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P M Grosheide

Publications and source records attributed to P M Grosheide.

At least 19 recordsLinked to original sources
PubMed1997

Ten-year neonatal hepatitis B vaccination program, The Netherlands, 1982-1992: protective efficacy and long-term immunogenicity.

From 1982 to 1989, 705 infants born to HBsAg-positive mothers entered the Dutch neonatal hepatitis B vaccination program and received passive-active hepatitis B immunization in three randomized controlled trials testing variations in time of starting active vaccination, dose and type of vaccine, and number of hepatitis B immunoglobulin (HBIg) injections. A meta-analysis of individual patient data of the three randomized trials was performed to determine which independent host and vaccination related factors influence protective efficacy and long-term immunogenicity, and to assess whether hepatitis B vaccination concomitant with standard DKTP vaccination provides optimal protection. Statistical methodology included multivariate logistic regression analysis. Eight infants (1.1%), all born to HBeAg-positive mothers, became HBsAg carriers within the first year of life. The protective efficacy rate (PER) of passive-active immunization at 12 months follow-up was 92% for the total group of children from 114 HBeAg-positive mothers with no significant differences between children starting active immunization at birth or at 3 months of age, between infants starting at 3 months of age receiving one or two doses of HBIg or between those receiving plasma derived or recombinant vaccine. The only factor that affected the PER significantly was the level of maternal HBV DNA; PER was 100% if maternal HBV DNA was < 150 pg ml-1 and 68% for HBV DNA levels > 150 pg ml-1. After 5 years of follow-up, the group that started active immunization at birth had significantly more infants with loss of seroprotection (anti-HBs levels < 10 IU l-1, 15%) than the corresponding group starting at 3 months of age (anti-HBs < 10 IU l-2, 2%). One of 35 children with loss of seroprotection at 2 years became a HBsAg carrier in the fifth year of follow-up. This meta-analysis shows that the protective efficacy of passive-active hepatitis B vaccination is mainly influenced by material HBV DNA levels, and independent of the time of starting active vaccination at birth or at 3 months of age; long-term immunity was enhanced by starting active vaccination concomitant with DKTP vaccination. These findings allow incorporation of hepatitis B vaccine into the standard infant immunization programs for countries with a passive-active immunization strategy for the control of hepatitis B. Additional measures are needed to protect neonates of highly viremic women.

DNA, Viral↗
PubMed1995

Proposal for routine antenatal screening at 14 weeks for hepatitis B surface antigen. Dutch Study Group on Prevention of Neonatal Hepatitis.

OBJECTIVE: To develop a low cost, high compliance screening programme for identification of carriers of hepatitis B surface antigen in the obstetric population of the Netherlands. DESIGN: A seven year open, descriptive study of screening for hepatitis B surface antigen as part of routine prenatal laboratory testing at 14 weeks of gestation. Compliance with programme evaluated by checking delivery records (hospitals) or registration of births in the 30 participating municipalities (rural area). SETTING: Three large city hospitals (two tertiary referral centres) and one rural area with a large number of home deliveries. SUBJECTS: 99,706 pregnant women applying for prenatal care for the first time. MAIN OUTCOME MEASURES: Proportion of pregnant women routinely screened; prevalence of hepatitis B surface antigen in large cities and rural area. RESULTS: Uptake of screening reached 97% in the hospitals after inclusion of 10% screened at delivery; the estimated uptake in the rural area was > 95%. Prevalence of hepatitis B surface antigen was 1.6% in the large cities and 0.3% in the rural area. For screening at delivery the prevalence was 2.5 times higher (4%, P < 0.01) than for screening at week 14 of gestation. CONCLUSION: Incorporation of universal testing for hepatitis B surface antigen into routine prenatal laboratory testing is practical; high compliance is achieved when screening is supplemented with rapid screening at delivery for those who escaped routine prenatal care.

Adolescent↗
PubMed1995

Programme for preventing perinatal hepatitis B infection through screening of pregnant women and immunisation of infants of infected mothers in The Netherlands, 1989-92. National Hepatitis B Steering Committee.

