AN OPEN-LABEL, SINGLE-TREATMENT, SINGLE-PERIOD, SINGLE DOSE, CLINICAL PHASE 1 STUDY TO ASSESS THE SAFETY AND TOLERABILITY OF LIVE MEASLES AND RUBELLA VACCINE, (MULTIPLE DOSE VIAL FORMULATION) OF M/s CADILA HEALTHCARE LTD., INDIA IN HEALTHY, ADULT, MALE, HUMAN SUBJECTS UNDER FASTING CONDITION

开始日期2012-08-13

申办/合作机构-

100 项与 Measles and rubella vaccine (Vaxxas) 相关的临床结果

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100 项与 Measles and rubella vaccine (Vaxxas) 相关的转化医学

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100 项与 Measles and rubella vaccine (Vaxxas) 相关的专利（医药）

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项与 Measles and rubella vaccine (Vaxxas) 相关的文献（医药）

2024-09-23·Vaccines

Exploring Important Attributes, the Potential Use Cases and Feasibility of Introduction of Measles and Rubella Microarray Patches (MR-MAPs): Insights from Nine Countries.

Article

作者: Kahn, Anna-Lea ; Silalahi, Olivi ; Giersing, Birgitte ; Pastor, Desiree ; Spasenoska, Dijana ; Gebrekidan, Abay Hagos ; Kisakye, Annet ; Masresha, Balcha Girma ; Hasso-Agopsowicz, Mateusz ; Woolford, Janice ; Jansen, Maarten Paul Maria

Background: Microarray patches (MAPs) are innovative, needle-free vaccine delivery systems, suitable for administration by minimally trained health care workers or trained community health workers. Their introduction may transform immunization programmes, particularly for vaccines where high coverage is required for population immunity, such as measles, and where vaccine delivery is challenging, such as in low- and middle-income countries. Recognizing the need to understand how best to tailor these products to reflect country priorities, workshops on measles and rubella MAPs (MR-MAPs) were conducted in multiple regions to collect insights on needs and preferences from relevant stakeholders at country level. Methods: The CAPACITI Innovation Framework was used to structure stakeholder discussions in nine countries in the period from August 2022 to July 2023. The discussions, building on the findings from a situation analysis on the barriers related to measles and rubella vaccine delivery, followed the four-step process outlined in the framework. Results: Key barriers hindering delivery of measles and rubella vaccines across the countries were in the categories of human resource management, service delivery, and demand generation. MR-MAP attributes that stakeholders believed would reduce or eliminate these barriers included ease of preparation and administration, improved thermostability, fewer (ancillary) components, and single-dose presentation. Some attributes such as the site of administration, wear time, and storage volume could exacerbate certain barriers. Based on an understanding of key barriers, product attributes, and underserved populations, stakeholders identified several potential use cases for MR-MAPs: (i) delivery at a fixed health post, (ii) delivery through outreach sessions conducted by health workers, and (iii) administration by community health workers. To enable robust national decision making about the introduction of MR-MAPs and successful implementation, global and national evidence on feasibility and acceptability of MR-MAPs should be generated. To prepare for the potential introduction of MR-MAPs, immunization programmes should evaluate their immunization policies based on their preferred use cases and modify them if needed, for example, to enable community health workers to administer vaccines, along with making programmatic adjustments to waste management and training. Conclusions: MR-MAPs have the potential to reduce key barriers to MR delivery. Yet, their future impact depends on the ability of global stakeholders to steer the development of MR-MAPs to be responsive to country needs and preferences. The generation of evidence to enable robust decision making, timely modification of vaccine policies, and addressing programmatic considerations will be key to successful uptake.

2024-05-01·LANCET

A measles and rubella vaccine microneedle patch in The Gambia: a phase 1/2, double-blind, double-dummy, randomised, active-controlled, age de-escalation trial

Article

作者: Akpalu, Edem ; Royals, Michael ; Henry, Sebastien ; Bruce, Andrew ; Yisa, Mohammed ; Johnstone, Hilary ; Adigweme, Ikechukwu ; Crooke, Stephen ; Prausnitz, Mark R ; Mendy, Anthony ; Donkor, Simon ; Jarju, Lamin B ; Njie, Abdoulie ; Ooko, Michael ; Clarke, Ed ; Rota, Paul A ; McAllister, Devin V ; El-Badry, Elina ; Goodson, James L ; Jeffries, David ; Danso, Baba ; Segonds-Pichon, Anne

BACKGROUND:

Microneedle patches (MNPs) have been ranked as the highest global priority innovation for overcoming immunisation barriers in low-income and middle-income countries. This trial aimed to provide the first data on the tolerability, safety, and immunogenicity of a measles and rubella vaccine (MRV)-MNP in children.

