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Biomedical subjects

K M Edwards

Publications and source records attributed to K M Edwards.

At least 91 records · Page 5Linked to original sources
PubMed1995

The effect of maternal antibody on the serologic response and the incidence of adverse reactions after primary immunization with acellular and whole-cell pertussis vaccines combined with diphtheria and tetanus toxoids.

OBJECTIVE: To evaluate the effect of maternally derived antibody on the immunogenicity and reactogenicity of acellular (DTaP) or whole-cell (DTP) pertussis vaccine with diphtheria and tetanus toxoids combined. METHODS: A total of 2342 infants were randomized to receive one of 13 DTaP or 2 DTP vaccines at 2, 4, and 6 months of age. The correlation between preimmunization and postimmunization antibody after three doses of vaccine and the relation between preimmunization antibody and adverse reactions after the first immunization were modeled by linear regression. RESULTS: After DTP but not DTaP, higher levels of preexisting antibody were associated with substantial (28% to 56%) reductions in the subsequent antibody response to pertussis toxin (PT). For other pertussis antibodies, modest inverse correlations were seen between preexisting antibody concentrations and most postimmunization antibody responses (resulting in 8% to 18% reductions in postimmunization antibody) for both DTP and DTaP. There was no consistent association in any DTP or DTaP group between adverse reactions and preimmunization antibody levels. CONCLUSION: The PT antibody response to DTaP, unlike DTP, is not adversely affected by preexisting antibody to PT. Inhibitory effects with respect to other antibodies, seen with both DTP and DTaP, were relatively modest. Our data suggest that the use of acellular pertussis vaccines in adults, which could confer higher levels of antibody in women before pregnancy, would be unlikely to adversely affect pertussis antibody responses after DTaP among infants born to mothers with high antibody levels.

Antibodies, Bacterial↗
PubMed1995

Effect of gender, race, and parental education on immunogenicity and reported reactogenicity of acellular and whole-cell pertussis vaccines.

OBJECTIVE: To determine whether gender, race (black or white), or level of parental education influenced serologic responses or reporting of clinical reactions after immunization with acellular (DTaP) or whole-cell (DTP) pertussis vaccine with diphtheria and tetanus toxoids combined. METHODS: Healthy infants were prospectively randomized to receive one of 13 DTaP, Lederle DTP, or another DTP. Parents recorded the occurrence of adverse reactions for 2 weeks after each inoculation. Sera obtained before the first immunization and 1 month after the third immunization were analyzed for antibody to pertussis toxin, filamentous hemagglutinin, fimbriae, and pertactin (PRN). Chinese hamster ovary cell pertussis toxin neutralization assays were performed, and levels of agglutinating antibodies determined. RESULTS: Prevaccination antibody levels did not differ by race, gender, or parental education. Postimmunization geometric mean titers (GMTs) were strongly and consistently associated with race. For both DTaP and DTP and for every included antigen, postimmunization GMTs were about twice as high for black as for white infants. Among DTaP recipients, these differences were significant for pertussis toxin, Chinese hamster ovary cell pertussis toxin neutralization assay, filamentous hemagglutinin, PRN, and agglutinins; among the much smaller sample of WCL recipients, the differences achieved or approached statistical significance for agglutinins, PRN, and fimbriae. These findings were confirmed by regression analyses that controlled for gender, parental education, study site, and preimmunization antibody level. Reported reactions were not correlated with parental education level and showed no material correlation with gender. Black infants were reported to have had more pain than white infants after receiving WCL and DTaP and were reported to be more fussy after receiving WCL. CONCLUSIONS: The consistently higher postimmunization GMTs among black infants seems to be a real finding for which we have no explanation; the infants did not significantly differ by race in vaccine assignment, preimmunization antibody levels, age at immunization, or interval from immunization to phlebotomy. These observations should be confirmed and further evaluated in future pertussis vaccine trials. Reported differences by race in pain and fussiness after receiving WCL might reflect chance, differences by race in the occurrence of reactions, or differences by race in the reporting of reactions.

Antibodies, Bacterial↗
PubMed1995

Defining the key parameters for comparing reactions among acellular and whole-cell pertussis vaccines.

