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Biomedical subjects

A Safary

Publications and source records attributed to A Safary.

At least 19 recordsLinked to original sources
PubMed2004

Immunogenicity and reactogenicity of two regimens of diphtheria-tetanus-acellular pertussis-hepatitis B-inactivated polio and Haemophilus influenzae type b vaccines administered to infants primed at birth with hepatitis B vaccine.

An open, randomized study evaluated the immune response and safety of two different regimens of diphtheria-tetanus-acellular pertussis-hepatitis B-inactivated poliovirus-Haemophilus influenzae type b (DTPa-HBV-IPV-Hib) immunization in infants primed at birth with hepatitis B vaccine. One-half of the 150 healthy, full-term infants received a DTPa HBV-IPV-Hib vaccine at 1 1/2, 3 and 5 months of age; the other received a DTPa-IPV-Hib vaccine at 1 1/2, 3 and 5 months of age with separate HBV vaccine at 1 and 5 months of age. Immune response was similar following the two regimens with 100% of the vaccinees seroprotected for HBV, diphtheria, tetanus, Hib and poliovirus types 2 and 3 diseases after the full vaccination course. One vaccinee in the DTPa HBV-HPV- Hib group failed to respond to the poliovirus type 1 antigen. Response to the three pertussis antigens ranged from 92-97% in the DTPa-IPV-Hib plus separate HBV group and 100% in the DTPa HBV-IPV-Hib group. The most frequently reported post-vaccination symptoms were irritability in the DTPa-IPV-Hib plus separate HBV group (49% of vaccinees) and fever, defined as axillary temperature > or =37.5 degrees C, in the DTPa HBV- IPV-Hib group (50% of vaccinees).

Antibodies, Bacterial↗
PubMed2001

Perspectives of vaccination against hepatitis E.

Hepatitis E, an important cause of morbidity and mortality in humans, accounts for more than 50% of acute viral hepatitis in young adults in developing countries with a 20-30% mortality rate among infected pregnant women primarily those in their third trimester. The development of inactivated or live attenuated virus vaccine has been hampered because this virus does not replicate efficiently in cell culture. A vaccine has been developed by an alternative approach through recombinant technology. Preliminary results of the first administration in man conducted in the US at Walter Reed Army Institute of Research indicate the vaccine to be safe and immunogenic and have led to the decision to further evaluate the vaccine in an endemic setting.

Clinical Trials, Phase I as Topic↗
PubMed2000

Comparison of the reactogenicity and immunogenicity of a two injection combined high-dose hepatitis A and hepatitis B vaccine to those of Twinrix.

Twinrix (SmithKline Beecham Biologicals) is a combined hepatitis A and B vaccine licensed with a three-dose schedule. A two-dose combined hepatitis A and B vaccine would facilitate immunisation programs. In this prospective study, 100 healthy adults, aged between 18 and 40, were enrolled. A first group of 50 was given a high-dose vaccine at month 0 and 6. A second group of 50 received Twinrix at month 0, 1 and 6. The reactogenicity was assessed after each vaccine dose. There were no severe local adverse events. Seven severe systemic reactions occurred, of which five were fatigue, one was headache and one consist in gastrointestinal symptoms. They all resolved during the 4-day follow-up period. One serious general adverse event was reported, but was clearly unrelated to the vaccine. Thus, both vaccines were well tolerated. The immunogenicity was evaluated by testing for anti-HBs and anti-HAV antibodies. Seroconversion rates and geometric mean titres (GMTs) were compared. At month 7, the anti-HAV GMTs were higher in the high-dose group than in the Twinrix group and, inversely, the anti-HBs GMTs were slightly higher in the Twinrix group than in the high-dose group. At month 7, all subjects in both groups were positive for anti-HAV. All subjects in the high-dose group and 97.6% subjects in the Twinrix group had seroconverted for anti-HBs. Therefore, it can be concluded that with two injections of the high-dose hepatitis A and B vaccine, 6 months apart, a similar immune response can be obtained as induced with three doses of Twinrix at months 0, 1 and 6.

Adolescent↗
PubMed2000

A comparison of two commercial recombinant vaccines for hepatitis B in adolescents.

