AdCOVID COVID-19 Vaccine Description
Altimmune Inc.'s AdCOVID is a single-dose intranasal vaccine candidate intending to prevent COVID-19 infections. The company announced on June 29, 2021, although AdCOVID was well tolerated, it did not stimulate an adequate immune response in healthy volunteers. Therefore, Altimmune confirmed it would discontinue further development of the AdCOVID vaccine candidate.
AdCOVID has completed preclinical studies that were conducted with the University of Alabama at Birmingham. AdCOVID is based on Altimmune's adenovirus-based intranasal vaccine platform and expresses the receptor-binding domain (RBD) of the SARS-CoV-2 spike protein. The RBD is essential for viral infection. The majority of neutralizing antibodies from people who have recovered from COVID-19 bind to the RBD, highlighting the RBD's importance in controlling the infection.
The AdCOVID vaccine is designed to offer significant advantages over other COVID-19 vaccine approaches, including intranasal administration, single-dose effectiveness, broad activation of the immune response, and the ability to ship and store the vaccine conveniently and inexpensively. AdCOVID is administered as a simple nasal spray and can bring a wide range of unique benefits to protect the public and address unmet needs.
Because intranasal dosing can stimulate local mucosal immunity, AdCOVID is expected to guard the respiratory tract against viral invasion and provide downstream protection against the viral spread. Local mucosal immunity may be essential for creating sterilizing immunity that eliminates the last traces of viral infection in the nasal cavity.
Based on data from Altimmune’s other intranasal platform vaccine candidates, AdCOVID is expected to have extended stability at room temperature that would allow for cold chain-free shipment of the vaccine. If demonstrated, AdCOVID could be stored in the common refrigerators found in community-based doctors’ offices and pharmacies for two years or more says the company.
Gaithersburg Maryland-based Altimmune is a clinical-stage biopharmaceutical company focused on developing intranasal vaccines, immune-modulating therapies, and treatments for liver disease.
AdCOVID COVID-19 Vaccine Cell Line
The AdCOVID COVID-19 Vaccine uses the following cell lines: Design and Development of AdCOVID: PER.C6 cells; Production: PER.C6 cells; Confirmatory Lab Tests: PER.C6 cells.
AdCOVID COVID-19 Vaccine History
In a non-peer-reviewed study published on October 11, 2020, the authors present data demonstrating strong activation of all (3) arms of the adaptive immune system following a single intranasal dose of AdCOVID. These data, conducted in two strains of mice, show that AdCOVID stimulated strong immune responses. AdCOVID showed strong serum neutralizing activity and potent mucosal immunity in the respiratory tract. The induction of mucosal IgA antibodies in the respiratory tract may be necessary to block both infection and transmission of the virus to prevent the further spread of COVID-19.
On December 23, 2020, the company issued a press statement, which stated Altimmune has responded to the Agency’s clinical hold letter received on December 22, 2020, and, at this time, does not anticipate a significant impact on the overall clinical development timeline as the Company has agreed to each of the FDA’s requests. “We appreciate the FDA’s support and guidance as we seek to bring a novel, single-dose intranasal COVID-19 vaccine candidate into the clinic,” said Vipin K. Garg, President and CEO of Altimmune.
“The commencement of our Phase 1 clinical trial of AdCOVID is an important milestone for our company and the global healthcare community in our fight against the SARS-CoV-2 virus,” stated Dr. Scott Harris, CMO of Altimmune, in a press release issued on February 25, 2021. “Delivering vaccine directly to the nasal cavity may stimulate a specialized type of immunity called ‘mucosal immunity,’ which has been shown in a preclinical study to provide sterilizing immunity, that is, complete clearance of the virus from the respiratory tract. As the rise of new variants of the SARS-CoV-2 virus is particularly troubling, to stop mutations of the virus, we must stop replication and transmission, and we believe AdCOVID could play an essential role in this endeavor.”
Maryland-based Altimmune is a clinical-stage biopharmaceutical company focused on developing intranasal vaccines, immune-modulating therapies, and liver disease treatments. The company's platform vaccines (NasoVAX and NasoShield) have shown an excellent stability profile and, when combined with the simple intranasal route of administration, may allow for efficient and inexpensive vaccine distribution.
