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A Phase 1, Double-blind, Randomized, Placebo-controlled, First-in-Human Study of the Safety and Immunogenicity of AdCOVID Administered as One or Two Doses

Trial Profile

A Phase 1, Double-blind, Randomized, Placebo-controlled, First-in-Human Study of the Safety and Immunogenicity of AdCOVID Administered as One or Two Doses

Status: Recruiting
Phase of Trial: Phase I

Latest Information Update: 17 May 2021

At a glance

  • Drugs Coronavirus vaccine-Altimmune (Primary)
  • Indications COVID 2019 infections
  • Focus Adverse reactions; First in man; Pharmacodynamics
  • Sponsors Altimmune
  • Most Recent Events

    • 17 May 2021 According to an Altimmune media release, protocol was amended to reduce the number of adult subjects to approximately 80 due to the widespread availability of authorized vaccines. The final sample size of the study is comparable to the number of participants in Phase 1 studies of the U.S. authorized vaccines.
    • 10 May 2021 According to an Altimmune media release, the company anticipates topline data from tis study in June 2021.
    • 25 Feb 2021 According to an Altimmune media release, the company anticipates having a full data readout from this Phase 1 study in Q2 2021.

Trial Overview

Purpose

This Phase 1 clinical trial is designed to evaluate the safety and immunogenicity of AdCOVID in 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.

Primary Endpoints

Reactogenicity

description: Counts and percentages of subjects with local and systemic events
time_frame: For 7 days after vaccination

Adverse Events (AEs)

description: Counts and percentages of subjects with AEs
time_frame: Day 1 to Day 57

Other Endpoints

Anti-SARS-CoV-2 spike IgG antibody levels

time_frame: Day 1 to Day 366

Neutralizing antibody titer against live and/or pseudotyped SARS-CoV-2 virus

time_frame: Day 1 to Day 366

Anti-SARS-CoV-2 RBD T cell responses by interferon (IFN)-gamma enzyme-linked immunosorbent spot (ELISpot)

time_frame: Day 1 to Day 366

Mucosal antibody responses in nasopharyngeal swabs (anti-SARS-CoV-2 spike IgA titers)

time_frame: Day 1 to Day 366 [1]

Diseases Treated

Indication Qualifiers Patient Segments
COVID 2019 infections prevention -

Subjects

  • Subject Type patients
  • Number

    Planned: 80

  • Sex male & female
  • Age Group 18-55 years; adult

Patient Inclusion Criteria

- Men and women ages 18 to 55 years, inclusive - Good general health status - Screening laboratory results within institutional normal range or Grade 1 abnormality if the Investigator documents clinical insignificance. Grade 2 laboratories may be permissible if considered not clinically significant by the investigator. - For women who have not been surgically sterilized or who do not have laboratory confirmation of postmenopausal status, negative pregnancy test - Willingness to practice a highly effective method of contraception - Ability and willingness to comply with all aspects of the study, including nasopharyngeal swabs and blood and urine samples, through the entire study period

Patient Exclusion Criteria

- Subjects at increased risk of exposure to SARS-CoV-2, including healthcare workers, emergency response personnel, and those with known contact with COVID-19 patients - Pregnant or lactating women or planning to conceive a child during the next 3 months - Body mass index (BMI) > 30.0 kg/m2 - Acute COVID-19, a positive test result for SARS-CoV2 infection, a positive SARS-CoV-2 serology for prior SARS-CoV-2 infection at screening, or exposure within 14 days to an individual with acute COVID-19 - An acute respiratory illness - Positive result for HIV, hepatitis B virus, or hepatitis C virus at screening - Chronic or current cigarette smoking - Any medical, psychiatric, or social condition or occupational or other responsibility that in the judgment of the Investigator would interfere with or serve as a contraindication to protocol adherence, assessment of safety (including reactogenicity), or a subject's ability to give informed consent

