A randomised double-blind phase 1 study to assess the pharmacokinetics of C2F5, C2G12 and C4E10 when administered together in a gel vehicle as a vaginal microbicide

ISRCTN ISRCTN64808733
DOI https://doi.org/10.1186/ISRCTN64808733
Secondary identifying numbers Mabgel1
Submission date
23/10/2008
Registration date
26/01/2009
Last edited
12/01/2015
Recruitment status
No longer recruiting
Overall study status
Completed
Condition category
Infections and Infestations
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data

Plain English summary of protocol

Not provided at time of registration

Contact information

Prof Charles Lacey
Scientific

York HIV Research Group
31 Monkgate
York
YO31 7WE
United Kingdom

Study information

Study designPhase I double-blind randomised controlled single-centre trial
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)
Study typePrevention
Participant information sheet Not available in web format, please use the contact details below to request a patient information sheet
Scientific titleA randomised double-blind phase 1 study to assess the pharmacokinetics of C2F5, C2G12 and C4E10 when administered together in a gel vehicle as a vaginal microbicide
Study acronymMABGEL1
Study objectivesThe investigational medicinal product used in this trial is designed to prevent infection with HIV. As this is a phase I study to investigate the pharmacokinetic properties of the product, the study endpoints will not include infection with HIV, and participants will be healthy volunteers.

Please note that as of 15/04/2013, the anticipated end date for this study was updated from 01/01/2010 to 01/07/2010.

Study aim: To assess the pharmacokinetics of the specified monoclonal antibody (MAb) combination when applied vaginally.
Ethics approval(s)Cambridgeshire 1 Research Ethics Committee, approval pending as of 23/10/2008 (ref: 08/HO304/87)
Health condition(s) or problem(s) studiedHIV
InterventionThe participants will be randomly allocated to the following three vehicles for vaginal administration of monoclonal antibodies C2F5, C2G12 and C4E10:

Arm 1: Mabgel (high dose)
Arm 2: Mabgel (low dose)
Arm 3: Placebo gel

For all arms, the duration of treatment is 12 days. Participants will be followed up for 4 to 5 weeks after their first dose (dependent on menstrual cycle).

Details of Co-Sponsor:
University of York
c/o Dr Sue Final
Research Support Office
University of York
York, YO10 5DD
United Kingdom
Email: smf3@york.ac.uk
Intervention typeDrug
Pharmaceutical study type(s)
PhasePhase I
Drug / device / biological / vaccine name(s)Mabgel
Primary outcome measureLevels of MAbs in Weck-Cel vaginal secretions 1 and 8 hours post-1st dose and 1 and 8 hours post-12th dose.
Secondary outcome measures1. 8 hour post-1st dose and 8 hour post-12th dose cervico-vaginal lavage MAb levels
2. 8 hour post-1st dose and 8 hour post-12th dose MAb levels in self-sampled vaginal aspirate
3. 8 hour post-1st dose and 1 hour post-12th dose plasma MAb levels
4. Number of grade 3 or above genital adverse events during the dosing or follow-up period
5. Number of grade 3 or above other clinical or laboratory adverse events confirmed at examination or on repeat testing respectively during the dosing or follow-up period
6. Number of events attributable to the study gel leading to discontinuation of gel
Overall study start date01/04/2009
Completion date01/07/2010

Eligibility

Participant type(s)Patient
Age groupAdult
Lower age limit18 Years
SexFemale
Target number of participants30
Key inclusion criteria1. Females
2. Aged >=18 and <=45 years
3. In good health as determined by medical history, physical examination and clinical judgement
4. Willing and able to give written informed consent
5. Available for the duration of the study
6. Willing to undergo screening for HIV, hepatitis B & C, and sexually transmitted infections
7. Willing to abstain from vaginal practices including receptive oral sex and sexual intercourse from 48 hours before the first dose of the study gel until after visit 5
8. If physiologically fertile, using a reliable method of contraception for the two to three menstrual cycles covering the pre-study, and study dosing periods (methods defined as one of: consistent use of condoms with every act of sexual intercourse; combined oral contraceptive pill; intra-uterine contraceptive device; injectable contraceptive; progesterone implant)
9. Willing to abstain from using any genital preparations, other than the study gel, during the period of gel administration until after visit 5
10. Willing to abstain from using tampons during the period of gel administration until after visit 5
11. Judged by clinician to be able, and likely, to comply with the procedures required as set out in the protocol
12. Have been registered with a GP for at least the past 3 months
13. Have access to a domestic refrigerator at home for the purposes of storing the study gel
Key exclusion criteria1. Untreated syphilis, gonorrhoea, trichomonas, chlamydia, Candida or bacterial vaginosis
2. Clinically significant (out of the normal range and deemed clinically significant by the Chief Investigator [CI]) haematological, biochemical, or coagulation assay abnormalities on screening
3. HIV infection, anti-HCV antibody positive, HbsAg positive
4. Abnormal findings on pelvic examination, deemed clinically significant by the CI
5. History of coagulation disorders
6. Significant current general medical illness
7. Irregular menstrual bleeding likely to cause vaginal bleeding during the dosing period as judged by the CI
8. Current participation, or participation within the last 2 months in another clinical trial
9. Treatment for cervical intraepithelial neoplasia (CIN) or other gynaecological instrumentation of the cervix within the past 3 months
10. Pregnant, within 12 weeks postpartum, or breast feeding
11. Unlikely to comply with protocol
12. Have any condition which, in the opinion of the investigator, might interfere with the evaluation of the study objectives
13. Unable to fluently read and speak English to a level adequate for the full comprehension of procedures required in participation and consent
Date of first enrolment01/04/2009
Date of final enrolment01/07/2010

Locations

Countries of recruitment

  • England
  • United Kingdom

Study participating centre

York HIV Research Group
York
YO31 7WE
United Kingdom

Sponsor information

Funders

Funder type

Other

European Commission (Belgium)
Government organisation / National government
Alternative name(s)
European Union, Comisión Europea, Europäische Kommission, EU-Kommissionen, Euroopa Komisjoni, EC, EU

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summary
Publication and dissemination planNot provided at time of registration
IPD sharing plan

Study outputs

Output type Details Date created Date added Peer reviewed? Patient-facing?
Results article results 29/12/2014 Yes No
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