Studies in man with cold-recombinant influenza virus (H1N1) live vaccines

Two cold-recombinant influenza A (H1N1) viruses were tested in several groups of human volunteers. Only minor clinical symptoms were seen and no febrile reactions occurred. With serologically primed individuals virus shedding was low, but a high proportion showed rises in serum antibody levels after vaccination and mean titres were high. With serologically unprimed volunteers shedding was high, about 75% yielding viruses but only at low titres and for a short duration. No revertant viruses were found and there was no evidence of transmission to potentially susceptible individuals housed in close contact to the vaccinees. Serum antibody responses with unprimed volunteers were, however, low. Only about one half showed increases in serum antibody titres after vaccination and mean titres were low. Nevertheless, challenge with live attenuated virus indicated a high degree of protection based on virological evidence of infection.