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MMWR. Morbidity and Mortality Weekly... Feb 2024In the United States, annual influenza vaccination is recommended for all persons aged ≥6 months. Using data from four vaccine effectiveness (VE) networks during the...
In the United States, annual influenza vaccination is recommended for all persons aged ≥6 months. Using data from four vaccine effectiveness (VE) networks during the 2023-24 influenza season, interim influenza VE was estimated among patients aged ≥6 months with acute respiratory illness-associated medical encounters using a test-negative case-control study design. Among children and adolescents aged 6 months-17 years, VE against influenza-associated outpatient visits ranged from 59% to 67% and against influenza-associated hospitalization ranged from 52% to 61%. Among adults aged ≥18 years, VE against influenza-associated outpatient visits ranged from 33% to 49% and against hospitalization from 41% to 44%. VE against influenza A ranged from 46% to 59% for children and adolescents and from 27% to 46% for adults across settings. VE against influenza B ranged from 64% to 89% for pediatric patients in outpatient settings and from 60% to 78% for all adults across settings. These findings demonstrate that the 2023-24 seasonal influenza vaccine is effective at reducing the risk for medically attended influenza virus infection. CDC recommends that all persons aged ≥6 months who have not yet been vaccinated this season get vaccinated while influenza circulates locally.
Topics: Adolescent; Adult; Humans; Child; Influenza Vaccines; Influenza, Human; Seasons; Case-Control Studies; Vaccine Efficacy
PubMed: 38421935
DOI: 10.15585/mmwr.mm7308a3 -
Human Vaccines & Immunotherapeutics Dec 2023Introduction of primary COVID-19 vaccination has helped reduce severe disease and death caused by SARS-CoV-2 infection. Understanding the protection conferred by... (Review)
Review
Introduction of primary COVID-19 vaccination has helped reduce severe disease and death caused by SARS-CoV-2 infection. Understanding the protection conferred by heterologous booster regimens informs alternative vaccination strategies that enable programmatic resilience and can catalyze vaccine confidence and coverage. Inactivated SARS-CoV-2 vaccines are among the most widely used vaccines worldwide. This review synthesizes the available evidence identified as of May 26, 2022, on the safety, immunogenicity, and effectiveness of a heterologous BNT162b2 (Pfizer-BioNTech) mRNA vaccine booster dose after an inactivated SARS-CoV-2 vaccine primary series, to help protect against COVID-19. Evidence showed that the heterologous BNT16b2 mRNA vaccine booster enhances immunogenicity and improves vaccine effectiveness against COVID-19, and no new safety concerns were identified with heterologous inactivated primary series with mRNA booster combinations.
Topics: Humans; COVID-19 Vaccines; BNT162 Vaccine; SARS-CoV-2; Vaccine Efficacy; COVID-19; mRNA Vaccines
PubMed: 36727201
DOI: 10.1080/21645515.2023.2165856 -
Current Opinion in HIV and AIDS Nov 2023There is a need to conduct multiple experimental medicine trials in regions with significant burden of disease to ensure the global relevance of vaccines under...
PURPOSE OF REVIEW
There is a need to conduct multiple experimental medicine trials in regions with significant burden of disease to ensure the global relevance of vaccines under development including the African context.
RECENT FINDINGS
African scientists can support accelerated HIV vaccine development by leading EMVTs in the region in a complementary fashion to global efforts and augment evidence generated to optimize and advance relevant vaccines towards licensure. The ADVANCE program enables EMVTs, where local scientists lead trial implementation and immunogenicity endpoint analysis of promising vaccine approaches. Concerted efforts towards scientific collaboration, enhancing specific clinical and lab capacity, and improving ethical and regulatory systems to review EMVTs in Africa will be catalytic. Appropriate engagement of local communities and stakeholders will be equally important, and the field needs to refine existing research literacy approaches to effectively partner with communities around current complex scientific approaches. Review of inclusion of relevant populations in early research is also needed.
