NCT00637962

Brief Summary

To determine the local (cervico-vaginal) and systemic (whole body) safety of vaginal immunisation with CN54gp140 glycoprotein administered 9 times over a 3 week period.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
23

participants targeted

Target at P25-P50 for phase_1 hiv-infections

Timeline
Completed

Started Sep 2007

Geographic Reach
1 country

2 active sites

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2007

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

March 11, 2008

Completed
7 days until next milestone

First Posted

Study publicly available on registry

March 18, 2008

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2008

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2009

Completed
Last Updated

February 11, 2011

Status Verified

February 1, 2011

Enrollment Period

1.1 years

First QC Date

March 11, 2008

Last Update Submit

February 10, 2011

Conditions

HIV InfectionsAcquired Immune Deficiency Syndrome

Keywords

HIVAIDSVaccineintravaginalmucosalHIV Seronegativity

Outcome Measures

Primary Outcomes (1)

  • To determine the local and systemic safety of vaginal immunisation with CN54gp140 glycoprotein administered 9 times over a 3 week period.

    13 weeks

Secondary Outcomes (4)

  • frequency of subjects mounting a cervico-vaginal IgA and IgG response to gp140 after a cycle of 9 vaginal immunisations

    13 wks

  • frequency of subjects mounting a serum IgG and IgA response to gp140 after a cycle of 9 vaginal immunisations

    13 wks

  • frequency of subjects with a T-cell response to gp140 in blood after a cycle of 9 vaginal immunisations

    13 wks

  • frequency of cellular responses to gp140 in cervical cells after a cycle of 9 vaginal immunisations

    13 wks

Study Arms (2)

Active product

EXPERIMENTAL

CN54gp140 + gel

Biological: HIV glycoprotein CN54gp140 (vaccine)

Gel alone

PLACEBO COMPARATOR

Gel alone

Biological: Carbopol 974

Interventions

HIV glycoprotein CN54gp140 (vaccine)BIOLOGICAL

vaginal immunisation with 100ug CN54gp140 antigen in gel on 9 occasions in one menstrual cycle

Also known as: Previously designated ZM96gp140
Active product
Carbopol 974BIOLOGICAL

vaginal immunisation with Carbopol 974 P 0.924%; benzyl alcohol 1.09%; sodium hydroxide 0.176%; and purified water 97.81%. alone on 9 occasions in one menstrual cycle

Also known as: Carbapol gel
Gel alone

Eligibility Criteria

Age18 Years - 45 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • They are adult female volunteers, 18 to 45 years of age, who have signed an informed consent form following a detailed written explanation of participation in the protocol.
  • They are volunteers who are in good health as determined by medical history, physical examination and clinical judgement.
  • They are available for the duration of the study.
  • They are women who, if capable of becoming pregnant during the study, have agreed to have a pregnancy test immediately before immunisation, and to use appropriate contraception methods during the whole study period. Appropriate contraception shall include physician-prescribed oral hormonal agents, barrier contraceptives, regular and consistent use of condoms without spermicidal agents, or intrauterine devices only. Progesterone-only contraceptives are not suitable due to the lack of a regular menstrual cycle.
  • They have agreed not to undertake any vaginal practices other than receptive intercourse with a male or use of sanitary tampons during menses. Use of condoms without spermicidal agents is encouraged.
  • They have not donated blood during 3 months prior to study entry and agree to not donate for 3 months after the end of their participation in the study.

You may not qualify if:

  • They have hypersensitivity to any component of the vaccine used in this study.
  • They are found to be HIV antibody or HIV proviral DNA positive at the time of initial screening.
  • They have a known or suspected history of cervico-vaginal disease, malignancy or abnormality discovered at time of screening.
  • They present in the samples obtained at the screening visit:
  • a clinically significant amount of protein or haemoglobin in the urine sample, determined by urine dipstick.
  • a clinically significant abnormality in the haematological or biochemical assays.
  • Positive tests for Hepatitis B and/or C infection An abnormal value will be defined by the ranges quoted by The Doctors Laboratory for the Vaccine Institute site and Pathology Department, York Hospital for the York site.
  • They have a known or suspected impairment of lung, heart, liver, kidney, diseases, blood disorders or immune dysfunction.
  • They are receiving immunosuppressive therapy (including systemic steroids).
  • They are receiving any medications via vaginal route.
  • They have any acute infections (including fever greater than or equal to 38°C) or any chronic disease.
  • They present a current problem with substance abuse or with a history of substance abuse which, in the opinion of the investigator, might interfere with participation in the study.
  • They have any condition which, in the opinion of the investigator, might interfere with the evaluation of the study objectives.
  • They have received an investigational agent within 3 months prior to study entry.
  • They cannot speak fluent English, or are planning to leave the area of the study site prior to the end of the study period, or are likely not to complete the study.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

St George's Vaccine Institute

London, England, SW17 0RE, United Kingdom

Location

York Hospital

York, England, YO31 7WA, United Kingdom

Location

Related Publications (1)

  • 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. Phase I randomised clinical trial of an HIV-1(CN54), clade C, trimeric envelope vaccine candidate delivered vaginally. PLoS One. 2011;6(9):e25165. doi: 10.1371/journal.pone.0025165. Epub 2011 Sep 30.

    PMID: 21984924DERIVED

Related Links

MeSH Terms

Conditions

HIV InfectionsAcquired Immunodeficiency Syndrome

Interventions

Vaccines

Condition Hierarchy (Ancestors)

Blood-Borne InfectionsCommunicable DiseasesInfectionsSexually Transmitted Diseases, ViralSexually Transmitted DiseasesLentivirus InfectionsRetroviridae InfectionsRNA Virus InfectionsVirus DiseasesGenital DiseasesUrogenital DiseasesImmunologic Deficiency SyndromesImmune System DiseasesSlow Virus Diseases

Intervention Hierarchy (Ancestors)

Biological ProductsComplex Mixtures

Study Officials

  • David JM Lewis, MD

    St George's, University of London, UK

    PRINCIPAL INVESTIGATOR

  • Charles Lacey, MD

    York Hospitals

    PRINCIPAL INVESTIGATOR

  • David JM Lewis, MD

    St George's, University of London, UK

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

March 11, 2008

First Posted

March 18, 2008

Study Start

September 1, 2007

Primary Completion

October 1, 2008

Study Completion

January 1, 2009

Last Updated

February 11, 2011

Record last verified: 2011-02

Locations

GB(2)