Vaccination Strategies Research Articles

Rotavirus Infections: A 2-Year Comprehensive Review in Admitted Pediastric Patients Amid Conflicting National Policies.

Highlighting rotavirus (RV) as a significant food and waterborne pathogen, particularly affecting infants and children, causing serious gastrointestinal infections and dehydration, is important. It should be noted that there are significant debates regarding the effectiveness and outcomes of RV vaccination. In contrast to Turkey's nonmandatory vaccination policy, many developed countries implement mandatory vaccination policies, raising questions about their impact on disease prevalence and healthcare expenditures. Our study aims to comprehensively understand RV infections in Turkey and compare them with countries that have mandatory vaccination policies. We found similar, and even better, hospitalization rates, length of hospital stays, and laboratory parameters demonstrating the effectiveness of Turkey's independent vaccination approach. These findings contribute valuable insights to global vaccination strategies and disease control.

SARS-CoV-2-Specific T Lymphocytes Analysis in mRNA-Vaccinated Patients with B-Cell Lymphoid Malignancies on Active Treatment

Background: Patients with B-lymphocyte malignancies (BCMs) receiving B-lymphocyte-targeted therapies have increased risk of severe COVID-19 outcomes and impaired antibody response to SARS-CoV-2 mRNA vaccination in comparison to non-hematologic oncologic patients or general population. Consequently, it is vital to explore vaccine-induced T-lymphocyte responses in patients referred for the understanding of immune protection against SARS-CoV2 infections. The objective of the present study was to analyze the recall immune responses carried out by T lymphocytes after two COVID-19 mRNA vaccine doses. Methods: We enrolled 40 patients with BCMs and 10 healthy controls (HCs) after 4 weeks from the second mRNA vaccine dose. Spike (S)-specific T-lymphocyte responses were assessed in peripheral blood mononuclear lymphocytes (PBMCs) by intracellular IFN-γ staining combined with flow cytometry. Furthermore, the humoral response was assessed with the measurement of anti-spike antibodies. Results: From March to July 2021, 40 patients (median age 68) received mRNA vaccines. The overall antibody response for BCMs was 52.5% versus 100% for the healthy controls (p = 0.008). The antibody response was different across BCMs: 18.75% for non-Hodgkin lymphoma, 54.5% for chronic lymphocytic leukemia, and 92.3% for multiple myeloma. Responses varied by malignancy type and treatment, with anti-CD20 therapies showing the lowest response (6.7%). T-lymphocyte analysis revealed reduced numbers and altered differentiation stages in patients compared to the controls. However, the vaccine-induced T response was generally robust, with variations in specific T subpopulations. Conclusions: mRNA vaccines induced significant humoral and cellular immune responses in B-cell lymphoid malignancy patients, although responses varied by treatment type and malignancy. Further research is needed to optimize vaccination strategies in this population.

Maternal-Fetal Transfer of Anti-SARS-CoV-2 Antibodies in Amniotic Fluid: Insights from Maternal Vaccination and COVID-19 Infection.

Objectives: As the COVID-19 pandemic wanes, understanding maternal-fetal antibody transfer remains crucial for optimizing vaccination strategies. This study evaluates anti-SARS-CoV-2 antibody levels in amniotic fluid following maternal BNT162b2 mRNA vaccination and/or COVID-19 infection during early pregnancy, focusing on the first and second trimesters. Methods: A retrospective cohort study was conducted at a tertiary university-affiliated hospital, involving 149 pregnant women who underwent amniocentesis. Anti-SARS-CoV-2 spike IgG levels were measured in amniotic fluid samples. Participants were categorized based on vaccination and infection status: vaccine-only, infection-only, vaccine + infection, and no vaccine/infection. Correlations between antibody levels and the time since vaccination or infection were analyzed. Results: The vaccine + infection group had a higher proportion of positive antibody levels compared to the vaccine-only group (63.6% vs. 35.9%, p = 0.029). Median SARS-CoV-2 IgG levels were significantly higher in the vaccine + infection group (283.0 AU/mL) than in the vaccine-only group (64.1 AU/mL, p = 0.006). Women who received three vaccine doses had higher antibody levels and more positive antibody rates compared to those with one or two doses. A significant negative correlation was found between antibody levels and the interval since the last vaccine dose or infection. Conclusions: Our results indicate the presence of anti-SARS-CoV-2 antibodies in the amniotic fluid, reflecting antibody transfer during early pregnancy. However, a noticeable decrease in immunity was observed, as indicated by declining amniotic fluid antibody levels over time. Further studies are needed to determine the optimal timing and number of boosters required to protect against new variants of SARS-CoV-2.

