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At least 19 recordsLinked to original sources
PubMed1989

Antibody response and characteristics of antibodies in women immunized with three contraceptive vaccines inducing antibodies against human chorionic gonadotropin.

Data are presented on antibody titers generated in 88 women immunized with three formulations of antihuman chorionic gonadotropin (hCG) vaccine, namely, beta-hCG (formulation B); beta-hCG associated with alpha-subunit of ovine luteinizing hormone (LH) (formulation A) and beta-hCG + beta-ovine LH (formulation M), each linked to tetanus toxoid and cholera toxin chain B as carriers. Each formulation was tested at two dose levels (100 and 500 micrograms). All women without exception developed anti-hCG antibodies having hCG-binding capacity above 20 ng mL-1 (0.5 nM), a level considered to be the threshold for prevention of pregnancy. Formulations A and B gave relatively better immunogenic response in human subjects than M. In each case, the antibody response was reversible. The mean duration of response above 20 ng was 35 to 37 weeks for formulation A, 34 weeks for B, and 17 to 20 weeks for M. Antibodies induced by three formulations of the vaccine had high-affinity (Ka 10(9)-10(10)M-1) for binding with hCG. They were devoid of cross-reaction with human follicle-stimulating hormone and thyroid-stimulating hormone but, as expected, cross-reacted with human LH. Antibodies were competent to block the hCG induced ovarian hyperemia.

Adult↗
PubMed1991

Evaluation of endocrine parameters in clinical trials with beta-hCG vaccine.

This report presents data on various endocrine parameters with respect to pituitary-ovarian axis in-depth in control vs 18 subjects immunized with three beta-hCG based vaccine formulations. Hormonal parameters such as TSH, PRL, ACTH, progesterone, cortisol, T3 and T4 were measured by RIA in sera in control pre-vaccine cycles as well as at 3, 6, and 12 months after primary vaccine immunization. In 6 women urinary E1G, PdG, LH and FSH were measured by ELISA/RIA tests on early morning urine (EMU) samples collected throughout the menstrual cycle in control vs post-booster vaccine cycles. The results indicated that none of the beta-hCG vaccine formulations altered the pituitary peptide or steroid hormone levels in blood at any time during the period of study. Serum P concentration was adequate and indicative of ovulatory cycle in almost all the cycles during the study. The in-depth study on urinary excretion pattern and levels of gonadotropins and E1G and PdG throughout the control vs post-vaccine booster cycles conclusively showed that pituitary-ovarian axis was not adversely affected by the vaccine.

Adrenocorticotropic Hormone↗
PubMed1991

Use of hCG stimulation test in women immunized with beta-hCG vaccine.

Eleven normally menstruating women, who had earlier been immunized with NII beta-hCG vaccine but had no detectable anti-hCG antibody titres, were selected as controls for the hCG challenge test using 1000/2000 I.U. The test was repeated in five of them after a booster immunization, which raised antibody titres to 18-450 ng/ml. Stimulation of serum progesterone secretion was used as an index of corpus luteum (CL) response to the I.V. hCG. In the control group, the progesterone (P) secretory response following hCG stimulus showed peak levels which were significantly higher than basal levels in all except 2 subjects. The non-responsiveness in 2 subjects cannot be easily explained but may be dose-related. No significant difference was noted between the two dose levels. Length of luteal phase was increased by 4-5 days in 6 out of 20 cycles studied. The results of this test in 5 women before and after the vaccine boosters were encouraging as peak P levels appeared higher than basal levels in controls, but not so in the immunized group. However, these results could not be confirmed statistically. Nonetheless, this study is suggestive that the antibodies generated by this vaccine were capable of intercepting the effect of exogenous hCG in the human female. Further studies with more subjects and higher dosage of hCG are called for.

Antibodies↗
PubMed1987

Factors associated with clinical reactions to rubella vaccination in women.

Two types of rubella vaccine were given to 272 seronegative healthy Japanese adult women. Clinical and laboratory studies on clinical reaction after vaccination were carried out on HI antibody response, HLA types, basal body temperature (BBT), menstrual cycles and serum progesterone levels of vaccinees. Clinical reactions were not associated with HLA types of vaccinees, but arthropathy occurred significantly more often in women vaccinated at the progestational stage than in women vaccinated at the estrogenic stage.

Adult↗
PubMed1991

Child mortality after high-titre measles vaccines: prospective study in Senegal.

