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At least 19 recordsLinked to original sources
PubMed1996

Use of a reformulated Oka strain varicella vaccine (SmithKline Beecham Biologicals/Oka) in healthy children.

UNLABELLED: The first live-attenuated Oka strain varicella vaccines needed to be stored at -20 degrees C. Reformulation of this vaccine by SmithKline Beecham Biologicals has provided a vaccine shelf life of up to 2 years when stored at +4 degrees C to +8 degrees C. In this study the immunogenicity and reactogenicity of two different production lots of this reformulated vaccine at two different titres each, which corresponded to the release and expected expiry titres, were evaluated. A double-blind randomised clinical trial was conducted in healthy children aged from 9 to 24 months. Immunogenicity was assessed by the measurement of varicella specific antibodies in paired serum samples taken before and from 35 to 63 days post vaccination. Reactogenicity was assessed by the evaluation of any untoward reactions occurring up to 42 days post vaccination. In order to assess protective efficacy, parents of these subjects were contacted approximately 6 months after completion of the trial. One hundred and ninety-one subjects were recruited into the study. Of the 181 initially seronegative subjects who completed the trial according to the protocol, 179 showed seroconversion (98.9%). Reactions to the vaccine were minor and observed in 46/191 (24%) of subjects. Rashes were present in 19, fever in 22, and both fever and rash in 5. Rashes were mainly maculo-papular in nature but were vesicular in 6. Febrile reactions were shortlived. After a 6-month follow up period, attenuated varicella with minor clinical symptoms was diagnosed in 6/52 vaccinees who had close contact with natural varicella (attack rate = 11.5%). CONCLUSION: This reformulated vaccine was well tolerated, highly immunogenic and provided protection against varicella. In increased stability allowing refrigerator storage makes it a good candidate for mass vaccination programmes.

Antibodies, Viral↗
PubMed1992

The SmithKline Beecham 'quality of life' scale: a validation and reliability study in patients with affective disorder.

The rationale for the development of Repertory-Grid based quality of life assessment (QOL) is described. The emergent scale, the SmithKline Beecham Quality of Life Scale (SBQOL) utilizes 23 predetermined constructs and three fixed elements: self now, ideal self and sick self. Inclusion of the latter two elements provides a personal frame of reference for the individual and recognizes the highly idiosyncratic and subjective nature of the experience which constitutes quality of life. A study of the validity and reliability of the SBQOL was conducted in 129 patients presenting to their GP with either major depression or generalized anxiety disorder, as defined by DSM III R. Patients were treated at the discretion of their GP and followed over a period of 12 weeks with assessments of treatment efficacy being performed at 6 weeks and 12 weeks in parallel with administration of the SBQOL. The results from co-administration of standard efficacy measures such as the Hamilton Depression Rating Scale (HAMD) and Hamilton Anxiety Scale (HAMA) with the SBQOL, provided good evidence of construct validity. Evidence in support of the concurrent validity of the SBQOL was provided by co-administration of the Sickness Impact Profile and General Health Questionnaire (external criteria) with the SBQOL scale. Test-retest reliability and internal consistency were high. No obvious advantage was conferred by the use of principal components analysis from the Flexigrid software package in contrast to a simple arithmetical procedure for computing interelement distances. It is concluded that the SBQOL provides a valid, reliable and practicable approach to the assessment of quality of life in patients with affective disorder.

Adolescent↗
PubMed1996

Comparative safety and immunogenicity of two recombinant hepatitis B vaccines given to infants at two, four and six months of age.

