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Query: UMLS:C0018681 (headache)
 56,091 document(s) hit in 31,850,051 MEDLINE articles (0.00 seconds)

Clinical trials of a hormonal contraceptive called Rigevidon (Chemical Works of Gedeon Richter Ltd) were carried out on 134 patients during August 1979-March 1980. The users were observed for a minimum of 4 cycles and a maximum of 9. Of the 134 subjects, 92 (69.4%) started taking hormonal contraception for the first time with this regimen; 42 subjects (30.6%) had used other kinds of hormonal contraception previously. The compound was also administered to 7 patients suffering from infectious hepatitis more than 5 years previous to the clinical trial. Results of the trials were encouraging. 1 case (.74%) had laboratory tests showing serum transaminase increased above normal values; urine and blood pressure values were unchanged, howere. 1 other case had a disorder in the lower limb venous system (Homans positive, tachycardia). In 4 patients (2.98%) Rigevidon application was stopped because of bleeding that could not be controlled by increasing dose. In 7 subjects, the spotting occurred in the 2nd phase of the cycle, but it was reduced during 3 days by increased Rigevidon doses. No method failures occurred, and no subjects stopped taking the preparation for subjective reasons, weight changes, or headaches. Cervical pathology remained unchanged.
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PMID:Rigevidon (clinical trial of the preparation). 676 44

A formalin-inactivated aluminium hydroxide adsorbed hepatitis A vaccine was evaluated in a dose-response study on 195 healthy male adults (age range: 18-31 years) in two French hospitals (Lyon, Rouen). Four doses (20, 40, 80, 160 RIA antigen units) were administered intramuscularly (i.m.) in two injections over a 6-month period. At the time of the first vaccine injection, 32 subjects (16.4%) were found positive (> 20 mIU ml-1) for HAV antibody (total Ig RIA HAVAB assay, Abbott Laboratories) and were excluded from the analysis of immunogenicity criteria. Fourteen days after the first vaccine injection, 78.1% (95% confidence interval (CI): 62-90) of seronegative subjects who received the 160 RIA antigen unit dose seroconverted with a geometric mean titre (GMT) of 43 mIU ml-1 (95% CI: 33-56). Seroconversion was 100% (95% CI: 91-100) at 1 month with a GMT of 95 mIU ml-1 (95% CI: 79-112). Statistical analysis revealed a significant dose-related effect (p < 0.0001) on GMT by multivariate regression analysis of the results after the first injection. Biological safety was evaluated and alanine aminotransferase and aspartate aminotransferase levels were similar prior to and 14 days after the first injection in the four groups. Reactions after injection were similar in the four dosage groups: 6.2% of subjects reported immediate reactions after first vaccination (feeling sick, spontaneous pain, headache), 8.9% reported local reactions at the site of injection (spontaneous pain, haematoma, local adenopathy) and 13.5% reported general reactions ('flu-like' syndrome, gastrointestinal tract disorders, fatigue, headache).(ABSTRACT TRUNCATED AT 250 WORDS)
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PMID:Good immunogenicity of GBM strain inactivated hepatitis A vaccine in healthy male adults. 762 20

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.
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PMID:Inactivated hepatitis A vaccine: reactogenicity, immunogenicity, and long-term antibody persistence. 789 79

Vaccination against Japanese Encephalitis (JE) has been carried out extensively in many Asian countries for the past 20 years. The vaccine was generally considered to be effective and of low reactogenity. However, since 1989 an unusual number of systemic reactions characterized mainly by generalized urticaria and/or angioedema following JE vaccination were reported from Australia, Canada and Denmark, 860 travellers were recruited during a period of 16 months for a prospective study with the aim to investigate the type and incidence of side effects following JE vaccination (JEV) in German travellers. 826 received a primary immunization (2 injections at days 0 and 7-14) and 34 received a single booster injection. A detailed standardized questionnaire was distributed to all vaccinees after the first injection. A total of 509 questionnaires could be evaluated, which represents a return rate of 59.2%. 46% of the vaccinees reported about no adverse events at all. 54% reported about one or more adverse effects. Local reactions at the injection site were observed by 209 vaccinees, while 65 reported about systemic side effects like headache, fever, dizziness and generalized rash. There was no significant difference following first or second injection of the primary immunization or the booster injection, respectively, regarding incidence, severity or type of side effects. 2.2% of the vaccinees reporting reactions sought medical advice and 1.8% were judged unfit for work for an average of 2.2 days. The amount of systemic reactions might indicate a potential hazard of serious anaphylactic reactions. Unlike hepatitis A. Japanese encephalitis is an extremely rare disease in travellers. Therefore, the risk of acquiring the disease when travelling to affected areas without prior immunization should be considered against the risk of developing serious side effects after vaccination. We conclude that JEV should remain restricted to travellers with an increased risk of acquiring JE.
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PMID:Adverse reactions to Japanese encephalitis vaccine in travellers. 870 68

