http://www.ncbi.nlm.nih.gov/htbin-post/Entrez/query?uid=11840081&form=6&db=m&dopt=r
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Pediatr Infect Dis J 2002 Feb;21(2):138-141 |
Books
Haemophilus influenzae type b conjugate
vaccine diluted tenfold in diphtheria-tetanus-whole cell pertussis vaccine: a
randomized trial.
Nicol M, Huebner R, Mothupi R, K yhty H, Mbelle N, Khomo E.
Pneumococcal Diseases Research Unit of the Medical Research Council, South
African Institute for Medical Research and University of the Witwatersrand,
Johannesburg, South Africa (MN, RH, RM, NM, KK); theDepartment of Vaccines,
National Public Health Institute, Helsinki, Finland (HK); the Department of
Health, Germiston City Council, South Africa (EK); and the Department of
International Health, Emory University, Atlanta, GA (KK).
BACKGROUND: Despite their proven efficacy Haemophilus influenzae type b (Hib)
conjugate vaccines are not given to most children in the developing world in
the face of an estimated global Hib disease burden of nearly 2 million cases
per annum. A major barrier to the introduction of the vaccine would be overcome
by diluting the vaccine 10-fold in diphtheria-tetanus-whole cell pertussis
(DTP). We report a randomized trial comparing the use of Hib conjugate vaccine
diluted in a multidose vial of DTP with that of the full Hib dose. METHODS: We
randomized 168 infants to receive either the full dose Hib
polysaccharide-tetanus toxoid conjugate (PRP-T) vaccine or a 1/10 dilution
prepared by reconstituting the full dose in a 10-dose DTP vial. Infants were
vaccinated at 6, 10 and 14 weeks of age and received a full dose as a test of
immunologic memory at 9 months of age. Sera were collected at each visit and at
1 week after the booster dose. Serum anti-capsular PRP antibody concentrations
were measured by enzyme-linked immunosorbent assay. RESULTS: After the primary
vaccination series, 95% of infants in the full dose arm and 94% of infants in
the 1/10 dose arm achieved anti-PRP IgG antibody concentrations of
[greater-than-or-equal]1.0 [mu]g/ml. Infants receiving the diluted vaccine had
significantly higher titers of anti-PRP antibody in response to the booster
dose (151.36 [mu]g/ml vs. 68.55 [mu]g/ml, P = 0.009). CONCLUSIONS: The 1/10
dose of PRP-T was as immunogenic and safe as the full dose. The technique of
diluting a single dose of PRP-T in a 10-dose DTP vial could potentially allow
the widespread introduction of Hib vaccine in resource-poor countries currently
unable to afford full dose Hib conjugate vaccine.
PMID: 11840081 [PubMed - as supplied by publisher]
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