Abstract: The gene for outer membrane protein P1 of Haemophilus influenzae b is expressed in E. coli. Methods for expression and demonstration of the immunogenicity of recombinant P1 and portions thereof are disclosed, along with an improved method for the purification of P1. The nucleotide sequence of the P1 gene and the derived amino acid sequence of the P1 protein of Haemophilus influenzae type b are disclosed and the methods used to determine the same. Also disclosed are the methods used to clone and express the P1 gene as well as the purification protocol for the P1 gene products (recombinant P1 and P1 fusion proteins). Fourteen peptides are synthesized corresponding to specific sequences of the mature P1 protein. The use of the P1 protein as n immunogens for immunization against the disease caused by Haemophilus influenzae type b and the use of the protein as a carrier for conjugation with an oligosaccharide derived from Haemophilus to generate a potentially efficacious vaccine against the disease, are described.

Abstract: The nucleotide sequence of the P2 gene and the derived amino acid sequence of the P2 protein of Haemophilus influenzae type b are disclosed and the methods used to determine the same. Also disclosed are the methods used to clone and express the P2 gene as well as the purification protocol for the gene and protein. Also disclosed is the synthesis of peptides corresponding to the N-terminal and C-terminal ends of the P2 protein. Also disclosed is the use of the P2 protein as a protective agent for the disease caused by Haemophilus influenzae type b and the use of the protein as a carrier for conjugation with an oligosaccharide derived from Haemophilus to generate a potentially efficacious vaccine against the disease. Also disclosed is the use of P2 peptide-conjugates as immunising agents.

Abstract: The dosage response of humans to conjugate vaccines comprising a bacterial polysaccharide and a strongly-immunogenic carrier protein is determined in animals by coadministering to the animal unconjugated strongly-immunogenic carrier protein in an amount corresponding, on a weight-related basis, to that administered to the human.