The immunogenicity and reactogenicity profiles of three doses each of Engerix-B(R) (10 microg hepatitis B surface antigen) and Recombivax(R) (5 microg hepatitis B surface antigen), given on a 0, 1, 6 month schedule to healthy adolescents were compared in a single-blind, randomized clinical trial. One month following the third dose, seroprotection rates after Engerix-B and Recombivax were similar (99 and 98%, respectively). The geometric mean titre (GMT) was statistically significantly higher following vaccination with Engerix-B (3961 vs. 1001 mIU/ml; P=0.0001, Fisher's exact test). Most of the symptoms reported were mild or moderate in intensity and transient. There were no vaccine-related serious adverse events.

Adolescent↗
PubMed2000

Immunogenicity and reactogenicity of the combined hepatitis A and B vaccine in young adults.

The combination of hepatitis A virus (HAV) and hepatitis B virus (HBV) vaccinations can offer convenience, increased compliance and cost saving. We have studied the immunogenicity, reactogenicity and safety of combined hepatitis A and B vaccination in young adults (16-35 years old). Eighty healthy young adults were divided into two random groups. One group received the combined hepatitis A and B vaccine (HAB) in one arm while the other group was administered concomitant hepatitis A and B vaccines (HAV + HBV) in the right and left arms, respectively. The immunogenicity, reactogenicity and safety were assessed after each dose in both the groups. In local symptoms, the percentage of the combined HAB group was lower than the HAV + HBV group, and the general symptoms were noted in approximately 30% of each group without any significant difference. No serious adverse effects were noted. All the subjects were seropositive for antibody to hepatitis A virus (anti-HAV) after one dose of vaccine, and remained seropositive after three doses in both groups. The seropositive rate for antibody to hepatitis B surface antigen (anti-HBs) was significantly higher (84%) in the combined HAB group than the concomitant HAV + HBV group (62%), (p<0.05) after dose two, and all the subjects were seropositive (100%) after the third dose. The GMTs of anti-HAV and anti-HBs were not significantly different between groups 1 and 2 (p>0.1) except in month 6 when the GMT of anti-HBs was higher in HAB group (p=0.0039). The combined HAB vaccine was found to be safe, well tolerated and had less local symptoms in young adults. The immunogenicity and reactogenicity were similar to the concomitant HAV + HBV vaccines.

Adult↗
PubMed2000

Vaccination against hepatitis B: current challenges for Asian countries and future directions.

AIMS: To review the current status of hepatitis B immunization programmes as well as future issues concerning hepatitis B immunization in Asian countries. METHODS: Pertinent literature was identified via in-house and MEDLINE (1980-99) searches and references cited in published articles. Articles within the Proceedings of the IX Triennial International Symposium on Viral Hepatitis and Liver Disease provided valuable state-of-the-art resource data. RESULTS: Chronic hepatitis B infection is responsible for 75-90% of primary hepatocellular carcinoma, one of the 10 most common cancers worldwide. Hepatitis B and its chronic sequelae can potentially be eradicated through vaccines that have been shown to be 95-99% efficacious in preventing development of the disease or the carrier state in immunized infants. Approximately 75% of the world's hepatitis B carriers live in Asian countries wherein wide variations in immunization strategies exist. Vaccination programmes in hyperendemic Asian countries have elicited decreases in the incidence of acute and chronic infections as well as a decrease in chronic carriers in the unvaccinated population. Decreases in the incidence of hepatocellular carcinoma have been recorded in Taiwan and Singapore after at least 10 years of universal hepatitis B immunization programmes. CONCLUSIONS: In Asian countries currently without nationwide hepatitis B programmes, utilization of the existing vaccination infrastructure for administration of other World Health Organization Expanded Programme on Immunization vaccines will provide the most economical and efficient means of administration of the hepatitis B vaccine.

Asia↗
PubMed2000

Immunization against hepatitis A in the first year of life: priming despite the presence of maternal antibody.

