A Phase I Study of Modified Vaccinia Virus Ankara (MVA-B) in Healthy Volunteers at Low Risk of HIV Infection (RisVac02)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Juan A. Arnaiz, Hospital Clinic of Barcelona
ClinicalTrials.gov Identifier:
NCT00679497
First received: May 15, 2008
Last updated: February 21, 2013
Last verified: February 2013

May 15, 2008
February 21, 2013
June 2008
March 2010   (final data collection date for primary outcome measure)
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 ] [ Designated as safety issue: Yes ]
Same as current
Complete list of historical versions of study NCT00679497 on ClinicalTrials.gov Archive Site
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 ] [ Designated as safety issue: Yes ]
Same as current
Not Provided
Not Provided
 
A Phase I Study of Modified Vaccinia Virus Ankara (MVA-B) in Healthy Volunteers at Low Risk of HIV Infection
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:

  1. HIV subtype B accounts for the most frequent virus strain in Europe and North America, as well as in many parts of the world.
  2. This novel vaccinia construct expressing HIV subtype B gag, pol, env and nef antigens is to be studied in humans for the first time.
Not Provided
Interventional
Phase 1
Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
HIV Infections
  • Biological: 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
  • Biological: Placebo
    -3 immunisations at week 0, 4 and 16
  • Experimental: 1
    MVA HIV-B
    Intervention: Biological: MVA-B
  • Placebo Comparator: 2
    Placebo
    Intervention: Biological: Placebo
García F, Bernaldo de Quirós JC, Gómez CE, Perdiguero B, Nájera JL, Jiménez V, García-Arriaza J, Guardo AC, Pérez I, Díaz-Brito V, Conde MS, González N, Alvarez A, Alcamí J, Jiménez JL, Pich J, Arnaiz JA, Maleno MJ, León A, Muñoz-Fernández MA, Liljeström P, Weber J, Pantaleo G, Gatell JM, Plana M, Esteban M. Safety and immunogenicity of a modified pox vector-based HIV/AIDS vaccine candidate expressing Env, Gag, Pol and Nef proteins of HIV-1 subtype B (MVA-B) in healthy HIV-1-uninfected volunteers: A phase I clinical trial (RISVAC02). Vaccine. 2011 Oct 26;29(46):8309-16. doi: 10.1016/j.vaccine.2011.08.098. Epub 2011 Sep 9.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
30
December 2010
March 2010   (final data collection date for primary outcome measure)

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
Both
18 Years to 55 Years
Yes
Contact information is only displayed when the study is recruiting subjects
Spain
 
NCT00679497
RisVac02, EudraCT: 2007-002367-27
Yes
Juan A. Arnaiz, Hospital Clinic of Barcelona
Juan A. Arnaiz
Not Provided
Principal Investigator: Josep M Gatell, MD Hospital Clinic of Barcelona
Hospital Clinic of Barcelona
February 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP