Safety and Immunological Response of a Boosting Dose of MVA-B in Healthy Volunteers After 4 Years of Receiving MVA-B

This study is not yet open for participant recruitment. (see Contacts and Locations)
Verified August 2013 by Hospital Clinic of Barcelona
Sponsor:
Information provided by (Responsible Party):
Juan A. Arnaiz, Hospital Clinic of Barcelona
ClinicalTrials.gov Identifier:
NCT01923610
First received: August 13, 2013
Last updated: August 14, 2013
Last verified: August 2013
  Purpose

24 healthy male and female volunteers who are at low risk of HIV infection and entered into the RISVAC02 study and were randomly allocated to receive 3 intramuscular injections of MVA-B at weeks 0, 4 and 16 will receive a boosting dose 4 years thereafter.

Participants will attend one of two clinical centres on at least 5 occasions over 16 weeks. These visits will comprise:

  • Screening
  • Trial entry and boosting immunisation
  • Early follow-up after immunisation
  • Follow-up x 2 including the final visit Participants will have blood and urine collected, and receive 1 immunisation. They will be counselled prior to and following a HIV test, and given health education on prevention of sexually transmitted infections including HIV. T

The two centres which participate are:

  • Hospital Clinic, Barcelona and
  • Hospital Gregorio Marañón, Madrid The primary objective is to explore the safety and immunogenicity of MVA-B.

Condition Intervention Phase
HIV Infections
Biological: Experimental
Phase 1

Study Type: Interventional
Study Design: Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Safety and Immunological Response of a Boosting Dose of MVA-B in Healthy Volunteers After 4 Years of Receiving MVA-B

Resource links provided by NLM:


Further study details as provided by Hospital Clinic of Barcelona:

Primary Outcome Measures:
  • Local adverse event [ Time Frame: 12 weeks ] [ Designated as safety issue: Yes ]
    Grade 3 or above local adverse event (pain, cutaneous reactions including induration)

  • Grade 3 or above systemic adverse event [ Time Frame: 12 weeks ] [ Designated as safety issue: Yes ]
    Grade 3 or above systemic adverse event (temperature, chills, headache, nausea, vomiting, malaise, and myalgia)

  • Grade 3 or above other clinical or laboratory adverse event [ Time Frame: 12 weeks ] [ Designated as safety issue: Yes ]
    Grade 3 or above other clinical or laboratory adverse event confirmed at examination or on repeat testing respectively

  • Event attributable to vaccine leading to discontinuation [ Time Frame: 12 weeks ] [ Designated as safety issue: Yes ]
    Any event attributable to vaccine leading to discontinuation of the immunisation regimen

  • Primary immunogenicity parameters [ Time Frame: 12 weeks ] [ Designated as safety issue: Yes ]
    The primary immunogenicity parameters will be quantitative or present/absent, and are cellular responses - CD8/CD4+ T cell responses (ELISPOT) at week 2, 4 and 12 following the immunisations


Secondary Outcome Measures:
  • All grade 1 and 2 adverse events [ Time Frame: 28 days of vaccination ] [ Designated as safety issue: Yes ]
  • Antibody responses [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
    • binding titration to the construct MVAB
    • binding titration to and neutralisation of vaccinia

  • cellular responses [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
    • CD8/CD4+ T cell responses (ELISPOT) at week 0
    • intracellular cytokine analysis at week 0, 2, 4 and 12


Estimated Enrollment: 24
Study Start Date: September 2013
Estimated Study Completion Date: September 2014
Estimated Primary Completion Date: September 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Main
MVA HIV-B
Biological: Experimental

Biological/Vaccine: MVA-B Modified Pox virus, strain MVA clade -B (expressing HIV-1 Bx08gp120 and IIIB gagpolnef)

-~ 1 x 10e8 pfu/ml 3 immunisations at week 0, 4 and 16


  Eligibility

Ages Eligible for Study:   18 Years to 55 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01923610

Contacts
Contact: Felipe Garcia, MD 932275400

Locations
Spain
Hospital Clínic i Provincial de Barcelona Not yet recruiting
Barcelona, Catalunya, Spain, 08036
Contact: Felipe Garcia, MD    +34 93 227 54 00    fgarcia@clinic.ub.es   
Principal Investigator: Felipe Garcia, MD         
Hospital Universitario Gregorio Marañón Not yet recruiting
Madrid, Spain, 28007
Principal Investigator: Juan Carlos López Bernaldo de Quirós, MD         
Sponsors and Collaborators
Hospital Clinic of Barcelona
Investigators
Principal Investigator: Felipe Garcia, MD Hospital Clínic i Provincial de Barcelona
  More Information

No publications provided

Responsible Party: Juan A. Arnaiz, Principal Investigator, Hospital Clinic of Barcelona
ClinicalTrials.gov Identifier: NCT01923610     History of Changes
Other Study ID Numbers: RisVac02 boost
Study First Received: August 13, 2013
Last Updated: August 14, 2013
Health Authority: Spain: Spanish Agency of Medicines

Keywords provided by Hospital Clinic of Barcelona:
Low risk HIV infection
HIV Seronegativity
HIV Preventive Vaccine

Additional relevant MeSH terms:
HIV Infections
Acquired Immunodeficiency Syndrome
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases
Slow Virus Diseases

ClinicalTrials.gov processed this record on August 27, 2014