An HIV Vaccine Trial in Individuals Who Started ART During Primary or Chronic Infection

Exclusion Criteria

• •1. Pregnant or lactating
• •2. HIV-2 infection (either isolated or associated with HIV-1)
• •3. VL \>200 copies/ml on 2 occasions in the 12 months prior to screening
• •4. Previous interruptions in cART
• •5. Previous virological failures defined by loss of virological suppression with the presence of resistant mutations
• •6. Haemoglobin (Hb \<12g/dL for males, \<11g/dL for females)
• •7. Concomitant or previous conditions that preclude injection of vaccines/infusion of monoclonal antibody and PML in the past
• •8. History of experimental vaccinations against HIV
• •9. Previous treatment with chemotherapy (except for chemotherapy injected into skin lesions for Kaposi's sarcoma)
• •10. Treatment with systemic corticoids or immuno-suppressive agents ongoing or in the previous 12 weeks before randomisation in the trial
• •11. Received natalizumab or rituximab ever in the past
• •12. Received a TNF blocker in the past 60 days
• •13. Administration of an inactivated vaccine within 30 days or a live vaccine within 60 days prior to randomisation
• •14. Presence of a skin condition or marking that precludes inspection of the injection/infusion site
• •15. History of cancer (except basal cellular skin carcinoma or Kaposi's sarcoma)
• •16. History of significant neurological disease, cardiovascular disease (angina, myocardial infarction, transient ischemic attack, stroke); participants with controlled blood pressure are eligible
• •17. Personal history of clinical autoimmune disease or reactive arthritis or family history of rheumatoid arthritis (parents or siblings)
• •18. Ongoing diseases including uncontrolled active severe infection, cardiac, pulmonary (excluding mild asthma), thyroid, renal or neurological (peripheral or central) diseases
• •19. Active or latent tuberculosis (unless prophylaxis in past as per local practice) - (participant must be screened for tuberculosis before starting infusions, according to routine practice)
• •20. Presence of pathogenic bacteria or parasites in faeces at screening
• •21. Participating in another biomedical research study within 30 days of randomisation.
• •22. Known hypersensitivity to any component of the vaccine formulations used in this trial including aminoglycosides and eggs or have severe or multiple allergies to drugs or pharmaceutical agents, or any hypersensitivity to the active substance or to any of the excipients of vedolizumab
• •23. Liver disease including hepatitis B (surface antigen positive) or hepatitis C (antigen or PCR positive)
• •24. A clinically significant abnormality on ECG
• •25. Hypernatraemia or hyperchloraemia
• •26. History of severe local or general reaction to vaccination defined as
• •1. local: extensive, indurated redness and swelling involving most of the arm, not resolving within 72 hours
• •2. general: fever \>= 39.5oC within 48 hours; anaphylaxis; bronchospasm; laryngeal oedema; collapse; convulsions or encephalopathy within 72 hours
• •27. Grade 2 or worse routine laboratory parameters (see Appendix 4 for definitions). Hyperbilirubinaemia to be considered an exclusion criterion only when confirmed to be conjugated bilirubinaemia