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• W46778635 abstract "Original ArticlesImmunogenicity of FDA DTP Versus WHO DTP Mohamed Khalil, MPH, MSc, MD Yagob Al-Mazrou, PhD, FRCGP Mansour Al-Howasi, and FRCP Mohammed Al-JeffriMTM Mohamed Khalil Address reprint requests and correspondence to Dr. Khalil: STAT Advisory Medical Center for Research Development, 47 Mohammed Sayed Ahmed St., Cairo 11421, Egypt. From the STAT Advisory Medical Center for Research Development, Cairo, Egypt Search for more papers by this author , Yagob Al-Mazrou From the Ministry of Health, Riyadh, Saudi Arabia. Search for more papers by this author , Mansour Al-Howasi From the Ministry of Health, Riyadh, Saudi Arabia. Search for more papers by this author , and Mohammed Al-Jeffri From the Ministry of Health, Riyadh, Saudi Arabia. Search for more papers by this author Published Online:1 Sep 1999https://doi.org/10.5144/0256-4947.1999.417SectionsPDF ToolsAdd to favoritesDownload citationTrack citations ShareShare onFacebookTwitterLinked InRedditEmail AboutAbstractBACKGROUND:The aim of this report was to study the immunogenicity of three doses of DTP in six-week-old Saudi infants when given either as World Health Organization (WHO) DTP or Federal Drug Administration (FDA) DTP formula.METHODS:As part of the Haemophilus influenzae type b immunization research protocol, six-week-old infants were randomized into three groups to receive three doses of HbOC and WHO DTP formula, HbOC and FDA DTP formula, or in a control group to receive the usual vaccines without HbOC, at six weeks, three months and five months. Antibody levels for PRP, tetanus, diphtheria and pertussis were measured after the third dose. The results of diphtheria, pertussis and tetanus are presented in this paper.RESULTS:After three doses, no difference was found between anti-PRP when given with either FDA DTP or WHO DTP formula. Also anti-tetanus and anti-diphtheria antibodies were significantly higher in the group vaccinated with HbOC and FDA DTP formula, compared to children vaccinated with WHO DTP formula. No negative interactions with other vaccines were observed after the third dose.CONCLUSION:Although diphtheria and tetanus antigens in the FDA formula are half the concentration in the WHO formula, they are more antigenic. There is a need for methods of potency assay to be re-evaluated.IntroductionSimultaneous immunization against diphtheria, tetanus and pertussis during infancy and childhood has been a routine practice in many countries since the late 1940s. These vaccines have played a major role in markedly reducing the incidence and mortality from each of these diseases.1 On the other hand, the perceived reactogenicity of the vaccine, especially pertussis, is of considerable public health importance.2Vaccine formulas for DTP and oral polio used in the USA are different from the formula used in the rest of the world, which is the WHO formula. While FDA DTP contains only 50% of the concentration of tetanus and diphtheria of the WHO formula (Table 1), the oral polio of the FDA contains much higher concentrations compared to the WHO formula. Since DTP is the core vaccine for most of the combined bacterial vaccines, the minimum requirements and specifications3–5 of both formulae should be re-evaluated, including comparing their respective immunogenicity in humans. Furthermore, simultaneous or prior vaccination with diphtheria or tetanus toxoid may modify anticapsular antibody response to Haemophilus influenzae vaccine,6 which is an important component of the extended program of immunization.Table 1. DTP vaccines.Table 1. DTP vaccines.The aim of this paper is to evaluate the immune response to two formulations of DTP, the US FDA formula, and the WHO formula given concurrently with the Hib conjugate vaccine.PATIENTS AND METHODSThis clinical trial was conducted in three health centers in Saudi Arabia. Infants were recruited for the study during their routine well-baby visit at six weeks. After obtaining informed parental consent and normal physical examination, infants at the age of six weeks were randomly put into three groups: the first group received HbOC (HibTITER, Lederle-Praxis), in