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cAd3-Marburg Vaccine in Healthy Adults

2018-03-29 03:17:24 | BioPortfolio

Summary

RV 507 is a Phase I, open-label study to examine safety, tolerability and immunogenicity of an investigational Marburg vaccine given by intramuscular (IM) injection to healthy adults. The study is a dose escalation of VRC-MARADC087-00-VP, a chimpanzee adenovirus serotype 3 vector vaccine, which encodes wild type (WT) glycoprotein (GP) from Marburgvirus.

Description

It is anticipated that about 100 volunteers will be screened in order to enroll a total of 40 participants. The 40 enrolled participants will be evenly split, with 20 in each of the two dosage groups for cAd3-Marburg. The dose escalation plan includes daily review of any new safety data by a study clinician, regular review of safety data by the protocol team and a staged enrollment plan with required interim safety reviews. The study will begin with enrollment of 3 participants into Group 1 at a rate of 1 participant per day. After at least 7 days of follow-up for the first 3 vaccinated participants, an interim safety review will occur before enrollment of additional participants into the group. If no safety issues are identified, an additional 17 participants will be enrolled to complete Group 1. When there is a minimum of seven days of follow-up safety data from the last enrolled participant in Group 1, an interim safety review will occur. Once no safety issues are identified, enrollment of participants into the next dose level will begin with the enrollment of 3 participants at a rate of 1 participant per day. After at least 7 days of follow-up for the first 3 vaccinated participants in Group 2, an interim safety review will occur before the enrollment of additional participants into Group 2. If no safety issues are identified, an additional 17 participants will be enrolled to complete Group 2.

Study Design

Conditions

Marburg Virus Disease

Intervention

cAd3-Marburg vaccine

Location

WRAIR Clinical Trials Center,
Silver Spring
Maryland
United States
20910

Status

Not yet recruiting

Source

National Institute of Allergy and Infectious Diseases (NIAID)

Results (where available)

View Results

Links

Published on BioPortfolio: 2018-03-29T03:17:24-0400

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