An HIV Vaccine Trial in Individuals Who Started ART During Primary or Chronic Infection (EHVAT01)

Inclusion Criteria:

1. Aged 18 - 65 years old
2. Weight >50kg
3. Able to give written informed consent including consent to long-term follow-up
4. Nadir CD4 count > 300 cells/mm3
5. CD4 count at screening > 600 cells/mm3
6. Started cART after 2009 and on cART for at least one year.
7. Viral load less than 50 copies/ml at screening.
8. Willing to interrupt cART for up to 24weeks
9. If sexually active, willing to use a reliable method of reducing the risk of transmission to their sexual partners during treatment interruption (which could include PrEP for their sexual partners)
10. If heterosexually active female able to have children, using a highly effective method of contraception with partner (combined oral contraceptive pill; injectable or implanted contraceptive; IUD/IUS; 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
11. If heterosexually active male able to have children, using an effective method of contraception with their partner from the first day of vaccination until 4 months after the last vaccination
12. Willing to avoid all other vaccines within 4 weeks of scheduled study vaccines
13. Willing and able to comply with visit schedule and provide blood sampling
14. Participants with medical insurance or in National Healthcare System

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 vaccination.
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. Administration of an inactivated vaccine within 30 days or a live vaccine within 60 days prior to randomisation
12. Presence of a skin condition or marking that precludes inspection of the administration site
13. History of cancer (except basal cellular skin carcinoma or Kaposi's sarcoma)
14. History of cardiovascular disease (angina, myocardial infarction, transient ischemic attack, stroke); participants with controlled blood pressure are eligible.
15. History of clinical autoimmune disease or reactive arthritis
16. Ongoing cardiac, pulmonary (excluding mild asthma), thyroid, renal or neurological (peripheral or central) diseases
17. Participating in another biomedical research study within 30 days of randomisation.
18. 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.
19. Liver disease including hepatitis B (surface antigen positive) or hepatitis C (antigen or PCR positive)
20. A clinically significant abnormality on ECG

21. 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
22. 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