OBJECTIVES: To evaluate the relative safety and immunogenicity of the two recombinant hepatitis B vaccines licensed in the United States with doses recommended for routine immunization of low risk infants and a schedule that corresponds with routine pediatric visits. METHODS: Healthy infants were immunized at 2, 4 and 6 months of age with hepatitis B vaccine manufactured by either SmithKline Beecham (Engerix-B, 10 micrograms/dose, n = 228) or Merck and Co. (Recombivax HB, 2.5 micrograms/dose, n = 200). Adverse reactions were ascertained by parental reports and interviews and by review of medical records. Antibody concentrations to hepatitis B surface antigen (anti-HBs) were measured in sequential serum specimens by enzyme immunoassay. RESULTS: Adverse reactions were mild and the rates were not significantly different between the two groups. After the first and second doses the rates of seropositivity (> or = 10 mIU/ml) and seroprotection (> or = 10 mIU/ml) were significantly higher in infants given SmithKline Beecham vaccine (P < 0.01). After the second and third doses infants given SmithKline Beecham vaccine also had significantly higher geometric mean anti-HBs concentrations compared with those given Merck vaccine (348.0 mIU/ml vs. 66.9 and 1914.8 mIU/ml vs. 514.8 mIU/ml, respectively, P < 0.001). Nevertheless after the third dose 99% of infants in both vaccine groups achieved seroprotective antibody concentrations. CONCLUSIONS: Both recombinant hepatitis B vaccines were safe and immunogenic when administered concurrently with other pediatric vaccines at 2, 4 and 6 months of age, but earlier protective responses were observed with the SmithKline Beecham vaccine than with the Merck vaccine.

Consumer Product Safety↗
PubMed1996

Preventing endoscopic retrograde cholangiopancreatography related sepsis: a randomized controlled trial comparing two antibiotic regimes.

Current antibiotic prophylaxis for endoscopic retrograde cholangiopancreatography (ERCP) is not standardized and may be inadequate. We aimed to evaluate the efficacy of 3 days of additional oral antibiotics in the prevention of ERCP-related sepsis. One hundred and fifty-six patients were randomized prospectively to receive either intravenous ticarcillin and clavulinic acid (Timentin; SmithKline Beecham, Dandenong, Victoria, Australia), pre-ERCP (group I) or Timentin and 3 days of oral amoxycillin and clavulinic acid (Augmentin; SmithKline Beecham, Dandenong, Victoria, Australia), group II). Blood cultures were taken 30 min after the procedure. The occurrence of sepsis, defined as a temperature over 38 degrees C, occurring in the first 7 days was recorded and the risk factors for the development of sepsis were evaluated. Four patients had significant positive blood cultures despite the prior administration of Timentin. Sepsis occurred in 10% of group I patients, but only 3% of group II patients (relative risk 3.30; 95% confidence intervals 0.74-14.8). The performance of sphincterotomy and the presence of common bile duct stones were significant risk factors for the development of sepsis. We would recommend 3 days of additional oral Augmentin after a single dose of intravenous antibiotics in patients at increased risk of sepsis, which would include those with bile duct stones and/or those undergoing a therapeutic procedure.

Amoxicillin↗
PubMed1996

Clinical experience of a tricomponent acellular pertussis vaccine combined with diphtheria and tetanus toxoids for primary vaccination in 22,505 infants.

OBJECTIVES: To assess the safety and tolerability of 12 lots of SmithKline Beecham Biologicals' diphtheria-tetanus-tricomponent acellular pertussis vaccine (DTaP) in a large cohort of 22,000 vaccinees, with detailed analyses of reactivity, immunogenicity, and immune response to pertussis toxin in subsets. METHODS: In a prospective, double-blind, multicenter trial in Germany, 22,505 healthy infants received three vaccinations of DTaP at age 3, 4, and 5 months. Serious adverse events were followed for 1 month after each vaccination, and neurologic events for 1 year or longer. Serum IgG antibodies were assayed before vaccination and 1 month after vaccination. RESULTS: After 67,000 doses, 153 serious adverse events (0.23%) were reported, 8 considered possibly related, and 5 related to vaccination, including 1 hypotonic-hyporesponsive episode. Incidence rates of sudden infant death syndrome (7; 0.01%) or acute neurologic events (20; 0.030%) were no higher than expected and not considered to be related to vaccination. Redness and swelling of 20 mm or greater occurred after 44 (0.6%) and 40 (0.6%) of the 7270 doses, respectively, and high fever (> 39.5 degrees C) in 6 (0.08%) subjects within 48 hours of vaccination. In the immunogenicity analysis of 580 infants, 98% responded to pertussis toxin, 96% to filamentous hemagglutinin, and 98% to pertactin. In an additional 5712 infants, the response rate to pertussis toxin was 99%. CONCLUSIONS: In a large cohort of 22,505 infants vaccinated, SmithKline Beecham Biologicals' tricomponent DTaP vaccine was shown to be safe, well-tolerated, and immunogenic for all component antigens.

