AdCOVID (COVID-19 vaccine) / Altimmune, The University of Alabama - LARVOL DELTA

The role of vaccination route with an adenovirus-vectored vaccine in protection, viral control, and transmission in the SARS-CoV-2/K18-hACE2 mouse infection model. (PubMed, Front Immunol) - "Utilizing a replication-deficient adenovirus serotype 5-vectored vaccine expressing the SARS-CoV-2 RBD (AdCOVID) in homozygous and heterozygous transgenic K18-hACE2, we investigated the impact of the route of administration on vaccine immunogenicity, SARS-CoV-2 transmission, and survival...Notably, in a novel transmission model, intranasal vaccination reduced viral transmission to naïve co-housed mice compared to intramuscular vaccination. Our data provide convincing evidence for the use of intranasal vaccination in protecting against SARS-CoV-2 infection and transmission."

Journal • Preclinical • Infectious Disease • Novel Coronavirus Disease • Otorhinolaryngology • Respiratory Diseases

Safety and Immunogenicity of AdCOVID in Healthy Adults (COVID-19 Vaccine Study) (clinicaltrials.gov) - P1 | N=92 | Completed | Sponsor: Altimmune, Inc. | Active, not recruiting ➔ Completed | Trial completion date: Feb 2022 ➔ Dec 2022

Trial completion • Trial completion date • Infectious Disease • Novel Coronavirus Disease

The role of vaccination route with an adenovirus-vectored vaccine in protection, viral control, and transmission in the SARS-CoV-2/K18-hACE2 mouse infection model (ASTMH 2022) - "Utilizing a replication-deficient adenovirus serotype 5-vectored vaccine expressing the SARS-CoV-2 RBD (AdCOVID) in the K18-human ACE2 mouse model, we investigated the impact of route of administration on vaccine immunogenicity, survival, and transmission...Overall, our data provides further evidence for the utility of IN vaccination in protecting against SARS-CoV-2 infection and transmission. Additional studies exploring the mechanism surrounding enhanced protection afforded by IN vaccination are needed."

Preclinical • Infectious Disease • Novel Coronavirus Disease • Respiratory Diseases

A single intranasal administration of AdCOVID protects against SARS-CoV-2 infection in the upper and lower respiratory tracts. (PubMed, Hum Vaccin Immunother) - "Finally, AdCOVID prevents SARS-CoV-2 induced pathological damage in the lungs of mice. These data show that AdCOVID not only limits viral replication in the respiratory tract, but it also prevents virus-induced inflammation and immunopathology following SARS-CoV-2 infection."

Journal • Immunology • Infectious Disease • Inflammation • Novel Coronavirus Disease • Respiratory Diseases

Single-Dose Intranasal Administration of AdCOVID Elicits Systemic and Mucosal Immunity against SARS-CoV-2 and Fully Protects Mice from Lethal Challenge. (PubMed, Vaccines (Basel)) - "Moreover, a single intranasal dose completely protected K18-hACE2 mice from lethal SARS-CoV-2 challenge, preventing weight loss and mortality. These data show that AdCOVID promotes concomitant systemic and mucosal immunity and represents a promising vaccine candidate."

Journal • Preclinical • Infectious Disease • Novel Coronavirus Disease • Respiratory Diseases • CD4 • CD8

Safety and Immunogenicity of AdCOVID in Healthy Adults (COVID-19 Vaccine Study) (clinicaltrials.gov) - P1; N=92; Active, not recruiting; Sponsor: Altimmune, Inc.; Recruiting ➔ Active, not recruiting; N=180 ➔ 92

Clinical • Enrollment change • Enrollment closed • Infectious Disease • Novel Coronavirus Disease

Data and Safety Monitoring of COVID-19 Vaccine Clinical Trials. (PubMed, J Infect Dis) - "DSMB reviews encompass 3 domains: 1) the conduct of trials, including overall and subgroup accrual and data quality and completeness; 2) safety, including individual events of concern and comparisons by randomized group; and 3) interim analyses of efficacy when event-driven milestones are met. Challenges have included the scale and pace of the trials, the frequency of safety events related to the combined enrollment of over 100,000 participants, many of whom are older adults or have comorbid conditions that place them at independent risk of serious health events, and the politicized environment in which the trials have taken place."