BACKGROUND: Maternal antibodies interfere with hepatitis A vaccination in young infants. We examined the response to a high dose hepatitis A vaccine administered concomitantly with a combination of diphtheria-tetanus toxoids-acellular pertussis-inactivated poliovirus vaccine/Haemophilus influenzae type b vaccine to initially seropositive vs. initially seronegative infants. METHODS: Three hundred subjects were originally planned to be enrolled at age 6 to 10 weeks and received hepatitis A vaccine (formalin-inactivated vaccine, SB-Bio, 720 enzyme-linked immunosorbent assay units) at 2, 4 and 6 months concomitantly with a diphtheria-tetanus toxoids-acellular pertussis-inactivated poliovirus vaccine/H. influenzae type b vaccine. Children initially seropositive received a booster dose at 12 months of age. An additional 100 twelve-month-old infants previously not vaccinated with hepatitis A vaccine were given 1 dose, to observe the primary response at that age. Reactogenicity was recorded on diary cards for the 3 subsequent days. Immunogenicity was measured at Months 2, 4, 5, 10 and 11 after administration of the first vaccine dose. For the subjects enrolled at 12 months, blood was drawn before and 1 month after the first vaccination. RESULTS: Of 297 initially enrolled infants 36% were seronegative before vaccination (Group A). The geometric mean concentration (GMC) (milli-International Units/ml) of the seropositive infants (Group B) before immunization was 2587. The GMCs of Group A infants 1 month after each dose and at 12 months of age were 93, 518, 1656 and 786, respectively. For Group B infants, the respective GMCs were 1165, 460, 508 and 167. One hundred subjects of Group B received a booster dose at age 12 months; at Month 13 all were seropositive with a GMC of 1902. For comparison, a third group of 100 not previously immunized 12-month-old infants (Group C) were enrolled and received 1 dose of hepatitis A vaccine with pre- and postimmunization GMCs of 52 and 120, respectively. CONCLUSIONS: Our results suggest that the initially seropositive infants were primed despite maternal antibody interference. The hepatitis A vaccine was well-tolerated in this population of young infants.

Female↗
PubMed1999

The first combined vaccine against hepatitis A and B: an overview.

Hepatitis A and B infections are prevalent world-wide and are a significant cause of morbidity and mortality. A vaccine providing dual protection against hepatitis A and B is now available (Twinrix, SmithKline Beecham Biologicals). Six pivotal vaccine trials, involving 843 healthy adults, aged between 17 and 60 years and vaccinated following a 0, 1, 6 month schedule are discussed. At month 2 more than 99% of the vaccinees were seropositive for anti-HAV and 84% were protected against hepatitis B. The third dose induced a 12-fold increase in geometric mean titres (GMTs) to 5404 mIU/ml. One month after completion of the vaccination course nearly all vaccinees had protective titres against hepatitis B with a GMT of 4818 mIU/ml. Long term follow-up data until month 48 is available for two studies. At month 48 all 129 vaccinees sampled were still positive for anti-HAV antibodies and > 95% were still protected against hepatitis B. The combined hepatitis A and B vaccine Twinrix proves to be consistently safe, well tolerated and highly immunogenic and compares well with serological responses reached with monovalent vaccines. This combined hepatitis A and B vaccine offers more convenience, potentially better compliance and lower administration costs.

Adolescent↗
PubMed1999

Safety and immunogenicity of hepatitis A vaccine in infants: a candidate for inclusion in the childhood vaccination programme.

Forty-eight infants received a single dose (720 ELISA units = 0.5 ml) of inactivated hepatitis A vaccine at the fifth month of age with booster at the 11th month of age, together with the second and third doses of the vaccines compulsory under Italian law (diphtheria, tetanus, oral polio and hepatitis B). Overall, the seroconversion rate was 100%. The anti-HAV geometric mean titre (GMT) reached 3,021 mIU/ml in infants born to anti-HAV-negative mothers, but only 399 mIU/ml in infants born to anti-HAV-positive mothers. Hepatitis A vaccine was immunogenic, safe and well tolerated without significant side-effects. There seems to be no reason for not including it in childhood vaccination programmes particularly in low endemic HAV areas.

Enzyme-Linked Immunosorbent Assay↗
PubMed1999

A two dose combined hepatitis A and B vaccine in Chinese youngsters.

This open, randomized study was conducted in healthy Chinese youngsters, aged between 10 and 19 years to compare the reactogenicity and immunogenicity of two vaccines: the combined vaccine against hepatitis A and B was administered in a two-dose schedule with the profile of the corresponding monovalent vaccines, while the concomitant vaccine was administered also on a two-dose schedule but simultaneously in opposite arms. All vaccinees had antibodies against hepatitis A (anti-HAV) after the 2-dose administration, whereas all but four in the first and two in the second group had protective titres against hepatitis B (anti-HBs). At month 7, the geometric mean titres for both antibodies were more than double for the group of subjects receiving the combined vaccine: 3,701 vs. 1,705 mIU/ml for the anti-HAV, and 1,524 vs. 720 mIU/ ml for the anti-HBs response. Injection site pain was the most commonly reported local symptom and headache was the most reported general symptom. It is concluded that this combined vaccine against hepatitis A and B, administered according to a two-dose schedule, is well-tolerated and highly immunogenic.