Diphtheria-Tetanus-Pertussis Vaccine↗
PubMed1996

A controlled trial of two acellular vaccines and one whole-cell vaccine against pertussis. Progetto Pertosse Working Group.

BACKGROUND: Concern about both safety and efficacy has made the use of whole-cell pertussis vaccines controversial. In some European countries, including Italy, the rate of vaccination against pertussis is low. METHODS: We conducted a double-blind trial in Italy in which infants were randomly assigned to vaccination at two, four, and six months of age with an acellular pertussis vaccine together with diphtheria and tetanus toxoids (DTP); a DTP vaccine containing whole-cell pertussis (manufactured by Connaught Laboratories); or diphtheria and tetanus toxoids without pertussis (DT). The acellular DTP vaccine was either one containing filamentous hemagglutinin, pertactin, and pertussis toxin inactivated with formalin and glutaraldehyde (SmithKline Beecham) or one with filamentous hemagglutinin, pertactin, and genetically detoxified pertussis toxin (Chiron Biocine). Pertussis was defined as 21 days or more of paroxysmal cough, with infection confirmed by culture or serologic testing. RESULTS: The efficacy of each vaccine, given in three doses, against pertussis was determined for 14,751 children over an average of 17 months, with cases included in the analysis if cough began 30 days or more after the completion of immunization. For both of the acellular DTP vaccines, the efficacy was 84 percent (95 percent confidence intervals, 76 to 89 percent for Biocine DTP and 76 to 90 percent for SmithKline DTP), whereas the efficacy of the whole-cell DTP vaccine was only 36 percent (95 percent confidence interval, 14 to 52 percent). The antibody responses were greater to the acellular vaccines than to the whole-cell vaccine. Local and systemic adverse events were significantly more frequent after the administration of the whole-cell vaccine. For the acellular vaccines, the frequency of adverse events was similar to that in the control (DT) group. CONCLUSIONS: The two acellular DTP vaccines we studied were safe, immunogenic, and efficacious against pertussis, whereas the efficacy of the whole-cell DTP vaccine was unexpectedly low.

Antibodies, Bacterial↗
PubMed1997

Cell-mediated and antibody responses to Bordetella pertussis antigens in children vaccinated with acellular or whole-cell pertussis vaccines. The Progetto Pertosse-CMI Working Group.

