and glycoprotein-based enzyme-linked immunosorbent assay (gpELISA). A positive antibody titer and the seroprotection level were set as ≥2-fold and ≥16-fold, respectively, for IAHA antibody and as ≥50 units and ≥105 units, respectively, for gpELISA-IgG antibody. The rates of IAHA antibody positivity in the five samples (in order of collection) were 0%, 65%, 38%, 100%, and 59%, and the rates of seroprotection were 0%, 43%, 8%, 100%, and 43%. The rates of gpELISA-IgG antibody positivity were 8%, 81%, 89%, 100%, and 100%, and the rates of seroprotection were 5%, 54%, 70%, 100%, and 89%. The mean IAHA antibody titer and mean gpELISA-IgG antibody titer before entering elementary school were both lower than the respective titers obtained after the second vaccination (both p < 0.01). Routine two-dose varicella vaccination leads to good antibody production, but titers of acquired antibodies decrease before children enter elementary school.