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HIVPhase 1NCT01889719

A Phase I Study to Evaluate the Safety and Immunogenicity of Heterologous Boost Immunizations With MVA-CMDR

A Phase 1 study testing MVA-CMDR in people with HIV, run by Rockefeller University at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

This trial will investigate whether immunizations with an MVA recombinant HIV vaccine are safe and whether they will boost immune responses generated by immunizations with a dendritic cell (DC) targeted protein vaccine, DCVax-001, plus poly ICLC in healthy HIV-uninfected volunteers. Read more about this study

Who is it for?
Ages 18 to 62 yearsHealthy volunteers can take part
Conditions the study is for
HIV
What is being tested?
MVA-CMDR
Could I receive a placebo?
No, everyone receives an active treatment
How many people
14 participants
Where
1 siteUnited States
Study dates
Jan 2014to May 2015
Phase
Phase 1
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 62 years
  • All sexes
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • Have completed protocol SSC-710 and received either DCVax-001 plus poly ICLC, poly ICLC only or sterile saline. If less than 6 volunteers who originally received placebo (poly ICLC only or sterile saline) under protocol SSC_710 are willing to participate and are found eligible to participate in this proposed study, new volunteers can be enrolled as long as they are eligible according to the remaining inclusion and exclusion criteria below.
  • Healthy adult males and females, as assessed by a medical history, physical exam, ECG, and laboratory tests;
  • Age of at least 18 years of age on the day of screening and no greater than 62 years at time of vaccination;
  • Willing to comply with the requirements of the protocol and available for follow-up for the planned duration of the study (screening plus 12 months);
  • In the opinion of the principal investigator or designee, has understood the information provided. (Written informed consent needs to be given before any study-related procedures are performed);
  • Amenable to HIV risk reduction counseling, committed to maintaining behavior consistent with low risk of HIV exposure through the last required protocol clinic visit;
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  • Assessed by the clinic staff as being at "low risk" for HIV infection on the basis of sexual behaviors within the 12 months prior to enrollment defined as follows:
  • Sexually abstinent OR
  • Had two or fewer mutually monogamous relationships with partners believed to be HIV-uninfected and who did not use illicit drugs (illicit drug use or abuse that includes any injection drugs, methamphetamines (crystal meth), heroin, cocaine, including crack cocaine or chronic marijuana abuse) OR
  • Had two or fewer partners believed to be HIV-uninfected and who did not use illicit drugs (as defined above) and with whom he/she regularly used condoms for vaginal and anal intercourse;
  • If sexually active female, willing to use one effective method of contraception (combined oral contraceptive pill; injectable contraceptive; diaphragm; Intra Uterine Device (IUD); condoms; anatomical sterility in self or partner) at least until 3 months after last immunization. All female volunteers must be willing to undergo urine pregnancy tests at time points as indicated in the Schedule of Procedures.

Who cannot join

  • Confirmed HIV-1 or HIV-2 infection
  • Any clinically significant abnormality on history or examination including history of immunodeficiency or autoimmune disease; use of systemic corticosteroids immunosuppressive anticancer, or other medications considered significant by the trial physician within the last 6 months
  • Any clinically significant acute or chronic medical condition requiring care of a physician (e.g., diabetes, coronary artery disease, myopericarditis, grand-mal epilepsy, rheumatologic illness, malignancy, substance abuse) that in the opinion of the investigator would preclude participation
  • History of clinically significant eczema or chronic urticaria
  • Any laboratory value outside of reference range, with the exception of any non-clinically significant Grade I elevations of liver function tests (AST, ALT, direct/total bilirubin), electrolytes (Na, K, Cl, CO2), CBC, urinalysis as determined by the Principal Investigator or his designee
  • Baseline ECG with features that would interfere with interpretation of myo/pericarditis including significant repolarization abnormality, bundle branch block, and AV block
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  • Within the 12 months prior to enrollment, the volunteer has had excessive daily alcohol use or frequent binge drinking or chronic marijuana abuse or any other use of illicit drugs
  • Within the 12 months prior to enrollment, the volunteer has a history of newly-acquired syphilis, gonorrhea, non-gonococcal urethritis, herpes simplex virus type 2 (HSV2), pelvic inflammatory disease (PID), mucopurulent cervicitis, epididymitis, proctitis, lymphogranuloma venereum, chancroid, hepatitis B (surface antigen, HbsAg) or hepatitis C (HCV antibodies);
  • If female, pregnant, planning a pregnancy during the 3-month follow up period after last immunization, or lactating
  • Receipt of a live attenuated vaccine within 30 days or other vaccine within 14 days prior to study vaccination
  • Prior use of medications for HIV PrEP
  • Receipt of an investigational product (not vaccine-related) within the last 12 months. Receipt of a non-HIV experimental vaccine(s) within the last 5 years in a prior vaccine trial. Exceptions may be made for vaccines that have subsequently undergone licensure by the FDA. For subjects who have received control/placebo in an experimental vaccine trial, or who have received an experimental vaccine(s) greater than 5 years ago, eligibility for enrollment will be determined by the investigators on a case-by-case basis.
  • History of severe local or systemic reaction to vaccination defined as:
  • Local: extensive, indurated redness and swelling involving most of the major circumference of the arm, not resolving within 72 hours;
  • Systemic: fever > 39.5°C within 48 hours, anaphylaxis, bronchospasm, laryngeal edema, circulatory collapse, convulsions or encephalopathy within 72 hours
  • History of immediate type hypersensitivity reaction to eggs or egg products
  • Major psychiatric illness
  • In the opinion of the investigator, unlikely to comply with protocol

