Evaluation of Persistence of Immunogenicity Following an Open-labelled, Randomized Controlled Trial Evaluating Non-inferiority of 1+1 Compared to 2+1 Dosing Schedules of 10-valent and 13-valent Pneumococcal Conjugate Vaccine in South Africa

This study will evaluate the persistence of immunogenicity following a reduced dosing schedule of 10- or 13-valent Pneumococcal Conjugate Vaccine (PCV10, PCV13). This is the follow-up of a randomized controlled trial in which children received a single priming dose of PCV10 or PCV13 (at 6 or 14 weeks of age) followed by booster dose at 9 months of age (1+1 schedule), compared to a 2+1 PCV schedule (6, 14 weeks of age and 9 months of age).

Start Date14 Feb 2020

Sponsor / Collaborator

University of the Witwatersrand

NCT03489018

/ CompletedPhase 4IIT

The Effect of Fractional Doses of Pneumococcal Conjugate Vaccines (PCV10 and PCV13) on Immunogenicity and Vaccine-serotype Carriage in Kenyan Infants

Before the introduction of pneumonia vaccines in 2000, between 700,000 - 1 million children died each year as a result of infection with the bacteria Streptococcus pneumoniae and the resulting diseases, namely, meningitis, sepsis and pneumonia. Most of the deaths were in Africa and Asia. Where the vaccines have been introduced, they have been highly effective and have already reduced disease. However, at 10 USD per child, they are not affordable to most low-income countries without financial support from Gavi, the Vaccine Alliance.
This project aims to assess whether lower doses of the two commercially available pneumonia vaccines can protect Kenyan infants as well as the full dose. The results could be used to increase the affordability of the pneumonia vaccine, and enable delivery of the vaccine to continue in the absence of Gavi support.

Start Date21 Mar 2019

Sponsor / Collaborator

London School of Hygiene & Tropical Medicine

[+4]

NCT03547271

/ CompletedPhase 3

Immunogenicity and Safety Study of an Investigational Quadrivalent Meningococcal Conjugate Vaccine When Administered Concomitantly With Routine Pediatric Vaccines in Healthy Infants and Toddlers in Europe

Primary objective:
This study aimed to demonstrate the non-inferiority of the antibody response against meningococcal serogroups A, C, Y, and W following the administration of a 3-dose series of MenACYW conjugate vaccine compared to a 3-dose series of a licensed meningococcal vaccine when each vaccine was given concomitantly with routine pediatric vaccines (10-valent pneumococcal vaccine and diphtheria, tetanus, pertussis, hepatitis B, poliomyelitis and Haemophilus influenzae type b [DTaP-IPV-HB-Hib vaccine]) to infants and toddlers 6 weeks to 18 months old
Secondary objectives:
This study aimed to demonstrate the non-inferiority of the antibody (Ab) response against meningococcal serogroups A, C, Y, and W following the administration of 2 doses in infancy of MenACYW conjugate vaccine compared to 2 doses of a licensed meningococcal vaccine when each vaccine was given concomitantly with routine pediatric vaccines (10-valent pneumococcal vaccine and DTaP-IPV-HB-Hib vaccine) to infants and toddlers 6 weeks to 18 months old.
- This study aimed to describe the Ab responses against meningococcal groups A, C, Y, and W and the antigens of the routine pediatric vaccines administered in the study.

Start Date14 Dec 2018

Sponsor / Collaborator

Sanofi Pasteur SA

100 Clinical Results associated with Pneumococcal Polysaccharide Conjugate Vaccine(Glaxosmithkline Plc)

100 Translational Medicine associated with Pneumococcal Polysaccharide Conjugate Vaccine(Glaxosmithkline Plc)

100 Patents (Medical) associated with Pneumococcal Polysaccharide Conjugate Vaccine(Glaxosmithkline Plc)

411

Literatures (Medical) associated with Pneumococcal Polysaccharide Conjugate Vaccine(Glaxosmithkline Plc)

31 Dec 2026·Human Vaccines & Immunotherapeutics

Serotype distribution of Streptococcus pneumoniae in children with invasive diseases in Türkiye, 2019–2025: An update in the 10th to 15th years of routine pneumococcal conjugate vaccination

Article

Author: Karadağ Öncel, Eda ; Ay Altıntop, Yasemin ; Öz, Fatma Nur ; Güdücüoğlu, Hüseyin ; Hazırolan, Gülşen ; Hasçelik, Gülşen ; Duman, Yücel ; Koyuncu Özyurt, Özlem ; Öztürk, Candan ; Özhak Baysan, Betil ; Yılmaz, Nisel ; Emiroğlu, Melike ; Uslu, Hakan ; Akgün Karapınar, Deniz Bahar ; Telli, Murat ; Özakın, Cüneyt ; Hasdemir, Ufuk ; Çizmeci, Zeynep ; Yaman, Akgün ; Öksüz, Lütfiye ; Aydın, Faruk ; Özbek, Özgen Alpay ; Karbuz, Adem ; Devrim, İlker ; Birinci, Asuman ; Öcal, Duygu ; Zer, Yasemin ; Dinleyici, Ener Çağrı ; Sorguç, Yelda ; Aydemir, Sabire Şöhret ; Özkaya, Esra ; Ceyhan, Mehmet ; Kara, Soner Sertan ; Akpolat, Nezahat

