Immunogenicity and Safety of 4 Prime-boost Combinations of HIV Vaccine Candidates in Healthy Volunteers (VRI01)

This is an interventional prevention trial for HIV Infection Read More

Inclusion Criteria:

• Written and signed informed consent

• Subject at low risk to contract HIV i.e.

  • no history of injecting drug use in the previous ten years;
  • no gonorrhea or syphilis in the last six months;
  • no high risk partner (e.g. injecting drug user, HIV positive partner) either currently or within the past six months ;
  • no unprotected anal intercourse in the last six months, outside a relationship with a regular partner known/presumed to be HIV negative ;
  • no unprotected vaginal intercourse in the last six months outside a relationship with a regular known/presumed HIV negative partner
• Available for follow-up for the duration of the study (56 weeks from screening)
• 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; contraceptive implant/patch; IntraUterine Contraceptive Device (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
• Subject registered in French Health ministry computerised file and authorised to participate in a clinical trial
• Subject covered by Health Insurance

Exclusion Criteria:

• Clinically relevant abnormality on history or examination including history of:

  • uncontrolled infection;
  • autoimmune disease;
  • immunodeficiency or use of immunosuppressive drugs within 3 months prior to screening;
  • cancer;
  • chronic diseases requiring long-term treatment whose interruption during the trial has no impact on the health status in the short or long-term
• Receipt of live attenuated vaccine within 60 days or other vaccine within 14 days prior to W0
• Planned receipt of other vaccines than those planned by the protocol and those recommended in France (excluding live attenuated vaccines) during the trial follow-up (reference : Weekly Epidemiological Newsletter 14-15 dated on April 10th, 2012 (Bulletin Epidémiologique hebdomadaire 14-15 / 10 avril 2012))
• Receipt of blood products or immunoglobin within 4 months prior to screening

• History of severe local or general reaction to vaccination defined as

  • local: extensive, indurated redness and swelling involving most of the antero-lateral thigh or the major circumference of the arm, not resolving within 72 hours
  • general: fever ≥ 39.5°C within 48 hours; anaphylaxis; bronchospasm; laryngeal oedema; collapse; convulsions or encephalopathy within 72 hours
• Positive for ANA antibodies at a titer considered clinically significant: titer ≥ local cut-off associated with positive anti-native DNA and extractable nuclear antigen antibodies
• HIV-1 or HIV-2 positive or indeterminate at screening
• Woman expecting to conceive during the study period
• Pregnant or breastfeeding woman
• Symptoms, physical signs or laboratory values suggestive of systemic disorders, including renal, hepatic, cardiovascular, pulmonary, skin, immunodeficiency, psychiatric, which could interfere with the interpretation of the trial results or compromise the health of the volunteers
• Clinically significant grade 1 routine laboratory parameters
• Grade 2 or above routine laboratory parameters
• Known hypersensitivity to aminoglycosides and eggs (as used in the vaccine production processes)
• Known hypersensitivity to one of the trial vaccine components, the metabolites or formulation excipients
• Anticipated non-compliance with the protocol
• Participation in another clinical trial with an on-going exclusion period at screening
• Participation in a HIV preventive vaccine clinical trial (unless participant were randomized in placebo arm)
• Subject under legal guardianship or incapacitation
• Subject who is an active blood donor and unwilling to interrupt blood donations during the his/her participation in the trial