NasoVAX is a recombinant intranasal vaccine that is RD-Ad5-based being developed for both seasonal and pandemic use.
NasoVAX can activate the humoral, mucosal, and cellular immune arms in unison for a more comprehensive immune response.
NasoVAX is indicated to prevent influenza, seasonal as well as pandemic (COVID-19)
NasoVAX is administered by intranasal spray, the dosage is being evaluated in clinical trials
June 1, 2020 - Altimmune Launches Clinical Trial Of T-COVIDTM, An Investigational Intranasal Immune Modulator For The Treatment Of Patients With Early COVID-19. The FDA has agreed that the Company may use its existing lot of RD-Ad5-based NasoVAX influenza vaccine for the planned T-COVID clinical trial allowing the Company to immediately initiate the study.
NasoVAX Clinical Trials
Clinical Trial NCT04442230: NasoVAX in Patients With Early Coronavirus Infectious Disease 2019 (COVID-19).
After being informed about the study and potential risks, all patient volunteers that have given written informed consent will undergo screening to determine eligibility for study entry. If the patient qualifies for the study, they will be randomized in a double-blind manner in a 1:1 ratio to receive NasoVAX or placebo. On the same day of qualifying into the study, the patient will be administered the investigational drug (either NasoVAX or placebo).
The patient will return home for the remainder of the study. During this period, the patient will be monitored remotely by the study center for clinical status. The patient will also be contacted by study center personnel by telephone to ask about the use of any medications and changes in health including information about any hospitalization.
Clinical Trial NCT03232567: Single-ascending-dose Study of the Safety and Immunogenicity of NasoVAX
This is a Phase 2a, randomized, double-blind, placebo-controlled trial to evaluate the safety and immunogenicity of NasoVAX in healthy adults 18 to 49 years of age.
Subjects will be screened within 28 days of randomization (Day 1).
Approximately 60 subjects who meet all inclusion and no exclusion criteria and provide written informed consent will be enrolled into 3 sequential cohorts of 20 subjects each defined by the viral particle dose (1×10(9th), 1×10(10th), and 1×10(11th) vp).
Within each cohort and its sentinel group, subjects will be randomized in a 3:1 ratio to receive 1 intranasal dose of NasoVAX or placebo (Day 1).
A sentinel group of 5 subjects from each cohort will be dosed and followed through Day 8.
Dosing of the remainder of each cohort may proceed if no events meeting stopping criteria have occurred.
The SRC, consisting of the Investigator, the Medical Monitor, and a Sponsor Representative, will review AE, reactogenicity, and laboratory data through Day 8 for all subjects in each cohort before subjects are randomized to the next higher dose.
If any event meeting stopping criteria occur, the SRC will review all available safety information before additional patients are dosed.
Clinical Trial NCT03760549: Study of the Safety and Immunogenicity of NasoVAX Extension
This study is an extension to Study ALT-103-201 to evaluate immunogenicity of NasoVAX administered by intranasal spray at a single dose of 1×1011 vp at Day 366 (± 60 days).
Up to 15 subjects who received NasoVAX at the 1×10(11th) vp dose in Study ALT-103-201 will be screened, and a serum sample will be collected from each eligible subject for evaluation of influenza HAI assay against influenza A/California/07/2009(H1N1), a strain homologous to the one used for NasoVAX (monovalent AdcoCA09.HA).
Ad5 antibody neutralization assay may also be performed