Clinical • Journal • Infectious Disease • Novel Coronavirus Disease • Respiratory Diseases

COVID-19 Vaccine Acceptance among College Students: A Theory-Based Analysis. (PubMed, Int J Environ Res Public Health) - "The model accounted for 60.6% of the variance in intention to take the COVID-19 vaccine. This study provides evidence for the utility of MTM as a timely intervention to design messages for college students to enhance COVID-19 vaccine acceptability."

Journal • Infectious Disease • Novel Coronavirus Disease

Safety and Efficacy of Single-Dose Ad26.COV2.S Vaccine against Covid-19. (PubMed, N Engl J Med) - P3 | "A single dose of Ad26.COV2.S protected against symptomatic Covid-19 and asymptomatic SARS-CoV-2 infection and was effective against severe-critical disease, including hospitalization and death. Safety appeared to be similar to that in other phase 3 trials of Covid-19 vaccines. (Funded by Janssen Research and Development and others; ENSEMBLE ClinicalTrials.gov number, NCT04505722.)."

Clinical • Journal • Infectious Disease • Novel Coronavirus Disease • Respiratory Diseases

Altimmune Partners with Summit Biosciences to Produce a Multidose Nasal Spray Presentation of its AdCOVID Vaccine Candidate (GlobeNewswire) - "Altimmune, Inc....announced today that it has retained Summit Biosciences...to manufacture a metered nasal spray presentation of AdCOVID, its intranasal COVID-19 vaccine candidate....'We are pleased to partner with Summit Biosciences to manufacture AdCOVID in a customized multidose nasal spray delivery device'..."

Commercial • Infectious Disease • Novel Coronavirus Disease

AdCOVID, Altimmune’s Single Dose, Intranasal COVID-19 Vaccine Candidate, Prevents SARS-CoV-2-induced Disease and Blocks Viral Replication in Preclinical Studies of SARS-CoV-2 Infection (GlobeNewswire) - "New Findings from Ongoing Collaborations with University of Alabama at Birmingham and Saint Louis University....Single intranasal dose of AdCOVID provided 100% protection against a lethal challenge from the SARS-CoV-2 virus...Initial immunogenicity analysis showed mean antibody levels of about 1 mg/mL...In a separate study...a single intranasal dose of AdCOVID resulted in a greater than 1000-fold reduction in replicating virus in the nasal cavity and respiratory tract..."

Preclinical • Infectious Disease • Novel Coronavirus Disease

Altimmune Expands AdCOVID Manufacturing Collaboration with Lonza (GlobeNewswire) - "Altimmune, Inc...announced that it has 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...AdCOVID is expected to be shipped without cold chain logistics, permitting common refrigerated storage at community-based vaccination centers without the need for specialized freezer storage."

Clinical • Commercial • Infectious Disease • Novel Coronavirus Disease

Altimmune Announces Financial Results for the Year Ended December 31, 2020 and Provides a Corporate Update (GlobeNewswire) - "Development of AdCOVID Vectors Targeting Emerging Variants of the SARS-CoV-2 Virus has Begun; Altimmune has commenced enrollment in its Phase 1 clinical trial of AdCOVID...Altimmune anticipates having a full data readout from this Phase 1 study in Q2 2021....Altimmune continues preclinical studies of AdCOVID...Data from these ongoing preclinical studies are expected in Q1 and Q2 2021....T-COVID: Completed Cohorts 1 and 2 in the Phase 1/2 trial of T-COVID in patients with early COVID-19....No significant safety findings have been observed to date. Cohort 3 is an efficacy and safety cohort that will include patients at higher-risk for severe COVID-19 infection...Based on these changes, data from this trial is now expected in Q2 2021."

Enrollment status • P1 data • P1/2 data • Preclinical • Trial status • Infectious Disease • Novel Coronavirus Disease

Safety and Immunogenicity of AdCOVID in Healthy Adults (COVID-19 Vaccine Study) (clinicaltrials.gov) - P1; N=180; Recruiting; Sponsor: Altimmune, Inc.; Not yet recruiting ➔ Recruiting

Clinical • Enrollment open • Infectious Disease • Novel Coronavirus Disease

Clinic-based HPV and COVID-19 Vaccine Promoting Intervention for AfAm Adolescents in Alabama (clinicaltrials.gov) - P=N/A; N=4; Not yet recruiting; Sponsor: University of Alabama at Birmingham; Initiation date: Jan 2021 ➔ May 2021

Clinical • Trial initiation date • Infectious Disease • Novel Coronavirus Disease

Altimmune Announces FDA Clearance of AdCOVID IND Application (GlobeNewswire) - "Altimmune, Inc....announced that the U.S. Food and Drug Administration (FDA) has cleared the Company’s Investigational New Drug (IND) 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....'We look forward to the data from this trial in the coming weeks'. The Phase 1 clinical trial will evaluate the safety and immunogenicity of AdCOVID in up to 180 healthy adult volunteers..."