Invasive pneumococcal disease (IPD) caused by Streptococcus pneumoniae remains a significant cause of pediatric morbidity. This study updates the serotype distribution and antibiotic resistance of pediatric IPD in Türkiye for 2019-2025, about a decade after 13-valent pneumococcal conjugate vaccine (PCV13) was introduced in the National Immunization Program. We conducted a multicenter, hospital-based prospective surveillance between January 2019-April 2025 in children <18 y across 28 tertiary hospitals. S. pneumoniae isolates from sterile sites (blood, cerebrospinal fluid, pleural fluid) were confirmed by standard methods and serotyped using the Quellung reaction. Antimicrobial susceptibility was determined by gradient test as per CLSI criteria. A total of 203 samples were identified from 203 pediatric cases (median age 4 y, 56.2% boys). The clinical presentations were bacteremia/sepsis (57.6%) and meningitis (26.1%). The leading serotypes were 3 (14.3%), 14 (10.3%), 19F (7.9%), 19A (6.4%), 9N (4.4%), 15A (4.4%). PCV13 serotypes accounted for 46.8% isolates, while PCV7 and PCV10 serotypes were detected in 23.2% and 24.6%, respectively. Broader vaccines would increase coverage: PCV15 (46.8%) and PCV20 (56.7%). Antibiotic susceptibility (non-meningitis breakpoint) remained high for beta-lactams; 91.9% of isolates were penicillin-susceptible, with only 0.7% fully resistant, and cefotaxime resistance was rare (2.7%). Conversely, macrolide resistance was high, with 60.2% of isolates resistant to erythromycin. A decade after PCV13 implementation, vaccine serotypes - particularly 3, 14, 19F, and 19A - still cause nearly half of pediatric IPD, though non-vaccine serotypes such as 9N and 15A are rising. Higher-valent PCVs may improve protection, and continued surveillance is critical to guide vaccine policy and treatment strategies.

01 Nov 2026·Lancet Child & Adolescent Health

Immunogenicity up to age 5 years following a single-dose or two-dose infant primary series of 10-valent or 13-valent pneumococcal conjugate vaccine each followed by a booster dose in South Africa: extended follow-up of a single-centre, open-label, non-inferiority, randomised controlled trial

Article

Author: Kapelus, Daniel J ; Ranchod, Heena ; Richter, Alex G ; Kwatra, Gaurav ; Koen, Anthonet ; Jose, Lisa ; Mukendi, Christian K ; Faustini, Sian E ; Madhi, Shabir A ; Olwagen, Courtney P ; Mutsaerts, Eleonora A M L ; Izu, Alane

BACKGROUND:

Reduced-dosing pneumococcal conjugate vaccine (PCV) schedules (single primary dose plus booster [1+1]) are being considered and have been deployed in the UK. We aimed to evaluate the persistence of serotype-specific immunity until age 5 years in infants randomly assigned to 1+1 or two primary doses plus booster (2+1) schedules of 10-valent (PCV10) or 13-valent (PCV13) vaccine.

METHODS:

In the original, single-centre, open-label, non-inferiority, randomised controlled trial, infants not exposed to HIV were randomly assigned (1:1:1:1:1:1) using block randomisation into the six following groups: single-dose PCV10 or PCV13 at 6 weeks (6w+1) or 14 weeks (14w+1), or two doses of PCV10 or PCV13 at 6 weeks and 14 weeks (2+1), with all receiving a 9-month booster. In this extended follow-up, serotype-specific serum IgG geometric mean concentrations (GMCs) were measured by in-house Luminex assay at age 3 years, 4 years, and 5 years. Non-inferiority was defined as the lower-bound of the 95% CI of the GMC ratio exceeding 0·5 for at least ten of the PCV13 serotypes and at least eight of the PCV10 serotypes. This follow-up study is registered at ClinicalTrials.gov (NCT04275284).

