Table of Contents

Volume 2, Issue 6

  November/December 2006

  Pages 233 - 261

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 Issue Catalogue (MARC XML)

SHORT REPORT

Open Access Article

Large-Scale Serologic Testing Program to Assess the Immunogenicity of Inactivated Hepatitis A Vaccine (VAQTA™) in Prefilled Syringes Following Product Recall in Germany

Gundula Jäger, Barbara J. Kuter, Hartmut Campe, Hassin Lakkis, Hans Nitschko, Michael Watson, Erika Harzer and Florian Schödel
Pages 233 - 236
http://dx.doi.org/10.4161/hv.2.6.3492
Abstract | PDF

A voluntary recall of VAQTA™ in prefilled syringes was implemented in Europe in late 2001 after the manufacturer noted a slight decrease in the antigen content of a small percentage of the syringes manufactured over a particular time frame. In Germany, a large-scale serologic testing program was implemented. The assay results were conveyed to the subject’s physician, and free vaccine was provided for anyone requesting revaccination. An analysis was performed on a subset of 58,546 vaccine recipients with hepatitis A antibody results. Of the 28,681 persons who received either two 25 units (25U) or two 50 units (50U) doses of VAQTA™, the seropositivity rate (SPR) was 99.5% after receipt of 2 doses, similar to the results in prelicensure clinical trials. The SPR was similar among recipients of lots that had been manufactured over the time frame associated with the recalled lots versus those receiving lots not associated with the recalled lots (25U: 99.7% versus 99,7%; 50U: 98.6% versus 99.6%, respectively). There were less recipients of 25U doses of the affected lots, who had high hepatitis A antibody titers (≥100 mIU/mL), compared to recipients of unaffected lots.




RESEARCH PAPERS

Open Access Article

Reactogenicity of Meningococcal C Conjugate Vaccines When Administered at the Same Time as, or a Month Prior to or After, Tetanus and Diphtheria Booster Vaccinations

Jo Southern, David Gelb, Nick Andrews, Pauline A. Waight, Rhonwen Morris, Keith Cartwright and Elizabeth Miller
Pages 237 - 242
http://dx.doi.org/10.4161/hv.2.6.3388
Abstract | PDF

Introduction: This single blind study was conducted to address safety concerns regarding co-administration of diphtheria/ tetanus (DT,Td) boosters and meningococcal C conjugate (MCC) vaccines containing diphtheria or tetanus conjugate proteins.

Methods: 1754 subjects (835 preschoolers and 919 school leavers) were randomised to receive one of three MCC products a month before, after or at the same as routine DT or Td boosters. They (or their parents) completed a health diary for 10 days to record local reactions and systemic symptoms after each vaccination. The effect of antibody levels pre- and post-vaccination, pre-existing allergies and medication taken before and for up to ten days after vaccination on reactogenicity was assessed.

Results: No relationship between pre-vaccination antibody levels and local reactions or systemic symptoms was found. Local reactions were more common after DT/Td than MCC vaccination and were related to post-vaccination diphtheria and tetanus antibody levels in younger children and to the post-vaccination tetanus only antibody levels in older children. Pre-existing allergies were not related to reactogenicity. Use of analgesics/ antipyretic medication significantly reduced the incidence of local reactions and of some systemic symptoms. In the first three days after vaccination there was an excess of some systemic symptoms including fatigue/ malaise and headache for all ages, and crying/ irritability for younger children and nausea/ vomiting and dizziness/ faintness for older subjects. Eleven serious adverse events were reported, none of which was deemed related to vaccination.

Conclusion: MCC vaccines can be given under the above schedules and safely in the presence of raised diphtheria and tetanus antibody levels without materially altering reactogenicity profiles of either vaccine.

Open Access Article

Parental Response to the Introduction of a Vaccine Against Human Papilloma Virus

Karen Noakes, Joanne Yarwood and David Salisbury
Pages 243 - 248
http://dx.doi.org/10.4161/hv.2.6.3391
Abstract | PDF

The introduction of a vaccine against human papillomavirus (HPV), a sexually transmitted virus that is the causal factor of at least 95% of invasive cervical cancer, could significantly reduce the number of cases of cervical cancer occurring in the UK each year. To ensure that individuals are protected before onset of sexual activity, it is likely that the vaccine will be offered to children around 10 years of age. It is important that parents’ attitudes to HPV vaccination are taken into account, particularly as the subject relates to sexual health issues. In order to gauge parents’ initial responses to the addition of HPV vaccine to the immunisation programme and identify the issues needing further research, in-depth interviews were held with parents of girls and boys aged 8-10 years. Our results show that most parents have not heard of HPV and were not aware of the role of HPV in cervical cancer. There were concerns about offering a vaccine that protects against a sexually transmitted infection to children and that the vaccine should be offered at an older age in conjunction with a sex education programme. In order to avoid rejection of this vaccine, work needs to take place now to raise awareness of HPV as a cause of cervical cancer prior to any introduction of the vaccination programme.

