Phase I Randomised Clinical Trial of an HIV-1CN54, Clade C, Trimeric Envelope Vaccine Candidate Delivered Vaginally
2011

HIV-1 Vaccine Trial in Women

Sample size: 22 publication Evidence: low

Author Information

Author(s): Lewis David J., Fraser Carol A., Mahmoud Abdel N., Wiggins Rebecca C., Woodrow Maria, Cope Alethea, Cai Chun, Giemza Rafaela, Jeffs Simon A., Manoussaka Maria, Cole Tom, Cranage Martin P., Shattock Robin J., Lacey Charles J.

Primary Institution: Centre for Infection & Immunity, Division of Clinical Sciences, St George's, University of London, United Kingdom

Hypothesis

Repeated delivery of gp140 may facilitate antigen uptake and presentation at the vaginal mucosal surface.

Conclusion

The vaginal gp140 vaccine candidate was safe but did not induce local or systemic immune responses in healthy women.

Supporting Evidence

  • The vaccine was well tolerated with no serious adverse events.
  • Participants received nine doses of the vaccine over three weeks.
  • Immunological responses were measured but none were detected.

Takeaway

The study tested a new HIV vaccine given in the vagina, but it didn't help the body fight the virus.

Methodology

A phase 1 double-blind randomised controlled trial with 22 healthy female volunteers receiving either the vaccine or placebo.

Limitations

The study did not detect any immune responses, which may be due to the lack of adjuvants or the method of delivery.

Participant Demographics

Healthy women aged 18-45, predominantly white ethnicity.

Digital Object Identifier (DOI)

10.1371/journal.pone.0025165

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