Dataset Information

Assessment of humoral and cell-mediated immune responses to pertussis vaccination: a systematic review protocol.

ABSTRACT:

Introduction

Globally, some studies show a resurgence of pertussis. The risks and benefits of using whole-cell pertussis (wP) or acellular pertussis (aP) vaccines in the control of the disease have been widely debated. Better control of pertussis will require improved understanding of the immune response to pertussis vaccines. Improved understanding and assessment of the immunity induced by pertussis vaccines is thus imperative. Several studies have documented different immunological outcomes to pertussis vaccination from an array of assays. We propose to conduct a systematic review of the different immunological assays and outcomes used in the assessment of the humoraland cell-mediated immune response following pertussis vaccination.

Methods and analysis

The primary outcomes for consideration are quality and quantity of immune responses (humoral and cell-mediated) post-pertussis vaccination. Of interest as secondary outcomes are types of immunoassays used in assessing immune responses post-pertussis vaccination, types of biological samples used in assessing immune responses post-pertussis vaccination, as well as the types of antigens used to stimulate these samples during post-pertussis vaccination immune response assessments. Different electronic databases (including PubMed, Cochrane, EBSCO Host, Scopus and Web of Science) will be accessed for peer-reviewed published and grey literature evaluating immune responses to pertussis vaccines between 1990 and 2019. The quality of included articles will be assessed using standardised risk and quality assessment tools specific to the study design used in each article. Data extraction will be done using a data extraction form. The extracted data will be analysed using STATA V.14.0 and RevMan V.5.3 software. A subgroup analysis will be conducted based on the study population, type of vaccine (wP or aP) and type of immune response (cell-mediated or humoral). Guidelines for reporting systematic reviews in the revised 2009 Preferred Reporting Items for Systematic Reviews and Meta-Analysis (PRISMA) statement will be used in this study.

Ethics and dissemination

Ethics approval is not required for this study as it is a systematic review. We will only make use of data already available in the public space. Findings will be reported via publication in a peer-reviewed journal and presented at scientific meetings and workshops.

Trial registration number

CRD42018102455.

SUBMITTER: Akinola F

PROVIDER: S-EPMC6561409 | biostudies-literature | 2019 Jun

REPOSITORIES: biostudies-literature

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Publications

Assessment of humoral and cell-mediated immune responses to pertussis vaccination: a systematic review protocol.

Akinola Funbi F Muloiwa Rudzani R Hussey Gregory D GD Dirix Violette V Kagina Benjamin B Amponsah-Dacosta Edina E

BMJ open 20190609 6

<h4>Introduction</h4>Globally, some studies show a resurgence of pertussis. The risks and benefits of using whole-cell pertussis (wP) or acellular pertussis (aP) vaccines in the control of the disease have been widely debated. Better control of pertussis will require improved understanding of the immune response to pertussis vaccines. Improved understanding and assessment of the immunity induced by pertussis vaccines is thus imperative. Several studies have documented different immunological out ...[more]

PMID: 31182449

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Project description:BACKGROUND:Infants <?3?months of age are at highest risk for developing severe complications after pertussis. The majority of pregnant women has low concentrations of pertussis-specific antibodies and thus newborns are insufficiently protected by maternally transferred antibodies. Acellular pertussis vaccination during pregnancy was recently implemented in various countries. Here, we assessed the evidence for safety and effectiveness of pertussis vaccination during pregnancy. METHODS:We searched Medline, Embase, and ClinicalTrials.gov from January 1st 2010 to January 10th 2019. We assessed risk of bias (ROB) using the Cochrane ROB tool and ROBINS-I. We evaluated the quality of evidence using the GRADE approach. RESULTS:We identified 1273 articles and included 22 studies (14 for safety; 8 for effectiveness), comprising 1.4 million pregnant women in safety studies and 855,546 mother-infant-pairs in effectiveness studies. No significant differences between vaccinated and unvaccinated women and their infants were observed for safety outcomes with the exception of fever and chorioamnionitis. Compared to no vaccination, three studies showed a significantly increased relative risk for the presence of the ICD-9 code for chorioamnionitis in electronic patient data after pertussis vaccination. However, no study reported an increased risk for clinical sequelae of chorioamnionitis after vaccination during pregnancy, such as preterm birth or neonatal intensive care unit admission. Vaccine effectiveness against pertussis in infants of immunized mothers ranged from 69 to 91% for pertussis prevention, from 91 to 94% for prevention of hospitalization and was 95% for prevention of death due to pertussis. Risk of bias was serious to critical for safety outcomes and moderate to serious for effectiveness outcomes. GRADE evidence quality was moderate to very low, depending on outcome. CONCLUSION:Although an increased risk for a diagnosis of fever and chorioamnionitis was detected in pregnant women after pertussis vaccination, there was no association with a higher frequency of clinically relevant sequelae. Vaccine effectiveness for prevention of infant pertussis, hospitalization and death is high. Pertussis vaccination during pregnancy has an overall positive benefit-risk ratio. In view of the overall quality of available evidence ongoing surveillance of chorioamnionitis and its potential sequelae is recommended when pertussis vaccination in pregnancy is implemented. TRIAL REGISTRATION:PROSPERO CRD42018087814, CRD42018090357.

