OVERVIEW OF EBOLA I STUDY DESIGN

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This is a Phase 1, randomized, placebo-controlled, observer-blind study

evaluating the safety, tolerability and immunogenicity of 4 regimens using

MVA-BN-Filo at a dose of 1x108 TCID50 and Ad26.ZEBOV at a dose of 5x1010 vp:

2 regimens will have MVA-BN-Filo as prime and Ad26.ZEBOV as boost at a

28- or 56-day interval and 2 regimens will have Ad26.ZEBOV as prime and

MVA-BN-Filo as boost at a 28- or 56-day interval. The study will be conducted

in approximately 72 healthy adult subjects who never received an experimental

Ebola candidate vaccine before and have no known exposure to or diagnosis of

Ebola disease.

 

The study consists of a screening period of up to 28 days, a vaccination period in

which subjects will be vaccinated at baseline (Day 1) followed by a boost on

Day 29 or 57, and a post-boost follow-up until all subjects have had their

21-day post-boost visit (Day 50 or Day 78) or discontinued earlier. At that

time the study will be unblinded. Subjects who received placebo will be

contacted to communicate that they have completed the study and do not

need to contact the site any longer. Subjects who received active vaccine will

enter a long-term follow-up, with visits on Days 180 (±15 days), 240 (±30 days)

and 360 (±30 days) post-prime.

 

The blinded Principal Investigator will be responsible for the safety monitoring

of the study. If at least one pre-specified pausing rule is met, study

vaccinations will be paused and an Independent Data Monitoring Committee

(IDMC) meeting will be convened. Subjects will be enrolled into 4 different

groups, comprising 18 healthy subjects each. Overall, subjects will be

randomized within group in a 5:1 ratio to receive either active vaccine or placebo

(0.9% saline) through intramuscular (IM) injections (0.5 mL) as follows:

 

  • MVA-BN-Filo (1x108 TCID50) administered on Day 1, followed by a booster of
  • Ad26.ZEBOV (5x1010 vp) on Day 29 (Group 1) or Day 57 (Group 2), or

 

  • Ad26.ZEBOV (5x1010 VP) administered on Day 1, followed by a booster of
  • MVA-BN-Filo (1x108 TCID50) on Day 29 (Group 3) or Day 57 (Group 4).

 

Enrollment of subjects in Groups 1 and 3 will start with vaccination of 1/1

subjects (active vaccine/placebo; Sentinel Cohort) to assess the tolerability of

the 2 study vaccines over a 24-hour period before exposing larger cohorts of

subjects to the vaccines. At least 24 hours (but no more than 30 hours) after the

prime vaccination, subjects will come to the site (or be visited at home) to

verify the absence of any predefined events (i.e., a serious adverse event

considered to be related to any of the study vaccines, signs of anaphylaxis or

generalized urticaria clearly attributable to study vaccination, a severe [grade 3] systemic adverse event considered to be related to any of the study vaccines, a severe [grade 3] solicited local [injection site] adverse event, a severe [grade 3]

solicited systemic adverse event considered to be related to any of the study

vaccines, or death). Enrollment of the next cohorts will be as follows:

 

  • Groups 1 and 3: 4/1 subjects (active vaccine/placebo; Cohort 1) followed, in the
  • absence of any of the above-mentioned events, confirmed during a visit (at the
  • site or at the subject’s home) for each subject at least 24 hours (but no more
  • than 30 hours) after prime vaccination, by 10/1 subjects (active vaccine/placebo;
  • Cohort 2)

 

  • Groups 2 and 4: 5/1 subjects (active vaccine/placebo; Cohort 1) followed, in the
  • absence of any of the above-mentioned events, confirmed during a visit (at the
  • site or at the subject’s home) for each subject at least 24 hours (but no more
  • than 30 hours) after prime vaccination, by 10/2 subjects (active vaccine/placebo;
  • Cohort 2)

 

The enrollment of all subjects of Cohort 1 will be carried out ideally on the same

day. Also the enrollment of all subjects of Cohort 2 will be carried out ideally

on the same day. If the enrollment of Cohort 1 is carried out over more than 1

day, enrollment of Cohort 2 in that group may only begin after the safety of

the last subject in Cohort 1 has been assessed (i.e., 24 to 30 hours after the

prime vaccination).

 

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Contacts

KAVI Institute of Clinical Research (KAVI-ICR)

College of Health Sciences

University of Nairobi

P.O. Box 19676 - 00202

Nairobi,

Kenya.

 

Telephone: +254-20-2717694/2725404

 

Mobile: +254-722-207417

 

Fax: +254-20-2714613

 

E-mail: kavi@kaviuon.org

 

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