- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00679497
A Phase I Study of Modified Vaccinia Virus Ankara (MVA-B) in Healthy Volunteers at Low Risk of HIV Infection (RisVac02)
February 21, 2013 updated by: Juan A. Arnaiz
A Phase I Study of MVA-B in Healthy Volunteers at Low Risk of HIV Infection
The purpose of this clinical trial is to study a modified pox viral vector considering:
- HIV subtype B accounts for the most frequent virus strain in Europe and North America, as well as in many parts of the world.
- This novel vaccinia construct expressing HIV subtype B gag, pol, env and nef antigens is to be studied in humans for the first time.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
30
Phase
- Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Barcelona, Spain, 08036
- Hospital Clinic de Barcelona
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Madrid, Spain, 28007
- Hospital Universitario Gregorio Marañón
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 55 years (Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
Inclusion Criteria:
- male or female
- age between 18 and 55 years on the day of screening
- available for follow-up for the duration of the study (52 weeks from screening)
- able to give written informed consent
- at low risk of HIV and willing to remain so for the duration of the study low risk of HIV infection defined as: no history of injecting drug use in the previous ten years no gonorrhoea or syphilis in the last six months no high risk partner (e.g. injecting drug use, HIV positive partner) either currently or within the past six months no unprotected anal intercourse in the last six months no unprotected vaginal intercourse outside a relationship with a regular known/presumed HIV negative partner in the last six months
- willing to undergo a HIV test
- willing to undergo a genital infection screen
- if heterosexually active female, using an effective method of contraception with partner (combined oral contraceptive pill; injectable contraceptive; IUCD; consistent record with condoms if using these; physiological or anatomical sterility in self or partner) from 14 days prior to the first vaccination until 4 months after the last, and willing to undergo urine pregnancy tests prior to each vaccination
- if heterosexually active male, using an effective method of contraception with their partner from the first day of vaccination until 4 months after the last vaccination
Exclusion Criteria:
- positive for hepatitis B surface antigen, hepatitis C antibody, antibody responses to vaccinia or serology indicating active syphilis requiring treatment
- pregnant or lactating
- clinically relevant abnormality on history or examination including history of grand-mal epilepsy, severe eczema, immunodeficiency or use of immunosuppressives in preceding 3 months
- receipt of live attenuated vaccine within 60 days or other vaccine within 14 days of enrolment
- receipt of blood products or immunoglobin within 4 months of screening
- participation in another trial of a medicinal product, completed less than 30 days prior to enrolment
- history of severe local or general reaction to vaccination defined as local: extensive, indurated redness and swelling involving most of the front-lateral thigh or the major circumference of the arm, not resolving within 72 hours general: fever >= 39.5oC within 48 hours; anaphylaxis; bronchospasm; laryngeal
- HIV 1/2 positive or indeterminate on screening
- positive for hepatitis B surface antigen, hepatitis C antibody or serology indicating active syphilis requiring treatment
- grade 1 routine laboratory parameters
- unlikely to comply with protocol
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Placebo Comparator: 2
Placebo
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-3 immunisations at week 0, 4 and 16
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Experimental: 1
MVA HIV-B
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Safety: proportion of patients with Grade 3 or above local, systemic or other clinical or laboratory adverse events. Adverse events attributable to discontinuation of the immunisation regimen. Immunogenicity: cellular responses (ELISPOT)
Time Frame: Safety: at any point of the study; Immunogenicity:week 6/8, 18/20, and at any point following immunisations
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Safety: at any point of the study; Immunogenicity:week 6/8, 18/20, and at any point following immunisations
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Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Proportion of patients with grade 1 and 2 adverse events within 28 days of a vaccination -antibody responses -cellular responses -intracellular cytokine analysis
Time Frame: at any point of the study and at week 6 and 18 for intracellular cytokine analysis
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at any point of the study and at week 6 and 18 for intracellular cytokine analysis
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Josep M Gatell, MD, Hospital Clinic of Barcelona
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
June 1, 2008
Primary Completion (Actual)
March 1, 2010
Study Completion (Actual)
December 1, 2010
Study Registration Dates
First Submitted
May 15, 2008
First Submitted That Met QC Criteria
May 16, 2008
First Posted (Estimate)
May 19, 2008
Study Record Updates
Last Update Posted (Estimate)
February 22, 2013
Last Update Submitted That Met QC Criteria
February 21, 2013
Last Verified
February 1, 2013
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Pathologic Processes
- RNA Virus Infections
- Virus Diseases
- Blood-Borne Infections
- Sexually Transmitted Diseases, Viral
- Sexually Transmitted Diseases
- Lentivirus Infections
- Retroviridae Infections
- Immunologic Deficiency Syndromes
- Immune System Diseases
- Disease Attributes
- Slow Virus Diseases
- HIV Infections
- Infections
- Communicable Diseases
- Acquired Immunodeficiency Syndrome
Other Study ID Numbers
- RisVac02
- EudraCT: 2007-002367-27
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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