For life and breath.
Live Attenuated Vaccines for Life-Threatening Respiratory Viruses
Respiratory viruses are one of the biggest threats to human health. Vaccines are the most effective healthcare tool to combat infectious diseases and have saved more lives than any other type of medicine. Meissa is dedicated to creating safe, potent, stable, and accessible intranasal live viral vaccines that can prevent infection and disease. Meissa’s RSV and COVID-19 live attenuated vaccine candidates were developed using the company’s AttenuBlock platform.
Meissa’s Vaccine Pipeline
Meissa’s pipeline of live viral vaccine candidates are being developed to protect against respiratory syncytial virus, SARS-CoV-2, human metapneumovirus, and parainfluenza viruses.
Our Intranasal Vaccines Induce Both Mucosal and Circulating Antibodies
Intranasal vaccines generate both mucosal (IgA) antibodies in the nasal cavity and antibodies that circulate in the blood (serum). In contrast, injected vaccines induce circulating but not mucosal antibodies. While circulating antibodies are important for preventing serious lung disease, mucosal antibodies are important for blocking infection and viral transmission. The potential to prevent viral transmission is a key advantage that intranasal vaccines have due to the mucosal immune response that is induced.
In a Phase 1 clinical trial, Meissa’s RSV vaccine candidate stimulated a strong mucosal IgA response in adults who already had circulating antibodies to RSV in their blood. These results were consistent with previous preclinical studies, in which Meissa’s RSV vaccine candidate stimulated strong mucosal IgA antibody and circulating antibody responses and prevented infection of both the upper and lower respiratory tracts. Collectively, these results warrant further development of our vaccine candidates by demonstrating both mucosal and systemic immunity that blocks infection and prevents disease.
Meissa's RSV Live Attenuated Vaccine Candidate
Meissa is developing MV-012-968, an intranasal (needle-free), adjuvant-free, live-attenuated vaccine candidate, to protect infants and at-risk, older adults from RSV. In Phase 1 clinical trials, Meissa’s RSV vaccine candidate was well-tolerated, heavily attenuated, and stimulated a strong RSV-specific mucosal IgA response in participants (adults and young children), who had previously been infected and already had circulating antibodies to RSV in their blood (ClinicalTrials.gov identifiers NCT04444284 and NCT04227210). These results differentiate Meissa’s RSV vaccine from other live attenuated RSV vaccine candidates and are consistent with previous preclinical studies, in which Meissa’s RSV vaccine candidate was highly attenuated yet led to robust immune responses and protected both the upper and lower respiratory tracts from RSV challenge.
MV-012-968 is currently being tested in seronegative children. The study is enrolling up to 63 participants between the ages of six and 36 months at multiple sites in the U.S. to evaluate the safety and immunogenicity of MV-012-968 (ClinicalTrials.gov Identifier: NCT04909021).
Respiratory syncytial virus (RSV) is the leading cause of infant hospitalization in the United States and is considered a “missing” mandatory pediatric vaccine. RSV is also a significant cause of morbidity and mortality in older adults. In the United States, approximately 1% of infants are hospitalized by RSV each year. Globally, RSV causes more than 118,000 deaths per year and over 3 million hospitalizations in children less than five years of age (Anderson 2013).
Meissa’s Intranasal COVID-19 Vaccine Candidate
Meissa is developing a live viral intranasal COVID-19 vaccine candidate, MV-014-212, to induce mucosal and systemic immunity and protect against SARS-CoV-2, the novel coronavirus that causes COVID-19. Like Meissa’s RSV vaccine candidate, MV-014-212 offers significant potential advantages for global deployment, including needle-free intranasal administration, a single adjuvant-free dose to induce mucosal and systemic immunity, as well as a straightforward, economical, and scalable manufacturing process. A Phase 1 clinical study has been initiated in the U.S. to evaluate the safety, tolerability, and immunogenicity of a single intranasal dose of MV-014-212 (ClinicalTrials.gov identifier: NCT04798001).
Preclinical data in nonhuman primates (NHPs) of MV-014-212 demonstrate that a single adjuvant-free dose of MV-014-212 provided equivalent protection against SARS-CoV-2 challenge compared to reported efficacy in NHP models of currently authorized vaccines. Furthermore, the data show that MV-014-212 stimulates mucosal (nasal IgA) antibodies in the upper respiratory tract, the major infection route for SARS-CoV-2, and systemic (serum neutralizing and binding IgG) antibodies. The mucosal immune response is the first line of defense against respiratory viruses, providing fast-acting protection at the primary site of exposure. In NHPs, Meissa’s intranasal COVID-19 vaccine generated both mucosal and systemic antibodies and was highly protective against wild-type SARS-CoV-2 challenge. Serum antibodies were able to neutralize wild-type SARS-CoV-2, B.1.351 (Beta, South Africa), and B.1.1.7 (Alpha, UK). Additional data from serial passaging in a manufacturing cell line and virus shed from NHPs showed that MV-014-212 has a stable genotype in vitro and in vivo (download the manuscript and supplemental material).
Initial preliminary clinical data from a Phase 1 study shows that Meissa’s intranasal recombinant live attenuated COVID-19 vaccine, MV-014-212, induces a nasal IgA antibody response in SARS-CoV-2 seropositive and seronegative adults. Safety data show that MV-014-012 is highly attenuated, with no serious adverse events reported and no infectious vaccine virus detected from any participants to date. The study is continuing to enroll participants to study MV-014-212 as a primary vaccine or a boost (ClinicalTrials.gov Identifier: NCT04798001).
Vaccines against SARS-CoV-2 and emerging variants will be needed on an ongoing basis so long as SARS-CoV-2 circulates. Meissa’s MV-014-212 stimulates cross-neutralizing serum antibodies against SARS-CoV-2 variants of concern. Furthermore, our AttenuBlock platform is amenable to generation of variant vaccine constructs to combat future variants as needed.
To stay informed about our clinical progress for our RSV and COVID-19 vaccine candidates,
Meissa Vaccines Expanded Access Policy (rev. August 2021)
Meissa Vaccines is developing investigational vaccines for the prevention of respiratory diseases. Since the vaccines are designed for prophylactic not treatment use, Meissa has chosen not to offer Expanded Access to these vaccines and will not accept Expanded Access requests. Meissa’s investigational vaccines will only be provided through ongoing clinical trials. To learn more about available clinical trials, please see above or visit ClinicalTrials.gov and search using the company name.