{"id":{"repo_id":"hull","oai_identifier":"oai:hull-repository.worktribe.com:4214589"},"canonical_url":"https://search.dev.ndltd.org/etd/hull/oai:hull-repository.worktribe.com:4214589","repository":{"repo_id":"hull","name":"University of Hull","base_url":"https://hull-repository.worktribe.com/oaiprovider"},"display":{"title":"MABGEL 1: C2F5, C4E10 & C2G12 as a vaginal microbicide","abstract":"Topical microbicides are being developed as a female-controlled method for preventing HIV-1 infection. Non-antiretroviral (ARV)-based candidates may be advantageous given increasing levels of ARV resistance in low and middle- income countries.MABGEL 1 was a phase 1 trial designed to evaluate the pharmacokinetics and safety of a vaginal microbicide containing the broadly HIV-1 neutralizing monoclonal antibodies (mAbs) C2F5, C4E10 and C2G12 in a hydroxyethylcellulose-based gel vehicle. It was the first study of topical mAb application to the human female genital tract.Twenty-eight healthy women were randomised to apply either high dose Mabgel (containing 20mg/g of each mAb) (n= 10), low dose Mabgel (containing 10mg/g of each mAb) (n=9) or placebo gel (n=9). Doses (2.5ml) were applied over 12 consecutive days. Genital tract sampling was performed at baseline, 1 hour, 8 hours and 24 hours post 1st dose and 12 and 36 hours post 12th dose with serum samples collected at baseline, 8 hours post 1st dose and 12 hours post 12th dose. Safety was assessed through participant report and clinical examination, including colposcopy.Residence half-lives (t ½) in vaginal secretions (Weck-Cel samples) were estimated to be between 4 and 5.5 hours for C4E10 and C2F5. In contrast, vaginal levels of C2G12 did not conform to a single overall exponential decay, displaying a more rapid initial rate of decline, which then slowed at lower concentrations. The estimated early t ½ of C2G12 was 1.4 hours (95% CI 1.2 to 1.8). There was no evidence of systemic absorption.Daily vaginal application of up to 50g of each mAb over 12 days was safe. Although adverse events (AEs) were reported by all but 1 participant, 95 % were mild, none were serious and only 4 were moderate. There was no statistically significant difference in the number of AEs reported per participant between the 3 study arms.Although there are a number of caveats, results demonstrate ‘proof of principle’ of the potential for combinations of HIV-1 neutralizing mAbs to be used as a coitally-dependent microbicide.","abstract_html":"Topical microbicides are being developed as a female-controlled method for preventing HIV-1 infection. Non-antiretroviral (ARV)-based candidates may be advantageous given increasing levels of ARV resistance in low and middle- income countries.MABGEL 1 was a phase 1 trial designed to evaluate the pharmacokinetics and safety of a vaginal microbicide containing the broadly HIV-1 neutralizing monoclonal antibodies (mAbs) C2F5, C4E10 and C2G12 in a hydroxyethylcellulose-based gel vehicle. It was the first study of topical mAb application to the human female genital tract.Twenty-eight healthy women were randomised to apply either high dose Mabgel (containing 20mg/g of each mAb) (n= 10), low dose Mabgel (containing 10mg/g of each mAb) (n=9) or placebo gel (n=9). Doses (2.5ml) were applied over 12 consecutive days. Genital tract sampling was performed at baseline, 1 hour, 8 hours and 24 hours post 1st dose and 12 and 36 hours post 12th dose with serum samples collected at baseline, 8 hours post 1st dose and 12 hours post 12th dose. Safety was assessed through participant report and clinical examination, including colposcopy.Residence half-lives (t ½) in vaginal secretions (Weck-Cel samples) were estimated to be between 4 and 5.5 hours for C4E10 and C2F5. In contrast, vaginal levels of C2G12 did not conform to a single overall exponential decay, displaying a more rapid initial rate of decline, which then slowed at lower concentrations. The estimated early t ½ of C2G12 was 1.4 hours (95% CI 1.2 to 1.8). There was no evidence of systemic absorption.Daily vaginal application of up to 50g of each mAb over 12 days was safe. Although adverse events (AEs) were reported by all but 1 participant, 95 % were mild, none were serious and only 4 were moderate. There was no statistically significant difference in the number of AEs reported per participant between the 3 study arms.Although there are a number of caveats, results demonstrate ‘proof of principle’ of the potential for combinations of HIV-1 neutralizing mAbs to be used as a coitally-dependent microbicide.","abstract_has_math":false,"creators":["Morris, Georgina Claire"],"institution":"Hull York Medical School, the University of Hull and the University of York","degree_name":"MD","degree_level":"Doctoral","degree_discipline":null,"degree_department":null,"school":null,"contributors":[],"advisors":[],"committee_chairs":[],"committee_members":[],"year":2012,"date_issued":"2012","date_published":"2012","updated_at":"2026-07-24T02:33:43Z","subjects":["Medicine"],"languages":["en"],"rights":[],"rights_urls":[],"identifier_entries":[{"key":"dc:identifier","label":"Identifier","values":["oai:hull-repository.worktribe.com:4214589"],"render_values":[{"text":"oai:hull-repository.worktribe.com:4214589","href":null,"code":true}]}]},"links":{"outbound_url":"https://hull-repository.worktribe.com/4214589/1/Thesis","outbound_label":"Repository record","outbound_source":"dc:identifier.uri"},"metadata_groups":[{"id":"people","label":"People","entries":[{"key":"dc:creator","label":"Author","values":["Morris, Georgina Claire"]}]},{"id":"academic_context","label":"Academic Context","entries":[{"key":"dc:date","label":"Dc Date","values":["2012-12-01"]},{"key":"dc:date.issued","label":"Date","values":["2012"]},{"key":"dc:publisher.institution","label":"Dc Publisher Institution","values":["Hull York Medical School, the University of Hull and the University of York"]},{"key":"dc:relation.isreferencedby","label":"Dc Relation Isreferencedby","values":["https://hull-repository.worktribe.com/output/4214589"]},{"key":"dc:type","label":"Dc Type","values":["Thesis"]},{"key":"dc:type.qualificationlevel","label":"Dc Type Qualificationlevel","values":["Doctoral"]},{"key":"dc:type.qualificationname","label":"Dc Type Qualificationname","values":["MD"]}]},{"id":"subjects_keywords","label":"Subjects and Keywords","entries":[{"key":"dc:subject","label":"Dc Subject","values":["Medicine"]}]},{"id":"language_rights","label":"Language and Rights","entries":[{"key":"dc:language","label":"Dc Language","values":["en"]}]},{"id":"identifiers","label":"Identifiers","entries":[{"key":"dc:identifier","label":"Identifier","values":["oai:hull-repository.worktribe.com:4214589"]},{"key":"dc:identifier.uri","label":"Identifier URI","values":["https://hull-repository.worktribe.com/4214589/1/Thesis"]}]},{"id":"additional","label":"Additional Metadata","entries":[{"key":"dc:description.abstract","label":"Abstract","values":["Topical microbicides are being developed as a female-controlled method for preventing HIV-1 infection. Non-antiretroviral (ARV)-based candidates may be advantageous given increasing levels of ARV resistance in low and middle- income countries.MABGEL 1 was a phase 1 trial designed to evaluate the pharmacokinetics and safety of a vaginal microbicide containing the broadly HIV-1 neutralizing monoclonal antibodies (mAbs) C2F5, C4E10 and C2G12 in a hydroxyethylcellulose-based gel vehicle. It was the first study of topical mAb application to the human female genital tract.Twenty-eight healthy women were randomised to apply either high dose Mabgel (containing 20mg/g of each mAb) (n= 10), low dose Mabgel (containing 10mg/g of each mAb) (n=9) or placebo gel (n=9). Doses (2.5ml) were applied over 12 consecutive days. Genital tract sampling was performed at baseline, 1 hour, 8 hours and 24 hours post 1st dose and 12 and 36 hours post 12th dose with serum samples collected at baseline, 8 hours post 