FINDINGS:

In the original trial, of the 1695 who were screened, 600 children were enrolled and randomly assigned to six study groups (100 in each group) from Jan 9 to Sept 20, 2017. Of these, 354 (59%) were included in the follow-up study, including 54 from 6w+1 PCV10, 56 from 14w+1 PCV10, 64 from 2+1 PCV10, 60 from 6w+1 PCV13, 57 from 14w+1 PCV13, and 63 from the 2+1 PCV13 study groups. 986 blood samples were collected across three annual visits (349 at 3 years, 334 at 4 years, and 303 at 5 years) between Feb 18, 2020 and Aug 24, 2022. Both PCV13 1+1 schedules remained non-inferior to the PCV13 2+1 schedule up until age 5 years. Both PCV10 1+1 schedules met non-inferiority at 3 years but did not meet the non-inferiority criteria at 4 years and 5 years. Comparison of the PCV10 2+1 and PCV13 2+1 schedules demonstrated similar IgG GMCs for the ten shared serotypes up until age 5 years, with PCV13 outperforming PCV10 across most serotypes in 1+1 groups.

INTERPRETATION:

A reduced PCV13 1+1 schedule, primed at either 6 weeks or 14 weeks, maintained non-inferior serotype-specific GMCs relative to the PCV13 2+1 schedule up until age 5 years, supporting schedule transition in countries with well established PCV programmes. The PCV10 1+1 schedules did not meet non-inferiority criteria compared with the PCV10 2+1 schedule by age 4 years.

FUNDING:

Gates Foundation and South African Medical Research Council.

01 Oct 2026·Infectious Diseases Now

Impact of pneumococcal conjugate vaccines on S. pneumoniae carriage in infant and toddlers with acute otitis media in Morocco

Article

Author: Abdallaoui, Maha Soussi ; Loudghiri, Abdellatif ; Katfy, Khalid ; Katfy, Mostafa ; Raji, Fatiha ; Benlahcène, Dalila

BACKGROUND:

Streptococcus pneumoniae remains a major cause of pediatric infections despite pneumococcal conjugate vaccines (PCVs). In Morocco, the concurrent use of PCV10 and PCV13 offers a unique opportunity to evaluate their impact on nasopharyngeal carriage and serotype distribution.

OBJECTIVE:

To describe pneumococcal serotypes in the nasopharyngeal flora of young children with acute otitis media (AOM) in Casablanca and to compare serotype distribution according to vaccination status.

METHODS:

In this prospective, multicenter, cross-sectional study (2020-2024), children aged 6-36 months with AOM had a nasopharyngeal swab performed. Isolates were serotyped by Quellung reaction and PCR and classified as vaccine (VTs) or non-vaccine types (NVTs); Haemophilus influenzae isolates were serotyped by slide agglutination.

RESULTS:

Of 442 children, 172 pneumococci were recovered (carriage rate of 38.9%), representing 18 serotypes. PCV10 serotypes accounted for 49.4% and additional PCV13 serotypes for 21.5%; the main non-PCV13 serotypes were 11 A, 15B, and 10 A. Theoretical coverage reached 73.8% for PCV15 and 92.4% for PCV20. Among 136 isolates tested, two were fully penicillin-resistant (MIC >2 mg/L). Of 74H. influenzae isolates, 10.8% were serotype b and 20.3% serotype f; β-lactamase production was found in 10.8%, and a BLNAR phenotype in six isolates (8.1%).

CONCLUSION:

Persistent vaccine-type carriage alongside emerging non-vaccine serotypes indicates incomplete serotype replacement in Morocco. PCV13 provided broader coverage than PCV10, mainly through serotypes 19 A and 3. Most non-PCV13 serotypes were included in PCV20, supporting its potential integration into the national immunization program and continuous serotype surveillance.

News (Medical) associated with Pneumococcal Polysaccharide Conjugate Vaccine(Glaxosmithkline Plc)

