Vaccine Safety Research Articles

Quality Control of mRNA Vaccines by Synthetic Ribonucleases: Analysis of the Poly-A-Tail.

The effectivity and safety of mRNA vaccines critically depends on the presence of correct 5' caps and poly-A tails. Due to the high molecular mass of full-size mRNAs, however, the direct analysis by mass spectrometry is hardly possible. Here we describe the use of synthetic ribonucleases to cleave off 5' and 3' terminal fragments which can be further analyzed by HPLC or by LC-MS. Compared to existing methods (e.g. RNase H), the new approach uses robust catalysts, is free of sequence limitations, avoids metal ions and combines fast sample preparation with high precision of the cut.

Safety, immunogenicity and efficacy of the self-amplifying mRNA ARCT-154 COVID-19 vaccine: pooled phase 1, 2, 3a and 3b randomized, controlled trials

Combination of waning immunity and lower effectiveness against new SARS-CoV-2 variants of approved COVID-19 vaccines necessitates new vaccines. We evaluated two doses, 28 days apart, of ARCT-154, a self-amplifying mRNA COVID-19 vaccine, compared with saline placebo in an integrated phase 1/2/3a/3b controlled, observer-blind trial in Vietnamese adults (ClinicalTrial.gov identifier: NCT05012943). Primary safety and reactogenicity outcomes were unsolicited adverse events (AE) 28 days after each dose, solicited local and systemic AE 7 days after each dose, and serious AEs throughout the study. Primary immunogenicity outcome was the immune response as neutralizing antibodies 28 days after the second dose. Efficacy against COVID-19 was assessed as primary and secondary outcomes in phase 3b. ARCT-154 was well tolerated with generally mild–moderate transient AEs. Four weeks after the second dose 94.1% (95% CI: 92.1–95.8) of vaccinees seroconverted for neutralizing antibodies, with a geometric mean-fold rise from baseline of 14.5 (95% CI: 13.6–15.5). Of 640 cases of confirmed COVID-19 eligible for efficacy analysis most were due to the Delta (B.1.617.2) variant. Efficacy of ARCT-154 was 56.6% (95% CI: 48.7– 63.3) against any COVID-19, and 95.3% (80.5–98.9) against severe COVID-19. ARCT-154 vaccination is well tolerated, immunogenic and efficacious, particularly against severe COVID-19 disease.

A lipid nanoparticle platform incorporating trehalose glycolipid for exceptional mRNA vaccine safety

The rapid development of messenger RNA (mRNA) vaccines formulated with lipid nanoparticles (LNPs) has contributed to control of the COVID-19 pandemic. However, mRNA vaccines have raised concerns about their potential toxicity and clinical safety, including side effects, such as myocarditis, anaphylaxis, and pericarditis. In this study, we investigated the potential of trehalose glycolipids-containing LNP (LNP S050L) to reduce the risks associated with ionizable lipids. Trehalose glycolipids can form hydrogen bonds with polar biomolecules, allowing the formation of a stable LNP structure by replacing half of the ionizable lipids. The efficacy and safety of LNP S050L were evaluated by encapsulating the mRNA encoding the luciferase reporter gene and measuring gene expression and organ toxicity, respectively. Furthermore, mice immunized with an LNP S050L-formulated mRNA vaccine expressing influenza hemagglutinin exhibited a significant reduction in organ toxicity, including in the heart, spleen, and liver, while sustaining gene expression and immune efficiency, compared to conventional LNPs (Con-LNPs). Our findings suggest that LNP S050L, a trehalose glycolipid-based LNP, could facilitate the development of safe mRNA vaccines with improved clinical safety.

