RECORD STATUS: None CITATION: Health Council of the Netherlands Gezondheidsraad. Protection against diphtheria. Health Council of the Netherlands/Gezondheidsraad (GR). 1996

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OBJECTIVE: To assess antenatal, birth, and infant outcomes for pregnant women, fetuses, and infants after antenatal vaccination with any antigen present in combination pertussis vaccines. DATA SOURCES: PubMed, EMBASE, Literature in the Health Sciences in Latin America and the Caribbean, ClinicalTrials.gov, Cochrane Library, and World Health Organization (inception to May 5, 2016). METHODS OF STUDY SELECTION: Studies reporting outcomes for pregnant women, their fetus, or infant after antenatal exposure to either monovalent or combined tetanus toxoid, reduced diphtheria toxoid, and acellular pertussis (Tdap) or inactivated polio vaccines were considered for inclusion. RESULTS: A total of 21 studies were included in this review. Point estimates ranged from 0.47 to 1.50 for preterm birth (less than 37 weeks of gestation), 0.65-1.00 for small for gestational age (birth weight less than the 10th percentile), 0.36-0.85 for stillbirth, 0.16-1.00 for neonatal death, 0.76-1.20 for low birth weight (less than 2,500 g), and 0.20-0.91 for congenital anomalies. All lower 95% confidence intervals (CIs) were less than 1.0. Of three retrospective studies assessing chorioamnionitis after vaccination, one showed a small but statistically significant increase. Point estimates for all anomalies after antenatal tetanus toxoid vaccination ranged from 1.20 to 1.60 and had 95% CIs that crossed 1.0. There was substantial clinical and methodologic heterogeneity from mainly retrospective observational studies with an overall high risk of bias. Objective rates of fever were low, 3% or below, and more common systemic events observed included headache, malaise, and myalgia. CONCLUSION: Evidence suggests that antenatal combined Tdap administered during the second or third trimester of pregnancy is not associated with clinically significant harms for the fetus or neonate. Medically attended events in pregnant women are similar between vaccinated and unvaccinated groups.

As part of a broader program in health communication assistance, project staff from Basic Support for Institutionalizing Child Survival worked with staff from Russia's oblast (regional) public health agencies to design and implement communication activities supporting local diphtheria immunization efforts. Because aggressive community outreach efforts and strong administrative sanctions had already achieved impressive adult coverage rates for first doses of diphtheria toxoid vaccine, communication interventions emphasized the need for second and third doses. Outcomes were assessed through vaccination coverage data and more qualitative measures. In one project site, the increase in adult coverage (two or more doses) was very modest. In a second site, with a stronger communications component, coverage increased significantly (from 20% to 80%). Although it is not possible to disentangle completely the effects of communications from other aspects of oblast immunization programs, these and other outcome data suggest that health communications can play an important role in Russia's ongoing mass immunization efforts.

BACKGROUND: The present randomized non-blind trial was conducted to clarify the effect of analgesics on febrile responses of booster diphtheria-tetanus-whole cell pertussis (DTP) vaccine in 15-20 months old infants. METHODS: A total of 270 healthy infants were randomized to receive acetaminophen (10 mg/kg) along with DTP vaccine (group 1), 2 hours after vaccination (group 2), and after the appearance of febrile reactions or irritability following vaccination (group 3, control). In addition to study medication, if the axillary temperature was higher than 38 degrees C or if the infant seemed to be irritable, the parents were told to give acetaminophen (10 mg/kg) and record on a diary card. Vaccinees were monitored for local and systemic reactions. RESULTS: The incidences of local swelling, pain and erythema were not significantly different among the 3 groups. No difference was observed in the incidence of systemic reactions including febrile responses, irritability, anorexia, and vomiting among the 3 groups during the 7 days after vaccination. Of the infants, 45.1%, 46.7% and 51.9% manifested fever (axillary temperature > or =38 degrees C) within 24 hours after the vaccination in groups 1, 2 and 3, respectively (P>0.05). The second dose of acetaminophen was less in the control group than in the prophylactic groups (P=0.009). CONCLUSIONS: Administration of acetaminophen along with DTP vaccine or 2 hours after vaccination does not affect the occurrence of febrile responses following booster vaccination. Unnecessary use of analgesics should be prevented.

