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

Sponsor

Juan A. Arnaiz (Other)

Overall Status

Completed

CT.gov ID

NCT00679497

Collaborator

(none)

Enrollment

Locations

Arms

Duration (Months)

Patients Per Site

0.5

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
HIV Infections	Biological: MVA-B Biological: Placebo	Phase 1

Study Design

Study Type:

Interventional

Actual Enrollment :

30 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Primary Purpose:

Prevention

Official Title:

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

Study Start Date :

Jun 1, 2008

Actual Primary Completion Date :

Mar 1, 2010

Actual Study Completion Date :

Dec 1, 2010

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 1 MVA HIV-B	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 Comparator: 2 Placebo	Biological: Placebo -3 immunisations at week 0, 4 and 16

Arm

Intervention/Treatment

Experimental: 1

MVA HIV-B

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 Comparator: 2

Placebo

Biological: Placebo

-3 immunisations at week 0, 4 and 16

Outcome Measures

Primary Outcome Measures

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]

Secondary Outcome Measures

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]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 55 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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