Safety, immunogenicity and protective effect of sequential vaccination with inactivated and recombinant protein COVID-19 vaccine in the elderly: a prospective longitudinal study

The safety and efficacy of COVID-19 vaccines in the elderly, a high-risk group for severe COVID-19 infection, have not been fully understood. To clarify these issues, this prospective study followed up 157 elderly and 73 young participants for 16 months and compared the safety, immunogenicity, and efficacy of two doses of the inactivated vaccine BBIBP-CorV followed by a booster dose of the recombinant protein vaccine ZF2001. The results showed that this vaccination protocol was safe and tolerable in the elderly. After administering two doses of the BBIBP-CorV, the positivity rates and titers of neutralizing and anti-RBD antibodies in the elderly were significantly lower than those in the young individuals. After the ZF2001 booster dose, the antibody-positive rates in the elderly were comparable to those in the young; however, the antibody titers remained lower. Gender, age, and underlying diseases were independently associated with vaccine immunogenicity in elderly individuals. The pseudovirus neutralization assay showed that, compared with those after receiving two doses of BBIBP-CorV priming, some participants obtained immunological protection against BA.5 and BF.7 after receiving the ZF2001 booster. Breakthrough infection symptoms last longer in the infected elderly and pre-infection antibody titers were negatively associated with the severity of post-infection symptoms. The antibody levels in the elderly increased significantly after breakthrough infection but were still lower than those in the young. Our data suggest that multiple booster vaccinations at short intervals to maintain high antibody levels may be an effective strategy for protecting the elderly against COVID-19.

Long-Term Safety Analysis of the BBV152 Coronavirus Vaccine in Adolescents and Adults: Findings from a 1-Year Prospective Study in North India.

Evidence on the long-term safety of COVID-19 vaccines is scarce. Here, in continuation of our previously published results on short-term safety, we provide data on the long-term safety of the BBV152 vaccine in adolescents and adults. This was a prospective observational study conducted from January 2022 to August 2023. Adolescents and adults receiving the BBV152 vaccine were interviewed telephonically about long-term adverse events of special interest (AESIs) after 1 year of vaccination. Risk factors of AESIs and AESIs persistent for at least 1 month were identified. Out of 1024 individuals enrolled, 635 adolescents and 291 adults could be contacted during the 1-year follow-up. Viral upper respiratory tract infections were reported by 304 (47.9%) adolescents and 124 (42.6%) adults in this period. New-onset skin and subcutaneous disorders (10.5%), general disorders (10.2%), and nervous system disorders (4.7%) were the common AESIs in adolescents. General disorders (8.9%), musculoskeletal disorders (5.8%), and nervous system disorders (5.5%) were the common AESIs in adults. Menstrual abnormalities were noticed in 4.6% of female participants. Ocular abnormalities and hypothyroidism were observed in 2.7% and 0.6% of participants, respectively. Among serious AESIs (1%), stroke and Guillain-Barre syndrome were identified in 0.3% and 0.1% of participants, respectively. Among adolescents, female individuals, those with a history of allergy and post-vaccination typhoid were respectively at 1.6, 2.8, and 2.8 times higher risk of AESIs. The majority of the AESIs persisted at the 1-year follow-up. Female individuals, adolescents with pre-vaccination COVID-19, those with co-morbidities, and those with post-vaccination typhoid had respectively 1.6, 2, 2.7, and 3.2 times higher odds of persistent AESIs. Adults with co-morbidities had more than 2 times higher odds of AESIs and persistent AESIs. The patterns of AESIs developing after BBV152 differed from those reported with other COVID-19 vaccines as well as between adolescents and adults. With the majority of AESIs persisting for a significant period, extended surveillance of COVID-19-vaccinated individuals is warranted to understand the course and outcomes of late-onset AESIs. Serious AESIs might not be uncommon and necessitate enhanced awareness and larger studies to understand the incidence of immune-mediated phenomena post-COVID-19 vaccination. The relationship of AESIs with sex, co-morbidities, pre-vaccination COVID-19, and non-COVID illnesses should be explored in future studies.

Safety and Immunogenicity of an mRNA-Based hMPV/PIV3 Combination Vaccine in Seropositive Children.