18 Mar 2025

·www.globenewswire.com

Curevo Raises $110 Million to Advance Amezosvatein Shingles Vaccine

-- Amezosvatein has shown excellent immunogenicity and improved tolerability in Phase 2 study -- Medicxi leads round, joined by new investors OrbiMed, HBM Healthcare Investments, and Sanofi Ventures -- Former Chair of GSK’s vaccine business and Chief Scientific Advisor to Operation Warp Speed, Moncef Slaoui, to join Curevo as Board Chair March 17, 2025 -- Curevo Vaccine (Curevo), a privately-held clinical-stage biotechnology company dedicated to developing varicella zoster virus (VZV) vaccines with improved tolerability, today announces the closing of a $110 million Series B round to advance development of amezosvatein, its vaccine for shingles. Leading the round is new investor Medicxi, a European biotech-focused investment firm with significant experience investing in vaccine companies such as Vaxcyte and ViceBio. Joining Medicxi is an international group of investment funds including OrbiMed, HBM Healthcare Investments, and Sanofi Ventures plus existing investors RA Capital Management, Janus Henderson Investors, Adjuvant Capital, and founding investor GC Biopharma. “This Series B round will fund the extension of our successful Phase 2 program into an additional 640 participants, including the key population of adults over age 70, to finalize dose selection ahead of the Phase 3 program,” said Curevo’s CEO, George Simeon, MBA/MPH. “Designed based upon feedback from regulators and other stakeholders, this short extension trial will begin mid-2025 and serve to set the company for clinical, strategic, and regulatory success.” Concurrent with the round, Moncef Slaoui, PhD, will join Curevo as Board Chair. Dr. Slaoui was most recently the Chief Scientific Advisor to Operation Warp Speed during the COVID-19 pandemic, helping deliver vaccines against the SARS-CoV-2 virus. He spent nearly 30 years at GlaxoSmithKline, during which he helped shape its vaccine business by contributing to the creation of numerous new vaccines including Shingrix® (shingles), Cervarix® (HPV-induced cervical cancer), Mosquirix® (malaria), Rotarix® (rotavirus gastroenteritis), and Synflorix® (pneumococcal disease). “I have been collaborating with the Curevo team for several weeks now,” stated Dr. Slaoui. “I’m very excited to work with them to help perfect shingles vaccination, adding good tolerability to the exceptional efficacy achieved by the current vaccine. The data so far show Curevo’s adjuvant technology has the attributes to succeed in this endeavor.” Also joining Curevo’s Board of Directors will be Giovanni Mariggi, PhD, co-founder and Partner at Medicxi, an experienced infectious disease investor and board member. “Patients, doctors, and payors are very clear a new shingles vaccine like amezosvatein would be welcome in the global marketplace. Amezosvatein’s activity and improved tolerability profile could allow it to be a significant product in the shingles vaccines market. We are excited to support Curevo’s plan with a streamlined path to approval,” stated Dr. Mariggi. Tal Zaks, MD/PhD, will be joining Curevo’s Board of Directors on behalf of OrbiMed. Dr. Zaks is the former Chief Medical Officer of Moderna, where he led development of their mRNA vaccine against the SARS-CoV-2 virus. He previously held senior leadership positions in drug development at GSK and Sanofi. “OrbiMed has a long history of investing in biotech companies like Curevo seeking to improve healthcare outcomes while creating long-term shareholder value,” said Dr. Zaks. “The fact amezosvatein contains an optimized version of the TLR4 agonist with a known mechanism of action reduces biological risk while providing the competitive advantage of potentially improved tolerability, which should position it as the first choice for people who want to be protected from shingles.” ‘Amezosvatein’ is the assigned non-proprietary name for CRV-101, a non-mRNA adjuvanted subunit vaccine under investigation by Curevo. Like Shingrix, amezosvatein uses a subunit protein antigen called glycoprotein ‘E’ (gE). Targeting the gE antigen is proven to elicit a long-term, protective immune response to prevent shingles. Amezosvatein’s adjuvant contains an optimized version of the TLR4 agonist proven by Shingrix to be biologically active in shingles vaccination. Amezosvatein was engineered to maintain exceptional efficacy and have a best-in-class tolerability profile. The SLA-SE adjuvant formulation was developed at Seattle-based Access to Advanced Health Institute (AAHI) and amezosvatein was licensed from the Mogam Institute for Biomedical Research, a research institute funded by South Korea’s GC Biopharma. Curevo is a privately held, clinical-stage biotechnology company based near Seattle dedicated to reducing the burden of infectious disease by developing vaccines with improved tolerability and accessibility. Curevo’s lead product is amezosvatein, a non-mRNA adjuvanted sub-unit vaccine to prevent shingles, a serious medical condition involving a painful, blistering skin rash where 10-18% of people also develop serious, long-lasting nerve pain. The current $4+ billion shingles vaccine market is characterized by accessibility issues and vaccine hesitancy/dose avoidance related to vaccine tolerability. For more information visit https://curevovaccine.com/. Medicxi is a