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Effects of vaccines in protecting against Ebola virus disease: protocol for a systematic review.

ABSTRACT: INTRODUCTION:Ebola virus disease is one of the most devastating infectious diseases in the world with up to 90% case fatality observed. There are at least 13 candidate vaccines developed and being tested to prevent the occurrence of the Ebola virus disease. While none of these candidate vaccines has received regulatory approval for use, one candidate vaccine (rVSVΔG-ZEBOV-GP) has been granted access for emergency use. Two other candidate vaccines (GamEvac-Combi and Ad5-EBOV) have been licensed for emergency use in their countries of origin. The objective of this systematic review is to summarise the effects of the Ebola candidate vaccines in humans. METHODS AND ANALYSIS:We will search for potentially eligible studies, with no language or date restrictions, in the Cochrane Central Register of Controlled Trials, PubMed, Scopus, the WHO International Clinical Trial Registry Platform, and reference lists of relevant publications. The Cochrane Database of Systematic Reviews (CDSR) and the Database of Abstracts of Reviews of Effect (DARE) will be searched for related reviews. Two review authors will independently screen search records, assess study eligibility, perform data extraction, and assess the risk of bias; and reconcile their findings. We will pool data from similar studies using Mantel-Haenszel's fixed-effect model. ETHICS AND DISSEMINATION:This study is exempted from ethical consideration since the data collected are publicly available and at no point will confidential information from human participants be used. We will disseminate our results through publications in peer-reviewed journals and relevant conferences. PROSPERO REGISTRATION NUMBER:CRD42018110505.

SUBMITTER: Mathebula L

PROVIDER: S-EPMC6615805 | biostudies-other | 2019 Jul

REPOSITORIES: biostudies-other

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Effects of vaccines in protecting against Ebola virus disease: protocol for a systematic review.

Mathebula Lindi L Ndwandwe Duduzile Edith DE Pienaar Elizabeth E Wiysonge Charles Shey CS

BMJ open 20190703 7

<h4>Introduction</h4>Ebola virus disease is one of the most devastating infectious diseases in the world with up to 90% case fatality observed. There are at least 13 candidate vaccines developed and being tested to prevent the occurrence of the Ebola virus disease. While none of these candidate vaccines has received regulatory approval for use, one candidate vaccine (rVSVΔG-ZEBOV-GP) has been granted access for emergency use. Two other candidate vaccines (GamEvac-Combi and Ad5-EBOV) have been li ...[more]

PMID: 31272985

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Project description:BackgroundSpecific treatments targeting Ebola virus are crucial in managing Ebola virus disease. To support the development of clinical practice guidelines on medications for Ebola virus disease, we aimed to evaluate the efficacy and safety of therapies for patients with Ebola virus disease.MethodsIn this systematic review and network meta-analysis, we searched MEDLINE, Embase, the Cochrane Central Register of Controlled Trials, Scopus, Global Health, African Index Medicus, World Health Organization Global Index Medicus, the Cumulative Index to Nursing and Allied Health Literature, ClinicalTrials.gov, Epistemonikos, bioRxiv, medRxiv, and SSRN without language restrictions for randomised controlled trials (RCTs) published between database inception and Jan 1, 2022, comparing at least one therapeutic agent for Ebola virus disease against standard care or another therapeutic agent for Ebola virus disease. Two reviewers assessed study eligibility and extracted summary data independently using a standardised form. Our outcomes of interest were mortality, adverse maternal outcomes, risk of onward transmission, duration of admission to a health-care facility, functional status after Ebola virus disease, serious adverse events from medication, adverse perinatal outcomes, time to symptom resolution, and time to viral clearance. We did frequentist network meta-analyses to estimate the effect of all interventions and applied the Grading of Recommendations Assessment, Development and Evaluation approach to rate the certainty of the evidence. We registered the protocol with PROSPERO, CRD42022296539.FindingsWe identified 7840 records through database searches, of which two RCTs with a total of 753 patients proved eligible. Only data on mortality, the duration of admission, serious adverse events, and time to viral clearance were available for meta-analysis. Compared with standard care, REGN-EB3 (relative risk [RR] 0·40, 95% CI 0·18 to 0·89; moderate certainty) and mAb114 (0·42, 0·19 to 0·93; moderate certainty) probably reduce mortality. Whether ZMapp (0·60, 0·28 to 1·26; very low certainty) and remdesivir (0·64, 0·29 to 1·39; very low certainty) reduce mortality compared with standard care is uncertain. With high certainty, REGN-EB3 reduces mortality compared with ZMapp (0·67, 0·52 to 0·88) and remdesivir (0·63, 0·49 to 0·82). With high certainty, mAb114 also reduces mortality compared with ZMapp (0·71, 0·55 to 0·91) and remdesivir (0·66, 0·52 to 0·84). Compared with standard care, REGN-EB3, mAb114, ZMapp, and remdesivir might have little or no effect on the time to viral clearance (mean difference ranged from -0·25 days to -1·14 days; low certainty). ZMapp might reduce the duration of admission compared with standard care (mean difference -2·02 days, 95% CI -4·05 to 0·01; low certainty). Findings for all comparisons suggested that there might be little or no difference in the prevalence of serious adverse events, but certainty was low or very low in all comparisons but one.InterpretationREGN-EB3 and mAb114 separately reduce mortality compared with ZMapp, remdesivir, or standard care in patients with Ebola virus disease. These findings suggest that health-care workers should prioritise the use of REGN-EB3 and mAb114 for patients with Ebola virus disease during future outbreaks.FundingWHO.

Project description:BackgroundInfluenza vaccines are most effective when the antigens in the vaccine match those of circulating influenza strains. The extent to which the vaccine is protective when circulating strains differ from vaccine antigens, or are mismatched, is uncertain. We propose to systematically review the cross-protection offered by influenza vaccines against circulating influenza A or B viruses that are not antigenically well-matched to vaccine strains.Methods/designThis is a protocol for a systematic review and meta-analysis. Placebo-controlled randomized clinical trials (RCTs) reporting laboratory-confirmed influenza among healthy participants vaccinated with antigens of influenza strains that differed from those circulating will be included. The primary outcome is the incidence of laboratory-confirmed influenza (polymerase chain reaction (PCR) or viral culture). The secondary outcome is the incidence of laboratory-confirmed influenza through antibody assay (a less sensitive test than PCR or viral culture) alone or combined with PCR, and/ or viral culture. The review will be limited to RCTs written in English.We will search MEDLINE, EMBASE, the Cochrane Central Register of Controlled Trials, previous influenza reviews, and the reference lists of included studies to identify potentially relevant RCTs. Two independent reviewers will conduct all levels of screening, data abstraction, and quality appraisal (using the Cochrane risk of bias tool).If appropriate, random effects meta-analysis of vaccine efficacy will be conducted in SAS (version 9.2) by calculating the relative risk. Vaccine efficacy will be calculated using the following formula: (1 - relative risk × 100). The results will be analyzed by type of vaccine (live attenuated, trivalent inactivated, or other). Subgroup analysis will include the effects of age (children, adults, older participants), and influenza A versus influenza B on the results. For influenza B we will also consider variable degrees of antigenic mismatch (lineage and drift mismatch).DiscussionOur results can be used by researchers and policy-makers to help predict the efficacy of influenza vaccines during mismatched influenza seasons. Furthermore, the review will be of interest to patients and clinicians to determine whether to get immunized or support immunization for a particular influenza season.

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Effects of vaccines in protecting against Ebola virus disease: protocol for a systematic review.

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Effects of vaccines in protecting against Ebola virus disease: protocol for a systematic review.

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