Safety, Tolerability and Immunogenicity Study of 2-dose Heterologous Regimens for Ebola Vaccines Ad26.ZEBOV/MVA-BN-Filo

NCT ID: NCT02598388

Last Updated: 2025-02-04

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 578 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-12-10
• Study Completion Date: 2018-12-12

Brief Summary

The purpose of this study is to assess the safety, tolerability and immunogenicity of different vaccination schedules of Ad26.ZEBOV and MVA-BN-Filo administered intramuscularly (IM) as 2-dose heterologous regimens in healthy and in HIV-infected adults.

Detailed Description

This is a randomized, observer-blind, placebo-controlled, parallel-group, multicenter, 2-part, Phase 2 study of Ad26.ZEBOV and MVA-BN-Filo in healthy and HIV infected adults. In part 1, dose 1 vaccination with MVA-Bn-Filo will be followed by dose 2 vaccination with Ad26 14 days later in the US. In part 2, two regimens will be investigated. The first regimen will be Ad26 dose 1 vaccination followed by MVA-BN-Filo dose 2, 28 days later and the second regimen will be MVA-BN-Filo dose 1 vaccination followed by Ad26.ZEBOV dose 2, 14 days later in Africa. The study consists of a Screening phase of up to 8 weeks (starting from the moment the participants signs the ICF), a Vaccination Phase, in which participants will be vaccinated at baseline (Day 1) followed by a dose 2 vaccination on Day 15 or 29, and a post-dose 2 follow-up phase of maximum 1 year post-dose 2 vaccination. Upon completion of 6-month post dose 2 visit those participants who received active vaccine will enter long-term follow-up until the 1 year post dose 2 vaccination visit to assess long-term safety and immunogenicity.

Conditions

Hemorrhagic Fever, Ebola

Study Design

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

Study Groups

Part 1 (US Participants)

Participants will receive MVA-BN-Filo or placebo on Day 1 followed by Ad26.ZEBOV or placebo on Day 15.

Group Type: EXPERIMENTAL

Ad26.ZEBOV

Intervention Type: BIOLOGICAL

One 0.5 mL intramuscular (IM) injection of (5x10\*10 viral particles).

MVA-BN-Filo

Intervention Type: BIOLOGICAL

One 0.5 mL IM injection of (1x10\*8 infectious units).

Placebo

Intervention Type: BIOLOGICAL

One 0.5 mL IM injection of 0.9 percent (%) saline.

Part 2 Group 1 (African Participants)

Participants will receive Ad26.ZEBOV or placebo on Day 1 followed by MVA-BN-Filo or placebo on Day 29.

Group Type: EXPERIMENTAL

Ad26.ZEBOV

Intervention Type: BIOLOGICAL

One 0.5 mL intramuscular (IM) injection of (5x10\*10 viral particles).

MVA-BN-Filo

Intervention Type: BIOLOGICAL

One 0.5 mL IM injection of (1x10\*8 infectious units).

Placebo

Intervention Type: BIOLOGICAL

One 0.5 mL IM injection of 0.9 percent (%) saline.

Part 2 Group 2 (African Participants)

Participants will receive MVA-BN-Filo or placebo on Day 1 followed by Ad26.ZEBOV or placebo on Day 15.

Group Type: EXPERIMENTAL

Ad26.ZEBOV

Intervention Type: BIOLOGICAL

One 0.5 mL intramuscular (IM) injection of (5x10\*10 viral particles).

MVA-BN-Filo

Intervention Type: BIOLOGICAL

One 0.5 mL IM injection of (1x10\*8 infectious units).

Placebo

Intervention Type: BIOLOGICAL

One 0.5 mL IM injection of 0.9 percent (%) saline.

Interventions

Ad26.ZEBOV

One 0.5 mL intramuscular (IM) injection of (5x10\*10 viral particles).

Intervention Type: BIOLOGICAL

MVA-BN-Filo

One 0.5 mL IM injection of (1x10\*8 infectious units).

Intervention Type: BIOLOGICAL

Placebo

One 0.5 mL IM injection of 0.9 percent (%) saline.