OBJECTIVES: To launch a programme for the prevention of perinatal infection with hepatitis B in the Netherlands. DESIGN: Routine antenatal screening and intervention programme. SETTING: Community antenatal programme, the Netherlands. SUBJECTS: Infants of mothers who were carriers of hepatitis B detected by routine screening. INTERVENTIONS: Infants of infected mothers received hepatitis B immunoglobulin at birth and four doses of hepatitis B vaccine in conjunction with routine immunisation at 3, 4, 5, and 11 months of age. MAIN OUTCOME MEASURES: Results of screening and immunisation from 1989-92. RESULTS: The coverage of screening increased from 46% in 1989 to 84% in 1992. Hepatitis B surface antigen was detected in 2145 women (0.44%). The coverage of postnatal immunoprophylaxis in 1645 neonates born to mothers who were carriers of hepatitis B was 85% (1391); in 3% (42) there was a delay in administration of immunoglobulin of over 24 hours. In 1991, 96% (537), 95% (532), 94% (525), and 87% (489) of the infants received the first, second, third, and fourth dose of vaccine, respectively. There was considerable variation in the timing of vaccination; 17% (258) of the infants received their first dose more than two weeks late. Of the 59% (583) of infants who received the fourth dose more than two weeks beyond target age, 14% (141) also received their first dose too late. CONCLUSIONS: A prevention programme for perinatal hepatitis B in an area of low prevalence, when incorporated into existing health care, is feasible and achieves satisfactory coverage rates. Intensive follow up is needed to improve adherence to the immunisation schedule.

Age Factors↗
PubMed1994

Early invasive prenatal diagnosis in HBsAg-positive women.

From 1982 to 1989, pregnant women in two large city hospitals in The Netherlands had serum samples screened for hepatitis B surface antigen (HBsAg). Infants of mothers found to be HBsAg-positive received hepatitis B immune globulin immediately after birth and hepatitis B vaccine in the first year of life. Blood samples of infants were regularly tested for HBsAg and antibodies directed against HBsAg. A retrospective analysis of the pregnancy outcome in HBsAg-positive women who had invasive tests for prenatal diagnosis was carried out to determine whether amniocentesis and chorionic villus sampling (CVS) are risk factors for the intrauterine transmission of the hepatitis B virus. Amniocentesis was carried out in 17 HBsAg-positive women and CVS in one case. Only two women were HBsAg- and HBeAg-positive. Prenatal diagnosis led to the termination of pregnancy for fetal chromosome abnormality in three cases. The remaining 15 pregnancies were uneventful; all infants were negative for HBsAg and developed an active immune response to the vaccine. These data suggest that amniocentesis in HBsAg-positive women constitutes a low risk for the intrauterine transmission of the hepatitis B virus, but definite conclusions in HBeAg-positive women cannot be drawn.

Adult↗
PubMed1994

Anti-HBs levels in infants of hepatitis B carrier mothers after delayed active immunization with recombinant vaccine concomitant with DTP-polio vaccine: is there need for a second dose of HBIg? Dutch Study Group on Prevention of Neonatal Hepatitis B.

The need for an additional dose of hepatitis B immune globulin (HBIg) was studied by comparing infants receiving 1 ml HBIg at birth followed by hepatitis B immunization, concomitant with DTP-polio vaccine, at 3, 4, 5 and 11 months (schedule E), with infants receiving the same schedule with additional HBIg at 3 months (schedule F). The immune response to recombinant hepatitis B vaccine (20 micrograms) was evaluated in 195 infants born to HBsAg-positive mothers allocated to groups E and F and compared with historic controls who received plasma vaccine (10 micrograms) according to schedule F. Blood samples were drawn at 0, 3, 4, 6, 11, 12 and 24 months of age. No difference in efficacy between the two schedules was observed; 8 and 6% of infants born to HBeAg-positive HBsAg carrier mothers in groups E and F, respectively, became HBsAg carriers. Passively acquired antibodies at birth remained present for about 5 months in most infants. The seroprotection rates (anti-HBs > or = 10 IU l-1) were over 90% at all time points and similar for groups E and F. The titres of anti-HBs attained during the first 6 months were statistically lower (p < or = 0.02) for group E than for group F but similar thereafter. Anti-HBs titres in infants receiving the recombinant vaccine were significantly lower than in infants receiving the plasma vaccine (p << 0.001). Supplemental doses of HBIg in infants receiving a high dose of HBIg ( > 200 IU) at birth and the first dose of vaccine at the age of 3 months are not advised.

Adult↗
PubMed1994

Failure of neonatal hepatitis B vaccination: the role of HBV-DNA levels in hepatitis B carrier mothers and HLA antigens in neonates.

