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Monitoring Serious Adverse Events in the Sierra Leone Trial to Introduce a Vaccine Against Ebola.

ABSTRACT: Clinical Trials Registration:ClinicalTrials.gov [NCT02378753] and Pan African Clinical Trials Registry [PACTR201502001037220].

SUBMITTER: Jarrett OD

PROVIDER: S-EPMC5961367 | biostudies-literature | 2018 May

REPOSITORIES: biostudies-literature

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Monitoring Serious Adverse Events in the Sierra Leone Trial to Introduce a Vaccine Against Ebola.

Jarrett Olamide D OD Seward Jane F JF Fombah Augustin E AE Lindblad Robert R Jalloh Mohamed I MI El-Khorazaty Jill J Dawson Peter P Burton Deron D Zucker Jane J Carr Wendy W Bah Mohamed M MM Deen Gibrilla F GF George Peter M PM James Faustine F Lisk Durodami R DR Pratt Dudley D Russell James B W JBW Sandy Jibao D JD Turay Patrick P Hamel Mary J MJ Schrag Stephanie J SJ Walker Robert E RE Samai Mohamed M Goldstein Susan T ST

The Journal of infectious diseases 20180501 suppl_1

<h4>Clinical trials registration</h4>ClinicalTrials.gov [NCT02378753] and Pan African Clinical Trials Registry [PACTR201502001037220]. ...[more]

PMID: 29788346

Similar Datasets

Health Conditions in an Adult Population in Sierra Leone: Data Reported From the Sierra Leone Trial to Introduce a Vaccine Against Ebola (STRIVE).

Project description:Clinical Trials Registration:ClinicalTrials.gov [NCT02378753] and Pan African Clinical Trials Registry [PACTR201502001037220].

| S-EPMC6927886 | biostudies-literature

Pregnancy Outcomes among Women Receiving rVSVΔ-ZEBOV-GP Ebola Vaccine during the Sierra Leone Trial to Introduce a Vaccine against Ebola.

Project description:Little information exists regarding Ebola vaccine rVSVΔG-ZEBOV-GP and pregnancy. The Sierra Leone Trial to Introduce a Vaccine against Ebola (STRIVE) randomized participants without blinding to immediate or deferred (18-24 weeks postenrollment) vaccination. Pregnancy was an exclusion criterion, but 84 women were inadvertently vaccinated in early pregnancy or became pregnant <60 days after vaccination or enrollment. Among immediate vaccinated women, 45% (14/31) reported pregnancy loss, compared with 33% (11/33) of unvaccinated women with contemporaneous pregnancies (relative risk 1.35, 95% CI 0.73-2.52). Pregnancy loss was similar among women with higher risk for vaccine viremia (conception before or <14 days after vaccination) (44% [4/9]) and women with lower risk (conception >15 days after vaccination) (45% [10/22]). No congenital anomalies were detected among 44 live-born infants examined. These data highlight the need for Ebola vaccination decisions to balance the possible risk for an adverse pregnancy outcome with the risk for Ebola exposure.

| S-EPMC7045819 | biostudies-literature

Clinical Surveillance and Evaluation of Suspected Ebola Cases in a Vaccine Trial During an Ebola Epidemic: The Sierra Leone Trial to Introduce a Vaccine Against Ebola.

Project description:Clinical Trials Registration:ClinicalTrials.gov [NCT02378753] and Pan African Clinical Trials Registry [PACTR201502001037220].

| S-EPMC6927893 | biostudies-literature

The Sierra Leone Trial to Introduce a Vaccine Against Ebola: An Evaluation of rVSV?G-ZEBOV-GP Vaccine Tolerability and Safety During the West Africa Ebola Outbreak.

Project description:Clinical Trials Registration:ClinicalTrials.gov [NCT02378753] and Pan African Clinical Trials Registry [PACTR201502001037220].

| S-EPMC5961340 | biostudies-literature

Implementing a Multisite Clinical Trial in the Midst of an Ebola Outbreak: Lessons Learned From the Sierra Leone Trial to Introduce a Vaccine Against Ebola.

