EHVA P01/ANRS VRI08: A Prophylactic HIV Vaccine Trial to Evaluate the Safety and Immunogenicity of HIV Clade C DREP Alone and in Combination With a Clade C ENV Protein in Healthy HIV-uninfected Adults

EHVA P01/ANRS VRI08

EHVA P01 is an international, phase I, prophylactic HIV vaccine trial to evaluate the safety and immunogenicity of HIV Clade C DREP alone and in Combination with a Clade C ENV protein in healthy HIV-uninfected adults.

2022-08-05

2024-09-30

2024-09-30

Active (not recruiting)

Early phase I

68

Inclusion Criteria: 1. Healthy adults aged 18- 55 years on the day of screening 2. BMI between 18-30 kg/m2 (inclusive) 3. Unlikely to acquire HIV during follow-up 4. Willing and able to provide written informed consent 5. If female and of childbearing potential\* age and not sterilised, willing to use a highly effective method of contraception from screening until 12 weeks after last injection 6. If male and not sterilised, willing to avoid impregnating female partners from screening until 12 weeks after last injection\*\* 7. Willing to avoid all other vaccines from 28 days before the first injection through to 28 days after subsequent study injections 8. Willing and able to comply with visit schedule and provide blood samples 9. Being covered by medical insurance or in National Healthcare System * A woman will be considered of childbearing potential following menarche and until becoming post-menopausal unless permanently sterile. Permanent sterilisation methods include hysterectomy, bilateral salpingectomy and bilateral oophorectomy. * It is recommended that participants have an up to date vaccination status for any required immunisations including authorised COVID-19 vaccines Exclusion Criteria: 1. Pregnant or lactating 2. Has a significant clinical history, physical finding on clinical examination during screening, or presence of a disease that is active or requires treatment to control it, including cardiac, respiratory, endocrine, metabolic, autoimmune, liver, neurological, oncological, psychiatric, immunosuppresive/immunodeficient or other disorders which in the opinion of the investigator is not compatible with healthy status, may compromise the volunteer's safety, preclude vaccination or compromise interpretation of the immune response to vaccine. Individuals with mild/moderate, well-controlled comorbidities are allowed. 3. HIV 1 or 2 infection or indeterminate test at screening 4. History of anaphylaxis or angioedema 5. History of severe or multiple allergies to drugs or pharmaceutical agents 6. Known hypersensitivity to any component of the vaccine formulation used in this trial 7. 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 8. Receipt of any experimental vaccine within 5 years from screening. 9. Receipt of blood products or immunoglobulins within 18 weeks of screening. 10. Receipt any of immunosuppressive agents within 18 weeks of screening by any route other than skin and intranasal. 11. Detection of antibodies to hepatitis B \& C 12. Participating in another clinical trial with an investigational drug or device, or treated with an investigational drug within 28 days of screening 13. Any of the values that are confirmed on repeat testing as defined in protocol

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2024-01-03