Vaccine trial

Altimmune Announces Update on AdCOVID™ Phase 1 Clinical Trial

Retrieved on: 
Tuesday, June 29, 2021

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.

Key Points: 
  • 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.
  • The Phase 1 AdCOVID clinical trial is evaluating the safety and immunogenicity of the intranasally administered vaccine candidate in approximately 80 healthy adult volunteers between the ages of 18 and 55.
  • Based on these data, and in view of the highly competitive COVID-19 vaccine landscape, Altimmune is discontinuing further development of AdCOVID beyond the completion of this Phase 1 trial.
  • The immune response to AdCOVID was inferior to that seen in our NasoVAX influenza vaccine trial, commented Scot Roberts, PhD, Chief Scientific Officer at Altimmune.

Sanofi and GSK COVID-19 vaccine candidate demonstrates strong immune responses across all adult age groups in Phase 2 trial

Retrieved on: 
Monday, May 17, 2021

Overall, the vaccine candidate elicited strong neutralizing antibody levels that were comparable to those generated by natural infection, with higher levels observed in younger adults (18 to 59 years old).

Key Points: 
  • Overall, the vaccine candidate elicited strong neutralizing antibody levels that were comparable to those generated by natural infection, with higher levels observed in younger adults (18 to 59 years old).
  • \xe2\x80\x9cWith these favorable results, we are set to progress to a global Phase 3 efficacy study.
  • The high titers observed in the non-na\xc3\xafve population after one dose of the vaccine candidate also suggest it may have strong potential for use as a booster vaccine.
  • In March 2021, Sanofi and Translate Bio initiated a Phase 1/2 clinical trial of their mRNA COVID-19 vaccine candidate, in order to assess safety, immune response and reactogenicity, after preclinical data showed high neutralizing antibody levels.

Altimmune Reports Data from its Phase 1b Clinical Trial of NasoShield™

Retrieved on: 
Thursday, April 1, 2021

GAITHERSBURG, Md., April 01, 2021 (GLOBE NEWSWIRE) -- Altimmune, Inc. (Nasdaq: ALT), a clinical-stage biopharmaceutical company, reported clinical data today on its NasoShield intranasal anthrax vaccine candidate.

Key Points: 
  • GAITHERSBURG, Md., April 01, 2021 (GLOBE NEWSWIRE) -- Altimmune, Inc. (Nasdaq: ALT), a clinical-stage biopharmaceutical company, reported clinical data today on its NasoShield intranasal anthrax vaccine candidate.
  • The Phase 1b trial evaluated the safety and immunogenicity of one and two-dose regimens of NasoShield in healthy volunteers.
  • The trial enrolled 42 healthy subjects who received intranasally administered NasoShield or saline placebo and were then monitored for 6 months post-dosing.
  • The clinical data from the Phase 1b trial showed that:
    Serum binding antibody responses to the protective antigen of Bacillus anthracis, the bacterium and causative agent of anthrax, were significantly greater than in the placebo arm.

ImmunityBio Announces Positive Interim Phase I Safety Data of hAd5 T-Cell COVID-19 Vaccine Candidate in Oral and Sublingual Formulations

Retrieved on: 
Monday, March 15, 2021

( NASDAQ: IBRX ), a clinical-stage immunotherapy company, today announced it has met the safety requirements for the first 12 participants in its Phase Ib human adenovirus (hAd5)-based T-cell COVID-19 vaccine trials in sublingual and oral formulations.

Key Points: 
  • ( NASDAQ: IBRX ), a clinical-stage immunotherapy company, today announced it has met the safety requirements for the first 12 participants in its Phase Ib human adenovirus (hAd5)-based T-cell COVID-19 vaccine trials in sublingual and oral formulations.
  • Phase Ib trials are studying a combination of subcutaneous/ sublingual (under the tongue) (NCT04591717) and subcutaneous/oral (NCT04732468) formulations of ImmunityBios hAd5 T-cell COVID-19 vaccine candidate.
  • The second-generation, non-replicating hAd5 vector platform is being used has been manufactured in both subcutaneous and oral formulations.
  • ImmunityBios COVID-19 vaccine candidate protects non-human primates from high-titer SARS-CoV-2 challenge when administered as subcutaneous prime with oral boost administration.

 ImmunityBio Announces Phase I Trial of COVID-19 Vaccine Candidate in South Africa as New Variants of SARS-CoV-2 Spread

Retrieved on: 
Tuesday, January 19, 2021

The same vaccine is currently being tested in a similar Phase I trial in the U.S., with no safety concerns identified to date.