Project description:The Sierra Leone Trial to Introduce a Vaccine against Ebola (STRIVE), a phase 2/3 trial of investigational rVSV?G-ZEBOV-GP vaccine, was conducted during an unprecedented Ebola epidemic. More than 8600 eligible healthcare and frontline response workers were individually randomized to immediate (within 7 days) or deferred (within 18-24 weeks) vaccination and followed for 6 months after vaccination for serious adverse events and Ebola virus infection. Key challenges included limited infrastructure to support trial activities, unreliable electricity, and staff with limited clinical trial experience. Study staff made substantial infrastructure investments, including renovation of enrollment sites, laboratories, and government cold chain facilities, and imported equipment to store and transport vaccine at ?-60oC. STRIVE built capacity by providing didactic and practical research training to >350 staff, which was reinforced with daily review and feedback meetings. The operational challenges of safety follow-up were addressed by issuing mobile telephones to participants, making home visits, and establishing a nurse triage hotline. Before the Ebola outbreak, Sierra Leone had limited infrastructure and staff to conduct clinical trials. Without interfering with the outbreak response, STRIVE responded to an urgent need and helped build this capacity. CLINICAL TRIALS REGISTRATION:ClinicalTrials.gov [NCT02378753] and Pan African Clinical Trials Registry [PACTR201502001037220].

| S-EPMC5961126 | biostudies-literature

Participant Retention in a Randomized Clinical Trial in an Outbreak Setting: Lessons From the Sierra Leone Trial to Introduce a Vaccine Against Ebola (STRIVE).

Project description:Clinical Trials Registration:ClinicalTrials.gov [NCT02378753] and Pan African Clinical Trials Registry [PACTR201502001037220].

| S-EPMC5961184 | biostudies-literature

Operationalizing International Regulatory Standards in a Limited-Resource Setting During an Epidemic: The Sierra Leone Trial to Introduce a Vaccine Against Ebola (STRIVE) Experience.

Project description:Clinical trials registrationClinicalTrials.gov [NCT02378753] and Pan African Clinical Trials Registry [PACTR201502001037220].

| S-EPMC6927842 | biostudies-literature

Ebola wreaks havoc in Sierra Leone.

Project description:BACKGROUND: Ebola virus disease has taken a toll on more than 8,000 lives in West Africa in 2014. The most affected countries are Guinea, Liberia, and Sierra Leone. The number of people infected by Ebola in Sierra Leone surpassed that of Liberia in the last month in this year and almost half of human cases are distributed in this country. DISCUSSION: The ignorance on Ebola among people, including health workers at the early stage, plaid an important role in spread of Ebola virus disease. Subsequently, Ebola ravages urban settings for the first time and takes a huge toll on the lives. The government and international partners do make efforts to control the epidemic, however, lack of synergy make them lip service. SUMMARY: The leading role of government in the response to the epidemic should be emphasized. Basic information of Ebola should be quickly spread among communities by health education programme and social mobilization should be a basic measure for Ebola control.

| S-EPMC4328734 | biostudies-literature

Utilizing Nurses to Staff an Ebola Vaccine Clinical Trial in Sierra Leone during the Ebola Outbreak.

Project description:Clinical Trials Registration:ClinicalTrials.gov [NCT02378753] and Pan African Clinical Trials Registry [PACTR201502001037220].

| S-EPMC5961084 | biostudies-literature

Post-Ebola sequelae among Ebola child survivors in Sierra Leone.

Project description:BackgroundThere are limited data regarding the long-term health effects of child survivors of the 2013-2016 West African Ebola virus disease (EVD) outbreak. Here, we assess post-Ebola sequelae among EVD child survivors by comparing the self-reported symptoms between EVD child survivors and their close household contacts over one year after the end of the outbreak.MethodsEVD child survivors(n=159) and their close contacts(n=303) were enrolled in Western and Eastern Sierra Leone. Demographics and self-reported symptoms data were collected using an interviewer-administered questionnaire. We compared a list of self-reported symptoms between EVD child survivors and their close household contacts using backward stepwise logistic regression.ResultsEVD child survivors were more likely to be orphans compared to their close contacts. Musculoskeletal, ocular, auditory and neurological symptoms were more prevalent among Ebola child survivors than their close contacts (p<0.001). Joint pain and headache were the most common self-reported symptoms in EVD child survivors and their close contacts. Joint pain (AOR=2.633; 95 % CI:1.31-5.28, p=0.006), eye pain (AOR=4.56;95 %CI: 2.16-9.64, p<0.001), hearing loss (AOR=3.85; 95 %CI: 1.15-12.87, p=0.029), memory impairment (AOR=7.76;0.95 %CI: 1.34-45.01 p=0.022), mood changes (AOR=5.07; 95 %CI: 2.35-10.94, p<0.001) were more common among survivors than their contacts.ConclusionsOur data suggest that EVD child survivors have higher odds than their close contacts of suffering from musculoskeletal, ophthalmic, auditory and neurological impairment more than a year after the end of the EVD outbreak. Routine screening, treatment and monitoring of these symptoms is required to prevent long-term disability among EVD child survivors.

| S-EPMC8556876 | biostudies-literature

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