ClinicalTrials.gov
ClinicalTrials.gov Menu

A Phase I Study of an HIV Vaccine in Healthy, HIV Uninfected Adults (MENSCH)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT02218125
Recruitment Status : Completed
First Posted : August 15, 2014
Last Update Posted : February 4, 2016
Sponsor:
Collaborators:
US Military HIV Research Program
National Institute of Allergy and Infectious Diseases (NIAID)
Beth Israel Deaconess Medical Center
Information provided by (Responsible Party):
Crucell Holland BV

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.

Condition or disease Intervention/treatment Phase
Healthy Biological: MVA Mosaic Biological: Placebo Phase 1

Detailed Description:
This is a Phase I, placebo-controlled (the use of an inactive substance identical in appearance to the active vaccine), double-blind (neither the participant or study personnel will know the identity of the treatment administered) study where participants will be randomized (treatment type assigned by chance) to receive a Modified Vaccinia Ankara (MVA) Mosaic vaccine (at 1x10E8 pfu) or placebo. This design is intended to reduce the likelihood of observer and selection bias, provide control for confounding variables, and aid an unbiased analysis of the study results. The study will include 4 groups of participants, 2 groups having previously been vaccinated with Ad26.ENVA.01 (A recombinant adenovirus [rAd] vaccine for HIV-1) and 2 groups not previously vaccinated with Ad26.ENVA.01. Participants will be randomized in a 4:1 ratio to receive either a MVA Mosaic vaccine or placebo. The trial comprises a 4-week screening period, a 12-week vaccination period during which participants will be vaccinated at baseline (Day 1) and Week 12 (Day 84), and a 40-week follow-up period to the final visit at Week 52.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 25 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: A Phase I Study of Modified Vaccinia Ankara With Mosaic HIV Inserts in Healthy, HIV-Uninfected Adults, Some of Whom Have Previously Received an Adenovirus Type 26 ENVA.01 Vaccine
Study Start Date : September 2014
Actual Primary Completion Date : November 2015
Actual Study Completion Date : November 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: HIV/AIDS

Arm Intervention/treatment
Experimental: Group 1- MVA Mosaic
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
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.

Placebo Comparator: Group 2 - Placebo
Healthy volunteers not previously vaccinated with Ad26.ENVA.01 will be administered placebo at Week 0 and at Week 12.
Biological: Placebo
0.5 mL Sodium Chloride Injection USP, 0.9%will be administered by intramuscular (IM) injection.

Experimental: Group 3 - MVA Mosaic
Healthy volunteers previously vaccinated with Ad26.ENVA.01 will be administered MVA Mosaic at Week 0 and at Week 12.
Biological: MVA Mosaic
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.

Placebo Comparator: Group 4- Placebo
Participants previously vaccinated with Ad26.ENVA.01 will be administered placebo at Week 0 and at Week 12.
Biological: Placebo
0.5 mL Sodium Chloride Injection USP, 0.9%will be administered by intramuscular (IM) injection.




Primary Outcome Measures :
  1. The Number of Participants who Experience Adverse Events Within 28 days After Vaccination [ Time Frame: For 28 days following vaccination on Day 1 and Day 84 ]
    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.

  2. The Number of Participants who Experience Reactogenicity Symptoms Following Vaccination [ Time Frame: 1 week following vaccination on Day 1 and Day 84 ]
    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)


Secondary Outcome Measures :
  1. The Number of Participants With Humoral Immune Responses [ Time Frame: 4 weeks after the second vaccination ]
    Humoral immune responses will be evaluated by the detection of env-specific binding antibody.

  2. Durability of Immune Response [ Time Frame: 6, 9, and 12 months after the first vaccination ]
    Determined by humoral immune response assays.

  3. The Number of Participants With T-cell Responses Following Vaccination [ Time Frame: 4 weeks after the second vaccination ]
    T-cell responses to be determined by epitope mapping.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02218125


Locations
United States, Massachusetts
Boston, Massachusetts, United States
Sponsors and Collaborators
Crucell Holland BV
US Military HIV Research Program
National Institute of Allergy and Infectious Diseases (NIAID)
Beth Israel Deaconess Medical Center
Investigators
Study Director: Crucell Holland BV Clinical Trial Crucell Holland BV

Additional Information:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Crucell Holland BV
ClinicalTrials.gov Identifier: NCT02218125     History of Changes
Other Study ID Numbers: CR100965
IPCAVD006 ( Other Identifier: Ragon Institute, Division of AIDS )
HIV-V-A002 ( Other Identifier: Crucell Holland BV )
First Posted: August 15, 2014    Key Record Dates
Last Update Posted: February 4, 2016
Last Verified: February 2016

Keywords provided by Crucell Holland BV:
Healthy
Human immunodeficiency virus type 1 (HIV-1) infection
Acquired immunodeficiency syndrome (AIDS)
recombinant adenovirus (rAd) vector-based vaccines
Vaccination
Ad26.ENVA.01
Recombinant
Modified Vaccinia Ankara (MVA) vector-based vaccines

Additional relevant MeSH terms:
Vaccines
Immunologic Factors
Physiological Effects of Drugs