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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; Manoussaka, M; et al. Lewis, DJ; Fraser, CA; Mahmoud, AN; Wiggins, RC; Woodrow, M; Cope, A; Cai, C; Giemza, R; Jeffs, SA; Manoussaka, M; Cole, T; Cranage, MP; Shattock, RJ; Lacey, CJ (2011) Phase I Randomised Clinical Trial of an HIV-1(CN54), Clade C, Trimeric Envelope Vaccine Candidate Delivered Vaginally. PLOS ONE, 6 (9). e25165. ISSN 1932-6203 https://doi.org/10.1371/journal.pone.0025165
SGUL Authors: Cranage, Martin Patrick Lewis, David John Murdoch Manoussaka, Maria

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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.

Item Type: Article
Additional Information: ©2011 Lewis et al. This is an open-access article distributed under the terms of the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited.
Keywords: AIDS Vaccines, Administration, Intravaginal, Adolescent, Adult, Enzyme-Linked Immunosorbent Assay, Female, HIV Antibodies, Humans, Immunoglobulin A, Immunoglobulin G, Middle Aged, Young Adult, env Gene Products, Human Immunodeficiency Virus, Science & Technology, Multidisciplinary Sciences, Science & Technology - Other Topics, FEMALE GENITAL-TRACT, SIMIAN IMMUNODEFICIENCY VIRUS, ANTIBODY-RESPONSES, IMMUNE-RESPONSES, MUCOSAL, INFECTION, TRANSMISSION, WOMEN, IMMUNIZATION, SECRETIONS
SGUL Research Institute / Research Centre: Academic Structure > Infection and Immunity Research Institute (INII)
Journal or Publication Title: PLOS ONE
ISSN: 1932-6203
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Dates:
DateEvent
30 September 2011Published
Web of Science ID: WOS:000295941300020
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URI: http://openaccess.sgul.ac.uk/id/eprint/191
Publisher's version: https://doi.org/10.1371/journal.pone.0025165

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