Human Immunodeficiency VirusPhase 1NCT01403792
A Safety Study Of A Single Vaginal Administration Of P2G12 Antibody In Healthy Female Subjects
A Phase 1 study testing P2G12 in people with Human Immunodeficiency Virus, run by University of Surrey at 1 site in United Kingdom.
Trial summary
The purpose of this study is to assess the safety and tolerability of intravaginal administration of P2G12. 11 subjects will receive P2G12/placebo. Three subjects in Group 1 will receive up to 7mg of P2G12, or placebo. Read more about this study
- Who is it for?
- Ages 18 to 50 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Human Immunodeficiency Virus
- What is being tested?
- P2G12
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 11 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Jun 2011to Nov 2011
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 50 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- A female adult subject aged between 18 and 50 years old.
- They are in good health as determined by medical history, physical examination and clinical judgement before entering into the study.
- Subjects must agree to abstain from vaginal sexual intercourse for 72 hours before and after dosing.
- Subject must agree not to undertake any vaginal practices during study participation other than receptive intercourse with a male, or use of sanitary tampons during menses. Use of condoms without spermicidal agents is encouraged.
- Confirmation from the subject's GP that there is nothing in the subject's medical history that would prevent the subject from participating in the study.
Who cannot join
- They have a known or suspected ongoing vaginal disease, malignancy or abnormality (including non-menstrual vaginal discharge) discovered at time of screening.
- They have an abnormality, or non-menstrual discharge noted at screening colposcopy.
- They present in the samples obtained at the screening visit:
- positive results for HIV 1 or 2 antibody.
- positive results for Hepatitis B sAg, anti-Hepatitis C antibody
- positive syphilis serology
Show all 11Show fewer
- positive test for Neisseria gonorrhoea or Chlamydia trachomatis on urine or urethral swab sample
- abnormal cervical smear cytology
- A clinically significant amount of protein or haemoglobin in the urine sample, determined by urine dipstick.
- They have received any form of immunosuppressive or immunomodulatory (e.g. vaccines) therapy in the past 6 months.
- They are receiving any medications via vaginal route.
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Surrey Clinical Research Centre
Guildford, Surrey, GU2 7XP
About this study
Official title: A Double-Blind, Placebo-Controlled, Randomised, Dose-Escalation Phase I Safety Study Of A Single Vaginal Administration Of P2G12 Antibody In Healthy Female Subjects
The purpose of this study is to assess the safety and tolerability of intravaginal administration of P2G12. 11 subjects will receive P2G12/placebo. Three subjects in Group 1 will receive up to 7mg of P2G12, or placebo. Three subjects in Group 2 will receive up to 14mg of P2G12, or placebo and five subjects in Group 3 will receive up to 28mg of P2G12, or placebo. A safety review will take place before subjects in Groups 2 and 3 receive study drug to determine if it is safe to proceed to the next dose of P2G12. Vaginal and cervical inspections will be performed to determine what effect, if any, the study drug has had on the site of administration. Adverse event data will be collected throughout the trial.
Read the detailed description
This is a phase I study in healthy women aged 18 to 50 years, which involves vaginal application of study drug P2G12 or placebo.
P2G12 is a monoclonal antibody (MAb) (a kind of protein), and belongs to a group of MAbs that can help to prevent and protect from HIV infection. Most of these MAbs have been produced using a system called Chinese Hamster Ovary cell (CHO-Cell) fermentation, e.g. C2G12. This method of production is very expensive and cannot produce enough MAbs on a scale required for the global market.
Unlike C2G12, P2G12 is manufactured from plants. It is hoped that plant manufacture of such MAbs may offer some solutions to the high cost and low output of CHO-cell fermentation.
This study is designed to confirm the safety of a vaginally delivered MAb (P2G12) derived from plants and manufactured to Good Manufacturing Practice (a quality standard used for the manufacture of medicinal products).
11 subjects will be enrolled consecutively in cohorts (groups); in each successive cohort a higher dose of study drug will be administered, as well as placebo. The dose range is from up to 7 to up to 28mg of P2G12 in saline.
Subjects attend 7 visits over 13 weeks. At visit 3 subjects receive a single administration of study drug/placebo. Study visits include the following procedures: physical exam, vital signs, blood and urine samples, cervical smear test and colposcopy (medical examination of the cervix).
The relationship of adverse events (AEs) and serious adverse events (SAEs) to P2G12 administration, and abnormal laboratory test results as compared to baseline (pre-dose) values, will determine the safety of P2G12 in the study.
Levels of P2G12 in vaginal and serum samples will be measured at particular time-points in order to understand how quickly P2G12 is broken down by the body (pharmacokinetics) and whether any P2G12 is absorbed into the systemic circulation.
- Conditions
- Human Immunodeficiency Virus
- Being tested
- P2G12
- Keywords
- Human Immunodeficiency Virus, Neutralising monoclonal antibody
- Medical subject headings
- Acquired Immunodeficiency Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
P2G12Drug
A single intravaginal administration of 1ml P2G12/placebo.
| Study group | Role | What they receive |
|---|---|---|
| Up to 7mg P2G12 | Experimental | Not described Receives: Drug: P2G12 |
| Up to 14mg P2G12 | Experimental | Not described Receives: Drug: P2G12 |
| Up to 28mg P2G12 | Experimental | Not described Receives: Drug: P2G12 |
| Placebo (saline solution) | Placebo comparator | Not described Receives: Drug: P2G12 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Occurrence, intensity and relationship to P2G12 administration of local and general adverse events (AEs) throughout the study period after drug administration.
Measured: 35 days.
Secondary outcomes (1)
Changes in levels of P2G12 in blood and vaginal secretions as compared to baseline.