In a hepatitis B vaccination program (1982-1992), 705 infants born to HBsAg-positive mothers received HBIg within 2 h of birth and were vaccinated according to a three- or four-dose vaccination schedule, starting either at 3 months or directly after birth. Eight children HBsAg-positive during the first year of life (group 1: infected nonresponders). To determine whether failure of the hepatitis B vaccination was due to perinatal high-level maternal viraemia or genetically determined infant nonresponsiveness to the vaccine, we measured HBsAg and anti-HBs levels in infants and HBeAg and hepatitis B virus-DNA levels in maternal serum, and determined the HLA type of the infants. Controls included 14 infants with a normal anti-HBs response 1 year after vaccination (group 2: noninfected responders) and all eight infants without HBsAg and anti-HBs 1 year after vaccination (group 3: noninfected low responders). HBsAg, HBeAg and anti-HBs were measured by radioimmunoassay (Abbott Laboratories), hepatitis B virus-DNA was measured quantitatively by solution hybridization for groups 1, 2, and 3 (Abbott hepatitis B virus-DNA assay, Abbott Laboratories), and HLA was characterized by microcytotoxicity test for groups 1 and 3. All infants in groups 1 and 2 were born to HBeAg carrier mothers, and those in group 3 to HBeAg-negative mothers. Hepatitis B virus-DNA levels in maternal serum in group 1 were significantly higher than in group 2 (Wilcoxon rank-sum test: p < 0.01). Hepatitis B virus-DNA was not observed in group 3 maternal serum samples.(ABSTRACT TRUNCATED AT 250 WORDS)

Carrier State↗
PubMed1994

Immunogenicity of two different dosages (10 and 5 micrograms) of recombinant DNA hepatitis B vaccine in healthy neonates.

The immunogenicity of a half (5 micrograms) and a full (10 micrograms) dosage of recombinant DNA yeast-derived hepatitis B vaccine (HB-Vax-DNA) in healthy neonates was assessed in order to compare two candidate dosages of vaccine. After randomization 174 newborns of HBsAg-negative mothers entered the study. Neonates received four doses of either 10 or 5 micrograms hepatitis B vaccine, according to the DTP-polio immunization schedule at months 3, 4, 5 and 11. No serious adverse reactions were observed; 15.5% of vaccinated newborns suffered mild transient local symptoms. The vaccine was highly immunogenic irrespective of dosage of vaccine; all infants developed anti-HBs levels > or = 10 IU l-1, 99% > or = 100 IU l-1. A dosage of 10 micrograms hepatitis B vaccine produced higher antibody levels than 5 micrograms hepatitis B vaccine after primary vaccination (first three doses) but not after booster vaccination (fourth dose) (p = 0.06 and 0.75, respectively). Either vaccine dosage can be recommended for incorporation in the Expanded Programme on Immunization in the Netherlands.

Antibodies, Viral↗
PubMed1993

[Evaluation of the hepatitis B prevention program in newborn infants. I. National data, 1990].

OBJECTIVE: To evaluate the effectiveness of the national programme for prevention of perinatal hepatitis B infections. SETTING: The regional public health laboratories and provincial immunization administrations in the Netherlands. DESIGN: Retrospective evaluation. METHODS: Starting October 1989 routine screening of pregnant women for HBsAg was performed and passive-active immunisation of infants of HBsAg-positive mothers was added to the national immunisation programme. Infants receive hepatitis B immunoglobulin at birth and hepatitis B vaccine at 3,4,5, and 11 months of age, concomitant with the DTP-polio vaccine. The effectiveness of screening and intervention in 1990 was evaluated. RESULTS: Screening covered about 85% of the pregnant population and the prevalence (0.44%) was less than expected. About 60% of the infants born to HBsAg-positive mothers were registered for vaccination. Of these infants the average coverage was 83% for immunoglobulin, and 90%, 86%, 80% and 55% for the four successive hepatitis B vaccinations. There was considerable delay in vaccine administration; frequently doses were administered later than recommended. CONCLUSION: Compliance with screening and vaccination appeared incomplete. Recommendations for the simplification of the current programme are made.

Adult↗
PubMed1993

[The course of hepatitis B in 9 children who became positive for viral surface antigen HBsAg in spite of vaccination].

OBJECTIVE: To describe the viral, clinical and biochemical course of infants, who, in spite of passive-active hepatitis B immunisation, became infected with hepatitis B. DESIGN: Prospective cohort study. SETTING: The Netherlands. MATERIAL AND METHOD: As part of the research programme of the Dutch study group 'Prevention neonatal hepatitis B', 705 newborns of HBsAg-positive mothers received passive and active immunisation. Despite passive-active immunisation, 9 children became positive for HBsAg. These children were analysed clinically and their HBsAg, anti-HBs, HBeAg, anti-HBc and anti HD were measured. RESULTS: Median follow up was 5 years (range 3-8 years). Of the 9 HBsAg-positive infants 8 also tested positive for HBeAg. At the end of the follow-up 1 child had lost HBsAg and 2 children had lost HBeAg. Only 1 child experienced a symptomatic hepatitis B infection with raised aminotransferase levels. The other 8 infants with chronic hepatitis B had no clinical symptoms. Aminotransferase levels were normal throughout in 7 infants. CONCLUSION: Most of the infants who, in spite of passive-active hepatitis B immunisation, became HBsAg positive developed a chronic hepatitis B infection without clinical or biochemical dysfunctions. On the basis of these findings and considering possible therapy, guidelines are given for the follow up of children with chronic hepatitis B.