The Clinical Effectiveness of Single-Dose Human Papillomavirus Vaccination

The human papillomavirus (HPV) vaccine was initially approved for a three-dose regimen. Due to resource limitations, budget constraints, low acceptance, and poor adherence, global vaccination coverage is only 15%. A single-dose regimen could simplify logistics, reduce costs, and improve accessibility. However, its clinical effectiveness remains debatable. This review systematically searched PubMed, Embase, and Cochrane Library, including 42 clinical studies, to assess the effectiveness of a single-dose HPV vaccination for preventing HPV infections, cervical abnormalities, and genital warts. We summarized the effectiveness of bivalent, quadrivalent, and nonavalent vaccines across different age groups and buffer periods, and analyzed the factors contributing to the inconsistency of results. The review also provides insights into designing robust future research to inform single-dose HPV vaccination policies and guidelines, highlighting the need for further research to refine vaccination strategies.

The progress of tumor vaccines clinical trials in non-small cell lung cancer.

Non-small cell lung cancer (NSCLC) remains a significant global health challenge, with high mortality rates and limited treatment options. Tumor vaccines have emerged as a potential therapeutic approach, aiming to stimulate the immune system to specifically target tumor cells. This study screened 283 clinical trials registered on ClinicalTrials.gov through July 31, 2023. After excluding data that did not meet the inclusion criteria, a total of 108 trials were assessed. Data on registered number, study title, study status, vaccine types, study results, conditions, interventions, outcome measures, sponsor, collaborators, drug target, phases, enrollment, start date, completion date and locations were extracted and analyzed. The number of vaccines clinical trials for NSCLC has continued to increase in recent years, the majority of which were conducted in the United States. Most of the clinical trials were at stages ranging from Phase I to Phase II. Peptide-based vaccines accounted for the largest proportion. Others include tumor cell vaccines, DNA/RNA vaccines, viral vector vaccines, and DC vaccines. Several promising tumor vaccine candidates have shown encouraging results in early-phase clinical trials. However, challenges such as heterogeneity of tumor antigens and immune escape mechanisms still need to be addressed. Tumor vaccines represent a promising avenue in the treatment of NSCLC. Ongoing clinical trials are crucial for optimizing vaccine strategies and identifying the most effective combinations. Further research is needed to overcome existing limitations and translate these promising findings into clinical practice, offering new hope for NSCLC patients.

Antibody response of endangered riparian brush rabbits to vaccination against rabbit hemorrhagic disease virus 2.

Rabbit hemorrhagic disease virus 2 (RHDV2; Caliciviridae, Lagovirus europaeus), the cause of a highly transmissible and fatal lagomorph disease, has spread rapidly through the western United States and Mexico, resulting in substantial mortality in domestic and wild rabbits. The disease was first detected in California in May 2020, prompting an interagency/zoo/academia/nonprofit team to implement emergency conservation actions to protect endangered riparian brush rabbits (Sylvilagus bachmani riparius) from RHDV2. Prior to vaccinating wild rabbits, we conducted a vaccine safety trial by giving a single SC dose of Filavac VHD K C+V (Filavie) vaccine to 19 adult wild riparian brush rabbits captured and temporarily held in captivity. Rabbits were monitored for adverse effects, and serum was collected before vaccination, and at 7-10, 14-20, and 60 d post-vaccination. Sera were tested using an ELISA to determine antibody response and timing of seroconversion. Reverse-transcription quantitative real-time PCR (RT-qPCR) was performed on rectal swabs to evaluate infection status. No adverse effects from the vaccine were observed. Before vaccination, 18 of 19 rabbits were seronegative, and RHDV2 was not detected by RT-qPCR on any rectal swabs. After vaccination, all rabbits developed an antibody response, with titers of 1:10-1:160. Seroconversion generally occurred at 7-10 d. The duration of antibody response was ≥60 d in 12 of 13 rabbits. Sixteen animals were released and 4 were recaptured several months later, offering a glimpse into longer duration immune response. Our study has informed vaccination strategies for this species and serves as a model for protecting other vulnerable lagomorphs against RHDV2.

Altered epitopes enhance macrophage-mediated anti-tumour immunity to low-immunogenic tumour mutations.