OBJECTIVE: To examine induction and persistence of cell-mediated immunity (CMI) and antibody responses to Bordetella pertussis antigens in infants receiving antipertussis vaccines. DESIGN AND SETTING: A randomized, blinded study of 142 children receiving acellular pertussis vaccines combined with diphtheria-tetanus toxoids (DTaP) (DTaP manufactured by SmithKline Beecham [DTaP-SB], Rixensart, Belgium, and DTaP manufactured by Chiron Biocin [DTaP-CB], Siena, Italy), or a whole-cell pertussis vaccine (DTwP) (Connaught Laboratories Inc, Swiftwater, Pa), or a diphtheria-tetanus (DT) (Chiron Biocine) only vaccine. Three doses of each vaccine were given at 2, 4, and 6 months of age, and CMI and antibody responses were evaluated before and at 1 and 14 months after vaccination. METHODS AND MAIN OUTCOME MEASURES: Cell-mediated immunity was assessed by proliferation of peripheral blood mononuclear cells stimulated in vitro by B pertussis antigens (pertussis toxin, filamentous hemagglutinin, and pertactin). Antibody titers against pertussis toxin, filamentous hemagglutinin, and pertactin were determined by a standardized enzyme-linked immunosorbent assay. RESULTS: A CMI-positive response to at least 1 B pertussis antigen at 1 or both postvaccination assays was detected in 46%, 55%, and 83% of DTwP, DTaP-SB, and DTaP-CB vaccine recipients, respectively. Frequency of CMI response to individual antigens ranged from less than 4.9% against pertussis toxin in DTwP recipients to 52% against pertactin in DTaP-CB recipients. The postvaccination responses measured at 14 months equalled, or had increased frequency or intensity, that of the 1-month postvaccination responses. Elevated antibody titers against the 3 antigens were present in all DTaP recipients 1 month after vaccination and were higher in CMI-positive children than in CMI-negative children. They fell, however, to low, if not negligible, levels 14 months after vaccination. CONCLUSIONS: Acellular pertussis vaccines were better inducers of CMI response than the whole-cell vaccine, particularly against pertussis toxin. Once acquired, CMI persisted, in contrast with the rapid antibody decline. Thus, CMI responses could be a useful adjunct to serology in the evaluation of pertussis vaccine immunogenicity and a better correlate of long-term immunity to B pertussis than antibody titers.

Bordetella pertussis↗
PubMed1994

Inactivated hepatitis A vaccine: reactogenicity, immunogenicity, and long-term antibody persistence.

This trial evaluated the reactogenicity, kinetics of antibody induction, and long-term immunogenicity of a 720 enzyme-linked immunosorbent assay units (EL.U.) antigen dose of an inactivated hepatitis A vaccine (Havrix, SmithKline Beecham Biologicals, Rixensart, Belgium). One hundred six healthy adult volunteers were enrolled to receive vaccine intramuscularly according to a 0, 1, and 6-month schedule. The vaccine was well tolerated. The most frequently reported local symptom was soreness, observed following 37.1% of all doses. Headache was the most frequently reported general symptom observed following 12.9% of documented vaccine doses. The administration of one vaccine dose induced seropositivity (anti-hepatitis A virus [HAV] > or = 20 mIU/ml) in 91% of all vaccinees 1 month later. The second vaccine dose resulted in seropositivity of the remaining vaccinees at month 2. All subjects remained seropositive for HAV antibodies at month 6, at which time the booster vaccine dose was given. At month 7, all vaccinees had anti-HAV titres > 200 mIU/ml. Serological results obtained at months 12, 18, 24, and 36 showed that antibodies against HAV induced by the vaccine booster dose persist for at least 30 months following its administration. All 49 subjects followed up until month 36 had antibody titres > or = 20 mIU/ml. The geometric mean titre (GMT) decreased by 60% from month 7 to month 12; between month 12 and 36, the GMT decreased by approximately 14% per period of 12 months. According to the vaccine-induced antibody kinetics and the magnitude of antibody level decrease over time, the predicted duration of antibody persistence is estimated to be at least 20 years.

Adolescent↗
PubMed1996

Analysis of the antibody response in humans with a new inactivated hepatitis A vaccine.

Sera from subjects vaccinated with the Pasteur Merieux (PM) inactivated hepatitis A vaccine (AVAXIM) have been analysed in order: (1) to assess comparability of the results provided by a modified radio-immunoassay (mRIA) in the different laboratories involved in testings of sera during clinical trials and by enzyme-linked immunoabsorbent assay (ELISA) used during development of other inactivated hepatitis A vaccines; (2) to describe the IgM responses elicited by this vaccine compared with one control vaccine [HAVRIX, 720 ELISA antigens units; Smithkline Beecham (SB), Rixensart, Belgium]; (3) to provide comparative data between the PM vaccine and the SB vaccine on neutralizing activities of vaccine-induced antibodies. Vaccine-induced antibody titres evaluated by a mRIA in different laboratories correlated well and validated the comparability of the results obtained in various vaccine trials conducted by PM. Geometric mean titres (GMTs) expressed as milli-international units (mlU/ml) were higher with ELISA especially after the first dose, but seroconversion rates were similar and a good correlation was found between the two assays. IgM vaccine-induced antibodies were detectable in nearly all vaccinated subjects from week 2 after vaccination, with a peak titre between weeks 2 and 4 after the first dose. Comparison of GMTs by the Student Fisher t-test was statistically significant (P < 0.05) only at week 2 with higher titres in PM vaccinees. Neutralizing antibodies were detected after vaccination with the PM inactivated hepatitis A vaccine. The titres gradually increased between the second week after the first dose and the booster dose (week 24). A strong booster effect of the second dose on neutralizing titres was observed. Seroneutralizing titres induced at week 2 in subjects vaccinated with the PM inactivated hepatitis A vaccine were statistically significantly higher (P < 0.05) from those induced by the SB vaccine.

