COMPARISON OF THE SAFETY AND IMMUNOGENICITY OF A PNEUMOCOCCAL CONJUGATE WITH A LICENSED POLYSACCHARIDE VACCINE IN HUMAN DEFICIENCY VIRUS AND NONHUMAN IMMUNODEFICIENCY VIRUS-INFECTED CHILDREN

Objective, To compare the safety and immunogenicity of a 5-valent pneu mococcal conjugate vaccine to a licensed 23-valent polysaccharide pneu mococcal vaccine in HIV-infected and non-HIV-infected children greater than or equal to 2 years old. Methods, Thirty HIV-infected and 30 non -HIV-infected children greater than or equal to 2 years old were rando mized to receive either a 5-valent pneumococcal conjugate vaccine (PCV ) or a 23-valent pneumococcal polysaccharide vaccine (PPV) intramuscul arly. Children who received PCV initially were given PPV after 6 weeks . Sera were obtained before and at 6 and 12 weeks after the first vacc ination to determine IgG pneumococcal antibody titers by enzyme-linked immunosorbent assay to the 5 serotypes represented in the PCV. Result s, Both vaccines were well-tolerated with no significant differences i n the rates of fever (0 to 14%) or local reactions (0 to 40%) noted be tween PCV and PPV recipients. Pre-first vaccination geometric mean ant ibody titers (combined PCV and PPV recipients) to 3 of the 5 pneumococ cal types tested were significantly lower in HIV-infected than in non- HIV-infected children (in mu g/ml: type 6B, 0.179 vs, 0.565; type 14, 0.026 vs, 0.060; type 23F, 0.025 vs, 0.119, respectively; P < 0.05), F ewer greater than or equal to 4-fold titer rises were observed in HIV vs, non-HIV-infected children whether they received PCV initially (60% vs, 79%, P < 0.05) or PPV (31% vs, 59%, P < 0.05). Also PCV elicited more greater than or equal to 4-fold titer rises compared with PPV in HIV-infected (60% vs, 31%, P < 0.05) and non-HIV-infected (79% vs, 59% , P < 0.05) children, No consistent antibody-boosting effect was noted in subjects who received PPV after PCV. Conclusions, We conclude that antibody responses to natural infection, PCV and particularly PPV are poorer in HIV-infected than in non-HIV-infected children, PCV is as s afe as and more immunogenic than the currently licensed PPV among HIV- infected and non-HIV-infected children.