Personalized neoantigen therapy has shown long-term and stable efficacy in specific patient populations. However, not all patients have sufficient levels of neoantigens for treatment. Although somatic mutations are commonly found in tumours, a significant portion of these mutations do not trigger an immune response. Patients with low mutation burdens continue to exhibit unresponsiveness to this treatment. We propose a design paradigm for neoantigen vaccines by utilizing the highly immunogenic unnatural amino acid p-nitrophenylalanine (pNO2Phe) for sequence alteration of somatic mutations that failed to generate neoepitopes. This enhances the immunogenicity of the mutations and transforms it into a suitable candidate for immunotherapy. The nitrated altered epitope vaccines designed according to this paradigm is capable of activating circulating CD8+ T cells and inducing immune cross-reactivity against autologous mutated epitopes in different MHC backgrounds (H-2Kb, H-2Kd, and human HLA-A02:01), leading to the elimination of tumour cells carrying the mutation. After immunization with the altered epitopes, tumour growth was significantly inhibited. It is noteworthy that nitrated epitopes induce tumour-infiltrating macrophages to differentiate into the M1 phenotype, surprisingly enhancing the MHC II molecule presenting pathway of macrophages. Nitrated epitope-treated macrophages have the potential to cross-activate CD4+ and CD8+ T cells, which may explain why pNO2Phe can enhance the immunogenicity of epitopes. Meanwhile, the immunosuppressive microenvironment of the tumour is altered due to the activation of macrophages. The nitrated neoantigen vaccine strategy enables the design of vaccines targeting non-immunogenic tumour mutations, expanding the pool of potential peptides for personalized and shared novel antigen therapy. This approach provides treatment opportunities for patients previously ineligible for new antigen vaccine therapy.

IgT-mediated mucosal immunity and microbiota dynamics in snakehead (Channa argus) post Aeromonas veronii TH0426 and Aeromonas hydrophila TPS infection: implications for aquaculture disease management.

The aquaculture sector, vital to global food security, grapples with bacterial pathogens compromising fish health and industry sustainability. This investigation probes mucosal immune responses and gut microbiota dynamics in snakehead (Channa argus) post-Aeromonas infection, a prevalent aquaculture challenge. Employing infection models, we delineated the integral role of immunoglobulin T (IgT) in mucosal immunity and its interaction with gut microbiota. Fish from a local farm, maintained under controlled conditions, were infected with Aeromonas veronii TH0426 and Aeromonas hydrophila TPS. Post-infection, daily monitoring and sample collection at specified intervals were conducted for comprehensive analysis. Histopathology, quantitative PCR, immunofluorescence, and microbiota profiling revealed significant immune and microbial changes, particularly at day 7. Intestinal IgT, IgM, and pIgR gene expression surged, indicative of a robust response. Immunofluorescence microscopy confirmed increased IgT+ and pIgR+ cell infiltration in the epithelium. Post-infection dysbiosis, with altered bacterial composition, was partially offset by elevated IgT levels. These insights underscore IgT's crucial function in mucosal defense and suggest potential for probiotic and vaccine strategies to enhance aquaculture disease resilience.

Development of a Ferritin-Based Nanoparticle Vaccine against Classical Swine Fever.

The occurrence of classical swine fever (CSF) poses a significant threat to the global swine industry. Developing an effective and safe vaccine is crucial for preventing and controlling CSF. Here, we constructed self-assembled ferritin nanoparticles fused with the classical swine fever virus (CSFV) E2 protein and a derived B cell epitope (Fe-E2B) using a baculovirus expression system (BVES), demonstrating enhanced immunogenicity. Furthermore, we provide a detailed evaluation of the immunological efficacy of the FeE2B in rabbits. The results showed that robust and sustained antibody responses were detected in rabbits immunized with the Fe-E2B nanoparticle vaccine, comparable to those elicited by commercially available vaccines. Additionally, we demonstrated that the vaccine effectively activated crucial immune factors IFN-γ and IL-4 in vivo, increasing their levels by 1.41-fold and 1.39-fold, respectively. Immunization with Fe-E2B enabled rabbits to avoid viremia and stereotypic fever after CSFV challenge. In conclusion, this study highlights the potential of ferritin nanoparticles as antigen-presenting carriers to induce robust immune responses, proposing a candidate vaccine strategy for the prevention and control of CSF.

Individual and contextual factors associated with measles infection in Malaysia: a multilevel analysis.