METHODS:

This single-centre, phase 1/2, double-blind, double-dummy, randomised, active-controlled, age de-escalation trial was conducted in The Gambia. To be eligible, all participants had to be healthy according to prespecified criteria, aged 18-40 years for the adult cohort, 15-18 months for toddlers, or 9-10 months for infants, and to be available for visits throughout the follow-up period. The three age cohorts were randomly assigned in a 2:1 ratio (adults) or 1:1 ratio (toddlers and infants) to receive either an MRV-MNP (Micron Biomedical, Atlanta, GA, USA) and a placebo (0·9% sodium chloride) subcutaneous injection, or a placebo-MNP and an MRV subcutaneous injection (MRV-SC; Serum Institute of India, Pune, India). Unmasked staff ransomly assigned the participants using an online application, and they prepared visually identical preparations of the MRV-MNP or placebo-MNP and MRV-SC or placebo-SC, but were not involved in collecting endpoint data. Staff administering the study interventions, participants, parents, and study staff assessing trial endpoints were masked to treatment allocation. The safety population consists of all vaccinated participants, and analysis was conducted according to route of MRV administration, irrespective of subsequent protocol deviations. The immunogenicity population consisted of all vaccinated participants who had a baseline and day 42 visit result available, and who had no protocol deviations considered to substantially affect the immunogenicity endpoints. Solicited local and systemic adverse events were collected for 14 days following vaccination. Unsolicited adverse events were collected to day 180. Age de-escalation between cohorts was based on the review of the safety data to day 14 by an independent data monitoring committee. Serum neutralising antibodies to measles and rubella were measured at baseline, day 42, and day 180. Analysis was descriptive and included safety events, seroprotection and seroconversion rates, and geometric mean antibody concentrations. The trial was registered with the Pan African Clinical Trials Registry PACTR202008836432905, and is complete.

FINDINGS:

Recruitment took place between May 18, 2021, and May 27, 2022. 45 adults, 120 toddlers, and 120 infants were randomly allocated and vaccinated. There were no safety concerns in the first 14 days following vaccination in either adults or toddlers, and age de-escalation proceeded accordingly. In infants, 93% (52/56; 95% CI 83·0-97·2) seroconverted to measles and 100% (58/58; 93·8-100) seroconverted to rubella following MRV-MNP administration, while 90% (52/58; 79·2-95·2) and 100% (59/59; 93·9-100) seroconverted to measles and rubella respectively, following MRV-SC. Induration at the MRV-MNP application site was the most frequent local reaction occurring in 46 (77%) of 60 toddlers and 39 (65%) of 60 infants. Related unsolicited adverse events, most commonly discolouration at the application site, were reported in 35 (58%) of 60 toddlers and 57 (95%) of 60 infants that had received the MRV-MNP. All local reactions were mild. There were no related severe or serious adverse events.

INTERPRETATION:

The safety and immunogenicity data support the accelerated development of the MRV-MNP.

FUNDING:

Bill & Melinda Gates Foundation.

2024-05-01·LANCET

Measles and rubella vaccine microneedle patch: new hope to reach the unreached children

Letter

作者: Coulborn, Rebecca M ; Alsalhani, Alain ; Danet, Corinne

项与 Measles and rubella vaccine (Vaxxas) 相关的新闻（医药）

2024-10-28

·PipelineReview

Vaxxas Licenses Next-Generation Vaccine for Respiratory Syncytial Virus (RSV) from the United States National Institutes of Health (NIH)