Adolescent↗
PubMed1999

Comparison study of combined DTPw-HB vaccines and separate administration of DTPw and HB vaccines in Thai children.

The safety, immunogenicity and tolerability of two different DTPw-HBV combination vaccines, containing 5 and 10 microg of HBsAg; were investigated in comparison with separate administration of DTPw and HBV (10 microg of HBsAg). A three dose primary vaccination course at 2, 4 and 6 months of age was followed by a booster dose at 18 months. All vaccines were safe and well tolerated. The DTPw-HBV combination vaccine containing 10 microg of HBsAg elicited significantly higher anti-HBs titres than the other two vaccines after the primary and booster vaccination course. All vaccines elicited a high response against the other components. Based on these results, DTPw-HBV (10 microg HBsAg) was the most effective vaccine at this schedule.

Antibody Formation↗
PubMed1998

Safety and immunogenicity of hepatitis A vaccine in patients with chronic liver disease.

Acute hepatitis A superimposed on chronic liver disease (CLD) has been associated with severe or fulminant hepatitis. An open, multicenter study was performed to compare the safety and immunogenicity of an inactivated hepatitis A vaccine in patients with CLD with that in healthy subjects. A secondary objective was to compare the safety of the hepatitis A vaccine with that of a commercial hepatitis B vaccine in subjects with chronic hepatitis C. A total of 475 subjects over the age of 18 years were enrolled into 1 of 5 groups according to history, serological data, and previous diagnosis. Patients in groups 1 (healthy adults), 2 (chronic hepatitis B), 3 (chronic hepatitis C), and 5 (other CLD not caused by viral hepatitis) were vaccinated with two doses of inactivated hepatitis A vaccine, 6 months apart. Patients in group 4 (chronic hepatitis C) received 3 doses of a recombinant hepatitis B vaccine, according to a 0-, 1-, and 6-month schedule. Local injection-site symptoms were the most common reactions reported following vaccination in all groups (35.5% of all doses), with the hepatitis B vaccine eliciting fewer injection-site symptoms than the hepatitis A vaccine (19.8% compared with 37.5%). Although a higher percentage of healthy subjects (93%) seroconverted after a single dose of the hepatitis A vaccine than did subjects with chronic hepatitis C (73.7%) or CLD of nonviral etiologies (83.1%), more than 94% of all vaccinees were seropositive for anti-HAV after the complete vaccination course. At each time point, a lower geometric mean concentration of anti-HAV was observed for each group of CLD patients compared with the healthy control subjects. In conclusion, hepatitis A vaccine was well tolerated and induced a satisfactory immune response in patients with chronic hepatitis B, chronic hepatitis C, and miscellaneous CLD.

Adolescent↗
PubMed1998

Safety and immunogenicity of a hepatitis B vaccine formulated with a novel adjuvant system.

A formulation of recombinant hepatitis B surface antigen (HBsAg) combined with a novel adjuvant system, SBAS4--a combination of aluminium salt and monophosphoryl lipid A (MPL), was assessed in 27 healthy adult volunteers with a commercial vaccine (Engerix-B) as control. After three doses (0, 1, 6 months schedule), reactogenicity profiles were similar. Local reactions were essentially mild, the most frequent being soreness at the injection site. Seroprotection was achieved after two doses in all subjects given the candidate vaccine, all Engerix-B vaccines being seroprotected after the third dose. After the second and third doses, higher anti-HBs Geometric Mean Titres (GMTs) were observed in the group which received the formulation with the novel adjuvant system, and cellular immunity, measured as HBsAg-specific lymphoproliferation was stronger than with Engerix-B. These results indicate that the new formulation is safe, well-tolerated and immunogenic and may promote more rapid protection against hepatitis B infection.

Adjuvants, Immunologic↗
PubMed1998

Production of antibody to hepatitis A virus and hepatitis B surface antigen measured after combined hepatitis A/hepatitis B vaccination in 242 adult volunteers.

Two batches of a new hepatitis A/hepatitis B combined vaccine were tested in 242 healthy students. Three injections, given at 0, 1 and 6 months, produced seroconversion rates and hepatitis A virus (HAV) and hepatitis B surface antigen (HBsAg) antibody levels comparable to those reported after administration of separate monocomponent vaccines. The vaccine proved to be safe and well-tolerated. Influence of host factors, such as elevated body mass index or gender, were investigated and proven to be of little influence on the immunoresponse.

