Breaking News
October 18, 2018 - Health Highlights: Oct. 15, 2018
October 18, 2018 - Largest study of ‘post-treatment controllers’ reveals clues about HIV remission
October 18, 2018 - Bad Blood in Silicon Valley: A conversation with John Carreyrou
October 18, 2018 - ANTRUK’s Annual Lecture sends out message on shortage of funds for antibiotic research
October 18, 2018 - NAM special publication outlines steps to ensure interoperability of health care systems
October 18, 2018 - Novel method uses just a drop of blood to monitor effect of lung cancer therapy
October 18, 2018 - New blood test could spare cancer patients from unnecessary chemotherapy
October 18, 2018 - Training young researchers to work with data volumes arising in the health sector
October 18, 2018 - New Metrohm IC method is reliable and convenient to use for zinc oxide assay
October 18, 2018 - Global AIDS, TB fight needs more money: health fund
October 18, 2018 - Understanding the forces that cause sports concussions
October 18, 2018 - Research points to new target for treating periodontitis
October 18, 2018 - New tool improves assessment of postpartum depression symptoms
October 18, 2018 - From Biopsy to Diagnosis
October 18, 2018 - Sexual harassment and assault linked to worse physical/mental health among midlife women
October 18, 2018 - Stumped by medical school? A Q&A with a learning specialist
October 18, 2018 - Targeting immune checkpoints in microglia could reduce out-of-control neuroinflammation
October 18, 2018 - FDA Approves Talzenna (talazoparib) for gBRCAm HER2-Negative Locally Advanced or Metastatic Breast Cancer
October 18, 2018 - Sleeping Beauty technique helps identify genes responsible for NAFLD-associated liver cancer
October 18, 2018 - Many U.S. adults confused about primary care, study shows
October 18, 2018 - UC researcher focuses on light-mediated therapies to target breast cancer
October 18, 2018 - With philanthropic gifts, Stanford poised to make major advances in neurosciences | News Center
October 18, 2018 - Mice study shows antibiotics are not always necessary to cure sepsis
October 18, 2018 - Researchers discover why heart contractions are weaker in individuals with HCM
October 18, 2018 - Participation in organized sport during childhood may have long-term skeletal benefits
October 18, 2018 - Probiotic/antibiotic combination could eradicate drug-resistant bacteria
October 17, 2018 - More Socioeconomic Challenges for Hispanic Women With HIV
October 17, 2018 - 49,XXXXY syndrome – Genetics Home Reference
October 17, 2018 - Scientists uncover possible new causes of Tourette syndrome
October 17, 2018 - Girl undergoes unusual heart surgery after compassionate-use exemption | News Center
October 17, 2018 - Health Issues That Are Sometimes Mistaken for Gluten Sensitivity
October 17, 2018 - Elective induction of labor at 39 weeks may be beneficial option for women and their babies
October 17, 2018 - New smart watch algorithms can accurately monitor wearers’ sleep patterns
October 17, 2018 - Researchers demonstrate epigenetic memory transmission via sperm
October 17, 2018 - FDA, DHS announce memorandum of agreement to address cybersecurity in medical devices
October 17, 2018 - Health Tip: Know the Risks of Chicken Pox
October 17, 2018 - Immunotherapy effective against hereditary melanoma
October 17, 2018 - Researchers reveal new mechanism for how animal cells stay intact | News Center
October 17, 2018 - Alzheimer's Goes Under the Cryo-Electron Microscope
October 17, 2018 - Medicare for all? CMS chief warns program has enough problems already
October 17, 2018 - Metrohm Raman introduces Mira P handheld Raman system
October 17, 2018 - Expanding the knowledge about hippocampus to better understand cognitive deficits in MS
