HIV InfectionsPhase 1SG06RS02NCT00637962
Reactogenicity and Immunogenicity of Vaginal CNgp140
A Phase 1 study testing HIV glycoprotein CN54gp140 (vaccine) and Carbopol 974 in people with HIV Infections and Acquired Immune Deficiency Syndrome, run by St George's, University of London at 2 sites in United Kingdom.
Trial summary
To determine the local (cervico-vaginal) and systemic (whole body) safety of vaginal immunisation with CN54gp140 glycoprotein administered 9 times over a 3 week period. Read more about this study
- Who is it for?
- Ages 18 to 45 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- HIV Infections, Acquired Immune Deficiency Syndrome
- What is being tested?
- HIV glycoprotein CN54gp140 (vaccine) and Carbopol 974
- Type of treatment
- Vaccines
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 23 participants
- Where
- 2 sitesUnited Kingdom
- Study dates
- Sep 2007to Jan 2009
- 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 45 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- They are adult female volunteers, 18 to 45 years of age, who have signed an informed consent form following a detailed written explanation of participation in the protocol.
- They are volunteers who are in good health as determined by medical history, physical examination and clinical judgement.
- They are available for the duration of the study.
- They are women who, if capable of becoming pregnant during the study, have agreed to have a pregnancy test immediately before immunisation, and to use appropriate contraception methods during the whole study period. Appropriate contraception shall include physician-prescribed oral hormonal agents, barrier contraceptives, regular and consistent use of condoms without spermicidal agents, or intrauterine devices only. Progesterone-only contraceptives are not suitable due to the lack of a regular menstrual cycle.
- They have agreed not to undertake any vaginal practices other than receptive intercourse with a male or use of sanitary tampons during menses. Use of condoms without spermicidal agents is encouraged.
- They have not donated blood during 3 months prior to study entry and agree to not donate for 3 months after the end of their participation in the study.
Who cannot join
- They have hypersensitivity to any component of the vaccine used in this study.
- They are found to be HIV antibody or HIV proviral DNA positive at the time of initial screening.
- They have a known or suspected history of cervico-vaginal disease, malignancy or abnormality discovered at time of screening.
- 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.
- a clinically significant abnormality in the haematological or biochemical assays.
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- Positive tests for Hepatitis B and/or C infection An abnormal value will be defined by the ranges quoted by The Doctors Laboratory for the Vaccine Institute site and Pathology Department, York Hospital for the York site.
- They have a known or suspected impairment of lung, heart, liver, kidney, diseases, blood disorders or immune dysfunction.
- They are receiving immunosuppressive therapy (including systemic steroids).
- They are receiving any medications via vaginal route.
- They have any acute infections (including fever greater than or equal to 38°C) or any chronic disease.
- They present a current problem with substance abuse or with a history of substance abuse which, in the opinion of the investigator, might interfere with participation in the study.
- They have any condition which, in the opinion of the investigator, might interfere with the evaluation of the study objectives.
- They have received an investigational agent within 3 months prior to study entry.
- They cannot speak fluent English, or are planning to leave the area of the study site prior to the end of the study period, or are likely not to complete the study.
Trial locations and contacts
2 sites in 1 country.
United Kingdom2 sites
St George's Vaccine Institute
London, England, SW17 0RE
York Hospital
York, England, YO31 7WA
About this study
Official title: Phase I Clinical Trial in Healthy Female Volunteers of Reactogenicity and Immunogenicity of Nine Vaginal Immunisations With HIV CN54gp140 Glycoprotein
To determine the local (cervico-vaginal) and systemic (whole body) safety of vaginal immunisation with CN54gp140 glycoprotein administered 9 times over a 3 week period.
Read the detailed description
This randomised, placebo-controlled, double-blind study will primarily assess the local and systemic safety and tolerability of CN54gp140 vaccine. We will also assess whether CN54gp140 vaccine is effective at inducing systemic and/or local specific immune responses.
Thirty healthy women volunteers will be enrolled in this study, at 2 clinical sites. Twenty will receive active CN54gp140 vaccine, and 10 will receive placebo. The placebo group will help us identify side effects caused by CN54gp140. The study is double-blind to eliminate any possibility of researcher or subject bias.
Before administration, CN54gp140 or placebo will be mixed into an aqueous gel vehicle. The treatments will be administered intravaginally in a regimen of 9 immunisations over 3 weeks. Each immunisation of CN54gp140 vaccine will contain 100 µg of CN54gp140 protein, meaning that a total dose of 900 µg will be given to subjects in the active treatment group.
Subjects will be required to make a total of 15 outpatient visits to their local clinical site, over 4 successive menstrual cycles.
