CompletedPhase 1

A Trial to Evaluate the Safety, Reactogenicity, and Immunogenicity of MVA-BN Yellow Fever Vaccine With and Without Montanide ISA-720 Adjuvant in 18-45 Year Old Healthy Volunteers

United States92 participantsStarted 2016-07-05

Plain-language summary

This study is a multi-center, double-blind, placebo-controlled, Phase I study to evaluate the safety, reactogenicity, tolerability, and immunogenicity of Modified Vaccinia Ankara-Bavarian Nordic-Yellow Fever (MVA-BN-YF) in Flavivirus-naive healthy male and non-pregnant female adult subjects. There are six dose groups in this study. Subjects who have never received a licensed or investigational smallpox vaccine will be randomized to Groups 1-5 and vaccine administration and follow-up will be conducted in a double-blinded fashion. Subjects who have previously received two, 1 x 10\^8 TCID50 doses of Modified Vaccinia Ankara-Bavarian Nordic (MVA-BN) between 19 and 45 days apart by s ubcutaneous (SC) or intramuscular (IM) routes will be enrolled in Group 6 and will be dosed open-label. Since this is a first in human, phase I study, a sentinel cohort will be utilized. The first two subjects (1st sentinel group) one at each clinical site will be randomized to Group 2 or 3 and vaccinated with MVA-BN-YF with or without Montanide ISA 720 adjuvant (ISA 720). Subjects and study personnel will be blinded as to whether ISA 720 was administered. The primary objectives are the: 1) assessment of the safety, tolerability, and reactogenicity of MVA-BN-YF vaccine administered with or without ISA 720; 2) comparison of the safety, tolerability, and reactogenicity of MVA-BN-YF vaccine administered with or without ISA 720 with Yellow Fever Vaccine (YF-VAX) and MVA-BN.

Who can participate

Age range

18 Years – 45 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

. Must be a male or female at least 18 to \< / = 45 years old at the time of screening.
. Must be able to read and provide written consent and complete the Informed Consent.
. Must have a body mass index (BMI) \> / = 18.5 and \< 35.0 kg/m\^2.
. Must be in good health on the basis of physical examination, vital signs\*, medical history, safety laboratories, and the investigator's clinical judgment. \*Safety laboratory normal ranges will be those used by the reference clinical lab. Protocol-specific criteria for individual subjects are listed in criteria #6
. For Group 6: subjects must have documented previous vaccination with MVA-BN\*. \*In order to be enrolled, a subject has to have received two 1x10\^8 TCID50 doses of MVA-BN 19-45 days apart subcutaneous (SC) or intramuscular (IM) as part of participation in DMID vaccine trials 11-0021 or 09-0002. First dose must have been administered no earlier than 2010.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Comparison of Grade 3 local, systemic or laboratory toxicities, continuous Grade 2 or greater local reactogenicity

Timeframe: Day 1 through Day 8

Comparison of Grade 3 local, systemic or laboratory toxicities, continuous Grade 2 or greater local reactogenicity

Timeframe: Day 29 through Day 36

Number of adverse events of special interest (AESIs) considered related to study vaccination in Group 1

Timeframe: Day 1 through Day 394

Number of adverse events of special interest (AESIs) considered related to study vaccination in Group 2

Timeframe: Day 1 through Day 394

Number of adverse events of special interest (AESIs) considered related to study vaccination in Group 3

Timeframe: Day 1 through Day 394

Number of adverse events of special interest (AESIs) considered related to study vaccination in Group 4

Timeframe: Day 1 through Day 394

Trial details

NCT IDNCT02743455

SponsorNational Institute of Allergy and Infectious Diseases (NIAID)

Sponsor typeNIH

Study typeINTERVENTIONAL

Primary completion2018-03-22

View on ClinicalTrials.gov More Yellow Fever trials

Plain-language summary

Who can participate

Age range

18 Years – 45 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

. Must be a male or female at least 18 to \< / = 45 years old at the time of screening.
. Must be able to read and provide written consent and complete the Informed Consent.
. Must have a body mass index (BMI) \> / = 18.5 and \< 35.0 kg/m\^2.
. Must be in good health on the basis of physical examination, vital signs\*, medical history, safety laboratories, and the investigator's clinical judgment. \*Safety laboratory normal ranges will be those used by the reference clinical lab. Protocol-specific criteria for individual subjects are listed in criteria #6
. For Group 6: subjects must have documented previous vaccination with MVA-BN\*. \*In order to be enrolled, a subject has to have received two 1x10\^8 TCID50 doses of MVA-BN 19-45 days apart subcutaneous (SC) or intramuscular (IM) as part of participation in DMID vaccine trials 11-0021 or 09-0002. First dose must have been administered no earlier than 2010.

What they're measuring

Comparison of Grade 3 local, systemic or laboratory toxicities, continuous Grade 2 or greater local reactogenicity

Timeframe: Day 1 through Day 8

Comparison of Grade 3 local, systemic or laboratory toxicities, continuous Grade 2 or greater local reactogenicity

Timeframe: Day 29 through Day 36

Number of adverse events of special interest (AESIs) considered related to study vaccination in Group 1

Timeframe: Day 1 through Day 394

Number of adverse events of special interest (AESIs) considered related to study vaccination in Group 2

Timeframe: Day 1 through Day 394

Number of adverse events of special interest (AESIs) considered related to study vaccination in Group 3

Timeframe: Day 1 through Day 394

Number of adverse events of special interest (AESIs) considered related to study vaccination in Group 4

Timeframe: Day 1 through Day 394

A Trial to Evaluate the Safety, Reactogenicity, and Immunogenicity of MVA-BN Yellow Fever Vaccine With and Without Montanide ISA-720 Adjuvant in 18-45 Year Old Healthy Volunteers

Plain-language summary

Who can participate

Inclusion criteria

Questions worth asking your doctor

Questions for the trial coordinator

What they're measuring

Trial details

A Trial to Evaluate the Safety, Reactogenicity, and Immunogenicity of MVA-BN Yellow Fever Vaccine With and Without Montanide ISA-720 Adjuvant in 18-45 Year Old Healthy Volunteers

Plain-language summary

Who can participate

Inclusion criteria

Questions worth asking your doctor

Questions for the trial coordinator

What they're measuring

Trial details

Exclusion criteria