SUMMARY
African scientists and communities can help accelerate HIV vaccine development through stronger global collaboration. Now is the time for bold investments to enable the conduct of innovative EMVTs in Africa where the eventual vaccines will have the greatest impact.
PubMed: 37712819
DOI: 10.1097/COH.0000000000000815 -
Vaccines Nov 2023New technological platforms, such as mRNA and adenoviral vector vaccines, have been utilized to develop coronavirus disease 2019 (COVID-19) vaccines. These new... (Review)
Review
New technological platforms, such as mRNA and adenoviral vector vaccines, have been utilized to develop coronavirus disease 2019 (COVID-19) vaccines. These new modalities enable rapid and flexible vaccine design and cost-effective and swift manufacturing, effectively combating pandemics caused by mutating viruses. Innovation ecosystems, including universities, startups, investors, and governments are crucial for developing these cutting-edge technologies. This review summarizes the research and development trajectory of these vaccine technologies, their investments, and the support surrounding them, in addition to the technological details of each technology. In addition, this study examines the importance of an innovation ecosystem in developing novel technologies, comparing it with the case of Japan, which has lagged behind in COVID-19 vaccine development. It also explores the direction of vaccine development in the post-COVID-19 era.
PubMed: 38140142
DOI: 10.3390/vaccines11121737 -
Clinical Infectious Diseases : An... May 2024Respiratory syncytial virus (RSV) and influenza are both typically seasonal diseases, with winter peaks in temperate climates. Coadministration of an RSV vaccine and... (Randomized Controlled Trial)
Randomized Controlled Trial
BACKGROUND
Respiratory syncytial virus (RSV) and influenza are both typically seasonal diseases, with winter peaks in temperate climates. Coadministration of an RSV vaccine and influenza vaccine could be a benefit, requiring 1 rather than 2 visits to a healthcare provider for individuals receiving both vaccines.
METHODS
The primary immunogenicity objective of this phase 3, 1:1 randomized, double-blind, placebo-controlled study in healthy adults aged ≥65 years in Australia was to demonstrate noninferiority of immune responses with coadministration of the stabilized RSV prefusion F protein-based vaccine (RSVpreF) and seasonal inactivated influenza vaccine (SIIV) versus SIIV or RSVpreF administered alone, using a 1.5-fold noninferiority margin (lower bound 95% confidence interval >.667). Safety and tolerability were evaluated by collecting reactogenicity and adverse event data.
RESULTS
Of 1403 participants randomized, 1399 received vaccinations (median age, 70; range, 65‒91 years). Local reactions and systemic events were mostly mild or moderate when RSVpreF was coadministered with SIIV or administered alone. No vaccine-related serious adverse events were reported. Geometric mean ratios were 0.86 for RSV-A and 0.85 for RSV-B neutralizing titers at 1 month after RSVpreF administration and 0.77 to 0.90 for strain-specific hemagglutination inhibition assay titers at 1 month after SIIV. All comparisons achieved the prespecified 1.5-fold noninferiority margin.
CONCLUSIONS
The primary study objectives were met, demonstrating noninferiority of RSVpreF and SIIV immune responses when RSVpreF was coadministered with SIIV and that RSVpreF had an acceptable safety and tolerability profile when coadministered with SIIV. The results of this study support coadministration of RSVpreF and SIIV in an older-adult population.
CLINICAL TRIALS REGISTRATION
https://clinicaltrials.gov/study/NCT05301322.
