NCT02218125

Brief Summary

The purpose of this study is to assess the safety and tolerability of Modified Vaccinia Ankara (MVA) Mosaic vaccine in healthy adult participants.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
25

participants targeted

Target at P25-P50 for phase_1 healthy

Timeline
Completed

Started Sep 2014

Longer than P75 for phase_1 healthy

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 14, 2014

Completed
1 day until next milestone

First Posted

Study publicly available on registry

August 15, 2014

Completed
1 month until next milestone

Study Start

First participant enrolled

September 23, 2014

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 30, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 30, 2015

Completed
Last Updated

November 27, 2018

Status Verified

November 1, 2018

Enrollment Period

1.2 years

First QC Date

August 14, 2014

Last Update Submit

November 23, 2018

Conditions

Healthy

Keywords

HealthyHuman immunodeficiency virus type 1 (HIV-1) infectionAcquired immunodeficiency syndrome (AIDS)recombinant adenovirus (rAd) vector-based vaccinesVaccinationAd26.ENVA.01RecombinantModified Vaccinia Ankara (MVA) vector-based vaccines

Outcome Measures

Primary Outcomes (2)

  • The Number of Participants who Experience Adverse Events Within 28 days After Vaccination

    In addition to the number of participants who experience adverse events within the time frame of 28 days after each vaccination, all adverse events that occur from the signing of the informed consent through to the last study visit (Visit 10 \[Day 365\]) will be reported.

    For 28 days following vaccination on Day 1 and Day 84

  • The Number of Participants who Experience Reactogenicity Symptoms Following Vaccination

    Reactogenicity symptoms monitored following vaccination will include erythema (redness), induration (hardening), and local pain/tenderness, itching, swelling, or warmth at the site of injection, temperature (fever \>37.7 degree Celsius); fatigue (extreme tiredness), headache, myalgia (muscle pain), arthralgia (joint pain), chills, nausea, vomiting, rashes, and itching (general and local)

    1 week following vaccination on Day 1 and Day 84

Secondary Outcomes (3)

  • The Number of Participants With Humoral Immune Responses

    4 weeks after the second vaccination

  • Durability of Immune Response

    6, 9, and 12 months after the first vaccination

  • The Number of Participants With T-cell Responses Following Vaccination

    4 weeks after the second vaccination

Study Arms (4)

Group 1- MVA Mosaic

EXPERIMENTAL

Healthy volunteers not previously vaccinated with Ad26.ENVA.01 will be administered Modified Vaccinia Ankara (MVA) Mosaic at Week 0 and at Week 12.

Biological: MVA Mosaic

Group 2 - Placebo

PLACEBO COMPARATOR

Healthy volunteers not previously vaccinated with Ad26.ENVA.01 will be administered placebo at Week 0 and at Week 12.

Biological: Placebo

Group 3 - MVA Mosaic

EXPERIMENTAL

Healthy volunteers previously vaccinated with Ad26.ENVA.01 will be administered MVA Mosaic at Week 0 and at Week 12.

Biological: MVA Mosaic

Group 4- Placebo

PLACEBO COMPARATOR

Participants previously vaccinated with Ad26.ENVA.01 will be administered placebo at Week 0 and at Week 12.

Biological: Placebo

Interventions

MVA MosaicBIOLOGICAL

0.5 mL (1x10E8 pfu) MVA Mosaic (comprised of MVA Mosaic 1 and MVA Mosaic 2 mixed in a 1:1 ratio before administration) will be administered by intramuscular (IM) injection.

Group 1- MVA MosaicGroup 3 - MVA Mosaic
PlaceboBIOLOGICAL

0.5 mL Sodium Chloride Injection USP, 0.9%will be administered by intramuscular (IM) injection.

Group 2 - PlaceboGroup 4- Placebo

Eligibility Criteria

Age18 Years - 55 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Healthy adults (determined by medical history, physical examination, and clinical judgment)
  • HIV uninfected
  • Female participants of child bearing potential must have a negative serum β-human chorionic gonadotrophin pregnancy test at the screening visit and immediately prior to each vaccine/placebo administration, practice adequate birth control measures from 28 days prior to the first vaccine/placebo administration through to at least 3 months after the final vaccine/placebo administration
  • Male participants who are sexually active with a woman of childbearing potential and has not had a vasectomy must agree to use a double barrier method of birth control, e.g. either condom with spermicidal foam/gel/film/cream/suppository or partner with occlusive cap (diaphragm or cervical/vault caps) with spermicidal foam/gel/film/cream/suppository

You may not qualify if:

  • Confirmed HIV-1/-2 infection
  • Chronic active hepatitis B or hepatitis C or active syphilis infection. Active syphilis documented by exam or serology unless positive serology is due to past treated infection
  • Within the 12 months prior to enrollment: a history of newly acquired syphilis, gonorrhea, non-gonococcal urethritis, herpes simplex virus type 2 (HSV2), Chlamydia, pelvic inflammatory disease (PID), trichomonas, mucopurulent cervicitis, epididymitis, proctitis, lymphogranulomavenereum, chancroid, or hepatitis B
  • A woman who is breastfeeding
  • Any clinically significant acute or chronic medical condition that, in the opinion of the investigator, would preclude participation
  • Major surgery within the 4 weeks prior to study entry or planned major surgery through the course of the study

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Unknown Facility

Boston, Massachusetts, United States

Location

Related Publications (1)

  • Baden LR, Walsh SR, Seaman MS, Cohen YZ, Johnson JA, Licona JH, Filter RD, Kleinjan JA, Gothing JA, Jennings J, Peter L, Nkolola J, Abbink P, Borducchi EN, Kirilova M, Stephenson KE, Pegu P, Eller MA, Trinh HV, Rao M, Ake JA, Sarnecki M, Nijs S, Callewaert K, Schuitemaker H, Hendriks J, Pau MG, Tomaka F, Korber BT, Alter G, Dolin R, Earl PL, Moss B, Michael NL, Robb ML, Barouch DH; IPCAVD006/RV380/HIV-V-A002 Study Group. First-in-Human Randomized, Controlled Trial of Mosaic HIV-1 Immunogens Delivered via a Modified Vaccinia Ankara Vector. J Infect Dis. 2018 Jul 13;218(4):633-644. doi: 10.1093/infdis/jiy212.

    PMID: 29669026DERIVED

MeSH Terms

Conditions

Acquired Immunodeficiency SyndromeInfectionsDyschromatosis symmetrica hereditaria 1

Condition Hierarchy (Ancestors)

HIV InfectionsBlood-Borne InfectionsCommunicable DiseasesSexually Transmitted Diseases, ViralSexually Transmitted DiseasesLentivirus InfectionsRetroviridae InfectionsRNA Virus InfectionsVirus DiseasesSlow Virus DiseasesGenital DiseasesUrogenital DiseasesImmunologic Deficiency SyndromesImmune System Diseases

Study Officials

  • Crucell Holland BV Clinical Trial

    Crucell Holland BV

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 14, 2014

First Posted

August 15, 2014

Study Start

September 23, 2014

Primary Completion

November 30, 2015

Study Completion

November 30, 2015

Last Updated

November 27, 2018

Record last verified: 2018-11

Locations

US(1)