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Phase I randomised clinical trial of an HIV-1(CN54), clade C, trimeric envelope vaccine candidate delivered vaginally.

Lewis, DJ, Fraser, CA, Mahmoud, AN, Wiggins, RC, Woodrow, M, Cope, A, Cai, C, Giemza, R, Jeffs, SA and Manoussaka, M (2011) Phase I randomised clinical trial of an HIV-1(CN54), clade C, trimeric envelope vaccine candidate delivered vaginally. PLoS One, 6 (9).

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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. TRIAL REGISTRATION: ClinicalTrials.gov NCT00637962.

Item Type: Article
Authors :
NameEmailORCID
Lewis, DJd.j.lewis@surrey.ac.ukUNSPECIFIED
Fraser, CAUNSPECIFIEDUNSPECIFIED
Mahmoud, ANUNSPECIFIEDUNSPECIFIED
Wiggins, RCUNSPECIFIEDUNSPECIFIED
Woodrow, MUNSPECIFIEDUNSPECIFIED
Cope, AUNSPECIFIEDUNSPECIFIED
Cai, CUNSPECIFIEDUNSPECIFIED
Giemza, RUNSPECIFIEDUNSPECIFIED
Jeffs, SAUNSPECIFIEDUNSPECIFIED
Manoussaka, MUNSPECIFIEDUNSPECIFIED
Date : 2011
Identification Number : https://doi.org/10.1371/journal.pone.0025165
Depositing User : Symplectic Elements
Date Deposited : 17 May 2017 09:37
Last Modified : 17 May 2017 14:43
URI: http://epubs.surrey.ac.uk/id/eprint/824448

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