Search

Background: Flavivirus infections pose a significant global health burden underscoring the need for the development of safe and effective vaccination strategies. Available flavivirus vaccines are from time to time concomitantly delivered to individuals. Co-administration of different vaccines saves time and visits to health care units and vaccine clinics. It serves to provide protection against multiple pathogens in a shorter time-span; e.g., for individuals travelling to different endemic areas. However, safety and immunogenicity-related responses have not been appropriately evaluated upon concomitant delivery of these vaccines. Therefore, we performed an open label, non-randomized clinical trial studying the safety and immunogenicity following concomitant delivery of the yellow fever virus (YFV) vaccine with tick-borne encephalitis virus (TBEV) and Japanese encephalitis virus (JE) virus vaccines., Methods and Findings: Following screening, healthy study participants were enrolled into different cohorts receiving either TBEV and YFV vaccines, JEV and YFV vaccines, or in control groups receiving only the TBEV, JEV, or YFV vaccine. Concomitant delivery was given in the same or different upper arms for comparison in the co-vaccination cohorts. Adverse effects were recorded throughout the study period and blood samples were taken before and at multiple time-points following vaccination to evaluate immunological responses to the vaccines. Adverse events were predominantly mild in the study groups. Four serious adverse events (SAE) were reported, none of them deemed related to vaccination. The development of neutralizing antibodies (nAbs) against TBEV, JEV, or YFV was not affected by the concomitant vaccination strategy. Concomitant vaccination in the same or different upper arms did not significantly affect safety or immunogenicity-related outcomes. Exploratory studies on immunological effects were additionally performed and included studies of lymphocyte activation, correlates associated with germinal center activation, and plasmablast expansion., Conclusions: Inactivated TBEV or JEV vaccines can be co-administered with the live attenuated YFV vaccine without an increased risk of adverse events and without reduced development of nAbs to the respective viruses. The vaccines can be delivered in the same upper arm without negative outcome. In a broader perspective, the results add valuable information for simultaneous administration of live and inactivated flavivirus vaccines in general., Trial Registration: Eudra CT 2017-002137-32., Competing Interests: The authors have declared that no competing interests exist., (Copyright: © 2023 Sandberg et al. This is an open access article distributed under the terms of the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited.)

Background and Aims: Substance use among adolescents especially smoking, is becoming a public health problem in the Kurdistan region of Iraq. School-based health education is an appropriate approach for improving students' knowledge regarding substance use in an attempt to prevent or reduce such problem The purpose of the study was to examine the effect of an educational intervention for high school students to improve their knowledge for substance use and its negative consequences, which will, in turn, motivate students to take protective measures against substance use., Methods: This quasi-experimental (one group; pre, and post-test) design was carried out in Erbil city from January 2017 to June 2017. A random sampling technique was employed to collect a sample of 280 students amongst four high schools in Erbil city which is the capital of Kurdistan Region-Iraq. A self- administered questionnaire on knowledge assessment regarding substance use was developed and validated by the experts regarding the relevance of the items. A structured teaching program for imparting knowledge on various aspects of substance use was developed based on extensive review of literature and experts' opinion. The intervention program consisted of a series of 4 education modules. These modules were mainly taught by "Rabers" over a period of four weeks (one session per week). SPSS version 21 was used for data entry and analysis. Data was analyzed through descriptive and inferential statistics (McNemar tests, paired t-test, and Chi-square test)., Results: Out of 280 students, a total of 270 students completed a pre and post-intervention survey. Of the 270 students, 124 (45.9%) were males and 146 (54.1%) were females. The mean age ± SD of the participants was 16.59 ± 0.784 years, ranging from 15-18 years. The study reveals a statistically significant improvement in the mean score of knowledge of students following the implementation of a health education program from 15.959 ± 3.25 to 20.633 ± 3.26 (p < 0.001). Moreover, no one of the students remained with poor knowledge, and relatively more than half (50.2%) of the students have upgraded to good knowledge level., Conclusion: Implementing a health education program about substance use on high school students in Erbil city had improved the knowledge of students about this topic., Competing Interests: The authors have declared that no competing interests exist.

Background: Acellular pertussis vaccines do not control pertussis. A new approach to offer protection to infants is necessary. BPZE1, a genetically modified Bordetella pertussis strain, was developed as a live attenuated nasal pertussis vaccine by genetically eliminating or detoxifying 3 toxins., Methods: We performed a double-blind, placebo-controlled, dose-escalating study of BPZE1 given intranasally for the first time to human volunteers, the first trial of a live attenuated bacterial vaccine specifically designed for the respiratory tract. 12 subjects per dose group received 10³, 10⁵ or 10⁷ colony-forming units as droplets with half of the dose in each nostril. 12 controls received the diluent. Local and systemic safety and immune responses were assessed during 6 months, and nasopharyngeal colonization with BPZE1 was determined with repeated cultures during the first 4 weeks after vaccination., Results: Colonization was seen in one subject in the low dose, one in the medium dose and five in the high dose group. Significant increases in immune responses against pertussis antigens were seen in all colonized subjects. There was one serious adverse event not related to the vaccine. Other adverse events were trivial and occurred with similar frequency in the placebo and vaccine groups., Conclusions: BPZE1 is safe in healthy adults and able to transiently colonize the nasopharynx. It induces immune responses in all colonized individuals. BPZE1 can thus undergo further clinical development, including dose optimization and trials in younger age groups., Trial Registration: ClinicalTrials.gov NCT01188512.