Adolescent↗
PubMed1996

Immunogenicity and reactogenicity of a combined DTPw-hepatitis B vaccine in Lithuanian infants.

UNLABELLED: A total of 120 healthy Lithuanian infants were enrolled in a double-blind, randomized trial to receive one of two lots of SmithKline Beecham Biologicals' combined diphtheria, tetanus, whole cell Bordatella pertussis hepatitis B (DTPw-HB) candidate vaccine administered according to a 0, 1.5, 3-month, primary immunization schedule (beginning at approximately 3-4 months of age). The immunogenicity (based on the antibody responses elicited by each of the four vaccine components) and the reactogenicity (based on documented solicited and unsolicited symptoms) of this candidate vaccine were evaluated. Of the 120 subjects enrolled, 100 were included in the analysis of immunogenicity. One month after the third vaccine dose, all infants had protective levels of antibodies against HBsAg and tetanus toxoid and all, except one infant, had protective levels of antibodies against the diphtheria toxoid (98.9%). At this time all subjects had responded to the B. pertussis component with antibody titres greater than or equal to the assay cut-off. Data collected for all enrolled infants were included in the analysis of reactogenicity. Most local symptoms were mild and occurred within the first 48 h following vaccination. Redness was the most frequently reported local symptom and irritability was the most frequently reported general symptom. One vaccine-related serious adverse event was reported (fever, diarrhea, vomiting and irritability). This event resolved within 20 h without any complications. CONCLUSION: The combined DTPw-HB vaccine was safe, well-tolerated and immunogenic for all four antigens when administered to a population of healthy infants beginning at 3-4 months of age.

Antibody Formation↗
PubMed1992

Effects of an anthelmintic treatment programme on sheep productivity in the Middle Atlas, Morocco.

This study evaluated the production advantages of the strategic anthelmintic treatment of both lambs and ewes in an area endemic for gastro-intestinal nematodes, lungworms and liver flukes. The liver fluke infections were generally chronic. The lambs were treated with albendazole (SmithKline Beecham), fenbendazole (Hoechst Roussel) or a vitamin supplement and their weight gains were followed over the next 7 months. The control group, which received a vitamin supplement only, gained 6.67 kg from July to January. The group that received fenbendazole, an anthelmintic with no activity against liver flukes, gained 10.42 kg over the study period. The third group which received albendazole, an anthelmintic with efficacy against liver flukes, gained 13.07 kg over the same period. Lamb deaths apparently due to liver flukes were 12, 4, and zero for the control, fenbendazole and albendazole groups, respectively. Similar advantages were observed in the ewes. Deaths were 16, 8, and zero in the control, fenbendazole and albendazole groups, respectively. The lambing rate in the control group was significantly lower than that in either of the 2 treated groups. The number of services per conception was significantly lower in the albendazole treated group than that in either of the other groups. These studies demonstrated the advantages of anthelmintic treatment in sheep in a helminth endemic area. While removing gastro-intestinal nematodes and lungworms improved production, the additional removal of liver flukes enhanced production gains as well as reducing deaths.

Albendazole↗
PubMed1995

Plasma concentrations after high-dose (45 mg.kg-1) rectal acetaminophen in children.

