NPJ VaccinesPub Date : 2024-07-25DOI: 10.1038/s41541-024-00922-z
Gang Wang, Abhishek K Verma, Juan Shi, Xiaoqing Guan, David K Meyerholz, Fan Bu, Wei Wen, Bin Liu, Fang Li, Stanley Perlman, Lanying Du
{"title":"Universal subunit vaccine protects against multiple SARS-CoV-2 variants and SARS-CoV.","authors":"Gang Wang, Abhishek K Verma, Juan Shi, Xiaoqing Guan, David K Meyerholz, Fan Bu, Wei Wen, Bin Liu, Fang Li, Stanley Perlman, Lanying Du","doi":"10.1038/s41541-024-00922-z","DOIUrl":"10.1038/s41541-024-00922-z","url":null,"abstract":"<p><p>Although Omicron RBD of SARS-CoV-2 accumulates many mutations, the backbone region (truncated RBD) of spike protein is highly conserved. Here, we designed several subunit vaccines by keeping the conserved spike backbone region of SARS-CoV-2 Omicron BA.1 subvariant (S-6P-no-RBD), or inserting the RBD of Delta variant (S-6P-Delta-RBD), Omicron (BA.5) variant (S-6P-BA5-RBD), or ancestral SARS-CoV-2 (S-6P-WT-RBD) to the above backbone construct, and evaluated their ability to induce immune responses and cross-protective efficacy against various SARS-CoV-2 variants and SARS-CoV. Among the four subunit vaccines, S-6P-Delta-RBD protein elicited broad and potent neutralizing antibodies against all SARS-CoV-2 variants tested, including Alpha, Beta, Gamma, and Delta variants, the BA.1, BA.2, BA.2.75, BA.4.6, and BA.5 Omicron subvariants, and the ancestral strain of SARS-CoV-2. This vaccine prevented infection and replication of SARS-CoV-2 Omicron, and completely protected immunized mice against lethal challenge with the SARS-CoV-2 Delta variant and SARS-CoV. Sera from S-6P-Delta-RBD-immunized mice protected naive mice against challenge with the Delta variant, with significantly reduced viral titers and without pathological effects. Protection correlated positively with the serum neutralizing antibody titer. Overall, the designed vaccine has potential for development as a universal COVID-19 vaccine and/or a pan-sarbecovirus subunit vaccine that will prevent current and future outbreaks caused by SARS-CoV-2 variants and SARS-related CoVs.</p>","PeriodicalId":19335,"journal":{"name":"NPJ Vaccines","volume":null,"pages":null},"PeriodicalIF":6.9,"publicationDate":"2024-07-25","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11272943/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141760061","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
NPJ VaccinesPub Date : 2024-07-22DOI: 10.1038/s41541-024-00924-x
Syamala Rani Thimmiraju, Rakesh Adhikari, JeAnna R Redd, Maria Jose Villar, Jungsoon Lee, Zhuyun Liu, Yi-Lin Chen, Suman Sharma, Amandeep Kaur, Nestor L Uzcategui, Shannon E Ronca, Wen-Hsiang Chen, Jason T Kimata, Bin Zhan, Ulrich Strych, Maria Elena Bottazzi, Peter J Hotez, Jeroen Pollet
{"title":"A trivalent protein-based pan-Betacoronavirus vaccine elicits cross-neutralizing antibodies against a panel of coronavirus pseudoviruses.","authors":"Syamala Rani Thimmiraju, Rakesh Adhikari, JeAnna R Redd, Maria Jose Villar, Jungsoon Lee, Zhuyun Liu, Yi-Lin Chen, Suman Sharma, Amandeep Kaur, Nestor L Uzcategui, Shannon E Ronca, Wen-Hsiang Chen, Jason T Kimata, Bin Zhan, Ulrich Strych, Maria Elena Bottazzi, Peter J Hotez, Jeroen Pollet","doi":"10.1038/s41541-024-00924-x","DOIUrl":"10.1038/s41541-024-00924-x","url":null,"abstract":"<p><p>The development of broad-spectrum coronavirus vaccines is essential to prepare for future respiratory virus pandemics. We demonstrated broad neutralization by a trivalent subunit vaccine, formulating the receptor-binding domains of SARS-CoV, MERS-CoV, and SARS-CoV-2 XBB.1.5 with Alum and CpG55.2. Vaccinated mice produced cross-neutralizing antibodies against all three human Betacoronaviruses and others currently exclusive to bats, indicating the epitope preservation of the individual antigens during co-formulation and the potential for epitope broadening.</p>","PeriodicalId":19335,"journal":{"name":"NPJ Vaccines","volume":null,"pages":null},"PeriodicalIF":6.9,"publicationDate":"2024-07-22","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11271464/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141734676","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
