A Phase I, Randomized, Double-Blind, Placebo-Controlled Safety, Tolerability and Immunogenicity Study of Candidate HIV-1 Vaccines ChAdOx1.HTI and MVA.HTI With Recombinant HIV-1 Envelope Protein ConM SOSIP.v7 gp140 Vaccine, Adjuvanted With MPLA Liposomes in ART-Suppressed HIV-1 Positive Individuals

1. If female, pregnant or planning a pregnancy during the study and until at least four months after the last IMP administration or until her pVL is \<50 copies/mL in two-consecutive determinations after ART resumption, whichever is later; or lactating.

2. ART initiated within 6 months from the estimated time of HIV-1 acquisition documented by immediate ART initation after a) an HIV-1 documented seroconversion (\<180 days), b) an HIV-1 diagnose with negative or indeterminate western blot test or positive p24 antigenemia and/or c) presenting with symptoms suggestive of acute retroviral syndrome.

3. When available, pre-ART genotypic data that demonstrates the presence of clinically significant drug resistance mutations that could prevent the construction of a viable ART regimen post-treatment interruption.

4. Reported periods of suboptimal adherence to ART or suboptimal ART regimens (dual therapy allowed as switch-regimens if sustained viral uppression pVL\<50 copies/ml is documented).

5. History of past ART interruptions longer than 2 weeks.

6. Participation in another clinical trial that involves a treatment intervention (active arm) within 12 weeks of study entry (at screening visit).

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

8. History of autoimmune disease.

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

10. Receipt of approved vaccines within 3 weeks of study entry(1)

11. Known hypersensitivity to any component of the IMP formulation, or severe or multiple allergies to drugs or pharmaceutical agents.

12. Previous immunisation with any experimental immunogens.

13. Potential participant received or plans to receive:

1. licensed live attenuated vaccines - within 28 days before or after planned administration of the first or subsequent study vaccinations. For details regarding COVID-19 vaccines, see bullet c and d below.

2. other licensed (not live) vaccines - within 14 days before or after planned administration of the first or subsequent study vaccinations. For details regarding COVID-19 vaccines, see bullet c and d below.

3. Recombinant viral vectored COVID-19 vaccines or live attenuated COVID-19 vaccines, either licensed or authorized for emergency use (eg. Emergency Use Authorization \[EUA\], Emergency Use Listing \[EUL\] or similar program) - within 28 days before or after planned administration of the first or subsequent study vaccinations.

4. Other COVID-19 vaccines than the ones specified in bullet c (eg. mRNA vaccines, protein-based vaccines) either licensed or authorized for emergency use (eg. EUA, EUL or similar program) - within 14 days before or after planned administration of the first or subsequent study vaccinations.

14. Receipt of blood products within 3 months of study entry.

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

16. 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).

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

18. Any laboratory abnormalities including:

Hematology

* Hemoglobin \< 10.0 g/dl

* Absolute Neutrophil Count ≤ 1,000 /mm3 (≤ 1 x 109/L)

* Absolute Lymphocyte Count ≤ 600 /mm3 (≤ 0.6 x 109/L)

* Platelets ≤100,000 /mm3, ≥ 550,000 /mm3 (≤ 100 /L, ≥ 550 /L) 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(2)

19. Refusal to an eventual ART interruption within the scope of the study objectives(3).

* (1)Efforts will be made to ensure all participants included are updated on their Hepatitis A, Hepatitis B and Pneumococcal vaccinations before enrolment. Seasonal Flu vaccinations or other required vaccinations will be scheduled to avoid the 3 weeks preceding and following IMP administrations and the first 12 weeks of ATI.

* (2) Cases in which positive RPR titres are detected but syphilis has been confirmed to have been properly treated will be allowed into the study if treatment has been given \>4 weeks prior to study entry/IMP administration.

* (3)A questionnaire related to ART interruption will be answered by the candidate during the screening visit to be able to address Expectations and Worries in a timely manner to reduce the risk of participants lost to follow-up during the study.

A Phase I, Randomized, Double-Blind, Placebo-Controlled Safety, Tolerability and Immunogenicity Study of Candidate HIV-1 Vaccines ChAdOx1.HTI and MVA.HTI With Recombinant HIV-1 Envelope Protein ConM SOSIP.v7 gp140 Vaccine, Adjuvanted With MPLA Liposomes in ART-Suppressed HIV-1 Positive Individuals

What this study is about

A Phase I, Randomized, Double-Blind, Placebo-Controlled Safety, Tolerability and Immunogenicity Study of Candidate HIV-1 Vaccines ChAdOx1.HTI and MVA.HTI With Recombinant HIV-1 Envelope Protein ConM SOSIP.v7 gp140 Vaccine, Adjuvanted With MPLA Liposomes in ART-Suppressed HIV-1 Positive Individuals

What this study is about