Trial Details

Identifiers

Identifier Owner
NCT04679909 ClinicalTrials.gov: US National Institutes of Health
ALT501-101 -

Organisations

  • Sponsors Altimmune
  • Affiliations Altimmune

Trial Dates

  • Initiation Dates

    Planned : 01 Feb 2021

  • Primary Completion Dates

    Planned : 01 Feb 2022

  • End Dates

    Planned : 01 Feb 2022

Other Details

  • Design double-blind; multicentre; parallel; prospective; randomised
  • Phase of Trial Phase I
  • Location USA
  • Focus Adverse reactions; First in man; Pharmacodynamics

Interventions

Drugs Route Formulation
Coronavirus vaccine-AltimmunePrimary Drug Nasal Spray

Single High Dose AdCOVID

Biological: AdCOVID (Administered intranasally)

Single Low Dose AdCOVID

Biological: AdCOVID (Administered intranasally)

Single Medium Dose AdCOVID

Biological: AdCOVID (Administered intranasally)

Two High Doses AdCOVID

Biological: AdCOVID (Administered intranasally)

Two Low Doses AdCOVID

Biological: AdCOVID (Administered intranasally)

Two Medium Doses AdCOVID

Biological: AdCOVID (Administered intranasally)

Single Dose Placebo

Other: Placebo (Administered intranasally)

Two Dose Placebo

Other: Placebo (Administered intranasally)

Trial Centres

Investigators

Investigator Centre Name Trial Centre Country
Altimmune CTM
(240) 654-1450
information@altimmune.com
show details
, Altimmune, Inc.
-
PI Optimal Research USA

Centres

Centre Name Location Trial Centre Country
-
-
-
Altimmune, Inc.
-
-
Optimal Research Austin, Texas USA
Optimal Research Melbourne, Florida USA
Optimal Research Peoria, Illinois USA
Optimal Research Rockville, Maryland USA

Trial History

Event Date Event Type Comment
17 May 2021 Protocol amendment According to an Altimmune media release, protocol was amended to reduce the number of adult subjects to approximately 80 due to the widespread availability of authorized vaccines. The final sample size of the study is comparable to the number of participants in Phase 1 studies of the U.S. authorized vaccines. Updated 22 May 2021
10 May 2021 Other trial event According to an Altimmune media release, the company anticipates topline data from tis study in June 2021. Updated 13 May 2021
25 Feb 2021 Other trial event According to an Altimmune media release, the company anticipates having a full data readout from this Phase 1 study in Q2 2021. Updated 01 Mar 2021
25 Feb 2021 Other trial event Last checked against the ClinicalTrials.gov record. Updated 25 Feb 2021
22 Feb 2021 Status change - recruiting Status changed from not yet recruiting to recruiting. Updated 25 Feb 2021
17 Feb 2021 Other trial event According to an Altimmune media release, the U.S. Food and Drug Administration (FDA) has cleared the Companys Investigational New Drug (IND) application for this Phase 1 clinical trial of AdCOVID.The company expects to commence patient enrollment in the coming week. Updated 23 Feb 2021
14 Jan 2021 Other trial event Planned initiation date changed from 1 Dec 2020 to 1 Feb 2021. Updated 20 Jan 2021
23 Dec 2020 Other trial event According to an Altimmune media release, the USA Food and Drug Administration (FDA) has issued a clinical hold on the Investigational New Drug (IND) application for AdCOVID. The FDA has requested certain protocol modifications and the submission of additional Chemistry, Manufacturing and Controls (CMC) data. Updated 31 Dec 2020
23 Dec 2020 Other trial event New source identified and integrated ClinicalTrials.gov: (US National Institutes of Health: NCT04679909). Updated 23 Dec 2020
25 Nov 2020 Other trial event According to an Altimmune media release, in a recent pre-IND meeting, the FDA agreed to the overall Phase 1 study design and patient population, as well as plans for manufacturing and product testing of AdCOVID. Updated 07 Dec 2020
25 Nov 2020 Other trial event According to an Altimmune media release, company has submitted an Investigational New Drug (IND) application to the U.S. Food and Drug Administration (FDA) to commence this trial. Updated 07 Dec 2020
09 Nov 2020 Other trial event According to an Altimmune media release, data read-out from this study is expected in Q1 2021. Updated 19 Nov 2020
29 Sep 2020 Other trial event According to an Altimmune media release, the company anticipates submitting an IND with the U.S. Food and Drug Administration in the fourth quarter of 2020. Updated 14 Oct 2020
11 Aug 2020 Other trial event According to an Altimmune media release, data from that study, including validation of the compounds weight loss and liver fat-reducing effects, is expected to read out in the spring of 2021. Updated 17 Aug 2020
29 Jun 2020 Other trial event According to an Altimmune media release, the Company intends to initiate manufacturing of AdCOVID in July with the Phase 1 clinical trial expected to begin in Q4 of this year. Updated 06 Jul 2020
13 May 2020 Other trial event According to an Altimmune media release, the company expects to initiate this study early as Q4 of this year. Updated 18 May 2020
31 Mar 2020 New trial record New trial record Updated 31 Mar 2020
27 Mar 2020 Other trial event According to an Altimmune media release, the company expects to initiate this study early as Q3 of this year. Updated 31 Mar 2020