NPJ VaccinesPub Date : 2024-07-20DOI: 10.1038/s41541-024-00925-w
Jianglong Li, Pengcheng Yu, Qi Liu, Long Xu, Yan Chen, Yan Li, Fan Zhang, Wuyang Zhu, Yucai Peng
{"title":"Safety and efficacy assessment of an mRNA rabies vaccine in dogs, rodents, and cynomolgus macaques.","authors":"Jianglong Li, Pengcheng Yu, Qi Liu, Long Xu, Yan Chen, Yan Li, Fan Zhang, Wuyang Zhu, Yucai Peng","doi":"10.1038/s41541-024-00925-w","DOIUrl":"10.1038/s41541-024-00925-w","url":null,"abstract":"<p><p>Rabies is a lethal disease caused by the rabies virus (RABV), which causes acute neurological infections in mammals, including human beings. We previously reported that an mRNA vaccine (LVRNA001) encoding the rabies virus's glycoprotein induced strong protective immune responses to rabies in mice and dogs. Here, we further evaluate the safety of LVRNA001. First, we performed a confirmative efficacy study in dogs, which showed that LVRNA001 fully protected the animals from the virus, both pre- and post-infection. Moreover, using pre- and post-exposure prophylaxis murine models, we showed that LVRNA001, built from the CTN-1 strain, was able to protect against various representative RABV strains from the China I-VII clades. To evaluate the safety of the vaccine, chronic and reproductive toxicity studies were performed with cynomolgus macaques and rats, respectively. In a repeated-dose chronic toxicity study, vaccinated monkeys displayed no significant alterations in body weight, temperature, or hematological and biochemical markers. Lymphocyte subset measurement and histopathological examination showed that no toxicity was associated with the vaccine. The immunogenicity study in cynomolgus macaques demonstrated that LVRNA001 promoted the generation of neutralizing antibodies and Th1-biased immune response. Evaluation of reproductive toxicity in rats revealed that administration of LVRNA001 had no significant effects on fertility, maternal performance, reproductive processes, and postnatal outcomes. In conclusion, LVRNA001 can provide efficient protection against rabies virus infection in dogs and mice, and toxicity studies showed no significant vaccine-related adverse effects, suggesting that LVRNA001 is a promising and safe vaccine candidate for rabies prophylaxis and therapy.</p>","PeriodicalId":19335,"journal":{"name":"NPJ Vaccines","volume":null,"pages":null},"PeriodicalIF":6.9,"publicationDate":"2024-07-20","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11271276/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141734677","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
NPJ VaccinesPub Date : 2024-07-20DOI: 10.1038/s41541-024-00913-0
Imaima Casubhoy, Alyssa Kretz, Heang-Lee Tan, Laura A St Clair, Maclaine Parish, Hana Golding, Susan J Bersoff-Matcha, Catherine Pilgrim-Grayson, Leah Berhane, Andrew Pekosz, Heba H Mostafa, Andrea L Cox, Irina Burd, Sabra L Klein, Rosemary Morgan
{"title":"A scoping review of global COVID-19 vaccine hesitancy among pregnant persons.","authors":"Imaima Casubhoy, Alyssa Kretz, Heang-Lee Tan, Laura A St Clair, Maclaine Parish, Hana Golding, Susan J Bersoff-Matcha, Catherine Pilgrim-Grayson, Leah Berhane, Andrew Pekosz, Heba H Mostafa, Andrea L Cox, Irina Burd, Sabra L Klein, Rosemary Morgan","doi":"10.1038/s41541-024-00913-0","DOIUrl":"10.1038/s41541-024-00913-0","url":null,"abstract":"<p><p>Uptake of the COVID-19 vaccine among pregnant persons is lower than the general population. This scoping review explored pregnant people's attitudes towards the COVID-19 vaccine, reasons for vaccine hesitancy, and whether attitudes about COVID-19 vaccines differ by country of origin. A scoping review was conducted across PubMed, Embase, CINHAL, and Scopus. Inclusion criteria were articles published in English from 2019-2022 focused on attitudes towards COVID-19 vaccination among pregnant persons. Data analysis was done via the 5Cs framework for vaccine hesitancy: Constraints, Complacency, Calculation, Confidence, and Collective Responsibility. 