Menstrual cycle 1: Screening visits There will be 2 screening visits, at about 4 and 2 weeks before the first immunisation. During these visits the volunteers will be asked questions about their health history and to give permission for us to contact their General Practitioner. Blood and urine samples will be taken for routine laboratory safety tests, and tests for HIV and hepatitis, sexual health, and pregnancy. Blood will also be collected for immunology tests to establish the pre-immunisation state of the immune system. The volunteers will also have a cervico-vaginal examination, and sampling of cervico-vaginal secretions and cells will be done for immunology tests. A photograph of the cervix will be taken to help identify any changes that might occur during the trial. Also, a full medical history and examination will be done.
The volunteers will be given a diary card to take home. They'll be asked to record in the diary any symptoms they have, and medication they take, during the course of the trial. The diaries be regularly checked by the trial staff, who will also make a symptom enquiry at each visit.
Menstrual cycle 2: Immunisation visits There will be 9 immunisation visits, on successive Mondays, Wednesdays and Fridays. The 1st of these visits will be about 7 days after the start of menses. At the 1st, 4th and 9th immunisation visits, blood and urine will be collected for routine laboratory safety and pregnancy tests, and blood collected for immunology tests. Subjects will also have a cervico-vaginal examination, and their temperature, blood pressure and heart rate measured, before self-administering the vaccine.
At the rest of the immunisation visits, subjects will self-administer the vaccine. No other procedures will be done.
Menstrual cycle 3: Sampling visits There will be 3 sampling visits, at about 9, 14 and 21 days after the start of menses. At each visit, subjects will have a cervico-vaginal examination, during which sampling of secretions and cells will be done for immunology tests. Also, blood will be collected for immunology tests, and subjects will have their temperature, blood pressure and heart rate measured. At the 1st and 3rd sampling visits only, blood and urine will be collected for routine laboratory safety tests also.
Menstrual cycle 4: End-of-study visit This visit will be about 10 days after the start of menses. Blood and urine will be collected for routine laboratory safety and pregnancy tests, tests for HIV, and immunology tests. The volunteers will also have a cervico-vaginal examination, during which sampling of secretions and cells will be done for immunology tests, and a full medical examination. A photograph of the cervix will be taken. This visit concludes the subject's participation in the study.
- Being tested
- HIV glycoprotein CN54gp140 (vaccine), Carbopol 974
- Keywords
- HIV, AIDS, Vaccine, intravaginal, mucosal, HIV Seronegativity
- Medical subject headings
- HIV Infections, Acquired Immunodeficiency Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HIV glycoprotein CN54gp140 (vaccine)Biological
Also called Previously designated ZM96gp140
vaginal immunisation with 100ug CN54gp140 antigen in gel on 9 occasions in one menstrual cycle
Carbopol 974Biological
Also called Carbapol gel
vaginal immunisation with Carbopol 974 P 0.924%; benzyl alcohol 1.09%; sodium hydroxide 0.176%; and purified water 97.81%. alone on 9 occasions in one menstrual cycle
| Study group | Role | What they receive |
|---|---|---|
| Active product | Experimental | CN54gp140 + gel Receives: Biological: HIV glycoprotein CN54gp140 (vaccine) |
| Gel alone | Placebo comparator | Gel alone Receives: Biological: Carbopol 974 |
What is being measured
The primary outcome is the main question the study is designed to answer.
To determine the local and systemic safety of vaginal immunisation with CN54gp140 glycoprotein administered 9 times over a 3 week period.
Measured: 13 weeks
Secondary outcomes (4)
frequency of subjects mounting a cervico-vaginal IgA and IgG response to gp140 after a cycle of 9 vaginal immunisations
Measured: 13 wks
frequency of subjects mounting a serum IgG and IgA response to gp140 after a cycle of 9 vaginal immunisations
Measured: 13 wks
frequency of subjects with a T-cell response to gp140 in blood after a cycle of 9 vaginal immunisations
Measured: 13 wks
frequency of cellular responses to gp140 in cervical cells after a cycle of 9 vaginal immunisations
Measured: 13 wks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Mar 2008 (estimated)
- Study startSep 2007
- Primary completionOct 2008
- Study completionJan 2009
Why it stopped: IMP expired prior to completion of recruitment
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for HIV InfectionsStudies 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
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 23 participants (actual)
Sponsor and investigators
- Lead sponsor
- St George's, University of London
- Sponsor type
- University, hospital or other
- Collaborators
- Bill and Melinda Gates Foundation, York Hospitals
- Investigators
- David JM Lewis, MD, Principal investigator, St George's, University of London, UKCharles Lacey, MD, Principal investigator, York HospitalsDavid JM Lewis, MD, Study director, St George's, University of London, UK
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00637962
- Sponsor's protocol ID
- 2007-000781-20
- Other IDs
- 07/Q0803/29, 2007-000781-20
- Acronym
- SG06RS02
- Status last verified
- Feb 2011
- First submitted
- 11 Mar 2008
- Last updated
- 11 Feb 2011
- Results posted
- No
- Data monitoring committee
- No
Publications
Lewis DJ, Fraser CA, Mahmoud AN, Wiggins RC, Woodrow M, Cope A, Cai C, Giemza R, Jeffs SA, Manoussaka M, Cole T, Cranage MP, Shattock RJ, Lacey CJ. Phase I randomised clinical trial of an HIV-1(CN54), clade C, trimeric envelope vaccine candidate delivered vaginally. PLoS One. 2011;6(9):e25165. doi: 10.1371/journal.pone.0025165. Epub 2011 Sep 30.
