NCT03204617

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

Completed Phase 1 Last updated 8 April 2021

What this trial tests

Phase 1 trial testing DNA.HTI 0.5mL at weeks 0, 4 and 8 + MVA.HTI 0.5mL at weeks 12 and 20 (DDDMM) in HIV in 45 participants. Completed in 10 March 2021.

Timeline

7 July 2017

Primary endpoint
1 July 2020

10 March 2021

Quick facts

Lead sponsor	Aelix Therapeutics
Phase	Phase 1
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	quadruple
Primary purpose	basic science
Enrollment	45
Start date	7 July 2017
Primary completion	1 July 2020
Estimated completion	10 March 2021
Sites	1 location across Spain

Drugs / interventions tested

• DNA.HTI 0.5mL at weeks 0, 4 and 8 + MVA.HTI 0.5mL at weeks 12 and 20 (DDDMM) — full drug profile →
• At least 24 weeks since DDDMM, ChAdOx1.HTI 0.5mL at weeks 0 and 12 + MVA.HTI 0.5mL at week 24 (CCM) — full drug profile →
• Placebo

Conditions studied

• HIV — all drugs for HIV →

Sponsor

Aelix Therapeutics — full company profile →

Who can join

Adults 18 to 60, any sex, with HIV. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

1. Safety, immunogenicity and effect on viral rebound of HTI vaccines in early treated HIV-1 infection: a randomized, placebo-controlled phase 1 trial.
   Bailón L, Llano A, Cedeño S, Escribà T, et al · · 2022 · cited 58× · PMID 36302893 · DOI 10.1038/s41591-022-02060-2
2. T cell-based strategies for HIV-1 vaccines.
   Korber B, Fischer W. · · 2020 · cited 44× · PMID 31584318 · DOI 10.1080/21645515.2019.1666957
3. Vaccines based on the replication-deficient simian adenoviral vector ChAdOx1: Standardized template with key considerations for a risk/benefit assessment.
   Folegatti PM, Jenkin D, Morris S, Gilbert S, et al · · 2022 · cited 24× · PMID 35715352 · DOI 10.1016/j.vaccine.2022.06.008
4. A Single and Un-Adjuvanted Dose of a Chimpanzee Adenovirus-Vectored Vaccine against Chikungunya Virus Fully Protects Mice from Lethal Disease.
   Campos RK, Preciado-Llanes L, Azar SR, Lopez-Camacho C, et al · · 2019 · cited 22× · PMID 31718104 · DOI 10.3390/pathogens8040231
5. Safety, immunogenicity and effect on viral rebound of HTI vaccines combined with a TLR7 agonist in early-treated HIV-1 infection: a randomized, placebo-controlled phase 2a trial.
   Bailón L, Moltó J, Curran A, Cadiñanos J, et al · · 2025 · cited 20× · PMID 40038256 · DOI 10.1038/s41467-025-57284-w
6. Post-intervention control in HIV immunotherapy trials.
   Sandel DA, Rutishauser RL, Peluso MJ. · · 2025 · cited 12× · PMID 39494630 · DOI 10.1097/coh.0000000000000890
7. Effect of epitope variant co-delivery on the depth of CD8 T cell responses induced by HIV-1 conserved mosaic vaccines.
   Wee EG, Moyo N, Hannoun Z, Giorgi EE, et al · · 2021 · cited 12× · PMID 34169114 · DOI 10.1016/j.omtm.2021.04.018
8. Vedolizumab and ART in recent HIV-1 infection unveil the role of α4β7 in reservoir size.
   Jimenez-Leon MR, Gasca-Capote C, Roca-Oporto C, Espinosa N, et al · · 2024 · cited 8× · PMID 38980725 · DOI 10.1172/jci.insight.182312