OBJECTIVE: To facilitate future vaccine reaction data collection and analysis, we sought to determine the minimum data set required to describe accurately and to compare common reactions after the administration of acellular (DTaP) or whole-cell (DTP) pertussis vaccine with diphtheria and tetanus toxoids combined. METHODS: Thirteen DTaP and 2 DTP vaccines were studied in a multicenter trial involving 2342 infants who received a primary series of vaccinations at 2, 4, and 6 months of age. Temperature, fussiness, redness, swelling and pain at the injection site, antipyretic use, drowsiness, loss of appetite, and vomiting were evaluated. Reactions were assessed at 3 hours and (if not immunized in the evening) 6 hours after immunization, at bedtime each evening for 7 evenings, and on the 14th evening after immunization. RESULTS: Two reaction assessment approaches were compared: (1) analysis of all reactions, regardless of the degree of severity; and (2) a condensation of the data to five key reactions (fever > 100 degrees F, moderate or more fussiness, any local redness, any local swelling, and moderate or more local pain). We found that the onset of reactions was infrequent beyond the second evening, and that collection and analysis of reaction data beyond that time did not further discriminate among the vaccines. Information regarding antipyretic use, loss of appetite, drowsiness, or vomiting did not assist in differentiating among these vaccines. CONCLUSION: Monitoring the occurrence of fever greater than 100 degrees F, moderate or severe fussiness, injection site redness or swelling, and moderate or severe injection site pain occurring through the second evening after immunization will provide the minimum data set needed to discriminate among DTaP and DTP vaccines with respect to the common adverse reactions.

Diphtheria-Tetanus-Pertussis Vaccine↗
PubMed1995

Association of reactions after consecutive acellular or whole-cell pertussis vaccine immunizations.

OBJECTIVE: To evaluate the relative frequency of adverse reactions after initial and subsequent immunizations among infants receiving primary immunization with acellular (DTaP) or whole-cell (DTP) pertussis vaccine with diphtheria and tetanus combined. METHODS: We examined the occurrence of common reactions in 2127 infants within 48 hours after immunization at 2, 4, and 6 months with one of 13 DTaP or with Lederle DTP (WCL). Data on at least two consecutive immunizations were available for 357 WCL recipients and 1770 DTaP recipients. For these analyses, reactions evaluated included fever of 100.4 degrees F (38 degrees C) or greater, redness of 21 mm or larger, swelling of 21 mm or larger, moderate or severe pain, moderate or severe fussiness, loss of appetite, drowsiness, and vomiting. RESULTS: With one exception, reactions were approximately 1.5 to 8 times more likely to occur in WCL recipients if the same reaction had been observed at the previous immunization (the single exception was redness after the second immunization). Both initial and repeated reactions were less likely in DTaP than in WCL recipients. As with WCL recipients, risks of repeated reactions in DTaP recipients were higher than the risks of initial reactions (from 2.5 to 24 times as high). CONCLUSION: Reactions after a second or third immunization with either WCL or DTaP vaccine are more likely to occur in infants who had the same reaction after the preceding immunization. Absolute risks of repeated reactions tended to be lower after DTaP vaccine than after the WCL vaccine.

Diphtheria-Tetanus-Pertussis Vaccine↗
PubMed1995

Pertussis in adolescents and adults: time to reimmunize?

The role of adults as reservoirs of pertussis infections and as victims of symptomatic disease has recently been recognized. Waning immunity after routine pertussis immunization in childhood appears to contribute to this problem. The expanded knowledge of the components of the Bordella pertussis organism has led to the production of new vaccines consisting of one or more bacterial components. These vaccines have been found to be safe and immunogenic in adults. It is likely that within the next several years the general use of acellular pertussis vaccines for the routine immunization of adolescents and adults will be recommended.

Adolescent↗
PubMed1994

Pertussis seroprevalence in emergency department staff.

