it's a Phase 1-2 preventive , prophilactic HIV vaccine trial. Vaccine target are healthy subjects aged from 18 to 55 years old. Safety and the immunogenicity of DREP-HIV-PT1 vaccine will be evaluated at first alone then in comparaison to the DNA-HIV-PT123 vacccine with CN54gp140 adjuvanted by MPLA-L coinjection. DREP-HIV-PT1 will be injected intramuscularly via the Stratis device (needle free seringue) manufactured by PharmaJet, the other products will be injected with a seringue with needle. M
Conditions
Interventions
Product Name: DREP-HIV-PT1
Product Code: SUB259135
Pharmaceutical Form: Solution for injection
Product Name: DNA-HIV-PT123
Product Code: SUB217960/SUB217962/SUB217961
Pharmaceutical Form: Solution fo
Sponsors
Inserm-ANRS
Eligibility
Sex/Gender
All
Inclusion criteria
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 childbearingi potential and not sterilised, willing to use a highly effective method of contraceptionii from screening until 12 weeks after last injection 6. If male and not sterilised, willing to avoid impregnating female partnersiii from screening until 12 weeks after last injection 7. Willing to avoid all other vaccines from at least 28 days before and after each study injectioniv 8. Willing and able to comply with visit schedule and provide blood samples 9. Being covered by medical insurance or in National Healthcare System Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 70 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range 0
Exclusion criteria
Exclusion criteria: 1. Pregnant or lactating 2. Has a significant clinical history or physical finding on clinical examination during screening that is not compatible with healthy status, may compromise the volunteer’s safety, preclude vaccination or compromise interpretation of the immune response to vaccine. For clarity, this could be the presence of active disease that is evolving and or likely to require escalation in treatment to control it. 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 a. local: extensive, indurated redness and swelling involving most of the arm, not resolving within 72 hours b. 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 before screening. 9. Receipt of blood products or immunoglobulins within 18 weeks before screening. 10. Receipt of any immunosuppressive agents within 18 weeks before screening by any route other than skin and intranasal. 11. Detection of antibodies to hepatitis C 12. Participating in another clinical trial with an investigational drug or device, or treated with an investigational drug within 28 days before screening 13. Any of the values indicated in the table 7 of the protocol confirmed on repeat testing
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Part 1 Dose escalation (Phase I) To evaluate the safety of 0.2 and 1mg of DREP-HIV-PT1 administered IM by Stratis® at weeks 0 and 4 Part 2 Randomised comparison (Phase II) To compare the safety of 0.2 and 1mg of DREP-HIV-PT1 combined with CN54gp140/MPLA-L with the safety of DNA-HIV-PT123 combined with CN54gp140/MPLA-L To compare the immunogenicity of 0.2 and 1mg of DREP-HIV-PT123 combined with CN54gp140/MPLA-L with the immunogenicity of DNA-HIV-PT123 combined with CN54gp140/MPLA-L;Secondary Objective: To characterise the humoral and cellular immune responses to the high and low dose DREP combination regimens in the context of the DNA combination regimen.;Primary end point(s): Part One (Phase I) Primary Outcome Measure -Any adverse reaction that results in a clinical decision that no further immunisations can be given Part Two (Phase II) Primary Outcome Measures- Immunogenicity -Env-specific total IgG binding antibody response rates assessed by binding antibody multiplex assay (BAMA) (week 26) -Magnitude of Env-specific total IgG binding antibody responses to HIV-1 Env proteins assessed by binding antibody multiplex assay (BAMA) (week 26) Primary Outcome Measure- Safety -Any adverse reaction that results in a clinical decision that no further immunisations can be given. ;Timepoint(s) of evaluation of this end point: Part 1 (Phase I) From Week 0 to Week 4 for the safety outcome Part 2 (Phase II) -From Week 0 to Week 24 for the safety outcome -Week 26 for the immunogenicity | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): For the part 1 (Phase I) Secondary Outcome Measures- Safety -Grade 3 or worse local or systemic solicited adverse events -Grade 1 or 2 local or systemic solicited adverse events -Non-solicited adverse events -Serious adverse events Secondary Outcome Measures – Immunological -Binding antibodies to ZM96gp140 measured by ELISA For the part 2 (Phase II) Secondary Outcome Measures- Immunogenicity -Env-specific total IgG binding antibody response rates assessed by binding antibody multiplex assay (BAMA) (week 6) -Magnitude of Env-specific total IgG binding antibody responses to HIV-1 Env proteins assessed by binding antibody multiplex assay (BAMA) (week 6) -Breadth of Env-specific total IgG binding antibody responses to HIV-1 Env proteins assessed by binding antibody multiplex assay (BAMA) (week 26) -Durability of Env-specific total IgG binding antibody responses to HIV-1 Env proteins assessed by binding antibody multiplex assay (BAMA) (week 36). This is defined as response rates and magnitudes at week 36 -Response rate and magnitude of Env-specific CD4+ and CD8+ T-cell responses measured by intracellular cytokine staining (ICS) (week 26) -Durability of Env-specific CD4+ and CD8+ T-cell responses measured by intracellular cytokine staining (ICS) (week 36). This is defined as response rates and magnitudes at week 36 Secondary Outcome Measures- Safety -Grade 3 or worse local or systemic solicited adverse events -Grade 1 or 2 local or systemic solicited adverse events -Non-solicited adverse events -Serious adverse events ;Timepoint(s) of evaluation of this end point: For the part 1 (Phase I) From Week 0 to Week 16 for the safety Week 0 and Week 6 for the immunogenicity For the part 2 (Phase II) From Week 0 to Week 48 for the safety Weeks 6,26 and 36 for the immunogenicity | — |
Countries
France, Switzerland, United Kingdom
Contacts
Public ContactPr Yves Lévy
Hôpital Henri Mondor
Outcome results
None listed