Dataset Information

Anaphylaxis following quadrivalent human papillomavirus vaccination.

ABSTRACT:

Background

In 2007, Australia implemented the National human papillomavirus (HPV) Vaccination Program, which provides quadrivalent HPV vaccine free to all women aged 12-26 years. Following notification of 7 presumptive cases of anaphylaxis in the state of New South Wales, Australia, we verified cases and compared the incidence of anaphylaxis following HPV vaccination to other vaccines in comparable settings.

Methods

We contacted all patients with suspected anaphylaxis and obtained detailed histories from telephone interviews and a review of medical records. A multidisciplinary team determined whether each suspected case met the standardized Brighton definition. Some participants also received skin-prick allergy testing for common antigens and components of the HPV vaccine.

Results

Of 12 suspected cases, 8 were classified as anaphylaxis. Of these, 4 participants had negative skin-prick test results for intradermal Gardasil. From the 269 680 HPV vaccine doses administered in schools, 7 cases of anaphylaxis were identified, which represents an incidence rate of 2.6 per 100 000 doses (95% CI 1.0-5.3 per 100 000). In comparison, the rate of identified anaphylaxis was 0.1 per 100 000 doses (95% CI 0.003-0.7) for conjugated meningococcal C vaccination in a 2003 school-based program.

Interpretation

Based on the number of confirmed cases, the estimated rate of anaphylaxis following quadrivalent HPV vaccine was significantly higher than identified in comparable school-based delivery of other vaccines. However, overall rates were very low and managed appropriately with no serious sequelae.

SUBMITTER: Brotherton JM

PROVIDER: S-EPMC2527382 | biostudies-literature | 2008 Sep

REPOSITORIES: biostudies-literature

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Publications

Anaphylaxis following quadrivalent human papillomavirus vaccination.

Brotherton Julia M L JM Gold Mike S MS Kemp Andrew S AS McIntyre Peter B PB Burgess Margaret A MA Campbell-Lloyd Sue S

CMAJ : Canadian Medical Association journal = journal de l'Association medicale canadienne 20080901 6

<h4>Background</h4>In 2007, Australia implemented the National human papillomavirus (HPV) Vaccination Program, which provides quadrivalent HPV vaccine free to all women aged 12-26 years. Following notification of 7 presumptive cases of anaphylaxis in the state of New South Wales, Australia, we verified cases and compared the incidence of anaphylaxis following HPV vaccination to other vaccines in comparable settings.<h4>Methods</h4>We contacted all patients with suspected anaphylaxis and obtained ...[more]

PMID: 18762618

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Project description:ImportanceHuman papillomavirus (HPV) infection is found in about 40% of women who survive allogeneic hematopoietic stem cell transplant and can induce subsequent neoplasms.ObjectiveTo determine the safety and immunogenicity of the quadrivalent HPV vaccine (HPV-6, -11, -16, and -18) in clinically stable women post-allogeneic transplant compared with female healthy volunteers.InterventionsParticipants received the quadrivalent HPV vaccine in intramuscular injections on days 1 and 2 and then 6 months later.Design, setting, and participantsThis prospective, open-label phase-1 study was conducted in a government clinical research hospital and included clinically stable women posttransplant who were or were not receiving immunosuppressive therapy compared with healthy female volunteers age 18 to 50 years who were followed up or a year after first receiving quadrivalent HPV vaccination. The study was conducted from June 2, 2010, until July 19, 2016. After all of the results of the study assays were completed and available in early 2018, the analysis took place from February 2018 to May 2019.Main outcomes and measuresAnti-HPV-6, -11, -16, and -18-specific antibody responses using L1 virus-like particle enzyme-linked immunosorbent assay were measured in serum before (day 1) and at months 7 and 12 postvaccination. Anti-HPV-16 and -18 neutralization titers were determined using a pseudovirion-based neutralization assay.ResultsOf 64 vaccinated women, 23 (35.9%) were receiving immunosuppressive therapy (median age, 34 years [range, 18-48 years]; median 1.2 years posttransplant), 21 (32.8%) were not receiving immunosuppression (median age, 32 years [range, 18-49 years]; median 2.5 years posttransplant), and 20 (31.3%) were healthy volunteers (median age, 32 years [range, 23-45 years]). After vaccine series completion, 18 of 23 patients receiving immunosuppression (78.3%), 20 of 21 not receiving immunosuppression (95.2%), and all 20 volunteers developed antibody responses to all quadrivalent HPV vaccine types (P = .04, comparing the 3 groups). Geometric mean antibody levels for each HPV type were higher at months 7 and 12 than at baseline in each group (all geometric mean ratios >1; P < .001) but not significantly different across groups. Antibody and neutralization titers for anti-HPV-16 and anti-HPV-18 correlated at month 7 (Spearman ρ = 0.92; P < .001 for both). Adverse events were mild and not different across groups.Conclusions and relevanceTreatment with the HPV vaccination was followed by strong, functionally active antibody responses against vaccine-related HPV types and no serious adverse events. These findings suggest that HPV vaccination may be safely administered to women posttransplant to potentially reduce HPV infection and related neoplasia.Trial registrationClinicalTrials.gov Identifier: NCT01092195.

Project description:BackgroundClaims of non-live vaccines having deleterious effects on non-targeted infectious disease and mortality among females persists. The majority of the available evidence is from West Africa and consists of observational studies and the interpretation and implications are controversial. Results from high-income countries have been conflicting. We evaluated the association between a human papillomavirus vaccine, a non-live vaccine primarily administered to pre-adolescent females, and non-targeted infectious disease in a high-income country.MethodsWe constructed a nationwide cohort of all Danish females 10 to 29 years of age during 2007 to 2016 with information on quadrivalent human papillomavirus vaccination status and infectious disease hospital contacts using national registers. Nested in this cohort, we conducted a self-controlled case series (SCCS) analysis comparing the rates of hospitalisation in a 90-day main risk period following the latest vaccination to reference period rates with adjustment for age and season.FindingsWe included 853,879 Danish-born females aged 10 to 29 years of age during the 2007 to 2016 study period in the study cohort. We identified a total of 65,293 infectious disease hospitalisations among 50,599 participants; 46,955 cases among 37,003 participants vaccinated during follow-up were included in the SCCS analysis. There was no statistically significantly increased risk of infectious disease hospitalisation in the 90-day main risk period (rate ratio 0.92, 95% CI 0.88 to 0.95).InterpretationReassuringly, our large well-controlled study does not support that human papillomavirus vaccination increases the risk of non-targeted infectious disease in any clinically meaningful way. While our study does not provide evidence against adverse effects of other non-live vaccines, it does provide evidence against the claim that all non-live vaccines increase risk of heterologous infections in females.FundingThe study was supported by the Novo Nordisk Foundation.

Dataset Information

Anaphylaxis following quadrivalent human papillomavirus vaccination.

Background

Methods

Results

Interpretation

Publications

Anaphylaxis following quadrivalent human papillomavirus vaccination.

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