HIV Vaccines 2022
According to the U.S. Centers for Disease Control and Prevention (CDC), notable gains have been made in increasing pre-exposure prophylaxis (PrEP) use for HIV prevention in the U.S. Preliminary data show that in 2020, about 25% of the 1.2 million people for whom PrEP is recommended were prescribed it, compared to only about 3% in 2015.
"Finding an HIV vaccine has proven a daunting scientific challenge," said Anthony S. Fauci, M.D. NIAID director, on March 14, 2022. "With the success of safe and highly effective COVID-19 vaccines, we have an exciting opportunity to learn whether mRNA technology can achieve similar results against HIV infection." Furthermore, HIV vaccines can not cause HIV infection, says the U.S. FDA.
HIV PrEP Vaccines U.S. FDA Approved - 2022
Apretude - The U.S. FDA granted approval of Apretude to London-based Viiv in December 2021. Patients can either start their treatment with Apretude or take oral cabotegravir (Vocabria) for four weeks to assess how well they tolerate the drug. Apretude was previously granted a Priority Review and Breakthrough Therapy designation.
HIV Vaccine Candidates 2022
mRNA-1574 - Produced by Moderna Inc., is participating in the HVTN 302 study to examine the safety and immune responses: 1) BG505 MD39.3 mRNA, 2) BG505 MD39.3 gp151 mRNA, and 3) BG505 MD39.3 gp151 CD4KO mRNA. Each investigational vaccine candidate is designed to present the spike protein found on the surface of HIV that facilitates entry into human cells. Each experimental vaccine encodes for different but highly related stabilized proteins.
mRNA-1644 (eOD-GT8 60mer) - Was developed by scientific teams at IAVI and Scripps Research and delivered via Moderna's mRNA platform. Recent findings from the Phase I clinical trial IAVI G001 showed that vaccination with the HIV immunogen eOD-GT8 60mer as a recombinant protein vaccine safely induced the targeted immune responses in 97% of recipients.
HIV Humanized Monoclonal Antibody 2022
Leronlimab, a CCR5 antagonist IgG4 monoclonal antibody, is designed to bind to C-C chemokine receptor type 5 (CCR5), a protein on the surface of specific immune system cells believed to play a role in numerous disease processes, including HIV.
A small phase I clinical trial led by Massachusetts General Hospital has tested an anti-HIV strategy involving an adeno-associated viral vector-based gene delivery system that instructs cells to pump out antibodies that block HIV. The treatment was safe and well-tolerated in the trial of eight adults with HIV. In addition, all participants produced measurable amounts of anti-HIV antibodies in the blood as of April 11, 2022.
HIV Vaccine Development News For 2021 - 2022
May 18, 2022 - IAVI and Moderna, Inc. announced that the first participant screenings would soon start for a Phase I clinical trial of an mRNA HIV vaccine antigen (mRNA-1644) in Rwanda and South Africa.
May 11, 2022 - The Coalition for Epidemic Preparedness Innovations (CEPI) and the Kenya-based Victoria Biomedical Research Institute announced a new clinical research program that aims to evaluate the safety and immunogenicity of homologous and heterologous COVID-19 vaccine booster regimens in adolescents and adults living with HIV. CEPI will provide up to US$12.5 million to assess this "mix and match" booster approach.
May 9, 2022 - NPR Health: One of the first clinical trials of a new mRNA vaccine for HIV is underway.
May 4, 2022 - Moderna Inc. announced 'The ongoing Phase 1 study of mRNA-1644 is the first study in a series of planned iterative clinical trials with the primary aim to validate a novel vaccination approach, i.e., to elicit specific broadly neutralizing antibodies against HIV using an antigen guided antibody germline targeting. A second study, mRNA-1574, evaluates multiple native-like HIV env trimer antigens. The Phase 1 study of mRNA-1574 is ongoing.
April 7, 2022 - Within the Moderna partnership, the program's furthest development is a Phase I clinical trial, IAVI G002, of HIV vaccine antigens delivered by mRNA. The trial was initiated in January 2022 and is testing vaccine antigens originally developed as proteins by a team led by William Schief, Ph.D., professor at Scripps Research and executive director of vaccine design at IAVI's Neutralizing Antibody Center.