Topics: Humans; Influenza Vaccines; Aged; Male; Female; Aged, 80 and over; Double-Blind Method; Influenza, Human; Respiratory Syncytial Virus Vaccines; Respiratory Syncytial Virus Infections; Antibodies, Viral; Vaccines, Inactivated; Australia; Immunogenicity, Vaccine; Seasons; Respiratory Syncytial Virus, Human
PubMed: 37992000
DOI: 10.1093/cid/ciad707 -
NPJ Vaccines Apr 2024Vaccine R&D is typically a lengthy process taking >10 years. However, vaccines still fail in clinical development because of unreliable animal models or absent... (Review)
Review
Vaccine R&D is typically a lengthy process taking >10 years. However, vaccines still fail in clinical development because of unreliable animal models or absent immunological correlates of protection. Without a correlate of protection, phase-1 and -2 studies of safety and immunogenicity can fail to predict phase-3 efficacy. Indeed, the history of vaccine development is replete with promising phase-1 and -2 results and failed phase-3 efficacy trials. To avoid this misfortune, we present Reverse Vaccine Development for vaccines against antimicrobial-resistant (AMR) pathogens. In this approach, instead of evaluating efficacy in phase 3, proof-of-principle efficacy is evaluated as early as possible in a population with a high incidence of disease, which may differ from the population intended for registration, and can be a controlled human infection population. To identify a correlate of protection in these populations, the vaccine-elicited immune response is compared between protected and unprotected subjects. If a correlate is identified, it can help to refine the vaccine dosage, schedule, and formulation, and facilitate the assessment of vaccine efficacy in other populations with different attack rates, subject characteristics, and disease manifestations. This may be the only way to provide life-saving vaccines to populations affected by AMR-pathogen diseases at incidences that are typically low and unsuited to phase-3 efficacy trials. The availability of a correlate of protection early in clinical development can potentially prevent failures of large phase-3 trials and unnecessary exposures of populations to inefficacious vaccines that have resulted in disinvestment in the development of vaccines against AMR pathogens.
PubMed: 38570502
DOI: 10.1038/s41541-024-00858-4 -
Diagnostics (Basel, Switzerland) Aug 2023Crimean-Congo hemorrhagic fever virus (CCHFV), a member of the family and order, is transmitted to humans via tick bites or contact with the blood of infected animals.... (Review)
Review
Crimean-Congo hemorrhagic fever virus (CCHFV), a member of the family and order, is transmitted to humans via tick bites or contact with the blood of infected animals. It can cause severe symptoms, including hemorrhagic fever, with a mortality rate between 5 to 30%. CCHFV is classified as a high-priority pathogen by the World Health Organization (WHO) due to its high fatality rate and the absence of effective medical countermeasures. CCHFV is endemic in several regions across the world, including Africa, Europe, the Middle East, and Asia, and has the potential for global spread. The emergence of the disease in new areas, as well as the presence of the tick vector in countries without reported cases, emphasizes the need for preventive measures to be taken. In the past, the lack of a suitable animal model susceptible to CCHFV infection has been a major obstacle in the development of vaccines and treatments. However, recent advances in biotechnology and the availability of suitable animal models have significantly expedited the development of vaccines against CCHF. These advancements have not only contributed to an enhanced understanding of the pathogenesis of CCHF but have also facilitated the evaluation of potential vaccine candidates. This review outlines the immune response to CCHFV and animal models utilized for the study of CCHFV and highlights the progress made in CCHFV vaccine studies. Despite remarkable advancements in vaccine development for CCHFV, it remains crucial to prioritize continued research, collaboration, and investment in this field.
PubMed: 37627967
DOI: 10.3390/diagnostics13162708 -
Frontiers in Public Health 2023The purpose of this systematic review was to report on the vaccine efficacy (VE) of three SARS-CoV-2 vaccines approved by Health Canada: Pfizer BioNTech, Moderna, and...
The purpose of this systematic review was to report on the vaccine efficacy (VE) of three SARS-CoV-2 vaccines approved by Health Canada: Pfizer BioNTech, Moderna, and AstraZeneca. Four databases were searched for primary publications on population-level VE. Ninety-two publications matched the inclusion criteria, and the extracted data were separated by vaccine type: mRNA vaccines (Pfizer and Moderna) and the AstraZeneca vaccine. The median VE for PCR-positive patients and various levels of clinical disease was determined for the first and second doses of both vaccine types against multiple SARS-CoV-2 variants. The median VE for PCR-positive infections against unidentified variants from an mRNA vaccine was 64.5 and 89%, respectively, after one or two doses. The median VE for PCR-positive infections against unidentified variants from the AstraZeneca vaccine was 53.4 and 69.6%, respectively, after one or two doses. The median VE for two doses of mRNA for asymptomatic, symptomatic, and severe infection against unidentified variants was 85.5, 93.2, and 92.2%, respectively. The median VE for two doses of AstraZeneca for asymptomatic, symptomatic, and severe infection against unidentified variants was 69.7, 71, and 90.2%, respectively. Vaccine efficacy numerically increased from the first to the second dose, increased from the first 2 weeks to the second 2 weeks post-vaccination for both doses, but decreased after 4 months from the second dose. Vaccine efficacy did not differ by person's age.