healthcare-focused investment firm with the mission to create and invest in companies across the full drug development continuum. Leveraging deep expertise in drug development and company creation spanning over two decades, Medicxi invests in early and late-stage therapeutics with a product vision that can fulfill a clear unmet medical need. For more information, please visit: https://www.medicxi.com. OrbiMed is a leading global healthcare investment firm with approximately $17 billion in assets under management. OrbiMed invests globally across the healthcare industry, from start-ups to large multinational corporations, via private equity funds, public equity funds, and royalty/credit funds. OrbiMed seeks to be a capital provider of choice, providing tailored financing solutions and extensive global team resources to help build world-class healthcare companies. OrbiMed’s team of over 100 professionals is based in New York City, London, San Francisco, Shanghai, Hong Kong, Mumbai, Herzliya, and other key global markets. For more information, please visit www.orbimed.com. Switzerland-based HBM Healthcare Investments focuses on the healthcare sector, holding and managing an international portfolio of promising companies in the human medicine, biotechnology, medical technology, diagnostics, and related areas. Many of these companies have their lead products already available on the market or are at an advanced stage of development. The portfolio companies are closely tracked and actively guided in their strategic direction. This is what makes HBM Healthcare Investments an interesting alternative to investments in big pharma and biotechnology companies. HBM Healthcare Investments has an international shareholder base and is listed on SIX Swiss Exchange (SIX:HBMN). Sanofi Ventures is the corporate venture capital arm of Sanofi, focused on investing in promising early-stage healthcare companies. The firm supports pioneering innovations in biotechnology, digital health, and life sciences aligning with Sanofi’s mission to bring life-changing treatments to patients worldwide. For more information, please visit www.sanofiventures.com. Founded in 2004, RA Capital Management is a multi-stage investment manager dedicated to evidence-based investing in public and private healthcare, life sciences, and planetary health companies. RA Capital creates and funds innovative companies, from private seed rounds to public follow-on financings, allowing management teams to drive value creation from inception through commercialization and beyond. RA Capital's knowledge engine is guided by its TechAtlas internal research division, and Raven, RA Capital's healthcare incubator, offers entrepreneurs and innovators a collaborative and comprehensive platform to explore the novel and the re-imagined. RA Capital has more than 150 employees and over $10 billion in assets under management. Janus Henderson Investors exists to help clients achieve their long-term financial goals. Its active management offers clients the opportunity to outperform passive portfolios over the course of market cycles. With more than 360 investment professionals, Janus Henderson Investors provides access to some of the industry’s most talented and innovative thinkers, spanning equities, fixed income, multi-asset, and alternatives, globally. Its investment teams blend insight, originality, and precision with rigorous analysis, structured processes, and robust risk management. Janus Henderson Investors builds client partnerships on openness and trust, channeling expertise from across the business and communicating the views of its experts in a timely and relevant way. https://www.janushenderson.com/ Headquartered in New York, with offices in Zürich, Adjuvant is a global life science investment fund built to accelerate the development of new technologies for the world's most pressing public health challenges. Backed by prominent healthcare and emerging market investors, Adjuvant draws upon its network of scientists, public health experts, biopharmaceutical industry veterans, and development finance professionals to identify new investment opportunities. Adjuvant invests in companies developing promising new vaccines, therapeutics, diagnostics, and medical devices targeting high-burden infectious diseases, maternal and child health, antimicrobial resistance, and malnutrition, with a commitment to make these interventions accessible globally. For more information, visit http://www.adjuvantcapital.com Founding investor GC Biopharma (formerly known as Green Cross Corporation) is a biopharmaceutical company headquartered in Yongin, South Korea. The company has over half a century of experience in the development and manufacturing of plasma derivatives and vaccines and expanded its global presence with the successful USA market entry of ALYGLO™ (intravenous immunoglobulin G) in 2024. In line with its mission to meet the demands of future healthcare, GC Biopharma continues to drive innovation by leveraging its core R&D capabilities in engineering of proteins, mRNAs, and lipid nanoparticle (LNP) drug delivery platforms to develop therapeutics for the field of rare disease as well as I&I (Immunology & Inflammation). To learn more about the company, visit https://www.gcbiopharma.com/eng/ The content above comes from the network. if any infringement, please contact us to modify.