Trial locations and contacts

1 site in 1 country.

United States1 site

  • The Rockefeller University

    New York, New York, 10065

Other trials in United States

About this study

Official title: Phase I Study to Evaluate the Safety/Immunogenicity of Boost Immunizations With MVA-CMDR in Healthy Volunteers Previously Immunized With Anti-DEC-205 Monoclonal Antibody Targeted HIV Gag p24 Vaccine Plus Poly-ICLC (RV 365 / WRAIR #2006)

This trial will investigate whether immunizations with an MVA recombinant HIV vaccine are safe and whether they will boost immune responses generated by immunizations with a dendritic cell (DC) targeted protein vaccine, DCVax-001, plus poly ICLC in healthy HIV-uninfected volunteers.

Read the detailed description

This trial will investigate whether immunizations with an MVA recombinant HIV vaccine are safe and whether they will boost immune responses generated by immunizations with a dendritic cell (DC) targeted protein vaccine, DCVax-001, plus poly ICLC in healthy HIV-uninfected volunteers. Investigators propose to assess the quality of immunity elicited by immunizations with MVA-CMDR only or by booster immunizations with MVA-CMDR in volunteers previously immunized with a DC-targeted HIV vaccine. This vaccination regimen can provide the proof-of-concept that DC targeted protein vaccines can prime strong immune responses and therefore be valuable in combination with other vaccine modalities against HIV or other diseases.

Conditions
HIV
Being tested
MVA-CMDR
Keywords
HIV Prevention

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • MVA-CMDRBiological

    injections of MVA-CMDR vaccine

Study groups in NCT01889719
Study groupRoleWhat they receive
Vaccination with MVA-CMDR Group 1ExperimentalSix to 27 subjects who previously received vaccination with DEC-205, will receive vaccination with MVA-CMDR
Receives: Biological: MVA-CMDR
Vaccination with MVA-CMDR Group 2Active comparatorSix to 27 subjects who previously did not receive vaccination with DEC-205, will receive vaccination with MVA-CMDR
Receives: Biological: MVA-CMDR

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. safety and tolerability of MVA-CMDR vaccine

    safety and tolerability of two intramuscular injections of MVA-CMDR vaccine candidate in healthy HIV-uninfected volunteers

    Measured: 16 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted28 Jun 2013 (estimated)
  2. Study startJan 2014
  3. Primary completionMay 2015
  4. Study completionMay 2015

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Basic science
Allocation
Non-randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
14 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01889719
Sponsor's protocol ID
SSC-0803
Status last verified
Feb 2016
First submitted
20 Jun 2013
Last updated
17 Feb 2016
Results posted
No
Data monitoring committee
Yes

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing MVA-CMDR in people with HIV, run by Rockefeller University at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 11 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 17 Feb 2016. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

safety and tolerability of MVA-CMDR vaccine (time frame: 16 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01889719.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Feb 2016.

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