PubMed 21984924
Study at a glance
From the registry record, last updated by the sponsor on 11 Feb 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase I Clinical Trial in Healthy Female Volunteers of Reactogenicity and Immunogenicity of Nine Vaginal Immunisations With HIV CN54gp140 Glycoprotein
- ClinicalTrials.gov ID
- NCT00637962
- Acronym / sponsor ID
- SG06RS02 / 2007-000781-20
- Keywords
- HIV, AIDS, Vaccine, intravaginal, mucosal, HIV Seronegativity
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: IMP expired prior to completion of recruitment
- Enrolment
- 23 participants (actual)
- Lead sponsor
- St George's, University of LondonUniversity, hospital or other
- Collaborators
- Bill and Melinda Gates Foundation, York Hospitals
- Study start
- Sep 2007
- Primary completion
- Oct 2008 (actual)
- Study completion
- Jan 2009 (actual)
- First posted
- 18 Mar 2008 (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.
To determine the local (cervico-vaginal) and systemic (whole body) safety of vaginal immunisation with CN54gp140 glycoprotein administered 9 times over a 3 week period.
Detailed description
This randomised, placebo-controlled, double-blind study will primarily assess the local and systemic safety and tolerability of CN54gp140 vaccine. We will also assess whether CN54gp140 vaccine is effective at inducing systemic and/or local specific immune responses.
Thirty healthy women volunteers will be enrolled in this study, at 2 clinical sites. Twenty will receive active CN54gp140 vaccine, and 10 will receive placebo. The placebo group will help us identify side effects caused by CN54gp140. The study is double-blind to eliminate any possibility of researcher or subject bias.
Before administration, CN54gp140 or placebo will be mixed into an aqueous gel vehicle. The treatments will be administered intravaginally in a regimen of 9 immunisations over 3 weeks. Each immunisation of CN54gp140 vaccine will contain 100 µg of CN54gp140 protein, meaning that a total dose of 900 µg will be given to subjects in the active treatment group.
Subjects will be required to make a total of 15 outpatient visits to their local clinical site, over 4 successive menstrual cycles.
Menstrual cycle 1: Screening visits There will be 2 screening visits, at about 4 and 2 weeks before the first immunisation. During these visits the volunteers will be asked questions about their health history and to give permission for us to contact their General Practitioner. Blood and urine samples will be taken for routine laboratory safety tests, and tests for HIV and hepatitis, sexual health, and pregnancy. Blood will also be collected for immunology tests to establish the pre-immunisation state of the immune system. The volunteers will also have a cervico-vaginal examination, and sampling of cervico-vaginal secretions and cells will be done for immunology tests. A photograph of the cervix will be taken to help identify any changes that might occur during the trial. Also, a full medical history and examination will be done.
The volunteers will be given a diary card to take home. They'll be asked to record in the diary any symptoms they have, and medication they take, during the course of the trial. The diaries be regularly checked by the trial staff, who will also make a symptom enquiry at each visit.
Menstrual cycle 2: Immunisation visits There will be 9 immunisation visits, on successive Mondays, Wednesdays and Fridays. The 1st of these visits will be about 7 days after the start of menses. At the 1st, 4th and 9th immunisation visits, blood and urine will be collected for routine laboratory safety and pregnancy tests, and blood collected for immunology tests. Subjects will also have a cervico-vaginal examination, and their temperature, blood pressure and heart rate measured, before self-administering the vaccine.
At the rest of the immunisation visits, subjects will self-administer the vaccine. No other procedures will be done.
Menstrual cycle 3: Sampling visits There will be 3 sampling visits, at about 9, 14 and 21 days after the start of menses. At each visit, subjects will have a cervico-vaginal examination, during which sampling of secretions and cells will be done for immunology tests. Also, blood will be collected for immunology tests, and subjects will have their temperature, blood pressure and heart rate measured. At the 1st and 3rd sampling visits only, blood and urine will be collected for routine laboratory safety tests also.