References

  1. ClinicalTrials.gov: US National Institutes of Health. Trial-Reg 2021;.

    Available from: URL: http://clinicaltrials.gov
  2. Altimmune. Altimmune Announces First Quarter 2020 Financial Results and Provides a Business Update. Media-Rel 2020;.

    Media Release
  3. Altimmune. Altimmune Presents Highlights of Intranasal COVID-19 Vaccine and Therapeutic Programs AdCOVID(Tm) and T-COVID(Tm) at the World Vaccine Congress. Media-Rel 2020;.

    Media Release
  4. Altimmune. Altimmune Receives Award from U.S. Department of Defense to Fund Phase 1/2 Clinical Trial of T-COVID(Tm) in Outpatients with Early COVID-19. Media-Rel 2020;.

    Media Release
  5. Altimmune. Altimmune Announces Submission of Investigational New Drug Application for AdCOVID(Tm) a Single-dose Intranasal COVID-19 Vaccine; On Track to Commence Phase 1 Clinical Study in December. Media-Rel 2020;.

    Media Release
  6. Altimmune. Altimmune Commences Enrollment in Phase 1 Clinical Trial of AdCOVID(Tm) -- a Needle-Free, Single-Dose Intranasal COVID-19 Vaccine Candidate. Media-Rel 2021;.

    Media Release
  7. Altimmune. Altimmune Announces Financial Results for the Year Ended December 31, 2019 and Provides a Corporate Update. Media-Rel 2020;.

    Media Release
  8. Altimmune. Altimmune Announces First Quarter 2021 Financial Results and Provides a Corporate Update. Media-Rel 2021;.

    Media Release
  9. Altimmune. Altimmune Announces FDA Clearance of AdCOVID(Tm) IND Application. Media-Rel 2021;.

    Media Release
  10. Altimmune. Altimmune Announces New Preclinical Data for AdCOVID(Tm) Demonstrating Sterilizing Immunity After a Single Intranasal Dose. Media-Rel 2021;.

    Media Release
  11. Altimmune. Altimmune Announces Third Quarter 2020 Financial Results and Provides a Business Update. Media-Rel 2020;.

    Media Release
  12. Altimmune. Altimmune Provides an Update on its Investigational New Drug Application for a Phase 1 AdCOVID(Tm) Clinical Trial. Media-Rel 2020;.

    Media Release
  13. Altimmune. Altimmune Announces Second Quarter 2020 Financial Results and Provides a Business Update. Media-Rel 2020;.

    Media Release
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