Safety and immunogenicity of a DTaP-IPV(Vero) (serum-free) combination vaccine in comparison to DTaP-IPV(Mkc) when administered simultaneously with Haemophilus influenzae type B conjugate vaccine (PRP-T) in children at 2, 3.5, 5 and 16 months of age.

Jagellonian University, Medical College, Institute of Pediatrics, Department of Pediatrics, Wielicka 265, 30-663 Krakow, Poland.
Vaccine (Impact Factor: 3.49). 10/2008; 26(41):5296-303. DOI: 10.1016/j.vaccine.2008.07.033
Source: PubMed

ABSTRACT In a phase III, double blind, randomized, noninferiority, multi-centre clinical trial, 817 infants were included and randomly assigned to vaccination with DTaP-IPV(Vero) (N=410) or DTaP-IPV(Mkc) (N=407) vaccines (Statens Serum Institut (SSI), Denmark) in the right thigh. All infants were vaccinated with Act-HIB (Sanofi Pasteur, France) in the left thigh at the same time. The vaccination schedule was 2, 3.5, 5 and 16 months and serum samples were obtained at 6, 16 and 17 months. The primary objective was to demonstrate noninferiority of DTaP-IPV(Vero) to DTaP-IPV(Mkc) as regards immunological protection against polio virus types 1, 2 and 3. Furthermore, the immunogenicity of all vaccine antigens and the safety profile of the vaccines were assessed. The study demonstrated that DTaP-IPV(Vero) was noninferior to DTaP-IPV(Mkc). All antibody concentrations/titres remained at an acceptable level from the end of the primary vaccination series (i.e. 2, 3.5 and 5 months) until the time of the booster vaccination at 16 months. A good booster response was, furthermore, demonstrated for all antigens. No vaccine-related serious adverse events and no injection site granulomas or swelling of the entire thigh occurred. The frequencies of local injection site erythema and swelling as well as systemic adverse events such as fever, irritability, somnolence and decreased appetite were low and acceptable in both treatment groups. In conclusion, DTaP-IPV(Vero) is immunogenic and safe for primary vaccination and for booster vaccination of healthy children.

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    ABSTRACT: Dalby T, Sørensen C, Petersen JW, Krogfelt KA. Pertussis serology: assessment of IgG anti-PT ELISA for replacement of the CHO cell assay. APMIS 2010; 118: 968–72. Two types of serological assays are commonly used for the assessment of pertussis vaccine-induced antibodies; the Chinese hamster ovary cell (CHO cell) assay and the immunoglobulin G (IgG) anti pertussis toxin (PT) enzyme-linked immunosorbent assay (IgG anti-PT ELISA). Recently, both the techniques have been modified to improve performance with sera with interfering activity (CHO cell assay) or with heat-treated sera (IgG anti-PT ELISA). These two improved techniques were compared by the analysis of 100 individual serum samples from a previous clinical trial and 213 sera from a longitudinal serum collection from 20 Danish adults recently vaccinated with the Danish acellular pertussis vaccine. The comparison showed a significant linear correlation between the results of the two assays with a p-value of <0.0001 for the 100 individual samples. We, therefore, conclude that the improved IgG anti-PT ELISA can be used as a replacement for the often troublesome and time-consuming CHO cell assay for the measurement of vaccine-induced human antibodies to PT.
    Apmis 12/2010; 118(12):968-72. DOI:10.1111/j.1600-0463.2010.02664.x · 1.92 Impact Factor
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    ABSTRACT: Combination vaccines containing a monocomponent acellular pertussis (aP) vaccine, manufactured at Statens Serum Institut (SSI), Denmark, have successfully controlled Bordetella pertussis infections in Denmark since 1997. The efficacy of this aP vaccine was 71% in a double-blind, randomised and controlled clinical trial. Its safety and immunogenicity have been demonstrated in infants, children, adolescents and adults. In approximately 500,000 children it was effective against pertussis requiring hospitalisation (VE: 93% after 3 doses) and against pertussis not requiring hospitalisation (VE: 78% after 3 doses). IgG antibodies against pertussis toxin (IgG anti-PT) response rates after booster vaccination of adults with tetanus, diphtheria and aP combination vaccine (TdaP) were considerably higher for this monocomponent aP vaccine containing 20μg pertussis toxoid, inactivated by hydrogen peroxide (92.0%), than for two multicomponent aP vaccines inactivated by formaldehyde and/or glutaraldehyde: 3-component aP with 8μg pertussis toxoid (77.2%) and 5-component aP with 2.5μg pertussis toxoid (47.1%), without compromising the safety profile. In Denmark where this monocomponent aP vaccine has been the only pertussis vaccine in use for 15 years, there has been no pertussis epidemic since 2002 (population incidence 36 per 100,000), in contrast to neighbouring countries, where epidemics have occurred. This monocomponent aP vaccine can be used in combination vaccines for primary and booster vaccination against pertussis in all age groups and is an important tool for the successful pertussis control.
    Vaccine 08/2013; 31(45). DOI:10.1016/j.vaccine.2013.08.034 · 3.49 Impact Factor
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    ABSTRACT: Background. The Gambia was the first country in Africa to introduce Conjugate Hib vaccine, which like other developing countries but unlike industrialised countries is delivered as 3-dose primary series with no booster. This study assessed its effectiveness 14 years post-introduction. Methods. Using methods standardised through over 20 years in the study site, clinical and microbiological surveillance for invasive Hib disease (primarily meningitis) in the Western Region of The Gambia from 2007-2010 was complemented with studies of Hib carriage in 1-2 year olds, Hib antibody levels in under-5 year olds, and Hib vaccine coverage and timing in 1-2 year olds. Results. The incidence of Hib meningitis remained low (averaging 1.3 per 100,000 children <5y annually), as did the Hib oropharyngeal carriage rate (0.9%). Hib antibody levels were protective in >99% of those surveyed, albeit with lower titres in older children; and coverage of conjugate Hib vaccination was high (91% having 3 doses at 1-2 years of age) using a schedule that was delivered at median ages of 2.6 months, 4 months and 6 months for the 1(st) 2(nd) and 3(rd) doses respectively. Conclusions. Conjugate Hib vaccine was delivered on time in a 3-dose primary series without booster to a high proportion of eligible children and this was associated with effective disease control out to 14 years post-introduction. It is important that surveillance continues in this first African country to introduce the vaccine to determine if effective control persists or if a booster dose becomes necessary as it has done in industrialised countries.
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May 30, 2014