October 17, 2018 - Study of Nigerian breast cancer patients reveals prevalence of aggressive molecular features
October 17, 2018 - Many healthy children may have metabolic risk factors, finds study
October 17, 2018 - A new antibiotic could be a better, faster treatment for tuberculosis
October 17, 2018 - “I will not become a Robot Doctor”: A medical student vows to practice compassion
October 17, 2018 - Study findings may explain sporadic outbreaks of C. difficile infections in hospitals
October 17, 2018 - Purdue researchers develop new chemical process to find better drug ‘fits’ for patients
October 17, 2018 - Yale researchers develop way to attack RNA with small-molecule drugs
October 17, 2018 - New pragmatic study launched to understand the effectiveness of new type 2 diabetes drug
October 17, 2018 - Alnylam Announces Plan to Initiate Rolling Submission of a New Drug Application and Pursue Full Approval for Givosiran
October 17, 2018 - Nine cases of polio-like illness suspected in children in illinois
October 17, 2018 - Eisai enters into agreement with Eurofarma for development and sales of lorcaserin in 17 countries
October 17, 2018 - Patients once thought incurable can benefit from high-dose radiation therapy
October 17, 2018 - Researchers awarded grant to advance testing of experimental heroin vaccine
October 17, 2018 - Researchers examine SSRI use during pregnancy and major gestational malformations
October 17, 2018 - FDA grants Rare Pediatric Disease Designation for Immusoft’s Iduronicrin genleukocel-T
October 17, 2018 - Reliable Respiratory announces acquisition of Attleboro Area Medical Equipment
October 17, 2018 - Study reveals link between childhood abuse and higher arthritis risk in adulthood
October 17, 2018 - Research shows people over 65 are not performing enough physical activity
October 17, 2018 - FDA Approves Liletta (levonorgestrel-releasing intrauterine system) 52 mg to Prevent Pregnancy for up to Five Years
October 17, 2018 - Weight gain after smoking cessation linked to increased short-term diabetes risk
October 17, 2018 - Researchers find opportunity to control salt-sensitive hypertension without exercising
October 17, 2018 - Women not warned about cancer associated with breast implants
October 17, 2018 - Metrohm offers robust handheld Raman analyzer for Defense and Security
October 17, 2018 - Modeling Non-Numerical Data in Systems Biology
October 17, 2018 - Research aims to address health disparities in African-American men
October 17, 2018 - Human and cattle decoys trap outdoor-biting mosquitoes in malaria endemic regions
October 17, 2018 - High Circulating Prolactin Level Inversely Linked to T2DM Risk
October 17, 2018 - Study finds gene variant predisposes people to both Type 2 diabetes and low body weight
October 17, 2018 - Metrohm software products make it easy to comply with ALOCA and ALCOA+ guidelines
October 17, 2018 - Network of doctors identify the cause of 31 new conditions
October 17, 2018 - Notable improvement in brain cancer survival among younger patients but not much for elderly
October 17, 2018 - Scientists shed light on roles of transcription factors, TP63 and SOX2, in squamous cell carcinoma
October 17, 2018 - Costs of Medicare Diabetes Prevention Program may be higher than expected reimbursement
October 17, 2018 - Misuse of prescription opioids or benzodiazepines associated with suicidal thoughts
October 17, 2018 - New research seeks to address sex disparities in women’s health
October 17, 2018 - C-Section Rates Have Nearly Doubled Since 2000: Study
October 17, 2018 - Talking to Your Kids About STDs
October 17, 2018 - New classification of periodontal and peri-implant diseases and conditions
Johnson & Johnson Announces Publication in The Lancet Highlighting Robust Immune Response to Janssen’s Mosaic-based Preventive Vaccine Regimen for HIV

