● Introduction [ver].
● Clinical trials with important results expected in 2024 [ver].
● HIV T-cell vaccine [ver].
● Long-term effectiveness of R21 malaria vaccine [ver].
● More information on this website, bibliographic references and recommended links [ver]. In a nutshell ● Nature Medicine publishes at the end of each year its predictions of what research will likely provide highly impactful results over the coming year.
● For 2024, the selected topics are: breast, lung and melanoma cancer, malaria, familial hypercholesterolemia, HIV infection, Parkinson’s disease, artificial intelligence in medical emergency care, child mental health and perinatal depression.
● The two investigations involving vaccines are discussed: the R21 vaccine against malaria and a candidate for the prevention of HIV infection.
Introduction
The beginning of each year is a favorable time to formulate wishes and forecasts for the year ahead. Every year the journal Nature Medicine publishes an article in which eleven important ongoing studies are briefly presented, the results of which are expected in this new year (Arnold C, Nature Med 2023).
A year ago, the Nature Medicine article referring to 2023 was already reviewed. Now 11 expert researchers are asked which trials from this year 2024, they believe, will probably have a great impact. Among the answers, in two cases they refer to vaccines, one against malaria and another against infection with the human immunodeficiency virus (HIV). In this note, a brief review is made of these two clinical trials from which important results are expected.
Clinical trials from which important results are expected in 2024
The attached table shows the trials selected by the journal Nature Medicine. They include studies on such relevant topics as breast, lung and melanoma cancer, malaria, familial hypercholesterolemia, HIV infection, Parkinson’s disease, artificial intelligence in medical emergency care, childhood mental health and perinatal depression.
Among them, two refer to vaccines, which are discussed below.
HIV T-cell vaccine
The expert who proposed this test is Carey Hwang (Vir Biotechnology, California, USA). He says: “The purpose of our essay (NCT05854381) is to evaluate the safety, reactogenicity and immunogenicity of VIR-1388, a vaccine for the prevention of HIV infection. It is a phase 1, multicenter, randomized, double-blind, placebo-controlled study that includes healthy, HIV-naïve adults aged 18 to 55 years who will receive one of three dose levels of VIR-1388 or placebo”.
VIR-1388 is a vaccine with a cytomegalovirus (CMV) as a vector that induces robust and sustained T cell responses that can potentially prevent HIV acquisition. This follows a proof-of-concept trial of VIR-1111 that demonstrated its safety, albeit without a strong immune response; VIR-1388 is less attenuated than VIR-1111 and is thought to be more immunogenic.
The overall study design includes two parts. The first will be an initial phase involving a small number of people of childbearing age who are seropositive for the CMV vector, with close monitoring for safety. The second part will expand participation to a broader CMV-seropositive population, including people of childbearing age (who will be required to use two forms of contraception), with safety monitoring. An optional long-term follow-up study is planned that would extend participation up to 3 years after the first dose.
The corresponding doses have recently been administered to the first study participants. The trial is being carried out at ten centers in the United States and two in South Africa, with the support of the NIAID of the United States and the Bill and Melinda Gates Foundation. From a public health perspective, having an HIV vaccine would obviously have an extraordinary impact.
Also see other news about HIV and its vaccines on this website.
Long-term effectiveness of R21 malaria vaccine
In this case, the answer is Adrian Hill (Jenner Institute, University of Oxford, United Kingdom).
A major problem with malaria vaccines, and one of the reasons it has taken more than 100 years to get here, is that an exceptionally high antibody response is needed for the vaccine to work. Forty vaccines with the same circumsporozoite protein antigen have reached the clinic, and only two of them have shown sufficient efficacy: RTS,S and R21. The efficacy of the RTS,S/ASO1 vaccine drops from 55% to around 30% four years after vaccination, so long-term follow-up is really important.
A. Hill continues saying: “we are halfway through a rehearsal (NCT04704830) multicenter, randomized controlled phase 3 R21/Matrix-M vaccine against symptomatic malaria in African children. This includes standard age-based and also seasonal vaccination regimens used in children 5 to 36 months of age. In each group, a booster dose (fourth) of the same vaccine was administered 12 months after the third dose. Initial follow-up will be 2 years after the third dose, with a primary analysis at 12 months. There are 2,400 participants already registered to receive the standard vaccination regimen in endemic areas in Burkina Faso, Kenya and Tanzania. “An additional 2,400 participants will be enrolled to receive the seasonal vaccination regimen in Burkina Faso and Mali.”
Also that: “we believe that R21 will show better efficacy than RTS,S, since R21 uses a nanoparticle that has a much higher density of the antigen on the surface. Vaccines like the HPV vaccine work for a lifetime due to that characteristic This trial is funded by the Serum Institute of India, which has committed to producing 100 million doses of the vaccine at a cost of US$3-4 per dose. We now have the first results on a preprint server and, in In the coming years, we will continue to publish more analyzes on the safety, immunogenicity and efficacy of the vaccine.
Also see other news about malaria and its vaccines on this website.
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More information on this website
Bibliographic references and recommended links
- Alpañés E. Gene editing, AI, an HIV vaccine and more: 11 clinical trials that will shape medicine in 2024. The ‘Nature’ journal selects the most promising ones coming next year, which could impact our health. El País, Health, December 7, 2023.
- Arnold C, et al. 11 clinical trials that will shape medicine in 2024. Night With. 2023;29:2964-8.
- ClinicalTrials.gov. To Investigate Safety, Reactogenicity and Immunogenicity of VIR-1388 Compared With Placebo in Participants Without HIV.
- ClinicalTrials.gov. R21/Matrix-M in African Children Against Clinical Malaria.
- Datoo MS, et al. A Phase III Randomised Controlled Trial Evaluating the Malaria Vaccine Candidate R21/Matrix-M™ in African Children. SSRN. 2023, 26/sep. DOI: 10.2139/ssrn.4584076.
- Datto MS, et al. Safety and efficacy of malaria vaccine candidate R21/Matrix-M in African children: a multicentre, double-blind, randomised, phase 3 trial. Lancet. 2024;403(10426):533-44. ►Comentado en: Lancet, editorial. Malaria vaccines: a test for global health. Lancet. 2024;403(10426):503. ►Comentado en: Nnaji CA, et al. R21/Matrix-M vaccine: optimising supply, maximising impact. Lancet. 2024;403(10426):525.
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2024-02-15 06:13:17
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