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Biomedical subjects

Pierre Van Damme

Publications and source records attributed to Pierre Van Damme.

At least 19 recordsLinked to original sources
PubMed2006

Convincing or confusing? Economic evaluations of childhood pneumococcal conjugate vaccination--a review (2002-2006).

We review 15 economic analyses of pneumococcal conjugate vaccines, published between 2002 and 2006, in terms of methodology, assumptions, results and conclusions. We found a great diversity in assumptions (eg, vaccine efficacy parameters, incidence rates for both invasive and non-invasive disease) mainly due to local variation in data and opinions. Accordingly, the results varied greatly, from total net savings to over euro 100,000 per discounted QALY gained. The cost of the vaccination program (determined by price per dose and schedule (4 or 3 doses, or fewer)), and likely herd immunity impacts are highly influential though rarely explored in these published studies. If the net long-term impact (determined by a mixture of effects related to herd immunity, serotype replacement, antibiotic resistance and cross reactivity) remains beneficial and if a 3-dose schedule confers near-equivalent protection to a 4-dose schedule, the cost-effectiveness of PCV7 vaccination programs can be viewed as attractive in developed countries.

Child, Preschool↗
PubMed2006

Chapter 14: HPV vaccine introduction in industrialized countries.

Introduction of a vaccine requires the achievement of three initial milestones. These are licensure by a national control authority that determines the vaccine is safe and effective, development of recommendations for use by expert advisory bodies on immunization, and obtaining funding for vaccination. Once these milestones have been achieved, a successful vaccination program requires that a number of interlinked programmatic components be brought together in a coordinated fashion. These include vaccine purchase and supply, vaccination service delivery, high coverage rates, surveillance of the vaccination program, immunization finance policies and practices, and political will. Human papillomavirus (HPV) vaccination provides unique challenges in all of these areas because of the many gaps in our knowledge.

Developed Countries↗
PubMed2006

Hepatitis A/B vaccination of adults over 40 years old: comparison of three vaccine regimens and effect of influencing factors.

Challenged by contrasting data on low immune responses in the elderly with a combined hepatitis A/B vaccine, a randomised, controlled study was conducted to assess the immunogenicity of three hepatitis A and B vaccination regimens (group 1: combined hepatitis A/B vaccine Twinrix [GSK]; group 2: co-administered hepatitis A vaccine, Havrix [GSK]+hepatitis B vaccine Engerix -B [GSK], group 3: co-administered hepatitis A vaccine, Vaqta [Sanofi-Pasteur MSD]+hepatitis B vaccine HB VAX PRO [Sanofi-Pasteur MSD]) and the effect of influencing factors in subjects >40 years. On completion of the full vaccination course, anti-HBs seroprotection (SP) rates were 92, 80 and 71% in groups 1, 2 and 3, respectively; anti-HAV seropositivity (S+) rates were 97, 99 and 99%, respectively. In group 1, anti-HBs SP rate was non-inferior as well as superior and anti-HAV S+ rate was non-inferior to that in groups 2 and 3. Anti-HBs response was most significantly influenced by the vaccine regimen, followed by age, gender and BMI (stepwise multiple regression analysis). BMI had the most significant influence on HAV response followed by age, gender and vaccine regimen. In conclusion, Twinrix induced superior hepatitis B SP rates and similar hepatitis A S+ rates compared to concomitant administration of monovalent vaccines in subjects aged >40 years.

Adult↗
PubMed2006

Safety and efficacy of a pentavalent human-bovine (WC3) reassortant rotavirus vaccine.