Despite effective vaccination strategies, measles remains a global public health challenge. The study explored individual and contextual factors associated with measles infection in Malaysia from 2018 to 2022, informing the development of targeted public health interventions. This cross-sectional study utilised data from the Ministry of Health, the Department of Statistics, and the Department of Environment Malaysia. Multilevel logistic regression analysis was employed to examine individual-level factors, including age, sex, ethnicity, nationality, contact history, travel history, and vaccination status. Concurrently, contextual factors were assessed, encompassing district-level determinants such as population density, median household income, urbanisation, the number of health and rural clinics, vaccination rates, PM2.5 levels, relative humidity, and temperature, to determine their impact on measles infection risk. Measles infection was significantly associated with various individual factors. These included age (adjusted odds ratio [aOR], 1.02; 95% confidence interval [CI], 1.02-1.03), ethnicity, non-Malaysian nationality (aOR, 34.53; 95% CI, 8.42-141.51), prior contact with a measles case (aOR, 2.36; 95% CI, 2.07-2.69), travel history (aOR, 2.30; 95% CI, 1.13-4.70), and vaccination status (aOR, 0.76; 95% CI, 0.72-0.79). Among contextual factors, urbanisation (aOR, 1.56; 95% CI, 1.16-2.10) and the number of clinics (aOR, 0.98; 95% CI, 0.97-0.99) were significant determinants. This multilevel logistic regression analysis illuminates the complexities of measles transmission, advocating public health interventions tailored to individual and contextual vulnerabilities. The findings highlight the need for a synergistic approach that combines vaccination campaigns, healthcare accessibility improvements, and socioeconomic interventions to effectively combat measles.

Update on Hepatitis C Vaccine: Results and Challenges.

Therapy against the Hepatitis C virus (HCV) has significantly improved with the introduction of direct-acting antiviral drugs (DAAs), achieving over 95% sustained virological response (SVR). Despite this, the development of an effective anti-HCV vaccine remains a critical challenge due to the low number of patients treated with DAAs and the occurrence of HCV reinfections in high-risk groups. Current vaccine strategies aim to stimulate either B-cell or T-cell responses. Vaccines based on E1 and E2 proteins can elicit broad cross-neutralizing antibodies against all major HCV genotypes, though with varying efficiencies and without full protection against infection. In humans, the neutralizing antibodies induced by such vaccines mainly target the AR3 region, but their levels are generally insufficient for broad neutralization. Various HCV proteins expressed through different viral vectors have been utilized to elicit T cell immune responses, showing sustained expansion of HCV-specific effector memory T cells and improved proliferation and polyfunctionality of memory T cells over time. However, despite these advancements, the frequency and effectiveness of T-cell responses remain limited.

Re-evaluating polio vaccination strategies in Nepal: transitioning from OPV to fIPV for sustained immunity.

Re-evaluating polio vaccination strategies in Nepal: transitioning from OPV to fIPV for sustained immunity.

Bacterial Membrane Vesicles as a Novel Vaccine Platform against SARS-CoV-2.

Throughout history, infectious diseases have plagued humanity, with outbreaks occurring regularly worldwide. Not every outbreak affects people globally; however, in the case of Coronavirus Disease 2019 (COVID-19), caused by a novel coronavirus (SARS-CoV-2), it reached a pandemic level within a remarkably short period. Fortunately, advancements in medicine and biotechnology have facilitated swift responses to the disease, resulting in the development of therapeutics and vaccines. Nevertheless, the persistent spread of the virus and the emergence of new variants underscore the necessity for protective interventions, leading researchers to seek more effective vaccines. Despite the presence of various types of vaccines, including mRNA and inactivated vaccines against SARS-CoV-2, new platforms have been investigated since the pandemic, and research on bacterial membrane vesicles (BMVs) has demonstrated their potential as a novel COVID-19 vaccine platform. Researchers have explored different strategies for BMV-based COVID-19 vaccines, such as mixing the vesicles with antigenic components of the virus due to their adjuvant capacity or decorating the vesicles with the viral antigens to create adjuvanted delivery systems. These approaches have presented promising results in inducing robust immune responses, but obstacles such as reproducibility in obtaining and homogeneous characterization of BMVs remain in developing vesicle-based vaccines. Overall, the development of BMV-based vaccines represents a novel and promising strategy in the fight against COVID-19. Additional research and clinical trials are needed to further evaluate the potential of these vaccines to offer long-lasting protection against SARS-CoV-2 and its evolving variants.