44 articles were extracted. A lack of confidence in vaccine safety was the most prevalent theme of hesitancy among pregnant persons. This was largely driven by a lack of access to information about the vaccine as well as mistrust of the vaccine and medical professionals. Meanwhile, vaccine acceptance was mostly driven by a desire to protect themselves and their loved ones. Overall, COVID-19 vaccine hesitancy among pregnant persons continues to be high. Vaccine hesitancy is primarily driven by fear of the unknown side effects of the vaccine on pregnant persons and their fetuses along with a lack of information and medical mistrust. Some differences can be seen between high income and low- and middle-income countries regarding vaccine hesitancy, showing that a single solution cannot be applied to all who are vaccine hesitant. General strategies, however, can be utilized to reduce vaccine hesitancy, including advocating for inclusion of pregnant persons in clinical trials and incorporating consistent COVID-19 vaccine counseling during prenatal appointments.</p>","PeriodicalId":19335,"journal":{"name":"NPJ Vaccines","volume":null,"pages":null},"PeriodicalIF":6.9,"publicationDate":"2024-07-20","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11271279/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141734675","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
NPJ VaccinesPub Date : 2024-07-17DOI: 10.1038/s41541-024-00919-8
Gemma E Hartley, Holly A Fryer, Paul A Gill, Irene Boo, Scott J Bornheimer, P Mark Hogarth, Heidi E Drummer, Robyn E O'Hehir, Emily S J Edwards, Menno C van Zelm
{"title":"Homologous but not heterologous COVID-19 vaccine booster elicits IgG4+ B-cells and enhanced Omicron subvariant binding.","authors":"Gemma E Hartley, Holly A Fryer, Paul A Gill, Irene Boo, Scott J Bornheimer, P Mark Hogarth, Heidi E Drummer, Robyn E O'Hehir, Emily S J Edwards, Menno C van Zelm","doi":"10.1038/s41541-024-00919-8","DOIUrl":"10.1038/s41541-024-00919-8","url":null,"abstract":"<p><p>Booster vaccinations are recommended to improve protection against severe disease from SARS-CoV-2 infection. With primary vaccinations involving various adenoviral vector and mRNA-based formulations, it remains unclear if these differentially affect the immune response to booster doses. We examined the effects of homologous (mRNA/mRNA) and heterologous (adenoviral vector/mRNA) vaccination on antibody and memory B cell (Bmem) responses against ancestral and Omicron subvariants. Healthy adults who received primary BNT162b2 (mRNA) or ChAdOx1 (vector) vaccination were sampled 1-month and 6-months after their 2nd and 3rd dose (homologous or heterologous) vaccination. Recombinant spike receptor-binding domain (RBD) proteins from ancestral, Omicron BA.2 and BA.5 variants were produced for ELISA-based serology, and tetramerized for immunophenotyping of RBD-specific Bmem. Dose 3 boosters significantly increased ancestral RBD-specific plasma IgG and Bmem in both cohorts. Up to 80% of ancestral RBD-specific Bmem expressed IgG1<sup>+</sup>. IgG4<sup>+</sup> Bmem were detectable after primary mRNA vaccination, and expanded significantly to 5-20% after dose 3, whereas heterologous boosting did not elicit IgG4<sup>+</sup> Bmem. Recognition of Omicron BA.2 and BA.5 by ancestral RBD-specific plasma IgG increased from 20% to 60% after the 3rd dose in both cohorts. Reactivity of ancestral RBD-specific Bmem to Omicron BA.2 and BA.5 increased following a homologous booster from 40% to 60%, but not after a heterologous booster. A 3rd mRNA dose generates similarly robust serological and Bmem responses in homologous and heterologous vaccination groups. The expansion of IgG4<sup>+</sup> Bmem after mRNA priming might result from the unique vaccine formulation or dosing schedule affecting the Bmem response duration and antibody maturation.</p>","PeriodicalId":19335,"journal":{"name":"NPJ Vaccines","volume":null,"pages":null},"PeriodicalIF":6.9,"publicationDate":"2024-07-17","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11252355/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141627230","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
NPJ VaccinesPub Date : 2024-07-16DOI: 10.1038/s41541-024-00921-0
Ali Azizi, Deborah Ogbeni, Gathoni Kamuyu, Lauren M Schwartz, Carolyn Clark, Peter Spencer, Valentina Bernasconi
