AdCOVID COVID-19 Vaccine Description
AdCOVID is a single dose intranasal vaccine candidate intending to prevent COVID-19 infections. AdCOVID has completed preclinical studies that were conducted with the University of Alabama at Birmingham.
AdCOVID is based on Altimmune Inc.'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.
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 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 further spread of COVID-19.
On November 10, 2020, Dr. Vipin K. Garg, President, and CEO of Altimmune, said in a press release, “We strongly believe there is a compelling need for next-generation COVID-19 vaccines and are rapidly advancing our development program for AdCOVID to meet this demand. We plan to commence a clinical study of AdCOVID in the fourth quarter, with a data readout from this study anticipated in the first quarter of 2021.”
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. “We look forward to working with the FDA and will continue preparing to commence our planned Phase 1 clinical trial of AdCOVID.”
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 distribution of the vaccine.
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.
Dependable, on-site availability of vaccines will be a critical issue for community clinics and pharmacies, as ultra-low freezers are not available in most institutions.
AdCOVID COVID-19 Vaccine News
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 the 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. Altimmune has responded to the Agency’s clinical hold letter received on December 22, 2020. At this time, it does not anticipate a significant impact on the overall clinical development timeline as the Company has agreed to each of the FDA’s requests.
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, a single-dose, intranasal vaccine candidate for COVID-19. Lonza is a leading global biopharmaceutical manufacturing company with facilities 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.