March 29, 2022 - The Janssen Pharmaceutical Companies of J&J announced the U.S. FDA approved CABENUVA for the treatment of HIV-1 in virologically suppressed adolescents (HIV-1 RNA less than 50 copies per milliliter [c/mL]) who are 12 years of age or older, weigh at least 35 kg and are on a stable antiretroviral regimen, with no history of treatment failure, nor known or suspected resistance to either cabotegravir or rilpivirine. Co-developed as part of a collaboration with ViiV Healthcare, CABENUVA is the first and only complete long-acting HIV-1 treatment regimen and the first to be made available for eligible adolescents.
March 28, 2022 - Gilead Sciences, Inc. announced $24 million in grants to help reduce health disparities, improve access to quality healthcare, advance medical education and support local communities most impacted by the HIV epidemic and COVID-19 pandemic. The Zeroing In: Ending the HIV Epidemic program will support 116 organizations in 41 countries.
March 24, 2022 - Moderna Inc. confirmed it is advancing clinical trials of HIV vaccines. First, enrollment is underway in two Phase 1 trials of mRNA-1644 in collaboration with IAVI and the Bill & Melinda Gates Foundation. Second, dosing is ongoing in a Phase 1 trial (mRNA-1574) designed to evaluate the safety and immunogenicity of experimental HIV trimer mRNA vaccines. The primary hypothesis is that the soluble and membrane-bound HIV envelope trimer mRNA vaccines will be safe and well-tolerated by HIV-uninfected individuals and elicit autologous neutralizing antibodies. The trial will enroll approximately 100 HIV-negative adults aged 18 to 55 years.
March 23, 2022 - New York Blood Center's Project ACHIEVE and Columbia University's Columbia Research Unit are working in partnership for the New York City effort to advance the Phase 1 trial, titled HVTN 302, which is the second trial of its kind and will be enrolling up to 108 people across ten sites in the United States to test 3 different experimental vaccines against HIV using the mRNA vaccine technology that has been successful in fighting COVID-19.
March 14, 2022 - Moderna, Inc. announced that the first participant had been dosed in a clinical trial of an experimental human immunodeficiency virus trimer mRNA vaccine (mRNA-1574).
March 14, 2022 - The National Institute of Allergy and Infectious Diseases launched a Phase 1 clinical trial evaluating three experimental HIV vaccines based on a messenger RNA platform.
February 1, 2022 - The Janssen Pharmaceutical Companies of Johnson & Johnson today announced the U.S. FDA approved an expanded label for CABENUVA (rilpivirine and cabotegravir) to be administered every two months for the treatment of HIV-1 in virologically suppressed adults (HIV-1 RNA less than 50 copies per milliliter [c/ml]) on a stable regimen, with no history of treatment failure, and with no known or suspected resistance to either rilpivirine or cabotegravir. On March 24, the FDA approved a label update for Cabenuva (cabotegravir, rilpivirine), making the oral lead-in with cabotegravir and rilpivirine tablets optional.
January 27, 2022 - IAVI and Moderna announced that the first doses had been administered in a clinical trial of experimental HIV vaccine antigens at George Washington University School of Medicine and Health Sciences in Washington, D.C.
December 20, 2021 - The U.S. FDA approved Apretude (cabotegravir extended-release injectable suspension) for at-risk adults and adolescents weighing at least 35 kilograms for pre-exposure prophylaxis (PrEP) to reduce the risk of sexually acquired HIV. Apretude is given first as two initiation injections administered one month apart and then every two months. Patients can either start their treatment with Apretude or take oral cabotegravir (Vocabria) for four weeks to assess how well they tolerate the drug.
Human immunodeficiency virus (HIV) is an infection that attacks the body's immune system, specifically the white blood cells called CD4 cells. HIV destroys these CD4 cells, weakening a person's immunity against opportunistic infections, such as tuberculosis and fungal infections, severe bacterial infections, and certain cancers. If untreated, HIV can lead to acquired immunodeficiency syndrome (AIDS).
However, the CDC recently reported that people aged 13-24 accounted for 21% of all new HIV diagnoses in the U.S. and dependent areas in 2018.