Safety of vitamin A and zinc supplementation in combination with vaccines in HIV-positive injection drug users.

摘要

Background. Currently available pneumococcal vaccines are not highly immunogenic in HIV-1 positive individuals. New conjugate formulations and supplementation with vitamin A and zinc may improve immunogenicity. But because they may also affect disease progression, we measured their effects on HIV-1 replication and changes in T-cell subsets.; Methods. HIV-1-positive injection drug users were enrolled in a double-masked, placebo-controlled trial and randomized to receive either 400,000 IU vitamin A, 300 mg zinc gluconate, vitamin A plus zinc, or placebo prior to immunization with heptavalent pneumococcal conjugate vaccine (PC-7) and Haemophilus influenzae type b vaccine (HbOC). The recommended 23-valent polysaccharide pneumococcal vaccine (PPS-23) was given 6 months later. Adverse effects to the nutrients and vaccines were recorded. Quantity of HIV-1 RNA, CD4+, CD8+, and CD3+ T-lymphocytes, and serum retinol were assessed following each intervention.; Results. 118 HIV-appositive men and women were enrolled and 90 (76%) completed supplementation, immunization with PC-7 and HbOC, and one-month follow-up. Both vitamin A and zinc were well tolerated. No severe adverse event was associated with vaccination and there was no consistent effect of the nutrients on reaction rates. Neither vitamin A nor zinc increased viral load. Zinc decreased CD4 (p = 0.06), while vitamin A increased CD4 (p = 0.03) and CD3 (p = 0.02). CD8, increased only among those who received vitamin A alone (p = 0.07). All changes in T-cells resolved within 7 months Vitamin A did not increase serum retinol concentration and the addition of zinc did not affect this response. Among placebo recipients, viral load 30 days after PC-7+HbOC (week 6) was similar to Day 0 levels (fold change = 1.04; p = 0.92), but higher than vaccination day levels (fold change = 1.69; p = 0.13). Viral load fell following PPS-23 (fold change = 0.75, p = 0.07).; Conclusions. This trial suggests that short-term, high-dose supplementation with vitamin A is safe in persons infected with HIV-1. In contrast, although zinc did not increase viral load, it may adversely affect CD4 cells in this population. Simultaneous administration of two conjugate vaccines may increase viral load, but not when given with vitamin A or zinc. A PPS-23 booster dose 6 months later did not increase viral load.