Open Access Article

Persistence of Antibodies in Children Primed with Two Different Hexavalent Diphtheria, Tetanus, Acellular Pertussis, Hepatitis B, Inactivated Poliovirus and Haemophilus influenzae Type b Vaccines and Evaluation of Booster Vaccination

Irmingard Tichmann, Detlef Grunert, Sami Habash, Helmut Preidel, Rainer Schult, Ulrich Pfletschinger, Per Kristian Gildberg, Francois Meurice and Roland Sänger
Pages 249 - 254
http://dx.doi.org/10.4161/hv.2.6.3432
Abstract | PDF

This study assessed the persistence of antibodies following primary vaccination with two commercially available, hexavalent diphtheria, tetanus, acellular pertussis, hepatitis B, inactivated poliovirus and Haemophilus influenzae type b vaccines (Infanrix hexa™ and Hexavac™). The immunogenicity and reactogenicity of booster vaccination with Infanrix hexa™ were also evaluated. A total of 329 children primed at 2, 4, and 6 months with Infanrix hexa™ (n=166) or Hexavac™ (n=163) received booster vaccination with Infanrix hexa™ at 12-19 months of age. Antibody concentrations were measured immediately before and 1 month after booster vaccination. Pre-booster persistence of antibodies to HBs, PRP and poliovirus types was significantly higher in children primed with Infanrix hexa™ than with Hexavac™, both in terms of seroprotection rate and GMCs/GMTs (p < 0.05). Boosting with Infanrix hexa™ elicited strong immune responses to all antigens irrespective of the primary vaccine used, with post-booster seroprotection rates comparable between the two primary vaccine groups (ranging from 98.1 to 100%). The incidence of clinically relevant solicited symptoms did not differ significantly between primary vaccine groups, even if the incidence of local symptoms appeared to be more frequent in subjects primed with Infanrix hexa™ than in those primed with Hexavac™. In summary, booster vaccination with Infanrix hexa™ during the second year of life is immunogenic and well tolerated, offering protection irrespective of the primary combination vaccine used.

Open Access Article

rDEN2/4Δ30(ME), a Live Attenuated Chimeric Dengue Serotype 2 Vaccine, is Safe and Highly Immunogenic in Healthy Dengue-Naïve Adults

Anna P. Durbin, Julie H. McArthur, Jennifer A. Marron, Joseph E. Blaney, Bhavin Thumar, Kimberli Wanionek and Brian R. Murphy
Pages 255 - 260
http://dx.doi.org/10.4161/hv.2.6.3494
Abstract | PDF

rDEN2/4Δ30(ME) is an attenuated chimeric dengue virus in which the prM and E structural proteins of the DEN4 candidate vaccine rDEN4∆30 have been replaced by those of the prototypic DEN2 NGC virus. rDEN2/4Δ30(ME) was evaluated at a dose of 1,000 PFU in 20 healthy dengue-naïve adult volunteers. Eight volunteers received placebo. Volunteers were monitored closely for adverse events and serum was collected for determination of the level and duration of viremia and neutralizing antibody response. The vaccine was well tolerated by all volunteers. The most common adverse events observed were a transient asymptomatic rash and mild neutropenia. All vaccinees seroconverted to DEN2 and maintained significant antibody titers throughout the six-month trial duration. Eleven vaccinees had vaccine virus recovered from the blood during the study. RNA derived from virus isolates obtained from viremic volunteers was sequenced for confirmation of retention of the ∆30 mutation in the 3´ UTR. The Δ30 mutation remained unchanged in each isolate, confirming the stability of the Δ30 mutation. Further evaluation of this vaccine in a tetravalent formulation is warranted.




COMMENTARY

Open Access Article

Advances in Vaccines, Therapeutics and Diagnostics Stability Monitoring Technology

Subhash Arya and Nirmala Agarawal
Page 261
http://dx.doi.org/10.4161/hv.2.6.3433
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