The AIDS Clinical Trials Group (ACTG), the biggest global HIV research network, which just recently expanded its focus to include examining outpatient treatment for COVID-19, today revealed the launch of A5404, a medical trial studying how previous infection with SARS-CoV-2 and receiving either an investigational COVID-19 therapy or placebo/active comparator impacts individuals immune reactions to mRNA COVID-19 vaccines. A5404 is a sub-study of the ACTIV-2 Outpatient Monoclonal Antibodies and Other Therapies Trial (ACTG A5401), which is assessing numerous investigational agents to treat early, symptomatic COVID-19 in non-hospitalized people.
” A5404 supplies us with a crucial opportunity to get insights into potentially various reactions to mRNA COVID-19 vaccines amongst participants who have actually had COVID-19, which will be particularly essential as we work to optimize the timing of vaccines for those people,” stated ACTG chair Judith Currier, M.D., M.Sc., University of California, Los Angeles (UCLA).
A5404 is a phase 4, open-label research study that aims to find out about the distinction in neutralizing antibody (NAb) actions to mRNA-based COVID-19 vaccines amongst individuals with prior SARS-CoV-2 infection who took part in ACTIV-2 (who either received an investigational COVID-19 treatment or placebo or active comparator) and individuals who have no history of COVID-19 and did not take part in ACTIV-2. A5404 will enlist 70 individuals each from five different ACTIV-2 treatment groups and approximately 70 participants without prior history of COVID-19 for each ACTIV-2 treatment group.
In the first friend, ACTIV-2 participants will either get the Moderna COVID-19 vaccine through the research study or the Moderna or Pfizer COVID-19 vaccine at a neighborhood website. They will get their vaccine 30-240 days after their last day of ACTIV-2 study treatment.
In the 2nd mate, individuals without history of previous COVID-19 will get the Moderna COVID-19 vaccine through the research study.
All individuals will have their blood gathered and their immune responses measured as near to when the vaccine is administered as possible and at eight and 20 weeks and one and 2 years after the very first vaccine dose.
” The advancement of COVID-19 vaccines and treatments is moving quickly, but we still have a lot to find out,” said Davey Smith, M.D., University of California, San Diego, A5404 research study chair. “A5404 aims to help us much better understand how individuals who have had COVID-19 and may have been dealt with for it respond to vaccination to prevent reinfection with COVID-19. As such, this study has the prospective to fill out a significant gap in our knowledge about the relationship between COVID-19 treatment and vaccination.”
ACTIV-2, the parent study of A5404, is currently evaluating a number of representatives in phase 3 after having finished a stage 2 research study of each treatment:
” The development of COVID-19 vaccines and treatments is moving fast, however we still have a lot to learn,” said Davey Smith, M.D., University of California, San Diego, A5404 study chair. “A5404 intends to assist us much better comprehend how people who have had COVID-19 and might have been dealt with for it respond to vaccination to prevent reinfection with COVID-19. This research study has the potential to fill in a significant gap in our understanding about the relationship in between COVID-19 treatment and vaccination.”
ACTIV-2 is part of NIHs Accelerating COVID-19 Therapeutic Interventions and Vaccines (ACTIV), a public-private collaboration program to develop a collaborated research study method that focuses on and speeds advancement of the most promising treatments and vaccines. It likewise gets support from the Federal COVID Response-Therapeutics, the U.S. governments multi-agency effort to accelerate the advancement, production, and distribution of COVID-19 vaccines, rehabs, and diagnostics.
BRII-196 plus BRII-198: two monoclonal antibodies administered as 2 separate infusions as a one-time dose (totally registered).
SAB-185: a polyclonal antibody, which combines numerous various antibodies in a single infusion.
SNG001: a nebulized solution of beta interferon being studied as an inhalant taken every day for 14 days.
A5404 is led by Dr. Smith (chair) and Kara W. Chew, M.D., M.S., UCLA, David Alain Wohl, M.D., University of North Carolina (UNC), and Eric S. Daar, M.D., Lundquist Institute at Harbor-UCLA Medical Center (vice-chairs). ACTIV-2 is led by Drs. Chew and Smith (procedure chairs) and Drs. Wohl and Daar (vice-chairs) and supported by Dr. Currier and ACTG Co-Chair Joseph J. Eron, M.D., UNC.
ACTIV-2 is sponsored by the National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health (NIH), which also moneys the ACTG. ACTIV-2 belongs to NIHs Accelerating COVID-19 Therapeutic Interventions and Vaccines (ACTIV), a public-private partnership program to produce a coordinated research strategy that prioritizes and speeds development of the most appealing treatments and vaccines. It likewise receives support from the Federal COVID Response-Therapeutics, the U.S. federal governments multi-agency effort to accelerate the development, production, and distribution of COVID-19 diagnostics, therapeutics, and vaccines.
About the ACTG.
Established in 1987, the AIDS Clinical Trials Group (ACTG) was the worlds first HIV research study network. The ACTG conducts innovative research studies to enhance the treatment of HIV and its problems, including tuberculosis and viral liver disease; decrease brand-new infections and HIV-related health problem; and advance brand-new approaches to avoid, treat, and ultimately cure HIV in adults and kids. ACTG detectives and research study systems in 15 nations serve as major resources for HIV/AIDS research, treatment, care, and training/education in their communities. ACTG studies have helped develop present paradigms for managing HIV illness, and have informed HIV treatment guidelines, leading to significant declines in HIV-related death worldwide.
ACTIV-2 is also presently assessing several representatives in stage 2 (both are fully registered):.
BMS 986414 and BMS-986413: two monoclonal antibodies administered as subcutaneous injections (shots) given at one visit.
AZD7442: a mix of two monoclonal antibodies (AZD8895 and AZD1061) that is being studied both as a single 15-minute infusion and a one-time intramuscular injection (shot).