Vaccine

04 Feb 2025

·ir.arcturusrx.com

Arcturus Therapeutics Announces Appointment of Moncef Slaoui, Ph.D., as Chair Designate

SAN DIEGO --(BUSINESS WIRE)--Feb. 4, 2025-- Arcturus Therapeutics Holdings Inc. (the “Company”, “Arcturus”, Nasdaq: ARCT), a commercial messenger RNA medicines company focused on the development of infectious disease vaccines and opportunities within liver and respiratory rare diseases, today announced the appointment of Moncef Slaoui , Ph.D., as Chair Designate. Dr. Slaoui has been serving on the Company’s Board of Directors since June 2024 . “Dr. Moncef Slaoui has a long-proven track record in the pharmaceutical and biotechnology industry, and we are delighted to have him as our Chair Designate,” said Joseph Payne , President & Chief Executive Officer of Arcturus. “We look forward to working with him as we enter a transformative year of advancing our pipeline of therapeutics and vaccines.” “Arcturus has deep expertise in mRNA delivery for therapeutics and a validated commercial stage vaccines platform,” said Dr. Moncef Slaoui . “I am excited to work with the company during this potentially transformational time with multiple key data readouts across its pipeline.” About Dr. Moncef Slaoui Dr. Moncef Slaoui was most recently the Chief Scientific Advisor to Operation Warp Speed. Under his leadership the operation enabled the fastest ever development, manufacturing, and approval of multiple COVID-19 vaccines in less than 11 months after the virus genetic sequence was described. Dr. Slaoui has sat on several biotechnology company boards, including Moderna, Inc. and Lonza Group AG , and he chaired the boards of Galvani, and Vaxcyte, a vaccine development platform company. Dr. Slaoui spent nearly 30 years at GlaxoSmithKline (GSK) holding leadership positions including as member of the Board of Directors of GSK PLC; Chairman of Pharmaceutical R&D; Chairman Global R&D, Vaccines & Oncology; and Chairman, Global Vaccines. As Chairman of Pharmaceutical R&D, Dr. Slaoui led a redesign of GSK’s R&D structure and culture to improve focus on innovation and productivity. As Chairman of Global Vaccines, Dr. Slaoui was directly involved in GSK's vaccine pipeline, leading to the creation of 14 new vaccines, including Shingrix®, to prevent shingles; Cervarix®, to prevent cervical cancer; Mosquirix, to prevent malaria; Rotarix®, to prevent rotavirus gastroenteritis; and Synflorix, to prevent pneumococcal disease. In 2016, Dr. Slaoui was recognized as one of Fortune's 50 Greatest World Leaders for his work in under-researched diseases common in the developing world. He served on the Advisory Committee to the Director of the NIH from 2011 to 2016 and has advised the U.S. President's Council of Advisors on Science and Technology . Dr. Slaoui holds a Ph.D. in Molecular Biology and Immunology from the Université Libre de Bruxelles , completed postdoctoral studies at Harvard Medical School and Tufts University School of Medicine , and was a Professor of Immunology at the University of Mons , Belgium . He received an accelerated Master of Business Administration from IMD, Switzerland in 1998. About Arcturus Founded in 2013 and based in San Diego, California , Arcturus Therapeutics Holdings Inc. (Nasdaq: ARCT) is a commercial mRNA medicines and vaccines company with enabling technologies: (i) LUNAR® lipid-mediated delivery, (ii) STARR® mRNA Technology (sa-mRNA) and (iii) mRNA drug substance along with drug product manufacturing expertise. Arcturus developed KOSTAIVE®, the first self-amplifying messenger RNA (sa-mRNA) COVID vaccine in the world to be approved. Arcturus has an ongoing global collaboration for innovative mRNA vaccines with CSL Seqirus, and a joint venture in Japan , ARCALIS , focused on the manufacture of mRNA vaccines and therapeutics. Arcturus’ pipeline includes RNA therapeutic candidates to potentially treat ornithine transcarbamylase (OTC) deficiency and cystic fibrosis (CF), along with its partnered mRNA vaccine programs for SARS-CoV-2 (COVID-19) and influenza. Arcturus’ versatile RNA therapeutics platforms can be applied toward multiple types of nucleic acid medicines including messenger RNA, small interfering RNA, circular RNA, antisense RNA, self-amplifying RNA, DNA, and gene editing therapeutics. Arcturus' technologies are covered by its extensive patent portfolio (over 400 patents and patent applications in the U.S. , Europe , Japan , China , and other countries). For more information, visit www.ArcturusRx.com. In addition, please connect with us on Twitter and LinkedIn. View source version on businesswire.com: https://www.businesswire.com/news/home/20250204663825/en/ Arcturus Therapeutics Public Relations & Investor Relations Neda Safarzadeh VP, Head of IR/PR/Marketing (858) 900-2682 IR@ArcturusRx.com Source: Arcturus Therapeutics Holdings Inc.

VaccineExecutive ChangemRNA

08 Jan 2025

·abzena.com

Abzena Strengthens Board with Appointment of Biopharma Industry Leader, Dr Moncef Slaoui

San Diego, CA, January 8, 2025 – Abzena, the leading end-to-end integrated CDMO + CRO for complex biologics and bioconjugates, has today announced the appointment of Moncef Slaoui, PhD, to its Board of Directors. A highly accomplished leader in the biopharmaceutical industry with over 40 years’ experience, Dr Slaoui has held numerous executive leadership and board level positions, to help drug development companies through high phases of growth. Matt Stober, Former CEO of Abzena said, “Dr Slaoui’s exceptional track record of leadership and expertise in product innovation will be extremely valuable as we continue to grow and position ourselves as the leading drug development and manufacturing organization for complex biologics and bioconjugates. We welcome him to our board and look forward to leveraging his extensive experience in supporting high‐growth pharmaceutical businesses.” “I am thrilled to be joining Abzena’s Board of Directors,” said Slaoui. “Abzena is a true innovator in the CRO and CDMO space, and I look forward to helping them develop new technologies and platforms that enable the better delivery of next gen therapeutics.” “I am delighted that Moncef has accepted this position,” said Geoffrey Glass, Chairman of Abzena’s Board. “Moncef brings a set of highly relevant skills and experience to the board, and I look forward to working with him and our executive team as we support Abzena through its next stage of growth.” Dr Moncef Slaoui currently serves as an advisor to Medicxi and is on the Board of Directors of several companies including Cedar Health, Arcturus Therapeutics, Altesa, Zephyr AI and Vicebio. He has previously sat on biotechnology company boards for Moderna, Inc., Lonza Group AG, Galvani, and Vaxcyte. During the COVID-19 pandemic, he served as the Chief Scientific Advisor to Operation Warp Speed, where his leadership enabled the fastest manufacturing, approval and deployment of multiple COVID-19 vaccines in the US. Dr Slaoui spent three decades of his career at GlaxoSmithKline (GSK), where he held several senior leadership positions, including being a member of the Board of Directors of GSK PLC, Chairman of Pharmaceutical R&D, Chairman Global R&D, Vaccines & Oncology, and Chairman, Global Vaccines. During his tenure, he led GSK’s Pharmaceutical R&D restructuring to improve its focus on innovation and productivity and was directly involved in the development of 14 new vaccines, including Shingrix, Cervarix, Mosquirix, Rotarix®, and Synflorix. Moncef holds a PhD in Molecular Biology and Immunology from the Université Libre de Bruxelles and completed his postdoctoral studies at Harvard Medical School and Tufts University. He also has an accelerated MBA from IMD in Switzerland.

