NCT01473810

Immunotherapy of HIV-infected Patients: A Single-blinded, Randomized, Immunogenicity, Pilot Study of Intranasal Administration of Vacc-4x With Endocine as Adjuvant

Completed Phase 1/Phase 2 Last updated 19 June 2012

What this trial tests

Phase 1/Phase 2 trial testing Vacc-4x low dose in HIV Infection in 24 participants. Completed in 1 March 2012.

Timeline

1 November 2011

Primary endpoint
1 March 2012

1 March 2012

Quick facts

Lead sponsor	Oslo University Hospital
Phase	Phase 1/Phase 2
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	factorial
Masking	single
Primary purpose	treatment
Enrollment	24
Start date	1 November 2011
Primary completion	1 March 2012
Estimated completion	1 March 2012
Sites	1 location across Norway

Drugs / interventions tested

• Vacc-4x low dose — full drug profile →
• Vacc-4x medium dose — full drug profile →
• Vacc-4x high dose — full drug profile →
• Zero dose

Conditions studied

• HIV Infection — all drugs for HIV Infection →

Sponsor

Oslo University Hospital

Who can join

Adults 18 to 70, any sex, with HIV Infection. Patients with the condition only — healthy volunteers not accepted.

What's being measured

Primary outcomes are the specific endpoints the trial is designed to prove or disprove.

• Evaluate the safety of intranasal administration of Vacc-4x with Endocine as adjuvant at three different dose levels
  Time frame: 2 months after completion of last patient.
  Record adverse events including severe adverse events according to GCP

Sponsor's own description

HIV-specific cellular immunity is hampered in most HIV-infected individuals. Therapeutic immunization in HIV aims to strengthen the HIV-specific cellular immunity, usually in the absence of replicating HIV with antiretroviral drugs. The aims of this strategy can be to decrease the mass of latently infected CD4+ T cells, better tolerance of drug-free periods, and better select candidates for preventive HIV vaccines.

Vacc-4x is one of the few peptide-based therapeutic vaccines tested, and consists of four, slightly modified HIV Gag p24 consensus peptides. Vacc-4x was first tested by intradermal injections using GM-CSF as adjuvant. A recent multinational placebo-controlled study found improvement of vaccine-specific T cell immunity and decrease in viral loads (presented at the AIDS vaccine 2011 conference, Bangkok).

In this study the investigators hypothesize that the Vacc-4x peptides, deposited on the nasal mucosal surfaces in conjunction with Endocine, a newly developed and documented mucosal adjuvant, will induce T cell responses to HIV and improve HIV-specific immunity both systemically and at mucosal surfaces (oral, rectal, vaginal).

Publications & conference data

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

1. Advances in intranasal vaccine delivery: A promising non-invasive route of immunization.
   Kehagia E, Papakyriakopoulou P, Valsami G. · · 2023 · cited 69× · PMID 37179163 · DOI 10.1016/j.vaccine.2023.05.011
2. Noninvasive vaccination against infectious diseases.
   Zheng Z, Diaz-Arévalo D, Guan H, Zeng M. · · 2018 · cited 46× · PMID 29624470 · DOI 10.1080/21645515.2018.1461296
3. Mucosal delivery of tuberculosis vaccines: a review of current approaches and challenges.
   Stylianou E, Paul MJ, Reljic R, McShane H. · · 2019 · cited 43× · PMID 31876199 · DOI 10.1080/14760584.2019.1692657
4. Development of Nasal Vaccines and the Associated Challenges.
   Nian X, Zhang J, Zhang J, Huang S, et al · · 2022 · cited 33× · PMID 36297419 · DOI 10.3390/pharmaceutics14101983
5. Intranasal administration of a therapeutic HIV vaccine (Vacc-4x) induces dose-dependent systemic and mucosal immune responses in a randomized controlled trial.
   Brekke K, Lind A, Holm-Hansen C, Haugen IL, et al · · 2014 · cited 20× · PMID 25398137 · DOI 10.1371/journal.pone.0112556
6. Conserved multiepitope vaccine constructs: A potent HIV-1 therapeutic vaccine in clinical trials.
   Akbari E, Seyedinkhorasani M, Bolhassani A. · · 2023 · cited 7× · PMID 37156468 · DOI 10.1016/j.bjid.2023.102774
7. Nanotechnology-driven advances in intranasal vaccine delivery systems against infectious diseases.
   Zhang Z, Yang Y, Huang L, Yuan L, et al · · 2025 · cited 4× · PMID 40416956 · DOI 10.3389/fimmu.2025.1573037