Clinical Trial: Clinical Trial of Ebola Vaccines cAd3-EBO, cAd3-EBOZ and MVA-EbolaZ in Healthy Adults in Uganda
Study Status: Active, not recruiting
Recruit Status: Active, not recruiting
Study Type: Interventional
Official Title: Phase 1B, Open-Label, Clinical Trial to Evaluate Safety, Tolerability and Immunogenicity of the Investigational Ebola Vaccines, VRC-EBOADC069-00-VP, VRC-EBOADC076-00-VP and VRC-EBOMVA079-00-VP in Heal
Brief Summary:
Phase Ib study in 90 healthy adults,18 years to 65 years of age, to evaluate the safety, tolerability and immunogenicity of the VRC-EBOADC069-00-VP (cAd3-EBO) and VRC-EBOADC076-00-VP (cAd3-EBOZ) investigational Ebola vaccines in Part 1 and boosting with the VRC-EBOMVA079-00-VP (MVA-EbolaZ) investigational Ebola vaccine in Part 2.
Part 1: Randomizations to cAd3-EBO or cAd3-EBOZ at two different dose levels within Group 1 will include at least 60 volunteers who have never received an investigational Ebola vaccine. Randomizations to cAd3-EBO at two different dose levels within Group 2 may include up to 30 eligible participants who previously participated in the RV 247 vaccine clinical trial and received the investigational VRC-EBODNA023-00-VP (Ebola DNA WT) vaccine.
Part 2: Participants in Part 1 may receive a booster vaccination with the MVA-EbolaZ vaccine at the same dose level.
Detailed Summary:
Study Design: This Phase 1b, open-label study to examine safety, tolerability and immunogenicity of investigational Ebola vaccines is conducted in two Parts. In Part 1 subjects are randomized to receive either the cAd3-EBO or cAd3-EBOZ vaccine at two different dose levels. In Part 2, participants from Part 1 may receive a booster injection with the MVA-EbolaZ vaccine; all at the same dose level. The hypotheses are that the study vaccines, cAd3-EBO, cAd3-EBOZ and MVA-EbolaZ, will be safe and will elicit immune responses to Ebola glycoprotein (GP). The primary objectives are to evaluate the safety and tolerability of the study vaccines administered as intramuscular (IM) injections. The secondary objectives are related to immunogenicity.
Study Products Description:
VRC-EBOADC069-00-VP (cAd3-EBO) is composed of two recombinant cAd3 vectors in a 1:1 ratio that express Ebola WT GPs from Zaire and Sudan strains. It is formulated at 2x10(11) particle units (PU)/mL.
VRC-EBOADC076-00-VP (cAd3-EBOZ) is composed of a cAd3 vector that expresses Ebola WT GP from the Zaire strain. It is formulated at 1x10(11) PU/mL.
VRC-DILADC065-00-VP (diluent) is the vaccine formulation buffer and will be used when needed to prepare the correct dosage of cAd3-EBO or cAd3-EBOZ.
VRC-EBOMVA079-00-VP (MVA-EbolaZ) is composed of a MVA vector that expresses Ebola WT GP from the Zaire strain. It is formulated at 3.2x10(8) PFU/mL.
Part 1 Study Plan:
Group 1: 60 volunteers will be randomized: 15 in each of the two dosage groups for VRC-EBOADC069-00-VP [2x10(10) PU or 2x10(11) PU] and 15 in each of the two dosage gro
Sponsor: National Institute of Allergy and Infectious Diseases (NIAID)
Current Primary Outcome:
- Incidence of solicited adverse events after vaccination [ Time Frame: 7 days ]Incidence is reported for solicited events for 7 days after each vaccination.
- Incidence of unsolicited adverse events of any severity 28 days after vaccination [ Time Frame: 28 days ]Incidence is reported for unsolicited events for 28 days after each vaccination. The reporting period is Day 0 to Day 28.
- Incidence of serious adverse events or new chronic medical conditions through the last study visit [ Time Frame: From first study injection through 48 weeks after final study injection ]Incidence is reported of serious adverse events and new chronic medical conditions for 48 weeks after vaccination.
- Mean change from baseline in safety laboratory measures [ Time Frame: 28 days after each vaccination ]At Days 2 or 3, 14, and 28 blood will be drawn to measure safety measures that many include CBC, creatinine, ALT, PT and PTT.
Original Primary Outcome:
- Incidence of solicited adverse events after vaccination [ Time Frame: 7 days ]Incidence is reported for solicited events for 7 days after vaccination.
- Incidence of unsolicited adverse events of any severity 28 days after vaccination [ Time Frame: 28 days ]Incidence is reported for unsolicited events for 28 days after vaccination. The reporting period is Day 0 to Day 28.
- Incidence of serious adverse events or new chronic medical conditions through the last study visit [ Time Frame: 48 weeks ]Incidence is reported of serious adverse events and new chronic medical conditions for 48 weeks after vaccination.
- Mean change from baseline in safety laboratory measures [ Time Frame: 28 days ]At Day 3, 14, and 28 blood will be drawn to measure safety measures that many include CBC, creatinine, ALT, PT and PTT.
Current Secondary Outcome:
- Antibody response to Ebola GP as measured by ELISA [ Time Frame: 4 weeks after each vaccination ]Blood is collected at baseline and 4 weeks after vaccination
- Antibody response to Ebola GP as measured by neutralization assay [ Time Frame: 4 weeks after vaccination ]Blood is collected at baseline and 4 weeks after vaccination
- T cell immune response measured by intracellular cytokine staining (ICS) [ Time Frame: 4 weeks after vaccination ]Blood is collected at baseline and 4 weeks after vaccination
Original Secondary Outcome:
- Antibody response as measured by ELISA [ Time Frame: 4 weeks after vaccination ]Blood is collected at baseline and every scheduled visit
- Antibody response measured by neutralization assay [ Time Frame: 4 weeks after vaccination ]Blood is collected at baseline and every scheduled visit
- T cell immune response measured by intracellular cytokine staining (ICS) [ Time Frame: 4 weeks after vaccination ]Blood is collected at baseline and every scheduled visit starting on Day 7
Information By: National Institute of Allergy and Infectious Diseases (NIAID)
Dates:
Date Received: January 29, 2015
Date Started: January 2015
Date Completion: June 2017
Last Updated: April 4, 2016
Last Verified: April 2016