Human metapneumovirus (hMPV) and parainfluenza virus type 3 (PIV3) are common respiratory illnesses in children. The safety and immunogenicity of an investigational mRNA-based vaccine, mRNA-1653, encoding membrane-anchored fusion proteins of hMPV and PIV3, was evaluated in hMPV/PIV3-seropositive children. In this phase 1b randomized, observer-blind, placebo-controlled, dose-ranging study, hMPV/PIV3-seropositive children were enrolled sequentially into 2 dose levels of mRNA-1653 administered 2 months apart; children aged 12 to 36 months were randomized (1:1) to receive 10-μg of mRNA-1653 or placebo and children aged 12 to 59 months were randomized (3:1) to receive 30-μg of mRNA-1653 or placebo. Overall, 27 participants aged 18 to 55 months were randomized; 15 participants received 10-μg of mRNA-1653 (n = 8) or placebo (n = 7), whereas 12 participants received 30-μg of mRNA-1653 (n = 9) or placebo (n = 3). mRNA-1653 was well-tolerated at both dose levels. The only reported solicited local adverse reaction was tenderness at injection site; solicited systemic adverse reactions included grade 1 or 2 chills, irritability, loss of appetite, and sleepiness. A single 10-μg or 30-μg mRNA-1653 injection increased hMPV and PIV3 neutralizing antibody titers (geometric mean fold-rise ratio over baseline: hMPV-A = 2.9-6.1; hMPV-B = 6.2-13.2; PIV3 = 2.8-3.0) and preF and postF binding antibody concentrations (geometric mean fold-rise ratio: hMPV preF = 5.3-6.1; postF = 4.6-6.5 and PIV3 preF = 13.9-14.2; postF = 11.0-12.1); a second injection did not further increase antibody levels in these seropositive children. Binding antibody responses were generally preF biased. mRNA-1653 was well-tolerated and boosted hMPV and PIV3 antibody levels in seropositive children aged 12 to 59 months, supporting the continued development of mRNA-1653 or its components for the prevention of hMPV and PIV3.

Prescription platform and autogenous vaccines – what are they and what is the difference?

Autogenous vaccines – farm- and ranch-specific – have been used for decades to prevent and control diseases where com­mercial vaccines have not been effective. Since the 1970s, the United States Department of Agriculture’s Center for Veterinary Biologics (CVB) has regulated the production of autogenous vaccines that are produced for interstate and intrastate use. In 2018, CVB extended this “autogenous” production to platform technology which allows an opportunity for a wider number of agents to have “prescription” vaccines developed. These “pre­scription” platform (RxP) vaccines can express the important immunizing antigens rather than the whole organism in tradi­tional inactivated autogenous vaccines There is a difference in the specificity and safety of autogenous and RxP vaccines, but both need to be administered with an adjuvant. They each have their advantages and disadvantages. These vaccines are tested for safety and purity, but there is no guarantee of efficacy.

Divided by the jab: affective polarisation based on COVID vaccination status

ABSTRACT Group-based affective polarisation can emerge around new issues that divide citizens. The public response to vaccines against COVID-19 provided a clear example of a new basis for group divides. Despite scientific consensus regarding the dangers of SARS-CoV-2 as well as the safety and effectiveness of available vaccinations, the public response to the COVID-19 pandemic was strongly politicised during the height of the health crisis. Positive social identities and negative out-group stereotyping developed around support or opposition to the vaccines. Panel survey data from Austria shows that vaccination identities are clearly identifiable and are related to extensive trait-based stereotyping of in- and out-group members. Moreover, we show that vaccination identities are linked to political identities and orientations that pre-date the politicisation of COVID-19 vaccines. Indeed, vaccination identities are more strongly related to political orientations than the decision to get vaccinated itself. Importantly, vaccination identities help us understand downstream attitudes, preferences, and behaviours related to the pandemic, even when controlling for other important predictors such as vaccination status and partisanship for anti-vaccine parties. We discuss the implications and generalizability of our findings beyond the context of the pandemic.

Preventive Efficacy, Safety, Immunogenic Activity, and Evaluation of Post-Vaccination Responses Following Immunization with Combined Trivalent Vaccine Vaktrivir (Measles-Rubella-Parotitis) in Premature Infants