{"title":"Standardized immunological assays for assessing COVID-19 vaccines by the CEPI-Centralized Laboratory Network.","authors":"Ali Azizi, Deborah Ogbeni, Gathoni Kamuyu, Lauren M Schwartz, Carolyn Clark, Peter Spencer, Valentina Bernasconi","doi":"10.1038/s41541-024-00921-0","DOIUrl":"10.1038/s41541-024-00921-0","url":null,"abstract":"<p><p>The CEPI Centralized Laboratory Network implemented key steps in the transfer and monitoring of the developed immunological SARS-CoV-2 assays to ensure standardization across all the facilities of the network. This comprehensive evaluation reinforces the reliability of the generated data and establishes a solid foundation for a standardized approach, enabling precise inter-laboratory comparisons and contributing to the overall integrity of our network's clinical results. Herein, we will provide a brief elaboration on the specific measures and procedures implemented to standardize the transfer of assays across our network.</p>","PeriodicalId":19335,"journal":{"name":"NPJ Vaccines","volume":null,"pages":null},"PeriodicalIF":6.9,"publicationDate":"2024-07-16","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11252371/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141627231","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
NPJ VaccinesPub Date : 2024-07-13DOI: 10.1038/s41541-024-00916-x
Annika Graaf-Rau, Kathrin Schmies, Angele Breithaupt, Kevin Ciminski, Gert Zimmer, Artur Summerfield, Julia Sehl-Ewert, Kathrin Lillie-Jaschniski, Carina Helmer, Wiebke Bielenberg, Elisabeth Grosse Beilage, Martin Schwemmle, Martin Beer, Timm Harder
{"title":"Reassortment incompetent live attenuated and replicon influenza vaccines provide improved protection against influenza in piglets.","authors":"Annika Graaf-Rau, Kathrin Schmies, Angele Breithaupt, Kevin Ciminski, Gert Zimmer, Artur Summerfield, Julia Sehl-Ewert, Kathrin Lillie-Jaschniski, Carina Helmer, Wiebke Bielenberg, Elisabeth Grosse Beilage, Martin Schwemmle, Martin Beer, Timm Harder","doi":"10.1038/s41541-024-00916-x","DOIUrl":"10.1038/s41541-024-00916-x","url":null,"abstract":"<p><p>Swine influenza A viruses (swIAV) cause an economically important respiratory disease in modern pig production. Continuous virus transmission and antigenic drift are difficult to control in enzootically infected pig herds. Here, antibody-positive piglets from a herd enzootically infected with swIAV H1N2 (clade 1 A.3.3.2) were immunized using a homologous prime-boost vaccination strategy with novel live attenuated influenza virus (LAIV) based on a reassortment-incompetent bat influenza-swIAV chimera or a vesicular stomatitis virus-based replicon vaccine. Challenge infection of vaccinated piglets by exposure to H1N2 swIAV-infected unvaccinated seeder pigs showed that both LAIV and replicon vaccine markedly reduced virus replication in the upper and lower respiratory tract, respectively, compared to piglets immunized with commercial heterologous or autologous adjuvanted whole-inactivated virus vaccines. Our novel vaccines may aid in interrupting continuous IAV transmission chains in large enzootically infected pig herds, improve the health status of the animals, and reduce the risk of zoonotic swIAV transmission.</p>","PeriodicalId":19335,"journal":{"name":"NPJ Vaccines","volume":null,"pages":null},"PeriodicalIF":6.9,"publicationDate":"2024-07-13","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11246437/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141603989","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
NPJ VaccinesPub Date : 2024-07-12DOI: 10.1038/s41541-024-00918-9
Christopher A Cottrell, Payal P Pratap, Kimberly M Cirelli, Diane G Carnathan, Chiamaka A Enemuo, Aleksandar Antanasijevic, Gabriel Ozorowski, Leigh M Sewall, Hongmei Gao, Joel D Allen, Bartek Nogal, Murillo Silva, Jinal Bhiman, Matthias Pauthner, Darrell J Irvine, David Montefiori, Max Crispin, Dennis R Burton, Guido Silvestri, Shane Crotty, Andrew B Ward
