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Tag: Clinical Trial

  • HIV: Moderna launches clinical trial for breakthrough vaccine

    HIV: Moderna launches clinical trial for breakthrough vaccine

    American pharmaceutical and biotechnology company, Moderna has announced launching early-stage clinical trials of a vaccine for human immunodeficiency virus (HIV).

    TheNewsGuru.com (TNG) reports Moderna made this known via a statement published on it’s official website on Thursday.

    According to the statement, the first doses of the HIV vaccine that uses mRNA technology were administered at George Washington University (GWU) School of Medicine and Health Sciences in Washington, D.C.

    Moderna teamed up with ​​International AIDS Vaccine Initiative (IAVI) to develop the shot, which uses the same technology as Moderna’s successful COVID-19 vaccine.

    Nearly 38 million people worldwide are living with HIV, which can lead to the potentially fatal disease, acquired immunodeficiency syndrome (AIDS).

    Being diagnosed with HIV in the past was considered a death sentence. However, today, HIV is much more manageable with medications that can reduce viral loads to undetectable so the virus can’t be transmitted, as well as pills that can be taken to prevent infecting those who are HIV-negative.

    Despite decades of research, no vaccine has ever been developed. Several candidates have entered clinical trials but failed in later stages.

    Meanwhile, researchers hope that this breakthrough HIV vaccine can induce specific white blood cells, called B cells, which can then turn into what are known as broadly neutralizing antibodies that can neutralize the virus.

    “We are tremendously excited to be advancing this new direction in HIV vaccine design with Moderna’s mRNA platform. The search for an HIV vaccine has been long and challenging, and having new tools in terms of immunogens and platforms could be the key to making rapid progress toward an urgently needed, effective HIV vaccine. We are grateful to all of our partners and especially to the Bill & Melinda Gates Foundation for funding this trial,” says Mark Feinberg, M.D., Ph.D., president and CEO of IAVI.

    On his part, Stephen Hoge, M.D., President of Moderna, said: “We are very pleased to be partnering with IAVI and the Bill & Melinda Gates Foundation to apply our mRNA technology in the setting of HIV. At Moderna, we believe that mRNA offers a unique opportunity to address critical unmet public health needs around the world.

    We believe advancing this HIV vaccine program in partnership with IAVI and Scripps Research is an important step in our mission to deliver on the potential for mRNA to improve human health”.

    According to the statement, Phase I of the trial will enroll 56 healthy, HIV-negative adult participants at GWU and three additional sites: Hope Clinic of Emory Vaccine Center in Atlanta; Fred Hutchinson Cancer Research Center in Seattle; and the University of Texas-Health Science Center at San Antonio.

    Of the volunteers, 48 will receive one or two doses of the mRNA vaccine, and 32 also will receive the booster. The remaining eight will receive just the booster.

    Researchers will then monitor for safety and efficacy of the new vaccine for up to six months after participants receive their final dose.

    “We’ve seen promising proof of concept for germline targeting in IAVI G001, and this trial lets us take that approach to the next stage. What’s more, we’ve been able to expedite production of clinical trial material at a remarkably rapid pace because of Moderna’s technology,” said William Schief, Ph.D., professor at Scripps Research and executive director of vaccine design at IAVI’s Neutralizing Antibody Center (NAC).

  • Clinical trials underway to evaluate plasma of COVID-19 recovered patients – WHO

    Clinical trials underway to evaluate plasma of COVID-19 recovered patients – WHO

    The World Health Organisation (WHO) says clinical trials are underway to evaluate the effectiveness of using plasma from the blood of recovered COVID-19 patients to reduce the severity of illness among people infected with the virus.

    WHO Regional Director for Africa, Dr Matshidiso Moeti said this in her message to mark the 2020 World Blood Donor Day (WBDD).

    WBDD is celebrated every June 14, to raise awareness on the need for safe blood and blood products, and to thank blood donors for their life-saving gifts of blood.

    “This approach was used by Guinea in the Ebola epidemic in 2014, prior to the availability of Ebola vaccines and therapies.

    “In Mauritius, 150 people who have recovered from COVID-19 have indicated they are willing to give plasma in line with the national decision to use serum plasma therapy for COVID-19 patients in intensive care.

    “The biggest challenge with this approach in many African countries is the insufficient resources of national blood services to safely collect, process and store COVID-19 convalescent plasma in a quality-assured manner.

    “However, the current pandemic is also an opportunity to improve this situation. Kenya, for instance, has allocated a portion of funding from the World Bank specifically to improving blood services during the pandemic,’’ Moeti said.

    In the COVID-19 pandemic, she said the supply of safe blood was at risk, saying: “regular blood donation drives are being postponed, and stay-at-home orders and fear of infection are preventing donors from accessing services.

    “Disruptions to the global supply chain also put countries at risk of shortages of critical supplies and equipment needed for blood donation and transfusion.’’

    According to her, universal access to safe blood is a key component of a resilient health system and contributes to achieving universal health coverage.

    “In the African Region, countries are making progress in improving access to quality-assured blood and blood products.

    “In 2019, eight countries collected 10 units or more per 1000 population as recommended by WHO and 19 countries reached the target of over 80 per cent voluntary non-remunerated blood donations in line with the regional strategy for blood safety.

    “At WHO, we are also exploring partnerships with Facebook to set-up a regional Blood Donations feature, and 15 countries have expressed interest in piloting this tool.

    “The feature connects blood donors with nearby opportunities to donate in collaboration with approved blood banks.’’

    The regional director, however, urged governments, in collaboration with blood donor associations and non-government organisations, to increase investment in blood transfusion services in line with WHO guidance.

    “I wish to thank all voluntary, unpaid blood donors for the life-saving gifts they offer to communities and all the phlebotomists.

    “I also thank other health workers who contribute to blood donation and transfusion services – because of your commitment, safe blood saves lives,’’ she said.

    According to her, On June 14, every year, the African Region joins the global community in celebrating World Blood Donor Day, because blood donors give the gift of life, and more lives will be saved if more people volunteer to donate blood on a regular basis.

    “This year we are calling on people to “give blood and make the world a healthier place” because by regularly volunteering to donate blood, we can all contribute to solidarity and saving lives.

    “Safe blood is a critical resource in severe infant anaemia, postpartum hemorrhage and trauma care. It is also vital in surgeries and the treatment of malaria, sickle cell disease, thalassemia, inherited blood disorders, and AIDS.’’