Child, Preschool↗
PubMed1993

Passive-active immunization in infants of hepatitis Be antigen-positive mothers. Comparison of the efficacy of early and delayed active immunization.

OBJECTIVE: To assess the efficacy of late active immunization against hepatitis B concomitant with diphtheria, pertussis, tetanus, and polio vaccine in high-risk infants receiving hepatitis B immune globulin at birth. DESIGN: Randomized study of infants born to mothers positive for hepatitis B surface antigen (HBsAg) and hepatitis Be antigen (HBeAg). SETTING: Three large city hospitals and one rural area providing prenatal care and obstetric services. SUBJECTS: Eighty neonates of HBsAg- and HBeAg-positive carrier mothers received 0.5 mL/kg of body weight hepatitis B immune globulin within 2 hours of birth and hepatitis B vaccine (10 micrograms) at 0, 1, 2, and 11 months of age (group A) or at 3, 4, 5, and 11 months of age concomitant with diphtheria, pertussis, tetanus, and polio immunization (group B). A second dose of hepatitis B immune globulin was given to infants on schedule B at 3 months. MAIN OUTCOME MEASURES: Blood samples were collected at 0, 3, 6, 11, and 12 months of age and tested for antibodies against hepatitis B core antigen and HBsAg. Follow-up visits were scheduled annually up to 5 years of age. RESULTS: Eight infants were excluded from analysis. During the study period, six children became HBsAg carriers, three in each group, which corresponds to a 5-year incidence of infection of 9% and 8% for groups A (three of 35) and B (three of 37), respectively. Subclinical infections (persistent anti-HBc positivity beyond month 12 or appearance of anti-HBc) were encountered in another eight infants (four in each group). CONCLUSION: Late active immunization starting at 3 months of age appears to provide similar protective efficacy as active immunization starting at birth when combined with hepatitis B immune globulin at 0 and 3 months of age.

Adult↗
PubMed1993

Immunogenicity of 20 micrograms of recombinant DNA hepatitis B vaccine in healthy neonates: a comparison of three different vaccination schemes.

The immunogenicity of a full dose (20 micrograms) of recombinant DNA yeast-derived hepatitis B vaccine (Engerix-B) was assessed in healthy neonates in order to compare three candidate vaccination schemes. After randomization 162 newborns of hepatitis B surface antigen (HBsAg) negative mothers entered the study. Neonates received hepatitis B vaccine according to a four-dose vaccination scheme starting either at month 3 (scheme I: months 3, 4, 5, and 11) or at birth (scheme III: months 0, 1, 2, and 11). Another group of neonates received hepatitis B vaccine according to a three-dose scheme starting at birth (scheme II: months 0, 1, and 6). Serious adverse reactions were not observed; 2.5% of the vaccinated newborns suffered mild transient local symptoms. The vaccine was highly immunogenic irrespective of vaccination scheme; all infants developed anti-HBs levels > or = 10 IU/L, 97% > or = 100 IU/L. The immunogenicity of hepatitis B vaccine after primary and booster vaccinations, administered in the four-dose scheme started at birth, was significantly higher (P < 0.05) than in the three-dose scheme started at birth. Hepatitis B vaccination according to the four-dose scheme started at month 3 produced significantly higher (P < 0.05) antibody levels in comparison to the four-dose scheme started directly after birth. This study showed that a four-dose hepatitis B vaccination scheme starting at month 3 resulted in the highest antibody levels of the three schemes investigated and can be recommended for incorporation in the Expanded Programme on Immunization in The Netherlands.

Female↗
PubMed1993

Influence of perceived psychological stress and distress on antibody response to low dose rDNA hepatitis B vaccine.

