Participants will be invited to reach into the bin to select a single sealed envelope containing a randomization assignment at the time of enrollment. randomized (1:1) to receive the 2-dose Ebola vaccine regimen (Ad26.ZEBOV, MVA-BN-Filo (group A)) or control (unvaccinated pregnant women (group B)). The primary objectives are to (1) assess adverse maternal/fetal outcomes in randomized pregnant women up to 1 1.5?months after delivery and (2) assess adverse neonatal/infant outcomes in neonates/infants born to randomized women up to 3.5?months after birth. The frequency and relatedness of all serious adverse events in women and newborns from SOCS-2 randomization or birth, respectively, until study end will be reported. The reactogenicity Eptapirone and unsolicited adverse events of the 2-dose Ebola vaccine regimen in all vaccinated pregnant women (group A) will be reported. We will also assess the immunogenicity of the 2-dose Ebola vaccine regimen in 150 pregnant women who are anticipated to receive both vaccine doses within the course of their pregnancy (a subset of the 1000 pregnant vaccinated women from group A) compared to 150 nonpregnant women vaccinated after delivery (a subset of group B). The persistence of maternal antibodies in 75 infants born to women from the group A subset will be assessed. Exploratory analyses include assessment of acceptability of the 2-dose Ebola vaccine regimen among group A and assessment of maternal antibodies in breast milk in 50 women from group A and 10 controls (women from group B prior to vaccination). Discussion This study is intended to support a label variation to relax restrictions on use in pregnant women, a vulnerable population with high medical need. Trial registration Clinicaltrials.gov “type”:”clinical-trial”,”attrs”:”text”:”NCT04556526″,”term_id”:”NCT04556526″NCT04556526. September 21, 2020. strong class=”kwd-title” Keywords: Ebola virus, Vaccine safety, Reactogenicity, Immunogenicity, Pregnancy Introduction Background and rationale 6a Ebola viruses spread in the human population through human-to-human transmission via direct contact (broken skin or mucous membranes) with blood, secretions, organs or other bodily fluids of infected persons, and with surfaces and materials (e.g., bedding and clothing) contaminated with these fluids. Ebola virus disease (EVD) has a mortality rate ranging from 40 to 90% according to the World Health Organization (WHO) [1]. The risks to mother and fetus following EVD infection Eptapirone during pregnancy are very high [2]. Prior to the 2013C2016 EVD epidemic, the case fatality rate for pregnant women was 89% (88/99) [3]. In the 2013C2016 epidemic, the case fatality rate was 53% (49/92). Pregnant women who survived EVD almost always lost their pregnancy, and survival among infants born to mothers with EVD is low [4]. Finally, infected mothers are a risk for infection of health care providers and other birth attendants. Recently, Eptapirone a vaccine (Ervebo, Merck) was licensed for protection against EVD which vaccine was utilized under an extended access program through the EVD outbreak in Democratic Republic of Congo (DRC) that finished in 2020, including in women that are pregnant. Because Ervebo is normally a live replicating vaccine, there are a few concerns with utilizing it in women that are pregnant and then the WHO Proper Advisory Band of Professionals (SAGE) functioning group suggested in Oct 2018 , the introduction of non-replicating Ebola vaccine applicants should move forward with priority, because they represent fewer basic safety concerns for make use of in being pregnant [5]. Janssen is rolling out a 2-dosage heterologous Ebola vaccine program comprising 1 dosage of Advertisement26.ZEBOV vaccine, accompanied by 1 dose of MVA-BN-Filo vaccine 8?weeks later, for dynamic immunization for avoidance of disease due to Ebola trojan (Zaire ebolavirus types) which is approved for folks??1?year old. Both Advertisement26.ZEBOV and MVA-BN-Filo are replication-incompetent vectored vaccines [6]. September 2019 On 27, the Rwanda FDA granted the Janssen Ebola vaccine conditional acceptance under exceptional crisis situations to facilitate a big vaccination advertising campaign (Umurinzi) that began on 8 Dec 2019 and aspires to vaccinate up to 200,000 nonpregnant Rwandans aged 2?years and older in the American districts bordering with DRC. Sept 2021 By 14, at least 200,000 folks have received both dosages. Clinical efficiency/basic safety studies in nonpregnant populationsThe basic safety, reactogenicity, and immunogenicity from the Ad26.ZEBOV and MVA-BN-Filo vaccines possess been/are getting evaluated in completed and ongoing clinical research in kids and adults??1?year old. Janssens current scientific development plan includes 4 finished phase 1 research (EBL1001 [7] EBL1002 [8], EBL1003 [9], EBL1004 [10, 11]), 1 finished phase 2 research (EBL2001) (manuscript under review), 2 finished phase 3 research (EBL3002 and 3003) (manuscript in planning), 3 finished phase 2/3 research (EBL2002, EBL2003, EBL3001), and a continuing phase 2/3 research that has finished dosing and it is in the follow-up stage (EBL4001) (manuscript under review). Unblinded basic safety data from 2390 adults from research (EBL1001, EBL1002,.