Skip to main content

Licensing agreement advances RSV vaccine patented by St. Jude Children’s Research Hospital

Photo of Julia Hurwitz

St. Jude Children's Research Hospital recently announced that it has signed a licensing agreement granting Serum Institute of India exclusive rights to complete the development of the hospital's respiratory syncytial virus, or RSV, vaccine.

Through this agreement, Serum Institute of India will be able to design and conduct clinical trials investigating the intranasal SeVRSV vaccine and commercialize the vaccine in South America, Africa and much of Asia, according to a press release.

"RSV remains a serious threat to infants worldwide during their first year of life and to anyone, including pediatric cancer patients, whose immune response has been weakened by illness or age," James R. Downing, MD, president and CEO at St. Jude, said in the release. "We are pleased that Serum's staff and leadership have recognized the life-saving potential of this vaccine. We look forward to working closely with them to make this vaccine accessible around the globe."

RSV is a common cause of lower respiratory infections, affecting as many as 43 million children younger than 5 years of age worldwide each year, the release said. About 10% of these patients may require hospitalization.

Julia Hurwitz, PhD, of the department of infectious disease at St. Jude Children's Research Hospital, told Infectious Disease News that the SeVRSV vaccine has been in development for more than 10 years. The vaccine is composed of a mouse parainfluenza virus type 1 that researchers modified to carry an RSV gene, according to the release. Because the mouse parainfluenza virus type 1 is similar to the human parainfluenza virus type 1 — a common cause of croup in children — researchers designed the vaccine to protect against serious infections caused by both RSV and croup. The vaccine, which is one of dozens currently in development for RSV worldwide, appeared to be safe and effective during preclinical trials, the release said.


ᐧ

Comments

Post a Comment

Popular posts from this blog

BE guidelines regarding investigator

BE guidelines recommend investigator should possess appropriate medical qualification, experience for conducting pharmacokinetic studies Can chairperson of EC directly write to sponsor to clarify some of the queries of clinical trial raised in EC meeting? Dr. Sreevatsa Please see an extract from FDA's comment on IRB-sponsor relationship. The interrelationship and interaction between the research sponsor (e.g., drug, biologic and device manufacturers), the clinical investigator and the Institutional Review Board (IRB) may be very complex. The regulations do not prohibit direct sponsor-IRB contacts, although, the sponsor-IRB interaction customarily occurs through the investigator who conducts the clinical study. The clinical investigator generally provides the communication link between the IRB and the sponsor. Such linkage is agreed to by the sponsors and investigators when they sign forms FDA-1571 and FDA-1572, respectively, for drug and biologic studies or a...
Post a Comment
Read more

ICH GCP requires EC members to be independent of investigator and sponsor to avoid conflicts of interest

Can an Ethics Committee member e.g. layman/chairman or anyone in the committee participate in the trial as a subject? Vidya If an Ethics Committee member becomes a trial subject on a trial that he/she was involved in approving then there has been a major conflict of interest. The following situations need to be considered: ● IEC member reviews study without any prior knowledge of the study, votes, and then afterwards is approached by clinical research team to participate. Possibly this is OK but the member should no longer be part of the IEC that reviews that study. This will be difficult in practice, so therefore it is not advisable. ● IEC member already knows about the study and is voting in order to be able to participate. This is clearly not acceptable and made worse if there is additional financial incentive for the study (e.g. volunteer study). ICH GCP requires Ethics Committee members to be independent of the investigator and the sponsor to avoid confl...
Post a Comment
Read more

Combination Vaccine for Kids withdrawn

A vaccine that combines conventional MMR (Measles, Mumps, Rubella) with Chikenpox has been withdrawn in the United States due to a higher rate of seizures in children. In a study children aged 12 to 23 months who received the combined MMR cum Chickenpox vaccine had double the rate of seizures compared to children who got separate vaccine for MMR and chickenpox. This equates to one additional case of convulsion per 2000 vaccinations.
Post a Comment
Read more