COMPARISON OF THE SAFETY AND IMMUNOGENICITY OF THE MVA-B VACCINE APPLIED VIA INTRAMUSCULAR AND TRASCUTANEOUS

Not Applicable

• Conditions: -B24 Unspecified human immunodeficiency virus [HIV] disease; Unspecified human immunodeficiency virus [HIV] disease; B24

• Registration Number: PER-073-13
• Lead Sponsor: Asociacion Civil Impacta Salud y Educacion,

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2014-05-06
• Last Update Posted: 4 September 2023

Recruitment & Eligibility

• Sex: All
• Target Recruitment: 20

Inclusion Criteria

HEALTHY HUMAN VOLUNTEERS
1.Men and women aged between 18 and 45 years on the day of screening
2.Body mass index between 19-30
3.Available for follow-up for the duration of the study (~24 weeks from screening)
4.Willing and able to give written informed consent
5.At low risk of HIV infection
6.Willing to undergo a HIV test
7.Willing to undergo a genital infection screen
8.If heterosexually active female, using an effective method of contraception with partner (combined oral contraceptive pill; injectable or implanted contraceptive; 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
9.Agree to abstain from donating blood for three months after the end of their participation in the trial, or longer if necessary

Exclusion Criteria

1.Pregnant or lactating
2.Use of any topical treatment on the injection or application site within the last four weeks
3.UV tanning sessions or strong sun exposure within four weeks prior to the study and a willingness to avoid these during the study period
4.Excessive terminal hair growth on the investigational skin areas (to be assessed by reference to a photograph which will be available during screening visit.
5.Individuals in which a skin-fold measurement (cutaneous and subcutaneous tissue) of the upper right or left thigh exceeds 40 mm.
6.Vaccinia (smallpox) vaccine. Clinical evidence of vaccinia scarification or self-reported history of vaccinia vaccination
7.Clinically relevant abnormality on history or examination
8.Known hypersensitivity to any component of the vaccine formulations used in this trial, such as eggs and derivated (whites. yolks, ovalbumin proteins, etc), or a seafood allergy or have severe or multiple allergies to drugs or pharmaceutical agents.
9.History of severe local or general reaction to vaccination
10.Receipt of a live attenuated vaccine within 60 days or other vaccine within 14 days of the screening visit.
11.Receipt of an experimental vaccine containing HIV antigens at any time in the past
12.Receipt of blood products or immunoglobin within 4 months of screening
13.Participation in another trial of a medicinal product, completed less than 30 days prior to enrolment
14.HIV 1 or 2 positive or indeterminate on screening
15.Positive for hepatitis B surface antigen, hepatitis C antibody or serology indicating active syphilis requiring treatment
16.Grade 1 or above routine laboratory parameters (see study specific tables for definitions). Hyperbilirubinaemia to be considered an exclusion criterion only when confirmed to be conjugated bilirubinaemia
17.Presence of any tattoos, surgical or traumatic metal implants at the sites of administration
18.Unable to read and speak Spanish to a fluency level adequate for the full comprehension of procedures required in participation and consent.
19.Unlikely to comply with protocol.

Study & Design

• Study Type: Interventional
• Study Design: Not specified