1st dose and 12 hours post 12th dose. Safety was assessed through participant report and clinical examination, including colposcopy.Residence half-lives (t ½) in vaginal secretions (Weck-Cel samples) were estimated to be between 4 and 5.5 hours for C4E10 and C2F5. In contrast, vaginal levels of C2G12 did not conform to a single overall exponential decay, displaying a more rapid initial rate of decline, which then slowed at lower concentrations. The estimated early t ½ of C2G12 was 1.4 hours (95% CI 1.2 to 1.8). There was no evidence of systemic absorption.Daily vaginal application of up to 50g of each mAb over 12 days was safe. Although adverse events (AEs) were reported by all but 1 participant, 95 % were mild, none were serious and only 4 were moderate. There was no statistically significant difference in the number of AEs reported per participant between the 3 study arms.Although there are a number of caveats, results demonstrate ‘proof of principle’ of the potential for combinations of HIV-1 neutralizing mAbs to be used as a coitally-dependent microbicide."]},{"key":"dc:title","label":"Title","values":["MABGEL 1: C2F5, C4E10 & C2G12 as a vaginal microbicide"]}]}],"canonical_facts":{"dc:creator":["Morris, Georgina Claire"],"dc:date":["2012-12-01"],"dc:date.issued":["2012"],"dc:description.abstract":["Topical microbicides are being developed as a female-controlled method for preventing HIV-1 infection. Non-antiretroviral (ARV)-based candidates may be advantageous given increasing levels of ARV resistance in low and middle- income countries.MABGEL 1 was a phase 1 trial designed to evaluate the pharmacokinetics and safety of a vaginal microbicide containing the broadly HIV-1 neutralizing monoclonal antibodies (mAbs) C2F5, C4E10 and C2G12 in a hydroxyethylcellulose-based gel vehicle. It was the first study of topical mAb application to the human female genital tract.Twenty-eight healthy women were randomised to apply either high dose Mabgel (containing 20mg/g of each mAb) (n= 10), low dose Mabgel (containing 10mg/g of each mAb) (n=9) or placebo gel (n=9). Doses (2.5ml) were applied over 12 consecutive days. Genital tract sampling was performed at baseline, 1 hour, 8 hours and 24 hours post 1st dose and 12 and 36 hours post 12th dose with serum samples collected at baseline, 8 hours post 1st dose and 12 hours post 12th dose. Safety was assessed through participant report and clinical examination, including colposcopy.Residence half-lives (t ½) in vaginal secretions (Weck-Cel samples) were estimated to be between 4 and 5.5 hours for C4E10 and C2F5. In contrast, vaginal levels of C2G12 did not conform to a single overall exponential decay, displaying a more rapid initial rate of decline, which then slowed at lower concentrations. The estimated early t ½ of C2G12 was 1.4 hours (95% CI 1.2 to 1.8). There was no evidence of systemic absorption.Daily vaginal application of up to 50g of each mAb over 12 days was safe. Although adverse events (AEs) were reported by all but 1 participant, 95 % were mild, none were serious and only 4 were moderate. There was no statistically significant difference in the number of AEs reported per participant between the 3 study arms.Although there are a number of caveats, results demonstrate ‘proof of principle’ of the potential for combinations of HIV-1 neutralizing mAbs to be used as a coitally-dependent microbicide."],"dc:identifier":["oai:hull-repository.worktribe.com:4214589"],"dc:identifier.uri":["https://hull-repository.worktribe.com/4214589/1/Thesis"],"dc:language":["en"],"dc:publisher.institution":["Hull York Medical School, the University of Hull and the University of York"],"dc:relation.isreferencedby":["https://hull-repository.worktribe.com/output/4214589"],"dc:subject":["Medicine"],"dc:title":["MABGEL 1: C2F5, C4E10 & C2G12 as a vaginal microbicide"],"dc:type":["Thesis"],"dc:type.qualificationlevel":["Doctoral"],"dc:type.qualificationname":["MD"]},"updated_at":"2026-07-24T02:33:43Z"}