VaccineExecutive Change

100 Deals associated with Pneumococcal Polysaccharide Conjugate Vaccine(Glaxosmithkline Plc)

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KEGG	Wiki	ATC	Drug Bank
D10601	Pneumococcal Polysaccharide Conjugate Vaccine(Glaxosmithkline Plc)	J07AL52	-

R&D Status

Approved

10 top approved records.

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Indication	Country/Location	Organization	Date
Otitis Media	Japan	GSK Plc	17 Apr 2015
Pneumococcal Infections	Japan	Japan Vaccine Co., Ltd.	26 Mar 2015
Pneumonia	Canada	GSK Plc	22 May 2009
Acute otitis media	European Union	GlaxoSmithKline Biologicals SA	29 Mar 2009
Acute otitis media	Iceland	GlaxoSmithKline Biologicals SA	29 Mar 2009
Acute otitis media	Liechtenstein	GlaxoSmithKline Biologicals SA	29 Mar 2009
Acute otitis media	Norway	GlaxoSmithKline Biologicals SA	29 Mar 2009
invasive Streptococcus pneumoniae infection	European Union	GlaxoSmithKline Biologicals SA	29 Mar 2009
invasive Streptococcus pneumoniae infection	Iceland	GlaxoSmithKline Biologicals SA	29 Mar 2009
invasive Streptococcus pneumoniae infection	Liechtenstein	GlaxoSmithKline Biologicals SA	29 Mar 2009
invasive Streptococcus pneumoniae infection	Norway	GlaxoSmithKline Biologicals SA	29 Mar 2009

Developing

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Pneumonia, Pneumococcal	Phase 3	Mexico	GSK Plc	03 Jul 2007
Community Acquired Pneumonia	Phase 3	Argentina	GSK Plc	28 Jun 2007
Community Acquired Pneumonia	Phase 3	Colombia	GSK Plc	28 Jun 2007
Community Acquired Pneumonia	Phase 3	Panama	GSK Plc	28 Jun 2007
Streptococcal Infections	Phase 3	Philippines	GSK Plc	07 Aug 2006
Streptococcal Infections	Phase 3	Poland	GSK Plc	07 Aug 2006

