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

HIV Infections Clinical Trial

— RisVac02  

Official title:

A Phase I Study of MVA-B in Healthy Volunteers at Low Risk of HIV Infection

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00679497
• Other study ID #: RisVac02
• Secondary ID: EudraCT: 2007-00
• Status: Completed
• Phase: Phase 1
• First received: May 15, 2008
• Last updated: February 21, 2013
• Start date: June 2008
• Est. completion date: December 2010

Study information

• Verified date: February 2013
• Source: Hospital Clinic of Barcelona
• Contact: n/a
• Is FDA regulated: No
• Health authority: Spain: Spanish Agency of Medicines
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: December 2010
• Est. primary completion date: March 2010
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 55 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Acquired Immunodeficiency Syndrome
• Communicable Diseases
• HIV Infections
• Infection

Intervention

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
• Placebo
-3 immunisations at week 0, 4 and 16

Locations

Country	Name	City	State
Spain	Hospital Clínic de Barcelona	Barcelona
Spain	Hospital Universitario Gregorio Marañón	Madrid

Sponsors (1)

Lead Sponsor	Collaborator
Juan A. Arnaiz

Country where clinical trial is conducted

Spain, 

References & Publications (1)

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 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)		Safety: at any point of the study; Immunogenicity:week 6/8, 18/20, and at any point following immunisations	Yes
Secondary	Proportion of patients with grade 1 and 2 adverse events within 28 days of a vaccination -antibody responses -cellular responses -intracellular cytokine analysis		at any point of the study and at week 6 and 18 for intracellular cytokine analysis	Yes