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Effect of high-dose vitamin A supplementation on the immune response to Bacille Calmette-Guérin vaccine^1,2,3,4

¹ From the Bandim Health Project, INDEPTH Network, Bissau, Guinea-Bissau (BRD, ABF, JEN, A Rodrigues, and PA); the Bandim Health Project, Statens Serum Institut, Copenhagen, Denmark (BRD, A Roth, HR, PA, and CSB); the Medical Research Council, Fajara, The Gambia (HW); the Department of Parasitology, Leiden University Medical Center, Leiden, the Netherlands (MY and ES); the Department of Pathology, Herlev University Hospital, Copenhagen, Denmark (IML); and the Medical Microbiology, Lund University, Malmö, Sweden (A Roth)

Background: Vitamin A supplementation (VAS) at birth has been associated with decreased mortality in Asia. Bacille Calmette-Guérin (BCG) vaccine is given at birth in tuberculosis-endemic countries. Previous studies suggest that VAS may influence the immune response to vaccines.

Objective: Our objective was to examine whether VAS influences the immune response to simultaneously administered BCG vaccine.

Design: Within a randomized trial of 50 000 IU vitamin A or placebo given with BCG vaccine at birth in Guinea-Bissau, 2710 infants were examined for BCG scar formation and delayed-type hypersensitivity (DTH) to purified protein derivative of Mycobacterium tuberculosis (PPD) at 2 and 6 mo of age. The ex vivo cytokine response to PPD was measured in 607 infants.

Results: At 2 mo of age, 39% (43% of the boys and 34% of the girls) responded to PPD. The prevalence ratio of a measurable PPD reaction for VAS compared with placebo recipients was 0.90 (95% CI: 0.80, 1.02) for all infants, 0.81 (95% CI: 0.69, 0.95) for boys, and 1.04 (95% CI: 0.86, 1.26) for girls. At 6 mo of age, 42% of the infants responded to PPD. No difference was observed between VAS and placebo recipients. The prevalence of BCG scar was not affected by VAS. The ex vivo interferon- response to PPD was increased by VAS (means ratio: 1.40; 95% CI: 1.03, 1.91).

Conclusions: VAS with BCG vaccination does not appear to interfere with the long-term immune response to BCG. However, VAS temporarily altered the DTH reaction to PPD in boys at 2 mo of age, suggesting sex differences in the immunologic response to VAS given with BCG. This trial was registered at www.clinicaltrials.gov as #NCT00168597.

Key Words: Bacille Calmette-Guérin • BCG vaccination • vitamin A • PPD response • purified protein derivative of Mycobacterium tuberculosis response • randomized trial • sex-differential effects

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