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
Not provided at time of registration
Contact information
Prof Charles Lacey
Scientific
Scientific
York HIV Research Group
31 Monkgate
York
YO31 7WE
United Kingdom
Study information
| Study design | Phase I double-blind randomised controlled single-centre trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Not specified |
| Study type | Prevention |
| Participant information sheet | Not available in web format, please use the contact details below to request a patient 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 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(s) | Cambridgeshire 1 Research Ethics Committee, approval pending as of 23/10/2008 (ref: 08/HO304/87) |
| 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 |
| Pharmaceutical study type(s) | |
| Phase | Phase I |
| Drug / device / biological / vaccine name(s) | Mabgel |
| Primary outcome measure | 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 study start date | 01/04/2009 |
| Overall study end date | 01/07/2010 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Female |
| Target number of participants | 30 |
| 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 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
- England
- United Kingdom
Study participating centre
York HIV Research Group
York
YO31 7WE
United Kingdom
YO31 7WE
United Kingdom
Sponsor information
York Hospitals NHS Foundation Trust (UK)
Hospital/treatment centre
Hospital/treatment centre
c/o Dr Caroline Mozley
North Yorkshire R&D Alliance
Learning and Research Centre
York Hospital
Wigginton Road
York
YO31 8HE
England
United Kingdom
| Phone | +44 (0)1904 726996 |
|---|---|
| caroline.mozley@york.nhs.uk | |
| Website | http://www.yorkhospitals.nhs.uk |
"ROR" |
https://ror.org/027e4g787 |
Funders
Funder type
Other
European Commission (Belgium)
Government organisation / National government
Government organisation / National government
- Alternative name(s)
- European Union, Comisión Europea, Europäische Kommission, EU-Kommissionen, Euroopa Komisjoni, Ευρωπαϊκής Επιτροπής, Европейската комисия, Evropské komise, Commission européenne, Choimisiúin Eorpaigh, Europskoj komisiji, Commissione europea, La Commissione europea, Eiropas Komisiju, Europos Komisijos, Európai Bizottságról, Europese Commissie, Komisja Europejska, Comissão Europeia, Comisia Europeană, Európskej komisii, Evropski komisiji, Euroopan komission, Europeiska kommissionen, EC, EU
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not 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 |