Multimodal profiling of biostabilized human skin modules reveals a coordinated ecosystem response to injected mRNA-1273 COVID-19 vaccine.

The field of drug development is witnessing a remarkable surge in the development of innovative strategies. There is a need to develop technological platforms capable of generating human data prior to progressing to clinical trials. Here we introduce a new flexible solution designed for the comprehensive monitoring of the natural human skin ecosystem's response to immunogenic drugs over time. Based on unique bioengineering to preserve surgical resections in a long survival state, it allows for the first time a comprehensive analysis of resident immune cells response at both organ and single-cell levels. Upon injection of the mRNA-1273 COVID-19 vaccine, we characterized precise sequential molecular events triggered upon detection of the exogenous substance. The vaccine consistently targets DC/macrophages and mast cells, regardless of the administration route, while promoting specific cell-cell communications in surrounding immune cell subsets. Given its direct translational relevance, this approach provides a multiscale vision of genuine human tissue immunity that could pave the way toward the development of new vaccination and drug development strategies.

First Nationwide Mpox Vaccination Program in the Republic of Korea: Implications for an Enhanced Public Health Response.

On May 1, 2024, the Republic of Korea lifted the infectious disease crisis alert for mpox, almost two years after the first case was reported. The Korea Disease Control and Prevention Agency (KDCA) has led the response, which included diagnosis, epidemiological investigations, treatment, and vaccination. This article particularly reviews the vaccination strategy implemented and proposes suggestions for enhancing future response efforts. Initially, the KDCA recommended pre-exposure prophylaxis for high-risk groups, later expanding to include broader demographics as domestic cases rose. By April 2024, a total of 6,863 individuals had received their first vaccine dose, with 3,875 completing the second dose of third-generation vaccines. Strategies to improve future responses include addressing stigma, securing nationally representative safety data, and conducting vaccine cost-benefit analyses. These measures will help ensure a robust and effective response to future outbreaks.

Sequential Immunization with Vaccines Based on SARS-CoV-2 Virus-like Particles Induces Broadly Neutralizing Antibodies.

Although many people have been vaccinated against COVID-19, infections with SARS-CoV-2 seem hard to avoid. There is a need to develop more effective vaccines and immunization strategies against emerging variants of infectious diseases. To understand whether different immunization strategies using variants sequence-based virus-like particles (VLPs) vaccines could offer superior immunity against future SARS-CoV-2 variants, our team constructed VLPs for the original Wuhan-Hu-1 strain (prototype), Delta (δ) variant, and Omicron (ο) variant of SARS-CoV-2, using baculovirus-insect expression system. Then we used these VLPs to assess the immune responses induced by homologous prime-boost, heterologous prime-boost, and sequential immunizations strategies in a mouse model. Our results showed that the pro+δ+ο sequential strategies elicited better neutralizing antibody responses. These sequential strategies also take advantage of inducing CD4+ T and CD8+ T lymphocytes proliferation and tendency to cytokine of Th1. Currently, our data suggest that sequential immunization with VLPs of encoding spike protein derived from SARS-CoV-2 variants of concern may be a potential vaccine strategy against emerging diseases, such as "Disease X".

Specific antibody responses to Qβ-displayed Plasmodium falciparum-derived UB05 and MSP3 proteins in mother-neonate couples.

Malaria blood-stage parasite is a critical pathogenic stage responsible for serious adverse outcomes in pregnant women and their neonates. Immunoglobulin G (IgG) antibody responses specific to various asexual blood-stage antigens were well reported in non-pregnant individuals. However, little is still known during placental malaria. To assess the antibody responses specific to Plasmodium falciparum-derived MSP3 and UB05 malaria vaccine candidates in mother-neonate couples, mother's peripheral blood and neonate's cord blood samples were collected at delivery. After malaria diagnostic, plasma levels of IgG and IgG subclass responses specific to UB05, MSP3 and UB05-MSP3 were determined using ELISA. As outcomes, both mothers and neonates had significantly higher IgG responses to UB05 and UB05-MSP3 compared to anti-MSP3 IgG (p < 0.05), irrespective of malaria status. Significant negative correlations were observed between IgG levels specific to the three antigens and parasitaemia (p < 0.01). Anti-UB05 and anti-UB05-MSP3 IgG levels in neonates showed a significant positive correlation with the corresponding mothers' antibodies (rs = 0.25 with p = 0.04; rs = 0.31 with p = 0.01, respectively). UB05MSP3-specific IgG3 and IgG1 subclass responses were significantly higher than the IgG4 subclass (p < 0.01). The neonates IgG1 and IgG3 levels positively correlated with the corresponding antibody subclasses of mothers. These findings suggest an association between UB05 and UB05-MSP3-specific antibody responses and malaria control during pregnancy. Maternal-foetal transfer of MSP3 and UB05-specific IgG occurs during pregnancy, suggesting the interest in the future malaria vaccination strategies in pregnant women to generate early protective immunity in baby against malaria.

