Safety and immunogenicity of a Haemophilus influenzae type b conjugate vaccine in a high risk American Indian population.

The safety and immunogenicity of a Haemophilus influenzae type b polysaccharide conjugate vaccine linked to the outer membrane protein complex of Neisseria meningitidis (Hib-OMP) were evaluated among Apache and Navajo infants and children. One dose of Hib-OMP was given to 42 children who were from 12 and 60 months of age. Ninety-two infants 6 to 8 weeks old were given one dose of Hib-OMP at the time of enrollment. A subsequent dose of the vaccine was given 2 months later and a third dose was offered between 12 and 15 months of age. All the 12- to 60-month old children achieved a protective antibody concentration 1-month postvaccination. Among the 6- to 8-week-old infants only 11% of the Apaches and 8% of the Navajos had a protective anti-PRP antibody concentration prevaccination. One month post vaccination, 68% of the Apaches and 69% of the Navajos had protective anti-PRP antibody concentrations. One month after the 2nd immunization 67% of the Apaches and 75% of the Navajos had protective anti-PRP concentrations. The authors conclude that the Hib-OMP is safe and highly immunogenic among Apache and Navajo infants and children.