The use of Edmonston-Zagreb high-titre (EZ-HT) vaccine at age 6 months has been recommended for countries in which measles before the age of 9 months is a substantial cause of death, but little is known about the long-term effects of high-titre live measles vaccines given early in life. In a randomised vaccine trial in a rural area of Senegal, children were randomly assigned at birth to three vaccine groups: EZ-HT at 5 months (n = 336); Schwarz high-titre (SW-HT) at 5 months (n = 321); and placebo at 5 months followed by standard low-titre Schwarz vaccine at 10 months (standard: n = 358). All children were prospectively followed for 24-39 months in a well-established demographic surveillance system. Child mortality after immunisation was significantly higher in the two groups which received high-titre vaccines than in the group given the standard vaccine. The relative risk of death was 1.80 (95% confidence interval [CI] 1.18-2.74; p = 0.007) in the EZ-HT group and 1.51 (0.97-2.34; p = 0.07) in the SW-HT group compared with the standard group. The three vaccine groups were comparable as regards various social, family, and health characteristics, and there was no difference in mortality between children who received the standard vaccine and those who were eligible for the trial but did not take part for various reasons. The higher risk of death in the two high-titre vaccine groups remained significant in multivariate analyses. These findings suggest a need to reconsider the use of high-titre measles vaccines early in life in less developed countries.

Cause of Death↗
PubMed1991

Oral immunisation against typhoid fever in Indonesia with Ty21a vaccine.

When tested under conditions of moderate transmission of typhoid fever, a liquid formulation of the oral typhoid fever vaccine Ty21a had a protective efficacy of 96% in Egypt, and an enteric coated capsule formulation had an efficacy of 67% in Chile. We compared the two formulations under conditions of intense transmission of typhoid fever in Indonesia in a randomised, double-blind trial. 20,543 subjects (age range 3-44 years) received either three doses of enteric coated capsules containing placebo or live Ty21a, or three doses of lyophilised placebo or live Ty21a reconstituted with phosphate buffer. During 30 months of follow-up, the rate of blood-culture-positive typhoid fever among controls was 810/100,000 per year. Rates of typhoid fever were 379/100,000 per year for subjects who received the liquid formulation of vaccine and 468/100,000 per year for subjects who received enteric coated capsules. The protective efficacies of the liquid and enteric coated formulations were 53% and 42%, respectively. Neither formulation protected against infection with Salmonella paratyphi A. No major side-effects were noted, but the overall incidence of side-effects was greater in the vaccine groups. Under conditions of intense transmission, Ty21a protected against typhoid fever; however, because Ty21a will not protect all individuals, there is a need for additional approaches to prevent the disease.

Administration, Oral↗
PubMed1986

Field trial of oral cholera vaccines in Bangladesh.

The protective efficacy of oral B subunit killed whole-cell (BS-WC) and killed whole-cell (WC) cholera vaccines was assessed in 63 498 Bangladeshi children aged 2-15 years and women aged over 15 years. Each received three doses of BS-WC, WC, or placebo in a randomised, double-blinded fashion. Surveillance for cases seeking medical care up to six months after the third dose revealed 26 cases of confirmed cholera in the placebo group, 4 cases in the BS-WC group (protective efficacy 85%; p less than 0.0001), and 11 cases in the WC group (protective efficacy 58%; p less than 0.01). For each vaccine protective efficacy was consistent in different age-groups (2-10 years versus greater than 10 years) and for different severities of cholera.

Administration, Oral↗
PubMed1987

Trial of an attenuated bovine rotavirus vaccine (RIT 4237) in Gambian infants.

A randomised, controlled trial of bovine rotavirus vaccine was undertaken in Gambian infants. Three doses were administered, from the age of ten weeks, concurrently with oral or killed polio vaccine. Prevaccination rotavirus neutralising antibody levels were high. 84/185 infants (45%) showed an increase in neutralising antibody titre after receiving rotavirus vaccine, compared with 20/91 (22%) unvaccinated infants. Clinical rotavirus infection was detected in 24/78 (31%) children in the rotavirus/oral polio group, 34/83 (41%) children in the placebo/oral polio group, and 23/92 (25%) children in the rotavirus/killed polio group, giving an overall vaccine efficacy of 33% (95% CI 4-53%). RIT 4237 did not appear to reduce the severity of clinical infections. Most cases (92%) were caused by rotaviruses with short RNA electropherotypes. Serological responses to rotavirus vaccination appeared unaffected by the concurrent administration of oral polio vaccine. Lower types 1 and 3 polio antibody levels were found in children who received oral polio and rotavirus vaccines but the differences were not statistically significant.

Animals↗
PubMed1987

Protection against severe rotavirus diarrhoea by rhesus rotavirus vaccine in Venezuelan infants.