A randomized controlled trial of acellular diphtheria/pertussis/tetanus (ADPT) freeze-dried and liquid vaccines in infants was conducted in a peri-urban community (Ashaiman) in southern Ghana. Immunogenicity of the acellular vaccines, persistence of antibodies and adverse reactions were compared with those achieved with a whole-cell diphtheria-pertussis-tetanus (DPT) vaccine. The incidence of pertussis in the vaccine groups and prevalence of pertussis in children under 5 years of age in the study area were also determined. The acellular vaccines produced significantly fewer local and systemic reactions. Local reactions such as swelling and redness were observed in 2% (8/399) to 2.3% (9/385) of the acellular vaccine recipients as against 31% (122/394) in the whole-cell vaccine group. Fever ( > or = 37.5 degrees C) occurred in 7.27% (29/399) to 9.8% (38/385) in the acellular vaccine groups compared with 36.6% (145/394) in the whole-cell vaccine group. Geometric mean titres (GMTs), measured by ELISA, to pertussis toxin (PT) and filamentous haemagglutinin (FHA) were significantly higher in the acellular vaccine groups than in the whole-cell DPT (WCDPT) group. There were no significant differences in the GMTs of tetanus and diphtheria antitoxins between the two groups after each vaccination. Twelve months after primary vaccination, GMTs to PT in the freeze-dried, liquid ADPT groups and the WCDPT group have fallen from 56.23, 62.63 and 44.97 ELISA U/ml to 6.08, 6.18 and 11.30 ELISA U/ml, respectively. GMTs to FHA in all the vaccine groups also dropped during the same period from 49.94, 41.73 and 20.74 ELISA U/ml to 7.26, 7.72 and 5.91 ELISA U/ml, respectively. In this comparative controlled trial, the ADPT vaccines were more immunogenic, with less local and systemic reactions, than the WCDPT vaccine but there was a considerable drop in antibody titres in all the vaccine groups 12 months after primary vaccination. However, the levels of titres of anti-PT and anti-FHA antibodies in all the three vaccines that confer protection are not known. Further studies are necessary to provide this information in order to assess the need for subsequent booster doses after primary immunization with both ADPT and WCDPT vaccines.

The aim of this study was to determine the effectivenes of ibuprofen prophylaxis in reducing the adverse effects of diphtheria-tetanus-pertussis (DTP) and oral polio vaccination in children 3, 5, and 7 months of age and to compare its effects with those of the present policy of treating adverse reactions when they occur. This 12-month, multicenter, randomized, open-label trial was conducted in six ambulatory, primary care centers. A total of 256 healthy children aged 3 months (±15 days) receiving DTP vaccine were studied at that age and at 5 and 7 months (ie, at the second and third DPT doses). Adverse effects of 719 vaccine doses were studied; 219 infants received all three doses. Patients were randomized to receive either ibuprofen prophylaxis (20 mg/kg per day in three equally divided doses over 24 hours, the first dose given together with the vaccine) or treatment (ibuprofen 7.5 mg/kg) for the adverse reactions when they occurred. The same therapeutic regimen was followed after the second and third DTP doses. Adverse effects after immunization were recorded by parents or guardians in a previously validated questionnaire and included elevated rectal temparature, systemic reactions (crying, drowsiness, fretfulnees, vomiting, diarrhea, and anorexia), and local reactions (redness, edema, induration, and pain). None of the patients were withdrawn from the study because of adverse effects. The results of the study suggest that children given ibuprofen prophylaxis had temperature increases after DTP vaccination similar to those who received treatment when reactions occurred, but they had fewer systemic and local effects. No remarkable adverse effects such as seizures, collapse, or shock-like state (hypotonic-hyporesponse episodes) occurred. One sterile abscess was seen at the injection site in the prophylaxis group. Thus ibuprofen prophylaxis after DTP vaccination at 3, 5, and 7 months of age slightly decreased the occurrence of systemic and local adverse effects but did not reduce temperature.

In human newborns, small amounts of sucrose reduce crying with procedural pain by about 50%. To determine whether "sucrose analgesia" could be extended to painful procedures beyond the newborn period, 57 infants were randomly assigned to receive three 250-microliters doses of 50% sucrose solution (g/100 mL) or water before their diphtheria-tetanus-pertussis immunizations at 2 and 4 months of age. Crying during and after injection was measured separately to determine whether sucrose modified crying during the noxious stimulus, recovery from the stimulus, or both. Sucrose was effective in reducing crying only from 83 to 69%, and the reduction was limited to the postinjection period. We conclude that, although sucrose continues to have some effect beyond the newborn period, the effect is limited to recovery from the noxious stimulus, is clinically modest, and is probably smaller than in the newborn period.

OBJECTIVE: To describe obstetricians' perspectives related to tetanus-diphtheria-acellular pertussis (Tdap) vaccination of mothers and other adults in close contact with infants. METHODS: Mail survey of national random sample of 400 obstetricians. RESULTS: Response rate was 54%. Most respondents would likely recommend Tdap for women during the postpartum hospital stay (78%) or during pregnancy (69%) if a national recommendation was issued. Expected barriers were knowing the date of patients' most recent Td booster (74%) and patient resistance (46%). Most felt that obstetricians have a role in promoting and administering Tdap vaccine to adults other than mothers likely to come in close contact with infants. CONCLUSION: Obstetricians are likely to agree with the recent provisional US recommendation to administer Tdap to postpartum mothers and other adults expected to come in close contact with infants. Obstetricians would also be likely to support a potential recommendation to administer Tdap during pregnancy. Barriers to adoption of new Tdap vaccine recommendations should be monitored.

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