Comparison of the immunogenicity and reactogenicity of two commercially available hexavalent vaccines administered as a primary vaccination course at 2, 4 and 6 months of age

Tichmann, Irmingard; Preidel, H.; Grunert, Detlef; Habash, Sami; Schult, R.; Maier, Reinhard; Gildberg, P.K.; Sengespeik, H C; Meurice, François; Sänger, Roland

doi:10.1016/j.vaccine.2005.01.087

Cited by 41 publications

(23 citation statements)

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“…Several studies have shown that the persistence of measurable antibody levels is related to peak anti-HBs levels after immunization [31][32][33]. The increasingly higher prevalence of anti-HBs <10 mIU/ml with time since completed vaccination in Hexavac vaccinees compared to Infanrix hexa vaccinees as suggested by our model is consistent with lower reported anti-HBs levels post-primary vaccination for Hexavac [27]. Similarly, the significantly higher proportion of children vaccinated with Infanrix hexa having anti-HBs levels o1000 mIU/ml within 2 years of the last vaccination compared to those vaccinated with Hexavac implies that Infanrix hexa vaccinees might have responded with substantially higher antiHBs levels post-vaccination.…”

Section: Discussionsupporting

confidence: 86%

“…In particular, another recent Italian study in children attending local health units found that 31 % of 113 Hexavac vaccinees had anti-HBs <10 mIU/ml compared to only 4 % of 129 Infanrix hexa vaccinees 15 months post-primary vaccination with three doses [35]. A clinical trial showed that both the proportion of children with anti-HBs o10 mIU/ml as well as geometric mean titres (GMTs) were significantly higher in children vaccinated with three doses of Infanrix hexa compared to three doses of Hexavac 1 month post-vaccination [27]. A follow-up trial reported significantly higher anti-HBs GMTs as well as seroprevalence rates at age 11-23 months in infants primed with Infanrix hexa in the first study [26].…”

Section: Discussionmentioning

confidence: 99%

“…Current knowledge on the immunogenicity of Hexavac and Infanrix hexa has largely been gained from clinical trials [23][24][25][26][27]. Questions remain about the short-and long-term hepatitis B immunogenicity in children vaccinated with these hexavalent vaccines during routine immunization.…”

Section: Introductionmentioning

confidence: 99%

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Low hepatitis B immunogenicity of a hexavalent vaccine widely used in Germany: results of the German Health Survey for Children and Adolescents, 2003–2006

et al. 2010

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SUMMARYThe success of childhood vaccination against hepatitis B relies on persistence of immunity into adolescence and adulthood. In 2000, two hexavalent vaccines with a hepatitis B component (Hexavac 1 , Infanrix hexa 1 ) were introduced in Germany. Hexavac was withdrawn in 2005 amidst concerns about its long-term hepatitis B protection. We compared hepatitis B surface antibody (anti-HBs) levels in children fully vaccinated with Hexavac or Infanrix hexa (n=477) in a secondary data analysis of a large cross-sectional health survey in Germany. On average 2 . 4 years after vaccination, 25 . 3 % of Hexavac vaccinees had anti-HBs levels <10 mIU/ml (95 % CI 19 . 0-32 . 8) compared to 4 . 7 % of Infanrix hexa vaccinees (95 % CI 2 . 4-8 . 9). These findings suggest that short-term hepatitis B immunogenicity in Hexavac vaccinees may also be weaker. Further studies are warranted to assess whether Hexavac vaccinees should be re-vaccinated or receive a booster vaccination before these birth cohorts reach adolescence.

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Section: Discussionsupporting

confidence: 86%

Section: Discussionmentioning

confidence: 99%

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Low hepatitis B immunogenicity of a hexavalent vaccine widely used in Germany: results of the German Health Survey for Children and Adolescents, 2003–2006

et al. 2010

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“…Similarly, anti-FHA responses were 300.3 EU/mL and 302.8 EU/mL (GMT) and 99.0% and 99.1% (≥4-fold rise) for these two DTaP vaccines, respectively. 25 …”

Section: Immunogenicity Comparison Versus Other Licensed Dtap Vaccinesmentioning

confidence: 99%

Immunogenicity of a two-component (PT&FHA) acellular pertussis vaccine in various combinations