AdCOVID COVID-19 Vaccine Indication
The AdCOVID vaccine candidate is indicated to prevent infection and transmission of COVID-19. Because intranasal dosing can stimulate local mucosal immunity, AdCOVID is expected to guard the respiratory tract against viral invasion and provide downstream protection against the viral spread. Local mucosal immunity may be essential for creating sterilizing immunity that eliminates the last traces of viral infection in the nasal cavity.
AdCOVID also provides an easier administration route than an injection eliminating the need for administration by trained medical personnel and may even allow for self-administration. Pediatric and pregnancy efficacy verification remains TBD.
AdCOVID COVID-19 Vaccine Storage
AdCOVID vaccines are stable for years when refrigerated and can withstand months at room temperature. The ability to distribute vaccines without cold-chain requirements will allow for more efficient distribution logistics.
AdCOVID COVID-19 Vaccine News
June 29, 2021 - Altimmune, Inc. provided an update on its AdCOVID investigational vaccine to prevent COVID-19. The Company also provided an update on its T-COVID Phase 1/2 clinical trial to evaluate the potential of T-COVID to prevent clinical worsening in patients with early COVID-19. Altimmune will discontinue further development of AdCOVID and focus its resources on its ongoing obesity and liver programs.
May 26, 2021 - Altimmune, Inc. (Nasdaq: ALT) announced new results from a preclinical study demonstrating the ability of its AdCOVID vaccine candidate to neutralize the rapidly emerging SARS-CoV-2 B.1.351 variant of concern that originated in South Africa. B.1.351 carries multiple mutations in the receptor-binding domain, including the E484K mutation that has been shown to substantially decrease the ability of authorized vaccines to neutralize the virus. AdCOVID also promoted a strong mucosal neutralizing response to the B.1.351 virus in the respiratory tract, with bronchoalveolar lavages showing neutralization of the variant virus. These preclinical data suggest that vaccination with AdCOVID leads to a cross-neutralizing antibody response both systemically and locally within the respiratory tract that can effectively neutralize the B.1.351 virus.
May 22, 2021 - The UAB researchers, led by Fran Lund, in collaboration with Altimmune, have found that a single intranasal dose provided sterilizing immunity in the lungs of vaccinated animals. In contrast, the lungs of nonvaccinated animals showed dense pulmonary infection and disease following infection with SARS-CoV-2, the virus that causes COVID-19. The Altimmune vaccine candidate has tantalizing promises, company leaders said. No need for refrigeration. Simple one-dose administration by a spray into the nose. The power to elicit mucosal immunity at the linings of the nose and lungs would protect not only against infection but against transmission. Existing intramuscular COVID-19 vaccines given as shots in the upper arm are not known to elicit this kind of immunity.
May 17, 2021 - The company confirmed a topline phase 1 study data readout is anticipated in June 2021, the initiation of preclinical evaluation of AdCOVID vaccine candidates targeting E484K variants, including P.1, B.1.351, and B.1.617, and initiation of a Phase 2 trial with a variant AdCOVID vaccine candidate expected in Q4 2021.
May 10, 2021 - Altimmune, Inc. announced positive results from a preclinical study of AdCOVID in a SARS-CoV-2 challenge model of infection. In this study, a single intranasal dose of AdCOVID provided sterilizing immunity in the lungs of vaccinated mice, in contrast to the development of dense pulmonary infection and disease in the lungs of non-vaccinated mice following infection with SARS-CoV-2. The UAB researchers, led by Fran Lund, Ph.D., have found that a single intranasal dose provided sterilizing immunity in the lungs of vaccinated animals. In contrast, the lungs of non-vaccinated animals showed dense pulmonary infection and disease following infection with SARS-CoV-2, the virus that causes COVID-19.
April 29, 2021 - Altimmune, Inc. announced that the Company’s management team members would be presenting at two scientific conferences in May 2021.
March 22, 2021 - Altimmune, Inc. announced it had retained Summit Biosciences to manufacture a metered nasal spray presentation of AdCOVID, its intranasal COVID-19 vaccine candidate. Vipin K. Garg, President and Chief Executive Officer of Altimmune, stated in a press release, “In addition, Altimmune will continue to produce a single dose presentation of AdCOVID to provide alternative forms of administration. Summit Biosciences has expertise in intranasal product innovation, and we are excited to align with their highly experienced team in our fight against COVID-19.”
