modRNA Vaccine for Flu
Recruiting in Palo Alto (17 mi)
+3 other locations
Age: 18+
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Phase 1
Recruiting
Sponsor: Pfizer
Disqualifiers: Seasonal influenza vaccine, others
Trial Summary
What is the purpose of this trial?The purpose of this study is to learn about the safety and effects of the study vaccine for the possible prevention of influenza. Influenza is a disease that can spread easily from one person to another and cause body aches, fever, cough, and other symptoms. The study vaccine is called Pandemic Influenza modRNA (pdmFlu) Vaccine.
This study is seeking for participants who are:
* between the ages of 18 to 49 years old or 65 to 84 years old.
* willing and able to follow with all scheduled visits, treatment plan, laboratory tests, lifestyle changes, and other study procedures.
* healthy as confirmed by medical history, physical examinations, and the study doctor.
* capable of signing informed consent.
Participants will receive either:
* the pdmFlu vaccine,
* a licensed influenza vaccine
* a placebo. A placebo does not have any medicine in it but looks just like the study medicine.
Participants will not know which vaccine they receive. Participants will receive the study vaccines as a single shot in the arm. The study will compare participant experiences to help understand if the pdmFlu vaccine is safe and effective. Participants will take part in this study for up to 13 months. During this time, the participants will receive the study vaccine and take part in follow-up visits.
Will I have to stop taking my current medications?
The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the study doctor to understand any specific requirements.
What data supports the effectiveness of the modRNA Vaccine for Flu treatment?
Research shows that quadrivalent influenza vaccines (QIVs), which are part of the treatment, are effective because they include two A strains and two B lineages, reducing the chance of a mismatch with circulating flu strains. This makes them more effective than trivalent vaccines, which only cover one B lineage.
12345Is the modRNA Vaccine for Flu safe for humans?
The quadrivalent influenza vaccines (QIVs) have been studied for safety in various age groups, showing a low rate of adverse events (side effects), with most not requiring medical attention. In a study with 2013 participants, only 9.09% reported any side effects, and none required hospitalization, indicating a generally safe profile.
12367How is the modRNA Vaccine for Flu different from other flu treatments?
The modRNA Vaccine for Flu is unique because it uses messenger RNA (mRNA) technology, which allows for rapid development and the potential to create a universal flu vaccine that provides long-lasting protection against multiple strains of the virus. This is different from traditional flu vaccines that typically use inactivated or live attenuated viruses.
13589Eligibility Criteria
This trial is for healthy adults aged 18 to 49 who can commit to the study's schedule and procedures. They must not have received any flu vaccine in the past 6 months and should be able to give informed consent.Inclusion Criteria
Healthy participants who are determined by medical history, physical examination (if required), and clinical judgment of the investigator to be eligible for inclusion in the study.
Exclusion Criteria
Vaccination with any investigational or licensed influenza vaccine within 6 months (175 days) before study intervention administration.
Trial Timeline
Screening
Participants are screened for eligibility to participate in the trial
2-4 weeks
Treatment
Participants receive a single shot of either the pdmFlu vaccine, a licensed influenza vaccine, or a placebo
1 day
1 visit (in-person)
Follow-up
Participants are monitored for safety and effectiveness after receiving the vaccine
12 months
Multiple visits (in-person and virtual)
Participant Groups
The trial is testing a new mRNA vaccine for pandemic influenza, comparing it with a licensed quadrivalent influenza vaccine (QIV) and a placebo. Participants will get shots on day 1 and day 21 without knowing which one they receive.
10Treatment groups
Experimental Treatment
Active Control
Placebo Group
Group I: pdmFlu vaccine 8Experimental Treatment1 Intervention
Group II: pdmFlu vaccine 7Experimental Treatment1 Intervention
Group III: pdmFlu vaccine 6Experimental Treatment1 Intervention
Group IV: pdmFlu vaccine 5Experimental Treatment1 Intervention
Group V: pdmFlu vaccine 4Experimental Treatment1 Intervention
Group VI: pdmFlu vaccine 3Experimental Treatment1 Intervention
Group VII: pdmFlu vaccine 2Experimental Treatment1 Intervention
Group VIII: pdmFlu vaccine 1Experimental Treatment1 Intervention
Group IX: Licensed influenza vaccineActive Control1 Intervention
Group X: PlaceboPlacebo Group1 Intervention
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
Research Centers of America ( Hollywood )Hollywood, FL
Research Centers of AmericaHollywood, FL
NYU Langone HealthNew York, NY
Pfizer Clinical Research Unit - New HavenNew Haven, CT
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Who Is Running the Clinical Trial?
PfizerLead Sponsor
References
Immunogenicity and safety of a quadrivalent inactivated influenza vaccine in healthy subjects aged 3 to 17 years old: A phase III, open label, single-arm study. [2021]Quadrivalent influenza vaccines are particularly valuable during seasons in which a mismatch occurs between the predicted influenza B lineage for the trivalent influenza vaccine and the circulating strain. This study evaluated the immunogenicity and safety of a quadrivalent inactivated influenza vaccine AdimFlu-S manufactured in Taiwan for the 2016-2017 influenza season in healthy children.
Immunogenicity and safety of two quadrivalent influenza vaccines in healthy adult and elderly participants in India - A phase III, active-controlled, randomized clinical study. [2022]This study was conducted to compare the immunogenicity and safety profile of two quadrivalent influenza vaccines (QIVs) in healthy adults (18-60 years) and elderly (>61 years) participants.
Immunogenicity and safety of inactivated quadrivalent influenza vaccine in adults: A systematic review and meta-analysis of randomised controlled trials. [2018]A quadrivalent influenza vaccine (QIV) includes two A strains (A/H1N1, A/H3N2) and two B lineages (B/Victoria, B/Yamagata). The presence of both B lineages eliminate potential B lineage mismatch of trivalent influenza vaccine (TIV) with the circulating strain.