addition to DTP (Berna) and oral polio (SKF), which comply with vaccine specifications established by WHO and are routinely used in Saudi Arabia; and the second group received HibTITER in addition to DTP (TRI-IMMUNOL, Lederle) and oral polio (ORIMUNE, Lederle). The latter two vaccines meet the release specifications required in the USA. The third group of infants were not given Hib vaccine but the usual vaccines (DTP Berna and OPV SKF). HibTITER vaccine was given concurrently with DTP, but in a separate limb, according to the routine immunization schedule in Saudi Arabia, at six weeks, three months and five months of age.The vaccine used in the study was the Haemophilus influenzae type b oligosaccharide-CRM197 conjugate (HbOC). The HbOC (HibTITER) was developed and manufactured by Lederle-Praxis Biologicals (Sanford, NC). DTP vaccines used in the study are shown in Table 1.A minimum blood sample of 3 cc was collected one month after the third dose of the vaccine from all the infants. Sera were identified by barcode. Antibody determination was performed on each coded sample in Lederle Laboratories, NY. Only the serological results of DTP are presented in this paper. Other serology results have been published in a previous report.7Antitetanus antibodies and antidiphtheria antibodies were measured using ELISA technique, and the results were expressed in international units, IU/mL. Antibodies against filamentous hemagglutination (FHA), 69-KDa protein (69K), pertussis toxin (PT), and fimbrial agglutinogens (FIM) were measured to compare the immunogenicity of the pertussis vaccines in different groups. The results were expressed in ELIZA units/mL.T-test and analysis of variance were performed on the logarithmic transformation of the antibody levels. Chisquare test was used to compare the proportion of children with the protective titers in the three groups, with a level of 0.01 antitoxin units/mL being regarded as protective for tetanus and diphtheria.8,9RESULTSRegarding anticapsular antibody of Hib, no statistical difference was found in the post-third dose GMT of HbOC when given with FDA DTP (14.48 μg/mL), or with WHO DTP (13.3 μg/mL). Table 2 shows the level of post-vaccination antitetanus and antidiphtheria antibodies. It was interesting to note that after the third dose of FDA DTP formula vaccines, antibodies in the second group were significantly higher than the WHO DTP formula (P=0.047 in the case of tetanus and P=0.0001 in diphtheria). Diphtheria antibody was also significantly higher in the first group vaccinated with WHO DTP and HbOC compared to the control group (P=0.043). No significant difference was found between the proportions of children with protective levels in different groups.Table 2. Antibodies against tetanus and diphtheria (IU/mL).Table 2. Antibodies against tetanus and diphtheria (IU/mL).In the case of pertussis (Table 3), where FHA, 69K and FIM antibodies were lower in the group vaccinated with the FDA DTP, only FHA was significantly lower (P=0.0001). On the other hand, PT antibodies were significantly higher in the group vaccinated with FDA DTP compared to the first group which was vaccinated with WHO DTP (P=0.043), and also higher, but not significantly, than the control group.Table 3. Antibodies against pertussis antigens.Table 3. Antibodies against pertussis antigens.DISCUSSIONIn our study, the formula or immunogenicity of DTP did not affect the GMT of anti-PRP.7 Priming within certain intervals is more likely than co-administration of the carrier protein vaccine to enhance the response to PRP.10 The effect of priming with different DTP formulae can be studied to evaluate the enhancement on PRP response, if any.Although the FDA formula of DTP contains 50% of tetanus and diphtheria compared to the WHO formula, the immunogenicity is higher after the third dose (Table 2). It is possible that the response after the third dose was enhanced because children were primed with a lower dose in the FDA group, or perhaps was a reflection of the quality of the antigen which can evoke a strong priming and a good immunological memory. To our knowledge, this is the first study to compare the FDA and WHO formula of DTP. On his