Although the recommended dose of rectal acetaminophen (25-30 mg.kg-1) is twice that for oral administration (10-15 mg.kg-1), the literature justifies the use of a higher dose when acetaminophen is administered via the rectal route. We measured venous plasma acetaminophen concentrations resulting from 45 mg.kg-1 of rectal acetaminophen in ten ASA 1, 15 kg paediatric patients undergoing minor surgery with a standardized anaesthetic. After induction of anaesthesia, a single 650 mg suppository (Abenol, SmithKline Beecham Pharma Inc.) was administered rectally. Plasma was sampled at t = 0, 15, 30, 45, 60, 90, 120, 180, 240 min in the first five patients and at t = 0, 30, 60, 90, 120, 180, 240, 300, 420 min in the subsequent five. Acetaminophen plasma concentrations were determined using a TDxFLx fluorescence polarization immunoassay (Abbott Laboratories, Toronto, Ontario). The maximum plasma concentration was 88 +/- 39 mumol.L-1 (13 +/- 6 micrograms.ml-1) and the time of peak plasma concentration was 198 +/- 70 min (mean +/- SD). At 420 min, the mean plasma concentration was 46 +/- 18 mumol.L-1 (7.0 +/- 0.9 micrograms.ml-1). No plasma concentrations associated with toxicity (> 800 mumol.L-1) were identified. A 45 mg.kg-1 rectal dose of acetaminophen resulted in peak plasma concentrations comparable with those resulting from 10-15 mg.kg-1 of oral acetaminophen at three hours after suppository insertion. It is concluded that the delayed and erratic absorption of acetaminophen after rectal administration leads to unpredictable plasma concentrations. Rectal acetaminophen will not be consistently effective for providing rapid onset of analgesia in children.

Absorption↗
PubMedDate not supplied

A randomized controlled trial comparing mebendazole and albendazole against Ascaris, Trichuris and hookworm infections.

The efficacies and side effects of single dose treatments with 500 mg mebendazole (Janssen Pharmaceutica) and 400 mg albendazole (SmithKline Beecham) against intestinal nematodes were compared in a single-blind, randomized controlled trial among 2294 children aged 6 to 12 years on Pemba Island, Zanzibar, among whom infections with Ascaris, hookworms and Trichuris were highly prevalent. Both drugs were highly effective against Ascaris, with cure rates of over 97%. The cure rates for Trichuris were low, but mebendazole was significantly better than albendazole and produced a greater reduction in the geometric mean egg count. Mebendazole was inferior to albendazole in curing hookworm infections and in reducing the geometric mean egg count. There was no difference in the frequency of side effects reported by heavily infected children treated with either drug. In a trial on 402 children, 500 mg mebendazole (Janssen) was compared with a generic version of the drug, 500 mg mebendazole (Pharmamed). No difference was apparent in the efficacies of the 2 treatments against any of the 3 parasites studied.

Albendazole↗
PubMed1994

An observer blind trial of co-amoxiclav versus cefuroxime plus metronidazole in the prevention of postoperative wound infection after general surgery.

A consecutive series of 509 patients undergoing abdominal surgery were entered into a randomized, observer and patient blind, controlled, prospective, study to evaluate the efficiency of co-amoxiclav ('Augmentin', SmithKline Beecham, UK) compared with cefuroxime ('Zinacef', Glaxo, UK) plus metronidazole (Flagyl, M&B, UK) for the prevention of postoperative wound infections. One or three doses of antibiotics were given depending on the type of surgery and operative factors. Co-amoxiclav was given to 230 patients with a total wound infection rate of 5.6% and cefuroxime plus metronidazole were given to 225 patients with a total wound infection rate of 3%. The difference between infection rates was not significant. Both groups were comparable in terms of demographic details, type and duration of surgery, risk factors associated with surgical procedures and postoperative management. Although not statistically significant, a difference in the wound infection rate for those patients undergoing colorectal surgery was seen: 8/69 for the co-amoxiclav group and 2/79 for the cefuroxime/metronidazole group. The estimated cost to our hospital (October, 1993) of one dose of co-amoxiclav was less that half the cost of cefuroxime and metronidazole. This study demonstrates that co-amoxiclav is an effective prophylactic antibiotic for abdominal surgery.