Background. Registration of combined trivalent vaccine Vaktrivir (measles-rubella-parotitis) in Russia necessitates studies on its preventive efficacy, safety, immunogenic activity, and post-vaccination responses following the immunization of premature infants. Objective. The aim of the study is to evaluate efficacy, safety, and immunogenic activity of combined trivalent vaccine (measles-rubella-parotitis) and level of post-vaccination responses following the immunization of premature infants. Methods. Experimental studies were conducted to evaluate safety, immunogenicity, and postvaccinal responses after immunization of premature infants with combined within prospective comparative clinical observation. Results. Administration of the combined trivalent vaccine Vaktrivir (measles-rubella-parotitis) in premature infants has shown: no cases of measles, rubella or parotitis among vaccinated persons within prospective clinical observation for 2 years; no disturbances in parameters of clinical blood analysis, biochemical blood count, total IgE, IgA, IgM, IgG (immunogram), or urine analysis among vaccinated children over time; no subjective perceptions, adverse events signs at physical examination among vaccinated compared to baseline parameters; low post-vaccination reactions (6.7%) and similar tolerance of trivalent vaccine Vaktrivir among full-term infants (3.3%) (p = 0.301). Conclusion. Administration of the combined trivalent vaccine Vaktrivir (measles-rubella-parotitis) in premature infants has demonstrated high safety profile and immunogenic properties for measles, rubella and parotitis components, good tolerability, and low post-vaccination responses after immunization, comparable to vaccination of full-term infants.

Dog ecology and rabies control including canine vaccination coverage: Impacts from a survey in Madagascar.

Rabies virus (RABV; species Lyssavirus rabies) is causing one of the oldest zoonotic diseases known to mankind, leading to fatal encephalomyelitis in animals and humans. Despite the existence of safe and effective vaccines to prevent the disease, an estimated 99% of human rabies deaths worldwide are caused by dog-mediated rabies with children at the highest risk of infection. Rabies has been endemic in Madagascar for over a century, yet there has been little research evaluating local knowledge and practices impacting on the rabies control and prevention. Thus, this study was undertaken to better understand the dog ecology including canine vaccine coverage and to assess knowledge and practices of dog owners and veterinarians. A cross-sectional study was conducted among 123 dog-owning households in thirteen fokontanys in Mahajanga from July 4 to September 13, 2016. Single and multi-member dog-owning households in the study area on the day of the interview were eligible for inclusion and purposively selected with the support of a local guide. The survey included a household questionnaire capturing information on the dog's demographics, husbandry practices, knowledge and practices towards rabies and its control measures; the dog ecology questionnaire collected dog characteristics, vaccination status and husbandry practices. All households that reported a dog bite incident, were invited to participate in a dog bite questionnaire. In addition, direct observations of roaming dogs were conducted to assess dog population demographics and to document behavioural characteristics. Two veterinarians were purposively selected and took part in an interview during the survey period, providing information on rabies control activities, including dog-care practices in the area. Descriptive and inferential data analyses were performed using Epi Info version 7.1.5.0 (CDC Atlanta, USA). We recorded a total of 400 dogs, of which 338 (84.5%) were owned amongst 123 households. More than half (67.8%) of owned dogs were between 1 to 5 years old and 95.6% were kept for guarding purposes. 45% of the surveyed dogs had free access to roam outside the premises. The majority (85.4%) of dog owners were knowledgeable that a dog bite could potentially transmit RABV to humans. 19 dog bites were reported and of these 73.6% were caused by the owner's or a neighbour's dog. In 6 of the 19 cases, children between 7 and 15 years of age were the victims. Dog vaccination coverage against rabies was 34% among owned dogs. Of the participants aware of a veterinarian, the majority (55/82) indicated that they accessed veterinarian services at irregular intervals. The main obstacles to vaccinations cited by dog owners were limited financial resources and difficulty accessing veterinary care. This study contributes to enhanced understanding of the dog ecology including canine vaccine coverage as well as knowledge and practices of dog owners in Madagascar. Most dogs in the study area were accessible for preventive vaccination through their owners, however only one third of the investigated canine population was vaccinated against rabies. Concerted national efforts towards rabies prevention and control should aim to address financial challenges and access to veterinary services.

Levels of high-sensitive troponin T and mid-regional pro-adrenomedullin after COVID-19 vaccination