The efficacy of the rhesus rotavirus vaccine candidate MMU-18006 was evaluated in a longitudinal double-blind field trial in Caracas, Venezuela. 247 infants aged 1-10 months were studied and followed for up to 1 year (201 completed the 1-year surveillance): 123 received a dose of 10(4) plaque-forming units of the vaccine orally and 124 received placebo. 21 episodes of rotavirus diarrhoea were detected, 16 in the controls and 5 in the vaccines: vaccine efficacy against any rotavirus diarrhoea was thus 68%. In the 1-5-month-old group the vaccine efficacy was 93%; only 1 episode of rotavirus diarrhoea was detected in 68 vaccinees and 15 such illnesses were observed in 65 controls (p less than 0.0001). For the entire study group vaccine efficacy was 100% against the most severe rotavirus diarrhoeal episodes.

Antibodies, Viral↗
PubMed1992

Epidemic poliomyelitis in The Gambia following the control of poliomyelitis as an endemic disease. II. Clinical efficacy of trivalent oral polio vaccine.

An epidemic of poliomyelitis caused by poliovirus type 1 occurred in The Gambia from May to November 1986. Descriptive findings and vaccination coverage levels are reported in part I. This article (part II) describes a case-control study to estimate the clinical efficacy of three or more doses of trivalent oral polio vaccine compared with zero doses. "Cases" were 1- to 7-year-old children paralyzed during the epidemic who were diagnosed as having poliomyelitis by designated referral physicians. They were identified by reports from referral physicians during the epidemic and by a nationwide village-to-village search after the epidemic. Up to five controls were randomly selected for each case from among children of the same age and sex living in neighboring households. In a matched analysis of 195 cases and 839 controls, the efficacy of three or more doses of trivalent oral polio vaccine was 72% (95% confidence interval 57-82) when children without vaccination cards were considered unvaccinated. The efficacy of three or more doses in 1- to 2-year-old children, in whom the determination of vaccination status was considered to be more accurate than in older children, was 81% (95% confidence interval 66-90). Vaccine failure was not associated with short intervals between doses. Higher levels of vaccination coverage and efficacy than those achieved in The Gambia may be needed in African countries to prevent the return of poliomyelitis as an epidemic disease after it has been controlled as an endemic disease.

Age Factors↗
PubMed1992

Nonparticipation as a determinant of adverse health outcomes in a field trial of oral cholera vaccines.

The authors estimated the incidence rates of cholera and death between 1985 and 1988 for 32,642 age- and sex-eligible persons who did not participate in a randomized, placebo-controlled field trial of killed oral cholera vaccines in rural Bangladesh. As compared with 20,744 placebo recipients, the relative risk of cholera for all nonparticipants, adjusted for potentially confounding demographic variables, was 1.20 (95% confidence interval (CI) 1.03-1.41); this adjusted relative risk reflected elevated adjusted relative risks in nonparticipants who were medically ineligible (RR = 1.65; 95% CI 1.22-2.22) or refused to participate (RR = 1.19; 95% CI 1.01-1.41), but not in persons absent at the time of vaccination (RR = 1.00; 95% CI 0.78-1.28). The adjusted relative risk of death was also elevated in nonparticipants as compared with placebo recipients (RR = 1.28; 95% CI 1.10-1.48), with the same pattern of adjusted relative risks for different categories of nonparticipants: for ineligible subjects, 2.64 (95% CI 2.12-3.29); for refusers, 1.20 (95% CI 1.02-1.41); and for absentees, 0.95 (95% CI 0.75-1.22). The authors concluded that nonparticipation was associated with clinically cogent adverse health outcomes, but that the magnitude of these associations varied according to the reason for nonparticipation. These findings underscore the caution required in assessing vaccine efficacy with controls who are not vaccinated because of choices made by patients or vaccinators.

Administration, Oral↗
PubMed1992

Expanded programme on immunization (EPI). Safety of high titre measles vaccines.

Unexpected results suggesting decreased survival when compared with standard titre vaccine administered at 9 months of age have been found in some field studies evaluating the performance of high titre measles vaccine. Analytical difficulties have arisen because the studies were not specifically designed to measure survival. Nonetheless, careful analysis of the results from all of the high titre vaccine trials showed decreased survival of high titre vaccine recipients, in areas with high background mortality rates, compared with recipients of standard measles vaccines at 9 months. No systematic biases could be found in the studies to explain these differences. Statistical analysis of these data suggested that the findings were unlikely to be attributable to chance alone. The panel recommended that high titre measles vaccine derived from the original Edmonston measles vaccine isolate should no longer be recommended for use in immunization programmes. Further post-licensure field studies of new measles vaccines should take into account the results of these studies. Additional detailed epidemiological studies in populations that have received high titre vaccines and their controls were encouraged.

