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

Juan A. Arnaiz

Status and phase

Completed

Phase 1

Conditions

HIV Infections

Treatments

Biological: MVA-B

Biological: Placebo

Study type

Interventional

Funder types

Other

Identifiers

EudraCT: 2007-002367-27

RisVac02

Details and patient eligibility

About

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.

Enrollment

30 patients

Sex

All

Ages

18 to 55 years old

Volunteers

Accepts Healthy Volunteers

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