Abstract Funding Acknowledgements Type of funding sources: Public grant(s) – National budget only. Main funding source(s): Federal Ministry of Education and Research. Background/Introduction To increase vaccine safety, adverse events of COVID-19 vaccines are continuously monitored. This also includes rare complications of the cardiovascular system. However, it has so far been scarcely investigated whether chronic and subtle, clinically inapparent myocardial and/or vascular injury occurs in a COVID-19 vaccinated population on a broader basis. Purpose The aim of this study was to analyse chronic and subclinical adverse effects of COVID-19 vaccines on the cardiovascular system. Vaccine-associated myocardial involvement was examined by measuring high-sensitive troponin T (hsTnT) while mid-regional pro-adrenomedullin (MR-proADM) levels were evaluated to assess endothelial dysfunction. Methods This was a prospective observational study with a vulnerable population of healthcare workers (HCWs) and elderly (> 70 years) patients who were vaccinated with either the ChAdOx1 nCov-19 adenoviral vector vaccine (AZ) and the BNT162b2 mRNA vaccine (BNT), or with BNT/BNT between the 12th of January and 30th of November 2021 (Figure 1). HsTnT and MR-proADM was measured in blood samples at three visits (V1: 1st baseline, immediately before vaccination; V2: 3-4 weeks after 1st vaccination; V3: 3-4 weeks after 2nd vaccination). HsTnT levels were further compared with a healthy reference cohort. Results 120 participants were included (V1=119, V2=120, V3=120). 50 (41.7%) received AZ/BNT. 70 (58.3%) were vaccinated with BNT/BNT of whom 20 (16.7%) were elderly and 50 (41.7%) were HCWs. Median hsTnT levels were at 4ng/L, 5ng/L and 4ng/L (V1-V3) for AZ/BNT and at 6ng/L, 6ng/L and 6ng/L (V1-V3) for BNT/BNT, respectively (Figure 2). Levels of MR-proADM were 0.43nmol/L, 0.46nmol/L and 0.44nmol/L (V1-V3) in the AZ/BNT cohort and 0.49nmol/L, 0.43nmol/L and 0.49nmol/L in the BNT/BNT group. Change of hsTnT and MR-proADM values between visits did not show significant increases. Two cases had a transient (7ng/L, 19ng/L, 5ng/L; male, 29 years) or permanent (15ng/L, 21ng/L, 25ng/L; male, 37 years) increase in hsTnT levels, exceeding the upper reference limit (≥ 14ng/L). Compared to the reference population (n=300), median hsTnT was significantly higher at all visits for both vaccination groups (p<0.05), without significant differences between the AZ/BNT and BNT/BNT cohorts. Conclusion(s) With two individual exceptions, no overall chronic myocardial injury or endothelial involvement was observed up to 4 weeks after the 2nd SARS-CoV-2 vaccination when comparing hsTnT and MR-proADM after both vaccinations to baseline values.Figure 1Vaccination scheme.Figure 2.hsTnT values at V1-V3.

Geospatial mapping of public sentiment and infodemic on human papillomavirus vaccination in India: An indication to formulation of strategies for effective implementation

ABSTRACT The implementation of Human Papillomavirus (HPV) vaccination is crucial for eliminating cervical cancer in India. The infodemic, characterised by misleading information, could hinder the successful implementation of the initiative. Misinformation related to the HPV vaccine, such as rumours, has been reported and circulated, contributing to an alarming pattern of vaccine hesitancy observed on social media. This study aimed to identify the public sentiment towards HPV vaccination based on the ‘Behavioral and Social Drivers (BeSD)’ framework through geospatial, content and sentiment analysis. A total of 1,487 tweets were extracted. After preprocessing, 1010 tweets were identified for sentiment and content analysis. The sentiments expressed towards the HPV vaccine are mixed, with a generally positive outlook on the vaccines. Within the population, there is a pervasive proliferation of misinformation, primarily focusing on vaccine safety and efficacy, contentious subjects, ethical considerations, and a prevalent sense of uncertainty in selecting the appropriate vaccine. These observations are crucial for developing targeted strategies to address public concerns and enhance vaccination rates. The insights gained from these results will guide policymakers, healthcare practitioners, and public health organisations to implement evidence-based interventions, thereby countering vaccine hesitancy and improving public health outcomes.