study on acellular pertussis, Pichichero et al.11 vaccinated the control group with whole cell pertussis in the form of WDTP of FDA formula. GMT of tetanus was significantly higher in children vaccinated with WDTP of FDA formula, 6.2 U/mL, compared to children vaccinated with ADTP containing the WHO formula, 1.2 U/mL (P<0.001). Also, diphtheria antibody was higher but did not reach a significant level. The significant increase in diphtheria antibody in our study may be attributed in part to the diphtheria carrier protein in the Hib vaccine. Antigen quality or dose may play an important role, as diphtheria antibody is significantly higher in children vaccinated with HbOC and FDA DTP compared to children vaccinated with HbOC and WHO DTP (P=0.043)A study which was done in Australia showed that the increase in diphtheria or tetanus concentration was not associated with an increase in the reported systemic or local clinical signs associated with the first three doses.12 Accordingly, the advantage of a vaccine with lower concentration is not safety but the optimum dose which gives required immunogenic response.Immunogenicity of tetanus and diphtheria did not correlate with the antigen dose contained in the vaccine. In fact, the FDA vaccine, which contains only 50% of the tetanus and diphtheria in the WHO formula, showed higher immunogenic response in Saudi children. There is a need to re-evaluate potency tests. We cannot explain this immunogenic response but antigen quality or priming with a lower dose may explain this response.ARTICLE REFERENCES:1. Edsall G. Immunization of adults against diphtheria and tetanus . Am J Public Health. 1952; 42:393–400. Google Scholar2. Diphtheria, tetanus and pertussis: recommendation for vaccine use and other preventive measures. Recommendations of the Immunization Practices Advisory Committee (ACIP) . Morb Mortal Wkly Rep. 1991; 40/No. RR-10. Google Scholar3. Federal Security Agency. National Institutes of Health . Minimum requirements: diphtheria toxoid. Bethesda 14, Maryland. 4th Revision. March1, 1947. Google Scholar4. U.S. Department of Health, Education and Welfare. Public Health Service. National Institutes of Health . Minimum requirements: tetanus toxoid. Bethesda 14, Maryland. 4th revision, December15, 1952. Google Scholar5. European Pharmacopia: Diphtheria, tetanus and pertussis vaccine.3rd edition. 1997; 0445:P:764–67. Google Scholar6. Granoff DM, Ratore MH, Holmes SJ, Granoff PD, Lucas AH. Effect of immunity to the carrier protein on antibody responses to Haemophilus influenzae type b conjugate . Vaccine. 1993; 11(Suppl 1):S46–51. Google Scholar7. Khalil M, Al-Mazrou Y, Al-Jeffri M, Al-Howasi M. Immunization of Saudi children against Haemophilus influenzae type b at the age of 6 weeks . Saudi Med J. 1997; 18:455–7. Google Scholar8. Ipsen J. Immunization of adults against diphtheria and tetanus . New Engl J Med. 1954; 251:459–66. Google Scholar9. Fed. Reg. Vol. 50, No. 240, Dec. 13, 1985. Google Scholar10. Heilman C. Opposite effects of actively and passively acquired immunity to the carrier on response of human infants to a Haemophilus influenzae type b conjugate vaccine . Infect Immunol. 1994; 62:9–14. Google Scholar11. Pichichero M, Francis A, Marsocci S, Lynd AM, Green J, Disney F, et al.. Vaccination of 2-month-old infants with a 3-component acellular pertussis vaccine (ADTP) . Pediatr Infect Dis J. 1994; 13:193–6. Google Scholar12. Harris G, Nolan T, Hartman L. Clinical signs associated with triple antigen (DTP) vaccination in infants . J Paediatr Child Health. 1995; 31:228–32. Google Scholar Previous article Next article FiguresReferencesRelatedDetails Volume 19, Issue 5September 1999 Metrics History Received31 October 1998Accepted7 June 1999Published online1 September 1999 KeywordsFDA DTPWHO DTPHaemophilus influenzaeantibodiesImmunogenicityACKNOWLEDGEMENTSThe authors acknowledge with thanks the effort of the physicians working in the health centers included in the study, particularly Dr. H.A. Al-Sawi. This study was supported in part by Wyeth-Lederle Company.InformationCopyright © 1999, Annals of Saudi MedicinePDF download" @default.
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