BRISBANE, Australia & CAMBRIDGE, MA, USA I October 28, 2024 I Vaxxas , a clinical-stage biotechnology company commercializing a novel high-density microarray patch (HD-MAP) vaccination platform , today announced that the United States National Institutes of Health (NIH) has granted the company a license to a next-generation vaccine antigen (DS2), designed for use in prophylactic vaccines against Respiratory Syncytial Virus (RSV). Vaxxas’ worldwide license from the NIH enables the company to create the first needle-free, room-temperature stable RSV vaccine to enter clinical studies. The next-generation DS2 RSV vaccine antigen licensed by Vaxxas was developed by scientists at the NIH’s Vaccine Research Center and the National Institute of Allergy and Infectious Diseases to prompt a more robust and durable immune response against RSV compared to the antigen used in currently approved vaccines (DS-Cav1). “ Published preclinical results show the potential immunogenic advantages of this next-generation antigen as the basis for an RSV vaccine that could offer more robust and durable protection against the virus, compared to vaccines already on the market,” David L. Hoey, President and CEO of Vaxxas, said. “These advantages, coupled with our needle-free technology’s potential to eliminate the need for refrigerated distribution and enable self-administration, could offer a vaccine that makes a significant impact on the way we protect populations against this serious respiratory infection in the future.” Vaxxas’ HD-MAP vaccine delivery platform is advancing toward commercialization, with five successful Phase I clinical trials involving more than 500 participants completed, including a second-generation COVID-19 vaccine candidate, a HD-MAP delivered flu vaccine showing greater immunogenicity than the approved injectable vaccine comparator, and a measles and rubella vaccine. With funding from the United States Biomedical Advanced Research and Development Authority (BARDA), the company is currently conducting its first U.S. IND-enabled Phase I clinical study for a pre-pandemic influenza vaccine involving 258 participants. Vaxxas plans to progress its needle-free HD-MAP/RSV vaccine to a Phase I clinical study after completing preclinical development of the product. About Respiratory Syncytial Virus (RSV) RSV is a common contagious virus affecting the lungs and breathing passages. The global burden of RSV is substantial, causing an estimated 33 million acute lower respiratory infection episodes per year, resulting in an estimated 3.6 million RSV-related hospitalizations and over 101,400 RSV-related deaths annually. RSV contributes substantially to morbidity and mortality burden globally in children aged 0-60 months, especially during the first six (6) months of life. Adults can be at increased risk for RSV disease due to comorbidities, immune compromised status, or advanced age. RSV can exacerbate conditions, including COPD, asthma, and chronic heart failure which can lead to severe outcomes, such as pneumonia, hospitalization, and death. The 2023 approval of the world’s first RSV vaccines in the US and Europe, GSK’s AREXVY and Pfizer’s ABRYSVO, was a significant milestone in addressing the grave unmet medical needs associated with RSV. About HD-MAP needle-free vaccines The Vaxxas HD-MAP is comprised of thousands of microscopic projections molded into a small patch. Each microprojection is coated with a small dose of vaccine in a dried formulation. When applied to the skin using a proprietary, easy to use applicator, the patch delivers the vaccine to the abundant immune cells that naturally reside immediately below the skin surface. HD-MAP vaccine delivery offers many potential benefits over more traditional ways of administering vaccines. For example, the dried form of the vaccine is more stable at higher temperatures than vaccines in liquid formulations, therefore potentially reducing the need for cold-chain storage and distribution. Vaxxas’ HD-MAPs have proven safe and tolerable in hundreds of trial participants to date , and have been shown to induce equal or greater immune responses to injected vaccines at lower doses. Compared with needle and syringe systems, HD-MAP vaccines are also much easier to administer and are likely to have greater acceptability by healthcare workers and patients/subjects. Ultimately, HD-MAPs could enable a future in which vaccine patches could be shipped directly to peoples’ homes, workplaces, and schools, avoiding the delay, inconvenience, and safety challenges associated with traditional needle-and-syringe vaccine scheduling and administration. About Vaxxas Vaxxas is a privately held biotechnology company focused on enhancing the performance of existing and next-generation vaccines with its proprietary HD-MAP. Vaxxas is targeting initial applications in infectious diseases and oncology. With success in several completed human clinical trials involving more than 500 participants; additional ongoing Phase I clinical studies for seasonal influenza and COVID-19; and other vaccine studies targeting pandemic influenza, funded by the United States Biomedical Advanced Research and Development Authority (BARDA), Vaxxas’ HD-MAP vaccine delivery platform is advancing toward commercialization. Vaxxas’ core technology was initially developed at The University of Queensland (UQ), and the company was established as a start-up in 2011 by UQ’s commercialization group UniQuest. The company was founded with the completion of an initial equity financing led by OneVentures Innovation Fund I with co-investors Brandon Capital Partners and US-based HealthCare Ventures, followed by a further financing led by OneVentures with UQ joining the most recent financing. OneVentures Innovation Fund I and Brandon BioCatalyst are supported by the Australian Government’s Innovation Investment Fund (IIF) program. The IIF is an Australian Government venture capital initiative that provides investment capital and managerial expertise through licensed venture capital fund managers to investee companies. Learn more at OneVentures and Brandon Capital . SOURCE: Vaxxas