A Chymotrypsin-Dependent Live-Attenuated Influenza Vaccine Provides Protective Immunity against Homologous and Heterologous Viruses

Influenza virus is one of the main pathogens causing respiratory diseases in humans. Vaccines are the most effective ways to prevent viral diseases. However, the limited protective efficacy of current influenza vaccines highlights the importance of novel, safe, and effective universal influenza vaccines. With the progress of the COVID-19 pandemic, live-attenuated vaccines delivered through respiratory mucosa have shown robustly protective efficacy. How to obtain a safe and effective live-attenuated vaccine has become a major challenge. Herein, using the influenza virus as a model, we have established a strategy to quickly obtain a live-attenuated vaccine by mutating the cleavage site of the influenza virus. This mutated influenza virus can be specifically cleaved by chymotrypsin. It has similar biological characteristics to the original strain in vitro, but the safety is improved by at least 100 times in mice. It can effectively protect against lethal doses of both homologous H1N1 and heterologous H5N1 viruses post mucosal administration, confirming that the vaccine generated by this strategy has good safety and broad-spectrum protective activities. Therefore, this study can provide valuable insights for the development of attenuated vaccines for respiratory viruses or other viruses with cleavage sites.

Seroprevalence of Measles (Rubeola) Antibodies in Childhood Cancer Survivors.

Background: Measles is reemerging as a public health threat, raising important questions about disease vulnerability among childhood cancer survivors. This secondary analysis assessed the seroprevalence of anti-measles immunoglobulin G (IgG) antibodies as a marker of immune status in survivors of childhood cancer and associated demographic/treatment variables. Method: Participants were childhood cancer survivors who were free of active disease, having routine blood studies drawn, and could provide documentation of having received two doses of measles, mumps, and rubella vaccine before their cancer diagnosis. Patient record review documented demographic and treatment variables. Antimeasles (rubeola) IgG antibody seroprevalence was assessed by enzyme immunoassay for vaccine-specific antibodies. Results: Of 270 survivors evaluated, 110 (42%) were female, 196 (75%) were White, and 159 (61%) were leukemia/lymphoma survivors. Of these 262, 110 (42%) had negative measles seroprevalence, suggesting loss of immunity. Conclusion: Measles antibody surveillance and the need for reimmunization for survivors of childhood cancer survivors outside the transplant setting remains controversial. Our analysis indicates that a substantial proportion of survivors lose vaccine-related immunity to measles. Pediatric oncology nurses play important roles in educating cancer survivors regarding their risk of measles infection, evaluating the need for reimmunization, correcting misinformation about vaccine safety and effectiveness, and working to optimize community herd-based immunity.

Graduate and Health Professional Student Knowledge, Attitudes, Beliefs, and Behavior Related to Human Papillomavirus and Human Papillomavirus Vaccination: A Scoping Review of the Literature

Human papillomavirus (HPV) is a common sexually transmitted infection. Despite a safe and effective vaccine, uptake continues to be suboptimal. Recently, focus has moved to college campuses in an effort to increase vaccination rates. Little is known about the extent of efforts to reach graduate students on college campuses in the United States and the vaccination rates within this subpopulation. This scoping review assessed the literature on knowledge, attitudes, beliefs, and behaviors about HPV and HPV vaccination among graduate and post-baccalaureate professional students in the United States. This review also aims to identify areas for further research to improve institutions’ abilities to create health programming to increase HPV awareness and HPV vaccination coverage on their campuses. Publications focusing on knowledge, attitudes, beliefs, and behaviors about HPV and HPV vaccination in post-baccalaureate students were included. The systematic review of PubMed, CINAHL, and Embase identified 2562 articles, and 56 articles met all inclusion criteria and were included in this scoping review. A majority of the reviewed studies investigated some combination of knowledge, attitudes, behaviors, and beliefs about HPV and the HPV vaccine in students in professional programs such as medicine. Study design approaches were primarily cross-sectional, utilizing web-based survey distribution methods. HPV vaccination status and HPV screening behaviors were primarily measured through participant self-report. There is limited research investigating post-baccalaureate student knowledge, attitudes, beliefs, and behaviors about HPV and HPV vaccination. There is a need for researchers to further investigate the needs of graduate students to create informative and effective HPV programming.

Communication Strategies to Promote COVID-19 Vaccination Intention: How Effective are Source, Appeal, Framing, and Evidence Type Approaches?

