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 range18 Years – 45 Years

SexALL

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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.
✓. Must have acceptable\* laboratory criteria within 28 days before enrollment.
✓. Women of childbearing potential must have a negative serum pregnancy test at screening and negative urine pregnancy tests prior to each vaccination.
✓. Women of childbearing potential must have an acceptable method of contraception\* from 28 days prior to the 1st vaccination until at least 60 days after the 2nd vaccination.

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

Number of adverse events of special interest (AESIs) considered related to study vaccination in Group 5

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 range18 Years – 45 Years

SexALL

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.
✓. Must have acceptable\* laboratory criteria within 28 days before enrollment.
✓. Women of childbearing potential must have a negative serum pregnancy test at screening and negative urine pregnancy tests prior to each vaccination.
✓. Women of childbearing potential must have an acceptable method of contraception\* from 28 days prior to the 1st vaccination until at least 60 days after the 2nd vaccination.

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

Number of adverse events of special interest (AESIs) considered related to study vaccination in Group 5

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

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

What they're measuring

Trial details

Exclusion criteria