Intervention Type: BIOLOGICAL

Eligibility Criteria

Inclusion Criteria

• Participant must be healthy in the Investigator's clinical judgment on the basis of medical history, physical examination and vital signs performed at Screening
• Participant must be healthy on the basis of clinical laboratory tests and electrocardiogram (ECG) (only in participants >50 years) performed at Screening. If the results of the laboratory screening tests and ECG are outside the institutional normal reference ranges, the participant may be included only if the Investigator judges the abnormalities or deviations from normal to be not clinically significant or to be appropriate and reasonable for the population under study
• A woman of childbearing potential must have a negative urine β-human chorionic gonadotropin [beta-hCG] pregnancy test at Screening and a negative urine [beta-hCG] pregnancy test immediately prior to each study vaccine administration
• A man who is sexually active with a woman of childbearing potential must be willing to use condoms for sexual intercourse beginning prior to dose 1 vaccination until at least 3 months after the dose 2 vaccination, unless a vasectomy was performed more than 1 year prior to Screening
• Participant must pass the test of understanding (TOU)

Exclusion Criteria

• Has received any candidate Ebola vaccine
• Diagnosed with Ebola virus disease, or prior exposure to EBOV, including travel to epidemic Ebola areas less than 1 month prior to Screening
• Has received any experimental candidate Ad26- or MVA-based vaccine in the past or received any other investigational drug or investigational vaccine or used an invasive investigational medical device within 3 months prior to Screening
• Known allergy or history of anaphylaxis or other serious adverse reactions to vaccines or vaccine products
• Presence of significant conditions (eg, history of seizure disorders, (auto)immune disease or deficiency, any spleen disease, active malignancy, ongoing tuberculosis treatment, other systemic infections) or clinically significant findings during screening of medical history, ECG (only in participants >50 years), physical examination, vital signs or laboratory testing for which, in the opinion of the investigator, participation would not be in the best interest of the participants (eg, compromise the safety or well-being) or that could prevent, limit, or confound the protocol-specified assessments

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Walter Reed Army Institute of Research (WRAIR)

FED

Sponsor Role: collaborator

Janssen Vaccines & Prevention B.V.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Janssen Vaccines & Prevention B.V. Clinical Trial

Role: STUDY_DIRECTOR

Janssen Vaccines & Prevention B.V.

Locations

Silver Spring, Maryland, United States

Kericho, , Kenya

Kisumu, , Kenya

Maputo, , Mozambique

Abuja, , Nigeria

Mbeya, , Tanzania

Kampala, , Uganda

Countries

United States; Kenya; Mozambique; Nigeria; Tanzania; Uganda

References

Ake JA, Paolino K, Hutter JN, Cicatelli SB, Eller LA, Eller MA, Costanzo MC, Paquin-Proulx D, Robb ML, Tran CL, Anova L, Jagodzinski LL, Ward LA, Kilgore N, Rusnak J, Bounds C, Badorrek CS, Hooper JW, Kwilas SA, Ilsbroux I, Anumendem DN, Gaddah A, Shukarev G, Bockstal V, Luhn K, Douoguih M, Robinson C. Safety and Immunogenicity of an Accelerated Ebola Vaccination Schedule in People with and without Human Immunodeficiency Virus: A Randomized Clinical Trial. Vaccines (Basel). 2024 May 4;12(5):497. doi: 10.3390/vaccines12050497.

Reference Type: DERIVED

PMID: 38793748 (View on PubMed)

Mwesigwa B, Sawe F, Oyieko J, Mwakisisile J, Viegas E, Akintunde GA, Kosgei J, Kokogho A, Ntinginya N, Jani I, Shukarev G, Hooper JW, Kwilas SA, Ward LA, Rusnak J, Bounds C, Overman R, Badorrek CS, Eller LA, Eller MA, Polyak CS, Moodley A, Tran CL, Costanzo MC, Leggat DJ, Paquin-Proulx D, Naluyima P, Anumendem DN, Gaddah A, Luhn K, Hendriks J, McLean C, Douoguih M, Kibuuka H, Robb ML, Robinson C, Ake JA. Safety and Immunogenicity of Accelerated Heterologous 2-Dose Ebola Vaccine Regimens in Adults With and Without HIV in Africa. Clin Infect Dis. 2024 Oct 15;79(4):888-900. doi: 10.1093/cid/ciae215.

Reference Type: DERIVED

PMID: 38657084 (View on PubMed)

Provided Documents

Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

VAC52150EBL2003

Identifier Type: OTHER

Identifier Source: secondary_id

CR108062

Identifier Type: -

Identifier Source: org_study_id