Adult↗
PubMed1998

Diphtheria, tetanus and whole cell pertussis vaccine combined with hepatitis B vaccines: a comparison of two doses (10 microg and 5 microg).

BACKGROUND: A combined diphtheria-tetanus-whole cell pertussis-hepatitis B (DTPwHB) vaccine might facilitate the achievement of universal vaccination of infants against hepatitis B. METHODS: A double blind, randomized, two-armed, single center study was undertaken to evaluate the immunogenicity and reactogenicity of combined tetravalent DTPwHB vaccine, with two dosages of hepatitis B component (10 microg and 5 microg). The combined vaccine was tested in the context of a simplified vaccination schedule at 1.5, 3.5 and 6 months of age, to 120 healthy infants born to hepatitis B surface antigen-negative mothers after priming with one dose of hepatitis B vaccine (10 microg) at birth. Antibodies to each antigenic component were measured from blood samples collected immediately after birth, pre- and postvaccination blood samples. RESULTS: The reactogenicity profiles were similar in the two groups. No serious adverse events were reported. One month after completion of the four-dose vaccination schedule, all subjects except one in Group 1 (10 microg) had protective titers of anti-HBs (10 mIU/ml). At this time the geometric mean titer in Group 1 (10 microg) was higher than that observed in Group 2 (5 microg), 696 vs. 488 mIU/ml (P = 0.19). One month after three doses all subjects in both groups had protective antidiphtheria titers and antitetanus titers. The vaccine response rate to the Bordetella pertussis component of the vaccine was 88.0% in Group 1 and 96.2% in Group 2 (P = 0.86). CONCLUSION: Both combined tetravalent vaccines are safe and immunogenic when administered to infants born to a hepatitis B surface antigen-negative mother, with a 10-microg dose of priming hepatitis B vaccine at birth. This combined tetravalent DTPwHB vaccine may play an important role to promote integration of HB vaccine into the Expanded Program of Immunization in hepatitis B-endemic areas.

Antibodies, Bacterial↗
PubMed1998

[Prevalence of antibodies against hepatitis A in school children].

BACKGROUND: As sanitary conditions of a population improve, hepatitis A virus infection occurs at higher ages, thus decreasing the prevalence of antibodies against the virus. In the eighties, the prevalence of antibodies among children was 97% and depended on the socioeconomic level. AIM: To assess the prevalence of antibodies against hepatitis A virus in school age children living in Valdivia. SUBJECTS AND METHODS: Two thousand three hundred thirty three school age children were studied. Total antibodies against hepatitis A virus were detected using an ELISA kit from Abbott. Children were stratified in age groups and school were classified as private, subsidized, municipal or foster homes. RESULTS: Antibodies were positive in 65% of children (59% in children aged 6 to 8 years old, 66% in children aged 9 to 11 years and 69% in children aged 12 to 15 years. In private schools, the prevalence was 26%, in subsidized schools the figure was 54%, in municipal schools 73% and in foster homes 91%. CONCLUSIONS: The general prevalence of antibodies against hepatitis A virus is higher in low socioeconomic level children. There is a global decrease in the prevalence of these antibodies in the last years.

Adolescent↗
PubMed1998

The new DTPw-HBV-Hib combination vaccine can be used at the who schedule with a monovalent dose of hepatitis B vaccine at birth.

An open, randomized, clinical trial was conducted in order to assess the reactogenicity and immunogenicity of DTPw-HBV and Haemophilus influenzae type b (Hib) vaccines when given either as a mixed administration or as separate concomitant injections using the WHO schedule at 6, 10 and 14 weeks of age, following a dose of HBV at birth. There were no clinically relevant differences in the immune response to any component between the mixed and separate administrations. In fact the anti-tetanus GMTs were significantly higher (p=0.002) in mixed administration (3.9 IU/ml) compared with the separate administration (1.9 IU/ml). However although all subjects achieved anti-PRP titers > or = 0.15 microg/ml, higher anti-PRP GMTs were seen in the group receiving the separate administration. Importantly, the addition of Hib did not adversely alter the reactogenicity profile of DTPw-HBV. This report which demonstrates that this novel combination can be used in WHO recommended schedule.

Analysis of Variance↗