BACKGROUND: Rotavirus is a leading cause of childhood gastroenteritis and death worldwide. METHODS: We studied healthy infants approximately 6 to 12 weeks old who were randomly assigned to receive three oral doses of live pentavalent human-bovine (WC3 strain) reassortant rotavirus vaccine containing human serotypes G1, G2, G3, G4, and P[8] or placebo at 4-to-10-week intervals in a blinded fashion. Active surveillance was used to identify subjects with serious adverse and other events. RESULTS: The 34,035 infants in the vaccine group and 34,003 in the placebo group were monitored for serious adverse events. Intussusception occurred in 12 vaccine recipients and 15 placebo recipients within one year after the first dose including six vaccine recipients and five placebo recipients within 42 days after any dose (relative risk, 1.6; 95 percent confidence interval, 0.4 to 6.4). The vaccine reduced hospitalizations and emergency department visits related to G1-G4 rotavirus gastroenteritis occurring 14 or more days after the third dose by 94.5 percent (95 percent confidence interval, 91.2 to 96.6 percent). In a nested substudy, efficacy against any G1-G4 rotavirus gastroenteritis through the first full rotavirus season after vaccination was 74.0 percent (95 percent confidence interval, 66.8 to 79.9 percent); efficacy against severe gastroenteritis was 98.0 percent (95 percent confidence interval, 88.3 to 100 percent). The vaccine reduced clinic visits for G1-G4 rotavirus gastroenteritis by 86.0 percent (95 percent confidence interval, 73.9 to 92.5 percent). CONCLUSIONS: This vaccine was efficacious in preventing rotavirus gastroenteritis, decreasing severe disease and health care contacts. The risk of intussusception was similar in vaccine and placebo recipients. (ClinicalTrials.gov number, NCT00090233.)

Administration, Oral↗
PubMed2006

Rotavirus vaccines: considerations for successful implementation in Europe.

A group of European experts in infectious diseases and vaccinology has met on several occasions to assess the rationale for universal vaccination against rotavirus infection of infants in Europe. On the basis of the available data, we concluded that vaccination was the best approach to prevent severe rotavirus gastroenteritis, and that European countries should consider implementing rotavirus vaccination in their routine immunisation programmes. The main barrier to the implementation of rotavirus vaccination in Europe is a general lack of awareness of stakeholders, policymakers, health-care professionals, and parents about rotavirus disease and the advantages of vaccination. Further studies on the cost of the disease and the benefit of vaccination, together with raising awareness are necessary steps to ensure successful implementation of rotavirus vaccination in Europe.

Europe↗
PubMed2005

Comparative pre-clinical and clinical experience with oral polio vaccine produced on MRC-5 cells or on primary monkey kidney cells.

The need to avoid using primates has prompted the replacement of primary monkey kidney cells (PMKC) as a substrate for oral polio vaccine (OPV) production. Here, we report on OPV produced on MRC-5 cells using an industrial process capable of producing over 1 billion doses. All serotypes produced on MRC-5 cells proved satisfactory in the monkey and transgenic mice neurovirulence tests. All the type 3 MRC-5 lots tested by Mutant Analysis by PCR and Restriction Enzyme Cleavage (MAPREC) had a 472-C content below the acceptable limit and similar to that of PMKC derived lots. The safety/reactogenicity and immunogenicity profiles following vaccination in infants and children were similar for OPV MRC-5 and OPV PMKC vaccine lots. Excretion rates and prevalence of revertants for the three serotypes following vaccination were also similar for both vaccines. These data support the use of MRC-5 cells as an alternative to PMKC for OPV production.

Animals↗
PubMed2005

Long-term efficacy of hepatitis B vaccine, booster policy, and impact of hepatitis B virus mutants.

The long-term efficacy of hepatitis B vaccine, long-term effectiveness of hepatitis B immunisation programmes, immune memory induced by hepatitis B vaccine, current booster policies, and impact of hepatitis B virus mutants on immunisation programmes were reviewed at the Viral Hepatitis Prevention Board (VHPB) meeting in Sevilla, Spain, March 2004. The main focus was on universal vaccination programmes with data being presented from Italy, Saudi Arabia, Singapore, Spain, Taiwan, Thailand, The Gambia, and USA (Alaska).

