A Safety Trial to Test MVA-BN(R)-Filo and Ad26.ZEBOV Vaccines in Healthy Volunteers (NCT02891980) | Clinical Trial Compass
CompletedPhase 1
A Safety Trial to Test MVA-BN(R)-Filo and Ad26.ZEBOV Vaccines in Healthy Volunteers
United States65 participantsStarted 2017-03-24
Plain-language summary
This is a Phase 1, double-blind, randomized trial to evaluate the safety and immunogenicity of two heterologous and two homologous prime-boost regimens using MVA-BN(R)-Filo and Ad26.ZEBOV administered in different sequences at Days 1 and 29 in healthy adult subjects aged 18 - 45 years. The study will evaluate the 'omics (transcriptomics, proteomics, lipidomics, metabolomics), antibodies for immunogenicity, CMI, ADCC, and plasmablast responses to MVA-BN(R)-Filo and Ad26.ZEBOV vaccines. The primary objectives of this study are: 1) To assess the safety and reactogenicity of each study group. 2) To assess responses to the study vaccination by study group after the first, second and third dose by transcriptomics. 3) To assess the peak antibody response to the study vaccination by study group to filovirus antigens.
Who can participate
Age range18 Years – 45 Years
SexALL
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Inclusion criteria
✓. Subject must be able to read and provide consent after completing the informed consent process.
✓. Subject must be able to understand and comply with planned procedures.
✓. Subject must be a man or woman aged \> / = 18 to \< / = 45 years.
✓. Subject must have a body mass index (BMI) \> / = 18.5 and \< 35 kg/m\^2.
✓. Subject must be healthy on the basis of patient-reported medical history, physical examination, and the investigator's clinical judgment.
✓. Subject must have acceptable laboratory parameters\* within 28 days of enrollment:
✓. A double-barrier method of birth control, such as condom and partner with occlusive cap (diaphragm, cervical/vault caps) with spermicidal foam/gel/film/cream/suppository.
✓. In case the female partner is using an adequate method of birth control (see Inclusion Criterion #8), a single barrier method of birth control for the male subject is acceptable.
Exclusion criteria
What they're measuring
1
Determine the differential expression from baseline in mRNA after each study vaccination by study group
Timeframe: Screening and Days 1, 2, 4, 8, 15, 29, 30, 32, 36, 43, and 57 for Groups 1 and 4; additionally Days 366, 367, 369, 373, 380, 394, and 546 for Groups 2 and 3.
2
Determine the number of subjects with a vaccine-related serious adverse event (SAE) from the time of first study vaccination by study group through the duration of the study
Timeframe: Day 1 through Day 366 in Groups 1 and 4; Day 1 through Day 546 in Groups 2 and 3
3
Determine the number of subjects with a vaccine-related unsolicited adverse event (AE) from the time of each study vaccination by study group
Timeframe: Day 1 through Day 29
4
Determine the number of subjects with solicited local and systemic reactogenicity events from the time of study vaccination by study group.
Timeframe: Day 1 through Day 8
5
Determine the peak antibody response against filovirus glycoproteins (GPs) for each study group
Timeframe: Days 1, 15, 29, 36, 43, 57, 209, and 366 for Groups 1 and 4; additionally Days 369, 373, 380, 394, 546 for Groups 2 and 3.
Trial details
NCT IDNCT02891980
SponsorNational Institute of Allergy and Infectious Diseases (NIAID)
✕. Has been diagnosed with Ebola disease, or exposed to Ebola including travel to West Africa\* in 2014-2016.
✕. Known or suspected receipt of an adenovirus serotype 26 (Ad26)-based vaccine.
✕. Known or suspected receipt of any licensed or investigational small pox (vaccinia)-based vaccine\* \*Note: Includes any MVA-based candidate vaccine (Imvamune or Imvanex), Dryvax, or Acam2000. Military history should be reviewed with potential subjects for receipt of vaccinia-based vaccine. The presence of a typical vaccinia scar should be considered exclusionary.
✕. Positive serology for human immunodeficiency virus (HIV)
✕. Positive Hepatitis B surface antigen
✕. Positive antibody to Hepatitis C virus (HCV)
✕. Known allergy or history of anaphylaxis or other serious adverse reactions to vaccines or vaccine products\*.