Key Points: 
  • The same vaccine is currently being tested in a similar Phase I trial in the U.S., with no safety concerns identified to date.
  • These exciting results have catalyzed our interest in pursuing human trials of the oral vaccine in South Africa.
  • Understanding sensitivities related to adeno vaccine platforms in South Africa, we have taken the utmost care in designing our trial, said Dr. Amy Ward, principal investigator of the Phase I trial.
  • ImmunityBio has engaged with government agencies and indicated a commitment to ensuring this vaccine is available in South Africa.

Prioritizing the COVID-19 Vaccine to Protect Patient Access to Diagnostics

Retrieved on: 
Thursday, December 17, 2020

Vaccine development in the United States is a rigorous process rooted in evidence and scientific protocols.

Key Points: 
  • Vaccine development in the United States is a rigorous process rooted in evidence and scientific protocols.
  • The clinical trials for the vaccine have also included diverse communities to ensure safety and efficacy for our patients.
  • It is essential that early access to the vaccine be provided to all pathologists and laboratory personnel.
  • Pathologists have led throughout this pandemic by bringing tests for the coronavirus online in communities across the country and we must ensure that patient access to testing continues.

Applied DNA, EvviVax, and GVS Receive Regulatory Approval to Conduct Veterinary Clinical Trial for Linear COVID-19 Vaccine Candidate

Retrieved on: 
Monday, November 30, 2020

The vaccine candidate is jointly developed by Applied DNA and EvviVax.

Key Points: 
  • The vaccine candidate is jointly developed by Applied DNA and EvviVax.
  • The trial will take place at GVS in Brewster, N.Y., and is expected to begin within the next 90 days.
  • The trials primary endpoint is to demonstrate the safety and immunogenicity (detection of neutralizing antibodies and T-cell response) of the vaccine candidate in domestic felines.
  • Should our veterinary COVID-19 vaccine gain conditional licensure, we believe it could have significant economic and public utility.

INOVIO Announces Initiation of Phase 2 Segment of its Phase 2/3 Clinical Trial for its COVID-19 DNA Vaccine Candidate, INO-4800; Trial Will Be Funded by the U.S. Department of Defense

Retrieved on: 
Monday, November 16, 2020

The planned Phase 2/3 clinical trial, called INNOVATE (INOVIO INO-4800 Vaccine Trial for Efficacy), is a randomized, blinded, placebo-controlled safety and efficacy trial of INO-4800 to be conducted in adults in the U.S.

Key Points: 
  • The planned Phase 2/3 clinical trial, called INNOVATE (INOVIO INO-4800 Vaccine Trial for Efficacy), is a randomized, blinded, placebo-controlled safety and efficacy trial of INO-4800 to be conducted in adults in the U.S.
  • The company plans to resolve the remaining device questions during the conduct of Phase 2 segment and prior to the start of the Phase 3 segment of the trial.
  • "I am extremely proud of the INOVIO team, which has been working tirelessly to develop a safe and effective vaccine in the fight against the COVID-19 pandemic.
  • Initiation of our Phase 2 trial marks a pivotal milestone for INO-4800," said INOVIO's President and CEO, Dr. J. Joseph Kim.

Sengenics Launches SEROMAX, an At-Home, Antibody Sample Collection Kit That Will Revolutionise Patient Recruitment and Monitoring in Clinical Trials

Retrieved on: 
Thursday, October 29, 2020

Conventional antibody sample collection methods require patients to visit a clinical site where a physician would commonly need to draw a minimum of 0.5 ml of blood.

Key Points: 
  • Conventional antibody sample collection methods require patients to visit a clinical site where a physician would commonly need to draw a minimum of 0.5 ml of blood.
  • By using a proprietary matrix to stabilise antibodies, the SEROMAX kit simplifies this process, enabling shipping at room temperature.
  • With SEROMAX enabling at-home sample collection, follow-ups in relevant clinical trials can be simplified, without compromising the quality of subsequent serological assays.
  • This kit can benefit researchers working in the COVID-19 R&D space with sample collection for seroprevalence studies and for monitoring of vaccine trials.

PPD Recognized at Vaccine Industry Excellence Awards

Retrieved on: 
Tuesday, October 6, 2020

PPD, Inc. (Nasdaq:PPD), was recognized for leadership at the 13th annual Vaccine Industry Excellence (ViE) Awards during the 2020 World Vaccine Congress.

Key Points: 
  • PPD, Inc. (Nasdaq:PPD), was recognized for leadership at the 13th annual Vaccine Industry Excellence (ViE) Awards during the 2020 World Vaccine Congress.
  • The ViE awards celebrate the outstanding achievements of organizations and individuals setting high standards of excellence and advocacy in the vaccine industry.
  • With more than 25 years of vaccine development experience for both government and commercial customers, PPD provides integrated clinical and laboratory vaccine expertise and global resources to advance its customers vaccine programs.
  • During the past five years, PPD has supported more than 200 vaccine trials globally.