Condition category
Infections and Infestations
Date applied
23/10/2008
Date assigned
26/01/2009
Last edited
12/01/2015
Prospective/Retrospective
Prospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Prof Charles Lacey

ORCID ID

Contact details

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

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

Mabgel1

Study information

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

Acronym

MABGEL1

Study hypothesis

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

Cambridgeshire 1 Research Ethics Committee, approval pending as of 23/10/2008 (ref: 08/HO304/87)

Study design

Phase I double-blind randomised controlled single-centre trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Not specified

Trial type

Prevention

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

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 names

Mabgel

Primary outcome measures

Levels of MAbs in Weck-Cel vaginal secretions 1 and 8 hours post-1st dose and 1 and 8 hours post-12th dose.

Secondary outcome measures

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

Overall trial start date

01/04/2009

Overall trial end date

01/07/2010

Reason abandoned

Eligibility

Participant 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

Participant type

Patient

Age group

Adult

Gender

Female

Target number of participants

30

Participant 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

Recruitment start date

01/04/2009

Recruitment end date

01/07/2010

Locations

Countries of recruitment

United Kingdom

Trial participating centre

York HIV Research Group
York
YO31 7WE
United Kingdom

Sponsor information

Organisation

York Hospitals NHS Foundation Trust (UK)

Sponsor details

c/o Dr Caroline Mozley
North Yorkshire R&D Alliance
Learning and Research Centre
York Hospital
Wigginton Road
York
YO31 8HE
United Kingdom
+44 (0)1904 726996
caroline.mozley@york.nhs.uk

Sponsor type

Hospital/treatment centre

Website

http://www.yorkhospitals.nhs.uk

Funders

Funder type

Other

Funder name

European Commission (Belgium)

Alternative name(s)

EC

Funding Body Type

government organisation

Funding Body Subtype

Federal/National Government

Location

Belgium

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

2014 results in: http://www.ncbi.nlm.nih.gov/pubmed/25546420

Publication citations

Additional files

Editorial Notes