IND • Trial initiation date • Infectious Disease • Novel Coronavirus Disease

Altimmune Provides an Update on its Investigational New Drug Application for a Phase 1 AdCOVID Clinical Trial (GlobeNewswire) - "Altimmune, Inc....announced that the U.S. Food and Drug Administration (FDA) has issued a clinical hold on the Company’s Investigational New Drug (IND) application for AdCOVID...The Agency requested certain protocol modifications and the submission of additional Chemistry, Manufacturing and Controls (CMC) data. 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."

FDA event • Infectious Disease • Novel Coronavirus Disease

Safety and Immunogenicity of AdCOVID in Healthy Adults (clinicaltrials.gov) - P1; N=180; Not yet recruiting; Sponsor: Altimmune, Inc.

Clinical • New P1 trial

Altimmune Announces Submission of Investigational New Drug Application for AdCOVID a Single-dose Intranasal COVID-19 Vaccine; On Track to Commence Phase 1 Clinical Study in December (GlobeNewswire) - "Altimmune, Inc....today announced that it has submitted an Investigational New Drug (IND) application to the U.S. Food and Drug Administration (FDA) to commence a Phase 1 clinical study...'IND included a preliminary proposal for evaluation of children as young as 2 years of age,'...The FDA also confirmed that additional nonclinical studies were not required and that the toxicology data previously submitted and reviewed for Altimmune’s NasoShield™ and NasoVAX™ intranasal vaccine candidates support the clinical development of AdCOVID...Altimmune anticipates commencing a Phase 1 safety and immunogenicity trial of AdCOVID in the fourth quarter of 2020 with a data readout in the first quarter of 2021."

IND • New P1 trial • P1 data • Infectious Disease • Novel Coronavirus Disease

Identification of COVID-19 Can be Quicker through Artificial Intelligence framework using a Mobile Phone-Based Survey in the Populations when Cities/Towns Are Under Quarantine. (PubMed, Infect Control Hosp Epidemiol) - "We are proposing to use machine learning algorithms to be able to improve possible case identifications of COVID-19 more quicker when we use a mobile phone-based web survey. This will also reduce the spread in the susceptible populations."

Clinical • Journal

VIROLOGY OF COVID-19 (CROI 2020) - No abstract available

EPIDEMIOLOGY OF COVID-19 (CROI 2020) - No abstract available

Clinical

Altimmune Adds Lonza as a Manufacturing Partner for Supply of AdCOVID its Single-Dose Intranasal Vaccine Candidate for COVID-19 (GlobeNewswire) - "Lonza Agreement Builds on Existing Partnerships and Expands Altimmune’s Commercial Readiness in Preparation to Produce the Commercial Vaccine in 2021; Altimmune, Inc....announced that it entered into an agreement with Lonza for the manufacturing of AdCOVID™....AdCOVID is expected to provide durable immunity of up to a year or more following a single dose....AdCOVID is expected to be shipped without cold chain and permit common refrigerated storage conditions....'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.'"

Clinical data • Commercial • New trial • Infectious Disease • Novel Coronavirus Disease

"And the Biopharmaceutical who has the #1 solution to defeat COVID-19 is Altimmune ticker $ALT Book mark it for future reference. Thank you" (@shurtleff_k)

Infectious Disease • Novel Coronavirus Disease

NasoVAX in Patients With Early Coronavirus Infectious Disease 2019 (COVID-19) (clinicaltrials.gov) - P2; N=96; Recruiting; Sponsor: Altimmune, Inc.; Not yet recruiting ➔ Recruiting; Initiation date: Jul 2020 ➔ Sep 2020; Trial primary completion date: Nov 2020 ➔ Feb 2021

Clinical • Enrollment open • Trial initiation date • Trial primary completion date • Infectious Disease • Novel Coronavirus Disease