STUDY OBJECTIVE: The purpose of this study was to look at the prevalence of pertussis immunity in emergency department employees. DESIGN: Prospective, observational study conducted in September 1992. SETTING: A university hospital ED. PARTICIPANTS: A convenience sample of 73 ED employees. INTERVENTIONS: Blood was collected from ED staff and assayed for antibody to pertussis toxin and filamentous hemagglutinin. RESULTS: Ninety-nine percent of the subjects reported childhood immunization. Geometric mean titers were 3.6 (geometric SD, 3.2) enzyme-linked immunosorbent assay (ELISA) units for pertussis toxin and 12.1 (geometric SD, 3.3) ELISA units for filamentous hemagglutinin. These titers are comparable to those previously reported in other adults not immunized since childhood and are substantially lower than the levels commonly seen in children or adults following immunization. Titers did not differ significantly between male and female subjects or between subjects with or without a recent prolonged cough, family members with a cough, or small children in the household. CONCLUSION: Most ED staff members have low levels of antibody to pertussis and may be at risk for acquiring the disease from infected children or adults, with subsequent risk of transmission to susceptible patients. Booster immunization with an acellular pertussis vaccine has been shown to be safe and immunogenic in adults and may be appropriate for adult ED personnel to reduce these risks.

Adult↗
PubMed1994

A randomized controlled trial of cold-adapted and inactivated vaccines for the prevention of influenza A disease.

A double-blind, randomized controlled trial over 5 years compared the safety, immunogenicity, and efficacy of cold-adapted and inactivated influenza A vaccines in 5210 normal subjects. Both vaccines were well tolerated. Inactivated vaccine significantly increased hemagglutination inhibition antibody titers. Significant titer rises were also noted after cold-adapted vaccine but of lesser magnitude than with inactivated vaccine. The efficacy of inactivated vaccine in preventing culture-positive influenza was 76% (95% confidence interval [CI], 58%-87%) for H1N1 disease and 74% (95% CI, 52%-86%) for H3N2; for cold-adapted vaccine, 85% (95% CI, 70%-92%) and 58% (95% CI, 29%-75%), respectively. The efficacy of inactivated vaccine in preventing a four-fold rise in antibody titer over the influenza season was 69% (95% CI, 61%-76%) for H1N1 and 73% (95% CI, 65%-79%) for H3N2; for cold-adapted vaccine, 54% (95% CI, 44%-62%) and 32% (95% CI, 17%-44%), respectively. Cold-adapted and inactivated influenza vaccines are safe and effective for preventing influenza A disease.

Administration, Intranasal↗
PubMed1994

Bacille Calmette-Guérin immunization in normal healthy adults.

Bacille Calmette-Guérin (BCG) vaccine was administered to 20 purified protein derivative (PPD) skin test-negative and human immunodeficiency virus serology-negative, healthy adults 18-65 years old. Local adverse reactions were monitored and intermediate-strength PPD skin test responses were evaluated 2 months and 1 year after vaccination. All vaccinees developed erythema, induration, and tenderness at the vaccination site. Muscular soreness was reported by 15 subjects, local ulceration with drainage by 14, and tender regional adenopathy by 2. BCG organisms were isolated from the ulcer of the only vaccinee who was cultured. PPD skin tests revealed induration in all subjects. Normal healthy adults at risk of occupational exposure to tuberculosis and considering BCG immunization should be fully informed about the local reactions seen after BCG administration and the high rate of persistent PPD skin test responses. Since viable organisms can be recovered from ulcer drainage, vaccination sites should be covered to reduce nosocomial transmission of the vaccine strain.

Adult↗
PubMed1994

Serologic response to standard inactivated influenza vaccine in human immunodeficiency virus-infected children.

We compared the serologic response of 46 human immunodeficiency virus (HIV)-infected children and adolescents and 61 age-matched controls to standard trivalent inactivated influenza vaccine (A/Taiwan (H1N1), A/Shanghai (H3N2), B/Yamagata). Children were immunized according to the package insert recommendations before the 1990 to 1991 influenza season. Serum antibody titers to influenza A were determined before and 1 month after each vaccination and compared for study and control subjects. Serologic responses of HIV-infected participants were correlated with absolute CD4 counts and stage of HIV disease. Regardless of age or HIV status, all groups responded with significant increases in antibody to the influenza A strains (range, 2.1-fold to 11.8-fold), with the exception that antibody to H3N2 rose only 1.5-fold (P = 0.058) among HIV-positive subjects > or = 9 years old. Pre- and postimmunization antibody titers were significantly higher for controls than for HIV-positive subjects. There was no correlation between serologic responses and CD4 counts among HIV-infected subjects, but those with Centers for Disease Control and Prevention-defined acquired immunodeficiency syndrome responded significantly less well to vaccine. We conclude that HIV-infected children and adolescents produce significant antibody rises after inactivated influenza A vaccination but that their absolute antibody concentrations are lower than those seen in age-matched controls.

