A Study to Assess the Safety and Immunogenicity of Heterologous Prime-Boost Ebola Vaccine Regimens in Healthy Participants

• Register: ClinicalTrials.gov
• Last refreshed on: 9 January 2017
• Main ID: NCT02376400
• Date of registration: 26/01/2015
• Prospective Registration: Yes
• Primary sponsor: Crucell Holland BV
• Public title: A Study to Assess the Safety and Immunogenicity of Heterologous Prime-Boost Ebola Vaccine Regimens in Healthy Participants
• Scientific title: A Phase 1 Study to Evaluate the Safety, Tolerability and Immunogenicity of Heterologous Prime-Boost Regimens Using MVA-BN®-Filo and Ad26.ZEBOV Administered in Different Sequences and Schedules in Healthy Adults
• Date of first enrolment: April 2015
• Target sample size: 78
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT02376400
• Study type: Interventional
• Study design: Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Prevention
• Phase: Phase 1

Countries of recruitment

Tanzania, Uganda

Contacts

• Name: Crucell Holland BV Clinical Trial
• Affiliation: Crucell Holland BV

Key inclusion & exclusion criteria

Inclusion Criteria:

- Must be healthy on the basis of physical examination, medical history, and the
investigator's clinical judgment

- Women of childbearing potential must have a negative serum beta-human chorionic
gonadotropin pregnancy test at screening, a negative urine pregnancy test immediately
prior to each study vaccine administration, and practice adequate birth control
measures from 28 days before the prime vaccination until at least 3 months after the
boost vaccination as specified in the study protocol. If not heterosexually active at
screening, must agree to practice adequate birth control measures if they become
heterosexually active during their participation in the study (from screening onwards
until at least 3 months after the boost vaccination).

- Must be available and willing to participate for the duration of the study visits and
follow-up, provide verifiable identification, and have a means to be contacted

Exclusion Criteria:

- Has been vaccinated with a candidate Ebola vaccine

- Has been diagnosed with Ebola disease or exposed to Ebola including travel to West
Africa in the last 12 months. West Africa includes but is not limited to the
countries of Guinea, Liberia, Mali, and Sierra Leone. Participants who anticipate
traveling to epidemic Ebola areas before the start of the long-term follow-up period
will also be excluded. During the long-term follow-up period, travel to epidemic
Ebola areas is allowed but during this period sampling can only take place if
participant has returned at least 1 month from the epidemic Ebola area to ensure the
samples are not carrying the Ebola-virus

- Has received any Ad26- or MVA-based candidate vaccine in the past

- Known allergy or history of anaphylaxis or other serious adverse reactions to
vaccines or vaccine products (including any of the constituents of the study
vaccines), including known allergy to egg or aminoglycosides

- A woman who is pregnant or breast-feeding, or planning to become pregnant while
enrolled in the study or within 3 months after the boost vaccination

- History of diabetes mellitus type 1 or type 2, including cases controlled with diet
alone; thyroidectomy, or thyroid disease requiring medication during the last 12
months; uncontrolled hypertension as defined in the study protocol; or, major
psychiatric illness and/or substance abuse problems during the past 12 months that in
the opinion of the investigator would preclude participation



Age minimum: 18 Years
Age maximum: 50 Years
Gender: Both

Health Condition(s) or Problem(s) studied

Healthy

Intervention(s)

Biological: Ad26.ZEBOV

Biological: MVA-BN-Filo

Biological: Placebo

Primary Outcome(s)

Number of Participants With Adverse Events [Time Frame: Up to 21 days post-boost (Day 50 for Groups 1 and 3 or Day 78 for Groups 2 and 4)]

Number of Participants With Serious Adverse Events [Time Frame: Up to the end of long-term follow-up (day 360)]

Number of Participants with Reactogenicity (that is, Solicited Local and Systemic Adverse Events) [Time Frame: 1 week after each study vaccine administration]

Secondary Outcome(s)

Immune Responses to the Study Vaccine Regimens as Measured by a Virus Neutralization Assay [Time Frame: Groups 1 and 3: Days 1 (pre-vaccination), 8, 29 (pre-vaccination), 36, 50, 113, 180, 240, and 360; Groups 2 and 4: Days 1 (pre-vaccination), 8, 29, 57 (pre-vaccination), 64, 78, 141, 180, 240, and 360)]

Immune Responses to the Study Vaccine Regimens as Measured by an Enzyme-linked Immunospot (ELIspot) Assay [Time Frame: Groups 1 and 3: Days 1 (pre-vaccination), 8, 29 (pre-vaccination), 36, 50, 113, 180, 240, and 360; Groups 2 and 4: Days 1 (pre-vaccination), 8, 29, 57 (pre-vaccination), 64, 78, 141, 180, 240, and 360)]

Immune Responses to the Study Vaccine Regimens Measured by an Enzyme-linked Immunosorbent Assay (ELISA) [Time Frame: Groups 1 and 3: Days 1 (pre-vaccination), 8, 29 (pre-vaccination), 36, 50, 113, 180, 240, and 360; Groups 2 and 4: Days 1 (pre-vaccination), 8, 29, 57 (pre-vaccination), 64, 78, 141, 180, 240, and 360)]

Secondary ID(s)

CR106459

VAC52150EBL1004

Source(s) of Monetary Support

Please refer to primary and secondary sponsors