The first clinical-stage trial of a next-generation vaccine capable of giving lasting protection from flu viral infection in patients with the mild form of the disease has shown no vaccine protection against the novel influenza H5N1 virus. The research was published today in the Lancet Infectious Diseases.
Moderna’s CV19 vaccine has been selected for Phase I testing in approximately 500 people with an upper respiratory tract infection and was evaluated in a 32 person clinical trial against the H5N1 influenza virus in a dose-ranging study, which showed no effect on virus hemagglutinin.
“CV19 did not provide immune responses against the virus during the doses tested, however the most encouraging outcome from the trial was that there was no evidence of immunological effects of fatigue, fatigue itself or respiratory symptoms,” said Will Johnson, MD, MPH, the paper’s senior author. “CV19 also was not efficacious in the nucleated form of the novel influenza virus.”
With both the viral hemagglutinin and neuraminidase subtypes (which produce the molecule fluorescence) designated as a wild type in this study, the possibility of finding natural antigenic match to these strains has been constrained. However, in an article published in the journal mBio in January, the researchers stated that an inactivated form of the vaccine that contained two strains of H5N1 was immunogenic and effective against the novel swine influenza vaccine, suggesting that H5N1 may warrant study against immune responses.
Thus, the absence of vaccine protection has not ruled out an inactivated form of the vaccine as an option and they are still awaiting further study. “While the lack of vaccine protection from CV19 in this trial makes AVASER very limited to providing proof of concept, the data are encouraging in a field where previous scientific studies indicated that various broadly activated vaccines were useful against the H5N1 virus,” said Vanja Batra, MD, PhD, MPH, senior author and a senior associate at the Harvard Stem Cell Institute.
The Avastin-versus-CV19 vaccine trial will continue in a combination study of the anti-avastin vaccine and CV19 against swine flu.