PER-073-13Unknown未知
A PHASE IB CLINICAL TRIAL TO ASSESS THE SAFETY AND IMMUNOGENICITY OF MVA-B IMMUNISATIONS ADMINISTERED VIA THE INTRAMUSCULAR AND TRANSCUTANEOUS ROUTES IN HEALTHY MALE AND FEMALE VOLUNTEERS
Asociacion Civil Impacta Salud y Educacion,0 sites20 target enrollmentStarted: May 6, 2014Last updated:
Conditions
Trial Snapshot
- Phase
- 未知
- Enrollment
- 20
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional
Eligibility Criteria
- Ages
- 18 to 45 (—)
- Sex
- All
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.
Investigators
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