Pharmaceutical

ImmunoVaccine’s (C:IMV) DepoVax prophylactic respiratory syncytial virus vaccine candidate (DPX-RSV) was illustrated to be well tolerated in safety data from a Phase 1 clinical trial.

ImmunoVaccine’s (C:IMV) DepoVax prophylactic respiratory syncytial virus vaccine candidate (DPX-RSV) was illustrated to be well tolerated in safety data from a Phase 1 clinical trial.
According to the press release:

[The drug] was well tolerated in the phase 1 study’s first 20 volunteers, of whom eight subjects received the DPX-RSV vaccine. This data marks an important milestone for Immunovaccine as it provides the first safety profile of the DepoVax(TM)-based vaccines for infectious diseases in healthy adults. Based on the vaccine candidate’s safety and immunogenicity demonstrated in the study, the independent Safety Review Committee (“SRC”) has allowed the study to proceed to its next step, which includes vaccinating volunteers with DPX-RSV at a higher dose.
The randomized, controlled, blinded Phase 1 study is evaluating the safety and immune response profile of DPX-RSV vaccine in 40 healthy adults who are 50 to 64 years of age. Respiratory Syncytial Virus (“RSV”) is a common virus that infects the lungs and breathing passages. While it usually leads to mild, cold-like symptoms, it can be severe in the elderly, infants and patients with compromised immune systems and is second only to influenza as the most commonly identified cause of viral pneumonia in older persons. Globally, it is estimated that 64 million cases of RSV infection occur annually in all age groups, with 160,000 deaths. There is no vaccine currently available to prevent RSV.
“To date the data indicate that the study vaccines have been generally well tolerated in all participants,” said Joanne Langley, M.D., the study’s principal investigator. “Preliminary blinded immunogenicity data has also indicated that participants are able to generate antigen-specific immune responses to the RSV antigen. We are very pleased that these results have enabled DPX-RSV to move to the next part of its clinical testing program. ”
The SRC reviewed the safety data from the study’s first 20 volunteers, who were given either a low-dose DPX vaccine, a low-dose vaccine with alum (control) or a placebo. The next step will be vaccinating volunteers with a higher dose of DPX-RSV (25 micrograms). Study investigators will assess the vaccine’s safety and immune response profile following two doses of the study vaccine.

Click here to read the full press release.

 

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