Phylogeography and reassortment patterns of human influenza A viruses in sub-Saharan Africa

The role of sub-Saharan Africa in the global spread of influenza viruses remains unclear due to insufficient spatiotemporal sequence data. Here, we analyzed 222 codon-complete sequences of influenza A viruses (IAVs) sampled between 2011 and 2013 from five countries across sub-Saharan Africa (Kenya, Zambia, Mali, Gambia, and South Africa); these genomes were compared with 1209 contemporaneous global genomes using phylogeographical approaches. The spread of influenza in sub-Saharan Africa was characterized by (i) multiple introductions of IAVs into the region over consecutive influenza seasons, with viral importations originating from multiple global geographical regions, some of which persisted in circulation as intra-subtype reassortants for multiple seasons, (ii) virus transfer between sub-Saharan African countries, and (iii) virus export from sub-Saharan Africa to other geographical regions. Despite sparse data from influenza surveillance in sub-Saharan Africa, our findings support the notion that influenza viruses persist as temporally structured migrating metapopulations in which new virus strains can emerge in any geographical region, including in sub-Saharan Africa; these lineages may have been capable of dissemination to other continents through a globally migrating virus population. Further knowledge of the viral lineages that circulate within understudied sub-Saharan Africa regions is required to inform vaccination strategies in those regions.

T cell activation markers CD38 and HLA-DR indicative of non-seroconversion in anti-CD20-treated patients with multiple sclerosis following SARS-CoV-2 mRNA vaccination

BackgroundMessenger RNA (mRNA) vaccines provide robust protection against SARS-CoV-2 in healthy individuals. However, immunity after vaccination of patients with multiple sclerosis (MS) treated with ocrelizumab (OCR), a B cell-depleting anti-CD20...

Efficacy and safety of Abdala COVID-19 subunit vaccine in children and adolescents: An open-label, single-arm, phase 2 trial (MEÑIQUE)

Objectives We evaluated the safety, immunogenicity and efficacy of Abdala, a protein subunit vaccine for 2019 coronavirus disease (COVID-19), in children and adolescents. Methods A phase 2, open-label, single-arm clinical trial was carried out. Subjects aged 3 to 18 years were eligible. Abdala vaccine was administered intramuscularly at 0–14-28 days. The main endpoints were safety and the immunobridging analysis with a non-inferiority design, to infer the efficacy of the vaccine in paediatric population based on the comparison of neutralizing antibodies (NAb) to SARS-CoV-2, with adults (19–21 years). The trial is registered with the Cuban Public Registry of Clinical Trials, RPCEC00000390. Results From September 13th to September 17th, 2021, 703 participants were included in the context of a predominantly SARS-CoV-2 Delta variant circulation. The number of individuals who experienced adverse reactions was 264/703 (37·6%). Adverse reactions were mostly mild and occurred at the injection site, which resolved within the first 24–48 h. There were no reports of severe adverse events. For the non-inferiority comparison of 297 children (3–11 years) with 297 adults, the geometric mean (GMT) ratio of SARS-CoV-2 NAb was 0·87 (95% CI 0·69–1·08) and 1·07 (0·82–1·39) in the same comparison for 203 adolescents (12–18 years) and 203 adults. For both age groups, the lower limit of GMT was higher than 0·67. The differences in seroresponse rates of Nab for children were 1% (−2%, 4%) and −3% (−7%, 1%) for adolescents, higher than −10% in both age groups. Conclusions The Abdala vaccine was safe and immunogenic in a paediatric population aged 3–18 years, with inferred efficacy based on non-inferior analysis. The vaccine is very suitable to fit into massive vaccination strategies, considering the advantages of using the same vaccine strength (RBD 50 μg) and schedule of administration for both adults and children, as well as the easy storage and handling conditions at 2–8 °C.