Cost-Effectiveness of Quadrivalent versus Trivalent Influenza Vaccine in the United States. [2017]Designed to overcome influenza B mismatch, new quadrivalent influenza vaccines (QIVs) contain one additional B strain compared with trivalent influenza vaccines (TIVs).
Vaccine for prevention of mild and moderate-to-severe influenza in children. [2014]Commonly used trivalent vaccines contain one influenza B virus lineage and may be ineffective against viruses of the other B lineage. We evaluated the efficacy of a candidate inactivated quadrivalent influenza vaccine (QIV) containing both B lineages.
From trivalent to quadrivalent influenza vaccines: Public health and economic burden for different immunization strategies in Spain. [2020]Quadrivalent influenza vaccine (QIV) includes the same strains as trivalent influenza vaccine (TIV) plus an additional B strain of the other B lineage. The aim of the study was to analyse the public health and economic impact of replacing TIV with QIV in different scenarios in Spain.
Improved post-marketing safety surveillance of quadrivalent inactivated influenza vaccine in Mexico using a computerized, SMS-based follow-up system. [2022]Quadrivalent influenza vaccines (QIVs) are designed to prevent influenza disease caused by two influenza A viruses (H1N1 and H3N2) and both influenza B lineages. Risk-monitoring of QIVs to identify adverse events (AEs) is necessary as influenza vaccines are reformulated each year. We developed a new active surveillance system (Sistema de Control de Vacunación; SICOVA) to improve pharmacovigilance in Mexico. Participants (N = 2013) aged 0 - 96 years from nine sites across three influenza seasons (n = 1166 in 2015 - 2016; n = 633 in 2016 - 2017; and n = 214 in 2017 - 2018) agreed to receive text messages 1, 7, 28, and 42 days post-vaccination to know if they had experienced any AEs. The study was completed electronically by 1763 (87.6%) participants; manual follow-up was conducted for 250 participants whose reporting was incomplete. The overall AE rate was 9.09%. At least one AE was reported by 183 participants, of whom 131 (71.58%) did not require a medical visit and 52 (28.42%) needed medical attention, with none requiring hospitalization. Most AEs requiring medical attention occurred in children aged 0 - 5 years (n = 22, 42.31%) and adults aged 31 - 35 years (n = 5, 9.62%). These results are consistent with the established safety profile of Fluzone® Quadrivalent, and show that SICOVA can facilitate surveillance and increase AE reporting in Mexico.
Alternative Strategy for a Quadrivalent Live Attenuated Influenza Virus Vaccine. [2020]Influenza virus infections continue to pose a major public health threat worldwide associated with seasonal epidemics and sporadic pandemics. Vaccination is considered the first line of defense against influenza. Live attenuated influenza virus vaccines (LAIVs) may provide superior responses compared to inactivated vaccines because the former can better elicit a combination of humoral and cellular responses by mimicking a natural infection. Unfortunately, during the 2013-2014, 2014-2015, and 2015-2016 seasons, concerns emerged about the effectiveness of the only LAIV approved in the United States that prevented the Advisory Committee on Immunization Practices (ACIP) from recommending its use. Such drawbacks open up the opportunity for alternative LAIV strategies that could overcome such concerns. Previously, we developed a combined strategy of temperature-sensitive mutations in the PB2 and PB1 segments and an epitope tag in the C terminus of PB1 that effectively attenuates influenza A viruses of avian and mammalian origin. More recently, we adopted a similar strategy for influenza B viruses. The resulting attenuated (att) influenza A and B viruses were safe, immunogenic, and protective against lethal influenza virus challenge in a variety of animal models. In this report, we provide evidence of the potential use of our att strategy in a quadrivalent LAIV (QIV) formulation carrying H3N2 and H1N1 influenza A virus subtype viruses and two antigenic lineages of influenza B viruses. In naive DBA/2J mice, two doses of the QIV elicited hemagglutination inhibition (HI) responses with HI titers of ≥40 and effectively protected against lethal challenge with prototypical pandemic H1N1 influenza A and influenza B virus strains.IMPORTANCE Seasonal influenza viruses infect 1 billion people worldwide and are associated with ∼500,000 deaths annually. In addition, the never-ending emergence of zoonotic influenza viruses associated with lethal human infections and of pandemic concern calls for the development of better vaccines and/or vaccination strategies against influenza virus. Regardless of the strategy, novel influenza virus vaccines must aim at providing protection against both seasonal influenza A and B viruses. In this study, we tested an alternative quadrivalent live attenuated influenza virus vaccine (QIV) formulation whose individual components have been previously shown to provide protection. We demonstrate in proof-of principle studies in mice that the QIV provides effective protection against lethal challenge with either influenza A or B virus.
Development of a pentavalent broadly protective nucleoside-modified mRNA vaccine against influenza B viruses. [2023]Messenger RNA (mRNA) vaccines represent a new, effective vaccine platform with high capacity for rapid development. Generation of a universal influenza virus vaccine with the potential to elicit long-lasting, broadly cross-reactive immune responses is a necessity for reducing influenza-associated morbidity and mortality. Here we focus on the development of a universal influenza B virus vaccine based on the lipid nanoparticle-encapsulated nucleoside-modified mRNA (mRNA-LNP) platform. We evaluate vaccine candidates based on different target antigens that afford protection against challenge with ancestral and recent influenza B viruses from both antigenic lineages. A pentavalent vaccine combining all tested antigens protects mice from morbidity at a very low dose of 50 ng per antigen after a single vaccination. These findings support the further advancement of nucleoside-modified mRNA-LNPs expressing multiple conserved antigens as universal influenza virus vaccine candidates.