疫苗临床1期上市批准引进/卖出

2024-04-29

·Science Daily

Microarray patches safe and effective for vaccinating children, trial suggests

The first study of the use of microarray patches to vaccinate children has shown that the method is safe and induces strong immune responses. The phase 1/2 randomized trial compared results from the measles and rubella vaccine delivered by a microarray patch, a small sticking plaster-like device with an array of microscopic projections that painlessly penetrate the skin and deliver the vaccine, or by conventional injection with a needle and syringe. The phase 1/2 randomized trial compared results from the measles and rubella vaccine delivered by a microarray patch, a small sticking plaster-like device with an array of microscopic projections that painlessly penetrate the skin and deliver the vaccine, or by conventional injection with a needle and syringe. The trial, which involved 45 adults (18-40 years old), 120 toddlers (15-18 months old) and 120 infants (9-10 months old) in The Gambia, found giving the measles and rubella vaccine by a microarray patch induced an immune response that was as strong as the response when the vaccine was given by conventional injection. Over 90% of infants were protected from measles and all infants were protected from rubella following a single dose of the vaccine given by the microarray patch. The measles and rubella vaccine used in the study has been given to many millions of children globally by conventional injection and is known to provide reliable protection. The trial found no safety concerns with delivering the measles and rubella vaccine using a microarray patch. The trial was led by researchers from the Medical Research Council (MRC) Unit The Gambia at the London School of Hygiene & Tropical Medicine (LSHTM) and supported by the US Centers for Disease Control and Prevention. The patch was developed and manufactured by Micron Biomedical Inc, who sponsored and supported all aspects of the trial. Funding came from the Bill & Melinda Gates Foundation. Results are published in The Lancet. The researchers hope microarray patches could help to achieve the very high levels of population immunity required to control childhood diseases such as measles and rubella, with WHO recommending at least 95% two-dose measles vaccine coverage and rubella requiring 80% population immunity. Microarray patches have been determined to be the highest priority innovation for overcoming barriers to immunization in low-resource settings. In low-resource settings microarray patches have several advantages over conventional vaccination technologies. They promise to be easier to transport and to eliminate, or vastly reduce, the need for cold storage (refrigeration) of vaccines, both major barriers to reaching remote areas across sub-Saharan Africa. Microarray patches also do not need to be administered by a medical professional and it is expected that volunteers would be able to give the vaccines after only brief training. Unlike conventional needles and syringes, the microarray patches do not risk 'needlestick' injuries which can transmit infections such as hepatitis and HIV. In countries, such as the UK, which have well-resourced childhood vaccination programmes, but which have also experienced rapid increases in measles cases recently due to low immunization coverage, microarray patches could offer greater convenience and a pain-free alternative to conventional injections. The hope is that offering vaccinations in a patch could encourage more parents, particularly those in disadvantaged areas, to get their child vaccinated. Professor Ed Clarke, a paediatrician who leads the Vaccines and Immunity Theme at MRC Unit The Gambia at LSHTM and co-author, said: "Although it's early days, these are extremely promising results which have generated a lot of excitement. They demonstrate for the first time that vaccines can be safely and effectively given to babies and young children using microarray patch technology. Measles vaccines are the highest priority for delivery using this approach but the delivery of other vaccines using microarray patches is also now realistic. Watch this space." Dr Ikechukwu Adigweme, from the Vaccines and Immunity Theme at MRC Unit The Gambia at LSHTM and co-author, said: "The positive results from this study are quite gratifying to us as a team. We hope this is an important step in the march towards greater vaccine equity among disadvantaged populations." The trial had several limitations. As it was the first trial to use microarray patches to deliver vaccine to children it had a small sample size and selected healthy adults, toddlers and infants. The researchers say larger trials of microarray patches are now being planned with broadly representative groups of children and infants to inform decisions about whether to recommend the patches for widespread use in childhood vaccination programmes.

疫苗临床结果临床研究

100 项与 Measles and rubella vaccine (Vaxxas) 相关的药物交易

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