Johnson & Johnson Announces Publication in The Lancet Highlighting Robust Immune Response to Janssen’s Mosaic-based Preventive Vaccine Regimen for HIV

image_pdfDownload PDFimage_print

NEW BRUNSWICK, N.J., 6 July 2018 –Johnson & Johnson today announced that The Lancet has published key early-stage data regarding an investigational mosaic-based preventive vaccine regimen against HIV-1 infection that is in development at its Janssen Pharmaceutical Companies. In the Phase 1/2a APPROACH study, based on the data generated, the vaccine regimen was safe and well-tolerated and elicited a robust HIV antibody response in all healthy volunteers receiving active vaccine. Additionally, in a parallel study in non-human primates (NHPs), the most immunogenic mosaic-based vaccine regimen in humans demonstrated similar immune responses in NHPs and afforded 67% protection against an HIV-like virus.

The Lancet paper provides the first detailed analysis of topline results presented by Janssen at the 9th IAS Conference on HIV Science (IAS 2017) in July 2017, and supports the recent advancement of the mosaic-based vaccine regimen into its first large-scale efficacy study.

“These are promising but still early-stage results. At 52 weeks, we observed that the mosaic-based vaccine regimen induced robust and comparable immune responses to HIV in humans and in nonhuman primates, and the vaccine protected against infection with an HIV-like virus in nonhuman primates,” said Professor Dan Barouch, Harvard Medical School, Director of the Center for Virology and Vaccine Research at Beth Israel Deaconess Medical Center and a lead author of The Lancet paper.

Janssen’s investigational mosaic-based vaccine regimen contains immunogens created using genes from different viral subtypes responsible for HIV infections worldwide.

“The progress made in the last thirty years in the fight against HIV is remarkable, yet HIV still persists as a global health threat affecting millions,” said Paul Stoffels, M.D., Vice Chairman of the Executive Committee and Chief Scientific Officer, Johnson & Johnson. “The genetic diversity inherent in HIV brings many challenges, but we are committed to developing a ‘global vaccine’ effective against the multiple strains of the virus. Our quest is to develop a vaccine that would put an end to the worldwide pandemic for good.”

In addition to the results reported in The Lancet, the first long-term immunological data from the APPROACH study will be presented in an oral presentation at the 22nd International AIDS Conference (AIDS 2018) on Tuesday, July 24, 2018 in Amsterdam, The Netherlands.

Based on results from APPROACH and other early-stage studies, in November 2017 Janssen and its global partners initiated the first efficacy study for a mosaic-based vaccine regimen. The Phase 2b trial, HVTN 705/HPX2008 (also known as ‘Imbokodo’), aims to enroll 2,600 young women aged 18-35 in five sub-Saharan African countries to see whether the vaccine is safe and able to reduce HIV infection in this at-risk population. Participants are now enrolling at clinical research sites in South Africa, Zimbabwe and Malawi. The study has been cleared to start in Zambia, and regulatory approval is pending in Mozambique. Results from HVTN 705/ HPX2008 are expected in 2021.

“The HVTN 705/HPX2008 trial is built on a partnership with our global communities, Janssen and other stakeholders who are committed to finding an effective HIV vaccine. The imperative, if we are successful, is to then make sure that the effective HIV vaccine can be taken to scale and is accessible”, says Larry Corey, M.D., Principal Investigator of the HVTN, virologist and faculty member at Fred Hutchinson Cancer Research Center.

Although great progress has been made in the fight against HIV/AIDS, a safe and effective vaccine will likely be required to truly end the HIV pandemic. In 2016, nearly 37 million people were living with HIV globally, 1.8 million people were newly infected with HIV, and 1 million people died of AIDS.[i]

About the APPROACH and NHP Bridging Studies

APPROACH (HIV-V-A004/NCT02315703) is a Phase 1/2a study in 393 healthy HIV-uninfected adults in the U.S., Rwanda, Uganda, South Africa and Thailand. It is evaluating the safety, tolerability and immunogenicity of various mosaic-based vaccine regimens for HIV-1. These vaccine regimens contain two prime doses (weeks 0 and 12) of the mosaic viral vector Ad26.Mos.HIV, utilizing Janssen’s AdVac® technology based on adenovirus serotype 26 (Ad26), followed by two boosts (weeks 24 and 48) of either Ad26.Mos.HIV, MVA-Mosaic and/or different doses of the soluble protein Clade C gp140 adjuvanted with aluminum phosphate. By first priming and then boosting the immune system, the goal is to produce a strong and long-lasting immune response to HIV.

At 52 weeks, four weeks after the last vaccine dose, all vaccine regimens evaluated in APPROACH were safe and generally well-tolerated. Additionally, all regimens elicited robust humoral and cellular HIV-1 immune responses. The most immunogenic regimen in humans comprised mosaic Ad26 as the prime, and Ad26+gp140 as the boost. It elicited Env-specific binding antibody responses, antibody-dependent cellular phagocytosis responses, and T-cell responses in 100%, 80% and 83% of recipients, respectively. In a parallel bridging study in NHPs (n=72), the same Ad26/Ad26+gp140 vaccine regimen induced a similar magnitude, durability, and phenotype of immune responses, and afforded 67% protection against acquisition of infection with simian-human immunodeficiency virus (SHIV).