Acquired Immunodeficiency Syndrome↗
PubMed1994

Enhanced antibody response in Venezuelan infants immunized with Haemophilus influenzae type b-tetanus toxoid conjugate vaccine.

The safety and immunogenicity of primary immunization at 2, 4 and 6 months of age with Haemophilus influenzae type b capsular polysaccharide conjugated to tetanus toxoid (PRP-T; Act-HIB) were evaluated in infants in Valencia, Venezuela. In order better to assess reactions to PRP-T, subjects received their initial PRP-T vaccine a mean of 6.5 days after their initial diphtheria-tetanus-pertussis (DTP) vaccine. The PRP-T vaccine was well tolerated. Serum was obtained at ages 2 and 7 months (before the first and 1 month after the third PRP-T dose). Antibody responses were compared with those from Nashville infants who had received PRP-T and DTP simultaneously in a previous trial. The preimmunization titers in the Venezuelan and Nashville infants did not differ. The geometric mean postimmunization titer in the Venezuelan infants was 37.9 micrograms/ml, as compared with 3.63 micrograms/ml in the Nashville infants (P < 0.00001). Possible explanations for the exceptional antibody response of these Venezuelan infants to PRP-T include carrier priming caused by prior DTP immunization, synergy associated with the specific DTP vaccine used, preimmunization immunologic experience that differed from their United States counterparts and genetic differences that altered response to the vaccines. Further studies are proposed to evaluate these possibilities.

Antibodies, Bacterial↗
PubMed1994

Detection of Rochalimaea henselae DNA by polymerase chain reaction from suppurative nodes of children with cat-scratch disease.

A polymerase chain reaction (PCR) assay was designed to amplify DNA from Rochalimaea henselae, Rochalimaea quintana and Afipia felis in the purulent material from lymph nodes in three patients with clinical cat-scratch disease (CSD) and two patients with lymphadenitis from other causes. All of the patients with CSD had positive immunofluorescent antibody serology for R. henselae, while none of the controls was positive. PCR amplification confirmed the presence of R. henselae DNA and the absence of R. quintana and A. felis DNA in the purulent material from CSD patients. PCR samples from control patients were negative. The PCR amplification of R. henselae DNA was performed quickly and with great sensitivity and specificity. It confirmed the presence of R. henselae in the CSD patients and eliminated the need for more extensive diagnostic and therapeutic procedures.

Bartonella henselae↗
PubMed1994

Acellular and whole-cell pertussis vaccines as booster doses: a multicenter study.

OBJECTIVE: To compare the safety and immunogenicity of a variety of acellular (AC) and whole-cell (WC) pertussis vaccines combined with diphtheria and tetanus toxoids. METHODS: Standard enrollment and reaction forms were used at five sites, and serologic evaluation was performed at a single site. Nine AC (Massachusetts Public Health Laboratories, Biocine Sclavo recombinant pertussis toxoid [PT], Connaught/BIKEN, Lederle three-component, Biocine Sclavo recombinant three-component, SmithKline Beecham three-component, Porton three-component, Takeda-Wyeth, and Connaught multicomponent), and three WC (Connaught Laboratories, Lederle Laboratories, and Massachusetts Public Health Laboratories) were studied. All AC contained varying concentrations of PT; some vaccines also contained filamentous hemagglutinin (FHA), pertactin, and/or agglutinogens. RESULTS: Two hundred forty children, aged 16 to 21 months and 4 to 6 years, were enrolled at five sites. Significantly less fever, redness, swelling, pain, limp, and use of pain medication were noted following AC compared with WC. Significant increases in antibody to PT were seen following all vaccines. Significant rises in FHA antibody were seen following all WC and the seven AC that contained FHA. Postbooster PT antibody levels were similar among the AC groups, regardless of the amount of PT administered (between 3.5 and 25 micrograms per dose). The dose of FHA did not affect PT antibody response. Infants primed with WC who were boosted with a monocomponent PT vaccine did not manifest a significant antibody response to FHA. CONCLUSION: The rate of adverse reactions was not a function of the number of antigens or the antigen quantity in the acellular vaccines, and antibody responses following AC were similar or better than antibody responses following WC. These results support the further evaluation of these vaccines in a larger National Institute of Allergy and Infectious Diseases-sponsored study in infants.