The aim of this study was to assess the immunogenicity and reactogenicity of a combined vaccine against hepatitis A virus (HAV) and hepatitis B virus (HBV) in young healthy adults. A total of 150 subjects (20 +/- 1.4 years; 111 females and 39 males) negative for anti-HAV, anti-HBs, anti-HBc and HBsAg markers, were enrolled and randomized to received the study vaccine from one of the three lots under double blind conditions. Three doses of the combined vaccine were administered by intramuscular route (deltoid) following a 0-, 1- and 6 months schedule. Each dose of 1 ml contained at least 720 ELISA Units of HAV antigen (Strain HM175) and 20 micrograms of recombinant HBsAg. Blood samples for anti-HAV (ELISA), anti-HBs (RIA) and transaminases determinations were obtained 1 month after the administration of each dose and before to the administration of the third dose (month 6). Local and general reactions were recorded by the vaccinee on the day of each vaccination and for the three following days on symptom sheets. A total of 147 subjects completed the study. There were not statistically significant differences between groups regarding to immunogenicity. All subjects had seroconverted [geometric mean titres (GMT): 1311 mIU ml-1] for hepatitis A component following the second dose; GMT increased to 8895 mIU ml-1 after the third dose. Seroconversion rates for hepatitis B component were 98% (GMT, 104 mIU ml-1) after the second dose and 100% after the third dose (GMT, 7097 mIU ml-1). There were not statistically significant differences between groups regarding to incidence of local and general symptoms. Soreness at the injection site and headache were the most commonly local and general symptoms reported, following 42% and 11% of the doses, respectively. This vaccine when given to young adults was well tolerated and induced high immunogenic response, similar to that obtained by hepatitis A and hepatitis B vaccines administered separately in previously reported trials.
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PMID:Immunogenicity and reactogenicity of a combined hepatitis A and B vaccine in young adults. 899 14

An attenuated vaccine against hepatitis A was developed from the GBM strain of the virus, cultured on human diploid MRC5 cells. Each dose contained 160 antigen units, inactivated by formalin and adsorbed onto 0.3 mg aluminum hydroxide, in a volume of 0.5 ml. Intramuscular injection of the vaccine conferred immunity to hepatitis A, with antibody titers greater than those obtained by passive immunization with immunoglobulin. In clinical studies, immunocompromised subjects became immune shortly after the first injection and more than 90% were found to be protected after 14 days (titer above 20 mIU/ml by RIA). All subjects (100%) were protected one month after the first injection. Immunity persisted for at least six months and was strengthened by a booster injection. The antibody titers determined after the first booster injection were consistent with a projected period of protection of ten years. Adverse reactions were mild and occurred within the first few days after vaccination, with the patient usually recovering spontaneously. The most common reaction was mild local pain, usually associated with redness of the skin. A nodule was observed at the injection site in a small number of cases. Mild fever, asthenia, headache, myalgia/arthralgia and gastrointestinal tract disorders were also reported. Reactions were reported less frequently after the booster injection than after the initial dose. The vaccine was as well tolerated by patients seropositive for the hepatitis A virus as by seronegative subjects. Thus, this vaccine can be used for active immunization against hepatitis A in adults and adolescents. It can be administered as primary immunization and as a booster injection.
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PMID:[Clinical development of a new inactivated hepatitis A vaccine]. 985 14

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.
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PMID:A two dose combined hepatitis A and B vaccine in Chinese youngsters. 1044 Aug

Shirley is a 42 year old woman who has rung you 5 days after returning from a 3 week resort holiday in Malaysia and Thailand. You saw her before her trip and administered a hepatitis A vaccine and advised her that she did not require anti malarial drugs as she was only going to large cities and beach resorts. She says she has had a high fever, headache and body aches for several days and that she feels exhausted, but is well enough to come to the surgery. When you see her later that morning, she looks fairly well, although she is moving rather gingerly. She says she has been resting, is drinking lots of fluids, has some anorexia, but no other significant symptoms. Examination reveals a temperature of 38 degrees C and she has a fine morbilliform rash on her body, limbs and neck. There are no other abnormal findings.
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PMID:A fever from the tropics. 1078 92

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.
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PMID:Comparison of the reactogenicity and immunogenicity of a two injection combined high-dose hepatitis A and hepatitis B vaccine to those of Twinrix. 1113 46

50 children under the age of 15 years were studied who had been hospitalized in two hospitals in the Dominican Republic with HIV diagnosed by the presence of biphasic hyperbilirubinemia and elevation of glutamic-pyruvic and glutamic-oxalacetic transaminases. The sera of the patients were examined for the presence of leptospirotic immunoglobulin M (IgM) antibodies by means of the enzymatic immunoassay method (UREASA-ELISA). The Leptospira-positive sera were also investigated for the presence of hepatitis B surface antigen (HBsAg) and for the IgM antibody (ab) of the hepatitis A virus (ab-HAV) by ELISA. 5 cases were positive for IgM Leptospira antibodies (10%), not finding in this percentage the presence of HBsAg; 3 of the 5 Leptospira-positive samples demonstrated the presence of ab-HVA-IgM. Only 2 cases (4%) presented IgM Leptospira antibodies. Out of the 5 cases with IgM antibodies, males predominated (3/5). When compared to negative cases, however, there were more rural elements among them than in negative cases: regarding origins (10% vs. 16%), agricultural workers (40% vs. 20%), contact with cattle and fresh water (80% vs. 40%), and daily contact with humid soil in living quarters (60% vs. 48%). The clinical picture of the 5 positive cases featured myalgia (p = 0.05) and abdominal pain (p = 0.05). The stiffness of neck was relatively more frequent in positive cases (20%) than in negative cases (7%); also, fever (100% vs. 80%), vomiting (60% vs. 22%), headache (80% vs. 56%), constipation (20% vs. 9%), and hepatomegaly (100% vs. 71%). There was clear evidence that leptospirotic infection must be watched and also its association with acute infectious hepatitis.
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PMID:[IgM Leptospira antibodies in acute infectious hepatitis cases in children]. 1229 May 51


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