{"title":"Priming antibody responses to the fusion peptide in rhesus macaques.","authors":"Christopher A Cottrell, Payal P Pratap, Kimberly M Cirelli, Diane G Carnathan, Chiamaka A Enemuo, Aleksandar Antanasijevic, Gabriel Ozorowski, Leigh M Sewall, Hongmei Gao, Joel D Allen, Bartek Nogal, Murillo Silva, Jinal Bhiman, Matthias Pauthner, Darrell J Irvine, David Montefiori, Max Crispin, Dennis R Burton, Guido Silvestri, Shane Crotty, Andrew B Ward","doi":"10.1038/s41541-024-00918-9","DOIUrl":"10.1038/s41541-024-00918-9","url":null,"abstract":"<p><p>Immunodominance of antibodies targeting non-neutralizing epitopes and the high level of somatic hypermutation within germinal centers (GCs) required for most HIV broadly neutralizing antibodies (bnAbs) are major impediments to the development of an effective HIV vaccine. Rational protein vaccine design and non-conventional immunization strategies are potential avenues to overcome these hurdles. Here, we report using implantable osmotic pumps to continuously deliver a series of epitope-targeted immunogens to rhesus macaques over the course of six months to prime and elicit antibody responses against the conserved fusion peptide (FP). GC responses and antibody specificities were tracked longitudinally using lymph node fine-needle aspirates and electron microscopy polyclonal epitope mapping (EMPEM), respectively, to show antibody responses to the FP/N611 glycan hole region were primed, although exhibited limited neutralization breadth. Application of cryoEMPEM delineated key residues for on-target and off-target responses that can drive the next round of structure-based vaccine design.</p>","PeriodicalId":19335,"journal":{"name":"NPJ Vaccines","volume":null,"pages":null},"PeriodicalIF":6.9,"publicationDate":"2024-07-12","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11245479/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141601065","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
NPJ VaccinesPub Date : 2024-07-06DOI: 10.1038/s41541-024-00920-1
Borimas Hanboonkunupakarn, Mavuto Mukaka, Podjanee Jittamala, Kittiyod Poovorawan, Pongphaya Pongsuwan, Lisa Stockdale, Samuel Provstgaard-Morys, Kesinee Chotivanich, Joel Tarning, Richard M Hoglund, Natenapa Chimjinda, Katie Ewer, Fernando Ramos-Lopez, Nicholas P J Day, Arjen M Dondorp, Adrian V Hill, Nicholas J White, Lorenz von Seidlein, Sasithon Pukrittayakamee
{"title":"A randomised trial of malaria vaccine R21/Matrix-M™ with and without antimalarial drugs in Thai adults.","authors":"Borimas Hanboonkunupakarn, Mavuto Mukaka, Podjanee Jittamala, Kittiyod Poovorawan, Pongphaya Pongsuwan, Lisa Stockdale, Samuel Provstgaard-Morys, Kesinee Chotivanich, Joel Tarning, Richard M Hoglund, Natenapa Chimjinda, Katie Ewer, Fernando Ramos-Lopez, Nicholas P J Day, Arjen M Dondorp, Adrian V Hill, Nicholas J White, Lorenz von Seidlein, Sasithon Pukrittayakamee","doi":"10.1038/s41541-024-00920-1","DOIUrl":"10.1038/s41541-024-00920-1","url":null,"abstract":"<p><p>In preparation for mass vaccinations with R21/Matrix-M™ combined with mass administrations of dihydroartemisinin, piperaquine, and a single low dose primaquine we assessed the tolerability, safety, and potential interactions of this combination affecting immunogenicity or pharmacokinetics. 120 healthy Thai volunteers were randomised to receive either antimalarials combined with vaccinations (n = 50), vaccinations alone (n = 50), or antimalarials only (n = 20). Three rounds of vaccines and antimalarials were administered one month apart. The vaccine was well tolerated alone and in combination with the antimalarials. None of the participants failed completion of the 3-dose vaccine course. There was no significant difference in the vaccine immunogenicity or in the pharmacokinetics of piperaquine given individually or in combination. This study supports proceeding to a large trial of mass vaccinations with R21/Matrix-M™ combined with mass antimalarial administration in Bangladesh.</p>","PeriodicalId":19335,"journal":{"name":"NPJ Vaccines","volume":null,"pages":null},"PeriodicalIF":6.9,"publicationDate":"2024-07-06","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11227592/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141545113","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
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