DNA, Viral↗
PubMed2005

Oral fluid as a medium for the detection of hepatitis B surface antigen.

Currently viral antigens and antibodies are detected by traditional serological tests. However, the introduction of oral fluid as an alternative medium would allow other alternatives. The collection of oral fluid is, in comparison with venepuncture, less invasive, less painful, less expensive (i.e., no trained personal required), and safe (prevention of needle stick injuries). Also large numbers of samples can be collected easily for epidemiological purposes. Forty-three HBsAg positive and seventy-three HBsAg negative paired serum/oral fluid samples were tested. They were collected from patients attending university hospitals. The oral fluid samples were collected using the Oracol collection device and they were subjected to an IgG quantification assay to ensure their quality and quantity. The detection of HBsAg in oral fluid was carried out using a modified ETI-MAK-4 ELISA. The validation of this oral fluid test gave a sensitivity and specificity of 90.7% and 100%, respectively. The modified ETI-MAK-4 ELISA is a suitable test for oral fluid samples collected by the Oracol collection device for epidemiological purposes.

Hepatitis B↗
PubMed2005

Immunisation in the current management of cystic fibrosis patients.

Although no special recommendations exist, clearly patients with cystic fibrosis (CF) can benefit from immunisation. We reviewed the literature regarding vaccination in CF and other chronic diseases. CF subjects should follow national immunisation programmes without delay to obtain optimal vaccination coverage. Indeed they may escape normal programmes due to frequent hospital admissions and school absenteeism and may be more at risk to get "vaccine-controlled" diseases at any age. There is no uniform European immunisation schedule for basic infant and childhood vaccines or for vaccines against hepatitis A (HAV) and B (HBV), varicella (VZ) and booster vaccinations. HAV and HBV vaccination is appropriate in CF as recommended in general for patients with chronic liver disease (CLD). Varicella (VZ) vaccination is not recommended in all European countries. There are no recent data about possible worsening of pulmonary status following VZ in CF, but it is known to cause pulmonary damage in non-CF adults and to be potentially fatal post transplantation and during steroid treatment. Therefore it is recommended at least for seronegative adolescents and transplant candidates. Influenza vaccine is recommended annually for CF patients aged > or =6 months. Pneumococcal vaccine is generally indicated for CF patients. RSV infection might play a role in the initial Pseudomonas colonization and the decline in pulmonary function. However no RSV vaccine is available at present. There are no recommendations for palivizumab in CF as an alternative but expensive prophylaxis. Anti-bacterial vaccinations protecting directly against Pseudomonas aeruginosa colonisation are promising for the future, potential candidates are currently being assessed in phase III clinical trials. More studies are needed to complete recommendations especially for CF adults and transplant candidates.

Adolescent↗
PubMed2005

Vaccine safety controversies and the future of vaccination programs.

In the years following the hepatitis B vaccination/multiple sclerosis controversy, a number of new issues regarding vaccine safety have been raised, in some cases leading to more debate and confusion. Against this background, an international group of experts was convened to review the current points of view concerning the use of thimerosal as a preservative and its potential risks; the suggested link between thimerosal-containing vaccines and acute lymphoblastic leukemia; the alleged association between aluminum-containing vaccines/macrophagic myofasciitis and general systemic complaints; a possible link between vaccination and autoimmune pathology; and a hypothetical link between measles-mumps-rubella vaccination and autism. At present, there are no data to conclude that childhood vaccines, and in particular hepatitis B vaccine, pose a serious health risk or justify a change in current immunization practice. However, vaccine "scares" continue to have an international impact on immunization coverage. Creating a positive environment for immunization can be achieved by repositioning the value of vaccines and vaccination, supported by evidence-based information. The role of international organizations, the media, and the industry in the implementation of communication strategies was discussed and the impact of litigation issues on vaccination was evaluated. The Viral Hepatitis Prevention Board confirms its commitment to current recommendations for universal and risk group hepatitis B vaccination and further encourages the conduct of vaccine safety studies and the dissemination of their results.