The present study focused on the relationship between psychological stress and immune reaction to a novel antigen. Participants completed questionnaires on daily hassles, psychoneurotic complaints, coping style, and loneliness, 2 and 6 months after the first of a series injections with a low dose recombinant DNA hepatitis B vaccine. Antibody response was determined 7 months after the first vaccination. Based on the psychological questionnaires two different stress measures were calculated: a Stress Index score-month-2 and a Stress Index score-month-6 indicating stress levels experienced at the beginning and at the end of the study respectively. Antibody levels were found to be negatively related with the Stress Index score-month-2. Although the influence of psychological stress reported on month 6 tended to be in the same direction, this effect was not significant. Coping styles and loneliness were not associated with antibody formation. These results suggest that antibody formation to rDNA hepatitis B vaccine is negatively influenced by psychological stress.

Adult↗
PubMed1993

Immune response to hepatitis B vaccine in pregnant women receiving post-exposure prophylaxis.

Hepatitis B immunoglobulin and vaccine were given as post-exposure prophylaxis to 73 women after an outbreak of hepatitis B due to in vitro fertilization treatment. The immunization schedule consisted of 5 ml of hepatitis B immunoglobulin (125 IU/ml) at months 0 and 1 and recombinant hepatitis B vaccine (10 micrograms of HBvaxDNA) at months 0, 1, 2 and 6. The safety and immunogenicity of hepatitis B vaccine were studied in 16 women who became pregnant after in vitro fertilization; 57 non-pregnant women receiving the same treatment served as controls. Blood samples were drawn at 0, 1, 2, 6 and 7 months. One patient had a clinical abortion 2 days after initial immunization; other side effects of vaccination were not found in vaccinees or in their offspring. All vaccinees exhibited antibodies against hepatitis B surface antigen after vaccination but relatively low peak geometric mean titers of 258 IU/l and 684 IU/l were attained in pregnant and non-pregnant women, respectively. There were no significant differences in seroconversion rates and geometric mean titers between the two groups although the immune response to hepatitis B vaccine was slower and lower in pregnant women at all times. Our results suggest that when post-exposure prophylaxis for hepatitis B infection is indicated, passive active immunization can be started safely during pregnancy. The relative weak response to the vaccine calls for monitoring of the anti-HBs 1 month after the initial series of vaccinations.

Abortion, Spontaneous↗
PubMed1992

[Premature infants and hepatitis B vaccination. Study Group Prevention Neonatal Hepatitis B].

Since 1986 health authorities in the Netherlands advise to vaccinate preterm infants at similar age as term infants, without correction for their shortened gestational age. This advice was based on a study, which showed comparable immune responses after DTP vaccination in preterm and term infants. To assess the immunogenicity of hepatitis B vaccination not corrected for gestational age in preterm infants, we compared the antiHBs titer after hepatitis B vaccination in 44 preterm infants with the antiHBs titer in 829 term infants. More than 95% of the preterm infants developed an adequate immune response (> 10 IU/l antiHBs), irrespective the vaccination scheme which varied in vaccine dose, the number of vaccinations and the onset of the first vaccination. The percentage preterm infants with an antiHBs titer > 10 IU/l (98%) was not different of the corresponding percentage of term infants (98%). Similarly, no difference between preterm and term infants was observed when an antiHBs value of 100 IU/l was considered a positive response, neither when active immunisation started at month 0 or month 3. The geometric mean titre at 12 months of age was considered.

Gestational Age↗
PubMed1991

Immunoprophylaxis to limit a hepatitis B epidemic among women undergoing in vitro fertilization.

Women (175) who participated in an in vitro fertilization (IVF) programme were possibly exposed to hepatitis B virus. Later it became evident that 79 women had a hepatitis B infection, 49 were exposed but not infected and 47 were not exposed. Hepatitis B immunoglobulin (HBIg) and recombinant hepatitis B vaccine (HBvaxDNA) were offered to all women and partners except for those with established hepatitis B. Women were given an 'intensive' schedule of HBIg (0, 1 months) and vaccine (0, 1, 2, 6 months). Spouses received HBIg (0, 1 months) and vaccine (0, 1, 6 months). Blood samples were taken at the time of diagnosis of the HBV epidemic and at regular intervals. Hospital personnel immunized according to the regular schedule (0, 1 and 6 months) with HBvaxDNA but without HBIg served as controls. During the observation period of 7 months anti-HBc seroconversion was not observed. At month 7 the seroconversion rate for males was 89%, significantly lower than that for females (100%). Intermediate rates were found for the control groups (94%). Significant differences in geometric mean titre between IVF-treated patients and controls were, however, observed at month 7 (551 mIU ml-1 for female patients versus 1582 mIU ml-1 for their controls and 171 mIU ml-1 for males versus 899 mIU ml-1 for their controls). Possible explanations for the low reactivity to HBsAg vaccine are discussed.

Antibodies, Viral↗