Project description:BackgroundThe Sinovac SARS-CoV-2 inactivated vaccine (CoronaVac) has been demonstrated to be safe, well tolerated, and efficacious in preventing mild and severe Covid-19. Although different studies have demonstrated its short-term immunogenicity, long-term cellular and humoral response evaluations are still lacking.MethodsCellular and humoral responses were assessed after enrollment of volunteers in the PROFISCOV phase 3 double-blind, randomized, placebo-controlled clinical trial to evaluate CoronaVac. Assays were performed using flow cytometry to evaluate cellular immune response and an antigen binding electrochemiluminescence assay to detect antigen-specific antibodies to the virus.ResultsFifty-three volunteers were selected for long term assessment of their SARS-CoV-2-specific immune responses. CD4 + T cell responses (including circulating follicular helper (cTfh, CD45RA - CXCR5 + ) expressing CD40L, as well as non-cTfh cells expressing CXCR3) were observed early upon the first vaccine dose, increased after the second dose, remaining stable for 6-months. Memory CD4 + T cells were detected in almost all vaccinees, the majority being central memory T cells. IgG levels against Wuhan/WH04/2020 N, S and receptor binding domain (RBD) antigens and the variants of concern (VOCs, including B.1.1.7/Alpha, B.1.351/Beta and P.1/Gamma) S and RBD antigens peaked 14 days after the second vaccine shot, and were mostly stable for a 1-year period.ConclusionsCoronaVac two-doses regimen is able to induce a potent and durable SARS-CoV-2 specific cellular response. The cellular reaction is part of a coordinated immune response that includes high levels of specific IgG levels against parental and SARS-CoV-2 VOC strains, still detected after one year.FundingFundação Butantan, Instituto Butantan and São Paulo Research Foundation (FAPESP) (grants 2020/10127-1 and 2020/06409-1). This work has also been supported by NIH contract 75N93019C00065 (A.S, D.W). PATH facilitated reagent donations for this work with support by the Bill & Melinda Gates Foundation (INV-021239). Under the grant conditions of the foundation, a Creative Commons Attribution 4.0 generic License has already been assigned to the Author Accepted Manuscript version that might arise from this submission.

Project description:BACKGROUND:Maternal pertussis vaccination has been introduced in several countries to prevent pertussis morbidity and mortality in infants too young to be vaccinated. Our review aimed to systematically collect and summarize the available evidence on the effectiveness of interventions used to improve pertussis vaccination uptake in pregnant women. METHODS:We conducted a systematic search of MEDLINE/PubMed, PMC and CINAHL. Before and after studies and those with a concurrent control group were considered for inclusion. Standardized effect sizes were described as the ratio of the odds to be vaccinated in the intervention group compared with the standard care group and absolute benefit increase (ABI) were calculated. RESULTS:Six studies were included in the review, of which three were randomized controlled trials (RCTs). Strategies to improve uptake were focused on healthcare providers, pregnant women, or enhancing vaccine access. Healthcare provider interventions included provider reminder, education, feedback and standing orders. Interventions directed at pregnant women focused solely on education. Observational studies showed: (1) the provision of maternal pertussis vaccination by midwives at the place of antenatal care has improved uptake of pertussis vaccine during pregnancy from 20% to 90%; (2) introduction of an automated reminder within the electronic medical record was associated with an improvement in the pertussis immunization rate from 48% to 97%; (3) an increase in prenatal pertussis vaccine uptake from 36% to 61% after strategies to increase provider awareness of recommendations were introduced. In contrast to these findings, interventions in all three RCTs (2 involved education of pregnant women, 1 had multi-component interventions) did not demonstrate improved vaccination uptake. CONCLUSIONS:Based on the existing research, we recommend incorporating midwife delivered maternal immunization programs at antenatal clinics, use of a provider reminder system to target unvaccinated pregnant women and include maternal pertussis immunization as part of standard antenatal care.

Dataset Information

Assessment of humoral and cell-mediated immune responses to pertussis vaccination: a systematic review protocol.

Introduction

Methods and analysis

Ethics and dissemination

Trial registration number

Publications

Assessment of humoral and cell-mediated immune responses to pertussis vaccination: a systematic review protocol.

Similar Datasets

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