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      Combination Vaccines

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          Abstract

          The combination of diphtheria, tetanus, and pertussis vaccines into a single product has been central to the protection of the pediatric population over the past 50 years. The addition of inactivated polio, Haemophilus influenzae, and hepatitis B vaccines into the combination has facilitated the introduction of these vaccines into recommended immunization schedules by reducing the number of injections required and has therefore increased immunization compliance. However, the development of these combinations encountered numerous challenges, including the reduced response to Haemophilus influenzae vaccine when given in combination; the need to consolidate the differences in the immunization schedule (hepatitis B); and the need to improve the safety profile of the diphtheria, tetanus, and pertussis combination. Here, we review these challenges and also discuss future prospects for combination vaccines.

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          Long-term immunogenicity of hepatitis B vaccination and policy for booster: an Italian multicentre study.

          Alessandro Zanetti, Andrea Mariano, Luisa Romanò … (2015)
          Universal anti-hepatitis-B vaccination of infants and adolescents was implemented in Italy in 1991. We undertook a multicentre study in previously vaccinated individuals to assess the duration of immunity and need for booster, over 10 years after vaccination. In 1212 children and 446 Italian Air Force recruits vaccinated as infants and adolescents, respectively, we measured the concentrations of antibodies to hepatitis-B surface antigen (anti-HBs) and the presence of antibodies to hepatitis-B core antigen (anti-HBc) at enrollment; postimmunisation values were not available. Individuals positive for anti-HBc were tested for hepatitis B surface antigen (HBsAg) and hepatitis B viral DNA. Individuals with anti-HBs concentrations at 10 IU/L or more were regarded as protected; those with antibody less than 10 IU/L were given a booster dose and retested 2 weeks later. Individuals showing postbooster anti-HBs concentrations of less than 10 IU/L were offered two additional vaccine doses and retested 1 month after the third dose. Protective anti-HBs concentrations were retained in 779 (64%, 95% CI 61.6-67) children and 398 (89%, 86.4-92.1) recruits. We recorded antibody amounts of less than 10 IU/L in 433 children (36%, 33-38.4) and 48 (11%, 7.9-13.6) recruits. One child and four recruits were positive for anti-HBc, but negative for HBsAg and hepatitis B viral DNA. Antibody concentrations were higher in recruits than in children (geometric mean titre 234.8 IU/L vs 32.1 IU/L, p=0.0001). 332 (97%) of 342 children and 46 (96%) of 48 recruits who received a booster showed an anamnestic response, whereas ten (3%) children and two (4%) recruits remained negative for anti-HBs or had antibody concentrations of less than 10 IU/L. Prebooster and postbooster antibody titres were strongly correlated with each other in both groups. All individuals given two additional vaccine doses (eight children and two recruits) showed anti-HBs amounts of more than 10 IU/L at 1 month after vaccination. Strong immunological memory persists more than 10 years after immunisation of infants and adolescents with a primary course of vaccination. Booster doses of vaccine do not seem necessary to ensure long-term protection.
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            The path to a successful vaccine adjuvant--'the long and winding road'.

            Derek O’Hagan, Ennio De Gregorio (2009)
            New generation vaccines will increasingly comprise highly purified recombinant proteins. Unfortunately, these antigens are often poorly immunogenic. Therefore, adjuvants will be required to enable these proteins to become effective vaccines. Although several novel adjuvants have recently emerged, including formulations comprising more than one adjuvant, the approval of vaccines containing novel adjuvants has been slow, particularly in the US. However, despite significant ongoing concerns, the necessary safety data is now emerging to show that new generation adjuvants can be safely used in diverse human populations. In combination with data showing the positive contributions of the adjuvants to the immune response, this safety data should allow several vaccines containing novel adjuvants to obtain licensure within the next few years.
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              Use of combination vaccines is associated with improved coverage rates.

              John Marshall, Evan Zahn, M. Szymanski … (2007)
              The number of shots represented by the routine childhood immunization schedule poses a logistical challenge for providers and a potential deterrent for parents. By reducing the number of injections, use of combination vaccines could lead to fewer deferred doses and improved coverage rates. To determine the effect of combination vaccines on coverage rates. This was a retrospective study of administrative claims data from the Georgia Department of Community Health Medicaid program conducted from January through September of 2003. Coverage rates were compared between children who received at least 1 dose of HepB/Hib (COMVAX) or DTaP/HepB/IPV (PEDIARIX) (the combination cohort) and children who received no doses of either combination (the reference cohort). Infants with fewer than 4 vaccination visits were excluded from the analysis. Multivariate logistic regression was performed on the whole study population to assess the effect of combination vaccines while controlling for potential confounders. Hepatitis B and pneumococcal conjugate vaccine coverage rates were not included as outcomes. The study population consisted of 18,821 infants, 16,007 in the combination cohort and 2814 in the reference cohort. Unadjusted coverage rates for DTaP, IPV and the 4 DTaP:3 IPV:1 MMR, 4 DTaP: 3 IPV: 1 MMR: 3 Hib: 1 varicella, and 3 DTaP:3 IPV: 3 Hib series were higher in the combination cohort. Receipt of at least 1 dose of a combination vaccine was independently associated with increased coverage for each of these vaccines and vaccine series when controlling for gender, birth quarter, race, rural versus urban residence and historical provider immunization quality. Use of combination vaccines in this Medicaid population was associated with improved coverage rates. Additional studies are warranted, including those examining private sector populations and outcomes such as timeliness and cost.
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                Author and article information

                Journal
                Journal ID (nlm-ta): J Glob Infect Dis
                Journal ID (publisher-id): JGID
                Title: Journal of Global Infectious Diseases
                Publisher: Medknow Publications (India )
                ISSN (Print): 0974-777X
                ISSN (Electronic): 0974-8245
                Publication date (Print): Jan-Mar 2011
                Volume: 3
                Issue: 1
                Pages: 63-72
                Affiliations
                [1] Novartis Vaccines, Via Fiorentina 1, Siena, Italy
                [1 ] Novartis Vaccines, Cambridge MA, USA
                Author notes
                Address for correspondence: Dr. David AG Skibinski, david.skibinski@ 123456novartis.com
                Article
                Publisher ID: JGID-3-63
                DOI: 10.4103/0974-777X.77298
                PMC ID: 3068581
                PubMed ID: 21572611
                SO-VID: 30f63729-5068-47d5-89ec-a26d940ed6f4
                Copyright © Copyright: © Journal of Global Infectious Diseases
                License:

                This is an open-access article distributed under the terms of the Creative Commons Attribution-Noncommercial-Share Alike 3.0 Unported, which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited.

                History
                Categories
                Subject: Symposium

                ScienceOpen disciplines: Infectious disease & Microbiology
                Keywords: streptococcus pneumoniae,poliovirus,haemophilus influenza,neisseria meningitidis,combination vaccine,adjuvant,diphtheria,pertussis,tetanus,hepatitis b
                Data availability:
                ScienceOpen disciplines: Infectious disease & Microbiology
                Keywords: streptococcus pneumoniae, poliovirus, haemophilus influenza, neisseria meningitidis, combination vaccine, adjuvant, diphtheria, pertussis, tetanus, hepatitis b

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