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

NCT ID: NCT02376400

Last Updated: 2016-12-08

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 78 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-04-30
• Study Completion Date: 2016-09-30

Brief Summary

The purpose of this study is to test the safety and immunogenicity of MVA-BN-Filo and Ad26.ZEBOV administered as heterologous prime-boost vaccine regimens in healthy adult participants.

Detailed Description

This is a randomized placebo-controlled, double-blind study evaluating the safety, tolerability and immunogenicity of MVA-BN-Filo and Ad26.ZEBOV administered in different sequences and schedules to healthy adult participants. The study consists of a screening period of up to 28 days, a vaccination period in which participants will be vaccinated at Baseline [Day 1] followed by a boost on Day 29 or 57 and a post-boost follow-up, until all participants have had their 21-day post-boost visit (Day 50 or Day 78). The participants who received active vaccine will enter a long-term follow-up. The total duration of the study will be about 1 year for participants who received vaccine and about 3 months for participants who received placebo. Immunogenicity and safety will be monitored during the study.

Conditions

Healthy

Keywords

Healthy; Ebola viruses; Ebola Viral Disease (EVD); Filoviruses; Monovalent vaccine; Human adenovirus serotype 26 (Ad26) expressing the Ebola virus Mayinga variant glycoprotein (Ad26.ZEBOV); Modified Vaccinia Virus Ankara - Bavarian Nordic Filo-vector (MVA-BN Filo); Safety; Immunogenicity

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: DOUBLE

Study Groups

Group 1

Participants will receive MVA-BN-filo/ Ad26.ZEBOV (Day 1 /Day 29) or Placebo (Day 1/Day 29).

Group Type: EXPERIMENTAL

MVA-BN-Filo

Intervention Type: BIOLOGICAL

One 0.5 milliliter (ml) intramuscular (IM) injection of 1\*10\^8, (50%Tissue Culture Infectious Dose \[TCID50\]) on Day 1, 29 or 57.

Ad26.ZEBOV

Intervention Type: BIOLOGICAL

One 0.5 mL IM injection of 5\*10\^10 viral particles (vp) on Day 1, 29 or 57.

Placebo

Intervention Type: BIOLOGICAL

One 0.5 mL IM injection of 0.9% saline on Day 1 and 29 or on Day 1 and 57.

Group 2

Participants will receive MVA-BN-filo/Ad26.ZEBOV (Day 1 /Day 57) or placebo ( Day 1/Day 57).

Group Type: EXPERIMENTAL

MVA-BN-Filo

Intervention Type: BIOLOGICAL

One 0.5 milliliter (ml) intramuscular (IM) injection of 1\*10\^8, (50%Tissue Culture Infectious Dose \[TCID50\]) on Day 1, 29 or 57.

Ad26.ZEBOV

Intervention Type: BIOLOGICAL

One 0.5 mL IM injection of 5\*10\^10 viral particles (vp) on Day 1, 29 or 57.

Placebo

Intervention Type: BIOLOGICAL

One 0.5 mL IM injection of 0.9% saline on Day 1 and 29 or on Day 1 and 57.

Group 3

Participants will receive Ad26.ZEBOV/ MVA-BN-filo (Day 1/Day 29) or placebo (Day 1/Day 29).

Group Type: EXPERIMENTAL

MVA-BN-Filo

Intervention Type: BIOLOGICAL

One 0.5 milliliter (ml) intramuscular (IM) injection of 1\*10\^8, (50%Tissue Culture Infectious Dose \[TCID50\]) on Day 1, 29 or 57.

Ad26.ZEBOV

Intervention Type: BIOLOGICAL

One 0.5 mL IM injection of 5\*10\^10 viral particles (vp) on Day 1, 29 or 57.

Placebo

Intervention Type: BIOLOGICAL

One 0.5 mL IM injection of 0.9% saline on Day 1 and 29 or on Day 1 and 57.

Group 4

Participants will receive Ad26.ZEBOV/ MVA-BN-filo (Day 1/Day 57) or placebo (Day 1/Day 57).

Group Type: EXPERIMENTAL

MVA-BN-Filo

Intervention Type: BIOLOGICAL

One 0.5 milliliter (ml) intramuscular (IM) injection of 1\*10\^8, (50%Tissue Culture Infectious Dose \[TCID50\]) on Day 1, 29 or 57.

Ad26.ZEBOV

Intervention Type: BIOLOGICAL

One 0.5 mL IM injection of 5\*10\^10 viral particles (vp) on Day 1, 29 or 57.

Placebo

Intervention Type: BIOLOGICAL

One 0.5 mL IM injection of 0.9% saline on Day 1 and 29 or on Day 1 and 57.

Interventions

MVA-BN-Filo

One 0.5 milliliter (ml) intramuscular (IM) injection of 1\*10\^8, (50%Tissue Culture Infectious Dose \[TCID50\]) on Day 1, 29 or 57.

Intervention Type: BIOLOGICAL

Ad26.ZEBOV

One 0.5 mL IM injection of 5\*10\^10 viral particles (vp) on Day 1, 29 or 57.

Intervention Type: BIOLOGICAL

Placebo

One 0.5 mL IM injection of 0.9% saline on Day 1 and 29 or on Day 1 and 57.

Intervention Type: BIOLOGICAL

Eligibility 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 50 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Crucell Holland BV

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Crucell Holland BV Clinical Trial

Role: STUDY_DIRECTOR

Crucell Holland BV

Locations

Mwanza, , Tanzania

Entebbe, , Uganda

Countries

Tanzania; Uganda

References

Anywaine Z, Whitworth H, Kaleebu P, Praygod G, Shukarev G, Manno D, Kapiga S, Grosskurth H, Kalluvya S, Bockstal V, Anumendem D, Luhn K, Robinson C, Douoguih M, Watson-Jones D. Safety and Immunogenicity of a 2-Dose Heterologous Vaccination Regimen With Ad26.ZEBOV and MVA-BN-Filo Ebola Vaccines: 12-Month Data From a Phase 1 Randomized Clinical Trial in Uganda and Tanzania. J Infect Dis. 2019 Jun 5;220(1):46-56. doi: 10.1093/infdis/jiz070.

Reference Type: DERIVED

PMID: 30796818 (View on PubMed)

Other Identifiers

VAC52150EBL1004

Identifier Type: OTHER

Identifier Source: secondary_id

CR106459

Identifier Type: -

Identifier Source: org_study_id