ABSTRACT This systematic review analyzed the effectiveness of key persuasive strategies – source, appeal, framing, and evidence (SAFE) – on COVID-19 vaccination intention. Quantitative studies were searched in Web of Science, Scopus, and PubMed following the PRISMA guidelines. From the 61 studies that met inclusion criteria, source and framing are the most commonly applied SAFE strategies. However, source characteristics are a more consistent influence on vaccine intentions than message framing strategies, with expert sources and general practitioners emerging as the key sources contributing to greater vaccine intentions. In addition, a range of mediators and moderators influence the process through which SAFE message strategies impact vaccine intentions. Framing effects, in particular, are moderated by political identity, source characteristics, and vaccine perceptions. Tests of mediating processes highlight how health behavior judgments (e.g. perceived vaccine benefits, risks, trust in vaccination, perceived severity) and message response/perceptions (e.g. counterarguing, perceived similarity/empathy) operate as key intervening factors between SAFE message strategies and vaccine intentions. Overall, when practitioners apply various structural approaches (narrative elements, fear appeals, framing cues) to vaccine promotion campaigns, they should be cognizant of who is providing that appeal. Targeted populations may benefit most from different structural elements if they are integrated with sources that resonate with the audience.

Safety and immunogenicity of a DNA vaccine with subtype C gp120 protein adjuvanted with MF59® or AS01B: a phase 1/2a HIV-1 vaccine trial

Despite progress in HIV prevention and treatment, an estimated 1.3 million people were newly infected with HIV in 2022,1 highlighting the urgent need for an effective vaccine. To date, the RV144 trial remains the only HIV vaccine trial that has demonstrated partial efficacy against acquisition.2 The Pox-Protein Public-Private Partnership (P5) was established with the aims of improving on RV144 by developing a vaccine capable of protecting against a broader diversity of HIV strains and achieving a better understanding of immune responses associated with preventing HIV infection.3 Vaccine concepts in the P5 program have focused on clade C immunogens, targeting predominant strains of East and Southern Africa, where approximately half of the 39 million people living with HIV reside.1 The RV144 regimen, originally designed to protect against subtype B/E strains, was adapted to incorporate clade C antigens and adjuvanted with MF59®.4 This regimen demonstrated adequate immunogenicity in the HVTN100 phase 1/2a trial,5 and was further evaluated in the HVTN702 efficacy trial in South Africa, but ultimately discontinued due to non-efficacy.6 In parallel, the P5 designed the correlates program: a series of phase 1/2a trials to evaluate vaccine candidates based on favorable immune profiles of putative correlates of protection. These trials employed novel prime-boost and co-administration regimens, varied protein doses, and used new adjuvants and vaccine delivery systems, with an emphasis on shared immunological endpoints to allow for cross-study comparisons. Preclinical studies have shown promising immune responses using DNA/protein combination vaccines.7,8 A comparison of responses between HVTN100 (ALVAC) and HVTN111 (DNA) trials indicated that DNA priming with a protein boost led to increased antibody and cellular responses compared to priming with the canarypox vector.9 In the HVTN105 trial, both a DNA prime-protein boost and a co-administration regimen induced potent and durable V1/V2 binding antibody responses (a known correlate of lower HIV-1 infection risk in RV144), with co-administration inducing early antibody responses.10 Furthermore, in the HVTN096 trial, including gp120 Env protein at the priming stage, co-administered with either NYVAC or DNA, elicited earlier and even greater antibody responses.11 The adjuvant system 01 (AS01) has been successfully tested in vaccine trials for other infectious diseases including malaria,12 shingles,13,14 and tuberculosis.15 Some HIV vaccine studies have also used AS01 and have shown that it contributes to the induction of robust and persistent cellular and humoral responses.16,17 MF59® has likewise been used in several licensed vaccines and pre-clinical studies,18 inducing strong and durable T-cell memory and humoral responses. MF59® was also used in HVTN studies with ALVAC 5 and was therefore chosen for comparison with AS01B in this trial. Thus, the aim of the HVTN108 trial was to evaluate the safety and immunogenicity of the DNA vaccine with different HIV clade C protein doses, adjuvanted with MF59® or AS01B, and dosed in prime-boost or co-administration regimens.