Child↗
PubMed2005

Prevention of hepatitis A by Havrix: a review.

Hepatitis A is one of the most common vaccine-preventable infectious diseases in the world. With at least 1.5 million cases of hepatitis A worldwide each year, disease management constitutes a substantial economic burden. The first effective vaccine against hepatitis A, Havrix was introduced in 1992. This review summarizes data accumulated following more than a decade of clinical experience with this vaccine and compares clinical data with other currently available hepatitis A vaccines. Based on this data and on the current immunological knowledge, a recent consensus concluded that hepatitis A vaccines induce lifelong protection, and thus booster vaccinations against hepatitis A are unnecessary in fully immunized, healthy people. In view of this, current regulatory recommendations for the use of hepatitis A vaccines are reviewed and possible future strategies identified.

Animals↗
PubMed2004

Prevention of viral hepatitis in Italy.

The overall situation on viral hepatitis prevention and control in Italy was reviewed and evaluated at a Viral Hepatitis Prevention Board (VHPB) meeting in Catania, Sicily, on 7-8 November 2002. Several specific conclusions, drawn from the presentations and discussions, were considered to constitute an example of how to handle these issues in other European and industrialized countries.

Disease Notification↗
PubMed2004

An economic evaluation of varicella vaccination in Italian adolescents.

An economic evaluation was performed to assess five varicella vaccination scenarios targeted to 11-year-old Italian adolescents. The scenarios were: "compulsory vaccination" of all adolescents, recommended vaccination of susceptible adolescents on the basis of an "anamnestic screening", a "blood test" or a combination of both ("both tests") and vaccination of adolescents in the private sector, at the parents' charge ("private vaccination"). Probabilities and unit costs were taken from published sources and experts opinion. The accuracy of the anamnestic screening (81.6% sensitivity and 87.3% specificity) was derived from a separate descriptive study among 344 Italian adolescents. The costs and benefits of each scenario were simulated using a Markov model and cost-effectiveness, budget-impact and cost-benefit analyses were conducted. Of all considered scenarios, "both tests" and "anamnestic screening" were the most appealing options with an estimated net direct cost of 5058 and 8929 per life-year gained (compared to no vaccination) versus 14,693-42,842 for the other scenarios. These two scenarios further resulted in substantial net savings for society (over 600,000 per cohort, BCR: 2.17). The need for a serological confirmation was highly dependent on the sensitivity of the anamnestic screening, which is believed to increase once such a program is launched. For practical considerations, "anamnestic screening" seems to be the most convenient option.

Adolescent↗
PubMed2004

Immunogenicity of a combined diphtheria-tetanus-acellular pertussis vaccine in adults.

Two clinical studies were undertaken to evaluate the immunogenicity of an adult-type dTpa booster vaccine (Boostrix by GlaxoSmithKline Biologicals). Blood samples taken prior to vaccination showed that 24.4 and 13.0% of subjects were seronegative for diphtheria and tetanus antibodies, respectively. Moreover, about one-third of the vaccinees had no detectable levels of antibodies to pertussis toxoid (PT) or pertactin (PRN). One month post-vaccination, more than 93% of all individuals, regardless of age or type of vaccine received, had seroprotective antibody levels for diphtheria and tetanus (> or = 0.1IU/ml). In those individuals vaccinated with the adult-type dTpa vaccine (Boostrix), more than 98% were found to be seropositive for antibodies to all three pertussis antigens (PT, filamentous haemogluttin (FHA), and PRN). These data suggest that immunity to diphtheria, tetanus and pertussis (DTP) in adults wanes and that booster vaccination with an adult-type combined dTpa vaccine would boost the serological response to diphtheria antitoxin, tetanus antitoxin and antibodies to Bordetella pertussis PT, FHA and PRN.

Adolescent↗