Child, Preschool↗
PubMed1992

Comparison of the immune response of four different dosages of a yeast-recombinant hepatitis B vaccine in Singapore children: a four-year follow-up study.

The immunogenicity of four different dosages of yeast-derived hepatitis B vaccine (Merck, Sharp & Dohme: 0.6 micrograms, 1.25 micrograms, 2.5 micrograms and 5.0 micrograms), administered at 0, 1 and 6 months (0-1-6 schedule) intramuscularly, was evaluated in 122 seronegative healthy children 1-12 years of age. Three months after the first dose, 83.9-100% of the vaccinees seroconverted. Peak geometric mean titres (GMT) of between 1088 mlU/ml and 1699 mlU/ml were attained 3 months after completion of the vaccination schedule. After 24 months, anti-HBs (antibody to hepatitis B surface antigen) was detected in 93.1-100% of the vaccinees, but the GMT dropped to between 214.3 mlU/ml and 303.5 mlU/ml. After 48 months, 88.8-100% of the vaccinees continued to possess anti-HBs and 70.3-87% had titres above 10 mlU/ml. As expected, the GMT declined further to between 72.6 mlU/ml and 118.8 mlU/ml. There were no significant differences in seroconversion rates and GMT among the different dosage groups. All the vaccinees remained asymptomatic and free from hepatitis B virus infection. The study showed that reduced dosages of the vaccine (0.6 micrograms, 1.25 micrograms and 2.5 micrograms) were as immunogenic as the standard dose (5 micrograms); the 2.5-micrograms dose was recommended for the national childhood immunization programme in Singapore. No booster is necessary for at least four years after vaccination.

Antibody Formation↗
PubMed1991

Monitoring impact of oral poliovirus vaccine on poliomyelitis trends from physiotherapy records, Ilorin, Nigeria, 1981-1988.

During the eight years of a poliomyelitis control programme in Ilorin Local Government Area, Nigeria, 85% of children aged 12-23 months were estimated to have received three doses of trivalent oral polio vaccine. The estimated incidence of paralytic poliomyelitis decreased by 59%, indicating a low vaccine efficacy for the currently used TOPV. This has a serious implication for the World Health Organization's global poliomyelitis eradication strategy of immunizing at least 80% of children aged one year by the year 2000, that eradication may not be achieved by this strategy alone in tropical Africa. Supplementary strategies of mass OPV campaigns, combined IPV/OPV vaccine regimens, or the introduction of new generation of poliomyelitis vaccines may be needed. Similar low-cost efforts at documenting the impact of TOPV on the incidence of poliomyelitis using physiotherapy clinics as independent sentinels, are needed from other states of Nigeria. To increase the efficacy of the primary series of TOPV in Nigeria, the number of doses constituting the primary series should be increased to four (including one at birth). There is now reason to consider a properly timed combination of both IPV and OPV in Nigeria.

Humans↗
PubMed1991

[Vaccines and developing countries].

Infectious diseases are the main cause of mortality and morbidity in developing countries. The Expanded Programme on Immunization, initiated by WHO in 1974, now reaches 60 mill. a year at a cost of less than 2 US $ per immunized child, and saves 2.2 mill. lives annually. The present vaccines, however, have significant shortcomings. Measles vaccine is given too late to prevent the large number of deaths occurring in the first year of life. Attenuated polio vaccine has to be given three times and inherits the risk of "vaccine palsy" and revertion to virulence. Tetanus vaccine given to children does not prevent neonatal tetanus, the main cause of tetanus casualties. BCG does not control spread of tuberculosis. Vaccines given parenterally involve some risk of spread of HIV, and some potentially useful vaccines are too expensive for developing countries. By only modest investments modern gene technology could give improved and new vaccines which would potentially save 20 mill. lives a year. Particularly promising is the recent development of multi-vaccine-vectors. However, poor prospects for profit in developing countries and patent "swapping" by commercial producers severely hamper development in the vaccine field.

Developing Countries↗
PubMed1979

Immunization against poliomyelitis: risk/benefit/cost in a changing context.

Benefit/risk factors in immunization against poliomyelitis are examined from the viewpoint of the relative risk and efficacy of killed and live poliovirus vaccines in the currently changing contexts of poliomyelitis prevalence in developed and developing countries. Risk factors include virus of vaccine origin gaining access to the CNS, and failure of the vaccine to immunize. Data are presented to illustrate the degree to which the respective risks occur in developed and developing countries. The ultimate elimination of risk by eradication of wild and vaccine virus from the population is discussed.

Adolescent↗