Clinical Result

Indication

Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT00624819 (CTgov)	Phase 3	Pneumonia, Pneumococcal	524	GSK1024805A+Varilrix+Infanrix hexa+Havrix (Synflorix + Infanrix + Havrix and/or Varilrix Group)	illovdrglr = chejddafuj uejapvatix (stytqssmtb, fjnlxksqws - pklqinksfj) View more	-	18 Mar 2020
				Varilrix+Infanrix hexa+Havrix+Prevenar (Prevenar + Infanrix + Havrix and/or Varilrix Group)	illovdrglr = etututmmdr uejapvatix (stytqssmtb, jwybnqgcfv - gswnttqbsm) View more
NCT01027845 (CTgov)	Phase 3	Streptococcal Infections	360	Pneumococcal vaccine GSK1024850A+DTPa (10Pn Group)	oeifkgxgnm(lttvxuiret) = ypinzkkaap cksjlsppfm (lihaovfosz, qclphymxud - ktellumpab) View more	-	29 Nov 2019
				DTPa (DTPa Group)	oeifkgxgnm(lttvxuiret) = pmgpvkzedg cksjlsppfm (lihaovfosz, yrzijmefbq - bchfcdsmkx) View more
NCT01175083 (CTgov)	Phase 3	Streptococcal Infections	300	GSK1024850A+Tritanrix-HepB/Hib+Polio Sabin (Tritanrix-HepB/Hib+Polio Sabin <6S Group)	tzmrcharfj(lvbocjqfyz) = yjixtuhaos hniqwozhhz (rarrwcolhb, smhksqyodu - omjltccwbq) View more	-	06 Jun 2019
				GSK1024850A+Tritanrix-HepB/Hib+Polio Sabin (Tritanrix-HepB/Hib+Polio Sabin <6NS Group)	tzmrcharfj(lvbocjqfyz) = tjmusdcmeg hniqwozhhz (rarrwcolhb, xuhjkkkndm - xpnjzmphzi) View more
NCT00496015 (CTgov)	Phase 3	Streptococcal Infections	750	Pneumococcal conjugate vaccine GSK1024850A.+Paracetamol.+Infanrix hexa. (Synflorix I Group)	fbabdetdoy = unmixtqjxy pnwyyrkzqn (mdkfadhwpm, glilxjqbqx - mjquwxorhy) View more	-	18 Jan 2019
				Pneumococcal conjugate vaccine GSK1024850A.+Infanrix hexa. (Synflorix II Group)	fbabdetdoy = cdifmiouyr pnwyyrkzqn (mdkfadhwpm, ywykjjgjde - zhdzquccet) View more
NCT00345358 (CTgov)	Phase 3	Streptococcal Infections	600	Synflorix+Infanrix IPV/Hib (Synflorix <6M Group)	ucdtwexnnt = ldzhvlvdrz fbtgoapobb (jtswwrzjtn, ddjqhygyfz - vetyksvidh) View more	-	15 Jan 2019
				Synflorix (Synflorix 7-11M Group)	ucdtwexnnt = uhcvgfetpf fbtgoapobb (jtswwrzjtn, qemkvlnkph - nfrruasemq) View more
NCT00547248 (CTgov)	Phase 3	Streptococcal Infections	756	Synflorix+Tritanrix-HepB+Hiberix+Polio Sabin (Synflorix + Tritanrix -HepB/ Hiberix + Polio Sabin Group)	ikvgzscvjl = lhbyoacwdl gxhttwfjmp (bovlixadpz, layivzkpku - jffbgsruje) View more	-	14 Jan 2019
				Tritanrix-HepB+Hiberix+Polio Sabin+Prevenar (Prevenar + Tritanrix - HepB/ Hiberix + Polio Sabin Group)	ikvgzscvjl = qkkkajnsry gxhttwfjmp (bovlixadpz, ufjqxbgijy - hzgopiotvt) View more
NCT00390910 (CTgov)	Phase 3	Pneumococcal Infections	286	Pneumococcal conjugate vaccine GSK1024850A+Infanrix hexa (Synflorix™ + Infanrix™ Hexa Group III)	uywzrtmxxt = llqcaqqfgm tknsztvsjw (mglwpytsrd, qzcsntokwt - ertoncqbwk) View more	-	17 Dec 2018
				Pneumococcal conjugate vaccine GSK1024850A+Infanrix hexa (Synflorix™ + Infanrix™ Hexa Group I)	fdhavbejyw = vlpqffcmxe vvtzmrltjy (bjrhylukwa, jkuaiggopm - axjbplpxai) View more
NCT00652951 (CTgov)	Phase 3	Streptococcal Infections	780	GSK Biologicals´ Pneumococcal Conjugate Vaccine GSK1024850A (Synflorix™)+Infanrix™ hexa. (Synflorix + Infanrix Hexa Group)	fkyorntrvq(oweoylglyr) = klpojqrqhz sqltjyfnqs (dnlwhfevbl, gyfnywrwwj - ccbivajbjw) View more	-	14 Dec 2018
				GSK Biologicals´ Pneumococcal Conjugate Vaccine GSK1024850A (Synflorix™)+Pediacel™ (Synflorix + Pediacel Group)	fkyorntrvq(oweoylglyr) = tbzjmvwscu sqltjyfnqs (dnlwhfevbl, padwoxpqsr - fymmlxhmuh) View more
NCT00985465 (CTgov)	Phase 3	Streptococcal Infections	218	Synflorix (Synflorix Primed Group)	uilkunzaxp = ympoudvkeg gisvomaiix (mugnisnevn, xjjqgssayu - soxfvqvjzf) View more	-	14 Dec 2018
				Synflorix™ vaccine (Synflorix Unprimed Group)	qkuzimsspq = bxnzumcfus caodhnmlsj (faksztzeid, pizvwbjgaa - savdqtetgd) View more
NCT00370396 (CTgov)	Phase 3	Streptococcal Infections	1,200	Synflorix+Infanrix hexa (Synflorix-Synflorix Group)	qbtjfxhwuc = wcmvucrwnf ztekcixdld (zfjzehepxi, xpgckwkura - yolqjascxr) View more	-	26 Nov 2018
				Infanrix hexa+Prevenar (Prevenar-Prevenar Group)	qbtjfxhwuc = vfiqllnxzs ztekcixdld (zfjzehepxi, jnetvuzpbu - oiprslzpvw) View more

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