Lutein-fortified infant formula fed to healthy term infants: evaluation of growth effects and safety.

BACKGROUND/OBJECTIVES: Breast milk contains lutein derived from the mother's diet. This carotenoid is currently not added to infant formula, which has a small and variable lutein content from innate ingredients. This study was conducted to compare the growth of infants fed lutein-fortified infant formula with that of infants fed infant formula without lutein fortification. SUBJECTS/METHODS: This 16-week study was prospective, randomized, controlled, and double-blind with parallel groups of healthy term infants fed either control formula (Wyeth S-26 Gold, designated as Gold) or experimental formula (Wyeth S-26 Gold fortified with lutein at 200 mcg/l, designated as Gold+Lutein). Two hundred thirty-two (232) infants

Safety and immunogenicity of three doses of an eleven-valent diphtheria toxoid and tetanus protein--conjugated pneumococcal vaccine in Filipino infants.

BACKGROUND: An 11-valent pneumococcal conjugate vaccine could provide significantly larger reduction in pneumococcal disease burden than the currently available 7-valent vaccine formulation in many countries. METHODS: In total, 50 infants were enrolled to this open, uncontrolled study, which evaluated the safety and immunogenicity of an aluminium adjuvanted 11-valent mixed-carrier diphtheria toxoid or tetanus protein-conjugated vaccine (11-PncTD) when administered in three doses at 6, 10 and 14 weeks of age simultaneously with DTwP//PRP-T and OPV vaccines in Filipino infants. RESULTS: The rates of local reactions between the two injection sites, those associated with the 11-PncTD vaccine and those with the DTwP//PRP-T were almost of equal frequency for all three vaccine doses except for induration, which was significantly more common in the DTP//PRP-T injection site. Fever was present in 39%, 22% and 21% of infants following each of the three doses. Antibody responses were determined by an enzyme immunoassay method before the first vaccination and after the three doses. The vaccine elicited a significant anti-pneumococcal polysaccharide antibody response against all serotypes included in the vaccine, except for type 14, for which the pre-vaccination geometric mean antibody concentration (GMC) was high (1.61 microg/ml). The GMCs one month after the vaccination series ranged from 1.1 micrograms/ml for type 6B to 23.4 microg/ml for type 4. CONCLUSION: The 11-PncTD vaccine is safe, well-tolerated and immunogenic. The effectiveness of the non-adjuvanted formulation of the vaccine in preventing pneumonia is currently being evaluated in the Philippines.

Immunogenicity and reactogenicity of 23-valent pneumococcal polysaccharide vaccine among pregnant Filipino women and placental transfer of antibodies.

This randomized, controlled study among pregnant women evaluated the prevaccination distribution of anti-pneumococcal (Pnc) antibodies (Ab), the immunogenicity and reactogenicity of Pnc polysaccharide vaccine, and transplacental transfer of Ab. The Pnc vaccine group (N=106) received Pnc PS vaccine, Hemophilus influenzae type b conjugate vaccine and tetanus toxoid; the control group (N=54) received tetanus toxoid only. Sera and cord blood were assayed for anti-pnc Ab using enzyme immunoassay. In the Pnc vaccine group, anti-Pnc Ab rose by 3- to 9-fold and was significantly higher in cord blood. In evaluating Pnc conjugate vaccines, the concentration of 0.35 microg/ml is suggested as the protective threshold against invasive disease. Around 90% of mothers had this level pre-vaccination. Considering the decay of passively acquired Ab and the growth of the infant, an Ab level in cord blood of at least 4.4 microg/ml is needed if infants are to be protected up to 4 months of age. Cord blood anti-Pnc Ab was above this level in 60% and 10% of the Pnc vaccine and control groups, respectively. Maternal immunization with Pnc polysaccharide vaccine can provide prolonged protection through passively acquired Ab.