National Institute of Allergy and Infectious Diseases

Children’s Hospital Los Angeles to study “Bubble Boy” syndrome

Tuesday, October 10, 2017

Michael Pulsipher, M.D., of the Children’s Center for Cancer and Blood Diseases at Children’s Hospital Los Angeles, along with co-principal investigator, Sung-Yun Pai, M.D., of Boston Children’s Hospital, has been awarded nearly $9 million from the National Institute of Allergy and Infectious Diseases of the NIH to study a new treatment approach for babies born with severe combined immunodeficiency (SCID), which prevents the immune system from functioning normally. In a multi-site study, investigators plan to determine the lowest dose of chemotherapy needed for babies with SCID undergoing bone marrow transplant—the standard treatment for SCID. The goal is to restore the immune system safely and effectively with less toxicity than the higher dose regimens currently in use.

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Profectus BioSciences to develop vaccine for Ebola, Marburg, Lassa Viruses

Tuesday, October 3, 2017

Profectus BioSciences has received a contract for up to $22.25 million from the National Institute of Allergy and Infectious Diseases (NIAID), a division of the National Institutes of Health. The base period of the contract, with a value of $6.96 million, will support a proof-of-concept (POC) study in non-human primates (NHP) and preparations for manufacture under Good Manufacturing Processes (GMP) of a vaccine designed to protect against Zaire ebolavirus, Sudan ebolavirus, Marburgvirus and Lassa viruses. The contract also includes $15.29 million in options that may be exercised by the NIAID to support GMP manufacture and clinical evaluation of the multi-component vaccine. The vaccine is being developed in lyophilized form to allow distribution without a cold chain and enable routine mass immunization.

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Revisiting patient diversity in clinical trials… again

Saturday, July 1, 2017

Minority groups have historically been excluded from clinical research, an inequity that has led to well-documented public health problems in which therapies tested primarily in Caucasian patients do not work as well in other ethnic and racial groups. This problem is famously exemplified by Sanofi’s blood thinner Plavix, which was approved in 1997 but slapped with a boxed warning in 2010 after researchers realized up to half of Asian and Pacific Islander populations cannot process the drug.

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NIH funds seven international centers of excellence for Malaria research

Monday, April 24, 2017

The National Institute of Allergy and Infectious Diseases (NIAID), part of the NIH, announced approximately $9 million in first-year funding, subject to availability, for seven malaria research centers around the world. The seven-year awards continue NIAID’s 2010 program that created the International Centers of Excellence for Malaria Research (ICEMRs) in regions where malaria is endemic. The awards fund three new and four existing centers that work in 14 countries in Africa, Asia and Latin America.

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NIH respiratory syncytial virus vaccine enters clinical testing

Friday, February 24, 2017

A phase I clinical trial to test the safety and tolerability of an investigational vaccine against respiratory syncytial virus (RSV) has begun at the NIH Clinical Center in Bethesda, Maryland. The trial will also assess the vaccine’s ability to prompt an immune response in healthy adult participants. The investigational vaccine was developed by scientists at the National Institute of Allergy and Infectious Diseases (NIAID), part of NIH.

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First new HIV vaccine efficacy study in seven years has begun

Tuesday, November 29, 2016

The first HIV vaccine efficacy study to launch anywhere in seven years is now testing whether an experimental vaccine regimen safely prevents HIV infection among South African adults. The study, called HVTN 702, involves a new version of the only HIV vaccine candidate ever shown to provide some protection against the virus. HVTN 702 aims to enroll 5,400 men and women, making it the largest and most advanced HIV vaccine clinical trial to take place in South Africa, where more than 1,000 people become infected with HIV every day.

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Barda grants $43.2 million to Sanofi Pasteur for Zika

Thursday, September 29, 2016

Sanofi and its vaccines global business unit Sanofi Pasteur have announced that the Biomedical Advanced Research and Development Authority (BARDA) within the Office of the Assistant Secretary for Preparedness and Response in the U.S. Department of Health and Human Services has agreed to a proposal to fund the manufacture of an inactivated Zika vaccine for phase II development. Sanofi Pasteur committed to researching and developing a vaccine to prevent Zika in February, shortly after the World Health Organization declared an emergency.

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Janssen completes WHO submission for EUAL for Ebola vaccine regimen

Wednesday, September 14, 2016

Bavarian Nordic has announced that Janssen Vaccines & Prevention has completed a submission to the World Health Organization (WHO) for Emergency Use Assessment and Listing (EUAL) for its investigational preventive Ebola prime-boost vaccine regimen, which includes Bavarian Nordic’s MVA-BN Filo vaccine. The EUAL is a special procedure that can be implemented when there is an outbreak of a disease with high rates of morbidity or mortality and a lack of treatment or prevention options.

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