Safety and Immunogenicity Study of DNA.HTI, MVA.HTI and ChAdOx1.HTI in HIV-1-positive Patients (AELIX-002)

• Status: Completed
• Trial end date: 2021-03-10
• Target enrollment: 0
• Participant gender: All

Summary

The AELIX-002 study aims to evaluate the safety and the immunogenicity of an heterologous prime-boost regimen with DNA.HTI, MVA.HTI and ChAdOx1.HTI in early diagnosed and treated HIV-1 positive individuals, males and females,18-60 years of age.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Aelix Therapeutics
• Treatments: Vaccines

Criteria

Inclusion Criteria:

1. Confirmed HIV-1 infection

2. On combined antiretroviral treatment (defined as ≥ 3 antiretroviral drugs) initiated within 6 months of estimated time of HIV-1 acquisition.

3. Willing and able to be adherent to their cART regimen for the duration of the study.

4. Optimal virological suppression for at least 1 year defined as maintained pVL below the limit of detection (based on current available assays, 20, 40 or 50 copies/ml) allowing for isolated blips.

5. Being on the same cART regimen for at least 4 weeks at screening visit.

6. Nadir CD4 count ≥ 200 cells per mm3. Isolated lower counts at the moment of acute HIV-1 infection will be allowed only if appropriate immune recovery was followed after cART initiation (as is criteria 7).

7. Stable CD4 counts ≥ 400 cells per mm^3 for the last 6 months at screening visit.

8. Availability of stored biological sample (including PBMC and plasma) before any cART initiation.

9. Aged at least 18 years on the day of screening and no greater than 60 years on the day of the first vaccination.

10. Willing to comply with the requirements of the protocol and available for follow-up for the planned duration of the study.

11. In the opinion of the principal investigator or designee, the patient has understood the information provided and capable of giving written informed consent.

12. If heterosexually active female; using an effective method of contraception (hormonal contraception, intra-uterine device (IUD), or anatomical sterility in self or partner) from 14 days prior to the first vaccination until at least 12 weeks after the last vaccination; all female volunteers must be willing to undergo urine pregnancy tests at time points specified in the Schedule of Procedures.

13. If heterosexually active male; willing to use an effective method of contraception (anatomical sterility in self) or agree on the use of an effective method of contraception by his partner (hormonal contraception, intra-uterine device (IUD), or anatomical sterility) from the day of the first vaccination until 12 weeks after the last vaccination.

14. Willing to accept blood draws and collect stool at time points specified in the Schedule of Procedures.

15. Willing to forgo donating blood during the study.

Exclusion Criteria:

1. Pregnancy or lactating.

2. Presence of resistance drug mutations in a pre-cART genotype.

3. Reported periods of suboptimal adherence to cART.

4. History of past antiretroviral treatment interruptions longer than 2 weeks.

5. Participation in another clinical trial within 12 weeks of study entry (at screening visit).

6. Any AIDS-defining disease or progression of HIV-related disease.

7. History of autoimmune disease.

8. History or clinical manifestations of any physical or psychiatric disorder which could impair the subject's ability to complete the study.

9. Receipt of approved vaccines within 2 weeks of study entry and along the duration of the trial.

10. History of anaphylaxis or severe adverse reaction to vaccines.

11. Previous immunisation with any experimental immunogens.

12. Receipt of blood products within 6 months of study entry.

13. Treatment for cancer or lymphoproliferative disease within 1 year of study entry.

14. Any other current or prior therapy which, in the opinion of the investigators, would make the individual unsuitable for the study or influence the results of the study.

15. Current or recent use (within last 3 months) of interferon or systemic corticosteroids or other immunosuppressive agents (use on inhaled steroids for asthma or topic steroids for localized skin conditions are permitted).

16. Any laboratory abnormalities including:

Haematology

• Haemoglobin < 10.0 g/dl

• Absolute Neutrophil Count (ANC) ≤ 1,000 /mm3

• Absolute Lymphocyte Count (ALC) ≤ 600 /mm3

• Platelets ≤100,000 /mm3, ≥ 550,000 /mm3

Biochemistry

• Creatinine > 1.3 x ULN

• Aspartate aminotransferase (AST) > 2.5 x ULN

• Alanine aminotransferase (ALT) > 2.5 x ULN

Microbiology

• Positive for hepatitis B surface antigen,

• Positive for hepatitis C antibody, unless confirmed clearance of HCV infection (spontaneous or following treatment)

• Positive serology indicating active syphilis requiring treatment

17. Complete refusal to cART interruption