Menstrual cycle 4: End-of-study visit This visit will be about 10 days after the start of menses. Blood and urine will be collected for routine laboratory safety and pregnancy tests, tests for HIV, and immunology tests. The volunteers will also have a cervico-vaginal examination, during which sampling of secretions and cells will be done for immunology tests, and a full medical examination. A photograph of the cervix will be taken. This visit concludes the subject's participation in the study.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Active product | Experimental | Biological: HIV glycoprotein CN54gp140 (vaccine)CN54gp140 + gel |
| Gel alone | Placebo comparator | Biological: Carbopol 974Gel alone |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- They are adult female volunteers, 18 to 45 years of age, who have signed an informed consent form following a detailed written explanation of participation in the protocol.
- They are volunteers who are in good health as determined by medical history, physical examination and clinical judgement.
- They are available for the duration of the study.
- They are women who, if capable of becoming pregnant during the study, have agreed to have a pregnancy test immediately before immunisation, and to use appropriate contraception methods during the whole study period. Appropriate contraception shall include physician-prescribed oral hormonal agents, barrier contraceptives, regular and consistent use of condoms without spermicidal agents, or intrauterine devices only. Progesterone-only contraceptives are not suitable due to the lack of a regular menstrual cycle.
- They have agreed not to undertake any vaginal practices other than receptive intercourse with a male or use of sanitary tampons during menses. Use of condoms without spermicidal agents is encouraged.
Key exclusion criteria (15 listed)
- They have hypersensitivity to any component of the vaccine used in this study.
- They are found to be HIV antibody or HIV proviral DNA positive at the time of initial screening.
- They have a known or suspected history of cervico-vaginal disease, malignancy or abnormality discovered at time of screening.
- 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.
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 |
|---|---|---|
| HIV glycoprotein CN54gp140 (vaccine)Also: Previously designated ZM96gp140vaginal immunisation with 100ug CN54gp140 antigen in gel on 9 occasions in one menstrual cycle | Biological | Active product |
| Carbopol 974Also: Carbapol gelvaginal immunisation with Carbopol 974 P 0.924%; benzyl alcohol 1.09%; sodium hydroxide 0.176%; and purified water 97.81%. alone on 9 occasions in one menstrual cycle | Biological | Gel alone |
Primary outcome
To determine the local and systemic safety of vaginal immunisation with CN54gp140 glycoprotein administered 9 times over a 3 week period.
Time frame: 13 weeks
4 secondary outcomes
frequency of subjects mounting a cervico-vaginal IgA and IgG response to gp140 after a cycle of 9 vaginal immunisations
Time frame: 13 wks
frequency of subjects mounting a serum IgG and IgA response to gp140 after a cycle of 9 vaginal immunisations
Time frame: 13 wks
frequency of subjects with a T-cell response to gp140 in blood after a cycle of 9 vaginal immunisations
Time frame: 13 wks
frequency of cellular responses to gp140 in cervical cells after a cycle of 9 vaginal immunisations
Time frame: 13 wks
Results and safety
The study was stopped early (reason given: IMP expired prior to completion of recruitment). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Feb 2011.
- Derived from this study: PubMed 21984924Lewis DJ, Fraser CA, Mahmoud AN, Wiggins RC, Woodrow M, Cope A, Cai C, Giemza R, Jeffs SA, Manoussaka M, Cole T, Cranage MP, Shattock RJ, Lacey CJ. Phase I randomised clinical trial of an HIV-1(CN54), clade C, trimeric envelope vaccine candidate delivered vaginally. PLoS One. 2011;6(9):e25165. doi: 10.1371/journal.pone.0025165. Epub 2011 Sep 30.
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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.
David JM Lewis, MD principal investigator
St George's, University of London, UK
Charles Lacey, MD principal investigator
York Hospitals
David JM Lewis, MD study director
St George's, University of London, UK
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing HIV glycoprotein CN54gp140 (vaccine) and Carbopol 974 in people with HIV Infections and Acquired Immune Deficiency Syndrome, run by St George's, University of London at 2 sites 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 6 inclusion and 15 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: stopped early, as of the sponsor's last update on 11 Feb 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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 was stopped early (reason given: IMP expired prior to completion of recruitment). Results are not available in the source record.
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?
To determine the local and systemic safety of vaginal immunisation with CN54gp140 glycoprotein administered 9 times over a 3 week period. (time frame: 13 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00637962, which also lists 1 linked publication.
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 11 Feb 2011.