title: Phase I randomised clinical trial of an HIV-1(CN54), clade C, trimeric envelope vaccine candidate delivered vaginally.
abstract: We conducted a phase 1 double-blind randomised controlled trial (RCT) of a HIV-1 envelope protein (CN54 gp140) candidate vaccine delivered vaginally to assess immunogenicity and safety. It was hypothesised that repeated delivery of gp140 may facilitate antigen uptake and presentation at this mucosal surface. Twenty two healthy female volunteers aged 18-45 years were entered into the trial, the first receiving open-label active product. Subsequently, 16 women were randomised to receive 9 doses of 100 µg of gp140 in 3 ml of a Carbopol 974P based gel, 5 were randomised to placebo solution in the same gel, delivered vaginally via an applicator. Participants delivered the vaccine three times a week over three weeks during one menstrual cycle, and were followed up for two further months. There were no serious adverse events, and the vaccine was well tolerated. No sustained systemic or local IgG, IgA, or T cell responses to the gp140 were detected following vaginal immunisations. Repeated vaginal immunisation with a HIV-1 envelope protein alone formulated in Carbopol gel was safe, but did not induce local or systemic immune responses in healthy women.
  
  
  BACKGROUND
  ClinicalTrials.gov NCT00637962.
authors: Centre for Infection & Immunity, Division of Clinical Sciences, St George's, University of London, United Kingdom.
authors: David J
authors: DJ
authors: Lewis
authors: Carol A
authors: CA
authors: Fraser
authors: Abdel N
authors: AN
authors: Mahmoud
authors: Rebecca C
authors: RC
authors: Wiggins
authors: Maria
authors: M
authors: Woodrow
authors: Alethea
authors: A
authors: Cope
authors: Chun
authors: C
authors: Cai
authors: Rafaela
authors: R
authors: Giemza
authors: Simon A
authors: SA
authors: Jeffs
authors: Maria
authors: M
authors: Manoussaka
authors: Tom
authors: T
authors: Cole
authors: Martin P
authors: MP
authors: Cranage
authors: Robin J
authors: RJ
authors: Shattock
authors: Charles J
authors: CJ
authors: Lacey
mesh_terms: D016915:AIDS Vaccines / Q000008:administration & dosage* / Q000009:adverse effects / Q000627:therapeutic use*; D000282:Administration, Intravaginal; D000293:Adolescent; D000328:Adult; D004797:Enzyme-Linked Immunosorbent Assay; D005260:Female; D015483:HIV Antibodies / Q000276:immunology; D006801:Humans; D007070:Immunoglobulin A / Q000276:immunology; D007074:Immunoglobulin G / Q000276:immunology; D008875:Middle Aged; D055815:Young Adult; D054299:env Gene Products, Human Immunodeficiency Virus / Q000276:immunology
chemical_list: D016915:AIDS Vaccines; D015483:HIV Antibodies; D007070:Immunoglobulin A; D007074:Immunoglobulin G; D054299:env Gene Products, Human Immunodeficiency Virus; C097729:gp140 envelope protein, Human immunodeficiency virus 1