Janssen’s partners on the APPROACH study included Beth Israel Deaconess Medical Center (BIDMC), Harvard Medical School; the United States Military HIV Research Program (MHRP) at the Walter Reed Army Institute of Research (WRAIR), with the Henry M. Jackson Foundation for the Advancement of Military Medicine (HJF); the National Institute of Allergy and Infectious Diseases (NIAID), part of the US National Institutes of Health (NIH); the Ragon Institute of Massachusetts General Hospital, MIT and Harvard; the International AIDS Vaccine Initiative (IAVI); and the HIV Vaccine Trials Network (HVTN).

Since 2005, Janssen Vaccines & Prevention B.V. has been participating in the NIH-supported Integrated Preclinical/Clinical AIDS Vaccine Development (IPCAVD) program under grants AI066305, AI078526 and AI096040.

Visit www.jnj.com/HIV to learn more about the breadth of HIV science being pursued by the Janssen Pharmaceutical Companies of Johnson & Johnson and its partners across prevention, treatment and cure research.

About Johnson & Johnson

At Johnson & Johnson, we believe good health is the foundation of vibrant lives, thriving communities and forward progress. That’s why for more than 130 years, we have aimed to keep people well at every age and every stage of life. Today, as the world’s largest and most broadly-based health care company, we are committed to using our reach and size for good. We strive to improve access and affordability, create healthier communities, and put a healthy mind, body and environment within reach of everyone, everywhere. We are blending our heart, science and ingenuity to profoundly change the trajectory of health for humanity.

About the Janssen Pharmaceutical Companies

At the Janssen Pharmaceutical Companies of Johnson & Johnson, we are working to create a world without disease. Transforming lives by finding new and better ways to prevent, intercept, treat and cure disease inspires us. We bring together the best minds and pursue the most promising science. We are Janssen. We collaborate with the world for the health of everyone in it. Learn more at www.janssen.com. Follow us at @JanssenGlobal.

Janssen Vaccines & Prevention B.V. is part of the Janssen Pharmaceutical Companies of Johnson & Johnson.

Cautions Concerning Forward-Looking Statements

This press release contains “forward-looking statements” as defined in the Private Securities Litigation Reform Act of 1995, regarding development of a potential preventive vaccine for HIV. The reader is cautioned not to rely on these forward-looking statements. These statements are based on current expectations of future events. If underlying assumptions prove inaccurate or known or unknown risks or uncertainties materialize, actual results could vary materially from the expectations and projections of Janssen Vaccines & Prevention B.V., any of the other Janssen Pharmaceutical Companies and/or Johnson & Johnson. Risks and uncertainties include, but are not limited to: challenges and uncertainties inherent in product research and development, including the uncertainty of clinical success and of obtaining regulatory approvals; uncertainty of commercial success; manufacturing difficulties and delays; competition, including technological advances, new products and patents attained by competitors; challenges to patents; product efficacy or safety concerns resulting in product recalls or regulatory action; changes in behavior and spending patterns of purchasers of health care products and services; changes to applicable laws and regulations, including global health care reforms; and trends toward health care cost containment. A further list and descriptions of these risks, uncertainties and other factors can be found in Johnson & Johnson’s Annual Report on Form 10-K for the fiscal year ended December 31, 2017 including in the sections captioned “Cautionary Note Regarding Forward-Looking Statements” and “Item 1A. Risk Factors,” and in the company’s subsequent Quarterly Reports on Form 10-Q and other filings with the Securities and Exchange Commission. Copies of these filings are available online at www.sec.gov, www.jnj.com or on request from Johnson & Johnson. None of the Janssen Pharmaceutical Companies or Johnson & Johnson undertakes to update any forward-looking statement as a result of new information or future events or developments.

[i] WHO. HIV / AIDS Factsheet. Available at: http://www.who.int/mediacentre/factsheets/fs360/en/ Last accessed: February 2018.

Source: Johnson & Johnson

Posted: July 2018

Tagged with:

About author

Related Articles