Abdomen↗
PubMed1991

Evaluation of initiating a hepatitis B vaccination schedule with one vaccine and completing it with another.

The purpose of this study was to determine if a hepatitis B vaccination schedule initiated with one recombinant DNA vaccine could be completed with another. Forty-eight adults on a hepatitis B vaccination schedule of 0, 1 and 6 months had received their first two doses with Merck Sharpe and Dohme's recombinant DNA (MSD rDNA) vaccine (Recombivax HB) at its adult dose of 10 micrograms. At month 6, the subjects were randomized to receive SmithKline Beecham's recombinant DNA (SB rDNA) vaccine (Engerix-B) at its adult dose of 20 micrograms or MSD rDNA vaccine. Just prior to the third dose of SB rDNA or MSD rDNA vaccine, the geometric mean anti-HBs titres (GMT) were 161 and 168 mIU ml-1 for the two groups, respectively. The GMT at month 7 were 4077 and 2654 mIU ml-1 for those who had received SB rDNA or MSD rDNA vaccine, respectively. This study demonstrates that a hepatitis B vaccination schedule initiated with MSD rDNA vaccine can be completed with SB rDNA vaccine.

Adult↗
PubMed1992

Placebo-controlled efficacy study of hepatitis A vaccine in Valdivia, Chile.

A placebo-controlled, double-blind study on the efficacy of a hepatitis A vaccine (SmithKline Beecham Biologicals) was started in a region of Chile in September 1990, using hepatitis B vaccine as control. A total of 260 healthy children, 6-15 years of age, negative for antibody to hepatitis A virus (anti-HAV), antibody to HAV immunoglobulin M (IgM), hepatitis B surface antigen, and antibody to hepatitis B surface and core antigens by ELISA tests within 7 days before vaccination, were randomly assigned to two study groups: 128 children received the vaccine with a yellow label (group 1), and 132 children the vaccine with an orange label (group 2) at months 0, 1 and 6. Blood for serology and transaminase determination was drawn at months 1, 2, 6, 7 and 12. Both vaccines were tolerated equally well and no serious side effects were seen. In group 1 (presumed hepatitis A vaccine group), anti-HAV was detected (20% inhibition was used as the cut-off level) in 122 of 128 children (95.5%) tested at month 1, in 126 of 127 (99.2%) at month 2, in 126 of 127 (99.2%) at month 6 and in 126 of 126 (100%) at month 7. One anti-HAV seroconversion seen at month 1 was associated with presence of anti-HAV IgM and therefore probably represents HAV infection. Geometric mean anti-HAV concentration of the other children was 128, 342, 214 and 2301 mIU/ml at months 1, 2, 6 and 7, respectively.(ABSTRACT TRUNCATED AT 250 WORDS)

Adolescent↗
PubMed1992

Field evaluation of a hepatitis A vaccine in a Norwegian contingent to the United Nations Interim Force in Lebanon.

The Norwegian population is basically seronegative regarding anti-hepatitis A antibodies. For this reason they are particularly vulnerable when exposed to hepatitis A virus when staying in highly endemic areas. Norwegian UN-personnel have so far been protected with serum immunoglobulins (Ig). Two studies are reported, one followed a vaccination schedule of 0, 1 and 2 months with a booster at month 12, while the other followed a schedule of day 0 and 14 with a booster at month 7. Both were field trials evaluating the new hepatitis A vaccine, from SmithKline Beecham Biological, in Norwegian UN soldiers serving in Lebanon. Both trials showed 100% seroconversion following the initial vaccination course, with low reactogenicity and no clinical or subclinical sign of hepatitis. The new vaccine has decisive advantages over immunoglobulins on medical, practical and economic grounds.

Adult↗