Antibodies, Bacterial↗
PubMed1993

Whose DNA is it anyway? Relationships between families and researchers.

DNA obtained for research may, at a later time, become crucial for carrier and prenatal diagnosis. Continuing rapid advances in human genetics make this scenario more and more common. The following case illustrates some of the problems that may occur when DNA donors and researchers do not establish a verbal or written agreement at the time the DNA is obtained. The legal and ethical ramifications of this situation are examined through case discussion and review of the literature. We propose that even in the absence of a verbal or written agreement, researchers continue to have a responsibility to share any significant information obtained from linkage studies with donor families if such information becomes available. If the DNA specimens become critical for prenatal or carrier testing at a later time, we feel that the family has a right to request and receive aliquots of such specimens. The research unit should have the right to charge a storage fee for DNA banking. Clear agreement between donor and researcher at the time of specimen collection may avoid legal and ethical problems in the future.

Contracts↗
PubMed1993

Adult immunization with acellular pertussis vaccine.

OBJECTIVE: To evaluate the safety and immunogenicity in adults of several different concentrations of an acellular pertussis vaccine. DESIGN: Double-blind, randomized, placebo-controlled trial. SETTING: Medical center immunization clinic. PARTICIPANTS: One hundred eighteen healthy adult volunteers. INTERVENTIONS: Participants received standard adult tetanus-diphtheria vaccine alone or combined with full-strength, half-strength, or quarter-strength concentrations of a currently licensed acellular pertussis vaccine used for booster doses in young children. Full-strength vaccine contained 40 micrograms of pertussis proteins, consisting of 86% filamentous hemagglutinin, 8% pertussis toxin, 4% 69-kd outer-membrane protein, and 2% agglutinogens. MAIN OUTCOME MEASURES: Local and systemic reactions were assessed for 14 days after vaccination. Serum samples for antibody assay were obtained before, 1 month after, and 1 year after immunization. RESULTS: Adverse reactions were few and minor and did not differ in frequency or severity among the four study groups. The groups receiving acellular pertussis vaccine showed strong antibody responses to pertussis antigens, which did not significantly differ by concentration of vaccine. After 1 year, levels of antibody to pertussis had declined by approximately 50% but remained substantially higher than preimmunization levels. The four groups did not differ in antibody responses to tetanus or diphtheria toxoids. CONCLUSIONS: Routine reimmunization of adults with a vaccine containing acellular pertussis antigens in addition to diphtheria and tetanus toxoids can substantially enhance pertussis antibody levels without an increase in adverse reactions or diminution in response to the diphtheria and tetanus components. Such a program might materially reduce respiratory illness among both adults and children.

Adult↗
PubMed1993

Responses of children to booster immunization with their primary conjugate Haemophilus influenzae type B vaccine or with polyribosylribitol phosphate conjugated with diphtheria toxoid.

Children primed with one of four conjugate Haemophilus influenzae type b vaccines received booster immunization with their primary vaccine or with polyribosylribitol phosphate conjugated with diphtheria toxoid. The latter vaccine produced postbooster antibody levels that equaled or exceeded those produced by boosting with the original vaccine, and thus may be used as a booster irrespective of the original vaccine.

Antibodies↗
PubMed1993

Acellular pertussis vaccines--a solution to the pertussis problem?

The expanded knowledge of the components of Bordetella pertussis has led to the production of new vaccines consisting of one or more components of the organism. The vaccines have been found to be safe and immunogenic in infants and children. Early efficacy studies failed to determine what component of the vaccine and what level of antibody were needed for protection; additional studies with many more vaccines are currently in progress. The role of adults as reservoirs of B. pertussis infections and as victims of symptomatic disease has also been appreciated. Component vaccines have been found to be safe and immunogenic in adults. There is reason to hope that within the next several years the information derived from ongoing and planned studies will support the general use of component acellular pertussis vaccines for the routine immunization of adults and children alike.

Adult↗