Trial reportPloS one2014
Intranasal administration of a therapeutic HIV vaccine (Vacc-4x) induces dose-dependent systemic and mucosal immune responses in a randomized controlled trial.
Trial report in PloS one, 2014. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT01473810 (Immunotherapy of HIV-infected Patients), which is not on this map. Cited by 17 papers.
What it found
Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.
The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Immunotherapy of HIV-infected Patients: A Single-blinded, Randomized, Immunogenicity, Pilot Study of Intranasal Administration of Vacc-4x With Endocine as Adjuvant
Who cites it
17 citing papers in PubMed, 27 citations in OpenAlex.
- The therapeutic HIV Env C5/gp41 vaccine candidate Vacc-C5 induces specific T cell regulation in a phase I/II clinical study.BMC infectious diseases · 2017Trial
- Design of a multi-epitope vaccine against Mycobacterium tuberculosis using reverse vaccinology and immunoreactive peptides.Genomics & informatics · 2026Article
- Tailoring biomaterials for vaccine delivery.Journal of nanobiotechnology · 2024Review
- Combined intranasal and intramuscular parainfluenza 5-, simian adenovirus ChAdOx1- and poxvirus MVA-vectored vaccines induce synergistically HIV-1-specific T cells in the mucosa.Frontiers in immunology · 2023Article
- Development of Nasal Vaccines and the Associated Challenges.Pharmaceutics · 2022Review
- Different Methods and Formulations of Drugs and Vaccines for Nasal Administration.Pharmaceutics · 2022Review
- Invaplex functions as an intranasal adjuvant for subunit and DNA vaccines co-delivered in the nasal cavity of nonhuman primates.Vaccine: X · 2021Article
- CD8Nature reviews. Immunology · 2020Review
- Mucosal delivery of tuberculosis vaccines: a review of current approaches and challenges.Expert review of vaccines · 2019Review
- Mucosal Vaccine Approaches for Prevention of HIV and SIV Transmission.Current immunology reviews · 2019Article
- Needle-Free Immunization with Chitosan-Based Systems.International journal of molecular sciences · 2018Review
- Noninvasive vaccination against infectious diseases.Human vaccines & immunotherapeutics · 2018Review
- Multiplexed Fc array for evaluation of antigen-specific antibody effector profiles.Journal of immunological methods · 2017Article
- The intranasal adjuvant Endocine™ enhances both systemic and mucosal immune responses in aged mice immunized with influenza antigen.Virology journal · 2017Article
- Article
- Article
- Conserved multiepitope vaccine constructs: A potent HIV-1 therapeutic vaccine in clinical trials.The Brazilian journal of infectious diseases : an official publication of the Brazilian Society of Infectious DiseasesReview
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
7 authors at 4 institutions in 1 country.
Funding
No grant is acknowledged in the PubMed record.
Abstract
backgroundVacc-4x, a Gag p24-based therapeutic HIV vaccine, has been shown to reduce viral load set-points after intradermal administration. In this randomized controlled pilot study we investigate intranasal administration of Vacc-4x with Endocine as adjuvant.
methodsSafety and immunogenicity were tested in patients on effective ART. They were randomized to low, medium or high dose Vacc-4x or adjuvant alone, administered four times at weekly intervals with no booster. Vacc-4x-specific T cell responses were measured in vitro by proliferation and in vivo by a single DTH skin test at the end of study. Nasal and rectal mucosal secretions were analyzed for Vacc-4x-specific antibodies by ELISA. Immune regulation induced by Vacc-4x was assessed by functional blockade of the regulatory cytokines IL-10 and TGF-β.
resultsVacc-4x proliferative T cell responses increased only among the vaccinated (p ≤ 0.031). The low dose group showed the greatest increase in Vacc-4x CD8+T cell responses (p = 0.037) and developed larger DTH (p = 0.005) than the adjuvant group. Rectal (distal) Vacc-4x IgA and IgG antibodies also increased (p = 0.043) in this group. In contrast, the high dose generated higher nasal (local) Vacc-4x IgA (p = 0.028) and serum IgG (p = 0.030) antibodies than the adjuvant. Irrespective of dose, increased Vacc-4x CD4+T cell responses were associated with low proliferation (r = -0.82, p < 0.001) and high regulation (r = 0.61, p = 0.010) at baseline.
conclusionIntranasal administration of Vacc-4x with Endocine was safe and induced dose-dependent vaccine-specific T cell responses and both mucosal and systemic humoral responses. The clinical significance of dose, immune regulation and mucosal immunity warrants further investigation.
trial registrationClinicalTrials.gov NCT01473810.
Indexed as
Identifiers
What OpenQuestion holds
Registered trials
Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.