Vidor

Plotkin²

2008

Human Vaccines

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“…3 We report two serological follow up studies conducted in Germany in healthy children between 4 and 9 years of age who had been previously primed and boosted with four doses of combined DTPa-HBV-IPV/Hib vaccine in previous GSK-sponsored clinical trials. 3,[5][6][7][8][9] The immune response to a challenge dose of hepatitis B vaccine in these subjects was also assessed and has been reported elsewhere.…”

mentioning

confidence: 99%

Immunological persistence in 4-6 and 7-9 year olds previously vaccinated in infancy with hexavalent DTPa-HBV-IPV/Hib

Zinke¹,

Disselhoff²,

Gartner³

et al. 2010

Human Vaccines

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Combination vaccines induce immunity against multiple diseases in a single injection and thus facilitate delivery of complex vaccination schedules. Use of combination vaccines increases both vaccine coverage and the timeliness of vaccination.1 Infanrix hexa TM , the combined hexavalent diphtheria-tetanus-pertussis-hepatitis B-inactivated poliomyelitis-Haemophilus influenzae type b conjugate vaccine [DTPa-HBV-IPV/Hib, GlaxoSmithKline Biologicals (GSK), Rixensart, Belgium] is the only hexavalent vaccine currently licensed for primary and booster vaccination of infants and provides simultaneous protection against six major diseases of childhood. DTPa-HBV-IPV/Hib contains ≥30 IU diphtheria toxoid, ≥40 IU tetanus toxoid, 25 μg pertussis toxin (PT), 25 μg filamentous haemagglutinin (FHA), 8 μg pertactin (PRN), 10 μg recombinant HBsAg, 40D, 8D and 32D antigen units of poliovirus types 1, 2 and 3 respectively and 10 μg Hib polyribosylribitol-phosphate (PRP) conjugated to tetanus toxoid.Background: the combined diphtheria-tetanus-pertussis-hepatitis B-inactivated poliomyelitis-Haemophilus influenzae conjugate vaccine (Dtpa-HBV-IpV/Hib, Infanrix Hexa tM GlaxoSmithKline Biologicals, rixensart, Belgium) is the only hexavalent vaccine currently licensed for primary and booster vaccination of infants and provides simultaneous protection against six major diseases of childhood. the persistence of the immune response in children aged 4-6 and 7-9 years of age previously vaccinated with four doses of Dtpa-HBV-IpV/Hib vaccine was assessed (www.clinical trials.gov.au 106744 NCt00356564 and 106745 NCt00335881).Methods: A blood sample was collected from 403 children, all of whom had received 3-dose primary vaccination and a booster dose in the second year of life with Dtpa-HBV-IpV/Hib, in previous clinical vaccine trials in Germany.results: Mean time from the fourth Dtpa-HBV-IpV/Hib dose until serological follow-up ranged between 3.6 and 6.4 years. After the 4 th Dtpa-HBV-IpV/Hib dose, in subjects who had not received additional booster doses, seroprotective antibody levels persisted up to 9 years of age in ≥90% of subjects for diphtheria, Hib and poliomyelitis, in 77.2% subjects for Hepatitis B and in 64.7% of subjects for tetanus. Anti-pertussis toxin antibodies remained detectable in no more than 38.2% of subjects.Conclusion: With the exception of pt, the combined Dtpa-HBV-IpV/Hib induces long lasting immune response against all vaccine antigens. Falling seropositivity against pt over time supports the recommended administration of a pertussis booster dose in 5-6 year old children in Germany.

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Comparison of the immunogenicity and reactogenicity of two commercially available hexavalent vaccines administered as a primary vaccination course at 2, 4 and 6 months of age

Cited by 41 publications

References 36 publications

Low hepatitis B immunogenicity of a hexavalent vaccine widely used in Germany: results of the German Health Survey for Children and Adolescents, 2003–2006

Low hepatitis B immunogenicity of a hexavalent vaccine widely used in Germany: results of the German Health Survey for Children and Adolescents, 2003–2006

Immunogenicity of a two-component (PT&FHA) acellular pertussis vaccine in various combinations

Immunological persistence in 4-6 and 7-9 year olds previously vaccinated in infancy with hexavalent DTPa-HBV-IPV/Hib

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