March 15, 2021 - Altimmune, Inc. announced additional preclinical data for its single-dose intranasal COVID-19 vaccine candidate, AdCOVID. The data obtained in the K18-hACE2 transgenic mouse model showed that a single intranasal dose of AdCOVID provided 100% protection against a lethal challenge from the SARS-CoV-2 virus. The preclinical studies were conducted at Altimmune’s collaborating institutions, the University of Alabama at Birmingham and Saint Louis University.
March 12, 2021 - Altimmune, Inc. announced that it had expanded its previously-announced AdCOVID manufacturing collaboration with Lonza. Under the expanded agreement, Lonza will commission a dedicated manufacturing suite for clinical and commercial production of AdCOVID, Altimmune’s single-dose intranasal vaccine candidate for COVID-19, at its facility near Houston, Texas.
February 25, 2021 - Altimmune, Inc. announced that it had commenced enrollment in the Phase 1 clinical trial of AdCOVID, a single-dose intranasal COVID-19 vaccine candidate. AdCOVID is an adenovirus-vector vaccine designed to stimulate a broad immune response, including systemic immunity (neutralizing antibody) and local immunity (mucosal IgA and resident memory T cells) nasal cavity and respiratory tract.
February 17, 2021 - Maryland-based Altimmune, Inc. announced that the U.S. Food and Drug Administration had cleared the Company’s Investigational New Drug application for its Phase 1 clinical trial of AdCOVID, a novel, single-dose, intranasal COVID-19 vaccine candidate. Altimmune expects to commence patient enrollment in Phase 1 clinical trial in the coming week.
December 23, 2020 - Altimmune, Inc. announced the U.S. FDA had issued a clinical hold on the Company’s Investigational New Drug application for AdCOVID, a single-dose intranasal COVID-19 vaccine candidate. The Agency requested certain protocol modifications and the submission of additional Chemistry, Manufacturing, and Controls data.
November 25, 2020 - Altimmune, Inc. announced that it had submitted an Investigational New Drug Application to the U.S. FDA to commence a Phase 1 clinical study of its single-dose intranasal COVID-19 vaccine candidate, AdCOVID.
November 10, 2020 - Altimmune, Inc. announced that it entered into an agreement with Lonza for the manufacturing of AdCOVID™, Altimmune’s next-generation, single-dose, intranasal vaccine candidate for COVID-19. Lonza is a leading global biopharmaceutical manufacturing company in Europe, North America, and South Asia.
October 12, 2020 - Altimmune Inc. announced a preclinical evaluation of its single-dose, intranasal vaccine candidate, AdCOVID. The pre-clinical studies were conducted as part of Altimmune’s ongoing collaboration with the University of Alabama at Birmingham. These researchers stated, 'AdCOVID, which promotes concomitant systemic and local mucosal immunity, represents a promising COVID-19 vaccine candidate.'
September 28, 2020 - Altimmune, Inc. announced that Scot Roberts, Ph.D., Chief Scientific Officer, presented an overview of the Company’s AdCOVID and T-COVID intranasal vaccine therapeutic candidates at the World Vaccine Congress Washington.
March 30, 2020 - Altimmune, Inc. announced that it is launching a collaboration with the University of Alabama at Birmingham (UAB) on developing its single-dose, intranasal COVID-19 vaccine, named AdCOVID.
AdCOVID COVID-19 Vaccine Clinical Trials
Clinical Trial NCT04679909: Safety and Immunogenicity of AdCOVID in Healthy Adults (COVID-19 Vaccine Study). Last Update Posted: January 19, 2021. The Phase 1 clinical trial will evaluate the safety and immunogenicity of AdCOVID in up to 180 healthy adult volunteers between the ages of 18 and 55. Volunteers will receive AdCOVID at one of three dose levels administered as a nasal spray. In addition to the primary study endpoint of safety and tolerability, the immunogenicity of AdCOVID will be evaluated by serum IgG binding and neutralizing antibody titers, mucosal IgA antibody from nasal samples, and T cell responses.