Topics: Humans; COVID-19 Vaccines; SARS-CoV-2; Vaccine Efficacy; COVID-19; Vaccines
PubMed: 37942238
DOI: 10.3389/fpubh.2023.1229716 -
Trends in Microbiology Aug 2023Herpesviruses are among the most successful viruses found in human populations. They establish lifelong latent infections, which are punctuated by recurrent... (Review)
Review
Herpesviruses are among the most successful viruses found in human populations. They establish lifelong latent infections, which are punctuated by recurrent reactivations. The entry process of herpesviruses into specific target cells requires a well-orchestrated teamwork involving multiple envelope glycoproteins. The conserved glycoprotein B (gB) is the membrane fusogen, of which conformational changes are induced by an entry complex (EC) consisting of at least gH and gL. Despite the high prevalence and heavy disease burdens associated with human herpesviruses (HHVs), vaccines against these pathogens are still lacking, except for varicella zoster virus (VZV). Recent advances in understanding the coordinated mechanisms of action of the key EC glycoproteins and fusogen will help to improve approaches for effective vaccine development and neutralizing antibody (nAb) screening.
Topics: Humans; Viral Envelope Proteins; Glycoproteins; Herpesviridae; Antibodies, Neutralizing; Virus Internalization
PubMed: 36967248
DOI: 10.1016/j.tim.2023.03.001 -
The American Journal of Tropical... Jul 2023The radiation-attenuated Plasmodium falciparum sporozoites (PfSPZ) Vaccine has demonstrated safety and immunogenicity in 5-month-old to 50-year-old Africans in multiple... (Randomized Controlled Trial)
Randomized Controlled Trial
The radiation-attenuated Plasmodium falciparum sporozoites (PfSPZ) Vaccine has demonstrated safety and immunogenicity in 5-month-old to 50-year-old Africans in multiple trials. Except for one, each trial has restricted enrollment to either infants and children or adults < 50 years old. This trial was conducted in Equatorial Guinea and assessed the safety, tolerability, and immunogenicity of three direct venous inoculations of 1.8 × 106 or 2.7 × 106 PfSPZ, of PfSPZ Vaccine, or normal saline administered at 8-week intervals in a randomized, double-blind, placebo-controlled trial stratified by age (6-11 months and 1-5, 6-10, 11-17, 18-35, and 36-61 years). All doses were successfully administered. In all, 192/207 injections (93%) in those aged 6-61 years were rated as causing no or mild pain. There were no significant differences in solicited adverse events (AEs) between vaccinees and controls in any age group (P ≥ 0.17). There were no significant differences between vaccinees and controls with respect to the rates or severity of unsolicited AEs or laboratory abnormalities. Development of antibodies to P. falciparum circumsporozoite protein occurred in 67/69 vaccinees (97%) and 0/15 controls. Median antibody levels were highest in infants and 1-5-year-olds and declined progressively with age. Antibody responses in children were greater than in adults protected against controlled human malaria infection. Robust immunogenicity, combined with a benign AE profile, indicates children are an ideal target for immunization with PfSPZ Vaccine.
Topics: Animals; Adult; Humans; Child; Infant; Child, Preschool; Middle Aged; Plasmodium falciparum; Malaria, Falciparum; Sporozoites; Vaccines, Attenuated; Equatorial Guinea; Malaria Vaccines; Double-Blind Method; Immunogenicity, Vaccine
PubMed: 37160281
DOI: 10.4269/ajtmh.22-0773