Assessment of Covid-19 vaccine confidence among healthcare personnel in the safety-net sector in the United States and Puerto Rico

BackgroundThis study aimed to assess COVID-19 vaccine confidence among healthcare personnel in the safety net sector of the United States and Puerto Rico. This study aimed to examine the extent to which increased knowledge and positive attitudes toward COVID-19 vaccine safety and efficacy were associated with healthcare workers’ COVID-19 vaccination status and their recommendation of the vaccine to all patients.MethodsOnline survey data were collected from health care workers working in Free and Charitable Clinics across the United States and Federally Qualified Health Centers in Puerto Rico. The survey consisted of 62 questions covering various demographic measures and constructs related to healthcare workers’ vaccination status, beliefs, and recommendations for COVID-19 vaccination. Statistical analyses, including multivariate analysis, were conducted to identify the factors associated with the COVID-19 vaccine status and recommendations among healthcare personnel.ResultsAmong the 2273 respondents, 93% reported being vaccinated against COVID-19. The analysis revealed that respondents who believed that COVID-19 vaccines were efficacious and safe were three times more likely to be vaccinated and twice as likely to recommend them to all their patients. Respondents who believed they had received adequate information about COVID-19 vaccination were 10 times more likely to be vaccinated and four times more likely to recommend it to all their patients.ConclusionsThe study results indicate that healthcare workers’ confidence in COVID-19 vaccines is closely tied to their level of knowledge, positive beliefs, and attitudes about vaccine safety and efficacy. The study emphasizes the significance of healthcare workers feeling well informed and confident in their knowledge to recommend the vaccine to their patients. These findings have important implications for the development of strategies to boost COVID-19 vaccine confidence among healthcare workers and increase vaccine uptake among patients.

Use of UK faith Centre as a COVID-19 community vaccination clinic: exploring a potential model for community-based health care delivery.

Effective and safe vaccines against COVID-19 are essential to achieve global control of the coronavirus (SARS-CoV-2). Using faith centres may offer a promising route for promoting higher vaccine uptake from certain minority ethnic groups known to be more likely to be vaccine hesitant. This cross-sectional study explored attendees' perceptions, experiences of being offered, and receiving COVID-19 vaccination in a local mosque in Woking, Surrey, UK. About 199 attendees completed a brief questionnaire on experiences, views, motivations about attending the mosque and vaccination on site. The most common ethnic groups reported were White British (39.2%) and Pakistani (22.6%); 36.2% identified as Christian, 23.6% as Muslim, 5.5% as Hindu, and 17.1% had no religion. Genders was relatively equal with 90 men (45.2%) and 98 women (49.2%), and 35-44-year-olds represented the most common age group (28.1%). Views and experiences around receiving vaccinations at the mosque were predominantly positive. Primary reasons for getting vaccinated at the mosque included convenience, accessibility, positive aspects of the venue's intercultural relations, and intentions to protect oneself against COVID-19, regardless of venue type. Negative views and experiences in regards to receiving the vaccination at the mosque were less common (7% expressed no intention of recommending the centre to others), and disliked aspects mostly referred to the travel distance and long waiting times. Offering COVID-19 vaccination in faith centres appears acceptable for different faith groups, ensuring convenient access for communities from all religions and ethnic backgrounds.

Vaccination against Measles in Patients with Oncological Disease

Relevance. Growing distrust of vaccines around the world, a decrease in vaccination rates have led to an increase in the incidence of measles and a rise in the vulnerability of people with immunodeficiency status. The aim. To study the efficacy and safety of measles vaccination in children with oncohematological diseases. Materials & methods. The study involved 107 children: 74 of them with a history of acute lymphoblastic leukemia and 33 with solid tumors. All children had a history of receiving standardized polychemotherapy. In all the subjects, the vaccination history was studied, the titers of specific antibodies to measles were determined. Children with non-protective levels of antibodies (53 children) were subsequently vaccinated against measles. Results and discussions. Of the 107 children examined, before cancer, 99 (92.5%) were vaccinated against measles, of which 68 (68.7%) patients were only vaccinated, and 31 (31.3%) had vaccination and revaccination. Protective titers of antibodies against measles were preserved in 51 people (51.5%), and 48 (48.5%) were seronegative. When assessing immunogenicity on days 14, 45 after the introduction of the vaccine, it turned out that by day 14, 27 out of 53 children (50.9%) developed measles antibodies, and by day 45, 33 out of 53 children (62.3%), the rest of the children did not developed a protective level of antibodies, including 3 of 6 revaccinated. Conclusion. Thus, children with malignant diseases, regardless of the number of previous vaccinations and the duration of the end of therapy, become unprotected or have low titers of antibodies to measles in 83.8%, and immunization after treatment is effective in 62.3% of cases.