Measured: 35 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jul 2011 (estimated)
- Study startJun 2011
- Primary completionNov 2011
- Study completionNov 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Human Immunodeficiency VirusStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 11 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Surrey
- Sponsor type
- University, hospital or other
- Collaborators
- European Commission
- Responsible party
- Sponsor
- Investigators
- Hubert A Bland, MBChB, Principal investigator, University of Surrey
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01403792
- Sponsor's protocol ID
- CRC282
- Status last verified
- Dec 2011
- First submitted
- 26 Jul 2011
- Last updated
- 22 Dec 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Dec 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Double-Blind, Placebo-Controlled, Randomised, Dose-Escalation Phase I Safety Study Of A Single Vaginal Administration Of P2G12 Antibody In Healthy Female Subjects
- ClinicalTrials.gov ID
- NCT01403792
- Acronym / sponsor ID
- CRC282
- Conditions
- Human Immunodeficiency Virus
- Keywords
- Human Immunodeficiency Virus, Neutralising monoclonal antibody
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 11 participants (actual)
- Lead sponsor
- University of SurreyUniversity, hospital or other
- Collaborators
- European Commission
- Study start
- Jun 2011
- Primary completion
- Nov 2011 (actual)
- Study completion
- Nov 2011 (actual)
- First posted
- 27 Jul 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to assess the safety and tolerability of intravaginal administration of P2G12. 11 subjects will receive P2G12/placebo. Three subjects in Group 1 will receive up to 7mg of P2G12, or placebo. Three subjects in Group 2 will receive up to 14mg of P2G12, or placebo and five subjects in Group 3 will receive up to 28mg of P2G12, or placebo. A safety review will take place before subjects in Groups 2 and 3 receive study drug to determine if it is safe to proceed to the next dose of P2G12. Vaginal and cervical inspections will be performed to determine what effect, if any, the study drug has had on the site of administration. Adverse event data will be collected throughout the trial.
Detailed description
This is a phase I study in healthy women aged 18 to 50 years, which involves vaginal application of study drug P2G12 or placebo.
P2G12 is a monoclonal antibody (MAb) (a kind of protein), and belongs to a group of MAbs that can help to prevent and protect from HIV infection. Most of these MAbs have been produced using a system called Chinese Hamster Ovary cell (CHO-Cell) fermentation, e.g. C2G12. This method of production is very expensive and cannot produce enough MAbs on a scale required for the global market.
Unlike C2G12, P2G12 is manufactured from plants. It is hoped that plant manufacture of such MAbs may offer some solutions to the high cost and low output of CHO-cell fermentation.
This study is designed to confirm the safety of a vaginally delivered MAb (P2G12) derived from plants and manufactured to Good Manufacturing Practice (a quality standard used for the manufacture of medicinal products).
11 subjects will be enrolled consecutively in cohorts (groups); in each successive cohort a higher dose of study drug will be administered, as well as placebo. The dose range is from up to 7 to up to 28mg of P2G12 in saline.
Subjects attend 7 visits over 13 weeks. At visit 3 subjects receive a single administration of study drug/placebo. Study visits include the following procedures: physical exam, vital signs, blood and urine samples, cervical smear test and colposcopy (medical examination of the cervix).
The relationship of adverse events (AEs) and serious adverse events (SAEs) to P2G12 administration, and abnormal laboratory test results as compared to baseline (pre-dose) values, will determine the safety of P2G12 in the study.
Levels of P2G12 in vaginal and serum samples will be measured at particular time-points in order to understand how quickly P2G12 is broken down by the body (pharmacokinetics) and whether any P2G12 is absorbed into the systemic circulation.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Up to 7mg P2G12 | Experimental | Drug: P2G12 |
| Up to 14mg P2G12 | Experimental | Drug: P2G12 |
| Up to 28mg P2G12 | Experimental | Drug: P2G12 |
| Placebo (saline solution) | Placebo comparator | Drug: P2G12 |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- A female adult subject aged between 18 and 50 years old.
- They are in good health as determined by medical history, physical examination and clinical judgement before entering into the study.
- Subjects must agree to abstain from vaginal sexual intercourse for 72 hours before and after dosing.
- Subject must agree not to undertake any vaginal practices during study participation other than receptive intercourse with a male, or use of sanitary tampons during menses. Use of condoms without spermicidal agents is encouraged.
- Confirmation from the subject's GP that there is nothing in the subject's medical history that would prevent the subject from participating in the study.
Key exclusion criteria (11 listed)
- They have a known or suspected ongoing vaginal disease, malignancy or abnormality (including non-menstrual vaginal discharge) discovered at time of screening.
- They have an abnormality, or non-menstrual discharge noted at screening colposcopy.
- They present in the samples obtained at the screening visit:
- A clinically significant amount of protein or haemoglobin in the urine sample, determined by urine dipstick.
- They have received any form of immunosuppressive or immunomodulatory (e.g. vaccines) therapy in the past 6 months.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| P2G12A single intravaginal administration of 1ml P2G12/placebo. | Drug | Placebo (saline solution), Up to 14mg P2G12, Up to 28mg P2G12, Up to 7mg P2G12 |
Primary outcome
Occurrence, intensity and relationship to P2G12 administration of local and general adverse events (AEs) throughout the study period after drug administration.
Time frame: 35 days.
1 secondary outcome
Changes in levels of P2G12 in blood and vaginal secretions as compared to baseline.
Time frame: 35 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Dec 2011.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Hubert A Bland, MBChB principal investigator
University of Surrey
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing P2G12 in people with Human Immunodeficiency Virus, run by University of Surrey at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Dec 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Occurrence, intensity and relationship to P2G12 administration of local and general adverse events (AEs) throughout the study period after drug administration. (time frame: 35 days.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Dec 2011.