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
Protocol serial number	Mabgel1
Sponsor	York Hospitals NHS Foundation Trust (UK)
Funder	European Commission (Belgium)

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

Primary study design	Interventional
Study design	Phase I double-blind randomised controlled single-centre trial
Secondary study design	Randomised controlled trial
Study type	Participant information sheet
Scientific title	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
Study acronym	MABGEL1
Study objectives	The 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) studied	HIV
Intervention	The 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 type	Drug
Phase	Phase I
Drug / device / biological / vaccine name(s)	Mabgel
Primary outcome measure(s)	Levels of MAbs in Weck-Cel vaginal secretions 1 and 8 hours post-1st dose and 1 and 8 hours post-12th dose.
Key secondary outcome measure(s)	1. 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
Completion date	01/07/2010

Eligibility

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Sex	Female
Target sample size at registration	30
Key inclusion criteria	1. 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 criteria	1. 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 enrolment	01/04/2009
Date of final enrolment	01/07/2010

Locations

Countries of recruitment

United Kingdom
England

Study participating centre

York HIV Research Group

York
YO31 7WE
United Kingdom

Results and Publications

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary
IPD sharing plan

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	results	29/12/2014		Yes	No
Participant information sheet	Participant information sheet	11/11/2025	11/11/2025	No	Yes